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 2005 and Fiscal Year 2006 

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 

Carlos E. Caban, Ph.D.

Office of Extramural Research 

Kim Jarema

Liaison, NIH Clinical Center 

Spring 2007 

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: FY2006 and Twelve-Year Trend Reports

NIH Wide Clinical Research Performed in 2005 and Reported in FY2006

Table 1. Summary of NIH Clinical Research Reported in FY2006: 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 FY2006: 

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

 Protocols 21 

Table 3. Summary of NIH Phase III Clinical Research Reported in FY2006: 

 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 FY2006: Number of Sex-Specific Protocols and Enrollment, and Domestic 

 versus Foreign Protocols 25 

Trend Summary Reports: FY1995-2006

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

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

 Clinical Research reported in FY1995-2006: 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 FY1995-2006: Enrollment by Race and Ethnicity 

Domestic and Foreign Clinical Research: Trend Reports FY2002-2005

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

 Clinical Research Reported in FY2002-2006: 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 FY2002-2006: Enrollment Using U.S. Race and 

 Ethnicity Categories 38 

Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural 
 Clinical Research Reported in FY2002-2006: 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 FY2002-2006: 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 FY2006 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

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 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 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. 

 

1
Continuing Implementation and Monitoring Activities 

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, 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. 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 Administrators (SRAs) 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 

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 

2
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 

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

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. 

Many of the training sessions are available electronically for all NIH staff, and the Office of Extramural 

Research (OER) has made available existing training materials on the Population tracking system website 

on the NIH Intranet. 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. Further information regarding training initiatives since the 2000 GAO report is 

discussed in the background section of the Appendices (See Appendix A)

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. 

3
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. 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 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. 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. 

Format Changes for Reporting Race and Ethnicity Data

4
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. 

5
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).

DEFINITIONS: 

6
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 

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 

7
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 2006 Summary Reports 

Twelve -year Trend Summary Reports 

9
10
Summary Report of NIH Inclusion Data

NIH AGGREGATE POPULATION DATA REPORTED IN FY2005 and FY2006 

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 FY2005 and FY2006 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. For 

this report, the FY2005 and FY2006 data tables have been reformatted and some tables may vary slightly 

or differ from prior reported summary data in an effort to better clarify reporting. 

NIH CLINICAL RESEARCH: Fiscal Years 2005 and 2006 

In FY2005, there were 14,798 extramural and intramural clinical research protocols, including Phase III 

and other clinical studies, of which 10,233 protocols reported human subject participation. Of these, 

96.4% were domestic protocols and 3.6% were foreign protocols. Approximately 15.7 million participants 

were enrolled in extramural and intramural research protocols of which 80.6% were domestic participants 

and 19.4% were foreign participants. Of the 15.7 million participants, 60.4% were women, 37.8% were 

men and 1.8% did not provide sex identification. Further, 39.7% of the total participants, and 27.4% of 

the Domestic-only participants, were reported as minorities following the OMB categories for race and 

ethnicity. (Table 6) 

Correspondingly, 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 1) 

11
While the number of participants in all extramural and intramural clinical research decreased (15.7M in 

FY2005 and 14.8M in FY2006), there was no significant change in the ratio of women and men (60.4%F 

and 37.8%M in FY2005; and 63.9%F and 34.9%M in FY2006). One large study involving 

approximately 1.6M participants that ended in FY2005 and therefore was not included in the FY2005 

figures, accounted for the net decreased number of participants reported. 

NIH Defined Phase III Clinical Research: FY2005 and FY2006

In FY2005, there were 665 extramural and intramural Phase III clinical research protocols, of which 547 

protocols reported human subject participation. Of these, 94.5% were domestic protocols and 5.5% were 

foreign protocols. Approximately 493,000 participants were enrolled in extramural and intramural Phase 

III research protocols of which 88.8% were domestic participants and 11.2% were foreign participants. Of 

the 493,000participants, 59% were women, 40% were men and 1% did not provide sex identification. 

Further, 31.3% of the total participants, and 25.1% of the Domestic-only participants, in Phase III clinical 

research were reported as minorities following the 1997 OMB categories for race and ethnicity. (Table 7) 

According to the trend summaries in this report , of the 210 extramural and intramural Phase III research 

protocols that report following the 1977 OMB standards, minority representation was highest for Blacks 

(not Hispanic) at 12.5 % and lowest for American Indian/Alaska Natives at 0.4%. Hispanics represented 

approximately 6.9%, Asian/Pacific Islanders were 5.6% and Whites (not Hispanic) 73.2% of the 

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

with the 1977 OMB standards. (Table 7) 

Furthermore, in FY2005, there were 337 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 28.5% and lowest for Hawaiian/Pacific 

Islanders 0.3%. Asians represented 5.2%, American Indian/Alaska Natives 1.2% and Whites 57.3% of 

participants. Participants identifying as More Than One Race were 1.7% of the total number of 

participants. In addition, 5.8% did not identify a race category. Of the 337 extramural and intramural 

Phase III research protocols designating an ethnicity in FY2005, 88.6 % of total participants identified as 

“Not Hispanic”, 5.9% of the total participants identified as “Hispanic or Latino” and 5.5% 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 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) 

12
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) 

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

increased (493,000 in FY2005 and 499,430 in FY2006), there was no significant change in the ratio of 

women and men (59.0% F and 40.0%M in FY2005; and 62.9%F and 36.0%M in FY2006). 

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

EXTRAMURAL CLINICAL RESEARCH: Fiscal Years 2005 and 2006 

In FY2005, there were 13,003 extramural clinical research protocols, including Phase III and other 

clinical studies, of which 8,763 protocols reported human subject participation as noted in this report’s 

trend summary tables. Approximately 13.8 million participants were enrolled in extramural research 

protocols of which 62.1% were women, 36.1% were men and 1.9% did not provide sex identification. 

(See 2006 Report, Table 2 and Appendix table 3A) 

Correspondingly, 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. (Table 2 and Appendix Table 3A) 

While the number of participants in all extramural clinical research decreased (13.8 million in FY2005 

and 13.02 million in FY2006), there was no significant change in the ratio of women and men (62%F and 

36%M in FY2005 and 65%F and 34%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. (52.4%F and 45.8 % M) 

NIH Defined Phase III Extramural Clinical Research: FY2005 and FY2006

In FY2005 of the 273 extramural Phase III research protocols that report following the 1977 OMB 

standards, minority representation was highest for Blacks (not Hispanic) at 12.9% and lowest for 

American Indian/Alaska Natives at 0.4%. Hispanics represented approximately 7%, Asian/Pacific 

Islanders were 1.9% and Whites (not Hispanic) 76% of the participants. The categories Hawaiian/Pacific 

Islander and More Than One Race were not designations with the 1977 OMB standards. (See 2006 

Report) 

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 

13
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. (Table 4 and Appendix Table 5A) 

According to trend summaries in the 2006 report, in FY2005, there were 621 extramural Phase III clinical 

research protocols, of which 511 protocols reported human subject participation. Of these, 88.5% were 

domestic protocols and 4.9% were foreign protocols. Approximately 465,956 participants were enrolled 

in extramural Phase III research protocols of which 86% of total enrollment is domestic participants and 

8.6% of total enrollment is foreign participants. Of the 465,956 participants, 59.5% were women, 39.5% 

were men and 1% did not provide sex identification. Further, 29.9% of the total participants in Phase III 

clinical research were reported as minorities following the OMB categories for race and ethnicity. (See 

2006 Report, Table 4 and Appendix Table 5A) 

Correspondingly, in FY2006, there were 382 extramural Phase III research protocols reporting data 

following the current 1997 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. (Appendix Table 5A) 

In FY 2005, there were 319 extramural Phase III research protocols reporting data following the current 

1997 OMB standards for reporting race and ethnicity. Accordingly, minority representation by race was 

highest for Blacks at 30.00 % and lowest for Hawaiian/Pacific Islanders 0.28%. Asians represented 

5.44%, American Indian/Alaska Natives 1.30% and Whites 55.75% of participants. Participants 

identifying as More Than One Race were 1.56% of the total number of participants. In addition, 5.66 % 

did not identify a race category. Of the 319 extramural Phase III research protocols designating an 

ethnicity in FY2005, 88.7 % of total participants identified as “Not Hispanic”, 5.98 % of the total 

participants identified as “Hispanic or Latino”, and 5.32 % of the total participants did not identify an 

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

separately. (See 2006 Report, Appendix Table5A) 

Of the 192 extramural Phase III research protocols that report following the 1977 OMB standards, 

minority representation was highest for Blacks (not Hispanic) at 13.03 and lowest for American 

Indian/Alaska Natives at 0.4%. Hispanics represented approximately 7.23%, Asian/Pacific Islanders were 

1.81% and Whites (not Hispanic) 76.1% of the participants. The categories Hawaiian/Pacific Islander

and More Than One Race were not designations with the 1977 OMB standards. (See 2006 Report, 

Appendix Table 5A)

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

there was also some change in the ratio of women and men (59.5%F and 39.5%M in FY2005 and 63.5 

%F and 35.4% M in FY2006). 

INTRAMURAL CLINICAL RESEARCH: Fiscal Years 2005 and 2006 

Substantial numbers of women and minorities were included in NIH intramural studies in FY 2005 and 

FY2006. 

14
In FY2005, there were 1,795 intramural clinical research protocols, including Phase III and other clinical 

studies, of which 1,470 protocols reported human subject participation. Of these, 13.7% of the total 

protocols were domestic protocols and 0.7% of the total protocols were foreign protocols. Approximately 

1.94 million participants were enrolled in intramural research protocols of which 10.4% of the total 

enrollment is domestic participation and 1.9% of the total enrollment is foreign participation. Of the 1.94 

million participants, 48.7% were women, 50.5% were men and 0.79% did not provide sex identification. 

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

In FY2005, approximately 1.94 million participants were reported in all intramural research including 

Phase III clinical trials, and other clinical studies. Of the 733 intramural research protocols that report data 

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

17.8% and lowest for American Indian/Alaska Natives at 1.8%. Blacks (not-Hispanic) represented 7.5%, 

Hispanics 4.7%; and Whites (not Hispanic) 60.9% 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 2006 Report, Appendix Table 7A) 

For the 737 intramural clinical research studies that reported data following the current 1997 OMB 

standards in FY 2005 the largest racial minority group was Blacks at 4.74% and the smallest racial 

minority group was Hawaiian/Pacific Islanders at 0.19%. Asians represented 3.1%, American 

Indian/Alaska Natives 0.42% and Whites 86.2% of participants in all intramural clinical research. 

