Department of Health and Human Services 

National Institutes of Health 

MONITORING ADHERENCE TO THE 

NIH POLICY ON THE INCLUSION 

OF WOMEN AND MINORITIES 

AS SUBJECTS IN CLINICAL RESEARCH 

 

Comprehensive Report: Tracking of Human Subjects Research 

As Reported in Fiscal Year 2006 and Fiscal Year 2007 

NIH Tracking/Inclusion Committee

Vivian W. Pinn, M.D., Co-Chair

Office of Research on Women’s Health 

Carl Roth, Ph.D., LL.M., Co-Chair

National Heart, Lung, and Blood Institute 

Angela C. Bates, M.B.A.

Office of Research on Women’s Health 

Israel Lederhendler, Ph.D.

Office of Extramural Research 

Kim Jarema

Liaison, NIH Clinical Center 

Fall 2008 

Table of Contents

Page

Historical Summary and Current Activities 

Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities 1 

as Subjects in Clinical Research 

Data Analyses and Report of NIH Inclusion Data 9 

Summary Data Tables: FY2007 and Thirteen-Year Trend Reports

NIH Wide Clinical Research Performed in FY2006 and Reported in FY2007

Table 1. Summary of NIH Clinical Research Reported in FY2007: Total Number of 

 Protocols and Enrollment by Sex and Domestic versus Foreign Protocols 19 

 

Table 2. Overview of NIH Extramural and Intramural Clinical Research Reported in FY2007: 

 Number of Sex- Specific Protocols and enrollment, and Domestic versus Foreign 

 Protocols 21 

Table 3. Summary of NIH Phase III Clinical Research Reported in FY2007: 

 Total Number of Protocols and Enrollment by Sex, and Domestic versus 

 Foreign Protocols 23 

Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported 

 in FY2007: Number of Sex-Specific Protocols and Enrollment, and Domestic 

 versus Foreign Protocols 25 

Trend Summary Reports: FY1995-2007

Table 5. Thirteen-Year Trend for Protocol and Enrollment Data 27 

Table 6. Twelve-Year Minority Trend Summary of NIH Extramural and Intramural 

 Clinical Research reported in FY1995-2007: Enrollment by Race and Ethnicity 30 

Table 7. Twelve-Year Minority Trend Summary of NIH Phase III Extramural and Intramural 33 

 Clinical Research Reported in FY1995-2007: Enrollment by Race and Ethnicity 

Domestic and Foreign Clinical Research: Trend Reports FY2002-2007

Table 8. DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural 

 Clinical Research Reported in FY2002-2007: Enrollment Using U.S. Race and 

 Ethnicity Categories 36 

Table 9. DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III 

 Clinical Research Reported in FY2002-2007: Enrollment Using U.S. Race and 

 Ethnicity Categories 38 

Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural 
 Clinical Research Reported in FY2002-2007: Enrollment Using U.S. Race and 

 Ethnicity Categories 40 

Table 11. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Phase III 

 Clinical Research Reported in FY2002-2007: Enrollment Using U.S. Race and 

 Ethnicity Categories 42 

APPENDICES

Appendix A Historical Narrative on the Implementation of the NIH Inclusion Policy ........................47 

Appendix B Explanation of Gender and Minority Codes .....................................................................58 

 

Appendix C NIH Tracking and Inclusion Committee Member List .....................................................61 

Appendix D Internet Homepage: Inclusion of Women and Minorities Policy Implementation............67 

Appendix E NIH Policy and Guidelines on the Inclusion of Women and Minorities as 

Subjects in Clinical Research - Amended, October, 2001 ................................................71 

Appendix F NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical 

Research ............................................................................................................................87 

Appendix G NIH Inclusion Tables for Target and Enrollment Data ....................................................99 

Appendix H Comparison of 1977 and 1997 OMB Classifications for Reporting Race and 

 Ethnicity ..........................................................................................................................105 

Appendix I FY2007 Aggregate Extramural and Intramural Data Tables ...........................................109 
Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research

Historical Context 

The establishment and implementation of policies for the inclusion of women and minorities in clinical 

research funded by the National Institutes of Health (NIH) has its origins in the women’s health 

movement. Following the issuance of the report of the Public Health Service Task Force on Women’s 

Health in 1985, the NIH established a policy in 1986 for the inclusion of women in clinical research. This 

policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and 

Contracts in 1987. Later that year, minority and other scientists at the NIH recognized the need to address 

the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a policy 

encouraging the inclusion of minorities in clinical studies was first published. 

In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made 

what had previously been policy into Public Law, through a section in the NIH Revitalization Act of 1993 

(PL 103-43)1

, entitled Women and Minorities as Subjects in Clinical Research. In 1994, the NIH revised 

its inclusion policy to meet this mandate that women and minorities must be included in all of its clinical 

research studies. The Revitalization Act essentially reinforced the existing NIH policies, but with four 

major differences: 

• that NIH ensure that women and minorities and their subpopulations be included in all clinical 

research; 

• that women and minorities and their subpopulations be included in Phase III clinical trials in numbers 

adequate to allow for valid analyses of differences in intervention effect; 

• that cost is not allowed as an acceptable reason for excluding these groups; and, 

• that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities 

and their subpopulations as participants in clinical studies 

Revised inclusion guidelines developed in response to this law were published in the Federal Register2

 in 

March 1994, and they became effective in September 1994. The result was that NIH could not and would 

not fund any grant, cooperative agreement or contract or support any intramural project to be conducted 

or funded in Fiscal Year 1995 and thereafter which did not comply with this policy. 

Strategies to ensure uniform implementation of the revised guidelines across the NIH were developed 

through the establishment and deliberations of an NIH Tracking and Inclusion Committee made up of 

representatives of the directors of each of the Institutes and Centers (ICs). This trans-NIH committee, 

convened by the Office of Research on Women’s Health (ORWH) and co-chaired with a senior IC 

official, meets on a regular basis, focusing on consistent and widespread adherence to the NIH guidelines 

by all the ICs. Working in collaboration with the Office of Extramural Research (OER), the Office of 

Intramural Research (OIR), and other components of the NIH, the ORWH coordinates the activity of 

developing and establishing data collection and reporting methodologies to ensure uniform standards and 

definitions in the reporting of data on women and minority participants in NIH-funded clinical research. 

To ensure NIH-wide adherence to the revised inclusion guidelines, in 1994 NIH conducted extensive 

training on the revised inclusion guidelines. In June 1994, the ORWH convened a meeting of Institutional 

Review Board (IRB) chairs to discuss their role in implementing the revised policy. Training was 

especially important in light of 1990 General Accounting Office (GAO) findings that an earlier policy 

was inconsistently applied and had not been well communicated or understood within the NIH or in the 

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research community. A variety of outreach activities were initiated to explain the revised policy to the 

scientific research community and to clear up common misunderstandings about the new requirements. 

 

GAO Report, May 2000: Recommendations and Actions Taken

Following a Congressional request for an assessment of NIH’s progress in implementing the1994 

guidelines on including women in clinical research, the GAO issued another report in May, 2000, entitled 

Women’s Health - NIH Has Increased Its Efforts to Include Women in Research.3

 It concluded that in the 

past decade, NIH has made significant progress in implementing a strengthened policy on including 

women in clinical research. 

The GAO report also included two specific recommendations to the Director of NIH to ensure the 

following: 

• that the requirement be implemented that Phase III clinical trials be designed and carried out to allow 

for the valid analysis of differences between women and men and communicate this requirement to 

applicants as well as requiring peer review groups to determine whether each proposed Phase III 

clinical trial is required to have such a study design, and that summary statements document the 

decision of the initial reviewers; and 

• that the NIH staff who transmit data to the inclusion tracking data system receive ongoing training on 

the requirements and purpose of the system. 

Immediately following the release of this report, a NIH Subcommittee Reviewing Inclusion Issues was 

formed, consisting of representatives from several ICs, ORWH, OER, and OIR, to reexamine NIH’s 

system for tracking data on the inclusion of women and minorities in clinical research, recommend any 

necessary changes to improve its accuracy and performance, and reiterate the NIH policy. Several actions 

resulted to clarify the requirement for NIH-defined Phase III clinical trials to include women and minority 

groups, if scientifically appropriate, and for analysis of sex/gender and/or racial/ethnic differences to be 

planned and conducted by investigators engaged in NIH-funded research. Significant actions in 2001 

included: 

• Updating the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects 

in Clinical Research and posting it on the ORWH home page http://orwh.od.nih.gov/inclusion.html 

and NIH web page, Inclusion of Women and Minorities Policy Implementation at: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm. 

• Developing a new term and condition of award statement for awards made after October 1, 2000 

that have NIH-defined Phase III clinical trials. 

• Incorporating language in the NIH solicitations for grant applications and contract proposals to 

clarify the submission requirement for NIH-defined Phase III clinical trials, a description of 

plans for sex/gender and/or race/ethnicity analysis including subgroups, if applicable, and reporting 

accrual annually and results of analyses, as appropriate. 

• Guidelines and instructions for reviewers and Scientific Review Officers (SROs) were 

developed to emphasize and clarify the need to review research proposals that are classified as NIHdefined Phase III clinical trials for both inclusion requirements and issues related to analyses by 

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sex/gender and/or race/ethnicity. Instructions were developed for the proper documentation to 

include in summary statements to address adherence to these policies. 

Training to ensure compliance with this policy was provided to NIH program and review officials, grants 

and contracts management staff, and current and prospective research investigators. Several initiatives 

were implemented for review, grants management and program staff since 2000, including specific topics 

addressing revisions to the NIH Inclusion policy, a grants policy update and Scientific Review Officer 

(SRO) orientation on specific issues related to review meetings and proceedings. 

Format Changes for Reporting Race and Ethnicity Data as of FY2002

Beginning in FY2002, NIH changed how data are reported based on the 1997 Office of Management and 

Budget (OMB) Directive 15 minimum standards for maintaining, collecting and reporting data on race 

and ethnicity. Implementation of the 1997 OMB standards involved a number of changes including 

collecting and reporting information on race and ethnicity separately, whereas the 1977 OMB standards 

used a combined race and ethnicity format. NIH aggregate population data tables describe data using both 

the 1997 and 1977 OMB standards for reporting data on race and ethnicity. Since 2002, the number of 

studies reporting data using the 1997 format (NEW FORM) has steadily increased, while the number of 

studies using the 1977 format (OLD FORM) has steadily decreased as the studies funded prior to FY2002 

are completed. 

The 1997 OMB reporting format (NEW FORM) and standards does not allow direct comparison of ethnic 

and racial data with similar data collected under the 1977 OMB reporting format (OLD FORM) and 

standards because the categories and methods for collecting the data are fundamentally different. 

Changes in the standardization of definitions and business rules across the NIH for improving the data 

entered in the population tracking system are reflected in data reported beginning in FY2002. While 

implementation of these changes will improve the consistency and comparability for future reporting, 

comparisons with prior FY 2002 data are difficult. 

As demonstrated below, the primary differences are: (1) the Hispanic population is considered an ethnic 

category and reported separately from racial data; (2) there is a separate racial category for Asian 

population data and Hawaiian and Pacific Islander population data; and 3) respondents are given the 

option of selecting more than one race. (See Appendix H) 

Race and ethnicity data from the OLD and NEW Forms are combined differently as described below for 

purposes of reporting on the minority population enrolled in NIH clinical research: 

• the OLD FORM uses the 1977 OMB combined Race and Ethnicity Format, which has mutually 

exclusive categories, and allows Hispanics to be reported as either "Hispanic, Not White" or "White". 

• the NEW FORM uses the 1997 OMB Race and Ethnicity Categories, with separate reporting for 

Ethnicity (Hispanic or Latino; Not Hispanic or Latino) and Race (Part A); in this format, an 

individual is classified both by Ethnic Category and by Race Category. Part B of the NEW FORM 

therefore provides a distribution of only "Hispanics or Latinos" by the five main Race categories. 

Since minority categories are defined to include both "Hispanic or Latino ethnicity" and non-white 

racial categories when providing summary totals of minorities, it is necessary to add White 

Hispanics" and "Unknown/Other Hispanics" based on their ethnicity to the non-white racial 

categories. 

• Hispanics are defined by country of origin, and may be identified as belonging to any one, or more 

than one, race category. 

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OLD FORM (1977) versus NEW FORM (1997) 

Race/Ethnicity Category Minority Total Minority Total 

 Old Form New Form 

OLD FORM: Combined 1977 OMB Race/Ethnicity Categories 

 

American Indian/Alaska Native X 

Asian/Pacific Islander X 

Black or African American X 

Hispanic, Not White X 

White 

Unknown/Other 

NEW FORM: Separate 1997 OMB Race/Ethnicity Categories 

Part A: Total Enrollment Report 

Ethnic Category 

 Hispanic or Latino** 

 Not Hispanic or Latino 

 Unknown (ethnicity not reported) 

 Ethnic Category Total of All Subjects* 

 

Racial Categories 

American Indian/Alaska Native X 

Asian X 

Black or African American X 

Hawaiian/Pacific Islander X 

White 

More Than One Race X 

Unknown/Other 

 Racial Categories: Total of all Subjects* 

 

Part B: Hispanic Enrollment by RACE 

American Indian/Alaska Native 

Asian 

Black or African American 

Hawaiian/Pacific Islander 

White (Hispanic) X 

More Than One Race 

Unknown/Other (Hispanic) X 

 

Racial Categories: Total of Hispanics or 

Latinos** 

* The "Ethnic Category Total of All Subjects" must be equal to the "Racial Categories: Total of All Subjects"

** The "Hispanic or Latino"(Part A) must be equal to "Racial Categories: Total of Hispanics or Latinos"(Part B).

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Continuing Implementation and Monitoring Activities 

In FY2007, two training sessions were developed and sponsored by the Office of Extramural Research.

The half-day training sessions were held in April and September in the Natcher Conference Center, 

Bethesda, MD and webcast throughout the NIH community. While some staff participated in the training 

via the web, approximately 300 grants management, program and review staff physically attended each 

session. Participants received a certificate of completion and if appropriate extramural scientist 

administrator (ESA) credits after completing a short test. The Office of Extramural Research (OER) has 

made available training materials on the Population tracking system website through the NIH Intranet.

The training subcommittee of the full NIH Tracking and Inclusion committee has developed new training 

documents and methods of training for NIH staff and the extramural research community. Further 

information regarding training initiatives since the 2000 GAO report is discussed in the background 

section of the Appendices (See Appendix A).

The PHS 398 Grant Application was significantly revised to provide additional instructions about the 

Women and Minorities Inclusion Policy and the revised form became mandatory as of May 10, 2005. 

These PHS 398 instructions about the Women and Minorities Inclusion Policy have also been included in 

the new federal application form SF-424 (R&R) for NIH grants using the federal Grants.gov system (see 

http://era.nih.gov/ElectronicReceipt/). The application instructions included two significant changes in 

definitions. First, the NIH required use of a revised definition of clinical research that was reported in the 

1997 Report of the NIH Director’s Panel on Clinical research and adopted by NIH. Secondly, the Office 

of Management and Budget (OMB) Directive 15, “Race and Ethnic Standards for Federal Statistics and 

Administrative Reporting”, revised the definitions for the racial and ethnic categories to be used when 

reporting population data (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html). In 

addition, NIH policy reemphasized that that NIH-defined Phase III clinical trials must be designed and 

conducted in a manner to allow for a valid analysis of whether the variables being studied affect women 

or members of minority groups differently than other subjects. 

Communication and Outreach Efforts to the Scientific Community 

NIH staff provides outreach to the scientific community to help increase understanding of the revised 

inclusion policy and OMB requirements. These training and outreach efforts are designed to improve 

understanding of the sex/gender and minority inclusion policy and assist investigators and NIH staff to 

appropriately address these issues throughout the research grant and contract process. Investigators are 

instructed to address women and minority inclusion issues in the development of their applications and 

proposals for clinical research. 

Reference documents such as the Outreach Notebook for the NIH Guidelines on Inclusion of Women and 

Minorities as Subjects in Clinical Research (http://orwh.od.nih.gov/inclusion/outreach.pdf) and the 

Frequently Asked Questions (FAQs) for the Inclusion , Recruitment and Retention of Women and 

Minority Subjects in Clinical Research (http://orwh.od.nih.gov/inclusion/outreachFAQ.pdf) have been 

published and distributed for investigators and NIH staff. These publications discuss the elements of 

recruitment and retention, the NIH inclusion policy, 1997 OMB requirements for reporting race and 

ethnicity data, as well as information for application submission, peer review, and funding. Both are 

posted on the ORWH website http://orwh.od.nih.gov as well as on the NIH website for the inclusion of 

women and minorities policy implementation at: http://grants1.nih.gov/grants/funding/women_min/women_min.htm. 

The revised Outreach Notebook and FAQs continue to be available to the research community to further 

explore the inclusion policy and its intent. Additionally, a slide show available electronically and in hard 

copy, “Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need to Know!” 

was developed for NIH staff to assist them in working with the extramural community. 

5
Monitoring Compliance: Extramural and Intramural Population Data Analysis 

As a way of monitoring compliance with the policy, we have provided the aggregate data tables compiled 

from each NIH Institute and Center. Analysis of aggregate NIH data on inclusion for FY2006 and 

FY2007 document that substantial numbers of women and men, especially non-minority men, and 

minorities have been included as research subjects in NIH-defined Phase III clinical trials and other 

human subject research studies during these fiscal years. Because the data included in the tables are 

aggregate data from across NIH, it does provide documentation of the tracking and inclusion across the 

NIH, and some degree of analysis of the data. But caution should be utilized in not over-interpreting the 

figures that are provided. The NIH Tracking and Inclusion committee has provided for the reader’s 

interest, conclusions that can be reasonably drawn from the data. 

When assessing inclusion data, enrollment figures should not be directly compared to the national 

census figures. The goal of the NIH policy is not to satisfy any quotas for proportional representation, 

but rather to conduct biomedical and behavioral research in such a manner that the scientific knowledge 

acquired will be generalizable to the entire population of the United States. The numbers of women or 

minority subgroups included in a particular study depends upon the scientific question addressed in the 

study and the prevalence among women and minority subpopulations of the disease, disorder, or 

condition under investigation. 

Scientific Review Groups are instructed to focus on scientific considerations when assessing the planned 

enrollment for a particular study. The Scientific Review Group (SRG) determines if the implementation 

plan for an application is unacceptable if it: 1) fails to provide sufficient information about target 

enrollment; 2) does not adequately justify limited or lack of inclusion of women or minorities; or 3) does 

not realistically address recruitment and retention. For NIH-defined Phase III clinical trials, the Scientific 

Review Group (SRG) also evaluates the description of plans to conduct analyses, as appropriate, to 

address differences in the intervention effect by sex/gender and/or racial/ethnic groups. Applications with 

unacceptable inclusion plans cannot be funded until NIH staff is assured that revised inclusion plans from 

the investigators meet the inclusion policy requirements. Research awards covered by this policy require 

the grantee to report annually on enrollment of women and men, and on the race and ethnicity of research 

participants so that accrual can be monitored. 

NIH has monitored aggregate demographic data for study populations through the evolving NIH 

computerized tracking system since fiscal year 1994, and tracking the inclusion of women and minorities 

in clinical studies is well established in all ICs. Members of the NIH Tracking and Inclusion Committee 

continuously work on ways to refine and improve data collection methods and the quality of the data 

entered by each IC into this system. In May 2002, the NIH successfully deployed a new population 

tracking system for monitoring the inclusion of women and minorities in clinical research. This system 

provides easier data entry and project monitoring of investigator data reporting for NIH staff. An eRA 

Population Tracking User Group consisting of representatives from several ICs provides continuous 

feedback related to system use. 

The aggregate data enable the NIH to monitor inclusion in order to formulate more specific questions 

about gaps in enrollment and to design studies to respond to those questions. Data compiled allows for 

longitudinal examination of trends and continued monitoring of compliance, although this will be more 

difficult for minority trends because of a change in how these data are collected (see next section). 

A review of intramural inclusion data indicates that the intramural research program continues to be 

compliant with the reporting requirements adhered to by the extramural community and outlined in the 

NIH Implementation Guidelines on the Inclusion of Women and Minority Subjects in Research Studies. 

6
The Clinical Center Medical Executive Committee (MEC) has taken a leading role in assuring that 

investigators conducting clinical research protocols in the Clinical Center are trained and competent in the 

conduct of clinical research. The MEC designed and endorsed the Standards for Clinical Research within 

the NIH Intramural Research Program which set forth guidelines for the infrastructure, training, 

education, and monitoring required for safe and effective conduct of clinical research. 

DEFINITIONS: 

Clinical Research as defined by the 1997 Report of the NIH Director’s Panel on Clinical Research, 

http://www.nih.gov/news/crp/97report/execsum.htm

(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin 

such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly 

interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues 

that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human 

disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; 

(2) Epidemiologic and behavioral studies; and 

(3) Outcomes research and health services research 

NIH-Defined Phase III Clinical Study 

For the purpose of these guidelines, an NIH-defined "clinical trial" is a broadly based prospective Phase 

III clinical investigation, usually involving several hundred or more human subjects, for the purpose of 

evaluating an experimental intervention in comparison with a standard or control intervention or 

comparing two or more existing treatments. Often the aim of such investigation is to provide evidence 

leading to a scientific basis for consideration of a change in health policy or standard of care. The 

definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease 

prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention 

trials are also included. 

Valid Analysis 

The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the 

correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and 

should be conducted for both small and large studies. A valid analysis does not need to have a high 

statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of 

the question of interest are: 

• allocation of study participants of both sexes/genders (males and females) and different racial/ethnic 

groups to the intervention and control groups by an unbiased process such as randomization, 

• unbiased evaluation of the outcome(s) of study participants, and 

• use of unbiased statistical analyses and proper methods of inference to estimate and compare the 

intervention effects among the sex/gender and racial/ethnic groups. 

Significant Difference 

For purposes of this policy, a "significant difference" is a difference that is of clinical or public health 

importance, based on substantial scientific data. This definition differs from the commonly used 

"statistically significant difference," which refers to the event that, for a given set of data, the statistical 

test for a difference between the effects in two groups achieves statistical significance. Statistical 

significance depends upon the amount of information in the data set. With a very large amount of 

information, one could find a statistically significant, but clinically small difference that is of very little 

clinical importance. Conversely, with less information one could find a large difference of potential 

importance that is not statistically significant. 

Domestic organization 

7
A public (including a State or other governmental agency) or private non-profit or for-profit organization 

that is located in the United States or its territories, is subject to U.S. laws, and assumes legal and 

financial accountability for awarded funds and for the performance of the grant-supported activities 

Foreign institution 

An organization located in a country other than the United States and its territories that is subject to the 

laws of that country, regardless of the citizenship of the proposed PI. 

CONCLUSION AND CURRENT STATUS 

NIH staff continues to monitor, document, and work with grantees and contractors to ensure compliance 

with the inclusion policy. Program Officials provide technical assistance to investigators as they develop 

their applications and proposals throughout the application process. Review Officials introduce and 

discuss with reviewers the Guidelines/Instructions for reviewing the Inclusion of Women and Minorities 

in Clinical Research as well as the instructions and requirements for designing Phase III Clinical Trials in 

order that valid analyses can be conducted for sex/gender and ethnic/racial differences. At the time of 

award and submission of progress reports, program officials monitor and verify that inclusion policy 

requirements are met. When new and competing continuation applications that are selected for payment 

are deficient in meeting policy requirements, grants management staff and program officials are required 

to withhold funding until the principal investigator has satisfactorily addressed the policy requirements. 

References

1. Public Law 103-43. National Institutes of Health Revitalization Act of 1993. 42 USC 289 (a)(1). 

2. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 59 

Fed. Reg. 14508-14513 (1994). 

3. Women’s Health: NIH Has Increased Its Efforts to Include Women in Research (GAO/HEHS-00-

96, May, 2000). 

4. NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical 

Research, NIH Guide for Grants and Contracts, Amended 2001. 

For Additional Information on the implementation of the inclusion policy, please visit: 

NIH Office of Extramural Research Inclusion of Women and Minorities Policy Implementation Website: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm 

Revitalization Act of 1993, 42 USC 289 (a)(1): http://grants.nih.gov/grants/guide/notice-files/not94-100.html 

NIH Policy on Reporting Racial and Ethnicity Data: Subjects in Clinical Research, NIH Guide for Grants and 

Contracts Web page: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html 

Office of Research on Women’s Health Website: http://orwh.od.nih.gov/inclusion.html 

8
Aggregate Enrollment Data Tables 

For Extramural and Intramural 

Research Protocols 

Fiscal Year 2007 Summary Reports 

Thirteen -year Trend Summary Reports 

9
10
Summary Report of NIH Inclusion Data

NIH AGGREGATE POPULATION DATA REPORTED IN FY2006 and FY2007 

The following section is provided in order to guide consideration of the data especially in trend of human 

subjects participation in NIH-funded extramural and intramural clinical research. Because new studies are 

added each year and other studies are ending, it is not appropriate to compare data over time or to 

compare data with census population data. Looking at the trend data represents the best interpretation of 

the aggregate data. Data on inclusion is tabulated from human subject populations in NIH-defined Phase 

III clinical trials and other human subject research studies. NIH clinical research studies are determined in 

accordance with the NIH definition of clinical research to include, for example, non-intervention clinical 

research, clinical trials, epidemiologic studies, behavioral studies, and database studies. 

Analysis of aggregate NIH data on inclusion for FY2006 and FY2007 document that substantial numbers 

of women and men, especially non-minority men, and minorities have been included as research subjects 

in NIH-defined Phase III clinical trials and other human subject research studies during these fiscal years. 

Because the data included in the tables are aggregate data from across NIH, it does provide 

documentation of the tracking and inclusion across the NIH, and some degree of analysis of the data. But 

caution should be utilized in not over-interpreting the figures that are provided. The NIH Tracking and 

Inclusion committee has provided for the reader’s interest, conclusions that can be reasonably drawn from 

the data. 

Previous inclusion reports and aggregate enrollment figures for women, men and minority groups for 

FY1994 to the present can be found on the ORWH website at http://orwh.od.nih.gov/inclusion.html. The 

FY2006 and FY2007 data tables may vary slightly or differ from prior reported summary data in an effort 

to better clarify reporting. 

NIH CLINICAL RESEARCH: Fiscal Years 2006 and 2007 

In FY2006 there were 15,320 extramural and intramural clinical research protocols, including Phase III 

and other clinical studies, of which 10,758 protocols reported human subject participation as noted in this 

report’s trend summary tables. Of these, 95.7% were domestic protocols and 4.3% were foreign protocols. 

Approximately 14.8 million participants were enrolled in extramural and intramural research protocols of 

which 77.0% were domestic participants and 23.0% were foreign participants. Of the 14.8 million 

participants, 63.9% were women, 34.9% were men and 1.3% did not provide sex identification. Further, 

43.1% of the total participants, and 28.9% of the Domestic-only participants, were reported as minorities 

following the OMB categories for race and ethnicity. (Table 6) 

Correspondingly, in FY2007 there were 15,567 extramural and intramural clinical research protocols, 

including Phase III and other clinical studies, of which 10,914 protocols reported human subject 

participation as noted in this report’s trend summary tables. Of these, 95.9% were domestic protocols and 

4.1% were foreign protocols. Approximately 17.4 million participants were enrolled in extramural and 

intramural research protocols of which 92.6% were domestic participants and 7.4% were foreign 

participants. Of the 17.4 million participants, 58.2% were women, 39.5% were men and 2.3% did not 

provide sex identification. Further, 29.9% of the total participants, and 26.5% of the Domestic-only 

participants, were reported as minorities following the OMB categories for race and ethnicity. (Table 1) 

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While the number of participants in all extramural and intramural clinical research increased (14.8M in 

FY2006 and 17.4M in FY2007), there was no significant change in the ratio of women and men (63.9%F 

and 34.9%M in FY2006; and 58.2%F and 39.5%M in FY2007). 

NIH Defined Phase III Clinical Research: FY2006 and FY2007

In FY2006 there were 760 extramural and intramural Phase III clinical research protocols, of which 624 

protocols reported human subject participation as noted in this report’s trend summary tables. Of these, 

90.4% were domestic protocols and 9.6% were foreign protocols. Approximately 499,430 participants 

were enrolled in extramural and intramural Phase III research protocols of which 80.2% were domestic 

participants and 19.8% were foreign participants. Of the 499,430 participants, 62.9% were women, 36.0% 

were men and 1.1% did not provide sex identification. Further, 33.5% of the total participants, and 20.7% 

of Domestic-only participants, in Phase III clinical research were reported as minorities following the 

OMB categories for race and ethnicity. (Table 3) 

According to the trend summaries in this report, of the 215 extramural and intramural Phase III research 

protocols that report following the 1977 OMB standards in FY2006, minority representation was highest 

for Blacks (not Hispanic) at 8.9% and lowest for American Indian/Alaska Natives at 0.4%. Hispanics 

represented approximately 4.1%, Asian/Pacific Islanders were 7.3% and Whites (not Hispanic) 76.5% of 

the participants. The categories Hawaiian/Pacific Islander and More Than One Race were not 

designations with the 1977 OMB standards. (Table 7) 

Moreover, in FY 2006, there were 409 extramural and intramural Phase III research protocols reporting 

data following the current 1997 OMB standards for reporting by both race and ethnicity. Accordingly, 

minority representation by race was highest for Blacks at 18.8% and lowest for Hawaiian/Pacific 

Islanders 0.2%. Asians represented 12.0%, American Indian/Alaska Natives 1.7% and Whites 47.0% of 

participants. Participants identifying as More Than One Race were 1.6% of the total number of 

participants. In addition, 18.7% did not identify a race category. Of the 409 extramural and intramural 

Phase III research protocols designating an ethnicity in FY2006, 75.0 % of total participants identified as 

“Not Hispanic”, 11.5 % of the total participants identified as “Hispanic or Latino”, and 13.5% of the total 

participants did not identify an ethnicity category. The racial distribution of the “Hispanic or Latino” 

participants is also provided separately. (Table 7) 

Correspondingly, in FY2007 there were 766 extramural and intramural Phase III clinical research 

protocols, of which 621 protocols reported human subject participation as noted in this report’s trend 

summary tables. Of these, 92.9% were domestic protocols and 7.1% were foreign protocols. 

Approximately 591,159 participants were enrolled in extramural and intramural Phase III research 

protocols of which 70.3% were domestic participants and 29.7% were foreign participants. Of the 

591,159 participants, 54.9% were women, 42.2% were men and 2.8% did not provide sex identification. 

Further, 41.4% of the total participants, and 20.6% of Domestic-only participants, in Phase III clinical 

research were reported as minorities following the OMB categories for race and ethnicity. (Table 3) 

According to the trend summaries in this report, of the 197 extramural and intramural Phase III research 

protocols that report following the 1977 OMB standards in FY2007, minority representation was highest 

for Blacks (not Hispanic) at 10.3% and lowest for American Indian/Alaska Natives at 0.4%. Hispanics 

represented approximately 4.5%, Asian/Pacific Islanders were 1.9% and Whites (not Hispanic) 81% of 

the participants. The categories Hawaiian/Pacific Islander and More Than One Race were not 

designations with the 1977 OMB standards. (Table 7) 

Moreover, in FY 2007, there were 424 extramural and intramural Phase III research protocols reporting 

data following the current 1997 OMB standards for reporting by both race and ethnicity. Accordingly, 

minority representation by race was highest for Blacks at 22.1% and lowest for Hawaiian/Pacific 

12
Islanders 0.1%. Asians represented 12.4%, American Indian/Alaska Natives 2.5% and Whites 34.9% of 

participants. Participants identifying as More Than One Race were 1.1% of the total number of 

participants. In addition, 26.9% did not identify a race category. Of the 424 extramural and intramural 

Phase III research protocols designating an ethnicity in FY2007, 66.8 % of total participants identified as 

“Not Hispanic”, 18.8 % of the total participants identified as “Hispanic or Latino”, and 14.5% of the total 

participants did not identify an ethnicity category. The racial distribution of the “Hispanic or Latino” 

participants is also provided separately. (Table 7) 

While the number of participants in Phase III extramural and intramural clinical research slightly 

increased (499,430 in FY2006 and 591,159 in FY2007), there was an increase in the ratio of women and 

men (62.9%F and 36.0%M in FY2006 and 54.9%F and 42.2% in FY2007). 

The following sections provide data on extramural research and intramural research separately. 

EXTRAMURAL CLINICAL RESEARCH: Fiscal Years 2006 and 2007 

In FY2006, there were 13,522 extramural clinical research protocols, including Phase III and other 

clinical studies, of which 9,235 protocols reported human subject participation. Of these, 95.7% were 

domestic protocols and 4.3% were foreign protocols. Approximately 13.02 million participants were 

enrolled in extramural research protocols of which 76.6% of the total enrollment is domestic participants 

and 23.4% of the total enrollment is foreign participants. Of the 13.02 million participants, 65% were 

women, 33.8% were men and 1.2% did not provide sex identification. Further, 45.9% of the total 

participants were reported as minorities following the OMB categories for race and ethnicity. (See 2006 

Report, Table 2 and Appendix table 3A) 

Correspondingly, in FY2007, there were 13,719 extramural clinical research protocols, including Phase 

III and other clinical studies, of which 9,362 protocols reported human subject participation. Of these, 

95.9% were domestic protocols and 4.2% were foreign protocols. Approximately 13.9 million participants 

were enrolled in extramural research protocols of which 92.8% of the total enrollment is domestic 

participants and 7.2% (from 23.4%) of the total enrollment is foreign participants. Of the 13.9 million 

participants, 61.8% were women, 35.5% were men and 2.62% did not provide sex identification. Further, 

31.4% of the total participants were reported as minorities following the OMB categories for race and 

ethnicity. (Table 2 and Appendix Table 3A) 

While the number of participants in all extramural clinical research increased (13.02 million in FY2006 

and 13.9 million in FY2007), there was no significant change in the ratio of women and men (65%F and 

34%M in FY206 and 61.8%F and 35.5%M). ). However, when sex-specific studies were excluded, the 

proportions of women and men in all extramural clinical research were proportional to the percentages of 

the general population. (46.5% F and 49.8 % M). 

NIH Defined Phase III Extramural Clinical Research: FY2006 and FY2007

In FY2006 there were 707 extramural Phase III clinical research protocols, of which 580 protocols 

reported human subject participation as noted in this report’s trend summary tables. Approximately 

467,954 participants were enrolled in extramural Phase III research protocols of which 63.5% were 

women, 35.4% were men and 1% did not provide sex identification. (See 2007 Report) 

In FY2007 there were 710 extramural Phase III clinical research protocols, of which 616 protocols 

reported human subject participation as noted in this report’s trend summary tables. Approximately 

547,687 participants were enrolled in extramural Phase III research protocols of which 61.8% were 

women, 35.5% were men and 2..62% did not provide sex identification. (Table 4 and Appendix Table 5A) 

13
According to trend summaries in the 2007 report, in FY2006, there were 382 extramural Phase III 

research protocols reporting data following the current 1977 OMB standards for reporting race and 

ethnicity. Accordingly, minority representation by race was highest for Blacks at 19.7% and lowest for 

Hawaiian/Pacific Islanders 0.2%. Asians represented 12.67%, American Indian/Alaska Natives 1.8% and 

Whites 46.32% of participants. Participants identifying as More Than One Race were 15% of the total 

number of participants. In addition, 17.8 % did not identify a race category. Of the 382 extramural Phase 

III research protocols designating an ethnicity in FY 2006, 75.8 % of total participants identified as “Not 

Hispanic”, 11.14 % of the total participants identified as “Hispanic or Latino”, and 13.1 % of the total 

participants did not identify an ethnicity category. The racial distribution of the “Hispanic or Latino” 

participants is also provided separately. 

Correspondingly in FY2007, there were 399 extramural Phase III research protocols reporting data 

following the 1997 OMB standards for reporting race and ethnicity. Minority representation by race was 

highest for Blacks at 23.2% and lowest for Hawaiian/Pacific Islanders 0.13%. Asians represented 13.1%, 

American Indian/Alaska Natives 2.59% and Whites 34.3% of participants. Participants identifying as 

More Than One Race were 1.02% of the total number of participants. In addition, 25.7 % did not identify 

a race category. Of the 399 extramural Phase III research protocols designating an ethnicity in FY 2007, 

67.7 % of total participants identified as “Not Hispanic”, 17.7% of the total participants identified as 

“Hispanic or Latino”, and 14.4 % of the total participants did not identify an ethnicity category. The racial 

distribution of the “Hispanic or Latino” participants is also provided separately. (See 2007 Report, Table 

4 and Appendix Table 5A) 

While the number of participants in extramural Phase III extramural clinical research protocols slightly 

increased (707 in FY2006 and 710 in FY2007), there was an increase in the ratio of women and men 

(63.9%F and 3.4%M in FY2006 and 55.1 %F and 41.8% M in FY2007). 

INTRAMURAL CLINICAL RESEARCH: Fiscal Years 2006 and 2007 

Substantial numbers of women and minorities were included in NIH intramural studies in FY 2006 and 

FY2007. 

In FY2006 there were 1,798 intramural clinical research protocols, including Phase III and other clinical 

studies, of which 1,523 protocols reported human subject participation. Approximately 1.8 million 

participants were enrolled in intramural research protocols of which 55.4% were women, 43.0% were 

men and 1.6% did not provide sex identification. (See Table 2 and Appendix Table 7A) 

In FY 2006, approximately 1.8 million participants were reported in all intramural research including 

Phase III clinical trials, and other clinical studies. Of the 590 intramural research protocols that report data 

following the 1977 OMB standards, minority representation was highest for Asian/Pacific Islanders at 

19.9% and lowest for American Indian/Alaska Natives at 3.3%. Blacks (not-Hispanic) represented 7.2%, 

Hispanics 3.5%; and Whites (not Hispanic) 62.0% of the intramural research study population. The 

categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 

OMB standards. (See Appendix Table 7A) 

For 933 intramural clinical research studies that reported data following the current 1997 OMB standards 

in FY 2006, the largest racial minority group was Asian at 8.6 % and the smallest racial minority group 

was Hawaiian/Pacific Islanders at 0.07%. Blacks represented 5.0%, American Indian/Alaska Natives 

0.4% and Whites 79.1% of participants in all intramural clinical research. Approximately 0.8% of 

participants reported More Than One Race as their racial category. In addition, 6.0 % did not identify a 

race category. Of the 933 intramural research protocols following the current 1997 OMB standards 

14
designating an ethnicity in FY2006, 91.3 % of total participants identified as “Not Hispanic”, 4.1 % of the 

total participants identified as “Hispanic or Latino”, and 4.6 % of the total participants did not identify an 

ethnicity category. The racial distribution of the “Hispanic or Latino” participants is also provided 

separately. (See Appendix Table 7A) 

 (See 2006 Report, Table 2 and Appendix Table 7A) 

Correspondingly, in FY2007 there were 1,848 intramural clinical research protocols, including Phase III 

and other clinical studies, of which 1,552 protocols reported human subject participation. Approximately 

3.5 million participants were enrolled in intramural research protocols of which 43.4% were women, 

55.4% were men and 1.2% did not provide sex identification. (See Table 2 and Appendix Table 7A) 

In FY 2007, approximately 3.5 million participants were reported in all intramural research including 

Phase III clinical trials, and other clinical studies. Of the 449 intramural research protocols that report data 

following the 1977 OMB standards, minority representation was highest for Blacks (not-Hispanic) at 

17.59% and lowest for American Indian/Alaska Natives at 0.17%. Asian/Pacific Islanders represented 

3.65%, Hispanics 4.3%; and Whites (not Hispanic) 73.16% of the intramural research study population. 

The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 

OMB standards. (See Appendix Table 7A) 

For 1,103 intramural clinical research studies that reported data following the current 1997 OMB 

standards in FY 2007, the largest racial minority group was Blacks at 9.72 % and the smallest racial 

minority group was Hawaiian/Pacific Islanders at 0.16%. Asian represented 7.66%, American 

Indian/Alaska Natives 0.89% and Whites 69.8% of participants in all intramural clinical research. 

Approximately 0.56% of participants reported More Than One Race as their racial category. In addition, 

11.16 % did not identify a race category. Of the 1,103 intramural research protocols following the current 

1997 OMB standards designating an ethnicity in FY2007, 85.5 % of total participants identified as “Not 

Hispanic”, 4.19 % of the total participants identified as “Hispanic or Latino”, and 10.3 % of the total 

participants did not identify an ethnicity category. The racial distribution of the “Hispanic or Latino” 

participants is also provided separately. (See Appendix Table 7A) 

There was a decrease in female participants from 55.0% to 43% and a corresponding increase in male 

participants from 43% to 55%. The number of participants in all intramural clinical research significantly 

increased from 1.8M to 3.4M from FY2006 to FY2007. 

NIH Defined Phase III Intramural Clinical Research: FY2006 and FY2007

In FY2006 there were 53 intramural Phase III clinical research protocols, of which 44 protocols reported 

human subject participation. Of these, 6.3% of the total number of protocols is domestic and 0.7% of the 

total number of protocols is foreign. Approximately 31,476 participants were enrolled in intramural Phase 

III research protocols of which 2.34% of the total enrollment is domestic participants and 3.5% are 

foreign participants. Of the 31,476 participants, 54% were women, 46% were men and 0% did not 

provide sex identification. Further, 54% of total participants in Phase III clinical research protocols were 

reported as minorities following the OMB categories for race and ethnicity. 

 (See 2007 Report, Table 4 and Appendix Table 9A) 

Correspondingly, in FY2007 there were 38 intramural Phase III clinical research protocols, of which 36 

protocols reported human subject participation. Of these, 4.5% of the total number of protocols is 

domestic and 0.5% of the total number of protocols is foreign. Approximately 43,472 participants were 

enrolled in intramural Phase III research protocols of which 5.67% of the total enrollment is domestic 

participants and 1.7% are foreign participants. Of the 43,472 participants, 52.8% were women, 47.2% 

were men and 0% did not provide sex identification. Further, 27.3% of total participants in Phase III 

15
clinical research protocols were reported as minorities following the OMB categories for race and 

ethnicity. (Table 4 and Appendix Table 9A) 

There was a small decrease in women (54.7% to 52.8%) and corresponding increase in men (46.0% to 

47%). The number of participants in Phase III intramural clinical research increased from 31,476 to 

43,472 in FY2006 and FY2007. 

16
TREND REPORT ON NIH AGGREGATE POPULATION DATA: FY1995 – FY2007 

The following section provides trend data on the collection and reporting of human subject participation 

in NIH funded clinical research, including Phase III clinical studies. The data are also provided in terms 

of foreign and domestic participation and minority representation. Trend data vary over time because the 

data for each year represent the net total of data resulting from: (1) studies continuing from the prior year; 

(2) the addition of new studies reported; and (3) the subtraction of studies that are no longer reported. 

Table 5 is a thirteen year summary report showing a steady increase in the number of protocols and 

enrollment. The number of protocols with enrollment increased from 3,188 in FY1995 to 10,914 in 

FY2007 – a 3.4 fold increase. Reported enrollment increased from approximately 1.0 million (FY1995) to 

17.1 million (FY2007) – a 17.1 fold increase; minority enrollment increased from approximately 0.4 

million (FY2002) to 5.2 million (FY2007) – a 13.9 increase in minority representation in NIH clinical 

research. Over the last six years, the total number of protocols reported with enrollment data has leveled 

off at about 10,000 protocols per year. 

With the deployment of an updated population tracking system in 2002 and the OMB requirement to 

report data using a new format, NIH was able to report domestic and foreign data in a better way. Thus, 

trend data are available for domestic and foreign protocols and participation beginning in FY2002. 

Domestic enrollment increased from 10.2 million (FY2002) to 16.2 million (FY2007) – a 1.6 fold 

increase. Foreign enrollment increased from 0.9 million (FY2002) to 1.2 million (FY2007) – a 1.3 fold 

increase. Overall, the total enrollment has increased with domestic participation averaging between 75.9-

92.7% and foreign participation averaging between 8.5-24.1%. In FY2007, domestic and foreign 

enrollment was 92.7% and 7.3% respectively. 

Table 6 is a summary report of all extramural and intramural clinical research by sex/gender and minority 

representation following the old and new data formats for domestic and foreign studies. The report 

demonstrates that female participation in all extramural and intramural research generally averaged 

between 51.7% and 63.9%, male participation in all extramural and intramural research averaged between 

34.0% and 45%. Overall minority participation in all extramural and intramural clinical research averaged 

between 30% and 43%. Table 6E provides a comparison of domestic and foreign participation between 

FY2002 and FY2007. The vast majority of protocols are domestic (~94%-96%) of the total clinical 

research protocols. While the number of foreign protocols has increased, they incorporate only about 4%-

6% of the total clinical research protocols with enrollment. Table 6F shows domestic and foreign 

enrollment for the six-year period. Domestic minority enrollment varied between 24% and 29.1% of total 

domestic participation, while foreign minority enrollment varied between 73.6% and 90.9% of total 

foreign participation. 

Table 7 is a summary report of NIH-funded Phase III extramural and intramural clinical research by 

sex/gender and minority representation following the old and new data reporting formats for domestic and 

foreign studies. The report demonstrates that female participation in NIH funded Phase III extramural and 

intramural clinical research generally averaged between 54.1% and 74.8% and male participation in NIHfunded Phase III extramural and intramural clinical research averaged between 24.3% and 44.6%. Overall 

minority participation in NIH-funded Phase III extramural and intramural clinical research increased from 

22.5% to 41.4%. Table 7E provides a comparison of domestic and foreign participation between FY2002 

and FY2007. The vast majority of protocols are domestic ranging from 75.5% and 95.8% of the total 

clinical research protocols. While the number of foreign protocols has decreased, they incorporate only 

about 4.2%-24.5% of the total clinical research protocols with enrollment in the last six years. Table 7F 

shows domestic and foreign enrollment for the six-year period. Domestic minority enrollment varied 

between 20.7% and 25.4% of total domestic participation, while foreign minority enrollment in NIH17
funded Phase III clinical research varied between 48.4% and 96.2% of total foreign participation. In 

comparing both domestic and foreign Phase III enrollment over the six year period shows that the small 

percentage of foreign protocols (6.7%) in FY2007 account for a significant proportion (27.5%) of the 

total foreign enrollment. 

Tables 8-11 provide summary reports of domestic and foreign participation for NIH funded clinical 

research and NIH-funded Phase III clinical research. For extramural and intramural clinical research, 

domestic participants enrolled in domestic protocols, female participation averaged between 58% and 

67.3% while male participation averaged between 31.2 and 39.5%. (Table 8) For NIH-funded Phase III 

extramural and intramural clinical research, domestic participants enrolled in domestic protocols, female 

participation averaged between 54.8 and 64.8% while male participation averaged between 34.4 and 

44.8%. (Table 9) For all extramural and intramural clinical research, foreign participants enrolled in 

foreign protocols, female participation varied from 39.2% to 59.5% while male participation varied from 

39.3% to 60.4%. (Table 10) For NIH-funded Phase III extramural and intramural clinical research, 

foreign participants enrolled in foreign protocols, female participation varied from 47.4% to 59.2% while 

male participation varied from 40.4% to 52.5%. (Table 11) 

18
Executive Summary 

Table 1. Summary of NIH Clinical Research Reported In FY2007: Total Number of 

Protocols and Enrollment By Sex and Domestic versus Foreign Protocols 

1A. PROTOCOLS REPORTED 

Total All Clinical 

Studies* Domestic % Foreign % 

Protocols with Enrollment 10,914 10,463 95.9% 451 4.1% 

% 70.1% 70.5% 62.6% 

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted 4,653 4,383 94.2% 270 5.8% 

29.9% 29.5% 37.4% 

Total Number of Protocols 15,567 14,846 95.4% 721 4.6% 

% 100.0% 100.0% 100.0% 

See Table 1A comments on next page. 

1B. ENROLLMENT REPORTED 

Total All Clinical 

Studies* Domestic % Foreign % 

Females Enrolled 10,152,589 9,397,957 92.6% 754,632 7.4% 

% 58.2% 58.1% 59.5% 

Males Enrolled 6,887,791 6,389,817 92.8% 497,974 7.2% 

% 39.5% 39.5% 39.3% 

Sex of Subjects is Unknown 408,078 392,814 96.3% 15,264 3.7% 

% 2.3% 2.4% 1.2% 

Total Subjects Enrolled 17,448,458 16,180,588 92.7% 1,267,870 7.3% 

% 100.0% 100.0% 100.0% 

See Table 1B comments on next page. 

1C. MINORITY ENROLLMENT 

REPORTED 

Total All Clinical 

Studies* Domestic % Foreign % 

Minority Total** 5,216,434 4,283,738 82.1% 932,696 17.9% 

% Minority Enrollment 29.9% 26.5% 73.6% 

See Table 1C comments on next page. 

* Clinical research studies include non-intervention clinical research, clinical trials, epidemiologic studies, behavioral 

studies, database studies, etc., based on the NIH definition of clinical research. "Total All Clinical Studies" includes 

NIH Defined Phase III Clinical Trials. 

** See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 

1997 U.S. OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity 

categories. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

19 
Executive Summary 

COMMENTS

Table 1. Summary of NIH Clinical Research Reported in FY2007: Total Number of Protocols and Enrollment 

by Sex and Domestic versus Foreign Protocols 

Table 1A: Total Number of Protocols 

1. The total number of protocols reported in the NIH database in FY2007 was 15,567; of these, 10,914 (70.1%) 

reported subject enrollment. Of these, the remainder are new clinical studies or studies pending enrollment. 

2. Subsequent tables reporting "Enrollment Reported" are based on the 10,914 protocols reporting subject 

enrollment, or a defined subset. 

3. Protocols with zero enrollment (data not yet submitted) are not included in subsequent tables reporting "Enrollment 

Reported." 

Total Domestic Protocols 

4. Domestic protocols made up the vast majority of protocols (14,846; 95.4%); of these, 10,463 (70.5%) reported 

domestic subject enrollment. 

5. Clinical research involving both domestic and foreign sites are reported as separate domestic and foreign 

protocols in subsequent tables. 

Total Foreign Protocols 

6. Foreign protocols account for only a small percentage of protocols 721 (4.6%); of these, 451 (62.6%) reported 

foreign subject enrollment. 

Table 1B: Total Enrollment Reported 

1. The total "Enrollment Reported" in the NIH database in FY2007 was 17,448,458 subjects in 10,914 protocols with 

enrollment. 

2. Females made up 58.2% (10.2M) of total subjects enrolled, while Males made up 39.5% (6.9M), with 2.3% 

unknown. 

3. Total Enrollment Reported increased by 18% in the past year (14,830,930 in FY2006; 17,448,458 in FY2007). 

Total Domestic Enrollment Reported 

4. The total Domestic Enrollment reported was 16,180,588 (92.7%) 

5. Females made up 58.1% (9.4M) of the domestic subjects enrolled, while Males made up 39.5% (6.4M) with 2.4% 

(0.4M) unknown. 

Total Foreign Enrollment 

6. The total Foreign Enrollment reported was 1,267,870 (7.3%). 

7. Females made up 59.5% (0.75M) of the foreign subjects enrolled, while males made up 39.3% (0.50M) with 1.2% 

unknown (0.015M). 

Table 1C: Minority Enrollment Reported 

1. Minorities made up 29.9% (5.2M) of the total subjects enrolled. 

2. Minorities made up 26.5% (4.3M) of the total Domestic Enrollment. 

3. Minority Enrollment Reported decreased 18% in the past year (6,388,316 in FY2006; 5,216,434 in FY2007). The 

small percentage of foreign protocols (4.1%) account for 17.9% of minority enrollment. 

20 
Executive Summary 

Table 2. Overview of NIH Extramural and Intramural Clinical Research Reported in FY2007: Number of SexSpecific Protocols, and Domestic versus Foreign Protocols 

Domestic Foreign 

2A. PROTOCOLS 

REPORTED 

Total All 

Clinical 

Studies Extramural % Intramural % Extramural % Intramural % 

Number of Protocols reporting 

females only 1,340 1,161 86.6% 127 9.5% 46 3.4% 6 0.4% 

% 8.6% 8.9% 7.2% 7.3% 6.9% 

Number of Protocols reporting 

males only 517 470 90.9% 27 5.2% 15 2.9% 5 1.0% 

% 3.3% 3.6% 1.5% 2.4% 5.7% 

Number of Protocols with Both 

Female and Male Enrollment 

(excluding sex-specific 

protocols) 9,057 7,351 81.2% 1,327 14.7% 319 3.5% 60 0.7% 

% 58.2% 56.2% 75.4% 50.3% 69.0% 

Total Number of Protocols 

with Enrollment 10,914 8,982 82.3% 1,481 13.6% 380 3.5% 71 0.7% 

% 70.1% 69% 84.1% 59.9% 81.6% 

Number of Protocols with zero 

enrollment. Enrollment data 

has not yet been submitted. 4,653 4,103 88.2% 280 6.0% 254 5.5% 16 0.3% 

% 29.9% 31.4% 15.9% 40.1% 18.4% 

Total Number of Protocols 15,567 13,085 84.1% 1,761 11.3% 634 4.1% 87 0.6% 

% 100.0% 100.0% 100.0% 100.0% 100.0% 

See Table 2A comments on next page. 

Domestic Foreign 

2B. ENROLLMENT 

REPORTED 

Total All 

Clinical 

Studies Extramural % Intramural % Extramural % Intramural % 

In Protocols reporting females 

only 9,000,648 6,830,795 75.9% 1,884,141 20.9% 142,737 1.6% 142,975 1.6% 

% 51.6% 52.2% 60.8% 15.7% 40.1% 

In Protocols reporting males 

only 377,803 335,655 88.8% 3,203 0.8% 11,998 3.2% 26,947 7.1% 

% 2.2% 2.6% 0.1% 1.3% 7.5% 

In Protocols excluding femaleonly and male-only enrollment 

protocols 8,070,007 5,913,901 73.3% 1,212,893 15.0% 756,196 9.4% 187,017 2.3% 

% 46.3% 45.2% 39.1% 83.0% 52.4% 

Enrollment Totals for all studies 17,448,458 13,080,351 75.0% 3,100,237 17.8% 910,931 5.2% 356,939 2.0% 

% 100.0% 100.0% 100.0% 100.0% 100.0% 

See Table 2B Comments on next page. 

Domestic Foreign 

2C. MINORITY ENROLLMENT 

REPORTED** Extramural % Intramural % Extramural % Intramural % 

Minority Totals for all studies 5,216,434 3,651,722 70.0% 632,016 12.1% 746,278 14.3% 186,418 3.6% 

% Minority enrollment 29.9% 27.9% 20.4% 81.9% 52.2% 

See Table 2C comments on next page. 

**See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB 

race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

21 
Executive Summary 

COMMENTS 

Table 2: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2006: Number of Sex-Specific Protocols 

and Domestic versus Foreign Protocols 

Table 2A: Total Number of Protocols with Enrollment 

1. Female Only Protocols: There were 1,340 protocols reporting females only, representing 12.3% (1,340/10,914) of protocols 

with enrollment.

 1,207 (90.1%) were Extramural Protocols; 132 (9.9%) were NIH Intramural Protocols.

 1,288 (96.1%) were Domestic Protocols; 52 (3.9%) were Foreign Protocols.

2. Male Only Protocols: There were 517 protocols reporting males only, representing 4.7% (516/10,914) of protocols with 

enrollment.

 485 (93.8%) were Extramural Protocols; 32 (6.2%) were NIH Intramural Protocols.

497 (96.1%) were Domestic Protocols; 20 (3.9%) were Foreign Protocols.

3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were 9,057 protocols reporting both 

female and male participants representing 83.0% (9,057/10,914) of protocols with enrollment.

 7,760 (84.7%) were Extramural protocols; 1,384 (15.3%) were NIH Intramural protocols

 8,678 (95.8%) were Domestic Protocols; 379 (4.2%) were Foreign Protocols.

Table 2B Total Enrollment Reported 

1. In Female Only Protocols: There were approximately 9.0 M females, representing 51.6% of total enrollment

 7.0M (77.5%) were in Extramural protocols; 2.03 (22.5%) were in NIH Intramural protocols.

 8.7M (96.8%) were Domestic protocols, 0.28 (3.2%) were Foreign Protocols.

2. In Male Only Protocols: There were approximately 377,803 males, representing 2.2% of total enrollment

 0.35M (92.0%) were in Extramural protocols; 0.3 (8.0%) were in NIH Intramural protocols.

 0.34M (89.7%) were Domestic protocols; 0.38M (10.3%) were Foreign protocols.

3. In Protocols reporting Both Females and Males (excluding sex-specific studies): There were approximately 8.1M subjects, 

representing 46.3% of total enrollment 

6.6M (82.7%) were in Extramural protocols; 1.4M (17.3%) were in NIH Intramural protocols.

7.13M (88.3%) were Domestic protocols, 0.94M (11.7%) were Foreign protocols.

Table 2C Minority Enrollment Reported 

Total Minority Enrollment: 29.9% of Total Enrollment (5.2M/17.4M) 

Total Domestic Minority Enrollment: 4.3M (82.1%) of Total Minority Enrollment (4,283,738/5,216,434). 

Total Foreign Minority Enrollment: 0.93M (17.9%) of Total Minority Enrollment (932,696/5,216,434).

Total Domestic Minority Enrollment (Extramural + Intramural): 4.3M (24.6%) of Total Enrollment (4,283,738/17,448,458). 

Total Foreign Minority Enrollment (Extramural + Intramural): 0.93M (5.3%) of Total Enrollment (932,696/17,448,458). 

Total Minority Enrollment in all Extramural protocols (Domestic + Foreign): 4.4M (25.2%) of Total Enrollment (4,398,000/17,448,458).

Total Minority Enrollment in all Intramural protocols (Domestic + Foreign): 0.82M (4.7%) of Total Enrollment (818,434/17,448,458). 

22 
Executive Summary 

Table 3. Summary of NIH Phase III Clinical Research Reported In FY2007: Total Number of 

Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols 

3A. PROTOCOLS REPORTED 

Total of Phase III 

Clinical Trials* Domestic % Foreign % 

Protocols with Enrollment 653 609 93.3% 44 6.7% 

% 87.2% 87.6% 81.5% 

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted. 96 86 89.6% 10 10.4% 

12.8% 12.4% 18.5% 

Total Number of Protocols 749 695 92.8% 54 7.2% 

% 100.0% 100.0% 100.0% 

See Table 3A comments on next page. 

3B. ENROLLMENT REPORTED 

Total of Phase III 

Clinical Trials* Domestic % Foreign % 

Females Enrolled 324,694 228,289 70.3% 96,405 29.7% 

% 54.9% 53.3% 59.2% 

Males Enrolled 249,633 183,878 73.7% 65,755 26.3% 

% 42.2% 42.9% 40.4% 

Sex of Subjects is Unknown 16,832 16,273 96.7% 559 0.0% 

% 2.8% 3.8% 0.3% 

Total Subjects Enrolled 591,159 428,440 72.5% 162,719 27.5% 

% 100.0% 100.0% 100.0% 

See Table 3B comments on next page. 

3C. MINORITY ENROLLMENT 

REPORTED** 

Total of Phase III 

Clinical Trials* Domestic % Foreign % 

Minority Total for all Phase III studies 244,932 88,339 36.1% 156,593 63.9% 

41.4% 20.6% 96.2% 

See Table 3C on next page. 

* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several 

hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or 

controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence 

leading to a scientific basis for consideration of a change in health policy or standard of care. 

**See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

23
Executive Summary 

COMMENTS 

Table 3. Summary of NIH Phase III Clinical Research Reported in FY2007: Total Number of 

Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols 

Table 3A: Total Number of Protocols 

1. The total number of NIH defined Phase III Clinical Protocols reported in the NIH database in FY2007 was 749; of 

these, 653 (87.2%) reported subject enrollment. Of these, the remainder are new clinical studies or studies pending 

enrollment. 

2. Subsequent tables reporting "Enrollment Reported" are based on the 653 protocols reporting subject enrollment, or 

a defined subset. 

3. Protocols with zero enrollment (data not yet submitted) are not included in subsequent tables reporting "Enrollment 

Reported" 

Total Domestic Protocols: 

4. Domestic protocols made up the majority of protocols with a total of 695 (92.8%); of these, 609 (87.6%) reported 

domestic subject enrollment. 

5. Clinical Research involving both domestic and foreign sites are reported as separate domestic and foreign protocols 

in subsequent tables. 

Total Foreign Protocols 

6. Total Foreign Protocols accounted for only a small percentage of protocols 54 (7.2%). Of these, 44 (6.7%) reported 

foreign enrollment. 

Table 3B: Total Enrollment Reported 

1. The total "Enrollment Reported" in NIH Defined Phase III Protocols in the NIH database in FY2007 was 591,159 

subjects in 653 protocols. 

2. Females 324,649 made up (54.9%) of the total subjects enrolled, while Males 249,633 made up (42.2%) with 

Unknowns 16,832 making up (2.8%). 

3. Minorities 244,932 made up (41.4%) of the total subjects enrolled 591,159. 

Total Domestic Enrollment Reported 

4. The total Domestic Enrollment reported was 428,440 (72.5%). 

5. Females 228,289 made up (53.3%) of the Domestic subjects enrolled, while Males 183,878 made up 42.9% with 

Unkowns 16,273 making up (3.8%). 

Total Foreign Enrollment Reported 

6. The total Foreign Enrollment Reported was 162,719 (27.5%). 

7. Females 96,405 made up (59.2%) of the Foreign subjects enrolled, while Males 65,755 made up (40.4%), with 

Unknowns 559 making up (0.3%). 

8. Total Foreign Enrollment increased by 64% from 99,133 in FY2006 to 162,719 in FY 2007). 

Table 3C: Minority Enrollment Reported 

1. Total Minority Enrollment was 41.4% (244,932) of Total Enrollment Reported 591,159. 

2. Minorities 88,339 made up (20.6%) of the Total Domestic Enrollment 428,440. 

3. Minorities 156,593 made up (96.2%) of the Total Foreign Enrollment 162,719. 

4. Total Minority Enrollment 88,339 was (36.1%) Domestic 156,593 and (63.9%) Foreign. 

24
Executive Summary 

Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2007: 

Number of Sex-Specific Protocols and Enrollment, and Domestic versus Foreign Protocols 

Domestic Foreign 

Total of 

Phase III 

Clinical Extra- Intra- Extra- Intra4A. PROTOCOLS REPORTED Trials* mural % mural % mural % mural % 

Protocols reporting female only 121 111 91.7% 4 3.3% 5 4.1% 1 0.8% 

% 16.2% 16.8% 11.8% 10.0% 25.0% 

Protocols reporting male only 41 40 97.6% 0 0.0% 1 2.4% 0 0.0% 

% 5.5% 6.1% 0.0% 2.0% 0.0% 

Protocols with Both Female and 

Male Enrollment (excluding sexspecific protocols) 491 426 86.8% 28 5.7% 34 6.9% 3 0.6% 

% 65.6% 64.4% 82.4% 68.0% 75.0% 

Total Number of Protocols with 

Enrollment 653 577 88.4% 32 4.9% 40 6.1% 4 0.6% 

% 87.2% 87% 94.1% 80.0% 100.0% 

Phase III Protocols with zero 

enrollment. Enrollment data has 

not yet been submitted. 96 84 87.5% 2 2.1% 10 10.4% 0 0.0% 

% 12.8% 12.7% 5.9% 20.0% 0.0% 

Total Number of Phase III 

Protocols 749 661 88.3% 34 4.5% 50 6.7% 4 0.5% 

% 100.0% 100.0% 100.0% 100.0% 100.0% 

See Table 4A comments on next page. 

Domestic Foreign 

Total of 

Phase III 

Clinical Extra- Intra- Extra- Intra4B. ENROLLMENT REPORTED Trials* mural % mural % mural % mural % 

Protocols reporting female only 181,625 144,902 79.8% 7 0.0% 29,707 16.4% 7,009 3.9% 

% 30.7% 36.7% 0.0% 19.4% 70.3% 

Protocols reporting male only 79,434 76,650 96.5% 0 0.0% 2,784 3.5% 0 0.0% 

% 13.4% 19.4% 0.0% 1.8% 0.0% 

Protocols excluding female-only 

and men-only enrollment protocols 330,100 173,384 52.5% 33,497 10.1% 120,260 36.4% 2,959 0.9% 

% 55.8% 43.9% 100.0% 78.7% 29.7% 

Total Subjects Enrolled 591,159 394,936 66.8% 33,504 5.67% 152,751 25.84% 9,968 1.7% 

% 100.0% 100.0% 100.0% 100.0% 100.0% 

See Table 4B comments on next page. 

Domestic Foreign 

Total of 

Phase III 

4C. MINORITY ENROLLMENT Clinical Extra- Intra- Extra- IntraREPORTED** Trials* mural % mural % mural % mural % 

Minority Total for all Phase III studies 244,932 83,634 34.1% 4,705 1.9% 149,424 61.0% 7,169 2.9% 

% 41.4% 21.2% 14.0% 97.8% 71.9% 

See Table 4C comments on next page. 

* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human 

subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more 

existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or 

standard of care. 

**See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. 

Foreign enrollment was reported using the U.S. race and ethnicity categories. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may

25 
Executive Summary 

COMMENTS

Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported in FY 2007: Number of SexSpecific Protocols and Enrollment, and Domestic versus Foreign 

Table 2A: Total Number of Protocols with Enrollment 

1. Female Only Protocols: There were 121 protocols reporting females only, representing 18.5% of protocols with 

enrollment.

 116 (95.8%) were Extramural Protocols; 5 (3.4%) were NIH Intramural Protocols.

 40 (97.6%) were Domestic Protocols; 1 (2.4%) were Foreign Protocols.

2. Male Only Protocols: There were 41 protocols reporting males only, representing 0.6% of protocols with enrollment.

 41 (100%) were Extramural Protocols; there were no NIH Intramural Protocols.

40 (97.6%) were Domestic Protocols; 1 (2.4%)3.9% were Foreign Protocols.

3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were 491 protocols reporting 

both female and male participants representing 75.2% of protocols with enrollment.

 460 (93.7%) were Extramural protocols; 31 (6.3%) were NIH Intramural projects.

 454 (92.5%) were Domestic Protocols; 36 (7.5% were Foreign Protocols.

Table 2B Total Enrollment Reported 

1. In Female Only Protocols: There were 181,625 females, representing 30.7% of total enrollment

 174,609 (96.2%) were in Extramural protocols; 7,016 (3.9%) were in NIH Intramural protocols.

 144,909 (79.8%) were Domestic protocols, 36,716 (20.3%) were Foreign protocols.

2. In Male Only Protocols: There were approximately 377,803 males, representing 2.2% of total enrollment

 79,434 (100%) were in Extramural protocols; there were no NIH Intramural protocols.

 76,650 (96.5%) were Domestic protocols; 2,784 (3.5%) were Foreign protocols.

3. In Protocols reporting Both Females and Males (excluding sex-specific studies): There were 330,100 subjects, 

representing 5.1% of total enrollment

 293,644 (88.9%) were in Extramural protocols; 36,456 (11%) were in NIH Intramural protocols.

 206,881 (62.6%) were Domestic protocols, 123,219 (36.4%) were Foreign protocols.

Table 2C Minority Enrollment Reported 

Total Minority Enrollment: 41% of Total Enrollment (244,932/591,159) 

Total Domestic Minority Enrollment: 36%% of Minority Enrollment (88,339/244,932). 

Total Foreign Minority Enrollment: 63%% of Minority Enrollment (156,593/244,932). 

Total Domestic Minority Enrollment (Extramural + Intramural): 15% of Total Enrollment (88,339/591,159)) 

Total Foreign Minority Enrollment (Extramural + Intramural): 26%% of Total Enrollment (156,593/591,159). 

Total Minority Enrollment in all Extramural projects (Domestic + Foreign): 39%% of Total Enrollment (233,058/591,159). 

Total Minority Enrollment in all Intramural projects (Domestic + Foreign): 2% of Total Enrollment (11,874/591,159). 

26
Executive Summary 

Table 5. NIH Thirteen Year Trends for Protocol and Enrollment Data: 1995-2007* 

5A Part I. Thirteen Year Increases in Protocols and Enrollment Data 

FY Reported 1995 2007 

Relative 

Increase, 

2007 / 1995 

Total Protocols 

with Enrollment 

Total Enrollment 

Total Minorities 

3,188 

1,021,493 

374,433 

10,914 3.4 

17,448,458 

5,216,434 

17.1 

13.9 

% of Minority 36.7% 29.9% 0.8 

5A Part II. Six Year Increases in Protocols and Enrollment Data: Foreign 

and Domestic 

FY Reported 

Total DOMESTIC 

Enrollment data 

2002 

10,192,401 

2007 

Relative 

Increase, 

2007 / 1995 

16,180,588 

1,267,870 

1.6 

1.3 

Total FOREIGN 

Enrollment 946,083 

Table 5A Comments: 

1. There was a 3.4 fold increase in protocols with enrollment reported from 1995 to 2007, from 3,188 protocols 

to 10,914 protocols. 

2. There was a 17.1 fold increase in enrollment reported from 1995 to 2007, from approximately 1M to 17M. 

3. There was a 13.9 fold increase in minority enrollment from 1995 to 2007, from approximately 0.4M to 5M. 

4. Domestic and Foreign data were reported for FY 2002-2007, showed a 1.6 fold increase in domestic 

enrollment (from 10.2M to 16M) and a 1.3 fold increase in foreign enrollment (from 0.95M to 1.2M). 

5. See Table 6 for 13 year enrollment totals 1995-2007. 

*NOTE: Trend data varies over time because the data for each year represent the net total of data resulting from (1) studies 

continuing from the prior year; (2) the addition of new studies reported and (3) the subtraction of studies that are no longer reported. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

27
Old + New Form Old Form 

12,000 

10,000 CHART Number of Protocols with Enrollment data 

8,000 (Old + New Forms): 

Number of DOMESTIC Protocols with 6,000 Enrollment data 

4,000 Number of FOREIGN Protocols with 

Enrollment data 

2,000 

0 

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 

Executive Summary 

Table 5. NIH Thirteen Year Trends for Protocol and Enrollment Data: 1995-2007* 

5B. Thirteen Year Summary of Total Number of Protocols Reported: FY 1995-2007 

FY Reported FY Funded 

Number of 

Protocols 

with 

Enrollment 

data (Old + 

New 

Forms): 

Number of 

DOMESTIC 

Protocols 

with 

Enrollment 

data 

Number of 

FOREIGN 

Protocols with 

Enrollment 

data 

Percent 

Domestic 

Protocols 

Protocol Form* 

1995 1994 3,188 

Old 

1996 1995 6,036 

1997 1996 5,692 

1998 1997 7,602 

1999 1998 8,285 

2000 1999 9,390 

2001 2000 10,212 

2002 2001 8,945 8,463 482 94.6% 

Old + New 

2003 2002 10,216 9,578 638 93.8% 

2004 2003 10,125 9,760 365 96.4% 

2005 2004 10,233 9,862 371 96.4% 

2006 2005 10,758 10,294 464 95.7% 

2007 2006 10,914 10,463 451 95.9% 

Table 5B Comments: 

Total Protocols by Year Reported 

1. Table 5B and 5B Graph provide the number of OLD and NEW protocols year by year (1995-2007) and the 

distribution between domestic and foreign protocols for years 2002-2007. 

2. The total number of protocols reported with enrollment have leveled off at about 10,000 over the last 6 years. 

3. The vast majority of protocols were for domestic studies for 2002-2007, ranging from 93.8% to 96.4% of 

protocols. 

* Data have been reported using a combined race/ethnicity format (OLD FORM) since 1995. New protocols began reporting 

separate race and ethnicity data in FY2002 (NEW FORM). During 2002-2007, data have been reported using both Old and New 

Forms. 

*See Appendix H for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB 

race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories. 

28
CHART

Executive Summary 

Table 5. NIH Thirteen Year Trends for Protocol and Enrollment Data: 1995-2007* 

5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2007 

FY Reported FY Funded 

Total 

Enrollment 

data (Old + 

New 

Forms): 

Total 

DOMESTIC 

Enrollment 

data 

Percent 

DOMESTIC 

Enrollment 

Total 

FOREIGN 

Enrollment 

Percent FOREIGN 

Enrollment 

2002 2001 11,138,484 10,192,401 91.5% 946,083 8.5% 

2003 2002 14,772,254 11,911,357 80.6% 2,860,897 19.4% 

2004 2003 18,923,920 14,359,793 75.9% 4,564,127 24.1% 

2005 2004 15,722,752 12,669,858 80.6% 3,052,894 19.4% 

2006 2005 14,830,930 11,425,701 77.0% 3,405,229 23.0% 

2007 2006 17,448,458 16,180,588 92.7% 1,267,870 7.3% 

0.0% 

20.0% 

40.0% 

60.0% 

80.0% 

100.0% 

2002 

Percent Comparison of Domestic and Foreign Enrolment 

% Comparison of Domestic and Foreign Enrollment 

2003 2004 2005 2006 2007 

Percent 

DOMESTIC 

Enrollment 

Percent 

FOREIGN 

Enrollment 

Table 5C Comments: 

1. Overall total enrollment has increased, as well as total domestic and foreign enrollment during the last 6 

years. 

2. The percentage of foreign enrollment has decreased to approximately 7.3% in FY 2007 as domestic enrollment increased to 

92.7%. 

29
Table 6. NIH Thirteen Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Executive Summary 

Reported in FY 1995-2007: Enrollment by Race and Ethnicity 

6A. Thirteen YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER AND MINORITY CATEGORIES IN ALL PROTOCOLS (Old + 

New Forms) 

Number of 

Total All Subtotal: All Subjects Protocols with FY FY Funded Form Females Males Unknown Subjects (Old + Enrolled by US Minority Enrollment Reported New Forms) Categories data (Old + 

New Forms): 

1995 1994 Old 528,421 459,921 33,151 1,021,493 374,433 3,188 

% 51.7% 45.0% 3.2% 100.0% 36.7% 

1996 1995 Old 4,130,385 2,583,865 91,054 6,805,304 2,125,958 6,036 

% 60.7% 38.0% 1.3% 100.0% 31.2% 

1997 1996 Old 3,320,610 1,930,783 65,540 5,316,933 1,709,223 5,692 

% 62.5% 36.3% 1.2% 100.0% 32.2% 

1998 1997 Old 4,246,130 2,716,880 115,566 7,078,576 2,923,662 7,602 

% 60.0% 38.4% 1.6% 100.0% 41.3% 

1999 1998 Old 5,102,306 2,712,068 169,863 7,984,237 3,108,228 8,285 

% 63.9% 34.0% 2.1% 100.0% 38.9% 

2000 1999 Old 5,585,042 3,919,065 64,990 9,569,097 3,406,297 9,390 

% 58.4% 41.0% 0.7% 100.0% 35.6% 

2001 2000 Old 6,808,822 4,740,887 44,547 11,594,256 3,619,119 10,212 

% 58.7% 40.9% 0.4% 100.0% 31.1% 

2002 2001 Old + New 7,155,549 3,904,560 78,375 11,138,484 3,666,880 8,945 

% 64.2% 35.1% 0.7% 100% 32.9% 

2003 2002 Old + New 8,514,481 6,121,496 136,277 14,772,254 5,387,692 10,216 

% 57.6% 41.4% 0.9% 100.0% 36.5% 

2004 2003 Old + New 10,889,097 7,741,892 292,931 18,923,920 7,611,611 10,125 

% 57.5% 40.9% 1.5% 100.0% 40.2% 

2005 2004 Old + New 9,503,922 5,941,907 276,923 15,722,752 6,245,436 10,233 

60.4% 37.8% 1.8% 100.0% 39.7% 

2006 2005 Old + New 9,473,273 5,172,205 185,452 14,830,930 6,388,316 10,758 

63.9% 34.9% 1.25% 100.0% 43.1% 

2007 2006 Old + New 10,152,590 6,887,793 408,075 17,448,458 5,216,890 10,914 

58.2% 39.5% 2.34% 100.0% 29.9% 

Total Minority Enrollment Reported by Year Sex/Gender Enrollm ent by Year Reported 

100.0% 

80% 80.0% Females 

60% Subtotal: All 60.0% 

Subjects Males 40.0% 40% Enrolled by Unknow n US Minority 20.0% 

20% Categories 0.0% 

0% 07 

1995 1997 

1999 

2001 2003 

2005 

20

1995 1997 1999 2001 2003 2005 2007 

Table 6A Comments: 

1. Table 6A summarizes enrollment by sex/gender and minority race/ethnicity categories for the Thirteen year reporting period (1995-2007). The data are 

compiled from Tables 6B, 6C and 6D below, which provide the detailed distributions by sex/gender and race/ethnicity using the OLD Enrollment Form 

(Table 6B) and the NEW Enrollment Form (Tables 6C and 6D). 

2. The Race and Ethnicity data in the OLD FORM and the NEW FORM cannot be combined by individual race and ethnicity categories because th 

categories reflect the different OMB Formats used based on the 1977 OMB standards (OLD FORM) and the 1997 OMB Standards (NEW FORM). 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

NOTE: Trend data varies over time because the data for each year represent the net total of data resulting from:(1) studies continuing from the prior year; (2) the addition of 

new studies reported; (3) and the subtraction of studies that are no longer reported.

30 
6B. OLD FORM: Total of All Subjects Reported Using the 1977 OMB Standards in a Combined Race/Ethnicity Format 

Number 

American Black or Subtotal Using US Minority Protocols with FY Asian/ Pacific Hispanic, Not Unknown/O FY Funded Indian/ Alaska African White Total Categories (shaded): OLD Enrollment Reported Islander White ther Native American FORM data (Old 

Form): 

1995 1994 11,221 38,952 234,976 89,284 540,313 106,747 1,021,493 374,433 3,188 

% 1.1% 3.8% 23.0% 8.7% 52.9% 10.5% 100.0% 36.7% 

1996 1995 146,319 617,211 823,102 539,326 4,114,249 565,097 6,805,304 2,125,958 6,036 

% 2.2% 9.1% 12.1% 7.9% 60.5% 8.3% 100.0% 31.2% 

1997 1996 36,638 321,479 864,102 487,004 3,199,778 407,932 5,316,933 1,709,223 5,692 

% 0.7% 6.0% 16.3% 9.2% 60.2% 7.7% 100.0% 32.1% 

1998 1997 85,957 1,237,030 1,096,218 504,457 3,713,759 441,155 7,078,576 2,923,662 7,602 

% 1.2% 17.5% 15.5% 7.1% 52.5% 6.2% 100.0% 41.3% 

1999 1998 71,436 1,429,022 1,081,210 526,560 4,470,966 405,043 7,984,237 3,108,228 8,285 

% 0.9% 17.9% 13.5% 6.6% 56.0% 5.1% 100.0% 38.9% 

2000 1999 82,728 1,525,392 1,209,769 588,408 5,588,942 573,858 9,569,097 3,406,297 9,390 

% 0.9% 15.9% 12.6% 6.1% 58.4% 6.0% 100.0% 35.6% 

2001 2000 105,067 1,495,279 1,199,625 819,148 7,314,449 660,688 11,594,256 3,619,119 10,212 

% 0.9% 12.9% 10.3% 7.1% 63.1% 5.7% 100.0% 31.2% 

2002 2001 45,843 1,222,296 702,234 398,657 4,044,052 321,349 6,734,431 2,369,030 6,187 

% 0.7% 18.1% 10.4% 5.9% 60.1% 4.8% 100.0% 35.2% 

2003 2002 36,579 730,542 472,426 288,523 3,238,284 278,901 5,045,255 1,528,070 4,903 

% 0.7% 14.5% 9.4% 5.7% 64.2% 5.5% 100.0% 30.3% 

2004 2003 29,387 307,052 342,188 214,322 2,348,529 172,130 3,413,608 892,949 2,782 

% 0.9% 9.0% 10.0% 6.3% 68.8% 5.0% 100.0% 26.2% 

2005 2004 22,375 254,598 229,615 134,972 1,267,089 102,405 2,011,054 641,560 1,786 

% 1.1% 12.7% 11.4% 6.7% 63.0% 5.1% 100.0% 31.9% 

2006 2005 19,648 131,786 148,948 78,596 883,041 63,231 1,325,250 378,978 1,391 

% 1.5% 9.9% 11.2% 5.9% 66.6% 4.8% 100.0% 28.6% 

2007 2006 5,372 51,742 238,004 83,192 1,097,387 48,630 1,524,327 378,310 1,098 

% 0.4% 3.4% 15.6% 5.5% 72.0% 3.2% 100.0% 24.8% 

Executive Summary 

Table 6. NIH Thirteen Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY 1995-

2007: Enrollment by Race and Ethnicity 

Notes Tables B-D 

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and 

later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New 

Form, and separate reporting for Foreign and Domestic Data. 

NOTE 2: Data from Tables 6B, 6C and 6D are combined to provide the summary data in Table 6A.

ORIENTATION TO TABLES 6C and 6D. 

1. The New Form consists of Parts A and B (Tables 6C and 6D) for reporting years 2002-2007. This Form is provided as part of the annual progress report. 

2. Table 6C displays the New Form Part A for reporting separate race and ethnicity data. 

3. Table 6D displays the New Form Part B, which is the Distribution of Hispanics reported by race, using the totals from the "Hispanic or Latino" column in Part A. 

6C. New Form Part A: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity Formats 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

FY 

Reported FY Funded 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian 

/Pacific 

Islander 

White More Than 

One Race 

Unknown 

/Other Total* Not Hispanic Hispanic or Latino** 

Unknown 

/Not 

Reported 

Total* 

2002 2001 77,734 354,049 547,776 21,636 2,651,541 30,955 720,362 4,404,053 3,071,952 292,429 1,039,672 4,404,053 

% 1.8% 8.0% 12.4% 0.5% 60.2% 0.7% 16.4% 100.0% 69.8% 6.6% 23.6% 100.0% 

2003 2002 63,544 2,138,002 960,090 37,569 5,415,710 99,462 1,012,622 9,726,999 8,162,259 611,641 953,099 9,726,999 

% 0.7% 22.0% 9.9% 0.4% 55.7% 1.0% 10.4% 100.0% 83.9% 6.3% 9.8% 100.0% 

2004 2003 98,047 4,345,396 1,379,857 54,452 8,065,069 186,241 1,381,250 15,510,312 13,168,842 756,339 1,585,131 15,510,312 

% 0.6% 28.0% 8.9% 0.4% 52.0% 1.2% 8.9% 100.0% 84.9% 4.9% 10.2% 100.0% 

2005 2004 292,215 3,046,370 1,358,262 53,286 7,672,890 182,953 1,105,722 13,711,698 11,804,164 773,939 1,133,595 13,711,698 

% 2.1% 22.2% 9.9% 0.4% 56.0% 1.3% 8.1% 100.0% 86.1% 5.6% 8.3% 100.0% 

2006 2005 141,567 3,463,202 1,251,339 38,460 7,089,017 321,554 1,200,541 13,505,680 11,308,244 1,054,313 1,143,123 13,505,680 

% 1.0% 25.6% 9.3% 0.3% 52.5% 2.4% 8.9% 100.0% 83.7% 7.8% 8.5% 100.0% 

2007 2006 145,417 1,356,900 2,012,695 57,149 10,341,483 278,068 1,732,419 15,924,131 13,017,124 1,169,092 1,737,915 15,924,131 

% 0.9% 8.5% 12.6% 0.4% 64.9% 1.7% 10.9% 100.0% 81.7% 7.3% 10.9% 100.0% 

6D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative) 

Number of 

American Black or Hawaiian Subtotal Using US Minority Protocols with FY More Than Unknown/Othe Total Hispanic FY Funded Indian/ Alaska Asian African /Pacific White Categories (shaded): NEW Enrollment Reported One Race r or Latino** Native American Islander FORM Parts A+B data (New 

Form): 

2002 2001 4,867 1,305 13,066 101 159,252 7390 106,448 292,429 1,297,850 2,758 

% 1.7% 0.4% 4.5% 0.0% 54.5% 2.5% 36.4% 100.0% 29.5% 

2003 2002 5,400 1,953 14,566 679 350,439 28,088 210,516 611,641 3,859,622 5,313 

% 0.9% 0.3% 2.4% 0.1% 57.3% 4.6% 34.4% 100.0% 39.7% 

2004 2003 6,408 5,040 25,276 2,037 361,112 62,909 293,557 756,339 6,718,662 7,343 

% 0.8% 0.7% 3.3% 0.3% 47.7% 8.3% 38.8% 100.0% 43.3% 

2005 2004 22,739 7,816 19,446 1,981 388,874 51,166 281,916 773,938 5,603,876 8,447 

% 2.9% 1.0% 2.5% 0.3% 50.2% 6.6% 36.4% 100.0% 40.9% 

2006 2005 45,074 6,641 21,712 2,193 417,495 185,477 375,721 1,054,313 6,009,338 9,367 

% 4.3% 0.6% 2.1% 0.2% 39.6% 17.6% 35.6% 100.0% 44.5% 

2007 2006 37,581 7,414 31,239 4,310 538,216 100,197 450,135 1,169,092 4,838,580 9,816 

% 3.2% 0.6% 2.7% 0.4% 46.0% 8.6% 38.5% 100.0% 30.4% 

* These totals must agree. 

**These totals must agree. 

31 
6E. Comparison of Domestic and Foreign Enrollment & Protocols with Total Enrollment for the period FY2002-2007 ENROLLMENT PROTOCOLS 

Number of 

Protocols Total Total Percent Total Percent with Number of Percent Number of Percent FY Enrollment FY Funded DOMESTIC DOMESTIC FOREIGN FOREIGN Enrollment DOMESTIC Domestic FOREIGN Foreign Reported data (Old + Enrollment Enrollment Enrollment Enrollment data (Old + Protocols Protocols Protocols Protocols New Forms): New 

Forms): 

2002 2001 11,138,484 10,192,401 91.5% 946,083 8.5% 8,945 8,463 94.6% 482 5.4% 

2003 2002 14,772,254 11,911,357 80.6% 2,860,897 19.4% 10,216 9,578 93.8% 638 6.2% 

2004 2003 18,923,920 14,359,793 75.9% 4,564,127 24.1% 10,125 9,760 96.4% 365 3.6% 

2005 2004 15,722,752 12,669,858 80.6% 3,052,894 19.4% 10,233 9,862 96.4% 371 3.6% 

2006 2005 14,830,930 11,425,701 77.0% 3,405,229 23.0% 10,758 10,294 95.7% 464 4.3% 

2007 2006 17,448,458 16,180,588 92.7% 1,267,870 6.1% 10,914 10,463 95.9% 451 4.1% 

100.0% 120.0% 

80.0% 100.0% 

80.0% 60.0% Percent Domestic 

Percent DOMESTIC Protocols 

Chart Enrollment 60.0% 

40.0% Percent Foreign 

Percent FOREIGN 40.0% Protocols 

Enrollment 20.0% 20.0% 

0.0% 0.0% 

2002 2003 2004 2005 2006 2007 2002 2003 2004 2005 2006 2007 

Table 6. NIH Thirteen Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY 1995- Executive Summary 

2007: Enrollment by Race and Ethnicity 

Table 6 E Comments: 

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2007. 