Approximately 1% of participants reported More Than One Race as their racial category. In addition, 4.42 

% did not identify a race category. Of the 737 intramural research protocols following the current 1997 

OMB standards designating an ethnicity in FY 2005, 95.58 % of total participants identified as “Not 

Hispanic”, 2.10 % of the total participants identified as “Hispanic or Latino”, and 2.32 % of the total 

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

participants is also provided separately. (See 2006 Report, Appendix 7A) 

Correspondingly, 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 

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) 

15
There was an increase in female participants from 48.7% to 55.4% and a corresponding decrease in male 

participants from 50.5% to 43.0%. The number of participants in all intramural clinical research 

decreased slightly from 1.9M to 1.8M from FY2005 to FY2006. 

NIH Defined Phase III Intramural Clinical Research: FY2005 and FY2006

In FY2005, there were 44 intramural Phase III clinical research protocols, of which 36 protocols reported 

human subject participation. Of these, 6% of the total protocols is domestic protocols and 0.5% of the 

total protocols is foreign protocols. Approximately 27,044 participants were enrolled in intramural Phase 

III research protocols of which 2.86% of total enrollment is domestic participation and 2.6% of total 

enrollment is foreign participation. Of the 27,044 participants, 50.5% were women, 49.5% were men and 

0% did not provide sex identification. Further, 54.5% of the total participants in Phase III clinical research 

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

4 and Appendix Table 9A) 

Correspondingly, 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. 

(Table 4 and Appendix Table 9A) 

There was a small increase in women (50.5% to 54.0%) and corresponding decrease in men (49.5% to 

46.0%). The number of participants in Phase III intramural clinical research increased from 27,044 to 

31,476. 

16
TREND REPORT ON NIH AGGREGATE POPULATION DATA: FY1995 – FY2006 

The following section is a new addition to the Annual Comprehensive report. Tables 5-11 provide trend 

data on the collection and reporting of human subject participation in NIH funded clinical research, which 

includes Phase III clinical studies; trend data are also provided in terms of foreign and domestic 

participation. 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 twelve 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 10,758 in 

FY2006 – a 3.4 fold increase. Reported enrollment increased from approximately 1.0 million (FY1995) to 

14.8 million (FY2006) – a 14.5 fold increase; minority enrollment increased from approximately 0.4 

million (FY2002) to 6.4 million (FY2006) – a 17.1 increase in minority representation in NIH clinical 

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

off at about 10,000 protocols per year. 

With the deployment of a new population tracking system in 2002 and the 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 now available for domestic and foreign protocols and participation beginning in FY2002. Domestic 

enrollment increased from 10.2 million (FY2002) to 11.4 million (FY2006) – a 1.1 fold increase. Foreign 

enrollment increased from 0.9 million (FY2002) to 3.4 million (FY2006) – a 3.6 fold increase. Overall, 

the total enrollment has increased with domestic participation averaging between 75.9-91.5% and foreign 

participation averaging between 8.5-24.1%. In FY2006, domestic and foreign enrollment was 77.0% and 

23.0% 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 

34.9% and 45.0%. Overall minority participation in all extramural and intramural clinical research 

averaged between 31% and 43%. Table 6E provides a comparison of domestic and foreign participation 

between FY2002 and FY2006. 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 five-year period. Domestic minority enrollment varied between 24.1% and 

28.9% of total domestic participation, while foreign minority enrollment varied between 82.2% 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 

26.9% to 33.5%. Table 7E provides a comparison of domestic and foreign participation between FY2002 

and FY2006. The vast majority of protocols are domestic (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%-9.6% 

of the total clinical research protocols with enrollment in the last three years. Table 7F shows domestic 

and foreign enrollment for the five-year period. Domestic minority enrollment varied between 20.7% and 

17
25.4% of total domestic participation, while foreign minority enrollment in NIH-funded Phase III clinical 

research varied between 48.4% and 85.2% of total foreign participation. Comparing both domestic and 

foreign Phase III enrollment over the five year period shows that the small percentage of foreign protocols 

(9.6%) in FY2006 account for a significant proportion (19.8%) of the total 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 61.8 and 

67.3% while male participation averaged between 31.2 and 36.9%. (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 64.6% 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 58.5% while male participation varied from 

40.1% 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 56.7% while 

male participation varied from 42.0% to 52.5%. (Table 11) 

18
Table 1. Summary of NIH Clinical Research Reported In FY2006: 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 10,758 10,294 95.7% 464 4.3%

% 70.2% 70.3% 69.3%

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted 4,562 4,356 95.5% 206 4.5%

29.8% 29.7% 30.7%

Total Number of Protocols 15,320 14,650 95.6% 670 4.4%

% 100.0% 100.0% 100.0%

See Table 1A comments on next page.

1B. ENROLLMENT REPORTED

Total All Clinical 

Studies* Domestic % Foreign %

Females Enrolled 9,473,273 7,684,453 81.1% 1,788,820 18.9%

% 63.9% 67.3% 52.5%

Males Enrolled 5,172,205 3,566,577 69.0% 1,605,628 31.0%

% 34.9% 31.2% 47.2%

Sex of Subjects is Unknown 185,452 174,671 94.2% 10,781 5.8%

% 1.3% 1.5% 0.3%

Total Subjects Enrolled 14,830,930 11,425,701 77.0% 3,405,229 23.0%

% 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** 6,388,316 3,301,135 51.7% 3,087,181 48.3%

% Minority Enrollment 43.1% 28.9% 90.7%

See Table 1C omments 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 1997U.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
COMMENTS

Table 1. Summary of NIH Clinical Research Reported In FY2006: 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 FY2006 was 15,320; of these, 10,758 (70.2%) 

reported subject enrollment.

2. Subsequent Tables reporting "Enrollment Reported" are based on the 10,758 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 (14,650; 95.6%); of these, 10,294 (70.3%) reported 

domestic subject enrollment.

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

protocols in subsequent tables.

Table 1B: Total Enrollment Reported

1. The total "Enrollment Reported" in the NIH database in FY2006 was 14,830,930 subjects in 10,758 protocols with 

enrollment.

2. Females made up 63.9% (9.5M) of the total subjects enrolled, while Males made up 31.2%(5.2M), with 1.3% 

unknown.

Total Domestic Enrollment Reported

3. The total Domestic Enrollment reported was 11,425,701 (77%).

4. Females made up 67.3%(7.7M) of the domestic subjects enrolled, while Males made up 31.2%(3.56M), 

with1.5%(.17M) unknown.

Table 1C Comments: Minority Enrollment Reported

1. Minorities made up 43.1% (6.4M) of the total subjects enrolled.

2. Minorities made up 28.9%(3.3M) of the Domestic Enrollment.

3. The Total Minority Enrollment was made up of 51.7% Domestic and 48.3% Foreign enrollment The small 

percentage of foreign protocols (4.0%) account for a significant proportion (48.3%) of the total minority enrollment.

20
Table 2: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2006: 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 1,338 1,162 86.8% 124 9.3% 46 3.4% 6 0.4%

% 8.7% 9.0% 7.3% 8.1% 6.1%

Number of Protocols reporting males 

only 581 468 80.6% 93 16.0% 17 2.9% 3 0.5%

% 3.8% 3.6% 5.5% 3.0% 3.0%

Number of Protocols with Both Female 

and Male Enrollment (excluding sexspecific protocols) 8,839 7,221 81.7% 1,226 13.9% 321 3.6% 71 0.8%

% 57.7% 55.8% 72.2% 56.2% 71.7%

Total Number of Protocols with 

Enrollment 10,758 8,851 82.3% 1,443 13.4% 384 3.6% 80 0.7%

% 70.2% 68% 84.9% 67.3% 80.8%

Number of Protocols with zero 

enrollment. Enrollment data has not 

yet been submitted. 4,562 4,100 89.9% 256 5.6% 187 4.1% 19 0.4%

% 29.8% 31.7% 15.1% 32.7% 19.2%

Total Number of Protocols 15,320 12,951 84.5% 1,699 11.1% 571 3.7% 99 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 4,120,055 3,678,382 89.3% 202,024 4.9% 115,369 2.8% 124,280 3.0%

% 27.8% 36.9% 13.9% 3.8% 35.0%

In Protocols reporting males only 336,717 274,774 81.6% 3,294 1.0% 32,552 9.7% 26,097 7.8%

% 2.3% 2.8% 0.2% 1.1% 7.3%

In Protocols excluding female-only and 

male-only enrollment protocols 10,374,158 6,018,281 58.0% 1,248,946 12.0% 2,902,088 28.0% 204,843 2.0%

% 69.9% 60.4% 85.9% 95.2% 57.7%

Enrollment Totals for all studies 14,830,930 9,971,437 67.2% 1,454,264 9.8% 3,050,009 20.6% 355,220 2.4%

% 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 6,388,316 3,102,731 48.6% 198,404 3.1% 2,878,826 45.1% 208,355 3.3%

% Minority enrollment 43.1% 31.1% 13.6% 94.4% 58.7%

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. 

21
COMMENTS

Table 2: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2006: Number of SexSpecific Protocols, and Domestic versus Foreign Protocols 

Table 2A Total Number of Protocols with Enrollment

1. Female Only Protocols: There were 1,338 protocols reporting females only, representing 12.4 %(1338/10,758) of 

protocols with enrollment.

 90% were Extramural projects(1,162+46); 10% were NIH intramural projects(124+6).

 96% were Domestic protocols(1162+124);4% were Foreign protocols(40+6).

2. Male Only Protocols: There were 581 protocols reporting males only, representing 5%(558/10,758) of protocols with 

enrollment.

 83 % were Extramural projects(468+17); 17% were NIH intramural projects(93+3)

 97% were Domestic protocols(468+93); 3 % were Foreign protocols(17+3).

3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were 8,839 protocols 

reporting both female and male participants representing 82%(8,839/10,758) of the total number of protocols. 

 85% were Extramural projects(7,221+321); 15% were NIH intramural projects(1,226+71)

Table 2B Total Enrollment Reported

1. In Female Only Protocols: There were approximately 4.1 M females, representing 28% of total enrollment.

 92.1% were in Extramural projects; 7.9% were in NIH intramural projects.

 94.2% were in Domestic protocols; 5.8% were in Foreign protocols.

2. In Male Only Protocols: There were approximately 336,717 males, representing 2.3% of total enrollment.

 91.3% were in Extramural projects; 18.8% were in NIH intramural projects.

 82.6% were Domestic in protocols 17.4 % were Foreign protocols.

3. In Protocols Reporting Both Females and Males (excluding sex-specific studies): There were approximately 10,374,158 

subjects, representing 70% of total enrollment.

 86% were in Extramural projects;14% were in NIH intramural projects.

 70% were in Domestic protocols; 30% were in Foreign protocols.

 96% were Domestic protocols(7,221+1,226);4% were Foreign protocols(321+71).