2. The Domestic enrollment increased to approximately 93%, while the Foreign enrollment decreased to approximately 6.1%. 

3. The vast majority of protocols are domestic protocols (approximately 94-96%), while foreign protocols make up approximately 4-6% of total protocols. 

4. Foreign enrollment was reported using the same race and ethnicity categories as domestic enrollment. Thousands 

6F. Comparison of Domestic and Foreign Minority Participation for FY 2002-2007 

Number of Participants for FY2002-2007 

FY FOREIGN Foreign DOMESTIC Domestic 

Reported FY Funded Minority Total Minority Total 4,500 

2002 2001 777,461 946,083 2,754,820 10,149,869 4,000 

82.2% 100.0% 27.1% 100.0% 3,500 

3,000 2003 2002 2,452,329 2,860,897 2,935,363 11,911,357 2,500 85.7% 100.0% 24.6% 100.0% 2,000 

2004 2003 4,147,255 4,564,127 3,464,356 14,359,793 1,500 

90.9% 100.0% 24.1% 100.0% 1,000 

2005 2004 2,776,565 3,052,894 3,468,864 12,669,858 500 

90.9% 100.0% 27.4% 100.0% 0 

2002 2003 2004 2005 2006 2007 2006 2005 3,087,181 3,405,229 3,301,135 11,425,701 

90.7% 100.0% 28.9% 100.0% FOREIGN Minority DOMESTIC Minority 

2007 2006 932,686 1,267,870 4,283,738 16,180,588 

73.6% 100.0% 26.5% 100.0% 

DOMESTIC Minority Enrollment FOREIGN Minority 

100% 

100% 

80% 80% 

60% 60% 

40% 40% 

20% 

20% 

0% 

2002 2003 2004 2005 2006 2007 0% 

2002 2003 2004 2005 2006 2007 DOMESTIC Minority 

FOREIGN Minority 

Table 6F Comments: 

1. Domestic Minority Enrollment has varied from 24.1% to 28.9% of Total Domestic Enrollment. 

2. Foreign Minority Enrollment has varied from 73.6% to 90.9% of Total Foreign Enrollment, reflecting that most of the foreign research is done in countries that are within the 

OMB race and ethnicity origin categories that are included in the summary minority data used in this report. 

32 
OLD FORM OLD + NEW FORM 

100.0% Charts

80.0% 

60.0% 

Subtotal: All Subjects 

40.0% Enrolled by US Minority 

Categories 

20.0% 

0.0% 

1995 1998 2001 2004 2007 

OLD FORM OLD + NEW FORM 

100% 

90% 

80% 

70% 

60% Unknown 

50% Males 

40% Females 

30% 

20% 

10% 

0% 

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 

Table 7: Thirteen Year Minority Trend Summary of NIH Extramural and Intramural Phase III Clinical Executive Summary 

Research Reported in FY1995-2007: Enrollment by Race and Ethnicity 

7A. Phase III Thirteen YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER IN ALL PROTOCOLS (Old + New Forms) 

Number of Total All Subtotal: All Protocols Subjects FY FY Subjects Enrolled by with Females Males Unknown (Old + Reported Funded US Minority Enrollment New Categories data (Old + Forms) New Forms): 

1995 1994 171,181 108,324 19,818 299,323 80,562 560 

% 57.2% 36.2% 6.6% 100.0% 26.9% 

1996 1995 264,755 203,698 21,210 489,663 110,669 608 

% 54.1% 41.6% 4.3% 100.0% 22.6% 

1997 1996 264,755 203,698 21,210 489,663 110,000 608 

% 54.1% 41.6% 4.3% 100.0% 22.5% 

1998 1997 228,417 74,389 2,705 305,511 69,599 320 

% 74.8% 24.3% 0.9% 100.0% 22.8% 

1999 1998 339,533 163,950 1,446 504,929 141,449 578 

% 67.2% 32.5% 0.3% 100.0% 28.0% 

2000 1999 313,952 180,705 1,086 495,743 120,339 589 

% 63.3% 36.5% 0.2% 100.0% 24.3% 

2001 2000 412,379 168,085 1,273 581,737 117,873 645 

% 70.9% 28.9% 0.2% 100.0% 20.3% 

2002 2001 278,876 195,090 781 474,747 111,269 754 

% 58.7% 41.1% 0.2% 100.0% 23.4% 

2003 2002 294,950 239,403 1,914 536,267 132,302 852 

% 55.0% 44.6% 0.4% 100.0% 24.7% 

2004 2003 301,353 242,913 1,101 545,367 150,456 573 

% 55.3% 44.5% 0.2% 100.0% 27.6% 

2005 2004 290,977 197,300 4,723 493,000 154,191 547 

59.0% 40.0% 1.0% 100.0% 31.3% 

2006 2005 314,066 179,975 5,389 499,430 167,446 624 

62.9% 36.0% 1.1% 100.0% 33.5% 

2007 2006 324,694 249,633 16,832 591,159 244,932 621 

54.9% 42.2% 2.8% 100.0% 41.4% 

Total Phase III Enrollment by Year Reported 

Sex/Gender Phase III Enrollment by Year Reported 

Table 7A Comments: 

1. Table7A summarizes enrollment by sex/gender and minority race/ethnicity categories for the Thirteen year reporting period (1995-2007). The data are 

compiled from Tables 7B, 7C and 7D below, which provide the detailed distributions by sex/gender and race/ethnicity using the OLD Enrollment Form 

(Table 7B) and the NEW Enrollment Form (Tables 7C and 7D). 

2. The Race and Ethnicity data in the OLD FORM and the NEW FORM cannot be combined by individual race and ethnicity categories because the 

categories reflect the different OMB Formats used based on the 1977 OMB standards (OLD FORM) and the 1997 OMB Standards (NEW FORM). 

NOTE: Trend data varies over time because the data for each year represent the net total of data resulting from:(1) studies continuing from the prior year; (2) the addition of new studies 

reported; (3) and the subtraction of studies that are no longer reported. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

33 
Table 7: Thirteen Year Minority Trend Summary of NIH Extramural and Intramural Phase III Clinical Research Executive Summary 

Reported in FY1995-2007: Enrollment by Race and Ethnicity 

Notes Tables 7B-D 

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data 

Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows 

separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data. 

NOTE 2: Data from Tables 7B, 7C and 7D are combined to provide the summary data in Table 7A. 

7B. Phase III OLD FORM: Total of All Subjects Reported Using the 1977 OMB Standards in a Combined Race/Ethnicity 

Format 

FY 

Reported 

FY 

Funded 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, 

Not White White Unknown/ Other Total 

Subtotal Using US 

Minority Categories 

(shaded): OLD FORM 

Number 

Protocols 

with 

Enrollment 

data (Old 

Form): 

1995 1994 5,358 2,740 52,433 20,031 172,773 45,988 299,323 80,562 560 

% 1.8% 0.9% 17.5% 6.7% 57.7% 15.4% 100.0% 26.9% 

1996 1995 4,235 40,126 46,838 19,470 321,445 57,549 489,663 110,669 608 

% 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0% 22.6% 

1997 1996 4,235 40,126 46,838 19,470 321,445 57,549 489,663 110,669 608 

% 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0% 22.6% 

1998 1997 5,030 5,324 42,805 16,440 229,534 6,378 305,511 69,599 320 

% 1.6% 1.7% 14.0% 5.4% 75.1% 2.1% 100.0% 22.8% 

1999 1998 3,685 20,276 76,921 40,567 336,703 26,777 504,929 141,449 578 

% 0.7% 4.0% 15.2% 8.0% 66.7% 5.3% 100.0% 28.0% 

2000 1999 3,726 24,017 62,512 30,084 335,824 39,580 495,743 120,339 589 

% 0.8% 4.8% 12.6% 6.1% 67.7% 8.0% 100.0% 24.3% 

2001 2000 4,079 11,132 70,110 32,552 422,802 41,062 581,737 117,873 645 

% 0.7% 1.9% 12.1% 5.6% 72.7% 7.1% 100.0% 20.3% 

2002 2001 1,645 20,560 51,991 29,636 315,543 12,228 431,603 103,832 660 

% 0.38% 4.8% 12.0% 6.9% 73.1% 2.8% 100.00% 24.1% 

2003 2002 1,689 20,038 49,255 29,066 337,654 16,615 454,317 100,048 656 

% 0.4% 4.4% 10.8% 6.4% 74.3% 3.7% 100.0% 22.0% 

2004 2003 1,505 18,807 45,285 32,974 265,764 14,050 378,385 98,571 296 

% 0.4% 5.0% 12.0% 8.7% 70.2% 3.7% 100.0% 26.1% 

2005 2004 1,319 17,740 39,402 21,829 231,492 4,507 316,289 80,290 210 

% 0.4% 5.6% 12.5% 6.9% 73.2% 1.4% 100.0% 25.4% 

2006 2005 1,012 16,800 20,355 9,524 175,724 6,348 229,763 47,691 215 

% 0.4% 7.3% 8.9% 4.1% 76.5% 2.8% 100.0% 20.8% 

2007 2006 751 3,943 21,582 9,333 169,789 4,259 209,657 35,609 197 

% 0.4% 1.9% 10.3% 4.5% 81.0% 2.0% 100.0% 17.0% 

ORIENTATION TO TABLES 7C and 7D. 

1. The New Form consists of Parts A and B (Tables 7C and 7D) for reporting years 2002-2007. This Form is provided as part of the annual progress 

report. 

2. Table 7C displays the New Form Part A for reporting separate race and ethnicity data. 

3. Table 7D displays the New Form Part B, which is the Distribution of Hispanics reported by race, using the totals from the "Hispanic or Latino" column in Part A. 

7C. Phase III New Form: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

FY 

Reported 

FY 

Funded 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian 

/Pacific 

Islander 

White More Than 

One Race 

Unknown 

/Other Total Not Hispanic 

Hispanic 

or Latino 

Unknow 

n/Not 

Reporte 

d 

Total 

2002 2001 159 799 4,647 52 34,654 560 2,273 43,144 36,224 1,629 5,291 43,144 

% 0.37% 1.85% 10.77% 0.12% 80.32% 1.30% 5.27% 100.00% 83.96% 3.78% 12.26% 100.00% 

2003 2002 484 2,609 21,641 220 47,869 989 8,138 81,950 64,295 7,831 9,824 81,950 

% 0.6% 3.2% 26.4% 0.3% 58.4% 1.2% 9.9% 100.0% 78.5% 9.6% 12.0% 100.0% 

2004 2003 1,396 4,385 43,721 611 106,793 4,419 5,657 166,982 145,742 13,435 7,805 166,982 

% 0.8% 2.6% 26.2% 0.4% 64.0% 2.6% 3.4% 100.0% 87.3% 8.0% 4.7% 100.0% 

2005 2004 2,164 9,192 50,338 462 101,238 3,063 10,254 176,711 156,650 10,397 9,664 176,711 

% 1.2% 5.2% 28.5% 0.3% 57.3% 1.7% 5.8% 100.0% 88.6% 5.9% 5.5% 100.0% 

2006 2005 4,630 32,360 50,780 535 126,670 4,246 50,446 269,667 202,358 31,034 36,275 269,667 

% 1.7% 12.0% 18.8% 0.2% 47.0% 1.6% 18.7% 100.0% 75.0% 11.5% 13.5% 100.0% 

2007 2006 9,351 47,364 84,468 555 133,002 4,145 102,617 381,502 254,692 71,622 55,188 381,502 

% 2.5% 12.4% 22.1% 0.1% 34.9% 1.1% 26.9% 100.0% 66.8% 18.8% 14.5% 100.0% 

7D. Phase III Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative) 

FY 

Reported FY Funded 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Subtotal Using US 

Minority Categories 

(shaded): NEW 

FORM Parts A+B 

Number of 

Protocols with 

Enrollment data 

(New Form): 

2002 2001 49 22 31 4 660 304 560 1,630 7,437 94

% 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0% 17.2% 

2003 2002 37 70 186 23 2,115 203 5,197 7,831 32,254 196

% 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0% 39.4% 

2004 2003 269 59 193 26 7,264 3,052 2,572 13,435 54,405 277

% 2.0% 0.4% 1.4% 0.2% 54.1% 22.7% 19.1% 100.0% 32.6% 

2005 2004 759 42 446 45 3,667 423 5,015 10,397 73,901 337

% 7.3% 0.4% 4.3% 0.4% 35.3% 4.1% 48.2% 100.0% 41.8% 

409 

424 

2006 2005 2,307 50 720 40 6,872 713 20,332 31,034 119,755 

2007 

% 

2006 

7.4% 

7,333 

0.2% 

45 

2.3% 

458 

0.1% 

24 

22.1% 

7,430 

2.3% 

322 

65.5% 

56,010 

100.0% 

71,622 209,323 

44.4% 

% 10.2% 0.1% 0.6% 0.0% 10.4% 0.4% 78.2% 100.0% 54.9% 

* These totals must agree 

** These totals must agree 

34 
7E. Comparison of Domestic and Foreign Phase III Enrollment and Protocols with Enrollment for the period FY2002-2007 

ENROLLMENT PROTOCOLS 

Number of 

Total Protocols 

Enrollment with Number of Percent Number of Percent FY FY Total Percent Total Percent data (Old + Enrollment DOMESTIC Domestic FOREIGN Foreign Reported Funded DOMESTIC DOMESTIC FOREIGN FOREIGN New data (Old + Protocols Protocols Protocols Protocols 

Forms): New 

Forms): 

2002 2001 474,747 444,436 93.6% 30,311 6.4% 754 582 77.2% 172 22.8% 

2003 2002 536,267 486,857 90.8% 49,410 9.2% 852 643 75.5% 209 24.5% 

2004 2003 545,367 496,241 91.0% 49,126 9.0% 573 549 95.8% 24 4.2% 

2005 2004 493,000 437,902 88.8% 55,098 11.2% 547 517 94.5% 30 5.5% 

2006 2005 499,430 400,297 80.2% 99,133 19.8% 624 564 90.4% 60 9.6% 

2007 2006 591,159 428,440 72.5% 162,719 27.5% 653 609 93.3% 44 6.7%

 Percentage of Phase III Domestic and Foreign Enrollment Number of Phase III Domestic and Foreign protocols 

100% 700 

90% 600 80% 

70% Charts 500 

60% Number of Percent DOMESTIC 400 50% DOMESTIC Protocols 

Percent FOREIGN 40% 300 

30% 200 Number of FOREIGN 

20% Protocols 100 10% 

0% 0 

2002 2003 2004 2005 2006 2007 2002 2003 2004 2005 2006 2007 

Table 7: Thirteen Year Minority Trend Summary of NIH Extramural and Intramural Phase III Clinical Research Executive Summary 

Reported in FY1995-2007: Enrollment by Race and Ethnicity 

Table 7E Comments: 

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increased from FY 2002 - 2007. 

2. The Domestic enrollment decreased to approximately 72.5%, while Foreign enrollment increased to approximately 27.5% in 2007. 

3. The vast majority of protocols in FY 2004 - 2007 are domestic protocols. 

7F. Phase III Foreign and Domestic Minority Comparison for FY 2002-2007 

FOREIGN FOREIGN DOMESTIC DOMESTIC 

FY Phase III Phase III Phase III Phase III 

Reported FY Funded Minority Total Minority Total 

2002 2001 18,308 30,311 92,961 444,436 

60.4% 100.0% 20.9% 100.0% 

2003 2002 23,927 49,410 109,376 486,857 

48.4% 100.0% 22.5% 100.0% 

2004 2003 37,126 49,126 125,813 496,241 

75.6% 100.0% 25.4% 100.0% 

2005 2004 44,281 55,098 109,910 437,902 

80.4% 100.0% 25.1% 100.0% 

2006 2005 84,412 99,133 83,034 400,297 

85.2% 100.0% 20.7% 100.0% 

2007 2006 156,533 162,713 79,769 383,050 

96.2% 100.0% 20.8% 100.0% 

Number of Minority Participants in Phase III Clinical Studies for FY 2002 - 2007 

400,000 

350,000 DOMESTIC Phase III 

300,000 Minority 

250,000 FOREIGN Phase III

Minority 200,000 

150,000 

100,000 

50,000 

0 

2002 2003 2004 2005 2006 2007 

Table 7F Comments: 

1. The Total Phase III Minority Foreign Participants increased from 60.4% in 2002 to 96.2% in 2007. 

2. The Total Phase III Minority Domestic Participants varied from 20.7% to 25.4% between 2002 and 2007. 

35 
Executive Summary 

Table 8: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Clinical 

Research Reported: FY2002-2007: Enrollment Using U.S. Race/Ethnicity Categories 

8A . FIVE YEAR SUMMARY TOTALS: DOMESTIC SUBJECTS IN DOMESTIC PROTOCOLS (Old + New Forms) 

Number of 

Domestic 

Protocols 

Total with 

Domestic Subtotal: Domestic Enrollment 

FY FY Subjects (Old Subjects Enrolled by US data (Old + 

Reported Funded Females Males Unknown + New Forms) Minority Categories New Forms): 

2002 2001 6,583,087 3,506,787 59,995 10,149,869 2,754,820 8,425 

% 64.9% 34.6% 0.6% 100.0% 27.1% 

2003 2002 7,392,404 4,393,496 125,457 11,911,357 2,935,363 9,578 

% 62.1% 36.9% 1.1% 100.0% 24.6% 

2004 2003 8,881,299 5,199,765 278,729 14,359,793 3,464,356 9,760 

% 61.8% 36.2% 1.9% 100.0% 24.1% 

2005 2004 7,887,209 4,515,242 267,407 12,669,858 3,468,864 9,862 

62.3% 35.6% 2.1% 100.0% 27.4% 

2006 2005 7,684,453 3,566,577 174,671 11,425,701 3,301,135 10,294 

67.3% 31.2% 1.5% 100.0% 28.9% 

2007 2006 9,397,957 6,389,817 392,814 16,180,588 4,283,738 10,463 

58.1% 39.5% 2.4% 100.0% 26.5% 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

Table 8A Comments 

1. There were approximately an average of 62.4% females, 36.0% males and 1.7% of unknown sex enrolled in domestic 

2. There were approximately an average of 26.3% domestic minority subjects enrolled in domestic protocols from 2002-2007. 

3. Total domestic enrollment ranged from 10.1M to 16.2M during the past 6 years. 

4. The number of domestic protocols increased from 8,425 to 10,463 in 6 years 

NOTE on FY2002 Reported Data: 

One domestic study had an enrollment of 540,833 subjects (Old Form). 

One domestic study had an enrollment of 1,571,305 subjects (Old Form). 

NOTE on FY2003 Reported Data: 

One domestic study had an enrollment of 800,000 subjects (New Form).

One domestic study had an enrollment of 1,389,920 subjects (New Form).

One domestic study had an enrollment of 1,799,820 subjects (New Form).

NOTE on FY2004 Reported Data: 

One domestic study had an enrollment of 540,833 subjects (New Form).

One domestic study had an enrollment of 800,000 subjects (New Form).

One domestic study had an enrollment of 1,138,302 subjects (New Form).

One domestic study had an enrollment of 1,419,475 subjects (New Form).

One domestic study had an enrollment of 1,799,820 subjects (New Form).

NOTE on FY2005 Reported Data: 

One domestic study had an enrollment of 540,833 subjects (New Form). 

One domestic study had an enrollment of 800,000 subjects (New Form). 

One domestic study had an enrollment of 1,595,620 subjects (New Form). 

One domestic study had an enrollment of 1,799,820 subjects (New Form). 

NOTE on FY2006 Reported Data: 

One domestic study had an enrollment of 875,010 subjects (New Form). 

One domestic study had an enrollment of 1,964,668 subjects (New Form). 

One domestic study had an enrollment of 540,833 subjects (New Form). 

NOTE of FY2007 Reported Data: 

One domestic study had an enrollment of 1,817,915 subjects (New Form). 

One domestic study had an enrollment of 1,879,841 subjects (New Form). 

One domestic study had an enrollment of 2,024,369 subjects (New Form). 

36 
Executive Summary 

Table 8: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research 

Reported in FY2002-2007: Enrollment Using U.S. Race/Ethnicity Categories 

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are 

from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate 

reporting for Foreign and Domestic Data. 

NOTE 2: Data from Tables 8B, 8C and 8D are combined to provide the summary data in Table A. 

8B. OLD FORM: Total of All Domestic Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity format 

FY 

Reported 

FY 

Funded 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, 

Not White White Unknown /Other 

Total 

Domestic 

Enrollment 

(Old Form) 

Domestic Subtotal 

Using US Minority 

Categories (shaded): 

OLD FORM 

Number of 

Domestic 

Protocols 

with 

Enrollment 

data (Old 

Form): 

2002 2001 45,639 752,203 673,726 378,300 3,880,431 316,053 6,046,352 1,849,868 5,783 

% 0.8% 12.4% 11.1% 6.3% 64.2% 5.2% 100.0% 30.6% 

2003 2002 36,238 249,420 455,329 264,336 3,100,815 266,339 4,372,477 1,005,323 4,478 

% 0.8% 5.7% 10.4% 6.0% 70.9% 6.1% 100.0% 23.0% 

2004 2003 28,953 196,647 322,078 194,762 2,273,619 157,464 3,173,523 742,440 2,702 

% 0.9% 6.2% 10.1% 6.1% 71.6% 5.0% 100.0% 23.4% 

2005 2004 22,375 89,119 210,465 126,351 1,245,337 93,239 1,786,886 448,310 1,736 

% 1.3% 5.0% 11.8% 7.1% 69.7% 5.2% 100.0% 25.1% 

2006 2005 19,628 51,701 148,224 74,312 866,683 61,480 1,222,028 293,865 1,361 

% 1.6% 4.2% 12.1% 6.1% 70.9% 5.0% 100.0% 24.0% 

2007 2006 5,372 51,740 238,003 81,677 1,095,702 48,625 1,521,119 376,792 1,092 

% 0.4% 3.4% 15.6% 5.4% 72.0% 3.2% 100.0% 24.8% 

8C. NEW FORM PART A: Inclusion Enrollment Report (Total of All Domestic Subjects Reported Using the 1997 OMB Standards 

for Separate Race and Ethnicity Formats) 

Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

FY 

Reported 

FY 

Funded 

American 

Indian or 

Alaska 

Native 

Asian 

Black or 

African 

American 

Native 

Hawaiian or 

Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown 

or Not 

Reported 

*Total of All 

Subjects by 

Racial 

Categories 

(New Form) 

Not 

Hispanic 

**Hispanic 

or Latino 

Unknown/ 

Not 

Reported 

*Total of All 

Subjects by 

Ethnic 

Category 

2002 2001 74,593 174,215 473,699 7,623 2,626,547 30,200 716,640 4,103,517 2,785,590 285,921 1,032,006 4,103,517 

% 1.8% 4.2% 11.5% 0.2% 64.0% 0.7% 17.5% 100.0% 67.9% 7.0% 25.1% 100.0% 

2003 2002 61,526 295,061 897,518 23,068 5,161,965 94,138 1,005,604 7,538,880 6,003,326 602,018 933,536 7,538,880 

% 0.8% 3.9% 11.9% 0.3% 68.5% 1.2% 13.3% 100.0% 79.6% 8.0% 12.4% 100.0% 

2004 2003 97,854 485,137 1,280,129 42,945 7,772,927 172,185 1,335,093 11,186,270 8,893,158 720,551 1,572,561 11,186,270 

% 0.9% 4.3% 11.4% 0.4% 69.5% 1.5% 11.9% 100.0% 79.5% 6.4% 14.1% 100.0% 

2005 2004 291,044 655,959 1,232,957 42,993 7,485,193 164,096 1,010,730 10,882,972 9,120,293 721,138 1,041,541 10,882,972 

% 2.7% 6.0% 11.3% 0.4% 68.8% 1.5% 9.3% 100.0% 83.8% 6.6% 9.6% 100.0% 

2006 2005 111,048 946,613 1,032,199 35,142 6,844,960 178,275 1,055,436 10,203,673 8,384,360 796,556 1,022,757 10,203,673 

% 1.1% 9.3% 10.1% 0.3% 67.1% 1.7% 10.3% 100.0% 82.2% 7.8% 10.0% 100.0% 

2007 2006 129,830 892,410 1,719,631 46,569 10,028,992 270,005 1,572,032 14,659,469 11,991,388 1,002,302 1,665,779 14,659,469 

% 0.9% 6.1% 11.7% 0.3% 68.4% 1.8% 10.7% 100.0% 81.8% 6.8% 11.4% 100.0% 

8D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative) Number of **Total of American Native Domestic Black or More Unknown Hispanics or Indian or Hawaiian or White Domestic Subtotal Protocols Asian African Than One or Not Latinos by Alaska Pacific (Hispanic) Using US Minority with American Race Reported Racial FY FY Native Islander Categories (shaded): Enrollment Categories Reported Funded NEW FORM Parts A+B data (New 

2002 2001 1,163 436 12,005 98 69,313 5,626 75,309 163,950 904,952 2,642 

% 0.7% 0.3% 7.3% 0.1% 42.3% 3.4% 45.9% 100.0% 22.1% 

2003 2002 3,756 1,950 13,345 678 349,844 23,560 208,885 602,018 1,930,040 5,100 

% 0.6% 0.3% 2.2% 0.1% 58.1% 3.9% 34.7% 100.0% 25.6% 

2004 2003 6,293 5,026 12,498 2,037 356,575 51,031 287,091 720,551 2,721,916 7,058 

% 0.9% 0.7% 1.7% 0.3% 49.5% 7.1% 39.8% 100.0% 24.3% 

2005 2004 22,057 7,810 19,282 1,981 362,707 36,503 270,798 721,138 3,020,554 8,126 

% 3.1% 1.1% 2.7% 0.3% 50.3% 5.1% 37.6% 100.0% 27.8% 

2006 2005 15,498 6,540 19,870 1,505 374,830 49,150 329,163 796,556 3,007,270 8,933 

% 1.9% 0.8% 2.5% 0.2% 47.1% 6.2% 41.3% 100.0% 29.5% 

2007 2006 20,932 6,875 28,078 3,199 493,196 94,717 355,305 1,002,302 3,906,946 9,371 

% 2.1% 0.7% 2.8% 0.3% 49.2% 9.4% 35.4% 100.0% 26.7% 

* These totals must agree 

** These totals must agree 

37 
Executive Summary 

Table 9: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical 

Research Reported in FY2002-2007:Enrollment Using U.S. Race/Ethnicity Categories 

9A . Phase III SIX YEAR SUMMARY TOTALS: DOMESTIC SUBJECTS IN DOMESTIC PROTOCOLS (Old + New 

Forms) 

Total 

Domestic Subtotal: Domestic Number of Domestic 

Subjects Subjects Enrolled Protocols with 

FY (Old + New by US Minority Enrollment data (Old + 

FY Reported Funded Females Males Unknown Forms) Categories New Forms): 

2002 2001 264,517 179,179 740 444,436 92,961 582 

% 59.5% 40.3% 0.2% 100.0% 20.9% 

2003 2002 266,913 218,166 1,778 486,857 109,376 643 

% 54.8% 44.8% 0.4% 100.0% 22.5% 

2004 2003 277,333 217,890 1,018 496,241 125,813 549 

% 55.9% 43.9% 0.2% 100.0% 25.4% 

2005 2004 261,589 174,137 2,176 437,902 109,910 517 

% 59.7% 39.8% 0.5% 100.0% 25.1% 

2006 2005 258,467 137,621 4,209 400,297 83,034 564 

% 64.6% 34.4% 1.1% 100.0% 20.7% 

2007 2006 228,289 183,878 16,273 428,440 88,339 609 

% 53.3% 42.9% 3.8% 100.0% 20.6% 

Table 9A Comments: 

1. There were approximately an average of 57.8% females, 41.2% males and 1.0% of unknown sex enrolled in Phase III domestic 

protocols from 2002-2007. 

2. There were approximately an average of 22.6% domestic minority subjects enrolled in domestic Phase III protocols from 2002-2007. 

3. Total domestic Phase III enrollment ranged from 400,297 to 496,241 during these 6 years. 

4. The number of domestic Phase III protocols ranged from 517 to 643 between Fiscal Years 2002 and 2007. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

38 
Executive Summary 

Table 9: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical 

Research Reported in FY2002-2007:Enrollment Using U.S. Race/Ethnicity Categories 

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority 

categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data 

reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for 

Foreign and Domestic Data. 

NOTE 2: Data from Tables 9B, 9C and 9D are combined to provide the summary data in Table A. 

9B. OLD FORM: Total of All Domestic Subjects Reported Using the 1977 OMB Standards in a combined 

race/ethnicity format 

FY Reported 

FY 

Funded 

America 

n Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, 

Not White White Unknown/ Other 

Total 

Domestic 

Enrollment 

(Old Form) 

Domestic Subtotal 

Using US Minority 

Categories 

(shaded): OLD 

FORM 

Number of Domestic 

Protocols with 

Enrollment data (Old 

Form): 

2002 2001 1,586 8,291 49,184 27,912 305,964 10,670 403,607 86,973 494 

% 0.4% 2.1% 12.2% 6.9% 75.8% 2.6% 100.0% 21.5% 

2003 2002 1,612 7,610 48,975 25,567 322,600 8,538 414,902 83,764 468 

% 0.4% 1.8% 11.8% 6.2% 77.8% 2.1% 100.0% 20.2% 

2004 2003 1,504 6,739 45,233 31,967 262,671 6,447 354,561 85,443 286 

% 0.4% 1.9% 12.8% 9.0% 74.1% 1.8% 100.0% 24.1% 

2005 2004 1,319 5,488 39,401 20,646 229,235 4,493 300,582 66,854 205 

% 0.4% 1.8% 13.1% 6.9% 76.3% 1.5% 100.0% 22.2% 

2006 2005 996 4,505 20,325 9,512 171,191 5,673 212,202 35,338 207 

% 0.5% 2.1% 9.6% 4.5% 80.7% 2.7% 100.0% 16.7% 

2007 2006 751 3,941 21,581 9,331 168,127 4,254 207,985 35,604 204 

% 0.4% 1.9% 10.4% 4.5% 80.8% 2.0% 100.0% 17.1% 

9C. NEW FORM Part A: Inclusion Enrollment Report (Total of All Domestic Subjects Reported Using the 1997 Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

FY Reported 

FY 

Funded 

America 

n Indian 

or Alaska 

Native 

Asian 

Black or 

African 

American 

Native 

Hawaiian 

or Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown 

or Not 

Reported 

*Total of All 

Subjects by 

Racial 

Categories 

(New Form) 

Not 

Hispanic 

**Hispani 

c or 

Latino 

Unknown/ 

Not 

Reported 

*Total of All Subjects 

by Ethnic Category 

2002 2001 159 798 3,199 52 34,541 560 1,520 40,829 34,662 1,629 4,538 40,829 

% 0.4% 2.0% 7.8% 0.1% 84.6% 1.4% 3.7% 100.0% 84.9% 4.0% 11.1% 100.0% 

2003 2002 477 2,586 14,031 220 46,774 989 6,878 71,955 55,575 7,828 8,552 71,955 

% 0.7% 3.6% 19.5% 0.3% 65.0% 1.4% 9.6% 100.0% 77.2% 10.9% 11.9% 100.0% 

2004 2003 1,396 4,373 22,307 611 106,260 1,849 4,884 141,680 123,770 10,863 7,047 141,680 

% 1.0% 3.1% 15.7% 0.4% 75.0% 1.3% 3.4% 100.0% 87.4% 7.7% 5.0% 100.0% 

2005 2004 1,775 4,920 24,390 462 93,662 3,063 9,048 137,320 118,528 9,773 9,019 137,320 

% 1.3% 3.6% 17.8% 0.3% 68.2% 2.2% 6.6% 100.0% 86.3% 7.1% 6.6% 100.0% 

2006 2005 2,724 5,312 23,267 530 118,577 4,077 33,608 188,095 141,688 13,550 32,857 188,095 

% 1.4% 2.8% 12.4% 0.3% 63.0% 2.2% 17.9% 100.0% 75.3% 7.2% 17.5% 100.0% 

2007 2006 2,314 4,294 21,141 553 130,085 3,974 58,094 220,455 146,482 21,600 52,373 220,455 

% 1.0% 1.9% 9.6% 0.3% 59.0% 1.8% 26.4% 100.0% 66.4% 9.8% 23.8% 100.0% 

9D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

FY Reported 

FY 

Funded 

America 

n Indian 

or Alaska 

Native 

Asian 

Black or 

African 

American 

Native 

Hawaiian 

or Pacific 

Islander 

White 

(Hispanic) 

More 

Than One 

Race 

Unknown 

or Not 

Reported 

**Total of 

Hispanics 

or Latinos 

by Racial 

Categories 

Domestic Subtotal 

Using US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B 

Number of Domestic 

Protocols with 

Enrollment data (New 

Form): 

2002 2001 49 21 31 4 660 304 560 1,629 5,988 88 

% 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0% 14.7% 

2003 2002 37 70 186 23 2,113 203 5,196 7,828 25,612 175 

% 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0% 35.6% 

2004 2003 269 59 193 26 7,262 482 2,572 10,863 40,370 263 

% 2.5% 0.5% 1.8% 0.2% 66.9% 4.4% 23.7% 100.0% 28.5% 

2005 2004 371 42 446 45 3,663 423 4,783 9,773 43,056 312 

% 3.8% 0.4% 4.6% 0.5% 37.5% 4.3% 48.9% 100.0% 31.4% 

2006 2005 458 47 507 40 5,544 712 6,242 13,550 47,696 357 

% 3.4% 0.3% 3.7% 0.3% 40.9% 5.3% 46.1% 100.0% 25.4% 

2007 2006 300 44 454 24 7,360 319 13,099 21,600 44,165 405 

% 1.4% 0.2% 2.1% 0.1% 34.1% 1.5% 60.6% 100.0% 23.9% 

* These totals must agree 

** These totals must agree 

39 
Executive Summary 

Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research 

Reported in FY2002-2007: Enrollment Using U.S. Race/Ethnicity Categories 

10A . SIX YEAR SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN PROTOCOLS (Old + New Forms) 

Number of 

Foreign 

Total Protocols 

Foreign with 

Subjects Subtotal: Foreign Enrollment 

FY FY (Old + New Subjects Enrolled by data (Old + 

Reported Funded Females Males Unknown Forms) US Minority Categories New Forms): 

2002 2001 553,056 379,294 13,833 946,083 777,461 482 

% 58.5% 40.1% 1.5% 100.0% 82.2% 

2003 2002 1,122,077 1,728,000 10,820 2,860,897 2,452,329 638 

% 39.2% 60.4% 0.4% 100.0% 85.7% 

2004 2003 2,007,798 2,542,127 14,202 4,564,127 4,147,255 365 

% 44.0% 55.7% 0.3% 100.0% 90.9% 

2005 2004 1,616,713 1,426,665 9,516 3,052,894 2,776,565 371 

% 53.0% 46.7% 0.3% 100.0% 90.9% 

2006 2005 1,788,820 1,605,628 10,781 3,405,229 3,087,181 464 

% 52.5% 47.2% 0.3% 100.0% 90.7% 

2007 2006 754,633 497,976 15,261 1,267,870 932,686 451 

% 59.5% 39.3% 1.2% 100.0% 73.6% 

Table 10AComments: 

1. The percent females varied from 39.2% to 59.5% in foreign protocols from 2002-2007; the percent males varied from 39.3% to 60.4%. 

2. The percent foreign subjects enrolled using OMB racial/ethnic categories in foreign protocols varied from 73.6% to 90.9% from 2002 

to 2007. 

3. Total foreign enrollment ranged from 946,083 to 4,564,127 during the past 6 years. 

4. The number of foreign protocols ranged from 365 to 638 during the past 6 years 

NOTE on FY2002 Reported Data: 

One study in Vietnam had an enrollment of 302,381 subjects (Old Form). 

NOTE on FY2003 Reported Data: 

One study in Vietnam had an enrollment of 302,381 subjects (Old Form). 

One study in China had an enrollment of 1,910,000 subjects (New Form). 

NOTE on FY2004 Reported Data: 

One study in China had an enrollment of 1,910,000 subjects (New Form). 

One study in India had an enrollment of 2,000,000 subjects (New Form). 

NOTE on FY2005 Reported Data: 

One study in India had an enrollment of 2,200,000 subjects (New Form). 

NOTE on FY2006 Reported Data: 

One study in India had an enrollment of 2,200,000 subjects (New Form). 

NOTE on FY2007 Reported Data: 

No foreign studies reported an enrollment greater than 100,000 subjects. 

40 
Executive Summary Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research 

Reported in FY2002-2007: Enrollment Using U.S. Race/Ethnicity Categories 

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority 

categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported 

in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and 

Domestic Data. 

NOTE 2: Data from Tables 10B, 10C and 10D are combined to provide the summary data in Table A. 

10B.OLD FORM: Total of All FOREIGN Subjects Reported Using the 1977 OMB Standards in a combined 

race/ethnicity format 

Number of 

FY FY 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, Not 

White White Unknown/ Other 

Total 

Foreign 

Enrollment 

(Old Form) 

FOREIGN Subtotal 

Using US Minority 

Categories (shaded): 

Foreign 

Protocols 

with 

Enrollment 

data (Old 

Reported Funded OLD FORM Form): 

2002 2001 69 468,958 21,407 19,075 143,768 3,565 656,842 509,509 380 

% 0.0% 71.4% 3.3% 2.9% 21.9% 0.5% 100.0% 77.6% 

2003 2002 341 481,122 17,097 24,187 137,469 12,562 672,778 522,747 425 

% 0.1% 71.5% 2.5% 3.6% 20.4% 1.9% 100.0% 77.7% 

2004 2003 434 110,405 20,110 19,560 74,910 14,666 240,085 150,509 80 

% 0.2% 46.0% 8.4% 8.1% 31.2% 6.1% 100.0% 62.7% 

2005 2004 0 165,479 19,150 8,621 21,752 9,166 224,168 193,250 50 

% 0.0% 73.8% 8.5% 3.8% 9.7% 4.1% 100.0% 86.2% 

2006 2005 20 80,085 724 4,284 16,358 1,751 103,222 85,113 30 

% 0.0% 77.6% 0.7% 4.2% 15.8% 1.7% 100.0% 82.5% 

2007 2006 0 2 1 1,515 1,685 5 3,208 1,518 6 

% 0.0% 0.1% 0.0% 47.2% 52.5% 0.2% 100.0% 47.3% 

10C. NEW FORM Part A: Inclusion Enrollment Report (Total of All FOREIGN Subjects Reported Using the 1997 

OMB Standards for Separate Race and Ethnicity Formats) 

Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

FY 

Reported 

FY 

Funded 

American 

Indian or 

Alaska 

Native 

Asian 

Black or 

African 

American 

Native 

Hawaiian or 

Pacific 

Islander 

White More Than 

One Race 

Unknown 

or Not 

Reported 

*Total of All 

Subjects by 

Racial 

Categories 

(New Form) 

Not 

Hispanic 

**Hispanic 

or Latino 

Unknown/ 

Not 

Reported 

*Total of All 

Subjects by 

Ethnic 

Category 

2002 2001 3,271 180,022 68,071 14,013 19,970 741 3,153 289,241 278,618 6,064 4,559 289,241 

% 1.1% 62.2% 23.5% 4.8% 6.9% 0.3% 1.1% 100.0% 96.3% 2.1% 1.6% 100.0% 

2003 2002 2,018 1,842,941 62,572 14,501 253,745 5,324 7,018 2,188,119 2,158,933 9,623 19,563 2,188,119 

% 0.1% 84.2% 2.9% 0.7% 11.6% 0.2% 0.3% 100.0% 98.7% 0.4% 0.9% 100.0% 

2004 2003 193 3,860,259 99,728 11,507 292,142 14,056 46,157 4,324,042 4,275,684 35,788 12,570 4,324,042 

% 0.0% 89.3% 2.3% 0.3% 6.8% 0.3% 1.1% 100.0% 98.9% 0.8% 0.3% 100.0% 

2005 2004 1,171 2,390,404 125,305 10,293 187,697 18,857 94,999 2,828,726 2,683,871 52,801 92,054 2,828,726 

% 0.0% 84.5% 4.4% 0.4% 6.6% 0.7% 3.4% 100.0% 94.9% 1.9% 3.3% 100.0% 

2006 2005 30,519 2,516,589 219,140 3,318 244,057 143,279 145,105 3,302,007 2,923,885 257,756 120,366 3,302,007 

% 0.9% 76.2% 6.6% 0.1% 7.4% 4.3% 4.4% 100.0% 88.5% 7.8% 3.6% 100.0% 

2007 2006 15,587 464,490 293,064 10,580 312,491 8,063 160,387 1,264,662 1,025,736 166,790 72,136 1,264,662 

% 1.2% 36.7% 23.2% 0.8% 24.7% 0.6% 12.7% 100.0% 81.1% 13.2% 5.7% 100.0% 

10D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Number of 

**Total of Foreign American Native Black or Unknown Hispanics Protocols Indian or Hawaiian or White More Than Asian African or Not or Latinos FOREIGN Subtotal with Alaska Pacific (Hispanic) One Race American Reported by Racial Using US Minority Enrollment Native Islander FY FY Categories Categories (shaded): data (New 

Reported Funded NEW FORM Parts A+B Form): 

2002 2001 1,461 0 4 0 1,659 683 175 3,982 267,952 102 

% 36.7% 0.0% 0.1% 0.0% 41.7% 17.2% 4.4% 100.0% 92.6% 

2003 2002 1,644 3 1,222 0 632 4,528 1,594 9,623 1,929,582 213 

% 17.1% 0.0% 12.7% 0.0% 6.6% 47.1% 16.6% 100.0% 88.2% 

2004 2003 115 14 12,778 0 4,537 11,878 6,466 35,788 3,996,746 285 

% 0.3% 0.0% 35.7% 0.0% 12.7% 33.2% 18.1% 100.0% 92.4% 

2005 2004 682 6 164 0 26,161 14,664 11,124 52,801 2,583,315 321 

% 1.3% 0.0% 0.3% 0.0% 49.5% 27.8% 21.1% 100.0% 91.3% 

2006 2005 29,576 101 1,842 688 42,665 136,326 46,558 257,756 3,002,068 434 

% 11.5% 0.0% 0.7% 0.3% 16.6% 52.9% 18.1% 100.0% 90.9% 

2007 2006 16,681 550 3,234 1,115 46,034 5,816 93,360 166,790 931,178 445 

% 10.0% 0.3% 1.9% 0.7% 27.6% 3.5% 56.0% 100.0% 73.6% 

* These totals must agree 

** These totals must agree 

41 
Table 11. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical 

Research Reported in FY2002-2007: Enrollment Using U.S. Race/Ethnicity Categories 

11A. Part A. Phase III SIX YEAR SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN PROTOCOLS (Old + New Forms) 

Number of 

Foreign 

Protocols 

with 

Total Foreign Subtotal: Foreign Enrollment 

FY FY Subjects (Old Subjects Enrolled by US data (Old + 

Reported Funded Females Males Unknown + New Forms) Minority Categories New Forms): 

2002 2001 14,359 15,911 41 30,311 18,308 172 

% 47.4% 52.5% 0.1% 100.0% 60.4% 

2003 2002 28,037 21,237 136 49,410 23,927 209 

% 56.7% 43.0% 0.3% 100.0% 48.4% 

2004 2003 24,020 25,023 83 49,126 37,126 24 

% 48.9% 50.9% 0.2% 100.0% 75.6% 

2005 2004 29,388 23,163 2,547 55,098 44,281 30 

% 53.3% 42.0% 4.6% 100.0% 80.4% 

2006 2005 55,599 42,354 1,180 99,133 84,412 60 

% 56.1% 42.7% 1.2% 100.0% 85.2% 

2007 2006 96,405 

59.2% 

65,755 

40.4% 

559 162,719 156,593 44 

% 0.3% 100.0% 96.2% 

Executive Summary 

Table 11A Comments: 

1. The percent females varied from 47.4% to 59.2% in Phase III foreign protocols from 2002-2007; the percent males varied 

from 40.4% to 52.5%. 