Table 2C Minority Enrollment Reported

1. Total Minority Enrollment: 43.1% of Total Enrollment (14.8M).

 Total Minority Enrollment, Domestic only: 28.9% (3,301,135/11,425,701)

 Total Domestic Minority Enrollment: 51.7% (3,301,135/6,388,316)

 Total Foreign Minority Enrollment: 48.3% (3,087,181/6,388,316)

 Total Extramural projects Minority enrollment: 40.33% (5,981,557/14,830,930)

 Total Intramural Projects Minority enrollment: 2.74% (406,759/14,830,930)

22
Table 3. Summary of NIH Phase III Clinical Research Reported In FY2006: 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 624 564 90.4% 60 9.6%

% 82.1% 82.0% 83.3%

Protocols with zero enrollment. Enrollment 

data has not yet been submitted. 136 124 91.2% 12 8.8%

17.9% 18.0% 16.7%

Total Number of Protocols 760 688 90.5% 72 9.5%

% 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 314,066 258,467 82.3% 55,599 17.7%

% 62.9% 64.6% 56.1%

Males Enrolled 179,975 137,621 76.5% 42,354 23.5%

% 36.0% 34.4% 42.7%

Sex of Subjects is Unknown 5,389 4,209 78.1% 1,180 0.0%

% 1.1% 1.1% 1.2%

Total Subjects Enrolled 499,430 400,297 80.2% 99,133 19.8%

% 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 167,446 83,034 49.6% 84,412 50.4%

33.5% 20.7% 85.2%

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 

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%.

23
COMMENTS

Table 3. Summary of NIH Phase III Clinical Research Reported In FY2006: 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 

FY2006 was 760; of these, 624(82.1%) reported subject enrollment.

2. Subsequent Tables reporting "Enrollment Reported" are based on the 624 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 (688; 90.5%); of these 564(82%) 

reported domestic subject enrollment.

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

and foreign protocols in subsequent tables.

Table 3B Total Enrollment Reported

1. The total "Enrollment Reported" in NIH Defined Phase III Protocols in the NIH database in 

FY2006 was 499,430 subjects in 624 protocols.

2. Females made up 62.9% (314,068) of the total subjects enrolled, while Males made up 

36.0%(179,975), with 1.1%(5,389) unknown.

3. Minorities made up 33.5% (167,446) of the total subjects enrolled.

Total Domestic Enrollment Reported

4. The total Domestic Enrollment reported was 400,297(80.2%).

5. Females made up 64.6%(258,467) of the domestic subjects enrolled, while Males made up 

34.4%(137,621), with 1.1%(4,209) unknown.

Table 3C Minority Enrollment Reported

1. Minorities made up 33.5% of total subjects enrolled.

2. Minorities made up 20.7%(83,034) of the Domestic Enrollment (400,297).

3. The Total Minority Enrollment was made up of 49.6% Domestic and 50.4% Foreign enrollment. 

24
Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2006: 

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

Domestic Foreign

4A. PROTOCOLS REPORTED

Total of Phase III 

Clinical Trials*

Extramural %Intramural %Extramural %Intramural %

Protocols reporting female only 118 101 85.6% 2 1.7% 14 11.9% 1 0.8%

% 15.5% 15.8% 4.2% 20.9% 20.0%

Protocols reporting male only 47 39 83.0% 4 8.5% 4 8.5% 0 0.0%

% 6.2% 6.1% 8.3% 6.0% 0.0%

Protocols with Both Female and Male 

Enrollment (excluding sex-specific 

protocols) 459 384 83.7% 34 7.4% 38 8.3% 3 0.7%

% 60.4% 60.0% 70.8% 56.7% 60.0%

Total Number of Protocols with 

Enrollment 624 524 84.0% 40 6.4% 56 9.0% 4 0.6%

% 82.1% 82% 83.3% 83.6% 80.0%

Phase III Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted. 136 116 85.3% 8 5.9% 11 8.1% 1 0.0%

% 17.9% 18.1% 16.7% 16.4% 20.0%

Total Number of Phase III Protocols 760 640 84.2% 48 6.3% 67 8.8% 5 0.7%

% 100.0% 100.0% 100.0% 100.0% 100.0%

See Table 4A comments on next page.

Domestic Foreign

4B. ENROLLMENT REPORTED 

Total of Phase III 

Clinical Trials*

Extramural %Intramural %Extramural %Intramural %

Protocols reporting female only 167,624 148,185 88.4% 4 0.0% 17,195 10.3% 2240 1.3%

% 33.6% 38.4% 0.0% 21.0% 13.0%

Protocols reporting male only 27,723 23,312 84.1% 177 0.6% 4,234 15.3% 0 0.0%

% 5.6% 6.0% 1.2% 5.2% 0.0%

Protocols excluding female-only and menonly enrollment protocols 304,083 214,619 70.6% 14,000 4.6% 60,409 19.9% 15,055 5.0%

% 60.9% 55.6% 98.7% 73.8% 87.0%

Total Subjects Enrolled 499,430 386,116 77.3% 14,181 2.84% 81,838 16.39% 17,295 3.5%

% 100.0% 100.0% 100.0% 100.0% 100.0%

See Table 4B comments on next page.

Domestic Foreign

4C. MINORITY ENROLLMENT 

REPORTED**

Total of Phase III 

Clinical Trials*

Extramural %Intramural %Extramural %Intramural %

Minority Total for all Phase III studies 167,446 80,622 48.1% 2,412 1.4% 69,820 41.7% 14,592 8.7%

% 33.5% 20.9% 17.0% 85.3% 84.4%

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. 

25
f 

COMMENTS

Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2006: 

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

Table 4A Total Number of Protocols with Enrollment

1. Female Only: There were 118 protocols reporting females only, representing 19 % (118/624) of protocols with enrollment, 

and 15.5% of the Total Number of Protocols.

 97% were Extramural projects (115);3% were NIH intramural projects (3).

 87% were Domestic protocols (103); 13% were Foreign protocols (15).

2. Male Only: There were 47 protocols reporting males only, representing 8% (47/624) of protocols with enrollment, and 6.2% o

the Total Number of Protocols.

 91% were Extramural projects (43); 9% were NIH intramural projects (4).

 91% were Domestic protocols (43);9% were Foreign protocols (4).

3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were 459 protocols reporting both 

males and females representing 60.4 % of the total number of protocols.

 92.0% were Extramural projects (422); 8.0% were NIH intramural projects (37).

 91% were Domestic protocols (418); 9.0% were Foreign protocols (41).

Table 4B Total Enrollment Reported

1. In Female Only Protocols: There were approximately 167,624 females, representing 33.6% of total enrollment.

 98.7% (165,380) were in Extramural projects; 1.3% (2,244) were in NIH intramural projects.

 88.4% (148,189) were in Domestic protocols; 11.67% (19,435) were in Foreign protocols.

2. In Male Only Protocols: There were approximately 27,723 males, representing 5.6% of total enrollment.

 99.4% (27,546) were in Extramural projects; 0.6% (177) were in NIH intramural projects.

 84.7% (23,489) were in Domestic protocols; 15.3% (4,234) were in Foreign protocols.

3. Protocols Reporting Both Females and Males (excluding sex-specific protocols): There were approximately 304,083 

subjects, representing 60.9% of total enrollment.

 90.45% (275,028) were in Extramural projects; 9.55% (29,055) were in NIH intramural projects.

 75.2% (228,619) were in Domestic protocols; 24.8% (75,464) were in Foreign protocols.

Table 4C Minority Enrollment Reported

1. Total Minority Enrollment was 33.5% (167,446) of Total Enrollment (499,430).

 Total Minority enrollment, Extramural protocols (150,442), was 30.12% of Total Enrollment (499,430) and 89.9% of Total 

Minority Enrollment (167,446).

 Total Minority enrollment, Intramural Projects (17,004), was 3.4% of Total Enrollment (499,430) and 10.15% of Total Minority 

Enrollment (167,446).

2. Total Minority Enrollment, Domestic only (83,034), was 20.7% of total Domestic Enrollment (400,297) and 49.6% of Total 

Minority Enrollment (167,446).

3. Total Minority Enrollment, Foreign (84,412), was 85.15% of Total Foreign Enrollment (99,133) and 50.4% of Total Minority 

Enrollment (167,446).

26
Table 5. NIH Twelve Year Trends for Protocol and Enrollment Data: 1995-2006*

5A. Twelve Year Increases in Protocols and Enrollment Data

FY Reported 1995 2006

Relative 

Increase, 

2006 / 1995

Total Protocols with 

Enrollment 3,188 10,758 3.4

Total Enrollment 1,021,493 14,830,930 14.5

Total Minorities 374,433 6,388,316 17.1

% of Minority 36.7% 43.1% 1.2

FY Reported 2002 2006

Relative 

Increase 

2006 / 2002

Total DOMESTIC 

Enrollment data 10,192,401 11,425,701 1.1

Total FOREIGN 

Enrollment 946,083 3,405,229 3.6

Table 5A Comments:

1. There was a 3.4 fold increase in protocols with enrollment reported from 1995 to 2006, from 3,188 protocols to 10,758 

protocols.

2. There was a 14.5 fold increase in enrollment reported from 1995 to 2006, from approximately 1M to 15 M.

3. There was a 17.1 fold increase in minority enrollment from 1995 to 2006, from approximately 0.4 M to 6.4 M.

4. Domestic and Foreign data were reported for FY 2002-2006, and showed 1.1 fold increase in domestic enrollment 

(from 10.2M to 11.4M) and a 3.6 fold increase in foreign enrollment (from 0.95M to 3.4M).

5. See Table 6 for 12 year enrollment totals 1995-2006.

*NOTE: Trend data varies over time because the data for each year represent the net toal 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. 

27
5B. Twelve Year Summary of Total Number of Protocols Reported: FY 1995-2006

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%

Total Protocols by Year Reported

Table 5B Comments:

1. Table 5B and 5B Graph provide the number of OLD and NEW protocols year by year (1995-2006) and the distribution 

between domestic and foreign protocols for years 2002-2006.

2. The total number of protocols reported with enrollment have leveled off at about 15,000 over the last 4 years. 

3. The vast majority of protocols were for domestic studies for 2002-2006, 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 2002-2006, 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. 

0

2000

4000

6000

8000

10000

12000

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

Number of DOMESTIC

Protocols with Enrollment

data

Number of FOREIGN

Protocols with Enrollment

data

Number of Protocols with

Enrollment data (Old +

New Forms):

OLD FORM OLD+NEW FORMS

28
5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2006

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%

Percent Comparison of Domestic and Foreign Enrollment

Table 5C Comments:

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

percentage of domestic enrollment has decreased to approximately 79% as the foreign enrollment has increased to 

approximately 21%.

0%

20%

40%

60%

80%

100%

2002 2003 2004 2005 2006

Percent DOMESTIC

Enrollment

Percent FOREIGN

Enrollment

29
Table 6. NIH Twelve Year Minority Trend Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY 1995-2006: Enrollment by Race and Ethnicity 

6A. TWELVE YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER AND MINORITY CATEGORIES IN ALL 

PROTOCOLS (Old + New Forms)

FY 

Reported

FY 

Funded Form Females Males Unknown

Total All 

Subjects (Old 

+ New 

Forms)

Subtotal: All Subjects 

Enrolled by US Minority 

Categories

Number of 

Protocols with 

Enrollment 

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%

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

Table 6A Comments:

1. Table 6A summarizes enrollment by sex/gender and minority race/ethnicity categories for the twelve year reporting 

period (1995-2006). 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 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.