2. The percent foreign subjects enrolled by U.S. Minority Categories in Phase III foreign protocols increased from 60.4% to 

96.2% from 2002 to 2007. 

3. Total Phase III foreign enrollment increased from 30,311 to 162,719 during these 6 years. 

4. The number of Phase III foreign protocols ranged from 24 to 209 between the years 2002 and 2007. 

42 
Executive Summary 

Table 11. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical 

Research Reported in FY2002-2007: Enrollment Using U.S. Race/Ethnicity Categories 

NOTE 1: The shaded portions of the Tables B, C and D below show the race/ethnicity categories that are identified as minority 

categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data 

reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign 

and Domestic Data. 

NOTE 2: Data from Tables 11B, 11C and 11D are combined to provide the summary data in Table A. 

11B.OLD FORM: Total of All FOREIGN Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity format 

FY 

Reported 

FY 

Funded 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, 

Not White White Unknown/ Other 

Total Foreign 

Enrollment 

(Old Form) 

FOREIGN Subtotal 

Using US Minority 

Categories (shaded): 

OLD FORM 

Number of 

Foreign 

Protocols 

with 

Enrollment 

data (Old 

Form): 

2002 2001 59 12,269 2,807 1,724 9,579 1,558 27,996 16,859 166

% 0.2% 43.8% 10.0% 6.2% 34.2% 5.6% 100.0% 60.2% 

2003 2002 77 12,428 280 3,499 15,054 8,077 39,415 16,284 188 

% 0.2% 31.5% 0.7% 8.9% 38.2% 20.5% 100.0% 41.3% 

2004 2003 1 12,068 52 1,007 3,093 7,603 23,824 13,128 10 

% 0.0% 50.7% 0.2% 4.2% 13.0% 31.9% 100.0% 55.1% 

2005 2004 0 12,252 1 1,183 2,257 14 15,707 13,436 5 

% 0.0% 78.0% 0.0% 7.5% 14.4% 0.1% 100.0% 85.5% 

2006 2005 16 12,295 30 12 4,533 675 17,561 12,353 8 

% 0.1% 70.0% 0.2% 0.1% 25.8% 3.8% 100.0% 70.3% 

2007 2006 0 2 1 2 1,662 5 1,672 5 1 

% 0.0% 0.1% 0.1% 0.1% 99.4% 0.3% 100.0% 0.3% 

11C. NEW FORM Part A: Inclusion Enrollment Report (Total of All FOREIGN Subjects Reported Using the 1997 OMB 

Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

FY 

Reported 

FY 

Funded 

American 

Indian or 

Alaska 

Native 

Asian 

Black or 

African 

American 

Native 

Hawaiian 

or Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown 

or Not 

Reported 

*Total of All 

Subjects by 

Racial 

Categories 

(New Form) 

Not 

Hispanic 

**Hispanic 

or Latino 

Unknown/ 

Not 

Reported 

*Total of All 

Subjects by 

Ethnic 

Category 

2002 2001 0 1 1,448 0 113 0 753 2,315 1,562 0 753 2,315 

% 0.0% 0.0% 62.5% 0.0% 4.9% 0.0% 32.5% 100.0% 0.0% 32.5% 32.5% 

2003 2002 7 23 7,610 0 1,095 0 1,260 9,995 8,720 3 1,272 9,995 

% 0.1% 0.2% 76.1% 0.0% 11.0% 0.0% 12.6% 100.0% 87.2% 0.0% 12.7% 100.0% 

2004 2003 0 12 21,414 0 553 2,570 753 25,302 21,972 2,572 758 25,302 

% 0.0% 0.0% 84.6% 0.0% 2.2% 10.2% 3.0% 100.0% 86.8% 10.2% 3.0% 100.0% 

2005 2004 389 4,272 25,948 0 7,576 0 1,206 39,391 38,122 624 645 39,391 

% 1.0% 10.8% 65.9% 0.0% 19.2% 0.0% 3.1% 100.0% 96.8% 1.6% 1.6% 100.0% 

2006 2005 1,906 27,048 27,513 5 8,093 169 26,838 91,572 60,670 17,484 3,418 81,572 

% 2.1% 29.5% 30.0% 0.0% 8.8% 0.2% 29.3% 100.0% 74.4% 21.4% 4.2% 100.0% 

2007 2006 7,037 43,070 63,327 2 2,917 171 44,523 161,047 108,210 50,022 2,815 161,047 

% 4.4% 26.7% 39.3% 0.0% 1.8% 0.1% 27.6% 100.0% 67.2% 31.1% 1.7% 100.0% 

11D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

FY 

Reported 

FY 

Funded 

American 

Indian or 

Alaska 

Native 

Asian 

Black or 

African 

American 

Native 

Hawaiian 

or Pacific 

Islander 

White 

(Hispanic) 

More 

Than One 

Race 

Unknown 

or Not 

Reported 

**Total of 

Hispanics or 

Latinos by 

Racial 

Categories 

FOREIGN Subtotal 

Using US Minority 

Categories (shaded): 

NEW FORM Parts A+B 

Number of 

Foreign 

Protocols 

with 

Enrollment 

data (New 

Form): 

2002 2001 0 0 0 0 0 0 0 0 1,449 6 

% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 62.6% 

2003 2002 0 0 0 0 2 0 1 3 7,643 21 

% 0.0% 0.0% 0.0% 0.0% 66.7% 0.0% 33.3% 100.0% 76.5% 

2004 2003 0 0 0 0 2 2,570 0 2,572 23,998 14 

% 0.0% 0.0% 0.0% 0.0% 0.1% 99.9% 0.0% 100.0% 94.8% 

2005 2004 388 0 0 0 4 0 232 624 30,845 25 

% 62.2% 0.0% 0.0% 0.0% 0.6% 0.0% 37.2% 100.0% 78.3% 

2006 2005 1,849 3 213 0 1,328 1 14,090 17,484 72,059 52 

% 10.6% 0.0% 1.2% 0.0% 7.6% 0.0% 80.6% 100.0% 78.7% 

2007 2006 7,033 1 4 0 70 3 42,911 50,022 156,588 43 

% 14.1% 0.0% 0.0% 0.0% 0.1% 0.0% 85.8% 100.0% 97.2% 

* These totals must agree 

** These totals must agree 

43 
45

APPENDICES 

Page

Appendix A Full Historical Narrative on the Implementation of the NIH Inclusion Policy..............47 

Appendix B Explanation of Gender and Minority Codes ..................................................................59 

Appendix C NIH Tracking and Inclusion Committee Members List ................................................61 

Appendix D Internet Homepage: Inclusion of Women and Minorities – Policy Implementation .....67 

Appendix E NIH Policy and Guidelines on the Inclusion of Women and Minorities as 

Subjects in Clinical Research – Amended, October 2001 .............................................71 

Appendix F NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research ......87 

Appendix G NIH Inclusion Tables for Target and Enrollment Data..................................................99 

Appendix H Comparison of 1977 and 1997 OMB Standards for Classification for Reporting 

 Race and Ethnicity .......................................................................................................105 

Appendix I FY2007 Aggregate Extramural and Intramural Data Tables .......................................109 
46

 
47

Appendix A 

Historical Narrative on the 

Implementation of the 

NIH Inclusion Policy 
48
49

Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research

Historical Background

The establishment and implementation of policies for the inclusion of women and minorities in clinical 

research funded by the National Institutes of Health (NIH) has its origins in the women’s health 

movement. Following the issuance of the report of the Public Health Service Task Force on Women’s 

Health in 1985, the NIH established a policy in 1986 for the inclusion of women in clinical research. This 

policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and 

Contracts in 1987. Later that year, minority and other scientists at the NIH recognized the need to address 

the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a policy 

encouraging the inclusion of minorities in clinical studies was first published. 

In July 1989, an NIH Memorandum on Inclusion stated that research solicitations should encourage 

inclusion of women and minorities and require a rationale if excluded, and that executive secretaries of 

scientific review groups should ensure that responsiveness to policy would be addressed and indicated in 

summary statements. In 1990, the Congressional Caucus for Women’s Issues requested the U.S. General 

Accounting Office (GAO) to conduct an investigation into the implementation of the guidelines for the 

inclusion of women by NIH. This report, in Congressional testimony, indicated that the implementation 

of the policy for the inclusion of women was slow, not well communicated, that gender analysis was not 

implemented, and that the impact of this policy could not be determined. The GAO testimony also 

indicated that there were differences in the implementation of the policy recommending the inclusion of 

minorities, and that not all Institutes and Centers (ICs) factored adherence to these policies into the 

scientific merit review. 

In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made 

what had previously been policy into Public Law, through a section in the NIH Revitalization Act of 1993 

(PL 103-43)1

, entitled Women and Minorities as Subjects in Clinical Research. In 1994, the NIH revised 

its inclusion policy to meet this mandate that women and minorities must be included in all of its clinical 

research studies. The Revitalization Act essentially reinforced the existing NIH policies, but with four 

major differences: 

• that NIH ensure that women and minorities and their subpopulations be included in all clinical 

research; 

• that women and minorities and their subpopulations be included in Phase III clinical trials in numbers 

adequate to allow for valid analyses of differences in intervention effect; 

• that cost is not allowed as an acceptable reason for excluding these groups; and, 

• that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities 

and their subpopulations as participants in clinical studies 

Revised inclusion guidelines developed in response to this law were published in the Federal Register2

 in 

March 1994, and they became effective in September 1994. The result was that NIH could not and would 

not fund any grant, cooperative agreement or contract or support any intramural project to be conducted 

or funded in Fiscal Year 1995 and thereafter which did not comply with this policy. NIH administrative 

procedures allow consideration of applications through a peer-review system. During initial peer review, 

the Scientific Review Group (SRG) evaluates the proposed enrollment of each project involving human 

subjects and determines whether the plan to include women and minority subjects is scientifically 

acceptable. The implementation plan determines that an application may be unacceptable if it: 1) fails to 

provide sufficient information about target enrollment; 2) does not adequately justify limited or lack of 
50

inclusion of women or minorities; or 3) does not realistically address recruitment and retention. For NIHdefined Phase III clinical trials, the Scientific Review Group (SRG) also evaluates the description of plans 

to conduct analyses, as appropriate, to address differences in the intervention effect by sex/gender and/or 

racial/ethnic groups. Applications with unacceptable inclusion plans receive an unacceptable gender or 

minority code, resulting in a bar-to-funding. Such clinical research studies cannot be funded until NIH 

staff is assured of compliance from the investigators. This may involve changes related to study design. 

Sometimes applicants are able to remedy the deficiencies found during initial review by providing 

additional information about the intended enrollment demographics. Research awards covered by this 

policy require the grantee to report annually on enrollment of women and men, and on the race and 

ethnicity of research participants so that accrual can be monitored. Annual progress reports submitted by 

the grantee contain information on research progress which includes research participant enrollment, 

retention, and when available, preliminary and/or final analyses including analyses by sex/gender and 

race/ethnicity.

Strategies to ensure uniform implementation of the revised guidelines across the NIH were developed 

through the establishment and deliberations of an NIH Tracking and Inclusion Committee made up of 

representatives of the directors of each of the ICs. This trans-NIH committee, convened by the Office of 

Research on Women’s Health (ORWH) and co-chaired with a senior IC official, meets on a regular basis, 

focusing on consistent and widespread adherence to the NIH guidelines by all the ICs. Working in 

collaboration with the Office of Extramural Research (OER), the Office of Intramural Research (OIR), 

and other components of the NIH, the ORWH coordinates the activity of developing and establishing data 

collection and reporting methodologies to ensure uniform standards and definitions in the reporting of 

data on women and minority participants in NIH-funded clinical research. 

To ensure NIH-wide adherence to the revised inclusion guidelines, in 1994 NIH conducted extensive 

training on the revised inclusion guidelines for more than 1,000 NIH staff members with review, program, 

grants management, and/or contract management responsibilities. Additionally, four publications were 

distributed to further reinforce adherence to the revised inclusion guidelines.(5-8) NIH staff, in turn, 

clarified the requirements to applicants, reviewers, and other members of the research community. NIH 

staff members, reviewers, and applicants received written guidance about the requirements that outlined, 

in great detail, the circumstances under which it may be acceptable to use study populations deficient in 

women or minority participants, pointing out that the justification must be compelling and the scientific 

objectives of the research must be maintained. Training was especially important in light of 1990 GAO 

findings that an earlier policy was inconsistently applied and had not been well communicated or 

understood within the NIH or in the research community. 

A variety of outreach activities were initiated to explain the revised policy to the scientific research 

community and to clear up common misunderstandings about the new requirements. Recognizing the 

importance of both recruitment and retention of human subject volunteers, NIH issued several articles(9-10)

and an outreach notebook, entitled Outreach Notebook for the NIH Guidelines on Inclusion of Women 

and Minorities as Subjects in Clinical Research (http://orwh.od.nih.gov/inclusion/outreach.pdf), that 

outlines elements of outreach processes, offers practical suggestions, and provides references to additional 

sources of information. The outreach notebook is available on the Office of Research on Women’s 

Health Website http://orwh.od.nih.gov. It also includes the full text of the 1994 implementation guidelines 

as well as a questions and answers document to provide more detailed policy guidance and some of the 

more commonly asked questions. The ORWH also has available a full report of its workshop on 

“Recruitment and Retention of Women in Clinical Studies."
In June 1994, the ORWH convened a meeting of Institutional Review Board (IRB) chairs to discuss their 

role in implementing the revised policy. In 1996, ORWH reconvened these IRB chairs, along with 

representative members of the ORWH Recruitment and Retention Task Force, other experts, and 

representatives from NIH ICs, to discuss their experiences in implementing the 1994 guidelines. In these 

meetings, investigators expressed a number of lingering concerns, most notably whether it was realistic 

for the law to declare that cost is not a factor in designing clinical studies. Participants also raised 

questions about inclusion of women of childbearing potential, liability in clinical trials, and barriers to the 

recruitment of minority subjects. Other participants, however, noted that their worst fears about the 1994 

guidelines did not materialize, in part because NIH focused on scientific considerations when developing 

its policy. They reported improved collaboration among institutions and emphasized the continued need 

for better outreach and for sharing information about effective recruitment strategies. Many noted the 

importance of considering community concerns, particularly those of minority populations who may feel 

that they are not included in enough research studies or who do not receive research results after 

participating in studies. 

Continuing Implementation and Monitoring Activities: 2000 to the Present 

Following a Congressional request for an assessment of NIH’s progress in implementing the1994 

guidelines on including women in clinical research, the GAO issued another report in May, 2000, entitled 

Women’s Health - NIH Has Increased Its Efforts to Include Women in Research.3

 It concluded that in the 

past decade, NIH has made significant progress in implementing a strengthened policy on including 

women in clinical research and highlighted several examples: 

• NIH issued guidelines to implement the 1993 NIH Revitalization Act and conducted extensive 

training for scientists and reviewers; 

• the review process for extramural research treats the inclusion of women and minorities as a matter of 

scientific merit, affecting a proposal’s eligibility for funding; 

• the intramural research program now implements the inclusion policy; 

• NIH maintains a centralized inclusion tracking data system which serves as a tool for monitoring the 

implementation of the inclusion policy; and 

• in fiscal year 1997, more that 62% of participants in NIH-funded clinical research studies were 

women; minority women were also well represented, however, the proportion of Hispanic women 

enrolled was below their proportion in the general population. 

The GAO report also included two specific recommendations to the Director of NIH to ensure the 

following: 

• that the requirement be implemented that Phase III clinical trials be designed and carried out to 

allow for the valid analysis of differences between women and men and communicate this 

requirement to applicants as well as requiring peer review groups to determine whether each 

proposed Phase III clinical trial is required to have such a study design, and that summary 

statements document the decision of the initial reviewers; and 

• that the NIH staff who transmit data to the inclusion tracking data system receive ongoing 

training on the requirements and purpose of the system. 

51
Immediately following the release of this report, an NIH Subcommittee Reviewing Inclusion Issues was 

formed, consisting of representatives from several ICs, ORWH, OER, and OIR, to reexamine NIH’s 

system for tracking data on the inclusion of women and minorities in clinical research, recommend any 

necessary changes to improve its accuracy and performance, and reiterate the NIH policy. Several actions 

resulted to clarify the requirement for NIH-defined Phase III clinical trials to include women and minority 

groups, if scientifically appropriate, and for analysis of sex/gender and/or racial/ethnic differences to be 

planned and conducted by investigators engaged in NIH-funded research. These included: 

• In October 2001, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as 

Subjects in Clinical Research and Amended Notice to the Guide for Grants and Contracts were 

updated and posted on the Internet with links to the ORWH home page and NIH web page, 

Inclusion of Women and Minorities Policy Implementation at: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm. These documents supercede the 

1994 Federal Register notice ( http://grants.nih.gov/grants/guide/notice-files/not94-100.html) and the 

August 2000 notice in the NIH Guide to Grants and Contracts 

(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). These updated versions 

incorporate the definition of clinical research as reported in the 1997 Report of the NIH Director’s 

Panel on Clinical Research and the Office of Management and Budget (OMB) Directive 15 racial and 

ethnic categories to be used when reporting population data. They also provide additional guidance 

on reporting analyses of sex/gender and racial/ethnic differences in intervention effects for NIHdefined Phase III clinical trials (See Appendix E). 

• The 1997 Report of the NIH Director’s Panel on Clinical Research defined clinical research as: 

(1) Patient-oriented research. Research conducted with human subjects (or on material of 

human origin such as tissues, specimens and cognitive phenomena) for which an 

investigator (or colleague) directly interacts with human subjects. Excluded from this 

definition are in vitro studies that utilize human tissues that cannot be linked to a living 

individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) 

therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) 

Epidemiologic and behavioral studies; and (3) Outcomes research and health services 

research http://www.nih.gov/news/crp/97report/execsum.htm

• The 1997 Office of Management and Budget (OMB) Directive 15 minimum standards for 

maintaining, collecting and reporting data on race and ethnicity were incorporated into the 

updated Guide Notice for Grants and Contracts. The primary differences from the previous 

categories were: (1) the Hispanic population are considered an ethnicity and reported separately 

from racial data; (2) there is a separate racial category for Asian population data and Hawaiian 

and Pacific Islander population data; and 3) respondents are given the option of selecting more 

than one race. http://www.whitehouse.gov/omb/fedreg/ombdir15.html (See Appendix E) 

• An NIH Guide Notice was posted on the Internet with a link to the web page, Inclusion of Women 

and Minorities Policy Implementation at: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm. This restated that NIHdefined Phase III clinical trials must be designed and conducted in a manner sufficient to allow 

for a valid analysis of whether the variables being studied affect women or members of minority 

groups differently than other subjects. 

• A new term and condition of award statement was developed and applied to awards made after 

October 1, 2000 that have NIH-defined Phase III clinical trials. This statement indicates that a 

description of plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups 

52
must be included in clinical trial protocols and the results of subset analyses must be reported to NIH 

in Progress Reports, Competitive Renewal Applications (or Contract Renewals/Extensions) and in the 

required Final Progress Report. 

• Effective October 1, 2000, language was incorporated in the NIH solicitations for grant applications 

and contract proposals [Program Announcements (PAs), Request for Applications (RFAs), and 

Request for Proposals (RFPs)] that stated the requirements for NIH-defined Phase III clinical trials 

clarifying the requirements that: a) all applications or proposals and/or protocols must provide a 

description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or 

racial/ethnic groups, including subgroups if applicable, and b) all investigators must report accrual, 

and conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 

• In April 2001, guidelines and instructions for reviewers and Scientific Review Administrators (SRAs) 

were developed to emphasize and clarify the need to review research proposals that are classified as 

NIH-defined Phase III clinical trials for both inclusion requirements and issues related to analyses by 

sex/gender and/or race/ethnicity. Instructions were developed for the proper documentation to 

include in summary statements to address adherence to these policies. 

• Following completion of the updated guidelines and instructions, training to ensure compliance with 

this policy was provided to NIH program and review officials, grants and contracts management staff, 

and current and prospective research investigators. Several training initiatives were implemented: 

• As part of an NIH Symposium: Human Subjects Update, the revised policy on inclusion of 

women and minorities and the revised NIH Instructions to Reviewers Guidelines for Evaluating 

the Inclusion of Women and Minorities as Subjects in Clinical Research were used as the basis 

for a required training session for NIH staff. The revised training materials are permanently 

archived in the training materials for NIH staff on the NIH OER Intranet. 

• An additional training session regarding a Grants Policy Update: Humans and Animals was held 

in December, 2000 where several hundred additional extramural and intramural researchers were 

trained. Additional training materials for NIH staff that addresses the inclusion of human subjects 

can be found on the NIH OER Intranet.

• Additional training sessions were held for all NIH program and grants management staff 

• The PHS 398 Grant Application was significantly revised to provide additional instructions about the 

Women and Minorities Inclusion Policy and the revised form became mandatory as of May 10, 2005. 

These PHS 398 instructions about the Women and Minorities Inclusion Policy have also been 

included in the new federal application form SF-424 for NIH grants using the federal Grants.gov 

system (see http://era.nih.gov/ElectronicReceipt/). The application instructions included two 

significant changes in definitions. First, the NIH required use of a revised definition of clinical 

research (see below) that was reported in the 1997 Report of the NIH Director’s Panel on Clinical 

research and adopted by NIH. Secondly, the Office of Management and Budget (OMB) Directive 

15, “Race and Ethnic Standards for Federal Statistics and Administrative Reporting”, revised the 

definitions for the racial and ethnic categories to be used when reporting population data (see: 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html). In addition, NIH policy 

reemphasized that that NIH-defined Phase III clinical trials must be designed and conducted in a 

manner to allow for a valid analysis of whether the variables being studied affect women or members 

of minority groups differently than other subjects. 

53
• A videocast training session was held on “Sex/Gender and Minority Inclusion in Clinical Research.” 

This session was developed for all program, grants management, review and contract staff who 

administer clinical research and provided information on the updated policies and procedures on 

sex/gender and minority inclusion. A comprehensive training manual explaining the new policies and 

procedures was developed as a training resource. The training session and manual is electronically 

available for all NIH staff. 

• Reviewers are instructed on the policy through instructions provided with review materials as well as 

by orientation from the Scientific Review Administrator at the beginning of each SRG meeting. 

Additionally, a training session, “Inclusion of Children, Women, and Minorities: What SRA’s and 

Reviewers Need to Know!” was held for the Center for Scientific Review and highlighted the 

requirements and issues for scientific review staff. 

• The Clinical Center now has available a web-based educational module for the comprehensive 

training programs for intramural and other research investigators. All principal investigators are 

required to complete the Clinical Research Training Course for Intramural Investigators or 

equivalent prior to implementing a protocol and consideration is being given to making this a 

requirement for all investigators. 

The NIH has a public web-based educational module also available any investigators and key 

personnel involved in clinical research, whether in the extramural research community or at NIH 

entitled “Human Participant Protections Education for Research Teams” at 

http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp.This training course is 

one way for investigators to meet the requirement for human subjects education for all key personnel 

involved in NIH funded human subjects research. 

• In 2003, the ORWH sponsored a workshop entitled, “Science Meets Reality: Recruitment and 

Retention of Women in Clinical Studies, and the Critical Role of Relevance.” This workshop 

discussed lessons learned, continuing challenges and emerging ethical and policy issues concerning 

the recruitment and retention of women and other participants in clinical studies over the past decade. 

A copy of the report from the workshop is available on the ORWH website at 

http://orwh.od.nih.gov/pubs/SMR_Final.pdf. 

The Office of Extramural Research (OER) has made available existing training materials on the 

Population tracking system website on the NIH Intranet. Information include: the training workbook, 

“Sex/Gender and Minority Inclusion in Clinical Research”, a series of quick tips and case examples as 

well as the Help section of the Population Tracking module itself. Both OER and IC staff have provided 

training sessions at ICs, and the improvements have been presented to the main NIH functional groups 

representing program, review, policy, grants, budget and administrative support staff, as well as the NIHwide Tracking and Inclusion Committee and the eRA Population Trackng User Group. The availability of 

training documents on the eRA Population Tracking User Group website has been widely distributed to 

NIH extramural staff. A training subcommittee of the full NIH Tracking and Inclusion committee has 

been established to develop new training documents and methods of training for NIH staff and the 

extramural research community during FY2007.

Major changes have been made to the Population tracking system to help NIH staff in monitoring 

compliance with the NIH Inclusion policy. For example, the Population Tracking Grant Snapshot report 

was revised to provide easy access for NIH staff to the population data. Additionally, several Population 

Inclusion reports were added to the NIH Query View Report (QVR) system, thus providing broader 

access to the data. As well, user roles were revised and expanded to all the Division of Extramural 

54
Activities Support (DEAS) staff to assist in the data entry functions. The NIH Population Tracking 

Module for NIH staff was converted into a web-based application for easier access by NIH staff, with 

extensive participation and testing by module users, and the number of users has increased. 

Communication and Outreach Efforts to the Scientific Community 

In addition to training NIH staff on the updated guidelines for monitoring the inclusion of women and 

minorities in clinical research and the purpose of the new tracking system, NIH staff is providing outreach 

to the scientific community to help increase understanding of the revised inclusion policy and OMB 

requirements. These include: 

• The slide show, “Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators 

Need to Know!” was made available to Institute and Center staff to assist them in working with the 

extramural community. This information was also presented at regional meetings attended by 

extramural scientists and administrators, faculty and students. 

• The Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in 

Clinical Research was published in the fall of 2002 and is available to the research community and 

NIH staff. This publication discusses the elements of recruitment and retention, the NIH inclusion 

policy, 1997 OMB requirements for reporting race and ethnicity data, as well as information for 

application submission, peer review, and funding. The publication is posted on the ORWH website 

http://orwh.od.nih.gov as well as on the NIH website for the inclusion of women and minorities 

policy implementation at: http://grants1.nih.gov/grants/funding/women_min/women_min.htm .

• In addition, the Frequently Asked Questions (FAQs) for the Inclusion, Recruitment and Retention of 

Women and Minority Subjects in Clinical Research complements the Outreach Notebook and 

provides additional guidance to researchers and NIH staff in a user friendly format. The FAQs is 

posted on the ORWH website http://orwh.od.nih.gov as well as on the NIH website for the inclusion 

of women and minorities policy implementation at: 

http://grants1.nih.gov/grants/funding/women_min/women_min.htm. 

These training and outreach efforts are designed to improve understanding of the sex/gender and minority 

inclusion policy and assist investigators and NIH staff to appropriately address these issues throughout 

the research grant and contract process. Investigators are instructed to address women and minority 

inclusion issues in the development of their applications and proposals for clinical research. 

Monitoring Compliance: Extramural and Intramural Population Data Analysis 

When assessing inclusion data, enrollment figures should not be directly compared to the national 

census figures. The goal of the NIH policy is not to satisfy any quotas for proportional representation, 

but rather to conduct biomedical and behavioral research in such a manner that the scientific knowledge 

acquired will be generalizable to the entire population of the United States. The numbers of women or 

minority subgroups included in a particular study depends upon the scientific question addressed in the 

study and the prevalence among women and minority subpopulations of the disease, disorder, or 

condition under investigation. Scientific Review Groups are instructed to focus on scientific 

considerations when assessing the planned enrollment for a particular study. 

NIH has monitored aggregate demographic data for study populations through the evolving NIH 

computerized tracking system since fiscal year 1994, and tracking the inclusion of women and minorities 

in clinical studies is well established in all ICs. Members of the NIH Tracking and Inclusion Committee 

55
continue to work on ways to refine and improve data collection methods and the quality of the data 

entered by each IC into this system. In May 2002, the NIH deployed a new population tracking system 

for monitoring the inclusion of women and minorities in clinical research. This system provides easier 

data entry and project monitoring for NIH staff, creates clear and timely NIH reports on inclusion data, 

and incorporates the 1997 OMB Office of Management and Budget (OMB) standards for the 

classification of federal data on race and ethnicity. Following the implementation of the population 

tracking module, an eRA Population Tracking User Group consisting of representatives from several ICs, 

was formed to evaluate the system, recommend improvements and modifications, and provide continuous 

feedback related to system use. The re-engineered population tracking system continues to be refined 

based on input from the NIH user community.

• NIH has published an on-line user’s guide and began offering 2-hour Population Tracking System 

demonstrations as well as in-depth, hands-on training sessions on the use of the population tracking 

system. The availability of training documents on the eRA Population Tracking User Group website 

has been widely distributed to NIH extramural staff. 

The aggregate data enable the NIH to measure inclusion in order to formulate more specific questions 

about gaps in enrollment and to design studies to respond to those questions. Data compiled in future 

years allows for longitudinal examination of trends and continued monitoring of compliance, although 

this will be more difficult for minority trends because of a change in how these data are collected (see 

next section). 

A review of intramural inclusion data indicates that the intramural research program continues to be 

compliant with the reporting requirements adhered to by the extramural community and outlined in the 

NIH Implementation Guidelines on the Inclusion of Women and Minority Subjects in Research Studies. 

The Clinical Center Medical Executive Committee (MEC) has taken a leading role in assuring that 

investigators conducting clinical research protocols in the Clinical Center are trained and competent in the 

conduct of clinical research. To this end, the MEC designed and endorsed the Standards for Clinical 

Research within the NIH Intramural Research Program. This set of standards, endorsed by the Clinical 

Center's Board of Governors and the NIH Institute Directors, sets forth guidelines for the infrastructure, 

training, education, and monitoring required for safe and effective conduct of clinical research. 

Format Changes for Reporting Race and Ethnicity Data Beginning in FY 2002

The 1997 Office of Management and Budget (OMB) Directive 15 minimum standards for maintaining, 

collecting and reporting data on race and ethnicity directs changes in how data are reported to NIH. The 

FY 2003 and FY 2004 tables describe data using both the 1977 and 1997 OMB standards for reporting 

data on race and ethnicity. Implementation of the 1997 OMB standards involved a number of changes 

including collecting and reporting information on race and ethnicity separately (Hispanic/Latinos are 

considered an ethnicity and reported separately from racial data); using the new definitions and categories 

for ethnicity and race (a separate racial category for Asian population data and Hawaiian/Pacific Islander 

data); and allowing respondents the option of selection more than one race or only one race. 

The 1997 OMB reporting format does not allow direct comparison of ethnic and racial data with similar 

data collected under the 1977 OMB standards because the categories and methods for collecting the data 

are fundamentally different. Changes in the standardization of definitions and business rules across the 

NIH for improving the data entered in the population tracking system are reflected in data reported 

beginning in FY2002. This transition period makes comparisons with prior FY 2002 data difficult. 

However, implementation of these changes will improve the consistency and comparability for future 

reporting. 

56
Conclusion and Current Status 

NIH staff continue to monitor, document, and work with grantees and contractors to ensure compliance 

with the inclusion policy. Program Officials provide technical assistance to investigators as they develop 

their applications and proposal throughout the application process. Review Officials introduce and discuss 

with reviewers the Guidelines/Instructions for reviewing the Inclusion of Women and Minorities in 

Clinical Research as well as the instructions and requirements for designing Phase III Clinical Trials in 

order that valid analyses can be conducted for sex/gender and ethnic/racial differences. At the time of 

award and submission of progress reports, program officials monitor and verify that inclusion policy 

requirements are met. When new and competing continuation applications that are selected for payment 

are deficient in meeting policy requirements, grants management staff and program officials will withhold 

funding until the principal investigator has satisfactorily addressed the policy requirements. 

57
References

1. Public Law 103-43. National Institutes of Health Revitalization Act of 1993. 42 USC 289 (a)(1). 

2. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 59 Fed. 

Reg. 14508-14513 (1994). 

3. Women’s Health: NIH Has Increased Its Efforts to Include Women in Research (GAO/HEHS-00-96, 

May, 2000). 

4. NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical 

Research, NIH Guide for Grants and Contracts, Amended 2001. 

5. Hayunga, E.G., Costello, M.D. Pinn, V.W., Demographics of Study Populations, Applied Clinical 

Trials, Vol. 6, No.1, p. 41-45, 1997. 

6. Hayunga, E.G. and Pinn V.W., Implementing the 1994 NIH Guidelines, Applied Clinical Trials, Vol. 

5, No.10, p. 34-40, 1996. 

7. Hayunga, E.G. and Pinn V.W., NIH Response to Researchers’ Concerns, Applied Clinical Trials, 

Vol.5, No.11, p.59-64, 1996. 

8. LaRosa, J. H., Seto, B., Caban, C.E., Hayunga, E.G., Including Women and Minorities in Clinical 

Research, Applied Clinical Trials, Vol. 4, No.5, p. 31-38, 1995. 

9. McCarthy, C.R., Historical Background of Clinical Trials Involving Women and Minorities, Academic 

Medicine, Vol. 69, No.9, p. 695-698, 1994. 

10.Pinn, V.W., The Role of the NIH’s Office of Research on Women’s Health, Academic Medicine, Vol. 

69, No. 9, p. 698-702, 1994. 

11.Gallin, J, (2002). Principles and Practices of Clinical Research: Chapter 11 NIH Policy on the 

Inclusion of Women and Minorities as Subjects of Clinical Research, Academic Press, San Diego, 

California, pp 146-157. 

For Additional Information on the implementation of the inclusion policy, please visit: 

NIH Office of Extramural Research Inclusion of Women and Minorities Policy Implementation Website: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm 

Revitalization Act of 1993, 42 USC 289 (a)(1): http://grants.nih.gov/grants/guide/notice-files/not94-100.html 

NIH Policy on Reporting Racial and Ethnicity Data: Subjects in Clinical Research, NIH Guide for Grants and 

Contracts Web page: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html 

Office of Research on Women’s Health Website: http://orwh.od.nih.gov/inclusion/inclreports.html

58
59

Appendix B

Explanation of Sex and Minority Codes

G1A Includes both genders, scientifically acceptable. 

G2A Includes only women, scientifically acceptable. 

G3A Includes only men, scientifically acceptable. 

G4A Gender representation unknown, scientifically acceptable. 

G1U Includes both genders, but scientifically unacceptable. 

G2U Includes only women, scientifically unacceptable. 

G3U Includes only men, scientifically unacceptable. 

G4U Gender representation unknown, scientifically unacceptable. 

M1A Includes minorities and non-minorities, scientifically acceptable. 

M2A Includes only minorities, scientifically acceptable. 

M3A Includes only non-minorities, scientifically acceptable. 

M4A Minority representation unknown, scientifically acceptable. 

M1U Includes minorities and non-minorities, but scientifically unacceptable. 

M2U Includes only minorities, scientifically unacceptable. 

M3U Includes only non-minorities, scientifically unacceptable. 

M4U Minority representation unknown, scientifically unacceptable. 

When an application receives a “U” (unacceptable) code it automatically receives a bar-tofunding as well. If the bar is removed, the “U” is converted to “R” to designate that change in 

status. 
60
61

Appendix C 

NIH Tracking and Inclusion Committee Members 

- Full Committee 
62
63 

NIH Tracking and Inclusion Committee 

2006 List of Members 

Office of the Director

Office of Research on Women’s Health

Vivian Pinn (Co-Chair), Angela Bates

Office of Extramural Research

Izja Lederhendler*, Katrina Pearson, Svetlana Diggs, Maria Koshy 

Office of Acquisition, Management and Procurement 

Rosemary Hamill* 

National Cancer Institute

Gail Blaufarb*, Kim Witherspoon, Clarissa Douglass 

National Eye Institute

Donald Everett*, William Darby 

National Heart, Lung, and Blood Institute

 Carl Roth (Co-Chair)*, Sharry Palagi, Barbara Marzetta 

National Human Genome Research Institute

Bettie Graham*, Pam Sellman, Joy Boyer 

National Institute on Aging 

Robin Barr *, Karen Bashir, Nina Silverberg, Marilyn Miller 

National Institute on Alcohol Abuse and Alcoholism

Van Van*, Patricia Powell 

National Institute of Allergy and Infectious Diseases

Diane Adger-Johnson*, Susan Schafer, Diane Yerg, Martin Gutierrez 

National Institute of Arthritis and Musculoskeletal and Skin Diseases

 Shahnaz Khan*, Frank Cromwell 

National Institute of Child Health and Human Development

 Eugene Hayunga*, Sandi Delcore

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
64 

List of Members, continued...

National Institute on Deafness and Other Communication Disorders

Castilla McNamara*, Lana Shekim

National Institute of Dental and Craniofacial Research

Trenita Davis*

National Institute of Diabetes, Digestive and Kidney Disorders

Karl Malik*, Lauren Meskill, Garman Williams, Michelle Johnson, Karen Salomon

National Institute on Drug Addiction

Christie Espinosa*, Quandra Scudder 

National Institute of Environmental Health Sciences

Martha Barnes* 

National Institute of General Medical Sciences

Lori Burge*, Alison Cole 

National Institute of Mental Health

Kathleen O’Leary *, Dawn Corbett, Sue Kennel 

National Institute of Neurological Disorders and Stroke

 Lynn Morin*, Kristy Woolbert, Aricia Ajose 

National Institute of Nursing Research

Paul Cotton *, Angela Marshall 

National Library of Medicine

Hua-Chuan Sim*, Valerie Florence 

Warren G. Magnuson Clinical Center

Kim Jarema* 

National Center for Complementary and Alternative Medicine

 April Bower* 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
65 

List of Members, continued...

National Center for Research Resources

Sheila McClure*, Delores Lee, Patricia Newman, Stephen Seidel, Louise Ramm 

Fogarty International Center

Aron Primack*, Shena Wilson 

Center for Scientific Review 

Joy Gibson* 

National Center for Minority Health and Health Disparaties

 Derrick Tabor*, Nathaniel Stinson, Francisco Sy 

National Institute of Biomedical Imaging and Bioengineering

Valery Gordon*, Anthony Dempsey 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee 
66 
67 

Appendix D 

Internet Homepage: 

Inclusion of Women and Minorities Policy 

Implementation 

http://grants.nih.gov/grants/funding/women_min/women_min.htm
68 
69 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

NATIONAL INSTITUTES OF HEALTH 

Office of Extramural Research 

Inclusion of Women and Minorities As Participants In Research 

Involving Human Subjects - Policy Implementation Page

Current Policy Documents and References: 

• Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need to Know!

(11/21/2002) - A PowerPoint slide show highlighting the rationale and major components of the NIH Policy 

on the Inclusion of Women and Minorities as Subjects in Clinical Research, as well as the 1997 OMB 

standards for collecting and presenting data on ethnicity and race. 

• Annual Comprehensive Reports on Monitoring Adherence to the NIH Policy on the Inclusion of Women 

and Minorities as Subjects in Clinical Research - Reports beginning with Fiscal Year 1997 data from the 

ORWH Inclusion of Women in Clinical Research Page. 

• 10/09/2001 NIH Guide Notice - The NIH Policy on the Inclusion of Women and Minorities as Subjects in 

Clinical Research was amended October 2001. Click here for a complete copy of the Amended Policy

that provides full explanation of the October 2001 policy notice. 

• Inclusion Table (PDF or RTF) - (07/25/2001) - Prior format for reporting sex/gender and race/ethnicity data 

using the 1977 OMB standards for the classification of federal data on race and ethnicity. This format is 

superceded by the Target/Planned Enrollment Table and Inclusion Enrollment Reports that use the 1997 

OBM standards for the classification of federal data on race and ethnicity. 

• What Form Should PIs Use for Population Tracking? (New versus OLD) - (PDF or MS Word) - (08/2003) - 

Information on when to use 05/01 Population Tracking form versus the previous 04/98 version. 

• 08/08/2001 NIH Guide Notice - NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical 

Research. This notice provides additional guidance and instruction for using the revised minimum 

standards for maintaining, collecting, and presenting data on race and ethnicity found in the PHS 398 (rev. 

9/04) and PHS 2590 (rev. 9/04) instructions and forms. 

• Outreach Notebook and Outreach Frequently Asked Questions - are available to help investigators to 

understand and comply with the NIH's inclusion policies. ORWH collaborated in the preparation and 

publication of these documents in December, 2002. 

• The Science of Sex and Gender in Human Health Online Course Web Site - This site was developed by 

NIH and FDA for researchers, clinicians, and members of academia to gain a basic scientific 

understanding of the major physiological differences between the sexes, the influences these differences 

have on illness and health outcomes, and the implications for policy, medical research, and health care. 

Continuing medical education credit is available for physicians 

Historical Documents and References:

• 08/02/2000 NIH Guide Notice - NIH Guidelines on The Inclusion of Women and Minorities as Subjects in 

Clinical Research - Updated August 2, 2000. Changes to the Guidelines, Sections 'III.B. NIH Phase III 

Clinical Trials' and 'V. Definitions' are highlighted in bold type. 
70 

• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research - Updated 

August 2, 2000 - A complete text of the Updated Guidelines, with changes to the Guidelines, Sections 

'III.B. NIH Phase III Clinical Trials' and 'V. Definitions' highlighted in bold type. The list of NIH Contacts has 

also been updated. 

• 03/18/1994 NIH Guide Notice - NIH Guidelines on The Inclusion of Women and Minorities as Subjects in 

Clinical Research. 

Weblink: http://grants.nih.gov/grants/funding/women_min/women_min.htm 
71 

Appendix E 

NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as 

Subjects in Clinical Research 

(Amended, October, 2001) 
72 
73 

NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND 

MINORITIES AS SUBJECTS IN CLINICAL RESEARCH; Amended, 

October, 2001. 

NOTE: Additional information concerning the NIH Policy on Inclusion of Women and 

Minorities as Subjects in Clinical Research is available at 

http://grants.nih.gov/grants/funding/women_min/women_min.htm . 

SUMMARY: This notice updates the NIH policy on the inclusion of women and minorities as 

subjects in clinical research. It supercedes the 1994 Federal Register notice 

(http://grants.nih.gov/grants/guide/notice-files/not94-100.html ) and the August 2000 notice in 

the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD00-048.html ). It incorporates the definition of clinical research as reported in the 1997 Report of 

the NIH Director’s Panel on Clinical research. Also, this notice provides additional guidance on 

reporting analyses of sex/gender and racial/ethnic differences in intervention effects for NIHdefined Phase III clinical trials. The guidelines ensure that all NIH-funded clinical research will 

be carried out in a manner sufficient to elicit information about individuals of both sexes/genders 

and diverse racial and ethnic groups and, particularly in NIH-defined Phase III clinical trials, to 

examine differential effects on such groups. Since a primary aim of research is to provide 

scientific evidence leading to a change in health policy or standard of care, it is imperative to 

determine whether the intervention or therapy being studied affects women or men or members 

of minority groups and their subpopulations differently. 

In June 2001, NIH adopted the definition of clinical research as: (1) Patient-oriented research. 

Research conducted with human subjects (or on material of human origin such as tissues, 

specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts 

with human subjects. Excluded from this definition are in vitro studies that utilize human tissues 

that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of 

human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new 

technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health 

services research http://www.nih.gov/news/crp/97report/execsum.htm . 

EFFECTIVE DATE: This amended policy is effective immediately and applies to all grants and 

cooperative agreements currently active and to be awarded. Contract solicitations issued as of 

October 2001 must adhere to the amended policy. 

I. LEGISLATIVE BACKGROUND 

The NIH Revitalization Act of 1993, PL 103-43, signed into law on June 10, 1993, directed the 

NIH to establish guidelines for inclusion of women and minorities in clinical research. 

The statute states that: 

In conducting or supporting clinical research for the purposes of this title, the Director of NIH 

shall ... ensure that (a) women are included as subjects in each project of such research; and (b) 

members of minority groups are included in such research. 492B(a)(1) 

The statute further directed the NIH to establish guidelines to specify: 
74 

(a) the circumstances under which the inclusion of women and minorities as subjects in projects 

of clinical research is inappropriate YY; (b) the manner in which clinical trials are required to be 

designed and carried out YY; and (c) the operation of outreach programs YY 492B(d)(1) 

The statute defines "clinical research" to include "clinical trials" and states that: 

In the case of any clinical trial in which women or members of minority groups will be included 

as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner 

sufficient to provide for valid analysis of whether the variables being studied in the trial affect 

women or members of minority groups, as the case may be, differently than other subjects in the 

trial. 492B(c) 

Specifically addressing the issue of minority groups, the statute states that: 

The term "minority group" includes subpopulations of minority groups. The Director of NIH 

shall, through the guidelines established...define the terms "minority group" and "subpopulation" 

for the purposes of the preceding sentence. 492B(g)(2) 

The statute speaks specifically to outreach and states that: 

The Director of NIH, in consultation with the Director of the Office of Research on Women's 

Health and the Director of the Office of Research on Minority Health, shall conduct or support 

outreach programs for the recruitment of women and members of minority groups as subjects in 

the projects of clinical research. 492B(a)(2) 

The statute includes a specific provision pertaining to the cost of clinical research and, in 

particular clinical trials. 

(A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in 

the trial is (sic) not a permissible consideration in determining whether such inclusion is 

inappropriate. 492B(d)(2) 

(ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of 

such inclusion in the project is (sic) not a permissible consideration in determining whether such 

inclusion is inappropriate unless the data regarding women or members of minority groups, 

respectively, that would be obtained in such project (in the event that such inclusion were 

required) have been or are being obtained through other means that provide data of comparable 

quality. 492B(d)(2) 

Exceptions to the requirement for inclusion of women and minorities are stated in the statute, as 

follows: 

The requirements established regarding women and members of minority groups shall not apply 

to the project of clinical research if the inclusion, as subjects in the project, of women and 

members of minority groups, respectively- 

(1) is inappropriate with respect to the health of the subjects; (2) is inappropriate with respect to 

the purpose of the research; or (3) is inappropriate under such other circumstances as the 

Director of NIH may designate. 492B(b) 
75 

(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not 

required if there is substantial scientific data demonstrating that there is no significant difference 

between- 

(i) the effects that the variables to be studied in the trial have on women or members of minority 

groups, respectively; and 

(ii) the effects that the variables have on the individuals who would serve as subjects in the trial 

in the event that such inclusion were not required. 492B(d)(2) 

II. POLICY 

A. Inclusion of Women and Minorities as Subjects in Clinical Research 

It is the policy of NIH that women and members of minority groups and their subpopulations 

must be included in all NIH-funded clinical research, unless a clear and compelling rationale and 

justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion 

is inappropriate with respect to the health of the subjects or the purpose of the research. 

Exclusion under other circumstances may be made by the Director, NIH, upon the 

recommendation of an Institute/Center Director based on a compelling rationale and justification. 

Cost is not an acceptable reason for exclusion except when the study would duplicate data from 

other sources. Women of childbearing potential should not be routinely excluded from 

participation in clinical research. This policy applies to research subjects of all ages in all NIHsupported clinical research studies. 

The inclusion of women and members of minority groups and their subpopulations must be 

addressed in developing a research design or contract proposal appropriate to the scientific 

objectives of the study/contract. The research plan/proposal should describe the composition of 

the proposed study population in terms of sex/gender and racial/ethnic group, and provide a 

rationale for selection of such subjects. Such a plan/proposal should contain a description of the 

proposed outreach programs for recruiting women and minorities as participants. 

B. NIH-defined Phase III Clinical Trials: Planning, Conducting, and Reporting of Analyses for 

Sex/Gender and Race/Ethnicity Differences. 

When an NIH-defined Phase III clinical trial is proposed, evidence must be reviewed to show 

whether or not clinically important sex/gender and race/ethnicity differences in the intervention 

effect are to be expected. This evidence may include, but is not limited to, data derived from 

prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology 

studies, and observational, natural history, epidemiology and other relevant studies. 

Investigators must consider the following when planning, conducting, analyzing, and reporting 

an NIH-Defined Phase III clinical trial. Based on prior studies, one of the three situations below 

will apply: 

1. Prior Studies Support the Existence of Significant Differences 

If the data from prior studies strongly support the existence of significant differences of clinical 

or public health importance in intervention effect based on sex/gender, racial/ethnic, and relevant 

subpopulation comparisons, the primary question(s) to be addressed by the proposed NIH-
76 

defined Phase III clinical trial and the design of that trial must specifically accommodate this. 

For example, if men and women are thought to respond differently to an intervention, then the 

Phase III clinical trial must be designed to answer two separate primary questions, one for men 

and the other for women, with adequate sample size for each. 

The Research Plan (for grant applications) or Proposal (for contract solicitations) must include a 

description of plans to conduct analyses to detect significant differences in intervention effect 

(see DEFINITIONS - Significant Difference) by sex/gender, racial/ethnic groups, and relevant 

subpopulations, if applicable. The final protocol(s) approved by the Institutional Review Board 

(IRB) must include these plans for analysis. The award will require that for each funded 

protocol, investigators must report in their annual Progress Report cumulative subject accrual 

and progress in conducting analyses for sex/gender and race/ethnicity differences. If final 

analyses of sex/gender and race/ethnicity are not available at the time of the Final Progress 

Report or Competing Continuation for the grant, a justification and plan ensuring completion and 

reporting of the analyses are required. If final analyses are required as part of the contract, these 

analyses must be included as part of the deliverables. These requirements will be cited in the 

terms and conditions of all awards for grants, cooperative agreements and contracts supporting 

NIH-defined Phase III clinical trials. 

Inclusion of the results of sex/gender, race/ethnicity and relevant subpopulations analyses is 

strongly encouraged in all publication submissions. If these analyses reveal no differences, a 

brief statement to that effect, indicating the groups and/or subgroups analyzed, will suffice. 

2. Prior Studies Support No Significant Differences 

If the data from prior studies strongly support no significant differences of clinical or public 

health importance in intervention effect based on sex/gender, racial/ethnic and/or relevant 

subpopulation comparisons, then sex/gender and race/ethnicity will not be required as subject 

selection criteria. However, the inclusion and analysis of sex/gender and/or racial/ethnic 

subgroups is still strongly encouraged. 

3. Prior Studies Neither Support nor Negate Significant Differences 

If the data from prior studies neither strongly support nor strongly negate the existence of 

significant differences of clinical or public health importance in intervention effect based on 

sex/gender, racial/ethnic, and relevant subpopulation comparisons, then the NIH-defined Phase 

III clinical trial will be required to include sufficient and appropriate entry of sex/gender and 

racial/ethnic participants, so that valid analysis of the intervention effects can be performed. 

However, the trial will not be required to provide high statistical power for these comparisons. 
77 

The Research Plan (for grant applications) or Proposal (for contract solicitations) must include a 

description of plans to conduct valid analysis (see DEFINITIONS - Valid Analysis) by 

sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable. The final protocol(s) 

approved by the Institutional Review Board (IRB) must include these plans for analysis. The 

award will require that for each funded protocol, investigators must report in their annual 

Progress Report cumulative subject accrual and progress in conducting analyses for sex/gender 

and race/ethnicity differences. If final analyses of sex/gender and race/ethnicity are not available 

at the time of the Final Progress Report or Competing Continuation for the grant, a justification 

and plan ensuring completion and reporting of the analyses are required. If final analyses are 

required as part of the contract, these analyses must be included as part of the deliverables. These 

requirements will be cited in the terms and conditions of all awards for grants, cooperative 

agreements and contracts supporting NIH-defined Phase III clinical trials. 

Inclusion of the results of sex/gender, race/ethnicity and relevant subpopulations analyses is 

strongly encouraged in all publication submissions. If these analyses reveal no differences, a 

brief statement to that effect, indicating the groups and/or subgroups analyzed, will suffice. 

For all three situations, cost is not an acceptable reason for exclusion of women and minorities 

from clinical trials. 

III. ROLES AND RESPONSIBILITIES 

While this policy applies to all applicants/offerors for NIH-supported clinical research, certain 

individuals and groups have special roles and responsibilities with regard to its implementation. 

1. NIH Staff 

The NIH staff provide educational opportunities for the extramural and intramural communities 

concerning this policy; monitor its implementation during the development, review, award and 

conduct of research; and manage the NIH research portfolio to comply with the policy. 

2. Principal Investigators 

Principal investigators should assess the theoretical and/or scientific linkages between 

sex/gender, race/ethnicity, and their topic of study. Following this assessment, the principal 

investigator and the applicant/offeror institution will address the policy in each application and 

proposal, providing the required information on inclusion of women and minorities and their 

subpopulations in clinical research projects, and any required justifications for exceptions to the 

policy. 

For foreign awards and domestic awards with a foreign component, the NIH policy on inclusion 

of women and minority groups in research is the same as that for research conducted in the U.S. 

If there is scientific rationale for examining subpopulation group differences within the foreign 

population, investigators should consider designing their studies to accommodate these 

differences. 

Investigators and their staff(s) are urged to develop appropriate and culturally sensitive outreach 

programs and activities commensurate with the goals of the study or objectives of the contract. 

The objective should be to actively recruit and retain the most diverse study population 

consistent with the purposes of the research project. Indeed, the purpose should be to establish a 
78 

relationship between the investigator(s) and staff(s) and populations and community(ies) of 

interest such that mutual benefit is derived for participants in the study. Investigator(s) should 

take precautionary measures to ensure that ethical issues are considered, such that there is 

minimal possibility of coercion or undue influence in the incentives or rewards offered in 

recruiting into or retaining participants in studies. 

To assist investigators and potential study participants, NIH staff have prepared educational 

materials, including a notebook titled the, "NIH Outreach Notebook On the Inclusion of Women 

and Minorities in Biomedical and Behavioral Research." The notebook as well as the Frequently 

Asked Questions document, are located at the following URL: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm

3. Institutional Review Boards (IRBs) 

It is the responsibility of the IRBs to address the ethical issues as outlined in Section IV(2) for 

Principal Investigators. As the IRBs implement the regulation for the protection of human 

subjects as described in Title 45 CFR Part 46, "Protection of Human Subjects", 

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm they must also attend to the 

guidelines for the inclusion of women and minorities and their subpopulations in clinical 

research. They should take into account the Food and Drug Administration's "Guidelines for the 

Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs," Vol. 58 

Federal Register 39406 http://www.fda.gov/cder/guidance/old036fn.pdf. 

4. Peer Review Groups 

In conducting peer review for scientific and technical merit, appropriately constituted initial 

review groups (including study sections), technical evaluation groups, and intramural review 

panels are instructed, as follows: 

• to evaluate the proposed plan for the inclusion of minorities and both genders for 

appropriate representation or to evaluate the proposed justification when 

representation is limited or absent, 

• to evaluate the proposed exclusion of minorities and women on the basis that a 

requirement for inclusion is inappropriate with respect to the health of the subjects, 

• to evaluate the proposed exclusion of minorities and women on the basis that a 

requirement for inclusion is inappropriate with respect to the purpose of the research, 

• to determine whether the design of clinical trials is adequate to measure differences 

when warranted, 

• to evaluate the plans for valid analysis for NIH-defined Phase III clinical trials, 

• to evaluate the plans for recruitment/outreach for study participants, and 

• to include these criteria as part of the scientific assessment and evaluation. 

The review instructions for grants are available on line at the following URL: 

http://grants.nih.gov/grants/peer/hs_review_inst.pdf 
79 

For contracts, the contracting officer will provide instructions for contract reviewers. Further 

information on instructions for contracts may be obtained at the following URL: 

http://oa.od.nih.gov/oamp/index.html. 

Or contact: 

National Institutes of Health, Division of Acquisition Policy and Evaluation, Office of 

Acquisition Management and Policy, 6100 Executive Boulevard, Room 6C01, Phone: 301-496-

6014Fax: 301- 402-1199 

5. NIH Advisory Councils 

In addition to other responsibilities for review of projects where the peer review groups have 

raised questions about the appropriate inclusion of women and minorities, the Advisory 

Council/Board of each Institute/Center shall prepare biennial reports, for inclusion in the overall 

NIH Director's biennial report, describing the manner in which the Institute/Center has complied 

with the provisions of the statute. 

6. Institute/Center Directors 

Institute/Center Directors and their staff shall ensure compliance with the policy. 

7. NIH Director 

The NIH Director may approve, on a case-by-case basis, the exclusion of projects, as 

recommended by the Institute/Center Director, that may be inappropriate to include within the 

requirements of these guidelines on the basis of circumstances other than the health of the 

subjects, the purpose of the research, or costs. 

IV. DEFINITIONS

Throughout the section of the statute pertaining to the inclusion of women and minorities, terms 

are used which require definition for the purpose of implementing these guidelines. These terms, 

drawn directly from the statute, are defined below. 

A. Clinical Research 

Clinical research is defined as: 

(1) Patient-oriented research. Research conducted with human subjects (or on material of human 

origin such as tissues, specimens and cognitive phenomena) for which an investigator (or 

colleague) directly interacts with human subjects. Excluded from this definition are in vitro 

studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented 

research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical 

trials, and (d) development of new technologies, (2) Epidemiologic and behavioral studies, (3) 

Outcomes research and health services research. 

http://www.nih.gov/news/crp/97report/execsum.htm

B. NIH-defined Clinical Trial 

For the purpose of these guidelines, an NIH-defined "clinical trial" is a broadly based prospective 

Phase III clinical investigation, usually involving several hundred or more human subjects, for 
80 

the purpose of evaluating an experimental intervention in comparison with a standard or control 

intervention or comparing two or more existing treatments. Often the aim of such investigation is 

to provide evidence leading to a scientific basis for consideration of a change in health policy or 

standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral 

interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials 

and other population-based intervention trials are also included. 

C. Valid Analysis 

The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, 

yield the correct estimate of the difference in outcomes between two groups of subjects. Valid 

analysis can and should be conducted for both small and large studies. A valid analysis does not 

need to have a high statistical power for detecting a stated effect. The principal requirements for 

ensuring a valid analysis of the question of interest are: 

• allocation of study participants of both sexes/genders (males and females) and 

different racial/ethnic groups to the intervention and control groups by an unbiased 

process such as randomization, 

• unbiased evaluation of the outcome(s) of study participants, and 

• use of unbiased statistical analyses and proper methods of inference to estimate and 

compare the intervention effects among the sex/gender and racial/ethnic groups. 

D. Significant Difference 

For purposes of this policy, a "significant difference" is a difference that is of clinical or public 

health importance, based on substantial scientific data. This definition differs from the 

commonly used "statistically significant difference," which refers to the event that, for a given 

set of data, the statistical test for a difference between the effects in two groups achieves 

statistical significance. Statistical significance depends upon the amount of information in the 

data set. With a very large amount of information, one could find a statistically significant, but 

clinically small difference that is of very little clinical importance. Conversely, with less 

information one could find a large difference of potential importance that is not statistically 

significant. 

E. Racial and Ethnic Categories 

1. Minority Groups 

A minority group is a readily identifiable subset of the U.S. population that is distinguished by 

racial, ethnic, and/or cultural heritage. 

The Office of Management and Budget (OMB) Directive No. 15 

http://www.whitehouse.gov/omb/fedreg/ombdir15.html defines minimum standards for 

maintaining, collecting and presenting data on race and ethnicity for all Federal reporting. NIH is 

required to use these definitions to allow comparisons to other federal databases, especially the 
81 

census and national health databases. The categories in this classification are social-political 

constructs and should not be interpreted as anthropological in nature. 

When an investigator is planning data collection on race and ethnicity, these categories shall be 

used. The collection of greater detail is encouraged. However, more detailed items should be 

designed in a way that they can be aggregated into these required categories. Using respondent 

self-report or self-identification to collect an individual’s data on ethnicity and race, investigators 

should use two separate questions with ethnicity information collected first followed by the 

option to select more than one racial designation. Respondents shall be offered the opportunity to 

select more than one racial designation. When data are collected separately, provision shall be 

made to report the number of respondents in each racial category who are Hispanic or Latino. 

The following definitions apply for ethnic categories. 

Hispanic or Latino - a person of Cuban, Mexican, Puerto Rican, South or Central American, or 

other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in 

addition to "Hispanic or Latino." 

Not Hispanic or Latino 

The following definitions apply for racial categories. 

American Indian or Alaska Native - a person having origins in any of the original peoples of 

North, Central, or South America, and who maintains tribal affiliations or community 

attachment. 

Asian - a person having origins in any of the original peoples of the Far East, Southeast Asia, or 

the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, 

Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine 

Islands have been recorded as Pacific Islanders in previous data collection strategies.) 

Black or African American - a person having origins in any of the black racial groups of 

Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African

American." 

Native Hawaiian or Other Pacific Islander - a person having origins in any of the original 

peoples of Hawaii, Guam, Samoa, or other Pacific Islands. 

2. Majority Group 

White - a person having origins in any of the original peoples of Europe, the Middle East, or 

North Africa. 

NIH recognizes the diversity of the U.S. population and that changing demographics are 

reflected in the changing racial and ethnic composition of the population. The terms "minority 

groups" and "minority subpopulations" are meant to be inclusive, rather than exclusive, of 

differing racial and ethnic categories. 

3. Subpopulations 

Each racial and ethnic group contains subpopulations that are delimited by geographic origins, 

national origins and/or cultural differences. It is recognized that there are different ways of 
82 

defining and reporting racial and ethnic subpopulation data. The subpopulation to which an 

individual is assigned depends on self-reporting of specific origins and/or cultural heritage. 

Attention to subpopulations also applies to individuals who self identify with more than one race 

or ethnicity. Researchers should be cognizant of the possibility that these racial/ethnic 

combinations may have biomedical, behavioral, and/or social-cultural implications related to the 

scientific question under study. 

F. Outreach Strategies 

These are outreach efforts by investigators and their staff(s) to appropriately recruit and retain 

populations of interest into research studies. Such efforts should represent a thoughtful and 

culturally sensitive plan of outreach and generally include involvement of other individuals and 

organizations relevant to the populations and communities of interest, e.g., family, religious 

organizations, community leaders and informal gatekeepers, and public and private institutions 

and organizations. The objective is to establish appropriate lines of communication and 

cooperation to build mutual trust and cooperation such that both the study and the participants 

benefit from such collaboration. 

V. NIH CONTACTS FOR MORE INFORMATION 

The following senior extramural staff from the NIH Institutes and Centers may be contacted for 

further information about the policy and relevant Institute/Center programs: 

Robin A. Barr, D. Phil. 

National Institute on Aging 

Gateway Building, Room 2C218 

7201 Wisconsin Avenue, MSC 9205 

Bethesda, MD 20892-9205 (20814 for courier service) 

Telephone: 301-496-9322 

Email: BarrR@mail.nih.gov

Howard B. Moss, M.D. 

National Institute on Alcohol Abuse and Alcoholism 

5635 Fishers Lane #3097 

Bethesda, MD 20892-9304 (20852 for courier service) 

Telephone: 301.402.0944 

Email: mossh@mail.nih.gov

Anna Ramsey-Ewing, Ph.D. 

National Institute of Allergy and Infectious Diseases 

6700B Rockledge Drive 

Room 2144 

Bethesda, MD 20892 

Telephone: 301-435-8536 

Email: arewing@mail.nih.gov
83 

Shahnaz Khan 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

6701 Democracy Blvd. Suite 800 

Bethesda, MD. 20892 

Telephone: 301-594-5058 

Email: Mturkeltaub@mail.nih.gov

Anthony Demsey, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

6707 Democracy Blvd. 

Suite 200, Rm. 241 

Bethesda, MD 20892 

Telephone: (301)402-7039 

Email: demseya@mail.nih.gov

Paulette S. Gray, Ph.D. 

National Cancer Institute 

6116 Executive Blvd., Room 8001 

Bethesda, MD 20892 

Telephone: 301/496-5147 

Email: grayp@mail.nih.gov

Eugene Hayunga, Ph.D. 

National Institute of Child Health and Human Development 

6100 Executive Boulevard, Room 2C01, MSC 7510 

Bethesda, MD 20892-7510 

Telephone: (301) 435-6856 

Email: hayungae@mail.nih.gov

Castilla F. McNamara, Ph.D., M.P.A. 

National Institute on Deafness and Other Communication Disorders 

EPS 400B, 6120 Executive Blvd., 

Rockville, MD 20852 

Telephone: 301 402-0909 

Email: McNamara@mail.nih.gov

Norman S. Braveman, Ph.D. 

National Institute of Dental and Craniofacial Research 

Building 31, Room 5B55 

Bethesda, MD 20852 

Telephone: (301) 594-2089 

Email: Norman.Braveman@nih.gov
84 

Brent Stanfield, Ph.D. 

National Institute of Diabetes and Digestive and Kidney Diseases 

6707 Democracy Blvd, Room 715 

Bethesda, MD 20892-5456 

Telephone: 301-594-8843 

Email: stanfibr@mail.nih.gov

Teresa Levitin, Ph.D. 

National Institute on Drug Abuse, 

6101 Executive Boulevard, Rm. 220, MSC 8401 

Bethesda, Maryland 20892-8401 

Telephone: (301) 443-2755 

Email: tlevitin@mail.nih.gov

Dennis Lang, Ph.D. 

National Institute of Environmental Health Sciences, 

NIH P.O. Box 12233, MD EC20 

Research Triangle Park, NC 27709 

Telephone: 919-541-7729 

Email: lang4@mail.nih.gov

Paivi H. Miskala, M.S.P.H., Ph.D. 

National Eye Institute 

5635 Fishers Lane, Suite 1300, MSC 9300 

Bethesda, MD 20892-9300 

Telephone 301-451-2020 

Email miskalap@mail.nih.gov

Alison Cole, Ph.D. 

National Institute of General Medical Sciences 

Natcher Building 

Building 45, Room 2AS49K 

Bethesda, MD 20892-6200 

Telephone: (301) 594-3827 

Email: coleal@mail.nih.gov

Stephen C. Mockrin, Ph.D. 

National Heart, Lung, and Blood Institute 

6701 Rockledge Drive MSC 7922 

Bethesda, MD 20892-7922 (20817 for courier service) 

Telephone: 301 435-0260 

Email: mockrins@mail.nih.gov
85 

Bettie J. Graham, Ph.D. 

National Human Genome Research Institute 

Suite 4076 MSC 9305 

5635 Fishers Lane 

National Institutes of Health 

Bethesda, MD 20892-9305 (20852 for courier service) 

Telephone: 301-496-7531 

EMail: grahambyj@mail.nih.gov

Sherman Ragland 

National Institute of Mental Health 

Neuroscience Building 

6001 Executive Boulevard, Room 8128 

Bethesda, MD 20852 

Telephone: (301)443-2847 

Email: sragland@mail.nih.gov

Frances Yee, Ph.D. 

National Institute of Neurological Disorders and Stroke 

6001 Executive Boulevard, Room 2227, MSC 9520 

Bethesda, MD 20892- 9525 

Telephone: 301-496-9135 

Email: yeef@mail.nih.gov

Barbara A. Smothers, Ph.D.

National Institute of Nursing Research 

6701 Democracy Blvd., Suite 710 

Bethesda MD 20892-4870 

Telephone: 301-594-5976 

EMail: bsmother@mail.nih.gov

Valerie Florance, Ph.D. 

National Library of Medicine 

Rockledge 1, Suite 301 

6705 Rockledge Drive, Bethesda, MD 20892 

Telephone: 301.594.4882 

Email: floranv@mail.nih.gov

April I. Bower RN, MS 

National Center for Complementary and Alternative Medicine 

6707 Democracy Blvd., Suite 401 

Bethesda MD 20892 USA 

Telephone: 301-451-3560 

Email: bowera@mail.nih.gov
86 

Derrick C. Tabor, Ph.D., 

National Center on Minority Health and Health Disparities 

6707 Democracy Blvd., Suite 800 

Bethesda, MD 20892-5465 

Telephone: (301) 402-1366 

Email: tabord@mail.nih.gov

Shelia McClure, Ph.D. 

National Center for Research Resources 

6701 Democracy Blvd., Rm 932 

Bethesda, MD 20892 

Telephone: (301) 451-6536 

Email: mcclurSh@mail.nih.gov

Barbara Sina, Ph.D. 

Fogarty International Center 

Building 31 Room B2C39 

Bethesda, MD 20892-2220 

Telephone: (301) 402-9467 

Email: sinab@mail.nih.gov
87 

Appendix F 

NIH Policy on 

Reporting Race and Ethnicity Data: 

Subjects in Clinical Research 
88 
89 

NIH POLICY ON REPORTING RACE AND ETHNICITY DATA: SUBJECTS IN 

CLINICAL RESEARCH 

Release Date: August 8, 2001 

NOTICE: NOT-OD-01-053 

National Institutes of Health 

POLICY: The NIH has adopted the 1997 Office of Management and Budget (OMB) revised 

minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all 

grant applications, contract and intramural proposals and for all active research grants, 

cooperative agreements, contract and intramural projects. The minimum standards are described 

in the 1997 OMB Directive 15, http://www.whitehouse.gov/OMB/fedreg/ombdir15.html. 

SUMMARY: This document provides additional guidance and instruction for using the revised 

minimum standards for maintaining, collecting, and presenting data on race and ethnicity found 

in the PHS 398 (rev. 5/01) and PHS 2590 (rev.5/01) instructions and forms 

http://grants.nih.gov/grants/forms.htm. Comparable information will be provided in research and 

development contract solicitations and awards for intramural projects. This document should be 

used in conjunction with the instructions in the PHS 398 and PHS 2590 instructions and forms. 

 

The 1997 OMB revised minimum standards include two ethnic categories (Hispanic or Latino, 

and Not Hispanic or Latino) and five racial categories (American Indian or Alaska Native, Asian, 

Black or African American, Native Hawaiian or Other Pacific Islander, and White). The 

categories in this classification are social-political constructs and should not be interpreted as 

being anthropological in nature. Using self-reporting or self-identification to collect an 

individual’s data on ethnicity and race, investigators should use two separate questions with 

ethnicity information collected first followed by the option to select more than one racial 

designation. 

Collection of this information and use of these categories is required for research that meets the 

NIH definition of clinical research. 

EFFECTIVE DATE: This policy applies to all new applications and proposals, annual progress 

reports, competing continuation applications, competing supplement applications for research 

grants, contracts, and intramural projects as of January 10, 2002. 

I. Revised Minimum Standards for Maintaining, Collecting, and Presenting Federal Data on 

Race and Ethnicity 

The following are the ethnic and racial definitions for the minimum standard categories (1997 

OMB Directive 15). 

Ethnic Categories: 
90 

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or 

other Spanish culture or origin, regardless of race. The term “Spanish origin” can also be used in 

addition to “Hispanic or Latino.” 

Not Hispanic or Latino 

Racial Categories: 

American Indian or Alaska Native: A person having origins in any of the original peoples of 

North, Central, or South America, and who maintains tribal affiliations or community 

attachment. 

Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or 

the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, 

Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine 

Islands have been recorded as Pacific Islanders in previous data collection strategies.) 

Black or African American: A person having origins in any of the black racial groups of Africa. 

Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.” 

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples 

of Hawaii, Guam, Samoa, or other Pacific Islands. 

White: A person having origins in any of the original peoples of Europe, the Middle East, or 

North Africa. 

Using respondent self-report or self-identification to collect an individual’s data on ethnicity and 

race, investigators should use two separate questions with ethnicity information collected first 

followed by the option to select more than one racial designation. 

When reporting these data in the aggregate, investigators should report: (a) the number of 

respondents in each ethnic category; (b) the number of respondents who selected only one 

category for each of the five racial categories; (c) the total number of respondents who selected 

multiple racial categories reported as the “number selecting more than one race”; and, (d) the 

number of respondents in each racial category who are Hispanic or Latino. Investigators may 

provide the detailed distributions, including all possible combinations, of multiple responses to 

the racial designations as additional information. However, more detailed items should be 

designed in a way that they can be aggregated into the required categories for reporting purposes. 

NIH is required to use these definitions to allow comparisons to other federal databases, 

especially the census and national health databases. Federal agencies will not present data on 

detailed categories if doing so would compromise data quality or confidentiality standards. 
91 

II. Guidance on Reporting Ethnicity/Race and Sex/Gender in Clinical Research 

NIH requires all grants, contracts, and intramural projects conducting clinical research to address 

the Inclusion of Women and Minorities (see 

http://grants.nih.gov/grants/funding/women_min/women_min.htm). NIH defines clinical 

research as: (1) Patient-oriented research. Research conducted with human subjects (or on 

material of human origin such as tissues, specimens and cognitive phenomena) for which an 

investigator (or colleague) directly interacts with human subjects. Excluded from this definition 

are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patientoriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) 

clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. 

(3) Outcomes research and health services research. 

New Applications (type 1), Competing Continuations (type 2), Requests for Proposals, and 

Intramural Projects 

Submitting Applications or Proposals Involving the Collection of New/Additional Data in 

Clinical Research: 

Investigators are instructed to provide plans for the total number of subjects proposed for the 

study and to provide the distribution by ethnic/racial categories and sex/gender. This information 

must be reported using the newly revised categories and according to the new format provided in 

the Targeted/Planned Enrollment table 

http://grants.nih.gov/grants/funding/phs398/enrollment.pdf 

Submitting Applications or Proposals Using Existing Data in Clinical Research with No Plans 

for Collecting New/Additional Data: 

Investigators are instructed to provide plans for the total number of subjects proposed for the 

study and to provide the distribution by ethnic/racial categories and sex/gender. Under these 

circumstances, investigators are not required to re-contact subjects solely to comply with the 

newly revised categories. If the existing data on ethnicity and race allows accurate 

correspondence with the new categories, the investigator can use the format in the 

Targeted/Planned Enrollment table. However, if the existing data do not allow accurate 

correspondence with the new categories, information may be reported using the former 

categories and according to the format in the 4/98 Version of the Inclusion Table 

http://grants.nih.gov/grants/funding/women_min/InclusionOld_Form.pdf 

Annual Progress Reports (type 5) and Competing Supplement Applications 

In Annual Progress Reports and Competing Supplement Applications, investigators conducting 

clinical research are required to provide the cumulative total enrollment of subjects to-date (as 

well as any proposed additions to the Targeted/Planned enrollment in the case of Competing 

Supplement Applications) and to present the distribution by ethnic/racial categories and 

sex/gender. 
92 

If Data Collection is Ongoing, Such that New Subjects Will be Enrolled and/or Additional Data 

Will be Collected from Human Subjects: 

Investigators may choose to report ethnicity/race and sex/gender sample composition using 

EITHER the format in the former 4/98 Version of the Inclusion Table OR the new Inclusion 

Enrollment Report http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf [Note: If 

investigators with on-going data collection choose to report information using the new Inclusion 

Enrollment Report, they must continue to use this format for the remaining years of the project.] 

If Data Collection is Complete, Such that No New/Additional Subject Contact is Planned: 

Investigators may EITHER continue to report using the former categories and according to the 

4/98 Version of the Inclusion Table, OR, if data allow accurate correspondence with the new 

categories, use the format in the new Inclusion Enrollment Report. 

III. Frequently Asked Questions 

1. What categories should I use in my application to estimate race and ethnicity, given the new 

OMB standards? 

Investigators should use the categories described in the PHS 398 instructions and listed in the 

table “Targeted/Planned Enrollment Table” for New Applications. First, the investigator should 

report the anticipated total number of males and females to be enrolled by Ethnicity (Hispanic or 

Latino, Not Hispanic or Latino). Then, the investigator should report the anticipated total number 

of males and females by Racial Categories (American Indian or Alaska Native, Asian, Native 

Hawaiian or Other Pacific Islander, Black or African American, White). The total number of 

subjects in the Ethnic Category section of the table should equal the total number of subjects in 

the Racial Categories section. Investigators do not need to estimate the anticipated number of 

individuals reporting multiple racial categories (either total number reporting multiple categories 

or number reporting specific combinations) for New Applications. However, the investigator 

must follow the OMB guidelines, which include allowing respondents to select multiple race 

categories, once data collection commences. 

2. What if my new application involves analyzing secondary data in which the race and ethnicity 

categories do not comply with the new OMB guidelines? 

If an investigator is using secondary data sets that do not conform to the new OMB guidelines 

and does not plan to collect any new/additional data from the subjects, this should be noted in the 

New Application. In this circumstance, the investigator should complete the “Targeted/Planned 

Enrollment Table” for a New Application and the “Inclusion Enrollment Report” for 

Continuation Applications, Competing Supplement Applications, and Annual Grant Progress 

Reports if the data allow. However, if the existing data do not allow accurate correspondence 

with the new categories, the investigator should report the information using the prior categories 

and use the 4/98 Version of the Inclusion Table. 
93 

3. There are many ways of tabulating the multiple race and ethnicity responses, particularly since 

the race and ethnicity categories are not mutually exclusive. Do the numbers I report have to 

“add up”? 

The numbers in several parts of the two tables must be the same. In both the “Targeted/Planned 

Enrollment Table” for a New Application and the “Inclusion Enrollment Report” for 

Continuation Applications, Competing Supplement Applications, and Annual Progress Reports, 

the sum in “Ethnic Category: Total of All Subjects” must equal the sum in “Racial Categories: 

Total of All Subjects.” In addition, the “Racial Categories: Total Hispanics or Latinos” in Part B 

of the “Inclusion Enrollment Report Table” must equal the Total Hispanic or Latino number 

reported in Part A of the “Inclusion Enrollment Report.” Footnotes in the tables clearly identify 

which numbers must be the same. 

4. Can I use the Targeted/Planned Enrollment Table or the Enrollment Inclusion Report to 

collect data from individuals? 

Neither the Targeted/Planned Enrollment Tablet nor the Enrollment Inclusion Report should be 

used for collecting data from individuals. These tables are only to be used for reporting aggregate 

data. 

To collect data from an individual respondent, investigators should use respondent self-report or 

self-identification and use two separate questions. The first question should be about ethnicity, 

followed by a question that provides the option of selecting one or more racial designations. An 

example of a format for collecting information from an individual can be found in the “Ethnic 

Origin and Race” section of the Personal Data Form Page in the PHS 398 (rev. 5/01) 

http://grants.nih.gov/grants/funding/phs398/personal.pdf 

5. Can I ask more detailed questions about ethnicity and race than these guidelines indicate? 

The revised OMB guidelines provide minimal standards for data collection. Indeed, researchers 

are encouraged to explore collecting additional types of information on race and ethnicity that 

will provide additional insights into the relationships between race and ethnicity and health. For 

example, after asking the ethnicity and then the race questions, researchers may opt to ask study 

participants who choose multiple categories to identify the group that they identify with 

primarily. Further questions identifying membership in subpopulations within the ethnic and 

racial categories provided by OMB may also be considered. The scientific question being 

addressed in the study should guide investigators’ decisions regarding collection of any 

additional information on ethnicity or race. Information on subpopulations may be reported by 

listing the information in an attachment to the required table. 

6. I have already begun data collection and my categories do not comply with the new OMB 

standards. Do I need to change my questions on race and ethnicity in the middle of the study? 

If data collection has already begun, we do not expect investigators to change their questions on 

race and ethnicity prior to the completion of the study. For Annual Progress Reports, in this 

circumstance, investigators should note that the research project was initiated prior to the 
94 

implementation of the new reporting guidelines. If the data do not accurately correspond with the 

new categories, the investigator may continue to use the format in the 4/98 Version of the 

Inclusion Table. 

7. I began data collection prior to the new standards, but my race and ethnicity questions comply 

with the new standards. I submitted my original estimates of the study composition using the old 

standards. How should I present the data in the progress report? 

If you began your data collection prior to the implementation of the new standards but your 

questions on race and ethnicity comply with the new standards, the choice is left up to the 

investigator as to how to present the data for Annual Progress Reports. We suggest completion of 

the new Inclusion Enrollment Report. 

8. How should I report race and ethnicity data when my research involves a foreign population? 

Investigators are encouraged to design their data collection instruments in ways that allow 

respondent self-identification of their racial and ethnic affiliation. However, these items should 

be designed in a way that they can be aggregated into the required categories. Also, the 

investigator can report on any racial/ethnic subpopulations by listing this information in an 

attachment to the required table. This may be particularly useful when distinctive subpopulations 

are relevant to the scientific hypotheses being studied. 

When completing the tables, investigators should asterisk and footnote the table indicating that 

data includes foreign participants. If the aggregated data only includes foreign participants, the 

investigator should provide information in one table with an asterisk and footnote. However, if 

the study includes both domestic and foreign participants, we suggest the investigator complete 

two separate tables -- one for domestic data and one for foreign data, with an asterisk and 

footnote accompanying the table with foreign data. 

9. How do the 1997 OMB revised standards differ from the previous standards? 

OMB issued the previous standards for maintaining, collecting, and presenting data on race and 

ethnicity in 1977. The minimum acceptable categories were: American Indian or Alaska Native; 

Asian or Pacific Islander; Black, not of Hispanic origin; Hispanic; White, not of Hispanic origin. 

The 1997 OMB revised standards now include two ethnic categories (Hispanic or Latino or Not 

Hispanic or Latino) and five racial categories (American Indian or Alaska Native, Asian, Black 

or African American, Native Hawaiian or Other Pacific Islander, and White). When using selfreporting or self-identification to collect data on ethnicity and race, investigators should use two 

separate questions with ethnicity information collected first followed by the option to select more 

than one racial designation. 

Additional Information and NIH Contacts Additional information on NIH policy regarding the 

Inclusion of Women and Minorities in Clinical Research can be found at the website 

http://grants.nih.gov/grants/funding/women_min/women_min.htm. 
95 

The following senior extramural staff from the NIH Institutes and Centers may be contacted for 

further information about the policy and relevant Institute/Center programs: 

Robin A. Barr, D. Phil. 

National Institute on Aging 

Gateway Building, Room 2C218 

7201 Wisconsin Avenue, MSC 9205 

Bethesda, MD 20892-9205 (20814 for courier service) 

Telephone: 301-496-9322 

Email: BarrR@mail.nih.gov

Howard B. Moss, M.D. 

National Institute on Alcohol Abuse and Alcoholism 

5635 Fishers Lane #3097 

Bethesda, MD 20892-9304 (20852 for courier service) 

Telephone: 301.402.0944 

Email: mossh@mail.nih.gov

Anna Ramsey-Ewing, Ph.D. 

National Institute of Allergy and Infectious Diseases 

6700B Rockledge Drive 

Room 2144 

Bethesda, MD 20892 

Telephone: 301-435-8536 

Email: arewing@mail.nih.gov

Madeline Turkeltaub, Ph.D. 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

6701 Democracy Blvd. Suite 800 

Bethesda, MD. 20892 

Telephone: 301-594-5058 

Email: Mturkeltaub@mail.nih.gov

Anthony Demsey, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

6707 Democracy Blvd. 

Suite 200, Rm. 241 

Bethesda, MD 20892 

Telephone: (301)402-7039 

Email: demseya@mail.nih.gov

Paulette S. Gray, Ph.D. 

National Cancer Institute 

6116 Executive Blvd., Room 8001 

Bethesda, MD 20892 
96 

Telephone: 301/496-5147 

Email: grayp@mail.nih.gov

Eugene Hayunga, Ph.D. 

National Institute of Child Health and Human Development 

6100 Executive Boulevard, Room 2C01, MSC 7510 

Bethesda, MD 20892-7510 

Telephone: (301) 435-6856 

Email: hayungae@mail.nih.gov

Castilla F. McNamara, Ph.D., M.P.A. 

National Institute on Deafness and Other Communication Disorders 

EPS 400B, 6120 Executive Blvd., 

Rockville, MD 20852 

Telephone: 301 402-0909 

Email: McNamara@mail.nih.gov

Norman S. Braveman, Ph.D. 

National Institute of Dental and Craniofacial Research 

Building 31, Room 5B55 

Bethesda, MD 20852 

Telephone: (301) 594-2089 

Email: Norman.Braveman@nih.gov

Brent Stanfield, Ph.D. 

National Institute of Diabetes and Digestive and Kidney Diseases 

6707 Democracy Blvd, Room 715 

Bethesda, MD 20892-5456 

Telephone: 301-594-8843 

Email: stanfibr@mail.nih.gov

Teresa Levitin, Ph.D. 

National Institute on Drug Abuse, 

6101 Executive Boulevard, Rm. 220, MSC 8401 

Bethesda, Maryland 20892-8401 

Telephone: (301) 443-2755 

Email: tlevitin@mail.nih.gov

Dennis Lang, Ph.D. 

National Institute of Environmental Health Sciences, 

NIH P.O. Box 12233, MD EC20 

Research Triangle Park, NC 27709 

Telephone: 919-541-7729 

Email: lang4@mail.nih.gov
97 

Paivi H. Miskala, M.S.P.H., Ph.D. 

National Eye Institute 

5635 Fishers Lane, Suite 1300, MSC 9300 

Bethesda, MD 20892-9300 

Telephone 301-451-2020 

Email miskalap@mail.nih.gov

Alison Cole, Ph.D. 

National Institute of General Medical Sciences 

Natcher Building 

Building 45, Room 2AS49K 

Bethesda, MD 20892-6200 

Telephone: (301) 594-3827 

Email: coleal@mail.nih.gov

Stephen C. Mockrin, Ph.D. 

National Heart, Lung, and Blood Institute 

6701 Rockledge Drive MSC 7922 

Bethesda, MD 20892-7922 (20817 for courier service) 

Telephone: 301 435-0260 

Email: mockrins@mail.nih.gov

Bettie J. Graham, Ph.D. 

National Human Genome Research Institute 

Suite 4076 MSC 9305 

5635 Fishers Lane 

National Institutes of Health 

Bethesda, MD 20892-9305 (20852 for courier service) 

Telephone: 301-496-7531 

EMail: grahambyj@mail.nih.gov

Sherman Ragland 

National Institute of Mental Health 

Neuroscience Building 

6001 Executive Boulevard, Room 8128 

Bethesda, MD 20852 

Telephone: (301)443-2847 

Email: sragland@mail.nih.gov

Frances Yee, Ph.D. 