0%

20%

40%

60%

80%

100%

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

Subtotal: All

Subjects

Enrolled by US

Minority

Categories

OLD FORM OLD+NEW FORMS

0%

20%

40%

60%

80%

100%

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

Unknown

Males

Females

OLD FORM OLD+NEW FORMS

30
Table 6. NIH Twelve Year Minority Trend Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY 1995-2006: 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.

6B. 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/Ot

her Total

Subtotal Using US 

Minority Categories 

(shaded): OLD FORM 

Number 

Protocols with 

Enrollment 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%

ORIENTATION TO TABLES 6C and 6D.

1. The New Form consists of Parts A and B (Tables 6C and 6D) for reporting years 2002-2006. 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%

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

FY Reported FY Funded

American Indian/ 

Alaska Native Asian Black or African 

American

Hawaiian 

/Pacific 

Islander

White More Than 

One Race

Unknown/

Other

Total Hispanic 

or Latino**

Minority Categories 

(shaded): NEW FORM 

Parts A+B

Number of

Protocols with 

Enrollment 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%

* These totals must agree.

**These totals must agree.

31
Table 6. NIH Twelve Year Minority Trend Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY 1995-2006: Enrollment by Race and Ethnicity 

6E. Comparison of Domestic and Foreign Enrollment & Protocols with Total Enrollment for the period FY2002-2006 ENROLLMENT PROTOCOLS

FY Reported FY Funded

Total Enrollment 

data (Old + New 

Forms):

Total DOMESTIC 

Enrollment

Percent 

DOMESTIC 

Enrollment 

Total FOREIGN 

Enrollment

Percent 

FOREIGN 

Enrollment 

Number of 

Protocols 

with 

Enrollment 

data (Old + 

New Forms):

Number 

of 

DOMESTI

C 

Protocols 

Percent 

Domestic 

Protocols

Number of 

FOREIGN 

Protocols 

Percent Foreign 

Protocols

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%

 Percentage of Domestic and Foreign Enrollment Number of Domestic and Foreign protocols

Table 6 E Comments:

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2006.

2. The Domestic enrollment decreased to approximately 80%, while the Foreign enrollment increased to approximately 20%.

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. 

6F. Comparison of Domestic and Foreign Minority Participation for FY 2002-2006

FY 

Reported FY Funded

FOREIGN 

Minority Foreign Total

DOMESTIC 

Minority

Domestic 

Total

2002 2001 777,461 946,083 2,754,820 10,149,869 Number of Minority Participants for FY2002-2005

82.2% 100.0% 27.1% 100.0%

2003 2002 2,452,329 2,860,897 2,935,363 11,911,357

85.7% 100.0% 24.6% 100.0%

2004 2003 4,147,255 4,564,127 3,464,356 14,359,793

90.9% 100.0% 24.1% 100.0%

2005 2004 2,776,565 3,052,894 3,468,864 12,669,858

90.9% 100.0% 27.4% 100.0%

2006 2005 3,087,181 3,405,229 3,301,135 11,425,701

90.7% 100.0% 28.9% 100.0%

NOTE MINORITY % WILL NOT ADD TO 100%

Percentage Comparison of Domestic Minority Enrollment to Total 

Domestic Enrollment for FY 2002-2006

Percentage Comparison of Foreign Minority Enrollment to Total 

Foreign Enrollment for FY 2002-2006

Table 6F Comments:

1. Domestic Minority Enrollment has varied from 24.1% to 28.9% of Total Domestic Enrollment.

research is done in countries that are within the OMB race and ethnicity origin categories that are included in the summary 

3. The Total Minority Enrollment reported in FY2006 was 52% Domestic and 48 % Foreign (see Table 1). The small percentage 

of foreign protocols account for a significant proportion (48%) of the Total Minority Enrollment, as shown by comparing both 

domestic and foreign enrollment data. 

0

2,000

4,000

6,000

8,000

10,000

12,000

2002 2003 2004 2005 2006

Number of DOMESTIC

Protocols 

Number of FOREIGN

Protocols 

0%

20%

40%

60%

80%

100%

2002 2003 2004 2005 2006

Percent DOMESTIC

Enrollment 

Percent FOREIGN

Enrollment 

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

2002 2003 2004 2005 2006

Thousands

FOREIGN Minority

DOMESTIC Minority

DOMESTIC Minority

0%

20%

40%

60%

80%

100%

2002 2003 2004 2005 2006

DOMESTIC Minority

FOREIGN Minority

0%

20%

40%

60%

80%

100%

2002 2003 2004 2005 2006

FOREIGN

Minority

32
Table 7: Twelve Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2006: Enrollment by Race and 

Ethnicity

7A. Phase III TWELVE YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER IN ALL 

PROTOCOLS (Old + New Forms)

FY 

Reported

FY 

Funded Females Males Unknown

Total All 

Subjects 

(Old + New 

Forms)

Subtotal: All 

Subjects Enrolled 

by US Minority 

Categories

Number of 

Protocols with 

Enrollment 

data (Old + 

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%

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 twelve year 

reporting period (1995-2006). 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.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1995 1997 1999 2001 2003 2005

Subtotal: All

Subjects

Enrolled by

US Minority

Categories

OLD FORM OLD+NEW FORMS

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

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

Unknown

Males

Females

OLD FORM OLD+NEW FORM

33
Table 7: Twelve Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2006: 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%

ORIENTATION TO TABLES 7C and 7D.

1. The New Form consists of Parts A and B (Tables 7C and 7D) for reporting years 2002-2006. 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

Unknown

/Not 

Reported

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%

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/P

acific 

Islander

White

More 

Than One 

Race

Unknown/O

ther Total

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

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%

2006 2005 2,307 50 720 40 6,872 713 20,332 31,034 119,755 409

% 7.4% 0.2% 2.3% 0.1% 22.1% 2.3% 65.5% 100.0% 44.4%

* These totals must agree

** These totals must agree

34
Table 7: Twelve Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2006: Enrollment by Race and 

Ethnicity

7E. Comparison of Domestic and Foreign Phase III Enrollment and Protocols with Enrollment for 

the period FY2002-2006

ENROLLMENT PROTOCOLS

FY 

Reported FY Funded

Total 

Enrollment 

data (Old + 

New 

Forms):

Total 

DOMESTIC 

Percent 

DOMESTIC 

Total 

FOREIGN

Percent 

FOREIGN 

Number

of 

Protocols 

with 

Enrollme

nt data 

(Old + 

New 

Forms):

Number of 

DOMESTIC 

Protocols 

Percent 

Domestic 

Protocols

Number 

of 

FOREIGN 

Protocols 

Percent 

Foreign 

Protocols

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%

 Percentage of Phase III Domestic and Foreign Enrollment Number of Phase III Domestic and Foreign protocols

Table 7E Comments:

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2006.

2. The Domestic enrollment decreased to approximately 80%, while the Foreign enrollment increased to 

approximately 20%.

3. The vast majority of protocols in FY2004-2006 are domestic protocols (approximately 90.4-95.8%), while foreign 

protocols make up approximately 4.2-9.6% of total protocols.

4. Foreign enrollment was reported using the same race and ethnicity categories as domestic enrollment. 

7F. Phase III Foreign and Domestic Minority Comparison for FY 2002-2006

FY 

Reported FY Funded

FOREIGN 

Phase III 

Minority

FOREIGN 

Phase III 

Total

DOMESTI

C Phase III 

Minority

DOMESTIC 

Phase III 

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%

Number of Minority Participants in Phase III Clinical Studies for 

FY2002-2006

Table 7F Comments:

1. Domestic Minority Enrollment has varied from 24.1% to 28.9% of Total Domestic Enrollment.

2. Foreign Minority Enrollment has varied from 82.2% 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.

3. The Total Minority Enrollment reported in FY2006 was 52% Domestic and 48 % Foreign (see Table 1). The small 

percentage of foreign protocols account for a significant proportion (48%) of the Total Minority Enrollment, as shown 

by comparing both domestic and foreign enrollment data. 

0

20

40

60

80

100

120

140

2002 2003 2004 2005 2006

Thousands

FOREIGN

Phase III

Minority

DOMESTIC

Phase III

Minority

0

100

200

300

400

500

600

700

800

900

2002 2003 2004 2005 2006

Number of 

DOMESTIC Protocols 

Number of FOREIGN

Protocols 

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005 2006

Percent

DOMESTIC 

Percent

FOREIGN 

35
Table 8: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Clinical 

Research Reported: FY2002-2006: Enrollment Using U.S. Race/Ethnicity Categories

Number of 8A . FIVE YEAR SUMMARY TOTALS: DOMESTIC SUBJECTS IN DOMESTIC PROTOCOLS (Old + New Forms)

FY 

Reported

FY 

Funded Females Males Unknown

Total 

Domestic 

Subjects (Old 

+ New Forms)

Subtotal: Domestic 

Subjects Enrolled by US 

Minority Categories

Domestic 

Protocols 

with 

Enrollment 

data (Old + 

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%

Table 8A Comments:

1. There were approximately an average of 63% females, 35% males and 2% of unknown sex enrolled in 

domestic protocols from 2002-2006.

2. There were approximately an average of 27% domestic minority subjects enrolled in domestic protocols 

from 2002-2006.

3. Total domestic enrollment ranged from 10.1M to 11.5M during these 5 years.

4. The number of domestic protocols increased from 8,425 to 10,294 in 2006.

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).

36
a

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

Research Reported in FY2002-2006: 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 dat

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%

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%

8D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

(Cumulative)

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

Domestic Subtotal 

Using US Minority 

Categories (shaded): 

NEW FORM Parts A+B

Number of 

Domestic 

Protocols 

with 

Enrollment 

data (New 

Form):

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%

* These totals must agree

** These totals must agree 37
Table 9: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III 

Clinical Research Reported in FY2002-2006:Enrollment Using U.S. Race/Ethnicity 

9A . Phase III FIVE YEAR SUMMARY TOTALS: DOMESTIC SUBJECTS IN DOMESTIC PROTOCOLS 

(Old + New Forms)

FY 

Reported

FY 

Funded Females Males Unknown

Total 

Domestic 

Subjects 

(Old + New 

Forms)

Subtotal: Domestic 

Subjects Enrolled by 

US Minority 

Categories

Number of 

Domestic 

Protocols with 

Enrollment 

data (Old + 

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%

Table 9A Comments:

1. There were approximately an average of 57% females, 42% males and 0.3% of unknown sex enrolled in 

domestic protocols from 2002-2005.

2. There were approximately an average of 23.5% domestic minority subjects enrolled in domestic Phase III 

protocols from 2002-2006.