National Institute of Neurological Disorders and Stroke 

6001 Executive Boulevard, Room 2227, MSC 9520 

Bethesda, MD 20892- 9525 

Telephone: 301-496-9135 

Email: yeef@mail.nih.gov
98 

Barbara A. Smothers, Ph.D.

National Institute of Nursing Research 

6701 Democracy Blvd., Suite 710 

Bethesda MD 20892-4870 

Telephone: 301-594-5976 

EMail: bsmother@mail.nih.gov

Valerie Florance, Ph.D. 

National Library of Medicine 

Rockledge 1, Suite 301 

6705 Rockledge Drive, Bethesda, MD 20892 

Telephone: 301.594.4882 

Email: floranv@mail.nih.gov

April I. Bower RN, MS 

National Center for Complementary and Alternative Medicine 

6707 Democracy Blvd., Suite 401 

Bethesda MD 20892 USA 

Telephone: 301-451-3560 

Email: bowera@mail.nih.gov

Derrick C. Tabor, Ph.D., 

National Center on Minority Health and Health Disparities 

6707 Democracy Blvd., Suite 800 

Bethesda, MD 20892-5465 

Telephone: (301) 402-1366 

Email: tabord@mail.nih.gov

Shelia McClure, Ph.D. 

National Center for Research Resources 

6701 Democracy Blvd., Rm 932 

Bethesda, MD 20892 

Telephone: (301) 451-6536 

Email: mcclurSh@mail.nih.gov

Barbara Sina, Ph.D. 

Fogarty International Center 

Building 31 Room B2C39 

Bethesda, MD 20892-2220 

Telephone: (301) 402-9467 

Email: sinab@mail.nih.gov
99 

APPENDIX G 

NIH Inclusion Tables for Target and Enrollment Data 

- Old Table for Target & Enrollment Data Collection 

- New Table for Target Data Collection 

- New Table for Enrollment Data Collection 
100 
Old Table for Target & Enrollment Data Collection 

101 
New Table for Target Data Collection

102 
New Table for Enrollment Data Collection

103 
104 
105 

Appendix H 

Comparison of 1977 and 1997 OMB Classifications 

For Reporting Race and Ethnicity 
106 
107 

Comparison of 1977 and 1997 OMB Classifications 

For Reporting Race and Ethnicity 

CLINICAL RESEARCH: NIH defines human clinical research as: 

(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as 

tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with 

human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to 

a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic 

interventions, (c) clinical trials, or (d) development of new technologies.

(2) Epidemiologic and behavioral studies. 

(3) Outcomes research and health services research. 

Appendix I. RACE AND ETHNICITY CATEGORIES INCLUDED IN 

SUMMARY MINORITY DATA 

OLD FORM (1977) versus NEW FORM (1997) 

 

Race/Ethnicity Category 

Minority 

Total 

Minority 

Total 

 Old Form New Form 

OLD FORM: Combined 1977 OMB Race/Ethnicity Categories 

 

American Indian/Alaska Native X 

Asian/Pacific Islander X 

Black or African American X 

Hispanic, Not White X 

White 

Unknown/Other 

NEW FORM: Separate 1997 OMB Race/Ethnicity Categories 

 

Part A: Total Enrollment Report 

Ethnic Category 

 Hispanic or Latino** 

 Not Hispanic or Latino 

 Unknown (ethnicity not reported) 

 Ethnic Category Total of All Subjects* 

Racial Categories 

 American Indian/Alaska Native X 

 Asian X 

 Black or African American X 

 Hawaiian/Pacific Islander X 

 White 

 More Than One Race X 

 Unknown/Other 

 Racial Categories: Total of All Subjects* 

 
108 

Part B: Hispanic Enrollment by RACE 

 American Indian/Alaska Native* 

 Asian* 

 Black or African American* 

 Hawaiian/Pacific Islander* 

 White (Hispanic) X 

 More Than One Race* 

 Unknown/Other (Hispanic) X 

Racial Categories: Total of Hispanics or Latinos** 

 

* The "Ethnic Category Total of All Subjects" must be equal to the "Racial Categories: Total of All Subjects" 

** The "Hispanic or Latino"(Part A) must be equal to "Racial Categories: Total of Hispanics or Latinos"(Part B). 

Note 1. Hispanics are defined by country of origin, and may be identified as belonging to any one, or more than one, race 

category. 

Note 2. The OLD FORM uses the 1977 OMB combined Race and Ethnicity Format, which has mutually 

exclusive categories, and allows Hispanics to be reported as either "Hispanic, Not White" or "White". 

Note 3. The NEW FORM uses the 1997 OMB Race and Ethnicity Categories, with separate reporting for 

Ethnicity (Hispanic or Latino; Not Hispanic or Latino) and Race. In this format, an individual is classified both by 

Ethnic Category and by Race Category. Part B of the NEW FORM therefore provides a distribution of only 

"Hispanics or Latinos" by the five main Race categories. Since minority categories are defined to include both 

"Hispanic or Latino ethnicity" and non-white racial categories when providing summary totals of minorities, it is 

necessary to add White Hispanics" and "Unknown/Other Hispanics" based on their ethnicity to the non-white 

racial categories. 
109 

Appendix I 

Aggregate Extramural and Intramural Data Tables 

Funded in FY2006 and Reported in FY2007 
110 
111 

Table of Contents: Fiscal Year 2006 Aggregate Data Tables 

Table 1A. Aggregate Enrollment Data for All Extramural and Intramural Research Protocols 

 Funded in FY2006 and Reported in FY2007: Percent Analysis 113 

Table 2A. Aggregate Enrollment Data for All Extramural and Intramural Phase III Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 115 

Table 3A. Aggregate Enrollment Data for Extramural Research Protocols Funded in 

 FY2006 and Reported in FY2007: Percent Analysis 117 

Table 4A. Aggregate Enrollment Data for Extramural Research Protocols Excluding 

 Male-Only and Female-Only Protocols Funded in FY2006 and Reported in 

 FY2007: Percent Analysis 119 

Table 5A. Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded 

 in FY2006 and Reported in FY2007: Percent Analysis 121 

Table 6A. Aggregate Enrollment Data for Extramural Phase III Research Protocols Excluding 

 Male-Only and Female-Only Research Protocols Funded in FY2006 and 

 Reported in FY2007: Percent Analysis 123 

Table 7A. Aggregate Enrollment Data for Intramural Research Protocols Funded in 

 FY2006 and Reported in FY2007: Percent Analysis 125 

Table 8A. Aggregate Enrollment Data for Intramural Research Protocols Excluding 

 Male-Only and Female-Only Protocols Funded in FY2006 and Reported in 

 FY2007: Percent Analysis 127 

Table 9A. Aggregate Enrollment Data for Intramural Phase III Research Protocols 

 Funded in FY2006 and Reported in FY2007: Percent Analysis 129 

Table 10A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Excluding 

 Male-Only and Female-Only Research Protocols Funded in FY2006 and 

 Reported in FY2007: Percent Analysis 131 

Domestic and Foreign Clinical Research Reported in FY 2006 and 2007

Table 11A. Domestic: Aggregate Enrollment Data for Extramural and Intramural Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 133 

Table 12A. Domestic: Aggregate Enrollment Data for Extramural Research Protocols 

 Funded in FY2006 and Reported in FY2007: Percent Analysis 135 

Table 13A. Domestic: Aggregate Enrollment Data for Intramural Research Protocols 

 Funded in FY2006 and Reported in FY2007: Percent Analysis 137 

Table 14A. Domestic: Aggregate Enrollment Data for Extramural Phase III Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 139 
112 

Table 15A. Domestic: Aggregate Enrollment Data for Intramural Phase III Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 141 

Table 16A. Foreign: Aggregate Enrollment Data for Extramural and Intramural Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 143 

Table 17A. Foreign: Aggregate Enrollment Data for Extramural Research Protocols 

 Funded in FY2006 and Reported in FY2007: Percent Analysis 145 

Table 18A. Foreign: Aggregate Enrollment Data for Intramural Research Protocols 

 Funded in FY2006 and Reported in FY2007: Percent Analysis 147 

Table 19A. Foreign: Aggregate Enrollment Data for Extramural Phase III Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 149 

Table 20A. Foreign: Aggregate Enrollment Data for Intramural Phase III Research 

 Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 151 
 Table 1A. Aggregate Enrollment Data for Extramural and Intramural Research Funded in FY2006 and Reported in FY2007: Percent 

Analysis 

Total Number of 

Protocols with Enrollment 10,914 

Data: 

I. SUMMARY TOTALS: Old Form + New Form 

Sex 

/Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 10,152,590 3,112,200 30.65% 

% 58.19% 59.66% 

Males 6,887,793 2,084,383 30.26% 

% 39.48% 39.95% 

Unknown 408,075 20,307 4.98% 

% 2.34% 0.39% 

TOTAL 17,448,458 5,216,890 29.90% 

Total % 100% 100.00% 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 9,816 

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not 

Hispanic 

Hispanic or 

Latino 

Unknown 

/Not 

Reported 

Total 

Female

96,979 924,257 1,051,568 33,903 6,172,785 170,128 912,286 9,361,906 7,806,041 739,223 816,642 9,361,906 

0.61% 5.80% 6.60% 0.21% 38.76% 1.07% 5.73% 58.79% 49.02% 4.64% 5.13% 58.79% 

1.04% 9.87% 11.23% 0.36% 65.94% 1.82% 9.74% 100.00% 83.38% 7.90% 8.72% 100.00%

66.69% 68.12% 52.25% 59.32% 59.69% 61.18% 52.66% 58.79% 59.97% 63.23% 46.99% 58.79%

Male 

47,890 430,074 953,258 22,891 4,142,378 105,168 460,949 6,162,608 5,179,293 424,302 559,013 6,162,608 

0.30% 2.70% 5.99% 0.14% 26.01% 0.66% 2.89% 38.70% 32.52% 2.66% 3.51% 38.70% 

0.78% 6.98% 15.47% 0.37% 67.22% 1.71% 7.48% 100.00% 84.04% 6.89% 9.07% 100.00%

32.93% 31.70% 47.36% 40.05% 40.06% 37.82% 26.61% 38.70% 39.79% 36.29% 32.17% 38.70%

Unknown 

548 2,569 7,869 355 26,320 2,772 359,184 399,617 31,790 5,567 362,260 399,617 

0.00% 0.02% 0.05% 0.00% 0.17% 0.02% 2.26% 2.51% 0.20% 0.03% 2.27% 2.51% 

0.14% 0.64% 1.97% 0.09% 6.59% 0.69% 89.88% 100.00% 7.96% 1.39% 90.65% 100.00%

0.38% 0.19% 0.39% 0.62% 0.25% 1.00% 20.73% 2.51% 0.24% 0.48% 20.84% 2.51%

Total 

145,417 1,356,900 2,012,695 57,149 10,341,483 278,068 1,732,419 15,924,131 13,017,124 1,169,092 1,737,915 15,924,131 

0.91% 8.52% 12.64% 0.36% 64.94% 1.75% 10.88% 100.00% 81.74% 7.34% 10.91% 100.00%

0.91% 8.52% 12.64% 0.36% 64.94% 1.75% 10.88% 100.00% 81.74% 7.34% 10.91% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 20,800 5,576 17,401 2,614 354,148 57,597 281,087 739,223 

% 1.78% 0.48% 1.49% 0.22% 30.29% 4.93% 24.04% 63.23% 

2.81% 0.75% 2.35% 0.35% 47.91% 7.79% 38.02% 100.00%

55.35% 75.21% 55.70% 60.65% 65.80% 57.48% 62.45% 63.23%

Male 16,606 1,802 13,750 1682 183,416 42,148 164,898 424,302 

% 1.42% 0.15% 1.18% 0.14% 15.69% 3.61% 14.10% 36.29% 

3.91% 0.42% 3.24% 0.40% 43.23% 9.93% 38.86% 100.00%

44.19% 24.31% 44.02% 39.03% 34.08% 42.07% 36.63% 36.29%

Unknown 175 36 88 14 652 452 4,150 5,567 

% 0.01% 0.00% 0.01% 0.00% 0.06% 0.04% 0.35% 0.48% 

3.14% 0.65% 1.58% 0.25% 11.71% 8.12% 74.55% 100.00%

0.47% 0.49% 0.28% 0.32% 0.12% 0.45% 0.92% 0.48%

37,581 7,414 31,239 4,310 538,216 100,197 450,135 1,169,092 

TOTAL 

3.21% 0.63% 2.67% 0.37% 46.04% 8.57% 38.50% 100.00% 

3.21% 0.63% 2.67% 0.37% 46.04% 8.57% 38.50% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

2,912,070 

18.29% 

31.11%

60.18%

1,907,595 

11.98% 

30.95%

39.42%

18,915 

0.12% 

4.73%

0.39%

4,838,580 

30.39% 

30.39%

100.00%

113 
1,098 

Table 1A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/ 

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

2,680 26,937 127,508 43,005 567,301 23,253 790,684 200,130 

0.18% 1.77% 8.36% 2.82% 37.22% 1.53% 51.87% 13.13% 

0.34% 3.41% 16.13% 5.44% 71.75% 2.94% 100.00% 25.31%

49.89% 52.06% 53.57% 51.69% 51.70% 47.82% 51.87% 52.90%

Male 

2,549 24,637 109,917 39,685 528,350 20,047 725,185 176,788 

0.17% 1.62% 7.21% 2.60% 34.66% 1.32% 47.57% 11.60% 

0.35% 3.40% 15.16% 5.47% 72.86% 2.76% 100.00% 24.38%

47.45% 47.62% 46.18% 47.70% 48.15% 41.22% 47.57% 46.73%

Unknown 

143 168 579 502 1,736 5,330 8,458 1392 

0.01% 0.01% 0.04% 0.03% 0.11% 0.35% 0.55% 0.09% 

1.69% 1.99% 6.85% 5.94% 20.52% 63.02% 100.00% 16.46%

2.66% 0.32% 0.24% 0.60% 0.16% 10.96% 0.55% 0.37%

Total 

5,372 51,742 238,004 83,192 1,097,387 48,630 1,524,327 378,310 

0.35% 3.39% 15.61% 5.46% 71.99% 3.19% 100.00% 24.82% 

0.35% 3.39% 15.61% 5.46% 71.99% 3.19% 100.00% 24.82%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

In FY2007 more females (10,152,590; 58.19%) than males (6,887,793; 39.48%) were enrolled in aggregate extramural and intramural research protocols. 

More minority females (3,112,200; 59.66%) than minority males (2,084,383; 39.95%) were enrolled in aggregate extramural and intramural research protocols. 

Race 

Approximately 29.90% (5,216,890) of participants in aggregate extramural and intramural research (17,448,458 total) were classified as U.S. minorities.

Largest identified racial group was White at 71.99% following the 1977 OMB standards and 64.94% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 15.61% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 12.64% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.35%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.36%.

Ethnicity 

7.34% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 46.04% (2nd highest category is Unknown/Other at 38.50%)

Smallest identified racial group was Hawaiian/Pacific Islander at 0.37%.

Of the 1,169,092 participants, 63.23% were women and 36.29% were men.

5.46% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

114 
Table 2A. Aggregate Enrollment Data for Extramural and Intramural Phase III Research Funded in FY2006 and Reported in FY2007: Percent 

Analysis 

621 

I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 324,694 143,482 44.19% 

% 54.92% 58.58% 

Males 249,633 100,656 40.32% 

% 42.23% 41.10% 

Unknown 16,832 794 4.72% 

% 2.85% 0.32% 

TOTAL 591,159 244,932 41.43% 

Total % 100% 100.00% 

Total Number of 

Protocols with 

Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 424 

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown/ 

Other Total Not Hispanic 

Hispanic or 

Latino 

Unknown 

/Not 

Reported 

Total 

Female 

5,080 22,248 45,603 335 70,059 2,088 63,705 209,118 131,464 54,936 22,718 209,118 

1.33% 5.83% 11.95% 0.09% 18.36% 0.55% 16.70% 54.81% 34.46% 14.40% 5.95% 54.81% 

2.43% 10.64% 21.81% 0.16% 33.50% 1.00% 30.46% 100.00% 62.87% 26.27% 10.86% 100.00%

54.33% 46.97% 53.99% 60.36% 52.68% 50.37% 62.08% 54.81% 51.62% 76.70% 41.16% 54.81%

Male 

4,225 25,081 38,460 218 62,624 1,985 22,980 155,573 122,403 16,419 16,751 155,573 

1.11% 6.57% 10.08% 0.06% 16.42% 0.52% 6.02% 40.78% 32.08% 4.30% 4.39% 40.78% 

2.72% 16.12% 24.72% 0.14% 40.25% 1.28% 14.77% 100.00% 78.68% 10.55% 10.77% 100.00%

45.18% 52.95% 45.53% 39.28% 47.09% 47.89% 22.39% 40.78% 48.06% 22.92% 30.35% 40.78%

Unknown 

46 35 405 2 319 72 15,932 16,811 825 267 15,719 16,811 

0.01% 0.01% 0.11% 0.00% 0.08% 0.02% 4.18% 4.41% 0.22% 0.07% 4.12% 4.41% 

0.27% 0.21% 2.41% 0.01% 1.90% 0.43% 94.77% 100.00% 4.91% 1.59% 93.50% 100.00%

0.49% 0.07% 0.48% 0.36% 0.24% 1.74% 15.53% 4.41% 0.32% 0.37% 28.48% 4.41%

Total 

9,351 47,364 84,468 555 133,002 4,145 102,617 381,502 254,692 71,622 55,188 381,502 

2.45% 12.42% 22.14% 0.15% 34.86% 1.09% 26.90% 100.00% 66.76% 18.77% 14.47% 100.00%

2.45% 12.42% 22.14% 0.15% 34.86% 1.09% 26.90% 100.00% 66.76% 18.77% 14.47% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown/ 

Other Total 

Female 

3,867 24 281 19 4,946 175 45,624 54,936 

5.40% 0.03% 0.39% 0.03% 6.91% 0.24% 63.70% 76.70% 

7.04% 0.04% 0.51% 0.03% 9.00% 0.32% 83.05% 100.00%

52.73% 53.33% 61.35% 79.17% 66.57% 54.35% 81.46% 76.70%

3,433 21 177 5 2,484 146 10,153 16,419 

4.79% 0.03% 0.25% 0.01% 3.47% 0.20% 14.18% 22.92% 

Male 20.91% 0.13% 1.08% 0.03% 15.13% 0.89% 61.84% 100.00%

46.82% 46.67% 38.65% 20.83% 33.43% 45.34% 18.13% 22.92%

33 0 0 0 0 1 233 267 

0.05% 0.00% 0.00% 0.00% 0.00% 0.00% 0.33% 0.37% 

Unknown 12.36% 0.00% 0.00% 0.00% 0.00% 0.37% 87.27% 100.00%

0.45% 0.00% 0.00% 0.00% 0.00% 0.31% 0.42% 0.37%

7,333 45 458 24 7,430 322 56,010 71,622 

TOTAL 

10.24% 0.06% 0.64% 0.03% 10.37% 0.45% 78.20% 100.00% 

10.24% 0.06% 0.64% 0.03% 10.37% 0.45% 78.20% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

125,924 

33.01% 

60.22%

60.16%

82,606 

21.65% 

53.10%

39.46%

793 

0.21% 

4.72%

0.38%

209,323 

54.87% 

54.87%

100.00%

115 
197 

Table 2A 

Number of Protocols 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards with Enrollment Data:

American 

Indian/ Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/ 

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

421 2,359 10,637 4,141 95,830 2,188 115,576 17,558 

0.20% 1.13% 5.07% 1.98% 45.71% 1.04% 55.13% 8.37% 

0.36% 2.04% 9.20% 3.58% 82.92% 1.89% 100.00% 15.19%

56.06% 59.83% 49.29% 44.37% 56.44% 51.37% 55.13% 49.31%

Male 

330 1,584 10,944 5,192 73,943 2,067 94,060 18,050 

0.16% 0.76% 5.22% 2.48% 35.27% 0.99% 44.86% 8.61% 

0.35% 1.68% 11.64% 5.52% 78.61% 2.20% 100.00% 19.19%

43.94% 40.17% 50.71% 55.63% 43.55% 48.53% 44.86% 50.69%

Unknown 

0 0 1 0 16 4 21 1 

0.000% 0.00% 0.00% 0.00% 0.01% 0.00% 0.01% 0.00% 

0.00% 0.00% 4.76% 0.00% 76.19% 19.05% 100.00% 4.76%

0.00% 0.00% 0.00% 0.00% 0.01% 0.09% 0.01% 0.00%

Total 

751 3,943 21,582 9,333 169,789 4,259 209,657 35,609 

0.36% 1.88% 10.29% 4.45% 80.98% 2.03% 100.00% 16.98% 

0.36% 1.88% 10.29% 4.45% 80.98% 2.03% 100.00% 16.98%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

In FY2007 more females (324,694; 54.92%) than males (249,633; 42.23%) were enrolled in aggregate extramural and intramural Phase III research protocols.

More minority females (143,482; 58.58%) than minority males (100,656; 41.10%) were enrolled in aggregate extramural and intramural Phase III research protocols.

Race 

Approximately 41.43% (244,932) of participants in aggregate extramural and intramural Phase III research (591,159 total) were classified as U.S. minorities.

Largest identified racial group was White at 80.98% following the 1977 OMB standards and 34.86% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 10.29% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 22.14% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.36%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.15%.

Ethnicity 

18.77% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 78.20% (2nd largest category is White at 10.37%)

Smallest identified racial group was Hawaiian/Pacific Islander at 0.03%. ( Note: this is a change from FY2006 when the smallest identified racial group was Asian)

Of the 71,622 participants, 76.70% were women and 22.92% were men.

4.45% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

116 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 8,652,645 2,716,478 31.39% 

% 61.84% 61.76% 

Males 4,971,895 1,663,177 33.45% 

% 35.54% 37.81% 

Unknown 366,742 18,789 5.12% 

% 2.62% 0.43% 

TOTAL 13,991,282 4,398,444 31.44% 

Total % 100% 100.00% 

Table 3A. Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 9,362

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 8,713 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

86,249 799,997 996,531 30,436 5,456,346 160,305 847,000 8,376,864 6,917,630 683,000 776,234 8,376,864 

0.64% 5.93% 7.39% 0.23% 40.46% 1.19% 6.28% 62.12% 51.30% 5.07% 5.76% 62.12% 

1.03% 9.55% 11.90% 0.36% 65.14% 1.91% 10.11% 100.00% 82.58% 8.15% 9.27% 100.00%

69.75% 68.38% 56.12% 57.28% 63.17% 60.63% 58.00% 62.12% 63.28% 64.02% 52.22% 62.12%

Male 

36,876 368,138 771,181 22,345 3,157,379 102,084 291,234 4,749,237 3,985,057 378,293 385,887 4,749,237 

0.27% 2.73% 5.72% 0.17% 23.41% 0.76% 2.16% 35.22% 29.55% 2.81% 2.86% 35.22% 

0.78% 7.75% 16.24% 0.47% 66.48% 2.15% 6.13% 100.00% 83.91% 7.97% 8.13% 100.00%

29.82% 31.46% 43.43% 42.05% 36.55% 38.61% 19.94% 35.22% 36.46% 35.46% 25.96% 35.22%

Unknown 

526 1,863 7,854 355 23,725 2,003 322,015 358,341 28,501 5,547 324,293 358,341 

0.00% 0.01% 0.06% 0.00% 0.18% 0.01% 2.39% 2.66% 0.21% 0.04% 2.40% 2.66% 

0.15% 0.52% 2.19% 0.10% 6.62% 0.56% 89.86% 100.00% 7.95% 1.55% 90.50% 100.00%

0.43% 0.16% 0.44% 0.67% 0.27% 0.76% 22.05% 2.66% 0.26% 0.52% 21.82% 2.66%

Total 

123,651 1,169,998 1,775,566 53,136 8,637,450 264,392 1,460,249 13,484,442 10,931,188 1,066,840 1,486,414 13,484,442 

0.92% 8.68% 13.17% 0.39% 64.05% 1.96% 10.83% 100.00% 81.07% 7.91% 11.02% 100.00%

0.92% 8.68% 13.17% 0.39% 64.05% 1.96% 10.83% 100.00% 81.07% 7.91% 11.02% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

19,600 5,562 17,069 2,574 328,520 55,722 253,953 683,000 

1.84% 0.52% 1.60% 0.24% 30.79% 5.22% 23.80% 64.02% 

2.87% 0.81% 2.50% 0.38% 48.10% 8.16% 37.18% 100.00%

55.79% 75.35% 60.43% 60.52% 68.30% 57.60% 61.33% 64.02%

15,372 1,784 11,091 1665 151,846 40,563 155,972 378,293 

1.44% 0.17% 1.04% 0.16% 14.23% 3.80% 14.62% 35.46% 

Male 4.06% 0.47% 2.93% 0.44% 40.14% 10.72% 41.23% 100.00%

43.76% 24.17% 39.26% 39.15% 31.57% 41.93% 37.67% 35.46%

159 36 88 14 652 452 4,146 5,547 

0.01% 0.00% 0.01% 0.00% 0.06% 0.04% 0.39% 0.52% 

Unknown 2.87% 0.65% 1.59% 0.25% 11.75% 8.15% 74.74% 100.00%

0.45% 0.49% 0.31% 0.33% 0.14% 0.47% 1.00% 0.52%

35,131 7,382 28,248 4,253 481,018 96,737 414,071 1,066,840 

TOTAL 3.29% 0.69% 2.65% 0.40% 45.09% 9.07% 38.81% 100.00% 

3.29% 0.69% 2.65% 0.40% 45.09% 9.07% 38.81% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

2,655,991 

19.70% 

31.71%

62.03%

1,608,442 

11.93% 

33.87%

37.56%

17,399 

0.13% 

4.86%

0.41%

4,281,832 

31.75% 

31.75%

100.00%

117 
649 

Table 3A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

1,804 7,845 30,985 19,853 198,153 17,141 275,781 60,487 

0.36% 1.55% 6.11% 3.92% 39.10% 3.38% 54.41% 11.93% 

0.65% 2.84% 11.24% 7.20% 71.85% 6.22% 100.00% 21.93%

49.10% 53.55% 52.52% 50.52% 56.14% 45.98% 54.41% 51.87%

Male 

1,727 6,638 27,428 18,942 153,077 14,846 222,658 54,735 

0.34% 1.31% 5.41% 3.74% 30.20% 2.93% 43.93% 10.80% 

0.78% 2.98% 12.32% 8.51% 68.75% 6.67% 100.00% 24.58%

47.01% 45.31% 46.50% 48.20% 43.37% 39.82% 43.93% 46.94%

Unknown 

143 168 578 501 1,717 5,294 8,401 1390 

0.028% 0.03% 0.11% 0.10% 0.34% 1.04% 1.66% 0.27% 

1.70% 2.00% 6.88% 5.96% 20.44% 63.02% 100.00% 16.55%

3.89% 1.15% 0.98% 1.27% 0.49% 14.20% 1.66% 1.19%

Total 

3,674 14,651 58,991 39,296 352,947 37,281 506,840 116,612 

0.72% 2.89% 11.64% 7.75% 69.64% 7.36% 100.00% 23.01% 

0.72% 2.89% 11.64% 7.75% 69.64% 7.36% 100.00% 23.01%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

In FY2007 more females (8,652,645; 61.84%) than males (4,971,895; 35.54%) were enrolled in aggregate extramural research protocols.

More minority females (2,716,4781; 61.76%) than minority males (1,663,177; 37.81%) were enrolled in aggregate extramural research protocols.

Race 

Approximately 31.44% (4,398,444) of participants in aggregate extramural research ( 16,979,004 total) were classified as U.S. minorities.

Largest identified racial group was White at 69.64% following the 1977 OMB standards and 64.05% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 11.64% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 13.17% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.72%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.39%.

Ethnicity 

7.91% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 45.09% (2nd largest category is Unknown/Other at 38.81%)

Smallest identified racial group was Hawaiian/Pacific Islanders at 0.40% 

Of the 1,066,840 participants, 64.02% were women and 35.46% were men.

7.75% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

118 
Table 4A. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and Female-Only Protocols Funded in FY2006 and Reported in 

FY2007: Percent Analysis 

7,651 

with Enrollment Data: 

Total Number of Protocols 

I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 4,435,292 1,645,545 37.10% 

% 46.45% 50.36% 

Males 4,761,326 1,606,976 33.75% 

% 49.87% 49.18% 

Unknown 350,892 14,743 4.20% 

% 3.68% 0.45% 

TOTAL 9,547,510 3,267,264 34.22% 

Total % 100% 100.00% 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 7,158 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

43,409 408,811 666,263 28,253 2,635,011 134,098 338,551 4,254,396 3,523,627 395,681 335,088 4,254,396 

0.47% 4.45% 7.26% 0.31% 28.71% 1.46% 3.69% 46.36% 38.39% 4.31% 3.65% 46.36% 

1.02% 9.61% 15.66% 0.66% 61.94% 3.15% 7.96% 100.00% 82.82% 9.30% 7.88% 100.00%

54.07% 53.12% 47.06% 55.61% 46.35% 57.38% 35.94% 46.36% 47.43% 51.37% 34.26% 46.36%

Male 

36,344 359,148 744,527 22,194 3,034,321 98,583 285,602 4,580,719 3,883,627 369,165 327,927 4,580,719 

0.40% 3.91% 8.11% 0.24% 33.06% 1.07% 3.11% 49.91% 42.32% 4.02% 3.57% 49.91% 

0.79% 7.84% 16.25% 0.48% 66.24% 2.15% 6.23% 100.00% 84.78% 8.06% 7.16% 100.00%

45.27% 46.67% 52.59% 43.69% 53.37% 42.18% 30.32% 49.91% 52.27% 47.92% 33.53% 49.91%

Unknown 

526 1,648 5,062 355 15,996 1,028 317,876 342,491 22,055 5,483 314,953 342,491 

0.01% 0.02% 0.06% 0.00% 0.17% 0.01% 3.46% 3.73% 0.24% 0.06% 3.43% 3.73% 

0.15% 0.48% 1.48% 0.10% 4.67% 0.30% 92.81% 100.00% 6.44% 1.60% 91.96% 100.00%

0.66% 0.21% 0.36% 0.70% 0.28% 0.44% 33.74% 3.73% 0.30% 0.71% 32.20% 3.73%

Total 

80,279 769,607 1,415,852 50,802 5,685,328 233,709 942,029 9,177,606 7,429,309 770,329 977,968 9,177,606 

0.87% 8.39% 15.43% 0.55% 61.95% 2.55% 10.26% 100.00% 80.95% 8.39% 10.66% 100.00%

0.87% 8.39% 15.43% 0.55% 61.95% 2.55% 10.26% 100.00% 80.95% 8.39% 10.66% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

14,546 1,914 12,613 2019 166,532 46,927 151,130 395,681 

1.89% 0.25% 1.64% 0.26% 21.62% 6.09% 19.62% 51.37% 

3.68% 0.48% 3.19% 0.51% 42.09% 11.86% 38.19% 100.00%

48.65% 51.48% 53.75% 54.76% 52.98% 54.58% 48.87% 51.37%

15,195 1,768 10,764 1654 147,159 38,607 154,018 369,165 

1.97% 0.23% 1.40% 0.21% 19.10% 5.01% 19.99% 47.92% 

Male 4.12% 0.48% 2.92% 0.45% 39.86% 10.46% 41.72% 100.00%

50.82% 47.55% 45.87% 44.86% 46.81% 44.90% 49.81% 47.92%

159 36 88 14 652 452 4,082 5,483 

0.02% 0.00% 0.01% 0.00% 0.08% 0.06% 0.53% 0.71% 

Unknown 2.90% 0.66% 1.60% 0.26% 11.89% 8.24% 74.45% 100.00%

0.53% 0.97% 0.38% 0.38% 0.21% 0.53% 1.32% 0.71%

29,900 3,718 23,465 3,687 314,343 85,986 309,230 770,329 

TOTAL 3.88% 0.48% 3.05% 0.48% 40.81% 11.16% 40.14% 100.00% 

3.88% 0.48% 3.05% 0.48% 40.81% 11.16% 40.14% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

1,598,496 

17.42% 

37.57%

50.37%

1,561,973 

17.02% 

34.10%

49.21%

13,353 

0.15% 

3.90%

0.42%

3,173,822 

34.58% 

34.58%

100.00%

119 
493 

Table 4A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

1,426 6,160 22,464 16,999 118,059 15,788 180,896 47,049 

0.39% 1.67% 6.07% 4.60% 31.92% 4.27% 48.90% 12.72% 

0.79% 3.41% 12.42% 9.40% 65.26% 8.73% 100.00% 26.01%

45.30% 49.49% 51.10% 50.16% 48.92% 44.94% 48.90% 50.35%

Male 

1,579 6,119 20,917 16,388 121,551 14,053 180,607 45,003 

0.43% 1.65% 5.65% 4.43% 32.86% 3.80% 48.83% 12.17% 

0.87% 3.39% 11.58% 9.07% 67.30% 7.78% 100.00% 24.92%

50.16% 49.16% 47.58% 48.36% 50.37% 40.00% 48.83% 48.16%

Unknown 

143 168 578 501 1,717 5,294 8,401 1390 

0.039% 0.05% 0.16% 0.14% 0.46% 1.43% 2.27% 0.38% 

1.70% 2.00% 6.88% 5.96% 20.44% 63.02% 100.00% 16.55%

4.54% 1.35% 1.31% 1.48% 0.71% 15.07% 2.27% 1.49%

Total 

3,148 12,447 43,959 33,888 241,327 35,135 369,904 93,442 

0.85% 3.36% 11.88% 9.16% 65.24% 9.50% 100.00% 25.26% 

0.85% 3.36% 11.88% 9.16% 65.24% 9.50% 100.00% 25.26%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender 

(Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: Reference Table 2A 

Sex/Gender 

Excluding sex-specific studies, the number of males (4,761,326 or 49.87%) exceeded the number of females (4,435,292 or 46.45%) enrolled in Extramural Research Protocols.

Excluding sex-specific studies, the number of minority females (1,645,545 or 50.36%) exceeded the number of minority males (1,606,976 or 49.18%) enrolled in Extramural Research Protocols.

Race 

Approximately 34.22% (3,267,264) of participants in aggregate Extramural Research Protocols (9,547,510 total) were classified as U.S. minorities.

Largest identified racial group was White at 65.24% following the 1977 OMB standards and 61.95% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 11.88% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 15.43% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.85%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.55%.

Ethnicity 

8.39% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 40.81% (2nd largest category was Unknown/Other at 40.14%)

Smallest identified racial groups were Hawaiian/Pacific Islander and Asian, both at 0.48%. 

Of the 770,329 participants, 51.37% were women and 47.92% were men.

9.16% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

120 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 301,735 134,342 44.52% 

% 55.10% 57.64% 

Males 229,062 97,934 42.75% 

% 41.83% 42.02% 

Unknown 16,830 794 4.72% 

% 3.07% 0.34% 

TOTAL 547,627 233,070 42.56% 

Total % 100% 100.00% 

Table 5A. Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 585

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 399 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

5,069 22,153 45,059 263 64,693 1,822 55,182 194,241 125,448 47,629 21,164 194,241 

1.41% 6.15% 12.51% 0.07% 17.96% 0.51% 15.32% 53.91% 34.82% 13.22% 5.87% 53.91% 

2.61% 11.40% 23.20% 0.14% 33.31% 0.94% 28.41% 100.00% 64.58% 24.52% 10.90% 100.00%

54.34% 46.98% 53.88% 54.45% 52.36% 49.70% 59.67% 53.91% 51.37% 74.34% 40.66% 53.91%

Male 

4,213 24,969 38,165 218 58,552 1,772 21,366 149,255 117,914 16,176 15,165 149,255 

1.17% 6.93% 10.59% 0.06% 16.25% 0.49% 5.93% 41.42% 32.73% 4.49% 4.21% 41.42% 

2.82% 16.73% 25.57% 0.15% 39.23% 1.19% 14.32% 100.00% 79.00% 10.84% 10.16% 100.00%

45.17% 52.95% 45.64% 45.13% 47.39% 48.34% 23.10% 41.42% 48.29% 25.25% 29.14% 41.42%

Unknown 

46 35 405 2 319 72 15,930 16,809 825 267 15,717 16,809 

0.01% 0.01% 0.11% 0.00% 0.09% 0.02% 4.42% 4.67% 0.23% 0.07% 4.36% 4.67% 

0.27% 0.21% 2.41% 0.01% 1.90% 0.43% 94.77% 100.00% 4.91% 1.59% 93.50% 100.00%

0.49% 0.07% 0.48% 0.41% 0.26% 1.96% 17.23% 4.67% 0.34% 0.42% 30.20% 4.67%

Total 

9,328 47,157 83,629 483 123,564 3,666 92,478 360,305 244,187 64,072 52,046 360,305 

2.59% 13.09% 23.21% 0.13% 34.29% 1.02% 25.67% 100.00% 67.77% 17.78% 14.44% 100.00%

2.59% 13.09% 23.21% 0.13% 34.29% 1.02% 25.67% 100.00% 67.77% 17.78% 14.44% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

3,847 21 234 16 4,492 174 38,845 47,629 

6.00% 0.03% 0.37% 0.02% 7.01% 0.27% 60.63% 74.34% 

8.08% 0.04% 0.49% 0.03% 9.43% 0.37% 81.56% 100.00%

52.60% 50.00% 56.93% 76.19% 64.41% 54.21% 79.29% 74.34%

3433 21 177 5 2,482 146 9,912 16,176 

5.36% 0.03% 0.28% 0.01% 3.87% 0.23% 15.47% 25.25% 

Male 21.22% 0.13% 1.09% 0.03% 15.34% 0.90% 61.28% 100.00%

46.94% 50.00% 43.07% 23.81% 35.59% 45.48% 20.23% 25.25%

33 0 0 0 0 1 233 267 

0.05% 0.00% 0.00% 0.00% 0.00% 0.00% 0.36% 0.42% 

Unknown 12.36% 0.00% 0.00% 0.00% 0.00% 0.37% 87.27% 100.00%

0.45% 0.00% 0.00% 0.00% 0.00% 0.31% 0.48% 0.42%

7,313 42 411 21 6,974 321 48,990 64,072 

TOTAL 11.41% 0.07% 0.64% 0.03% 10.88% 0.50% 76.46% 100.00% 

11.41% 0.07% 0.64% 0.03% 10.88% 0.50% 76.46% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

117,703 

32.67% 

60.60%

58.78%

81,731 

22.68% 

54.76%

40.82%

793 

0.22% 

4.72%

0.40%

200,227 

55.57% 

55.57%

100.00%

121 
186 

Table 5A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

415 2,190 10,067 3,967 88,698 2,157 107,494 16,639 

0.22% 1.17% 5.37% 2.12% 47.35% 1.15% 57.38% 8.88% 

0.39% 2.04% 9.37% 3.69% 82.51% 2.01% 100.00% 15.48%

57.24% 62.64% 50.83% 44.99% 59.01% 51.80% 57.38% 50.66%

Male 

310 1,306 9,736 4,851 61,601 2,003 79,807 16,203 

0.17% 0.70% 5.20% 2.59% 32.89% 1.07% 42.60% 8.65% 

0.39% 1.64% 12.20% 6.08% 77.19% 2.51% 100.00% 20.30%

42.76% 37.36% 49.16% 55.01% 40.98% 48.10% 42.60% 49.33%

Unknown 

0 0 1 0 16 4 21 1 

0.000% 0.00% 0.00% 0.00% 0.01% 0.00% 0.01% 0.00% 

0.00% 0.00% 4.76% 0.00% 76.19% 19.05% 100.00% 4.76%

0.00% 0.00% 0.01% 0.00% 0.01% 0.10% 0.01% 0.00%

Total 

725 3,496 19,804 8,818 150,315 4,164 187,322 32,843 

0.39% 1.87% 10.57% 4.71% 80.24% 2.22% 100.00% 17.53% 

0.39% 1.87% 10.57% 4.71% 80.24% 2.22% 100.00% 17.53%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (301,735 or 55.10%) than males (229,062 or 41.83%) were enrolled in aggregate Pase III Extramural Research Protocols.

More minority females (134,342 or 57.64%) than males (97,934 or 42.02%) were enrolled in aggregate Pase III Extramural Research Protocols.

Race 

Approximately 42.56% (233,070) of participants in aggregate Phase III Extramural Research (547,627 total) were classified as U.S. minorities.

Largest identified racial group was White at 80.24% following the 1977 OMB standards and 32.99% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 10.57% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 23.21% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.39%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.13%.

Ethnicity 

About 17.78% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 76.46% (2nd largest category was American Indian/Alaska Native at 11.41%)

Smallest identified racial group was Hawaiian/Pacific Islander at 0.07%. 

Of the 187,322 participants, 57.38% were women and 42.60% were men.

About 4.71% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

122 
Table 6A. Aggregate Enrollment Data for Extramural Phase III Protocols, Excluding Male-Only and Female-Only Protocols Funded in FY2006 and Reported 

in FY2007: Percent Analysis 

452 

with Enrollment Data: 

Total Number of Protocols 

I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 171,908 93,409 54.34% 

% 48.41% 52.64% 

Males 167,127 83,241 49.81% 

% 47.06% 46.91% 

Unknown 16,087 794 4.94% 

% 4.53% 0.45% 

TOTAL 355,122 177,444 49.97% 

Total % 100% 100.00% 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 330 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

4,845 20,155 37,682 186 37,546 1,488 23,282 125,184 92,229 13,046 19,909 125,184 

1.80% 7.50% 14.02% 0.07% 13.97% 0.55% 8.66% 46.59% 34.32% 4.86% 7.41% 46.59% 

3.87% 16.10% 30.10% 0.15% 29.99% 1.19% 18.60% 100.00% 73.67% 10.42% 15.90% 100.00%

53.38% 45.47% 52.06% 45.93% 46.92% 45.95% 39.29% 46.59% 48.57% 45.11% 39.91% 46.59%

Male 

4,186 24,136 34,292 217 42,162 1,678 20,791 127,462 96,855 15,606 15,001 127,462 

1.56% 8.98% 12.76% 0.08% 15.69% 0.62% 7.74% 47.43% 36.04% 5.81% 5.58% 47.43% 

3.28% 18.94% 26.90% 0.17% 33.08% 1.32% 16.31% 100.00% 75.99% 12.24% 11.77% 100.00%

46.12% 54.45% 47.38% 53.58% 52.69% 51.82% 35.08% 47.43% 51.00% 53.96% 30.07% 47.43%

Unknown 

46 35 405 2 318 72 15,188 16,066 824 267 14,975 16,066 

0.02% 0.01% 0.15% 0.00% 0.12% 0.03% 5.65% 5.98% 0.31% 0.10% 5.57% 5.98% 

0.29% 0.22% 2.52% 0.01% 1.98% 0.45% 94.54% 100.00% 5.13% 1.66% 93.21% 100.00%

0.51% 0.08% 0.56% 0.49% 0.40% 2.22% 25.63% 5.98% 0.43% 0.92% 30.02% 5.98%

Total 

9,077 44,326 72,379 405 80,026 3,238 59,261 268,712 189,908 28,919 49,885 268,712 

3.38% 16.50% 26.94% 0.15% 29.78% 1.21% 22.05% 100.00% 70.67% 10.76% 18.56% 100.00%

3.38% 16.50% 26.94% 0.15% 29.78% 1.21% 22.05% 100.00% 70.67% 10.76% 18.56% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

3727 12 83 3 1,883 125 7,213 13,046 

12.89% 0.04% 0.29% 0.01% 6.51% 0.43% 24.94% 45.11% 

28.57% 0.09% 0.64% 0.02% 14.43% 0.96% 55.29% 100.00%

51.86% 37.50% 34.58% 37.50% 44.57% 46.64% 42.53% 45.11%

3426 20 157 5 2,342 142 9,514 15,606 

11.85% 0.07% 0.54% 0.02% 8.10% 0.49% 32.90% 53.96% 

Male 21.95% 0.13% 1.01% 0.03% 15.01% 0.91% 60.96% 100.00%

47.68% 62.50% 65.42% 62.50% 55.43% 52.99% 56.10% 53.96%

33 0 0 0 0 1 233 267 

0.11% 0.00% 0.00% 0.00% 0.00% 0.00% 0.81% 0.92% 

Unknown 12.36% 0.00% 0.00% 0.00% 0.00% 0.37% 87.27% 100.00%

0.46% 0.00% 0.00% 0.00% 0.00% 0.37% 1.37% 0.92%

7,186 32 240 8 4,225 268 16,960 28,919 

TOTAL 24.85% 0.11% 0.83% 0.03% 14.61% 0.93% 58.65% 100.00% 

24.85% 0.11% 0.83% 0.03% 14.61% 0.93% 58.65% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

73,452 

27.33% 

58.68%

48.77%

76,365 

28.42% 

59.91%

50.70%

793 

0.30% 

4.94%

0.53%

150,610 

56.05% 

56.05%

100.00%

123 
122 

Table 6A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

136 714 2,994 16,113 25,805 962 46,724 19,957 

0.16% 0.83% 3.46% 18.65% 29.86% 1.11% 54.07% 23.10% 

0.29% 1.53% 6.41% 34.49% 55.23% 2.06% 100.00% 42.71%

45.33% 47.22% 45.56% 87.33% 44.97% 43.89% 54.07% 74.37%

Male 

164 798 3,576 2,338 31,563 1,226 39,665 6,876 

0.19% 0.92% 4.14% 2.71% 36.53% 1.42% 45.90% 7.96% 

0.41% 2.01% 9.02% 5.89% 79.57% 3.09% 100.00% 17.34%

54.67% 52.78% 54.42% 12.67% 55.00% 55.93% 45.90% 25.62%

Unknown 

0 0 1 0 16 4 21 1 

0.000% 0.00% 0.00% 0.00% 0.02% 0.00% 0.02% 0.00% 

0.00% 0.00% 4.76% 0.00% 76.19% 19.05% 100.00% 4.76%

0.00% 0.00% 0.02% 0.00% 0.03% 0.18% 0.02% 0.00%

Total 

300 1,512 6,571 18,451 57,384 2,192 86,410 26,834 

0.35% 1.75% 7.60% 21.35% 66.41% 2.54% 100.00% 31.05% 

0.35% 1.75% 7.60% 21.35% 66.41% 2.54% 100.00% 31.05%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: Reference Table 4A 

Sex/Gender 

Excluding sex-specific studies, the number of females (171,908 or 48.41%) exceeded the number of males (167,127 or 47.06%) enrolled in Phase III Extramural Research Protocols.

Excluding sex-specific studies, the number of minority females (93,409 or 52.64%) exceeded the number of minority males (83,241 or 46.91%) enrolled in Phase III Extramural Research Protocols.

Race 

Approximately 49.97% (177,444) of participants in Phase III Extramural Research (355,122 total) were classified as U.S. minorities.

Largest identified racial group was White at 66.41% following the 1977 OMB standards.

Largest identified racial group was White at 29.78% following the 1997 OMB standards. 

Largest identified racial minority group was Hispanic at 21.35% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 26.94% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.35%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.15%.

Ethnicity 

10.76% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 58.65% (2nd largest category is American Indian/ Alaska Native at 24.85%)

Smallest identified racial group was Hawaiian/Pacific Islander at 0.03%. 

Of the 28,919 participants, 45.11% were women and 53.96% were men.

21.35% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

124 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 1,499,945 395,722 26.38% 

% 43.39% 48.34% 

Males 1,915,898 421,306 21.99% 

% 55.42% 51.47% 

Unknown 41,333 1,518 3.67% 

% 1.20% 0.19% 

TOTAL 3,457,176 818,546 23.68% 

Total % 100% 100.00% 

Table 7A. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 1,552

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 1,103 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American Indian/ 

Alaska Native Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

10,730 124,260 55,037 3,467 716,439 9,823 65,286 985,042 888,411 56,223 40,408 985,042 

0.44% 5.09% 2.26% 0.14% 29.37% 0.40% 2.68% 40.38% 36.41% 2.30% 1.66% 40.38% 

1.09% 12.61% 5.59% 0.35% 72.73% 1.00% 6.63% 100.00% 90.19% 5.71% 4.10% 100.00%

49.30% 66.48% 23.21% 86.39% 42.04% 71.83% 23.99% 40.38% 42.59% 54.98% 16.07% 40.38%

Male 

11,014 61,936 182,077 546 984,999 3,084 169,715 1,413,371 1,194,236 46,009 173,126 1,413,371 

0.45% 2.54% 7.46% 0.02% 40.37% 0.13% 6.96% 57.93% 48.95% 1.89% 7.10% 57.93% 

0.78% 4.38% 12.88% 0.04% 69.69% 0.22% 12.01% 100.00% 84.50% 3.26% 12.25% 100.00%

50.60% 33.14% 76.78% 13.61% 57.80% 22.55% 62.36% 57.93% 57.25% 45.00% 68.84% 57.93%

Unknown 

22 706 15 0 2,595 769 37,169 41,276 3289 20 37,967 41,276 

0.00% 0.03% 0.00% 0.00% 0.11% 0.03% 1.52% 1.69% 0.13% 0.00% 1.56% 1.69% 

0.05% 1.71% 0.04% 0.00% 6.29% 1.86% 90.05% 100.00% 7.97% 0.05% 91.98% 100.00%

0.10% 0.38% 0.01% 0.00% 0.15% 5.62% 13.66% 1.69% 0.16% 0.02% 15.10% 1.69%

Total 

21,766 186,902 237,129 4,013 1,704,033 13,676 272,170 2,439,689 2,085,936 102,252 251,501 2,439,689 

0.89% 7.66% 9.72% 0.16% 69.85% 0.56% 11.16% 100.00% 85.50% 4.19% 10.31% 100.00%

0.89% 7.66% 9.72% 0.16% 69.85% 0.56% 11.16% 100.00% 85.50% 4.19% 10.31% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American Indian/ 

Alaska Native Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

1200 14 332 40 25,628 1,875 27,134 56,223 

1.17% 0.01% 0.32% 0.04% 25.06% 1.83% 26.54% 54.98% 

2.13% 0.02% 0.59% 0.07% 45.58% 3.33% 48.26% 100.00%

48.98% 43.75% 11.48% 70.18% 44.81% 54.19% 75.03% 54.98%

1234 18 2559 17 31,570 1,585 9,026 46,009 

1.21% 0.02% 2.50% 0.02% 30.87% 1.55% 8.83% 45.00% 

Male 2.68% 0.04% 5.56% 0.04% 68.62% 3.44% 19.62% 100.00%

50.37% 56.25% 88.52% 29.82% 55.19% 45.81% 24.96% 45.00%

16 0 0 0 0 0 4 20 

0.02% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.02% 

Unknown 80.00% 0.00% 0.00% 0.00% 0.00% 0.00% 20.00% 100.00%

0.65% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.02%

2,450 32 2,891 57 57,198 3,460 36,164 102,252 

TOTAL 2.40% 0.03% 2.83% 0.06% 55.94% 3.38% 35.37% 100.00% 

2.40% 0.03% 2.83% 0.06% 55.94% 3.38% 35.37% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

256,079 

10.50% 

26.00%

45.99%

299,253 

12.27% 

21.17%

53.74%

1,516 

0.06% 

3.67%

0.27%

556,848 

22.82% 

22.82%

100.00%

125 
449 

Table 7A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American Indian/ 

Alaska Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

876 19,092 96,523 23,152 369,148 6,112 514,903 139,643 

0.09% 1.88% 9.49% 2.28% 36.28% 0.60% 50.61% 13.72% 

0.17% 3.71% 18.75% 4.50% 71.69% 1.19% 100.00% 27.12%

0.00% 51.47% 53.92% 52.74% 49.59% 53.85% 50.61% 53.36%

Male 

822 17,999 82,489 20,743 375,273 5,201 502,527 122,053 

0.08% 1.77% 8.11% 2.04% 36.88% 0.51% 49.39% 12.00% 

0.16% 3.58% 16.41% 4.13% 74.68% 1.03% 100.00% 24.29%

0.00% 48.53% 46.08% 47.25% 50.41% 45.83% 49.39% 46.64%

Unknown 

0 0 1 1 19 36 57 2 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 

0.00% 0.00% 1.75% 1.75% 33.33% 63.16% 100.00% 3.51%

0.00% 0.00% 0.00% 0.00% 0.00% 0.32% 0.01% 0.00%

Total 

1,698 37,091 179,013 43,896 744,440 11,349 1,017,487 261,698 

0.17% 3.65% 17.59% 4.31% 73.16% 1.12% 100.00% 25.72% 

0.17% 3.65% 17.59% 4.31% 73.16% 1.12% 100.00% 25.72%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols (Old 

or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender 

(Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More males (1,915,298 or 55.42%) than females (1,499,945 or 43.39%) were enrolled in aggregate Intramural Research Protocols. 

More minority males (421,306 or 51.47%) than females (395,722 or 48.34%) were enrolled in aggregate Intramural Research Protocols. 

Race 

Approximately 23.68% (818,546) of participants in aggregate Intramural Research (3,457,176 total) were classified as U.S. minorities.

Largest identified racial group was White at 73.16% following the 1977 OMB standards and 69.85% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 17.59% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 9.72% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.17%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.16%.

Ethnicity 

4.19% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 55.94% (2nd largest category Unknown/Other at 35.37%).

Smallest identified racial group was Asian at 0.03%.

Of the 102,252 participants, 54.98% were women and 45.00% were men.

4.31% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

126 
Table 8A. Aggregate Enrollment Data for Intramural Research Protocols Excluding Male-Only and Female-Only Protocols Funded in FY2006 and Reported 

in FY2007: Percent Analysis 

1,387 

with Enrollment Data: 

Total Number of Protocols 

I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 1,139,063 245,722 21.57% 

% 37.14% 37.26% 

Males 1,886,711 412,304 21.85% 

% 61.51% 62.51% 

Unknown 41,333 1,517 3.67% 

% 1.35% 0.23% 

TOTAL 3,067,107 659,543 21.50% 

Total % 100% 100.00% 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 977 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

9,339 45,617 41,041 3,180 497,405 2,762 34,975 634,319 586,994 14,302 33,023 634,319 

0.45% 2.21% 1.99% 0.15% 24.14% 0.13% 1.70% 30.79% 28.49% 0.69% 1.60% 30.79% 

1.47% 7.19% 6.47% 0.50% 78.42% 0.44% 5.51% 100.00% 92.54% 2.25% 5.21% 100.00%

45.84% 42.20% 18.54% 85.35% 34.11% 41.75% 14.47% 30.79% 33.43% 23.73% 13.53% 30.79%

Male 

11,012 61,772 180,356 546 958,276 3,084 169,584 1,384,630 1,165,633 45,947 173,050 1,384,630 

0.53% 3.00% 8.75% 0.03% 46.51% 0.15% 8.23% 67.21% 56.58% 2.23% 8.40% 67.21% 

0.80% 4.46% 13.03% 0.04% 69.21% 0.22% 12.25% 100.00% 84.18% 3.32% 12.50% 100.00%

54.05% 57.15% 81.46% 14.65% 65.71% 46.62% 70.15% 67.21% 66.38% 76.24% 70.91% 67.21%

Unknown 

22 706 15 0 2,595 769 37,169 41,276 3289 20 37,967 41,276 

0.00% 0.03% 0.00% 0.00% 0.13% 0.04% 1.80% 2.00% 0.16% 0.00% 1.84% 2.00% 

0.05% 1.71% 0.04% 0.00% 6.29% 1.86% 90.05% 100.00% 7.97% 0.05% 91.98% 100.00%

0.11% 0.65% 0.01% 0.00% 0.18% 11.63% 15.38% 2.00% 0.19% 0.03% 15.56% 2.00%

Total 

20,373 108,095 221,412 3,726 1,458,276 6,615 241,728 2,060,225 1,755,916 60,269 244,040 2,060,225 

0.99% 5.25% 10.75% 0.18% 70.78% 0.32% 11.73% 100.00% 85.23% 2.93% 11.85% 100.00%

0.99% 5.25% 10.75% 0.18% 70.78% 0.32% 11.73% 100.00% 85.23% 2.93% 11.85% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

1169 7 272 14 1836 6,424 4,580 14,302 

1.94% 0.01% 0.45% 0.02% 3.05% 10.66% 7.60% 23.73% 

8.17% 0.05% 1.90% 0.10% 12.84% 44.92% 32.02% 100.00%

48.33% 28.00% 9.28% 45.16% 53.67% 43.29% 12.51% 23.73%

1234 18 2659 17 1585 8,414 32,020 45,947 

2.05% 0.03% 4.41% 0.03% 2.63% 13.96% 53.13% 76.24% 

Male 2.69% 0.04% 5.79% 0.04% 3.45% 18.31% 69.69% 100.00%

51.01% 72.00% 90.72% 54.84% 46.33% 56.70% 87.48% 76.24%

16 0 0 0 0 1 3 20 

0.03% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.03% 

Unknown 80.00% 0.00% 0.00% 0.00% 0.00% 5.00% 15.00% 100.00%

0.66% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.03%

2,419 25 2,931 31 3,421 14,839 36,603 60,269 

TOTAL 4.01% 0.04% 4.86% 0.05% 5.68% 24.62% 60.73% 100.00% 

4.01% 0.04% 4.86% 0.05% 5.68% 24.62% 60.73% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

108,355 

5.26% 

17.08%

27.07%

290,375 

14.09% 

20.97%

72.55%

1,515 

0.07% 

3.67%

0.38%

400,245 

19.43% 

19.43%

100.00%

127 
410 

Table 8A. Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

866 18,820 94,841 22,840 361,664 5,713 504,744 137,367 

0.09% 1.87% 9.42% 2.27% 35.92% 0.57% 50.13% 13.64% 

0.17% 3.73% 18.79% 4.53% 71.65% 1.13% 100.00% 27.22%

51.30% 51.12% 53.51% 52.44% 49.10% 52.23% 50.13% 52.98%

Male 

822 17,993 82,399 20,715 374,962 5,190 502,081 121,929 

0.08% 1.79% 8.18% 2.06% 37.24% 0.52% 49.86% 12.11% 

0.16% 3.58% 16.41% 4.13% 74.68% 1.03% 100.00% 24.28%

48.70% 48.88% 46.49% 47.56% 50.90% 47.44% 49.86% 47.02%

Unknown 

0 0 1 1 19 36 57 2 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 

0.00% 0.00% 1.75% 1.75% 33.33% 63.16% 100.00% 3.51%

0.00% 0.00% 0.00% 0.00% 0.00% 0.33% 0.01% 0.00%

Total 

1,688 36,813 177,241 43,556 736,645 10,939 1,006,882 259,298 

0.17% 3.66% 17.60% 4.33% 73.16% 1.09% 100.00% 25.75% 

0.17% 3.66% 17.60% 4.33% 73.16% 1.09% 100.00% 25.75%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

Excluding sex-specific studies, the number of males (1,886,711 or 61.51%) exceeded the number of females (1,139,063 or 37.14%) enrolled in Intramural Research Protocols.

Excluding sex-specific studies, the number of minority males (412,304 or 62.51%) exceeded the number of minority females (245,722 or 37.26%) enrolled in Intramural Research Protocols.

Race 

Approximately 21.50% (659,543) of participants in aggregate Intramural Research (3,067,107 total) were classified as U.S. minorities.

Largest identified racial group was White at 73.16% following the 1977 OMB standards and 70.78% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 17.60% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 10.75% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.17%.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.18%.

Ethnicity 

2.93% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 60.73% (2nd largest category was More Than One Race at 24.62%)

Smallest identified racial group was Asian at 0.04%. 

Of the 60,269 participants, 76.24% were men and 23.73% were women.

4.33% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

128 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 22,959 9,212 40.12% 

% 52.81% 77.58% 

Males 20,511 2,662 12.98% 

% 47.18% 22.42% 

Unknown 2 0 0.00% 

% 0.00% 0.00% 

TOTAL 43,472 11,874 27.31% 

Total % 100% 100.00% 

Table 9A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 36

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 25 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

11 95 544 72 5,366 266 8,523 14,877 6,016 7,307 1,554 14,877 

0.05% 0.45% 2.57% 0.34% 25.31% 1.25% 40.21% 70.18% 28.38% 34.47% 7.33% 70.18% 

0.07% 0.64% 3.66% 0.48% 36.07% 1.79% 57.29% 100.00% 40.44% 49.12% 10.45% 100.00%

47.83% 45.89% 64.84% 100.00% 56.86% 55.53% 84.06% 70.18% 57.27% 96.78% 49.46% 70.18%

Male 

12 112 295 0 4,072 213 1,614 6,318 4,489 243 1,586 6,318 

0.06% 0.53% 1.39% 0.00% 19.21% 1.00% 7.61% 29.81% 21.18% 1.15% 7.48% 29.81% 

0.19% 1.77% 4.67% 0.00% 64.45% 3.37% 25.55% 100.00% 71.05% 3.85% 25.10% 100.00%

52.17% 54.11% 35.16% 0.00% 43.14% 44.47% 15.92% 29.81% 42.73% 3.22% 50.48% 29.81%

Unknown 

0 0 0 0 0 0 2 2 0 0 2 2 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 0.00% 0.01% 0.01% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.02% 0.01% 0.00% 0.00% 0.06% 0.01%

Total 

23 207 839 72 9,438 479 10,139 21,197 10,505 7,550 3,142 21,197 

0.11% 0.98% 3.96% 0.34% 44.53% 2.26% 47.83% 100.00% 49.56% 35.62% 14.82% 100.00%

0.11% 0.98% 3.96% 0.34% 44.53% 2.26% 47.83% 100.00% 49.56% 35.62% 14.82% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

1 0 0 0 2 1 7,303 7,307 

0.01% 0.00% 0.00% 0.00% 0.03% 0.01% 96.73% 96.78% 

0.01% 0.00% 0.00% 0.00% 0.03% 0.01% 99.95% 100.00%

100.00% 0.00% 0.00% 0.00% 66.67% 100.00% 96.79% 96.78%

0 0 0 0 1 0 242 243 

0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 3.21% 3.22% 

Male 0.00% 0.00% 0.00% 0.00% 0.41% 0.00% 99.59% 100.00%

0.00% 0.00% 0.00% 0.00% 33.33% 0.00% 3.21% 3.22%

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

1 0 0 0 3 1 7,545 7,550 

TOTAL 0.01% 0.00% 0.00% 0.00% 0.04% 0.01% 99.93% 100.00% 

0.01% 0.00% 0.00% 0.00% 0.04% 0.01% 99.93% 100.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

FORM Parts 

A+B 

8,293 

39.12% 

55.74%

90.46%

875 

4.13% 

13.85%

9.54%

0 

0.00% 

0.00%

0.00%

9,168 

43.25% 

43.25%

100.00%

129 
11 

Table 9A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

6 169 570 174 7,132 31 8,082 919 

0.03% 0.76% 2.56% 0.78% 32.02% 0.14% 36.28% 4.13% 

0.07% 2.09% 7.05% 2.15% 88.25% 0.38% 100.00% 11.37%

0.00% 37.81% 33.18% 33.79% 36.62% 32.63% 36.28% 33.96%

Male 

20 278 1,148 341 12,342 64 14,193 1,787 

0.09% 1.25% 5.15% 1.53% 55.41% 0.29% 63.72% 8.02% 

0.14% 1.96% 8.09% 2.40% 86.96% 0.45% 100.00% 12.59%

0.00% 62.19% 66.82% 66.21% 63.38% 67.37% 63.72% 66.04%

Unknown 

0 0 0 0 0 0 0 0 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

26 447 1,718 515 19,474 95 22,275 2,706 

0.12% 2.01% 7.71% 2.31% 87.43% 0.43% 100.00% 12.15% 

0.12% 2.01% 7.71% 2.31% 87.43% 0.43% 100.00% 12.15%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (22,959 or 52.81%) than males (20,511 or 47.18%) were enrolled in aggregate Intramural Phase III Research Protocols. 

More minority females (9,212 or 77.58%) than males (2,662 or 22.42%) are enrolled in aggregate Intramural Phase III Research Protocols. 

Compared to FY2006, minority female enrollment decreased by 1.16% and minority male enrollment increased by 1.15%. 

Race 

Approximately 27.31% (11,874) of participants in aggregate Intramural Phase III Research (43,472 total) were classified as U.S. minorities.

Largest identified racial group was White at 87.43% following the 1977 OMB standards and 44.53% following the 1997 OMB standards.

This is a significant change from FY2006 when, according to the 1977 OMB standards, Asian/Pacific Islander was the largest identified racial group at 78.7%.

Largest identified racial minority group was Black or African American at 7.71% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 3.96% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.11%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.12%.

Ethnicity 

35.62% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 99.93% (2nd largest category is White at 0.04%).

Asian, Black or African American and Hawaiian/Pacific Islander all had 0.0%.

Of the 7,550 participants, 96.78% were women and 3.22% were men.

2.31% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

130 
Table 10A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Excluding Male-Only and Female-Only Protocols 

Funded in FY2006 and Reported in FY2007: Percent Analysis 

31 

with Enrollment Data: 

Total Number of Protocols 

I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 15,928 2,182 13.70% 

% 43.71% 45.05% 

Males 20,511 2,662 12.98% 

% 56.29% 54.95% 

Unknown 2 0 0.00% 

% 0.01% 0.00% 

TOTAL 36,441 4,844 13.29% 

Total % 100% 100.00% 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 20 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

11 95 539 56 5,365 266 1,514 7,846 6,010 298 1,538 7,846 

0.08% 0.67% 3.80% 0.40% 37.87% 1.88% 10.69% 55.39% 42.43% 2.10% 10.86% 55.39% 

0.14% 1.21% 6.87% 0.71% 68.38% 3.39% 19.30% 100.00% 76.60% 3.80% 19.60% 100.00%

47.83% 45.89% 64.63% 100.00% 56.85% 55.53% 48.37% 55.39% 57.24% 55.08% 49.20% 55.39%

Male 

12 112 295 0 4,072 213 1,614 6,318 4,489 243 1,586 6,318 

0.08% 0.79% 2.08% 0.00% 28.74% 1.50% 11.39% 44.60% 31.69% 1.72% 11.20% 44.60% 

0.19% 1.77% 4.67% 0.00% 64.45% 3.37% 25.55% 100.00% 71.05% 3.85% 25.10% 100.00%

52.17% 54.11% 35.37% 0.00% 43.15% 44.47% 51.57% 44.60% 42.76% 44.92% 50.74% 44.60%

Unknown 

0 0 0 0 0 0 2 2 0 0 2 2 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.00% 0.00% 0.01% 0.01% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.06% 0.01% 0.00% 0.00% 0.06% 0.01%

Total 

23 207 834 56 9,437 479 3,130 14,166 10,499 541 3,126 14,166 

0.16% 1.46% 5.89% 0.40% 66.62% 3.38% 22.10% 100.00% 74.11% 3.82% 22.07% 100.00%

0.16% 1.46% 5.89% 0.40% 66.62% 3.38% 22.10% 100.00% 74.11% 3.82% 22.07% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

1 0 0 0 2 1 294 298 

0.18% 0.00% 0.00% 0.00% 0.37% 0.18% 54.34% 55.08% 

0.34% 0.00% 0.00% 0.00% 0.67% 0.34% 98.66% 100.00%

100.00% 0.00% 0.00% 0.00% 66.67% 100.00% 54.85% 55.08%

0 0 0 0 1 0 242 243 

0.00% 0.00% 0.00% 0.00% 0.18% 0.00% 44.73% 44.92% 

Male 0.00% 0.00% 0.00% 0.00% 0.41% 0.00% 99.59% 100.00%

0.00% 0.00% 0.00% 0.00% 33.33% 0.00% 45.15% 44.92%

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

1 0 0 0 3 1 536 541 

TOTAL 0.18% 0.00% 0.00% 0.00% 0.55% 0.18% 99.08% 100.00% 

0.18% 0.00% 0.00% 0.00% 0.55% 0.18% 99.08% 100.00% 

100.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

1,263 

8.92% 

16.10%

59.07%

875 

6.18% 

13.85%

40.93%

0 

0.00% 

0.00%

0.00%

2,138 

15.09% 

15.09%

100.00%

131 
11 

Table 10A. Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

6 169 570 174 7,132 31 8,082 919 

0.03% 0.76% 2.56% 0.78% 32.02% 0.14% 36.28% 4.13% 

0.07% 2.09% 7.05% 2.15% 88.25% 0.38% 100.00% 11.37%

23.08% 37.81% 33.18% 33.79% 36.62% 32.63% 36.28% 33.96%

Male 

20 278 1,148 341 12,342 64 14,193 1,787 

0.09% 1.25% 5.15% 1.53% 55.41% 0.29% 63.72% 8.02% 

0.14% 1.96% 8.09% 2.40% 86.96% 0.45% 100.00% 12.59%

76.92% 62.19% 66.82% 66.21% 63.38% 67.37% 63.72% 66.04%

Unknown 

0 0 0 0 0 0 0 0 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

26 447 1,718 515 19,474 95 22,275 2,706 

0.12% 2.01% 7.71% 2.31% 87.43% 0.43% 100.00% 12.15% 

0.12% 2.01% 7.71% 2.31% 87.43% 0.43% 100.00% 12.15%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols (Old or 

New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row 

Total) 

Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity 

(Column Total) 

Data Table Comments: 

Sex/Gender 

There were 36 Phase III Intramural Research Protocols of which 5 (13.89%) were female-only protocols and 0 (0.0%) were male-only protocols.

Excluding sex-specific studies, the number of males (20,511 or 56.29%) exceeded the number of females (15,928 or 43.71%) enrolled in Phase III Intramural Research Protocols.

Excluding sex-specific studies, the number of minority males (2,662 or 54.95%) exceeded the number of minority females (2,182 or 45.05%) enrolled in Phase III Intramural Research Protocols.

Race 

Approximately 13.29% (4,844) of participants in aggregate Phase III Intramural Research (36,441 total) were classified as U.S. minorities.

Largest identified racial group was White at 87.43% following the 1977 OMB standards and 66.62% following the 1997 OMB Standards

Largest identified racial minority group was Black or African American at 7.71% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 5.89% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.12%.

According to the 1997 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.16%.

Ethnicity 

3.82% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 99.08% (2nd largest category was White at 0.55%)

Smallest identified racial groups were Hawaiian/Pacific Islander, Asian and Black or African American, all at 0.00%. 

Of the 541 participants, 55.08% were women and 44.92% were men.

2.31% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

132 
Table 11A. DOMESTIC Aggregate Enrollment Data for Extramural and Intramural Research Protocols Funded in 

FY2006 and Reported in FY2007: Percent Analysis 

Total Number of 

Protocols with Enrollment 10,463 

Data: 

I. SUMMARY TOTALS: Old Form + New Form 

Sex 

/Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 9,397,957 2,534,431 26.97% 

% 58.08% 59.16% 

Males 6,389,817 1,736,038 27.17% 

% 39.49% 40.53% 

Unknown 392,814 13,269 3.38% 

% 2.43% 0.31% 

TOTAL 16,180,588 4,283,738 26.47% 

Total % 100% 100.00% 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 9,371 

Number of Protocols 

with Enrollment Data: 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown/ 

Other Total Not 

Hispanic 

Hispanic or 

Latino 

Unknown 

/Not 

Reported 

Total 

Female 

88,458 615,470 897,939 28,356 6,004,328 165,960 808,187 8,608,698 7,198,571 628,417 781,710 8,608,698 

0.60% 4.20% 6.13% 0.19% 40.96% 1.13% 5.51% 58.72% 49.11% 4.29% 5.33% 58.72% 

1.03% 7.15% 10.43% 0.33% 69.75% 1.93% 9.39% 100.00% 83.62% 7.30% 9.08% 100.00%

68.13% 68.97% 52.22% 60.89% 59.87% 61.47% 51.41% 58.72% 60.03% 62.70% 46.93% 58.72%

Male 

40,950 275,267 816,588 18,075 4,004,182 101,442 409,911 5,666,415 4,770,679 371,472 524,264 5,666,415 

0.28% 1.88% 5.57% 0.12% 27.31% 0.69% 2.80% 38.65% 32.54% 2.53% 3.58% 38.65% 

0.72% 4.86% 14.41% 0.32% 70.67% 1.79% 7.23% 100.00% 84.19% 6.56% 9.25% 100.00%

31.54% 30.85% 47.49% 38.81% 39.93% 37.57% 26.08% 38.65% 39.78% 37.06% 31.47% 38.65%

Unknown 

422 1,673 5,104 138 20,482 2,603 353,934 384,356 22,138 2,413 359,805 384,356 

0.00% 0.01% 0.03% 0.00% 0.14% 0.02% 2.41% 2.62% 0.15% 0.02% 2.45% 2.62% 

0.11% 0.44% 1.33% 0.04% 5.33% 0.68% 92.08% 100.00% 5.76% 0.63% 93.61% 100.00%

0.33% 0.19% 0.30% 0.30% 0.20% 0.96% 22.51% 2.62% 0.18% 0.24% 21.60% 2.62%

Total 

129,830 892,410 1,719,631 46,569 10,028,992 270,005 1,572,032 14,659,469 11,991,388 1,002,302 1,665,779 14,659,469 

0.89% 6.09% 11.73% 0.32% 68.41% 1.84% 10.72% 100.00% 81.80% 6.84% 11.36% 100.00%

0.89% 6.09% 11.73% 0.32% 68.41% 1.84% 10.72% 100.00% 81.80% 6.84% 11.36% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown/ 

Other Total 

Female 

11,781 5,303 15,648 2131 329,924 54,739 208,891 628,417 

1.18% 0.53% 1.56% 0.21% 32.92% 5.46% 20.84% 62.70% 

1.87% 0.84% 2.49% 0.34% 52.50% 8.71% 33.24% 100.00%

56.28% 77.13% 55.73% 66.61% 66.90% 57.79% 58.79% 62.70%

9,112 1,536 12,377 1054 162620 39,644 145,129 371,472 

0.91% 0.15% 1.23% 0.11% 16.22% 3.96% 14.48% 37.06% 

Male 2.45% 0.41% 3.33% 0.28% 43.78% 10.67% 39.07% 100.00%

43.53% 22.34% 44.08% 32.95% 32.97% 41.86% 40.85% 37.06%

39 36 53 14 652 334 1,285 2,413 

0.00% 0.00% 0.01% 0.00% 0.07% 0.03% 0.13% 0.24% 

Unknown 1.62% 1.49% 2.20% 0.58% 27.02% 13.84% 53.25% 100.00%

0.19% 0.52% 0.19% 0.44% 0.13% 0.35% 0.36% 0.24%

20,932 6,875 28,078 3,199 493,196 94,717 355,305 1,002,302 

TOTAL 

2.09% 0.69% 2.80% 0.32% 49.21% 9.45% 35.45% 100.00% 

2.09% 0.69% 2.80% 0.32% 49.21% 9.45% 35.45% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

2,334,998 

15.93% 

27.12%

59.77%

1,560,071 

10.64% 

27.53%

39.93%

11,877 

0.08% 

3.09%

0.30%

3,906,946 

26.65% 

26.65%

100.00%

133 
1,092 

Table 11 A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/ 

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

2,680 26,935 127,508 42,310 566,576 23,250 789,259 199,433 

0.18% 1.77% 8.38% 2.78% 37.25% 1.53% 51.89% 13.11% 

0.34% 3.41% 16.16% 5.36% 71.79% 2.95% 100.00% 25.27%

0.00% 52.06% 53.57% 51.80% 51.71% 47.81% 51.89% 52.93%

Male 

2,549 24,637 109,916 38,865 527,390 20,045 723,402 175,967 

0.17% 1.62% 7.23% 2.56% 34.67% 1.32% 47.56% 11.57% 

0.35% 3.41% 15.19% 5.37% 72.90% 2.77% 100.00% 24.32%

0.00% 47.62% 46.18% 47.58% 48.13% 41.22% 47.56% 46.70%

Unknown 

143 168 579 502 1,736 5,330 8,458 1392 

0.009% 0.01% 0.04% 0.03% 0.11% 0.35% 0.56% 0.09% 

1.69% 1.99% 6.85% 5.94% 20.52% 63.02% 100.00% 16.46%

0.00% 0.32% 0.24% 0.61% 0.16% 10.96% 0.56% 0.37%

Total 

5,372 51,740 238,003 81,677 1,095,702 48,625 1,521,119 376,792 

0.35% 3.40% 15.65% 5.37% 72.03% 3.20% 100.00% 24.77% 

0.35% 3.40% 15.65% 5.37% 72.03% 3.20% 100.00% 24.77%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 0.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (9,397,957 or 58.08%) than males (6,389,817 or 39.49%) were enrolled in aggregate Domestic Extramural and Intramural Research Protocols.

More minority females (2,534,431 or 59.16%) than males (1,736,038 or 40.53%) were enrolled in aggregate Domestic Extramural and Intramural Research Protocols.

Race 

Approximately 26.47% (4,283,738) of participants in aggregate Domestic Extramural and Intramural Research (16,180,602 total) were classified as U.S. minorities.

Largest identified racial group was White at 72.03% following the 1977 OMB standards and 70.60% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 15.65% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 11.73% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.32%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.35%.

Ethnicity 

6.84% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards (Decrease of 0.97% over FY2006).

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 49.21% (2nd largest category was Unknown/Other at 35.45%).

Smallest identified racial group was Asian at 0.69%.

Of the 1,002,302 participants, 62.70% were women and 37.06% were men.

5.37% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

134 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 8,130,874 2,273,947 27.97% 

% 62.16% 62.27% 

Males 4,594,511 1,365,350 29.72% 

% 35.13% 37.39% 

Unknown 354,966 12,425 3.50% 

% 2.71% 0.34% 

TOTAL 13,080,351 3,651,722 27.92% 

Total % 100% 100.00% 

Table 12A. DOMESTIC Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2006 and Reported in FY2007: 

Percent Analysis 

8,906 

with Enrollment Data: 

Total Number of Protocols 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 8,272 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

77,732 601,048 845,597 24,891 5,377,482 157,995 771773 7,856,518 6,506,712 595,980 753,826 7,856,518 

0.62% 4.78% 6.72% 0.20% 42.76% 1.26% 6.14% 62.47% 51.74% 4.74% 5.99% 62.47% 

0.99% 7.65% 10.76% 0.32% 68.45% 2.01% 9.82% 100.00% 82.82% 7.59% 9.59% 100.00%

71.93% 69.93% 56.79% 58.49% 63.43% 60.84% 57.57% 62.47% 63.75% 64.20% 52.28% 62.47%

Male 

29,936 256,822 638,263 17,529 3,079,485 99,879 251722 4,373,636 3,677,924 329,885 365,827 4,373,636 

0.24% 2.04% 5.07% 0.14% 24.49% 0.79% 2.00% 34.78% 29.24% 2.62% 2.91% 34.78% 

0.68% 5.87% 14.59% 0.40% 70.41% 2.28% 5.76% 100.00% 84.09% 7.54% 8.36% 100.00%

27.70% 29.88% 42.87% 41.19% 36.33% 38.46% 18.78% 34.78% 36.03% 35.54% 25.37% 34.78%

Unknown 

400 1,641 5,089 138 20,372 1,834 317,091 346,565 22,008 2,409 322,148 346,565 

0.00% 0.01% 0.04% 0.00% 0.16% 0.01% 2.52% 2.76% 0.17% 0.02% 2.56% 2.76% 

0.12% 0.47% 1.47% 0.04% 5.88% 0.53% 91.50% 100.00% 6.35% 0.70% 92.95% 100.00%

0.37% 0.19% 0.34% 0.32% 0.24% 0.71% 23.65% 2.76% 0.22% 0.26% 22.34% 2.76%

Total 

108,068 859,511 1,488,949 42,558 8,477,339 259,708 1,340,586 12,576,719 10,206,644 928,274 1,441,801 12,576,719 

0.86% 6.83% 11.84% 0.34% 67.41% 2.06% 10.66% 100.00% 81.16% 7.38% 11.46% 100.00%

0.86% 6.83% 11.84% 0.34% 67.41% 2.06% 10.66% 100.00% 81.16% 7.38% 11.46% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

11,727 5,289 15,391 2092 305,819 54,587 201,075 595,980 

1.26% 0.57% 1.66% 0.23% 32.94% 5.88% 21.66% 64.20% 

1.97% 0.89% 2.58% 0.35% 51.31% 9.16% 33.74% 100.00%

56.25% 77.29% 61.06% 66.56% 69.69% 57.82% 59.32% 64.20%

9,082 1,518 9,761 1037 132380 39,480 136,627 329,885 

0.98% 0.16% 1.05% 0.11% 14.26% 4.25% 14.72% 35.54% 

Male 2.75% 0.46% 2.96% 0.31% 40.13% 11.97% 41.42% 100.00%

43.56% 22.18% 38.73% 32.99% 30.17% 41.82% 40.30% 35.54%

39 36 53 14 652 334 1,281 2,409 

0.00% 0.00% 0.01% 0.00% 0.07% 0.04% 0.14% 0.26% 

Unknown 1.62% 1.49% 2.20% 0.58% 27.07% 13.86% 53.18% 100.00%

0.19% 0.53% 0.21% 0.45% 0.15% 0.35% 0.38% 0.26%

20,848 6,843 25,205 3,143 438,851 94,401 338,983 928,274 

TOTAL 2.25% 0.74% 2.72% 0.34% 47.28% 10.17% 36.52% 100.00% 

2.25% 0.74% 2.72% 0.34% 47.28% 10.17% 36.52% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

2,214,157 

17.61% 

28.18%

62.61%

1,311,436 

10.43% 

29.99%

37.08%

11,035 

0.09% 

3.18%

0.31%

3,536,628 

28.12% 

28.12%

100.00%

135 
634 

Table 12A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

1,804 7,843 30,985 19,158 197,428 17,138 274,356 59,790 

0.36% 1.56% 6.15% 3.80% 39.20% 3.40% 54.48% 11.87% 

0.66% 2.86% 11.29% 6.98% 71.96% 6.25% 100.00% 21.79%

49.10% 53.54% 52.53% 50.71% 56.21% 45.98% 54.48% 51.95%

Male 

1,727 6,638 27,427 18,122 152,117 14,844 220,875 53,914 

0.34% 1.32% 5.45% 3.60% 30.20% 2.95% 43.86% 10.71% 

0.78% 3.01% 12.42% 8.20% 68.87% 6.72% 100.00% 24.41%

47.01% 45.31% 46.49% 47.97% 43.31% 39.82% 43.86% 46.84%

Unknown 

143 168 578 501 1,717 5,294 8,401 1,390 

0.028% 0.03% 0.11% 0.10% 0.34% 1.05% 1.67% 0.28% 

1.70% 2.00% 6.88% 5.96% 20.44% 63.02% 100.00% 16.55%

3.89% 1.15% 0.98% 1.33% 0.49% 14.20% 1.67% 1.21%

Total 

3,674 14,649 58,990 37,781 351,262 37,276 503,632 115,094 

0.73% 2.91% 11.71% 7.50% 69.75% 7.40% 100.00% 22.85% 

0.73% 2.91% 11.71% 7.50% 69.75% 7.40% 100.00% 22.85%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (8,130,874 or 62.16%) than males (4,594,511 or 35.13%) were enrolled in aggregate Domestic Extramural Research Protocols.

More minority females (2,273,947 or 62.27%) than males (1,365,350 or 37.39%) were enrolled in aggregate Domestic Extramural Research Protocols.

Race 

Approximately 27.92% (3,651,722) of participants in aggregate Domestic Extramural Research (13,080,351 total) were classified as U.S. minorities.

Largest identified racial group was White at 69.75% following the 1977 OMB standards and 67.41% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 11.71% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 11.84% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.34%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.73%.

Ethnicity 

7.38% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 47.28% (2nd largest category was Unknown/Other at 36.52%).

Smallest identified racial group was Hawaiian/Pacific Islander at 0.34%.

Of the 928,274 participants, 64.20% were women and 35.54% were men.

7.50% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

136 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 1,267,083 260,484 20.56% 

% 40.87% 41.21% 

Males 1,795,306 370,688 20.65% 

% 57.91% 58.65% 

Unknown 37,848 844 2.23% 

% 1.22% 0.13% 

TOTAL 3,100,237 632,016 20.39% 

Total % 100% 100.00% 

Table 13A. DOMESTIC Aggregate Enrollment Data for Intramural Research Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 1,481

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 1,032 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

10,726 14,422 52,342 3,465 626,846 7,965 36,414 752,180 691,859 32,437 27,884 752,180 

0.51% 0.69% 2.51% 0.17% 30.10% 0.38% 1.75% 36.11% 33.22% 1.56% 1.34% 36.11% 

1.43% 1.92% 6.96% 0.46% 83.34% 1.06% 4.84% 100.00% 91.98% 4.31% 3.71% 100.00%

49.29% 43.84% 22.69% 86.39% 40.40% 77.35% 15.73% 36.11% 38.77% 43.82% 12.45% 36.11%

Male 

11,014 18,445 178,325 546 924,697 1,563 158,189 1,292,779 1,092,755 41,587 158,437 1,292,779 

0.53% 0.89% 8.56% 0.03% 44.40% 0.08% 7.60% 62.07% 52.47% 2.00% 7.61% 62.07% 

0.85% 1.43% 13.79% 0.04% 71.53% 0.12% 12.24% 100.00% 84.53% 3.22% 12.26% 100.00%

50.61% 56.07% 77.30% 13.61% 59.59% 15.18% 68.35% 62.07% 61.23% 56.18% 70.74% 62.07%

Unknown 

22 32 15 0 110 769 36,843 37,791 130 4 37,657 37,791 

0.00% 0.00% 0.00% 0.00% 0.01% 0.04% 1.77% 1.81% 0.01% 0.00% 1.81% 1.81% 

0.06% 0.08% 0.04% 0.00% 0.29% 2.03% 97.49% 100.00% 0.34% 0.01% 99.65% 100.00%

0.10% 0.10% 0.01% 0.00% 0.01% 7.47% 15.92% 1.81% 0.01% 0.01% 16.81% 1.81%

Total 

21,762 32,899 230,682 4,011 1,551,653 10,297 231,446 2,082,750 1,784,744 74,028 223,978 2,082,750 

1.04% 1.58% 11.08% 0.19% 74.50% 0.49% 11.11% 100.00% 85.69% 3.55% 10.75% 100.00%

1.04% 1.58% 11.08% 0.19% 74.50% 0.49% 11.11% 100.00% 85.69% 3.55% 10.75% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

54 14 257 39 24,107 152 7,814 32,437 

0.07% 0.02% 0.35% 0.05% 32.56% 0.21% 10.56% 43.82% 

0.17% 0.04% 0.79% 0.12% 74.32% 0.47% 24.09% 100.00%

64.29% 43.75% 8.95% 69.64% 44.36% 48.10% 47.89% 43.82%

30 18 2616 17 30,243 164 8,499 41,587 

0.04% 0.02% 3.53% 0.02% 40.85% 0.22% 11.48% 56.18% 

Male 0.07% 0.04% 6.29% 0.04% 72.72% 0.39% 20.44% 100.00%

35.71% 56.25% 91.05% 30.36% 55.64% 51.90% 52.09% 56.18%

0 0 0 0 0 0 4 4 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 

Unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.02% 0.01%

84 32 2,873 56 54,350 316 16,317 74,028 

TOTAL 0.11% 0.04% 3.88% 0.08% 73.42% 0.43% 22.04% 100.00% 

0.11% 0.04% 3.88% 0.08% 73.42% 0.43% 22.04% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

120,841 

5.80% 

16.07%

32.63%

248,635 

11.94% 

19.23%

67.14%

842 

0.04% 

2.23%

0.23%

370,318 

17.78% 

17.78%

100.00%

137 
449 

Table 13A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

876 19,092 96,523 23,152 369,148 6,112 514,903 139,643 

0.09% 1.88% 9.49% 2.28% 36.28% 0.60% 50.61% 13.72% 

0.17% 3.71% 18.75% 4.50% 71.69% 1.19% 100.00% 27.12%

51.59% 51.47% 53.92% 52.74% 49.59% 53.85% 50.61% 53.36%

Male 

822 17,999 82,489 20,743 375,273 5,201 502,527 122,053 

0.08% 1.77% 8.11% 2.04% 36.88% 0.51% 49.39% 12.00% 

0.16% 3.58% 16.41% 4.13% 74.68% 1.03% 100.00% 24.29%

48.41% 48.53% 46.08% 47.25% 50.41% 45.83% 49.39% 46.64%

Unknown 

0 0 1 1 19 36 57 2 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 

0.00% 0.00% 1.75% 1.75% 33.33% 63.16% 100.00% 3.51%

0.00% 0.00% 0.00% 0.00% 0.00% 0.32% 0.01% 0.00%

Total 

1,698 37,091 179,013 43,896 744,440 11,349 1,017,487 261,698 

0.17% 3.65% 17.59% 4.31% 73.16% 1.12% 100.00% 25.72% 

0.17% 3.65% 17.59% 4.31% 73.16% 1.12% 100.00% 25.72%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More males (1,795,306 or 57.91%) than females (1,267,083 or 40.87%) were enrolled in aggregate Domestic Intramural Research Protocols. 