3. Total domestic Phase III enrollment ranged from 400,297to 496,241 during these 5 years.

4. The number of domestic Phase III protocols ranged from 517 to 564 in 2006.

38
Table 9: DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III 

Clinical Research Reported in FY2002-2006: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

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 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%

9C. 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 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%

9D. 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

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%

* These totals must agree

** These totals must agree 39
Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY2002-2006: Enrollment Using U.S. Race/Ethnicity Categories

10A . FIVE YEAR SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN PROTOCOLS (Old + New 

Forms)

FY 

Reported

FY 

Funded Females Males Unknown

Total Foreign 

Subjects (Old 

+ New Forms)

Subtotal: Foreign 

Subjects Enrolled by US 

Minority Categories

Number of 

Foreign 

Protocols with 

Enrollment 

data (Old + 

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%

Table 10AComments:

1. The percent females varied from 39.2% to 58.5% in foreign protocols from 2002-2005; the percent males varied from 

40.1% to 60.4%.

2. The percent foreign subjects enrolled by U.S. Minority Categories in foreign protocols increased from 82.2% to 90.9% 

from 2002 to 2005.

3. Total foreign enrollment ranged from 777,461 to 4.15M during these 5 years.

4. The number of foreign protocols ranged from 638 in 2003 to 317 in 2005.

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 India had an enrollment of 2,000,000 subjects (New Form).

One study in China had an enrollment of 1,910,000 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).

40
Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY2002-2006: 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

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 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%

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/N

ot 

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%

10D. 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 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%

* These totals must agree

** These totals must agree

41
FY Reported

FY 

Funded Females Males Unknown

Total Foreign 

Subjects (Old 

+ New 

Forms)

Number of 

Foreign 

Protocols 

with 

Enrollment 

data (Old + 

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%

Table 11A Comments:

3. Total Phase III foreign enrollment increased from 30,311 to 99,133 during these 5 years.

4. The number of Phase III foreign protocols dropped from 209 in 2003 to 60 in 2006.

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

Clinical Research Reported in FY2002-2006: Enrollment Using U.S. Race/Ethnicity 

Categories

11A. Part A. Phase III FIVE YEAR SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN 

PROTOCOLS (Old + New Forms)

Subtotal: Foreign 

Subjects Enrolled by 

US Minority 

Categories

1. The percent females varied from 47.4% to 56.7% in Phase III foreign protocols from 2002-2006; the percent 

males varied from 42.0% to 52.5%.

2. The percent foreign subjects enrolled by U.S. Minority Categories in Phase III foreign protocols increased 

from 60.4% to 85.2% from 2002 to 2006.

42
NOTE 2: Data from Tables 11B, 11C and 11D are combined to provide the summary data in Table A.

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)

Number of 

Foreign 

Protocols 

with 

Enrollment 

data (Old 

Form):

2002 2001 59 12,269 2,807 1,724 9,579 1,558 27,996 166

% 0.2% 43.8% 10.0% 6.2% 34.2% 5.6% 100.0%

2003 2002 77 12,428 280 3,499 15,054 8,077 39,415 188

% 0.2% 31.5% 0.7% 8.9% 38.2% 20.5% 100.0%

2004 2003 1 12,068 52 1,007 3,093 7,603 23,824 10

% 0.0% 50.7% 0.2% 4.2% 13.0% 31.9% 100.0%

2005 2004 0 12,252 1 1,183 2,257 14 15,707 5

% 0.0% 78.0% 0.0% 7.5% 14.4% 0.1% 100.0%

2006 2005 16 12,295 30 12 4,533 675 17,561 8

% 0.1% 70.0% 0.2% 0.1% 25.8% 3.8% 100.0%

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/N

ot 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% 67.5% 0.0% 32.5% 100.0%

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%

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

Number of 

Foreign 

Protocols 

with 

Enrollment 

data (New 

Form):

2002 2001 0 0 00 0 0 0 0 6

% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%

2003 2002 0 0 00 2 0 1 3 21

% 0.0% 0.0% 0.0% 0.0% 66.7% 0.0% 33.3% 100.0%

2004 2003 0 0 0 0 2 2,570 0 2,572 14

% 0.0% 0.0% 0.0% 0.0% 0.1% 99.9% 0.0% 100.0%

2005 2004 388 0 0 0 4 0 232 624 25

% 62.2% 0.0% 0.0% 0.0% 0.6% 0.0% 37.2% 100.0%

2006 2005 1,849 3 213 0 1,328 1 14,090 17,484 52

% 10.6% 0.0% 1.2% 0.0% 7.6% 0.0% 80.6% 100.0%

** These totals must agree

94.8%

16,859

60.2%

16,284

41.3%

7,643

76.5%

23,998

11D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to 

Date 

FOREIGN Subtotal 

Using US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

78.7%

30,845

78.3%

* These totals must agree

72,059

1,449

62.6%

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

13,128

55.1%

13,436

85.5%

11C. 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

12,353

70.3%

11B.OLD FORM: Total of All FOREIGN Subjects Reported Using the 1977 OMB Standards in a 

combined race/ethnicity format

FOREIGN Subtotal 

Using US Minority 

Categories 

(shaded): OLD 

FORM 

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

Clinical Research Reported in FY2002-2006: 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. 

43
44
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 FY2006 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 

must be included in clinical trial protocols and the results of subset analyses must be reported to NIH 

52
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. 

 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 

53
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 

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. 

54
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 

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 

55
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. 

Conclusion and Current Status 

56
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

Carlos Caban*, Viktoriya Anufriyeva, Maria Koshy, Peter Pruesch, Sam Shekar 

Office of Acquisition, Management and Procurement 

Barbara Levy 

National Cancer Institute

Gail Blaufarb*, Marilyn Gaston, Kim Witherspoon, Lisa Krueger, Clarissa Douglass 

National Eye Institute

Lore Anne McNicol*, William Darby, Pavi Miskala 

National Heart, Lung, and Blood Institute

 Carl Roth (Co-Chair)*, Sharry Palagi, Barbara Liu 

National Human Genome Research Institute

Bettie Graham*, Pam Sellman 

National Institute on Aging 

Robin Barr *, Karen Bashir, Kate Nagy, Jamie Gulin 

National Institute on Alcohol Abuse and Alcoholism

Dorita Sewell*, 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

 Madeline Turkeltaub*, 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

Maria Canto*, Trenita Davis

National Institute of Diabetes, Digestive and Kidney Disorders

Patricia Robuck*, Christine Densmore, Lauren Meskill, Garman Williams

National Institute on Drug Addiction

Christie Baxter* 

National Institute of Environmental Health Sciences

Martha Barnes * 

National Institute of General Medical Sciences

Lori Burge *, Alison Cole 

National Institute of Mental Health

Catherine Roca *, Sue Kennel, Ernesto Marquez, Dawn Corbett, Kathleen O’Leary 

National Institute of Neurological Disorders and Stroke

 Frances Yee *, Kristy Woolbert, Aricia Ajose 

National Institute of Nursing Research

Paul Cotton *, Christine Shaw 

National Library of Medicine

Hua-Chuan Sim *, Valerie Florence 

Warren G. Magnuson Clinical Center

Kim Jarema *, Dee Koziol 

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*, Ivy Chan 

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 

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 

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
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 

99 
100 
Old Table for Target & Enrollment Data Collection 

101 
New Table for Target Data Collection

102 
New Table for Enrollment Data Collection

103 
104 
Appendix H 

Comparison of 1977 and 1997 OMB Classifications 

For Reporting Race and Ethnicity 

105 
106 
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* 

 

107 
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** 

 

ust be equal to the "Racial Categories: Total of All Subjects" 

l 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 

7 OMB combined Race and Ethnicity Format, which has mutually 

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

ce and Ethnicity Categories, with separate reporting for 

thnicity (Hispanic or Latino; Not Hispanic or Latino) and Race. In this format, an individual is classified both by 

thnic Category and by Race Category. Part B of the NEW FORM rovide tion of onl

e five main Race categories. Since mino ries ar to include both

" and non-white racial categories when mm in rities, it is 

their e n-w te 

* The "Ethnic Category Total of All Subjects" m

** The "Hispanic or Latino"(Part A) must be equal to "Racia

category. 

Note 2. The OLD FORM uses the 197

e

Note 3. The NEW FORM uses the 1997 OMB Ra

E

E therefore p

rity catego

s a distribu

e defined 

y 

"Hispanics or Latinos" by th

"Hispanic or Latino ethnicity

ne

 providing su

" based on 

ary totals of m

ethnicity to th

o

cessary to add White Hispanics" and "Unknown/Other Hispanics no

racial categories. 

hi

108 
Appendix I 

Aggregate Extramural and Intramural Data Tables 

Funded in FY2005 and Reported in FY2006 

109 
110 
Table of Contents: Fiscal Year 2006 Aggregate Data Tables 

Table 1A. Aggregate Enrollment Data for All Extramural and Intramural Research Protocols 

 Funded in FY2005 and Reported in FY2006: Percent Analysis 113 

Table 2A. Aggregate Enrollment Data for All Extramural and Intramural Phase III Research 

 Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis 115 

Table 3A. Aggregate Enrollment Data for Extramural Research Protocols Funded in 

 FY2005 and Reported in FY2006: Percent Analysis 117 

Table 4A. Aggregate Enrollment Data for Extramural Research Protocols Excluding 

 Male-Only and Female-Only Protocols Funded in FY2005 and Reported in 

 FY2006: Percent Analysis 119 

Table 5A. Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded 

 in FY2005 and Reported in FY2006: Percent Analysis 121 

Table 6A. Aggregate Enrollment Data for Extramural Phase III Research Protocols Excluding 

 Male-Only and Female-Only Research Protocols Funded in FY2005 and 

 Reported in FY2006: Percent Analysis 123 

Table 7A. Aggregate Enrollment Data for Intramural Research Protocols Funded in 

 FY2005 and Reported in FY2006: Percent Analysis 125 

Table 8A. Aggregate Enrollment Data for Intramural Research Protocols Excluding 

 Male-Only and Female-Only Protocols Funded in FY2005 and Reported in 

 FY2006: Percent Analysis 127 

Table 9A. Aggregate Enrollment Data for Intramural Phase III Research Protocols 

 Funded in FY2005 and Reported in FY2006: Percent Analysis 129 

Table 10A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Excluding 

 Male-Only and Female-Only Research Protocols Funded in FY2005 and 

 Reported in FY2006: Percent Analysis 131 

Domestic and Foreign Clinical Research Reported in FY 2005 and 2006

Table 11A. Domestic: Aggregate Enrollment Data for Extramural and Intramural Research 

 Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis 133 

Table 12A. Domestic: Aggregate Enrollment Data for Extramural Research Protocols 

 Funded in FY2005 and Reported in FY2006: Percent Analysis 135 

Table 13A. Domestic: Aggregate Enrollment Data for Intramural Research Protocols 

 Funded in FY2005 and Reported in FY2006: Percent Analysis 137 

Table 14A. Domestic: Aggregate Enrollment Data for Extramural Phase III Research 

 Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis 139 

111 
Table 15A. Domestic: Aggregate Enrollment Data for Intramural Phase III Researc

Protocols Funded in FY2005 and Reported in FY2006: Percent Analys

h 

is 141 

able 16A. ural Research 

Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis 143 

Analysis 

T Foreign: Aggregate Enrollment Data for Extramural and Intram

T Foreign: Aggregate Enrollment Da able 17A. ta for Extramural Research Protocols 

Funded in FY2005 and Reported in FY2006: Percent Analysis 145 

Table 18A. Foreign: Aggregate Enrollment Data for Intramural Research Protocols 

Funded in FY2005 and Reported in FY2006: Percent 147 

T Foreign: Aggregate Enrollmen able 19A. t Data for Extramural Phase III Research 

 Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis 149 

Table 20A. Foreign: Aggregate Enrollment Data for Intramural Phase III Research 

 Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis 151 

112 
 

 Table 1A. Aggregate Enrollment Data for Extramural and Intramural Research Funded in FY2005 and Reported in FY2006: Percent 

I. SUMMARY TOTALS: Old Form + New Form

Total Number of 

Protocols with 

Enrollment Data: 

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% 

Minority 

by Sex 10,758

Females 9,473,273 3,818,620 40.31%

% 63.88% 59.78%

Males 5,172,205 2,539,314 49.10%

% 34.87% 39.75%

Unknown 185,452 30,382 16.38%

% 1.25% 0.48%

TOTAL 14,830,930 6,388,316 43.07%

Total % 100% 100.00%

Number of Protocols 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data: 9,367

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/O

ther Total Not 

Hispanic

Hispanic or 

Latino

Unknown 

/Not 

Reported

Total

Female

95,866 1,945,321 822,173 22,825 4,822,122 178,585 765,876 8,652,768 7,301,261 676,197 675,310 8,652,768

0.71% 14.40% 6.09% 0.17% 35.70% 1.32% 5.67% 64.07% 54.06% 5.01% 5.00% 64.07%

1.11% 22.48% 9.50% 0.26% 55.73% 2.06% 8.85% 100.00% 84.38% 7.81% 7.80% 100.00%

67.72% 56.17% 65.70% 59.35% 68.02% 55.54% 63.79% 64.07% 64.57% 64.14% 59.08% 64.07%

Male

44,963 1,513,810 418,413 15,568 2,221,924 139,053 334,142 4,687,873 3,945,254 369,120 373,499 4,687,873

0.33% 11.21% 3.10% 0.12% 16.45% 1.03% 2.47% 34.71% 29.21% 2.73% 2.77% 34.71%

0.96% 32.29% 8.93% 0.33% 47.40% 2.97% 7.13% 100.00% 84.16% 7.87% 7.97% 100.00%

31.76% 43.71% 33.44% 40.48% 31.34% 43.24% 27.83% 34.71% 34.89% 35.01% 32.67% 34.71%

Unknown

738 4,071 10,753 67 44,971 3,916 100,523 165,039 61,730 8,995 94,314 165,039

0.01% 0.03% 0.08% 0.00% 0.33% 0.03% 0.74% 1.22% 0.46% 0.07% 0.70% 1.22%

0.45% 2.47% 6.52% 0.04% 27.25% 2.37% 60.91% 100.00% 37.40% 5.45% 57.15% 100.00%

0.52% 0.12% 0.86% 0.17% 0.63% 1.22% 8.37% 1.22% 0.55% 0.85% 8.25% 1.22%

Total

141,567 3,463,202 1,251,339 38,460 7,089,017 321,554 1,200,541 13,505,680 11,308,245 1,054,312 1,143,123 13,505,680

1.05% 25.64% 9.27% 0.28% 52.49% 2.38% 8.89% 100.00% 83.73% 7.81% 8.46% 100.00%

1.05% 25.64% 9.27% 0.28% 52.49% 2.38% 8.89% 100.00% 83.73% 7.81% 8.46% 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/O

ther Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

24,676 4,469 12,781 1,262 295,420 96,288 241,301 676,197 3,601,491

2.34% 0.42% 1.21% 0.68% 28.02% 9.13% 22.89% 64.14% 26.67%

3.65% 0.66% 1.89% 1.31% 43.69% 14.24% 35.69% 100.00% 41.62%

54.75% 67.29% 58.87% 57.55% 70.76% 51.91% 64.22% 64.14% 59.93%

Male 

20,288 2,163 8,888 920 121,327 88,600 126,934 369,120 2,380,068

1.92% 0.21% 0.84% 0.50% 11.51% 8.40% 12.04% 35.01% 17.62%

5.50% 0.59% 2.41% 1.04% 32.87% 24.00% 34.39% 100.00% 50.77%

45.01% 32.57% 40.94% 41.95% 29.06% 47.77% 33.78% 35.01% 39.61%

Unknown 

110 9 43 11 748 588 7,486 8,995 27,779

0.01% 0.00% 0.00% 0.01% 0.07% 0.06% 0.71% 0.85% 0.21%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 16.83%

0.24% 0.14% 0.20% 0.50% 0.18% 0.32% 1.99% 0.85% 0.46%

TOTAL

45,074 6,641 21,712 2,193 417,495 185,476 375,721 1,054,312 6,009,338

4.28% 0.63% 2.06% 0.21% 39.60% 17.59% 35.64% 100.00% 44.49%

4.28% 0.63% 2.06% 1.18% 39.60% 17.59% 35.64% 100.00% 44.49%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

113
Table 1A

Number of Protocols 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards with Enrollment Data: 1,391

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

10,562 66,795 93,303 46,469 573,873 29,503 820,505 217,129

0.80% 5.04% 7.04% 3.51% 43.30% 2.23% 61.91% 16.38%

1.29% 8.14% 11.37% 5.66% 69.94% 3.60% 100.00% 26.46%

53.76% 50.68% 62.64% 59.12% 64.99% 46.66% 61.91% 57.29%

Male

9,009 64,715 55,012 30,510 304,220 20,866 484,332 159,246

0.68% 4.88% 4.15% 2.30% 22.96% 1.57% 36.55% 12.02%

1.86% 13.36% 11.36% 6.30% 62.81% 4.31% 100.00% 32.88%

45.85% 49.11% 36.93% 38.82% 34.45% 33.00% 36.55% 42.02%

Unknown

77 276 633 1,617 4,948 12,862 20,413 2603

0.006% 0.02% 0.05% 0.12% 0.37% 0.97% 1.54% 0.20%

0.38% 1.35% 3.10% 7.92% 24.24% 63.01% 100.00% 12.75%

0.39% 0.21% 0.42% 2.06% 0.56% 20.34% 1.54% 0.69%

Total

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

1.48% 9.94% 11.24% 5.93% 66.63% 4.77% 100.00% 28.60%

1.48% 9.94% 11.24% 5.93% 66.63% 4.77% 100.00% 28.60%

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 females (9,473,273 or 63.88%) than males (5,172,205 or 34.87%) are enrolled in aggregate extramural and intramural research protocols. 

More minority females (3,818,620 or 59.78%) than minority males (2,539,314 or 39.75%) are enrolled in aggregate extramural and intramural research protocols. 

Approximately 43.07% (6,388,316) of participants in aggregate extramural and intramural research (14,830,930) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 66.63% following the 1977 OMB standards and 52.49% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 11.24% following the 1977 OMB standards.

Largest identifiec racial minority group is Asians at 25.64% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 1.48%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0.28%.

Ethnicity: 

7.81% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is White at 39.6.25% (2nd hightest category is Unk/Other at 35.64%)

Smallest identified racial group is Hawaiian/Pacific islander at 0.21%

Of the 1,054,312 participants, 64.14% are women and 35% are men. 

5.93% of participants identified as Hispanic according to the 1977 OMB standards. 

114
 Table 2A. Aggregate Enrollment Data for Extramural and Intramural Phase III Research Funded in FY2005 and Reported in FY2006: Percent 

Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of 

Protocols with 

Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 624

Females 314,066 100,403 31.97%

% 62.88% 59.96%

Males 179,975 66,450 36.92%

% 36.04% 39.68%

Unknown 5,389 593 11.00%

% 1.08% 0.35%

TOTAL 499,430 167,446 33.53%

Total % 100% 100.00%

Number of Protocols 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data: 409

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

2,814 15,768 27,512 265 62,142 2,286 29,607 140,394 101,368 20,899 18,127 140,394

1.04% 5.85% 10.20% 0.10% 23.04% 0.85% 10.98% 52.06% 37.59% 7.75% 6.72% 52.06%

2.00% 11.23% 19.60% 0.19% 44.26% 1.63% 21.09% 100.00% 72.20% 14.89% 12.91% 100.00%

60.78% 48.73% 54.18% 49.53% 49.06% 53.84% 58.69% 52.06% 50.09% 67.34% 49.97% 52.06%

Male

1,810 16,550 23,047 269 63,559 1,913 16,877 124,025 99,781 9,864 14,380 124,025

0.67% 6.14% 8.55% 0.10% 23.57% 0.71% 6.26% 45.99% 37.00% 3.66% 5.33% 45.99%

1.46% 13.34% 18.58% 0.22% 51.25% 1.54% 13.61% 100.00% 80.45% 7.95% 11.59% 100.00%

39.09% 51.14% 45.39% 50.28% 50.18% 45.05% 33.46% 45.99% 49.31% 31.78% 39.64% 45.99%

Unknown

6 42 221 1 969 47 3,962 5,248 1,209 271 3,768 5,248

0.00% 0.02% 0.08% 0.00% 0.36% 0.02% 1.47% 1.95% 0.45% 0.10% 1.40% 1.95%

0.11% 0.80% 4.21% 0.02% 18.46% 0.90% 75.50% 100.00% 23.04% 5.16% 71.80% 100.00%

0.13% 0.13% 0.44% 0.19% 0.76% 1.11% 7.85% 1.95% 0.60% 0.87% 10.39% 1.95%

Total

4,630 32,360 50,780 535 126,670 4,246 50,446 269,667 202,358 31,034 36,275 269,667

1.72% 12.00% 18.83% 0.20% 46.97% 1.57% 18.71% 100.00% 75.04% 11.51% 13.45% 100.00%

1.72% 12.00% 18.83% 0.20% 46.97% 1.57% 18.71% 100.00% 75.04% 11.51% 13.45% 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