More minority males (370,688 or 58.65%) than females (260,484 or 41.21%) were enrolled in aggregate Domestic Intramural Research Protocols. 

Race 

Approximately 20.39% (632,016) of participants in aggregate Domestic Intramural Research (3,100,237 total) were classified as U.S. minorities.

Largest identified racial group was White at 73.16% following the 1977 OMB standards and 74.50% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 17.59% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 11.08% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.19%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.17%.

Ethnicity 

3.55% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was White at 73.42% (2nd largest category was Unknown/Other at 22.04%).

Smallest identified racial group was Asian at 0.04%.

Of the 74,028 participants, 43.82% were women and 56.18% were men.

This is a significant change from FY2006 when 72.5% were women (decrease of 28.68%) and 27.5% were men (increase of 28.68%).

4.31% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

138 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 213,778 47,367 22.16% 

% 54.13% 56.64% 

Males 164,887 36,032 21.85% 

% 41.75% 43.08% 

Unknown 16,271 235 1.44% 

% 4.12% 0.28% 

TOTAL 394,936 83,634 21.18% 

Total % 100% 100.00% 

Table 14A. DOMESTIC Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 577

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 384 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

1,411 1,737 13,859 262 63,838 1,799 24,098 107,004 73,489 12,367 21,148 107,004 

0.67% 0.83% 6.62% 0.13% 30.51% 0.86% 11.52% 51.14% 35.12% 5.91% 10.11% 51.14% 

1.32% 1.62% 12.95% 0.24% 59.66% 1.68% 22.52% 100.00% 68.68% 11.56% 19.76% 100.00%

61.59% 42.50% 67.75% 54.47% 52.91% 51.47% 41.72% 51.14% 53.98% 58.71% 40.65% 51.14%

Male 

866 2,331 6,570 217 56,492 1,666 17,830 85,972 62,253 8,554 15,165 85,972 

0.41% 1.11% 3.14% 0.10% 27.00% 0.80% 8.52% 41.09% 29.75% 4.09% 7.25% 41.09% 

1.01% 2.71% 7.64% 0.25% 65.71% 1.94% 20.74% 100.00% 72.41% 9.95% 17.64% 100.00%

37.80% 57.03% 32.12% 45.11% 46.82% 47.67% 30.86% 41.09% 45.73% 40.61% 29.15% 41.09%

Unknown 

14 19 28 2 317 30 15,840 16,250 390 143 15,717 16,250 

0.01% 0.01% 0.01% 0.00% 0.15% 0.01% 7.57% 7.77% 0.19% 0.07% 7.51% 7.77% 

0.09% 0.12% 0.17% 0.01% 1.95% 0.18% 97.48% 100.00% 2.40% 0.88% 96.72% 100.00%

0.61% 0.46% 0.14% 0.42% 0.26% 0.86% 27.42% 7.77% 0.29% 0.68% 30.21% 7.77%

Total 

2,291 4,087 20,457 481 120,647 3,495 57,768 209,226 136,132 21,064 52,030 209,226 

1.09% 1.95% 9.78% 0.23% 57.66% 1.67% 27.61% 100.00% 65.06% 10.07% 24.87% 100.00%

1.09% 1.95% 9.78% 0.23% 57.66% 1.67% 27.61% 100.00% 65.06% 10.07% 24.87% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

209 24 280 19 4936 172 6,727 12,367 

0.99% 0.11% 1.33% 0.09% 23.43% 0.82% 31.94% 58.71% 

1.69% 0.19% 2.26% 0.15% 39.91% 1.39% 54.39% 100.00%

69.90% 54.55% 61.67% 79.17% 67.09% 54.09% 53.52% 58.71%

89 20 174 5 2421 145 5,700 8,554 

0.42% 0.09% 0.83% 0.02% 11.49% 0.69% 27.06% 40.61% 

Male 1.04% 0.23% 2.03% 0.06% 28.30% 1.70% 66.64% 100.00%

29.77% 45.45% 38.33% 20.83% 32.91% 45.60% 45.35% 40.61%

1 0 0 0 0 1 141 143 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.67% 0.68% 

Unknown 0.70% 0.00% 0.00% 0.00% 0.00% 0.70% 98.60% 100.00%

0.33% 0.00% 0.00% 0.00% 0.00% 0.31% 1.12% 0.68%

299 44 454 24 7,357 318 12,568 21,064 

TOTAL 1.42% 0.21% 2.16% 0.11% 34.93% 1.51% 59.67% 100.00% 

1.42% 0.21% 2.16% 0.11% 34.93% 1.51% 59.67% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

30,731 

14.69% 

28.72%

60.57%

19,771 

9.45% 

23.00%

38.97%

234 

0.11% 

1.44%

0.46%

50,736 

24.25% 

24.25%

100.00%

139 
193 

Table 14A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

415 2,188 10,067 3,966 87,984 2,154 106,774 16,636 

0.22% 1.18% 5.42% 2.14% 47.38% 1.16% 57.50% 8.96% 

0.39% 2.05% 9.43% 3.71% 82.40% 2.02% 100.00% 15.58%

57.24% 62.62% 50.68% 44.99% 59.19% 51.79% 57.50% 50.57%

Male 

310 1,306 9,795 4,850 60,653 2,001 78,915 16,261 

0.17% 0.70% 5.27% 2.61% 32.66% 1.08% 42.49% 8.76% 

0.39% 1.65% 12.41% 6.15% 76.86% 2.54% 100.00% 20.61%

42.76% 37.38% 49.31% 55.01% 40.80% 48.11% 42.49% 49.43%

Unknown 

0 0 1 0 16 4 21 1 

0.000% 0.00% 0.00% 0.00% 0.01% 0.00% 0.01% 0.00% 

0.00% 0.00% 4.76% 0.00% 76.19% 19.05% 100.00% 4.76%

0.00% 0.00% 0.01% 0.00% 0.01% 0.10% 0.01% 0.00%

Total 

725 3,494 19,863 8,816 148,653 4,159 185,710 32,898 

0.39% 1.88% 10.70% 4.75% 80.05% 2.24% 100.00% 17.71% 

0.39% 1.88% 10.70% 4.75% 80.05% 2.24% 100.00% 17.71%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (213,778 or 54.13%) than males (164,887 or 41.75%) were enrolled in aggregate Domestic Extramural Phase III Research Protocols. 

More minority females (47,367 or 56.64%) than males (36,032 or 43.08%) are enrolled in aggregate Domestic Extramural Phase III Research Protocols. 

Race 

Approximately 21.18% (83,634) of participants in aggregate Domestic Extramural Phase III Research (394,936 total) were classified as U.S. minorities.

Largest identified racial group was White at 80.05% following the 1977 OMB standards and 57.66% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 10.70% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 9.78% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.23%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.39%.

Ethnicity 

10.07% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 59.67% (2nd largest category was White at 34.93%).

Smallest identified racial group was Hawaiian/Pacific Islander at 0.11%.

Of the 21,064 participants, 58.71% were women and 40.61% were men.

4.75% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

140 
I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 14,511 2,110 14.54% 

% 43.31% 44.85% 

Males 18,991 2,595 13.66% 

% 56.68% 55.15% 

Unknown 2 0 0.00% 

% 0.01% 0.00% 

TOTAL 33,504 4,705 14.04% 

Total % 100% 100.00% 

Table 15A. DOMESTIC Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2006 and Reported in FY2007: Percent Analysis 

Total Number of Protocols 32

with Enrollment Data: 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 21 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

11 95 452 72 5,366 266 167 6,429 5,924 297 208 6,429 

0.10% 0.85% 4.03% 0.64% 47.79% 2.37% 1.49% 57.25% 52.76% 2.64% 1.85% 57.25% 

0.17% 1.48% 7.03% 1.12% 83.47% 4.14% 2.60% 100.00% 92.14% 4.62% 3.24% 100.00%

47.83% 45.89% 66.08% 100.00% 56.86% 55.53% 51.23% 57.25% 57.24% 55.41% 60.64% 57.25%

Male 

12 112 232 0 4,072 213 157 4,798 4,426 239 133 4,798 

0.11% 1.00% 2.07% 0.00% 36.26% 1.90% 1.40% 42.73% 39.42% 2.13% 1.18% 42.73% 

0.25% 2.33% 4.84% 0.00% 84.87% 4.44% 3.27% 100.00% 92.25% 4.98% 2.77% 100.00%

52.17% 54.11% 33.92% 0.00% 43.14% 44.47% 48.16% 42.73% 42.76% 44.59% 38.78% 42.73%

Unknown 

0 0 0 0 0 0 2 2 0 0 2 2 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.02% 0.02% 0.00% 0.00% 0.02% 0.02% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.61% 0.02% 0.00% 0.00% 0.58% 0.02%

Total 

23 207 684 72 9,438 479 326 11,229 10,350 536 343 11,229 

0.20% 1.84% 6.09% 0.64% 84.05% 4.27% 2.90% 100.00% 92.17% 4.77% 3.05% 100.00%

0.20% 1.84% 6.09% 0.64% 84.05% 4.27% 2.90% 100.00% 92.17% 4.77% 3.05% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

1 0 0 0 2 1 293 297 

0.19% 0.00% 0.00% 0.00% 0.37% 0.19% 54.66% 55.41% 

0.34% 0.00% 0.00% 0.00% 0.67% 0.34% 98.65% 100.00%

100.00% 0.00% 0.00% 0.00% 66.67% 100.00% 55.18% 55.41%

0 0 0 0 1 0 238 239 

0.00% 0.00% 0.00% 0.00% 0.19% 0.00% 44.40% 44.59% 

Male 0.00% 0.00% 0.00% 0.00% 0.42% 0.00% 99.58% 100.00%

0.00% 0.00% 0.00% 0.00% 33.33% 0.00% 44.82% 44.59%

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

1 0 0 0 3 1 531 536 

TOTAL 0.19% 0.00% 0.00% 0.00% 0.56% 0.19% 99.07% 100.00% 

0.19% 0.00% 0.00% 0.00% 0.56% 0.19% 99.07% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

1,191 

10.61% 

18.53%

59.58%

808 

7.20% 

16.84%

40.42%

0 

0.00% 

0.00%

0.00%

1,999 

17.80% 

17.80%

100.00%

141 
11 

Table 15A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ Alaska 

Native 

Asian/ Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Othe 

r Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

6 169 570 174 7,132 31 8,082 919 

0.03% 0.76% 2.56% 0.78% 32.02% 0.14% 36.28% 4.13% 

0.07% 2.09% 7.05% 2.15% 88.25% 0.38% 100.00% 11.37%

23.08% 37.81% 33.18% 33.79% 36.62% 32.63% 36.28% 33.96%

Male 

20 278 1,148 341 12,342 64 14,193 1,787 

0.09% 1.25% 5.15% 1.53% 55.41% 0.29% 63.72% 8.02% 

0.14% 1.96% 8.09% 2.40% 86.96% 0.45% 100.00% 12.59%

76.92% 62.19% 66.82% 66.21% 63.38% 67.37% 63.72% 66.04%

Unknown 

0 0 0 0 0 0 0 0 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

26 447 1,718 515 19,474 95 22,275 2,706 

0.12% 2.01% 7.71% 2.31% 87.43% 0.43% 100.00% 12.15% 

0.12% 2.01% 7.71% 2.31% 87.43% 0.43% 100.00% 12.15%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research Protocols 

(Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender 

(Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More males (18,991 or 56.68%) than females (14,511 or 43.31%) were enrolled in aggregate Domestic Intramural Phase III Research Protocols.

More minority males (2,595 or 55.15%) than females (2,110 or 44.85%) were enrolled in aggregate Domestic Intramural Phase III Research Protocols.

Race 

Approximately 14.04% (4,705) of participants in aggregate Domestic Intramural Phase III Research (33,504 total) were classified as U.S. minorities.

Largest identified racial group was White at 87.43% following the 1977 OMB standards and 84.05% following the 1997 OMB standards.

Largest identified racial minority group was Black or African American at 7.71% following the 1977 OMB standards.

Largest identified racial minority group was Black or African American at 6.09% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.20%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.12%.

Ethnicity 

4.77% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 99.07% (2nd largest category was White at 0.56%).

Asian, Black/African American and Hawaiian/Pacific Islander were the smallest identified racial groups with 0.0%.

Of the 536 participants, 55.41% were women and 44.59% were men.

2.31% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

142 
Table 16A. FOREIGN Aggregate Enrollment Data for Extramural and Intramural Research Protocols Funded in FY2006 and Reported in FY2007: 

Percent Analysis 

451 

I. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% 

Minority 

by Sex 

Females 754,633 577,468 76.52% 

% 59.52% 61.91% 

Males 497,976 348,190 69.92% 

% 39.28% 37.33% 

Unknown 15,261 7,038 46.12% 

% 1.20% 0.75% 

TOTAL 1,267,870 932,696 73.56% 

Total % 100% 100.00% 

Total Number of 

Protocols with Enrollment 

Data: 

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 445

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total Not 

Hispanic 

Hispanic or 

Latino 

Unknown 

/Not 

Reported 

Total 

Female 

8,521 308,787 153,629 5,547 168,457 4,168 104,099 753,208 607,469 110,806 34,932 753,207 

0.67% 24.42% 12.15% 0.44% 13.32% 0.33% 8.23% 59.56% 48.03% 8.76% 2.76% 59.56% 

1.13% 41.00% 20.40% 0.74% 22.37% 0.55% 13.82% 100.00% 80.65% 14.71% 4.64% 100.00%

54.67% 66.48% 52.42% 52.43% 53.91% 51.69% 64.90% 59.56% 59.22% 66.43% 48.43% 59.56%

Male 

6,940 154,807 136,670 4,816 138,196 3,726 51,038 496,193 408,612 52,830 34,749 496,191 

0.55% 12.24% 10.81% 0.38% 10.93% 0.29% 4.04% 39.24% 32.31% 4.18% 2.75% 39.24% 

1.40% 31.20% 27.54% 0.97% 27.85% 0.75% 10.29% 100.00% 82.35% 10.65% 7.00% 100.00%

44.52% 33.33% 46.63% 45.52% 44.22% 46.21% 31.82% 39.24% 39.84% 31.67% 48.17% 39.24%

Unknown 

126 896 2,765 217 5838 169 5,250 15,261 9,652 3,154 2,455 15,261 

0.01% 0.07% 0.22% 0.02% 0.46% 0.01% 0.42% 1.21% 0.76% 0.25% 0.19% 1.21% 

0.83% 5.87% 18.12% 1.42% 38.25% 1.11% 34.40% 100.00% 63.25% 20.67% 16.09% 100.00%

0.81% 0.19% 0.94% 2.05% 1.87% 2.10% 3.27% 1.21% 0.94% 1.89% 3.40% 1.21%

Total 

15,587 464,490 293,064 10,580 312,491 8,063 160,387 1,264,662 1,025,733 166,790 72,136 1,264,659 

1.23% 36.73% 23.17% 0.84% 24.71% 0.64% 12.68% 100.00% 81.11% 13.19% 5.70% 100.00%

1.23% 36.73% 23.17% 0.84% 24.71% 0.64% 12.68% 100.00% 81.11% 13.19% 5.70% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Female 

9,042 283 1813 486 25,043 3,063 71,076 110,806 

5.42% 0.17% 1.09% 0.29% 15.01% 1.84% 42.61% 66.43% 

8.16% 0.26% 1.64% 0.44% 22.60% 2.76% 64.14% 100.00%

54.21% 51.45% 56.06% 43.59% 54.40% 52.67% 76.13% 66.43%

7,503 267 1386 629 20,991 2,635 19,419 52,830 

4.50% 0.16% 0.83% 0.38% 12.59% 1.58% 11.64% 31.67% 

Male 14.20% 0.51% 2.62% 1.19% 39.73% 4.99% 36.76% 100.00%

44.98% 48.55% 42.86% 56.41% 45.60% 45.31% 20.80% 31.67%

136 0 35 0 0 118 2,865 3,154 

0.08% 0.00% 0.02% 0.00% 0.00% 0.07% 1.72% 1.89% 

Unknown 4.31% 0.00% 1.11% 0.00% 0.00% 3.74% 90.84% 100.00%

0.82% 0.00% 1.08% 0.00% 0.00% 2.03% 3.07% 1.89%

16,681 550 3,234 1,115 46,034 5,816 93,360 166,790 

TOTAL 

10.00% 0.33% 1.94% 0.67% 27.60% 3.49% 55.97% 100.00% 

10.00% 0.33% 1.94% 0.67% 27.60% 3.49% 55.97% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

576,771 

45.61% 

76.58%

61.94%

347,369 

27.47% 

70.01%

37.30%

7,038 

0.56% 

46.12%

0.76%

931,178 

73.63% 

73.63%

100.00%

143 
6 

Table 16A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown/Ot 

her Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

0 2 0 695 725 3 1,425 697 

0.00% 0.06% 0.00% 21.66% 22.60% 0.09% 44.42% 21.73% 

0.00% 0.14% 0.00% 48.77% 50.88% 0.21% 100.00% 48.91%

0.00% 100.00% 0.00% 45.87% 43.03% 60.00% 44.42% 45.92%

Male 

0 0 1 820 960 2 1,783 821 

0.00% 0.00% 0.03% 25.56% 29.93% 0.06% 55.58% 25.59% 

0.00% 0.00% 0.06% 45.99% 53.84% 0.11% 100.00% 46.05%

0.00% 0.00% 100.00% 54.13% 56.97% 40.00% 55.58% 54.08%

Unknown 

0 0 0 0 0 0 0 0 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

0 2 1 1,515 1,685 5 3,208 1,518 

0.00% 0.06% 0.03% 47.23% 52.52% 0.16% 100.00% 47.32% 

0.00% 0.06% 0.03% 47.23% 52.52% 0.16% 100.00% 47.32%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (754,632 or 59.52%) than males (497,974 or 39.28%) were enrolled in aggregate Foreign Intramural and Extramural Research Protocols.

More minority females (577,468 or 61.91%) than males (348,190 or 37.33%) were enrolled in aggregate Foreign Intramural and Extramural Research Protocols.

Race 

Approximately 73.56% (932,686) of participants in aggregate Foreign Intramural and Extramural Research (1,267,857 total) were classified as minorities.

Largest identified racial group was White at 52.52% following the 1977 OMB standards.

Largest identified racial group was Asian at 36.73% following the 1997 OMB standards (with 24.71%, White was not the largest identified racial group).

Largest identified racial minority group was Hispanic at 47.23% following the 1977 OMB standards.

Largest identified racial minority group was Asian at 36.73% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.84%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.0%.

Ethnicity 

13.19% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 55.97% (2nd largest category was White at 27.60%).

Smallest identified racial group was Asian at 0.33%.

Of the 166,790 participants, 66.43% were women and 31.67% were men.

47.23% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

144 
I. SUMMARY TOTALS: Old Form + New Form 

Sex 

/Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 521,771 442,240 84.76% 

% 57.28% 59.26% 

Males 377,384 297,674 78.88% 

% 41.43% 39.89% 

Unknown 11,776 6,364 54.04% 

% 1.29% 0.85% 

TOTAL 910,931 746,278 81.92% 

Total % 100% 100.00% 

Table 17A. FOREIGN Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2006 and Reported in 

FY2007: Percent Analysis 

Total Number of Protocols 

with Enrollment Data: 380 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 374 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total Not Hispanic 

Hispanic or 

Latino 

Unknown 

/Not 

Reported 

Total 

Female 

8,517 198,949 150,934 5,545 78,864 2,310 75,227 520,346 410,918 87,020 22,408 520,346 

0.94% 21.92% 16.63% 0.61% 8.69% 0.25% 8.29% 57.32% 45.27% 9.59% 2.47% 57.32% 

1.64% 38.23% 29.01% 1.07% 15.16% 0.44% 14.46% 100.00% 78.97% 16.72% 4.31% 100.00%

54.66% 64.08% 52.66% 52.42% 49.26% 49.32% 62.87% 57.32% 56.71% 62.80% 50.23% 57.32%

Male 

6,940 111,316 132,918 4,816 77,894 2,205 39,512 375,601 307,133 48,408 20,060 375,601 

0.76% 12.26% 14.64% 0.53% 8.58% 0.24% 4.35% 41.38% 33.84% 5.33% 2.21% 41.38% 

1.85% 29.64% 35.39% 1.28% 20.74% 0.59% 10.52% 100.00% 81.77% 12.89% 5.34% 100.00%

44.54% 35.85% 46.37% 45.53% 48.65% 47.08% 33.02% 41.38% 42.39% 34.93% 44.96% 41.38%

Unknown 

126 222 2,765 217 3,353 169 4,924 11,776 6,493 3,138 2,145 11,776 

0.01% 0.02% 0.30% 0.02% 0.37% 0.02% 0.54% 1.30% 0.72% 0.35% 0.24% 1.30% 

1.07% 1.89% 23.48% 1.84% 28.47% 1.44% 41.81% 100.00% 55.14% 26.65% 18.22% 100.00%

0.81% 0.07% 0.96% 2.05% 2.09% 3.61% 4.11% 1.30% 0.90% 2.26% 4.81% 1.30%

Total 

15,583 310,487 286,617 10,578 160,111 4,684 119,663 907,723 724,544 138,566 44,613 907,723 

1.72% 34.21% 31.58% 1.17% 17.64% 0.52% 13.18% 100.00% 79.82% 15.27% 4.91% 100.00%

1.72% 34.21% 31.58% 1.17% 17.64% 0.52% 13.18% 100.00% 79.82% 15.27% 4.91% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total 

Female 

7,896 283 1,735 485 23,511 1,333 51,777 87,020 

5.70% 0.20% 1.25% 0.35% 16.97% 0.96% 37.37% 62.80% 

9.07% 0.33% 1.99% 0.56% 27.02% 1.53% 59.50% 100.00%

55.16% 51.45% 55.77% 43.54% 54.47% 50.02% 70.31% 62.80%

6,299 267 1,341 629 19,654 1,214 19,004 48,408 

4.55% 0.19% 0.97% 0.45% 14.18% 0.88% 13.71% 34.93% 

Male 13.01% 0.55% 2.77% 1.30% 40.60% 2.51% 39.26% 100.00%

44.00% 48.55% 43.11% 56.46% 45.53% 45.55% 25.80% 34.93%

120 0 35 0 0 118 2,865 3,138 

0.09% 0.00% 0.03% 0.00% 0.00% 0.09% 2.07% 2.26% 

Unknown 3.82% 0.00% 1.12% 0.00% 0.00% 3.76% 91.30% 100.00%

0.84% 0.00% 1.13% 0.00% 0.00% 4.43% 3.89% 2.26%

14,315 550 3,111 1,114 43,165 2,665 73,646 138,566 

TOTAL 10.33% 0.40% 2.25% 0.80% 31.15% 1.92% 53.15% 100.00% 

10.33% 0.40% 2.25% 0.80% 31.15% 1.92% 53.15% 100.00% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B 

441,543 

48.64% 

84.86%

59.29%

296,853 

32.70% 

79.03%

39.86%

6,364 

0.70% 

54.04%

0.85%

744,760 

82.05% 

82.05%

100.00%

145 
6 

Table 17A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown 

/Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

0 2 0 695 725 3 1,425 697 

0.00% 0.06% 0.00% 21.66% 22.60% 0.09% 44.42% 21.73% 

0.00% 0.14% 0.00% 48.77% 50.88% 0.21% 100.00% 48.91%

0.00% 100.00% 0.00% 45.87% 43.03% 60.00% 44.42% 45.92%

Male 

0 0 1 820 960 2 1,783 821 

0.00% 0.00% 0.03% 25.56% 29.93% 0.06% 55.58% 25.59% 

0.00% 0.00% 0.06% 45.99% 53.84% 0.11% 100.00% 46.05%

0.00% 0.00% 100.00% 54.13% 56.97% 40.00% 55.58% 54.08%

Unknown 

0 0 0 0 0 0 0 0 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

0 2 1 1,515 1,685 5 3,208 1,518 

0.00% 0.06% 0.03% 47.23% 52.52% 0.16% 100.00% 47.32% 

0.00% 0.06% 0.03% 47.23% 52.52% 0.16% 100.00% 47.32%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (521,770 or 57.28%) than males (377,382 or 41.43%) were enrolled in aggregate Foreign Extramural Research Protocols.

More minority females (442,240 or 59.26%) than males (297,674 or 39.89%) were enrolled in aggregate Foreign Extramural Research Protocols.

Race 

Approximately 81.93% (746,278) of participants in aggregate Foreign Extramural Research (910,928 total) were classified as minorities.

Largest identified racial group was White at 52.52% following the 1977 OMB standards.

Largest identified racial group was Asian at 34.21% following the 1997 OMB standards.

Largest identified racial minority group was Hispanic at 47.23% following the 1977 OMB standards.

Largest identified racial minority group was Asian at 34.21% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was More Than One Race at 0.52%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.0%.

Ethnicity 

15.27% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 53.15% (2nd largest category was White at 31.15%).

Smallest identified racial group was Asian at 0.40%.

Of the 138,566 participants, 62.80% were women and 34.93% were men.

47.23% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

146 
I. SUMMARY TOTALS: Old Form + New Form 

Sex 

/Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 232,862 135,228 58.07% 

% 65.24% 72.54% 

Males 120,592 50,516 41.89% 

% 33.79% 27.10% 

Unknown 3,485 674 19.34% 

% 0.98% 0.36% 

TOTAL 356,939 186,418 52.23% 

Total % 100% 100.00% 

Table 18A. FOREIGN Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2006 and Reported in 

FY2007: Percent Analysis 

Total Number of Protocols 

with Enrollment Data: 71 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 71 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total Not Hispanic 

Hispanic or 

Latino 

Unknown 

/Not 

Reported 

Total 

Female 

4 109,838 2,695 2 89,593 1,858 28,872 232,862 196,552 23,786 12,524 232,862 

0.00% 30.77% 0.76% 0.00% 25.10% 0.52% 8.09% 65.24% 55.07% 6.66% 3.51% 65.24% 

0.00% 47.17% 1.16% 0.00% 38.47% 0.80% 12.40% 100.00% 84.41% 10.21% 5.38% 100.00%

100.00% 71.32% 41.80% 100.00% 58.80% 54.99% 70.90% 65.24% 65.26% 84.28% 45.50% 65.24%

Male 

0 43,491 3,752 0 60,302 1,521 11,526 120,592 101,481 4,422 14,689 120,592 

0.00% 12.18% 1.05% 0.00% 16.89% 0.43% 3.23% 33.79% 28.43% 1.24% 4.12% 33.79% 

0.00% 36.06% 3.11% 0.00% 50.00% 1.26% 9.56% 100.00% 84.15% 3.67% 12.18% 100.00%

0.00% 28.24% 58.20% 0.00% 39.57% 45.01% 28.30% 33.79% 33.69% 15.67% 53.37% 33.79%

Unknown 

0 674 0 0 2,485 0 326 3,485 3,159 16 310 3,485 

0.00% 0.19% 0.00% 0.00% 0.70% 0.00% 0.09% 0.98% 0.89% 0.00% 0.09% 0.98% 

0.00% 19.34% 0.00% 0.00% 71.31% 0.00% 9.35% 100.00% 90.65% 0.46% 8.90% 100.00%

0.00% 0.44% 0.00% 0.00% 1.63% 0.00% 0.80% 0.98% 1.05% 0.06% 1.13% 0.98%

Total 

4 154,003 6,447 2 152,380 3,379 40,724 356,939 301,192 28,224 27,523 356,939 

0.00% 43.15% 1.81% 0.00% 42.69% 0.95% 11.41% 100.00% 84.38% 7.91% 7.71% 100.00%

0.00% 43.15% 1.81% 0.00% 42.69% 0.95% 11.41% 100.00% 84.38% 7.91% 7.71% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total 

Female 

1,146 0 78 1 1,532 1,730 19,299 23,786 

4.06% 0.00% 0.28% 0.00% 5.43% 6.13% 68.38% 84.28% 

4.82% 0.00% 0.33% 0.00% 6.44% 7.27% 81.14% 100.00%

48.44% 0.00% 63.41% 100.00% 53.40% 54.90% 97.89% 84.28%

1,204 0 45 0 1,337 1,421 415 4,422 

4.27% 0.00% 0.16% 0.00% 4.74% 5.03% 1.47% 15.67% 

Male 27.23% 0.00% 1.02% 0.00% 30.24% 32.13% 9.38% 100.00%

50.89% 0.00% 36.59% 0.00% 46.60% 45.10% 2.11% 15.67%

16 0 0 0 0 0 0 16 

0.06% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.06% 

Unknown 100.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00%

0.68% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.06%

2,366 0 123 1 2,869 3,151 19,714 28,224 

TOTAL 8.38% 0.00% 0.44% 0.00% 10.17% 11.16% 69.85% 100.00% 

8.38% 0.00% 0.44% 0.00% 10.17% 11.16% 69.85% 100.00% 

100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

FORM Parts 

A+B 

135,228 

37.89% 

58.07%

72.54%

50,516 

14.15% 

41.89%

27.10%

674 

0.19% 

19.34%

0.36%

186,418 

52.23% 

52.23%

100.00%

147 
0 

Table 18A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown 

/Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Male 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Unknown 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender 

More females (232,862 or 65.24%) than males (120,592 or 33.79%) were enrolled in aggregate Foreign intramural research protocols.

More minority females (135,228 or 72.54%) than males (50,516 or 27.10%) were enrolled in aggregate Foreign intramural research protocols.

Race 

Approximately 52.23% (186,418) of participants in aggregate Foreign intramural research (356,939 total) were classified as minorities.

Largest identified racial group was Asian at 43.15% following the 1997 OMB standards.

Largest identified racial minority group was Asian at 43.15% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minorites were Hawaiian/Pacific Islander and American Indian/Alaska Native both at 0.0%.

NOTE: The data represented in Table 18A required no forgein reporting using the 1977 OMB Standards. 

Ethnicity 

7.91% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 69.85%.

Smallest identified racial groups were Asian and Hawaiian/Pacific Islander at 0.0%.

Of the 28,224 participants, 84.28% were women and 15.67% were men.

148 
I. SUMMARY TOTALS: Old Form + New Form 

Sex 

/Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 87,957 86,903 98.80% 

% 57.58% 58.16% 

Males 64,235 61,962 96.46% 

% 42.05% 41.47% 

Unknown 559 559 100.00% 

% 0.37% 0.37% 

TOTAL 152,751 149,424 97.82% 

Total % 100% 100.00% 

Table 19A. FOREIGN Aggregate Enrollment Data for Phase III Extramural Research Protocols Funded in FY2006 and Reported in FY2007: Percent 

Analysis 

Total Number of Protocols with 

Enrollment Data: 40 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 39 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total Not Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

3,658 20,416 31,200 1 855 23 31,084 87,237 51,959 35,262 16 87,237 

2.42% 13.51% 20.65% 0.00% 0.57% 0.02% 20.57% 57.74% 34.39% 23.34% 0.01% 57.74% 

4.19% 23.40% 35.76% 0.00% 0.98% 0.03% 35.63% 100.00% 59.56% 40.42% 0.02% 100.00%

51.98% 47.40% 49.39% 50.00% 29.31% 13.45% 89.55% 57.74% 48.09% 81.99% 100.00% 57.74%

Male 

3,347 22,638 31,595 1 2,060 106 3,536 63,283 55,661 7,622 0 63,283 

2.22% 14.98% 20.91% 0.00% 1.36% 0.07% 2.34% 41.89% 36.84% 5.05% 0.00% 41.89% 

5.29% 35.77% 49.93% 0.00% 3.26% 0.17% 5.59% 100.00% 87.96% 12.04% 0.00% 100.00%

47.56% 52.56% 50.01% 50.00% 70.62% 61.99% 10.19% 41.89% 51.51% 17.72% 0.00% 41.89%

Unknown 

32 16 377 0 2 42 90 559 435 124 0 559 

0.02% 0.01% 0.25% 0.00% 0.00% 0.03% 0.06% 0.37% 0.29% 0.08% 0.00% 0.37% 

5.72% 2.86% 67.44% 0.00% 0.36% 7.51% 16.10% 100.00% 77.82% 22.18% 0.00% 100.00%

0.45% 0.04% 0.60% 0.00% 0.07% 24.56% 0.26% 0.37% 0.40% 0.29% 0.00% 0.37%

Total 

7,037 43,070 63,172 2 2,917 171 34,710 151,079 108,055 43,008 16 151,079 

4.66% 28.51% 41.81% 0.00% 1.93% 0.11% 22.97% 100.00% 71.52% 28.47% 0.01% 100.00%

4.66% 28.51% 41.81% 0.00% 1.93% 0.11% 22.97% 100.00% 71.52% 28.47% 0.01% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total 

Female 

3,657 0 1 0 8 2 31,594 35,262 

8.50% 0.00% 0.00% 0.00% 0.02% 0.00% 73.46% 81.99% 

10.37% 0.00% 0.00% 0.00% 0.02% 0.01% 89.60% 100.00%

52.00% 0.00% 25.00% 0.00% 11.43% 66.67% 88.01% 81.99%

3,344 1 3 0 62 1 4,211 7,622 

7.78% 0.00% 0.01% 0.00% 0.14% 0.00% 9.79% 17.72% 

Male 43.87% 0.01% 0.04% 0.00% 0.81% 0.01% 55.25% 100.00%

47.55% 100.00% 75.00% 0.00% 88.57% 33.33% 11.73% 17.72%

32 0 0 0 0 0 92 124 

0.07% 0.00% 0.00% 0.00% 0.00% 0.00% 0.21% 0.29% 

Unknown 25.81% 0.00% 0.00% 0.00% 0.00% 0.00% 74.19% 100.00%

0.45% 0.00% 0.00% 0.00% 0.00% 0.00% 0.26% 0.29%

7,033 1 4 0 70 3 35,897 43,008 

TOTAL 16.35% 0.00% 0.01% 0.00% 0.16% 0.01% 83.47% 100.00% 

16.35% 0.00% 0.01% 0.00% 0.16% 0.01% 83.47% 100.00% 

100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00%

Subtotal Using US 

Minority 

Categories 

(shaded): NEW 

FORM Parts A+B 

86,900 

57.52% 

99.61%

58.16%

61,960 

41.01% 

97.91%

41.47%

559 

0.37% 

100.00%

0.37%

149,419 

98.90% 

98.90%

100.00%

149 
1 

Table 19A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown 

/Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

0 2 0 1 714 3 720 3 

0.00% 0.12% 0.00% 0.06% 42.70% 0.18% 43.06% 0.18% 

0.00% 0.28% 0.00% 0.14% 99.17% 0.42% 100.00% 0.42%

0.00% 100.00% 0.00% 50.00% 42.96% 60.00% 43.06% 60.00%

Male 

0 0 1 1 948 2 952 2 

0.00% 0.00% 0.06% 0.06% 56.70% 0.12% 56.94% 0.12% 

0.00% 0.00% 0.11% 0.11% 99.58% 0.21% 100.00% 0.21%

0.00% 0.00% 100.00% 50.00% 57.04% 40.00% 56.94% 40.00%

Unknown 

0 0 0 0 0 0 0 0 

0.000% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

0 2 1 2 1,662 5 1,672 5 

0.00% 0.12% 0.06% 0.12% 99.40% 0.30% 100.00% 0.30% 

0.00% 0.12% 0.06% 0.12% 99.40% 0.30% 100.00% 0.30%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender: 

More females (87,957; 57.58%) than males (64,235; 42.05%) were enrolled in Aggregate Foreign Phase III Extramural Research Protocols.

More minority females (86,903; 58.16%) than males (61,962; 41.47%) were enrolled in Aggregate Foreign Phase III Extramural Research Protocols.

Race 

Approximately 97.82% (149,424) of participants in aggregate Foreign Phase III Extramural Research (152,751 total) were classified as minorities.

Largest identified racial group was White at 99.40% following the 1977 OMB standards. 

Largest identified racial group was Black/African American at 41.81% following the 1997 OMB standards.

Largest identified racial minority groups were Hispanic and Asian/Pacific Islander at 0.12% following the 1977 OMB standards.

Largest identified racial minority group was Black/African American at 41.81% following the 1997 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority was Hawaiian/Pacific Islander at 0.0%.

According to the 1977 OMB standards, the smallest identified racial minority was American Indian/Alaska Native at 0.0%.

Ethnicity 

28.47% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 83.47% (2nd largest category was American Indian/Alaska Native at 16.35%).

Smallest identified racial groups were Asian and Hawaiian/Pacific Islander at 0.00%.

Of the 43,008 participants, 81.99% were women and 17.72% were men.

0.12% of participants identified their ethnicity as Hispanic according to the 1977 OMB standards.

150 
I. SUMMARY TOTALS: Old Form + New Form 

Sex 

/Gender 

Total 

Enrollment 

Minority 

Enrollment 

Total % 

Minority 

% Minority 

by Sex 

Females 8,448 7,102 84.07% 

% 84.75% 99.07% 

Males 1,520 67 4.41% 

% 15.25% 0.93% 

Unknown 0 0 0.00% 

% 0.00% 0.00% 

TOTAL 9,968 7,169 71.92% 

Total % 100% 100.00% 

Table 20A. FOREIGN Aggregate Enrollment Data for Phase III Intramural Research Protocols Funded in FY2006 and 

Reported in FY2007: Percent Analysis 

Total Number of Protocols 

with Enrollment Data: 4 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

Number of Protocols with 

Enrollment Data: 4 

Total of All Subjects by Race Total of All Subjects by Ethnicity 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total Not 

Hispanic Hispanic or Latino 

Unknown 

/Not 

Reported 

Total 

Female 

0 0 92 0 0 0 8,356 8,448 92 7,010 1,346 8,448 

0.00% 0.00% 0.92% 0.00% 0.00% 0.00% 83.83% 84.75% 0.92% 70.33% 13.50% 84.75% 

0.00% 0.00% 1.09% 0.00% 0.00% 0.00% 98.91% 100.00% 1.09% 82.98% 15.93% 100.00%

0.00% 0.00% 59.35% 0.00% 0.00% 0.00% 85.15% 84.75% 59.35% 99.94% 48.09% 84.75%

Male 

0 0 63 0 0 0 1,457 1,520 63 4 1,453 1,520 

0.00% 0.00% 0.63% 0.00% 0.00% 0.00% 14.62% 15.25% 0.63% 0.04% 14.58% 15.25% 

0.00% 0.00% 4.14% 0.00% 0.00% 0.00% 95.86% 100.00% 4.14% 0.26% 95.59% 100.00%

0.00% 0.00% 40.65% 0.00% 0.00% 0.00% 14.85% 15.25% 40.65% 0.06% 51.91% 15.25%

Unknown 

0 0 0 0 0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

0 0 155 0 0 0 9,813 9,968 155 7,014 2,799 9,968 

0.00% 0.00% 1.55% 0.00% 0.00% 0.00% 98.45% 100.00% 1.55% 70.37% 28.08% 100.00%

0.00% 0.00% 1.55% 0.00% 0.00% 0.00% 98.45% 100.00% 1.55% 70.37% 28.08% 100.00%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Subjects by Race 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown / 

Other Total 

Female 

0 0 0 0 0 0 7,010 7,010 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 99.94% 99.94% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 99.94% 99.94%

0 0 0 0 0 0 4 4 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.06% 0.06% 

Male 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.06% 0.06%

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% #DIV/0!

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0 0 0 0 0 0 7,014 7,014 

TOTAL 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

Subtotal Using US 

Minority 

Categories 

(shaded): NEW 

FORM Parts A+B 

7,102 

71.25% 

84.07%

99.07%

67 

0.67% 

4.41%

0.93%

0 

0.00% 

0.00%

0.00%

7,169 

71.92% 

71.92%

100.00%

151 
0 

Table 20A 

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data:

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic White Unknown 

/Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Female 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Male 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Unknown 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Total 

0 0 0 0 0 0 0 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Legend 

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total) 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total) 

Data Table Comments: 

Sex/Gender: 

More females (8,448; 84.75%) than males (1,520; 15.25%) were enrolled in aggregate Foreign Phase III Intramural Research Protocols. 

More minority females (7,102; 99.07%) than males (67; 0.93%) were enrolled in aggregate Foreign Phase III Intramural Research Protocols. 

Race 

Approximately 71.92% (7,169) of participants in aggregate Foreign Phase III Intramural Research (9,968 total) were classified as minorities.

Largest identified racial group was Unknown/Other at 98.45% following the 1997 OMB standards.

Largest identified racial minority group was Black/African American at 1.55% following the 1997 OMB standards.

According to the 1997 OMB standards the smallest identified racial minorities were, American Indian/Alaska Native, Asian, Hawaiian/Pacific Islander and White at 0.0%.

NOTE: The data represented in Table 20A required no forgein reporting using the 1977 OMB Standards. 

Ethnicity 

70.37% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards.

For participants reporting ethnicity as Hispanic/Latino:

Largest identified racial group was Unknown/Other at 100%.

Of the 7,014 participants, 99.94% were women and 0.06% were men.

152