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

1,384 31 370 28 4,378 382 14,326 20,899 67,349

4.46% 0.10% 1.19% 3.93% 14.11% 1.23% 46.16% 67.34% 24.97%

6.62% 0.15% 1.77% 7.33% 20.95% 1.83% 68.55% 100.00% 47.97%

59.99% 62.00% 51.39% 70.00% 63.71% 53.58% 70.46% 67.34% 56.24%

Male 

923 18 350 12 2,477 330 5,754 9,864 51,820

2.97% 0.06% 1.13% 1.68% 7.98% 1.06% 18.54% 31.78% 19.22%

9.36% 0.18% 3.55% 3.64% 25.11% 3.35% 58.33% 100.00% 41.78%

40.01% 36.00% 48.61% 30.00% 36.04% 46.28% 28.30% 31.78% 43.27%

Unknown 

0 1 0 0 17 1 252 271 586

0.00% 0.00% 0.00% 0.00% 0.05% 0.00% 0.81% 0.87% 0.22%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 11.17%

0.00% 2.00% 0.00% 0.00% 0.25% 0.14% 1.24% 0.87% 0.49%

TOTAL

2,307 50 720 40 6,872 713 20,332 31,034 119,755

7.43% 0.16% 2.32% 0.13% 22.14% 2.30% 65.52% 100.00% 44.41%

7.43% 0.16% 2.32% 5.61% 22.14% 2.30% 65.52% 100.00% 44.41%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

115
Table 2A

Number of Protocols 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards with Enrollment Data: 215

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

775 9,626 15,860 6,793 136,836 3,782 173,672 33,054

0.34% 4.19% 6.90% 2.96% 59.56% 1.65% 75.59% 14.39%

0.45% 5.54% 9.13% 3.91% 78.79% 2.18% 100.00% 19.03%

76.58% 57.30% 77.92% 71.33% 77.87% 59.58% 75.59% 69.31%

Male

237 7,172 4,490 2,731 38,864 2,456 55,950 14,630

0.10% 3.12% 1.95% 1.19% 16.91% 1.07% 24.35% 6.37%

0.42% 12.82% 8.03% 4.88% 69.46% 4.39% 100.00% 26.15%

23.42% 42.69% 22.06% 28.67% 22.12% 38.69% 24.35% 30.68%

Unknown

0 2 5 0 24 110 141 7

0.000% 0.00% 0.00% 0.00% 0.01% 0.05% 0.06% 0.00%

0.00% 1.42% 3.55% 0.00% 17.02% 78.01% 100.00% 4.96%

0.00% 0.01% 0.02% 0.00% 0.01% 1.73% 0.06% 0.01%

Total

1,012 16,800 20,355 9,524 175,724 6,348 229,763 47,691

0.44% 7.31% 8.86% 4.15% 76.48% 2.76% 100.00% 20.76%

0.44% 7.31% 8.86% 4.15% 76.48% 2.76% 100.00% 20.76%

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 females (314,066 or 62.88%) than males (179,975 or 36.04%) are enrolled in aggregate extramural and intramural Phase III research protocols. 

More minority females (100,403 or 59.96%) than minority males (66,450 or 39.68%) are enrolled in aggregate extramural and intramural Phase III research protocols. 

Approximately 33.53% (167,446) of participants in aggregate extramural and intramural Phase IIII research (499,430) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 76.48% following the 1977 OMB standards and 46.97% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 8.86% following the 1977 OMB standards.

Largest identifiec racial minority group is Black or African American at 18.83% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.44%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0.20%.

Ethnicity: 

11.51% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at65.52% (2nd hightest category is White at 22.14%)

Smallest identified racial group is Asian at .016%

Of the 31,034 participants, 67.34% are women and 31.78% are men. 

4.15% of participants identified as Hispanic according to the 1977 OMB standards. 

116
 Table 3A. Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 9,235

Females 8,470,418 3,551,143 41.92%

% 65.05% 59.37%

Males 4,394,092 2,401,100 54.64%

% 33.75% 40.14%

Unknown 156,936 29,314 18.68%

% 1.21% 0.49%

TOTAL 13,021,446 5,981,557 45.94%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 8,434

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

92,373 1,849,953 782,188 22,372 4,270,798 169,431 724,291 7,911,406 6,629,408 632,810 649,188 7,911,406

0.76% 15.22% 6.44% 0.18% 35.14% 1.39% 5.96% 65.09% 54.54% 5.21% 5.34% 65.09%

1.17% 23.38% 9.89% 0.28% 53.98% 2.14% 9.16% 100.00% 83.80% 8.00% 8.21% 100.00%

67.84% 55.27% 66.05% 59.67% 70.94% 54.58% 64.69% 65.09% 65.80% 63.37% 60.07% 65.09%

Male

43,065 1,493,004 391,311 15,056 1,705,983 137,052 310,850 4,096,321 3,384,743 356,842 354,698 4,096,283

0.35% 12.28% 3.22% 0.12% 14.04% 1.13% 2.56% 33.70% 27.85% 2.94% 2.92% 33.70%

1.05% 36.45% 9.55% 0.37% 41.65% 3.35% 7.59% 100.00% 82.63% 8.71% 8.66% 100.00%

31.63% 44.61% 33.04% 40.15% 28.34% 44.15% 27.76% 33.70% 33.59% 35.73% 32.82% 33.70%

Unknown

716 4,070 10,746 67 43,152 3,916 84,449 147,116 61,255 8,992 76,869 147,116

0.01% 0.03% 0.09% 0.00% 0.36% 0.03% 0.69% 1.21% 0.50% 0.07% 0.63% 1.21%

0.49% 2.77% 7.30% 0.05% 29.33% 2.66% 57.40% 100.00% 41.64% 6.11% 52.25% 100.00%

0.53% 0.12% 0.91% 0.18% 0.72% 1.26% 7.54% 1.21% 0.61% 0.90% 7.11% 1.21%

Total

136,154 3,347,027 1,184,245 37,495 6,019,933 310,399 1,119,590 12,154,843 10,075,406 998,644 1,080,755 12,154,805

1.12% 27.54% 9.74% 0.31% 49.53% 2.55% 9.21% 100.00% 82.89% 8.22% 8.89% 100.00%

1.12% 27.54% 9.74% 0.31% 49.53% 2.55% 9.21% 100.00% 82.89% 8.22% 8.89% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

24,639 4,439 11,869 1,229 275,830 94,668 220,136 632,810 3,412,283

2.47% 0.44% 1.19% 0.67% 27.62% 9.48% 22.04% 63.37% 28.07%

3.89% 0.70% 1.88% 1.30% 43.59% 14.96% 34.79% 100.00% 43.13%

54.74% 67.26% 59.32% 57.48% 69.75% 51.87% 63.46% 63.37% 59.26%

Male 

20,261 2,152 8,097 898 118,879 87,266 119,289 356,842 2,317,656

2.03% 0.22% 0.81% 0.49% 11.90% 8.74% 11.95% 35.73% 19.07%

5.68% 0.60% 2.27% 1.03% 33.31% 24.46% 33.43% 100.00% 56.58%

45.01% 32.61% 40.47% 42.00% 30.06% 47.81% 34.39% 35.73% 40.25%

Unknown 

110 9 43 11 748 588 7,483 8,992 27,746

0.01% 0.00% 0.00% 0.01% 0.07% 0.06% 0.75% 0.90% 0.23%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 18.86%

0.24% 0.14% 0.21% 0.51% 0.19% 0.32% 2.16% 0.90% 0.48%

TOTAL

45,010 6,600 20,009 2,138 395,457 182,522 346,908 998,644 5,757,685

4.51% 0.66% 2.00% 0.21% 39.60% 18.28% 34.74% 100.00% 47.37%

4.51% 0.66% 2.00% 1.17% 39.60% 18.28% 34.74% 100.00% 47.37%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

117
Table 3A

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 801

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

2,643 24,769 73,843 37,605 398,749 21,403 559,012 138,860

0.30% 2.86% 8.52% 4.34% 46.01% 2.47% 64.51% 16.02%

0.47% 4.43% 13.21% 6.73% 71.33% 3.83% 100.00% 24.84%

57.62% 61.06% 63.65% 59.96% 66.61% 48.51% 64.51% 62.03%

Male

1,867 15,560 41,532 24,485 197,293 17,034 297,771 83,444

0.22% 1.80% 4.79% 2.83% 22.77% 1.97% 34.36% 9.63%

0.63% 5.23% 13.95% 8.22% 66.26% 5.72% 100.00% 28.02%

40.70% 38.36% 35.80% 39.04% 32.96% 38.61% 34.36% 37.27%

Unknown

77 236 632 623 2,568 5,684 9,820 1568

0.009% 0.03% 0.07% 0.07% 0.30% 0.66% 1.13% 0.18%

0.78% 2.40% 6.44% 6.34% 26.15% 57.88% 100.00% 15.97%

1.68% 0.58% 0.54% 0.99% 0.43% 12.88% 1.13% 0.70%

Total

4,587 40,565 116,007 62,713 598,610 44,121 866,603 223,872

0.53% 4.68% 13.39% 7.24% 69.08% 5.09% 100.00% 25.83%

0.53% 4.68% 13.39% 7.24% 69.08% 5.09% 100.00% 25.83%

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 females (8,470,418 or 65.05%) than males (4,394,092 or 33.75%) are enrolled in aggregate extramural research protocols. 

More minority females (3,551,143 or 59.37%) than minority males (2,401,100 or 40.14%) are enrolled in aggregate extramural research protocols. 

Approximately 45.94% (5,981,557) of participants in aggregate extramural research (13,021,446) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 69.08% following the 1977 OMB standards and 49.53% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 13.39% following the 1977 OMB standards.

Largest identified racial minority group is Asian at 27.54% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.53%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0.31%.

Ethnicity: 

8.22% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is White at 39.6.25% (2nd hightest category is Unk/Other at 34.74%)

Smallest identified racial group is Hawaiian/Pacific islander at 0.21%

Of the 998,644 participants, 63.37% are women and 35.73% are men. 

7.24% of participants identified 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 FY2005 and Reported in 

FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 7,542

Females 4,676,672 2,470,214 52.82%

% 52.43% 51.75%

Males 4,086,772 2,274,128 55.65%

% 45.81% 47.64%

Unknown 156,925 29,314 18.68%

% 1.76% 0.61%

TOTAL 8,920,369 4,773,656 53.51%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 6,901

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

American 

Indian/ Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

50,404 1,427,672 453,526 18,831 1,955,114 150,208 288,636 4,344,391 3,754,525 386,779 203,087 4,344,391

0.61% 17.23% 5.47% 0.23% 23.59% 1.81% 3.48% 52.42% 45.30% 4.67% 2.45% 52.42%

1.16% 32.86% 10.44% 0.43% 45.00% 3.46% 6.64% 100.00% 86.42% 8.90% 4.67% 100.00%

55.11% 50.26% 54.92% 55.70% 54.60% 52.11% 46.00% 52.42% 53.47% 52.10% 38.71% 52.42%

Male

40,338 1,408,865 361,574 14,907 1,582,618 134,112 254,321 3,796,735 3,205,404 346,625 244,668 3,796,697

0.49% 17.00% 4.36% 0.18% 19.09% 1.62% 3.07% 45.81% 38.67% 4.18% 2.95% 45.81%

1.06% 37.11% 9.52% 0.39% 41.68% 3.53% 6.70% 100.00% 84.43% 9.13% 6.44% 100.00%

44.11% 49.60% 43.78% 44.10% 44.20% 46.53% 40.54% 45.81% 45.65% 46.69% 46.64% 45.81%

Unknown

716 4,070 10,746 67 43,152 3,916 84,449 147,116 61,255 8,992 76,869 147,116

0.01% 0.05% 0.13% 0.00% 0.52% 0.05% 1.02% 1.77% 0.74% 0.11% 0.93% 1.78%

0.49% 2.77% 7.30% 0.05% 29.33% 2.66% 57.40% 100.00% 41.64% 6.11% 52.25% 100.00%

0.78% 0.14% 1.30% 0.20% 1.21% 1.36% 13.46% 1.77% 0.87% 1.21% 14.65% 1.78%

Total

91,458 2,840,607 825,846 33,805 3,580,884 288,236 627,406 8,288,242 7,021,184 742,396 524,624 8,288,204

1.10% 34.27% 9.96% 0.41% 43.20% 3.48% 7.57% 100.00% 84.71% 8.96% 6.33% 100.00%

1.10% 34.27% 9.96% 0.41% 43.20% 3.48% 7.57% 100.00% 84.71% 8.96% 6.33% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

20,614 2,031 8,715 946 120,586 87,921 145,966 386,779 2,367,193

2.78% 0.27% 1.17% 0.54% 16.24% 11.84% 19.66% 52.10% 28.56%

5.33% 0.53% 2.25% 1.08% 31.18% 22.73% 37.74% 100.00% 54.49%

53.59% 48.73% 52.40% 51.22% 51.10% 50.39% 53.90% 52.10% 51.61%

Male 

17,739 2,128 7,875 890 114,638 85,977 117,378 346,625 2,191,812

2.39% 0.29% 1.06% 0.51% 15.44% 11.58% 15.81% 46.69% 26.44%

5.12% 0.61% 2.27% 1.04% 33.07% 24.80% 33.86% 100.00% 57.73%

46.12% 51.06% 47.35% 48.19% 48.58% 49.27% 43.34% 46.69% 47.79%

Unknown 

110 9 43 11 748 588 7,483 8,992 27,746

0.01% 0.00% 0.01% 0.01% 0.10% 0.08% 1.01% 1.21% 0.33%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 18.86%

0.29% 0.22% 0.26% 0.60% 0.32% 0.34% 2.76% 1.21% 0.60%

TOTAL

38,463 4,168 16,633 1,847 235,972 174,486 270,827 742,396 4,586,751

5.18% 0.56% 2.24% 0.25% 31.79% 23.50% 36.48% 100.00% 55.34%

5.18% 0.56% 2.24% 1.06% 31.79% 23.50% 36.48% 100.00% 55.34%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

119
Table 4A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 641

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

1,686 19,287 53,256 28,792 212,018 17,242 332,281 103,021

0.27% 3.05% 8.42% 4.55% 33.54% 2.73% 52.57% 16.30%

0.51% 5.80% 16.03% 8.66% 63.81% 5.19% 100.00% 31.00%

46.70% 55.08% 56.34% 53.56% 52.17% 44.40% 52.57% 55.12%

Male

1,847 15,494 40,638 24,337 191,807 15,914 290,037 82,316

0.29% 2.45% 6.43% 3.85% 30.34% 2.52% 45.88% 13.02%

0.64% 5.34% 14.01% 8.39% 66.13% 5.49% 100.00% 28.38%

51.16% 44.25% 42.99% 45.28% 47.20% 40.98% 45.88% 44.04%

Unknown

77 236 632 623 2,568 5,673 9,809 1568

0.012% 0.04% 0.10% 0.10% 0.41% 0.90% 1.55% 0.25%

0.78% 2.41% 6.44% 6.35% 26.18% 57.83% 100.00% 15.99%

2.13% 0.67% 0.67% 1.16% 0.63% 14.61% 1.55% 0.84%

Total

3,610 35,017 94,526 53,752 406,393 38,829 632,127 186,905

0.57% 5.54% 14.95% 8.50% 64.29% 6.14% 100.00% 29.57%

0.57% 5.54% 14.95% 8.50% 64.29% 6.14% 100.00% 29.57%

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: Reference Table 2A

Sex/Gender: 

There were 9,235 protocols of which 1,208 (13.1%) were female-only protocols and 485 (5.25%) were male-only protocols.

Excluding sex-specific studies, the number of females (4,676,672 or 52.43%) exceeds the number of males (4,086,772 or 45.8%) enrolled in extramural research protocols. 

Excluding sex-specific studies, the number of minority females (2,470,214 or 51.75%) exceeds the number of males (2,274,128 or 47.64%) enrolled in extramural research protocols. 

Approximately 53.5% (4,773,656) of participants in aggregate extramural research excluding sex-specific studies (8,920,369) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 43.2% following the 1997 OMB standards and 64.3% following the 1977 OMB standards.

Largest identified racial minority group is Asian at 34.3% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 14.95% following the 1977 OMB standards. 

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.4%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.57%.

Ethnicity: 

8.96% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 36.5% (2nd hightest category is White at 31.79%)

Smallest identified racial group is Hawaiian/Pacific Islander at 0.25%

Of the 742,396 participants, 52.1% are women and 46.7% are men. 

8.5% of participants identified as Hispanic according to the 1977 OMB standards. 

120
 Table 5A. Aggregate Enrollment Data for Extramural PhaseIII Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 580

Females 297,077 90,794 30.56%

% 63.48% 60.35%

Males 165,488 59,055 35.69%

% 35.36% 39.25%

Unknown 5,389 593 11.00%

% 1.15% 0.39%

TOTAL 467,954 150,442 32.15%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 382

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

2,806 15,679 27,019 264 56,963 2,021 25,881 130,633 95,599 18,373 16,661 130,633

1.11% 6.18% 10.64% 0.10% 22.44% 0.80% 10.20% 51.46% 37.66% 7.24% 6.56% 51.46%

2.15% 12.00% 20.68% 0.20% 43.61% 1.55% 19.81% 100.00% 73.18% 14.06% 12.75% 100.00%

60.87% 48.75% 54.02% 49.44% 48.44% 53.64% 57.32% 51.46% 49.71% 64.96% 50.11% 51.46%

Male

1,798 16,443 22,778 269 59,657 1,700 15,309 117,954 95,493 9,641 12,820 117,954

0.71% 6.48% 8.97% 0.11% 23.50% 0.67% 6.03% 46.47% 37.62% 3.80% 5.05% 46.47%

1.52% 13.94% 19.31% 0.23% 50.58% 1.44% 12.98% 100.00% 80.96% 8.17% 10.87% 100.00%

39.00% 51.12% 45.54% 50.37% 50.73% 45.12% 33.91% 46.47% 49.66% 34.09% 38.56% 46.47%

Unknown

6 42 221 1 969 47 3,962 5,248 1,209 271 3,768 5,248

0.00% 0.02% 0.09% 0.00% 0.38% 0.02% 1.56% 2.07% 0.48% 0.11% 1.48% 2.07%

0.11% 0.80% 4.21% 0.02% 18.46% 0.90% 75.50% 100.00% 23.04% 5.16% 71.80% 100.00%

0.13% 0.13% 0.44% 0.19% 0.82% 1.25% 8.77% 2.07% 0.63% 0.96% 11.33% 2.07%

Total

4,610 32,164 50,018 534 117,589 3,768 45,152 253,835 192,301 28,285 33,249 253,835

1.82% 12.67% 19.70% 0.21% 46.32% 1.48% 17.79% 100.00% 75.76% 11.14% 13.10% 100.00%

1.82% 12.67% 19.70% 0.21% 46.32% 1.48% 17.79% 100.00% 75.76% 11.14% 13.10% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

1,384 31 370 28 4,378 382 11,800 18,373 63,967

4.89% 0.11% 1.31% 0.10% 15.48% 1.35% 41.72% 64.96% 25.20%

7.53% 0.17% 2.01% 7.33% 23.83% 2.08% 64.22% 100.00% 48.97%

59.99% 62.00% 51.39% 70.00% 63.71% 53.58% 67.11% 64.96% 55.36%

Male 

923 18 350 12 2,477 330 5,531 9,641 50,996

3.26% 0.06% 1.24% 1.68% 8.76% 1.17% 19.55% 34.09% 20.09%

9.57% 0.19% 3.63% 3.64% 25.69% 3.42% 57.37% 100.00% 43.23%

40.01% 36.00% 48.61% 30.00% 36.04% 46.28% 31.46% 34.09% 44.13%

Unknown 

0 1 0 0 17 1 252 271 586

0.00% 0.00% 0.00% 0.00% 0.06% 0.00% 0.89% 0.96% 0.23%

0.00% 0.37% 0.00% 0.00% 6.27% 0.37% 92.99% 0.00% 11.17%

0.00% 2.00% 0.00% 0.00% 0.25% 0.14% 1.43% 0.96% 0.51%

TOTAL

2,307 50 720 40 6,872 713 17,583 28,285 115,549

8.16% 0.18% 2.55% 0.14% 24.30% 2.52% 62.16% 100.00% 45.52%

8.16% 0.18% 2.55% 5.61% 24.30% 2.52% 62.16% 100.00% 45.52%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

121
Table 5A

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 198

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

649 3,633 15,783 6,762 135,840 3,777 166,444 26,827

0.30% 1.70% 7.37% 3.16% 63.44% 1.76% 77.73% 12.53%

0.39% 2.18% 9.48% 4.06% 81.61% 2.27% 100.00% 16.12%

77.63% 80.99% 78.41% 71.61% 78.57% 59.65% 77.73% 76.88%

Male

187 851 4,340 2,681 37,030 2,445 47,534 8,059

0.09% 0.40% 2.03% 1.25% 17.29% 1.14% 22.20% 3.76%

0.39% 1.79% 9.13% 5.64% 77.90% 5.14% 100.00% 16.95%

22.37% 18.97% 21.56% 28.39% 21.42% 38.61% 22.20% 23.10%

Unknown

0 2 5 0 24 110 141 7

0.000% 0.00% 0.00% 0.00% 0.01% 0.05% 0.07% 0.00%

0.00% 1.42% 3.55% 0.00% 17.02% 78.01% 100.00% 4.96%

0.00% 0.04% 0.02% 0.00% 0.01% 1.74% 0.07% 0.02%

Total

836 4,486 20,128 9,443 172,894 6,332 214,119 34,893

0.39% 2.10% 9.40% 4.41% 80.75% 2.96% 100.00% 16.30%

0.39% 2.10% 9.40% 4.41% 80.75% 2.96% 100.00% 16.30%

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 (297,077 or 63.5%) than males (165,488 or 35.36%) are enrolled in aggregate Phase III Extramural research protocols. 

More minority females (90,794 or 60.35%) than minority males (59,055 or 39.25%) are enrolled in aggregate PhaseIII Extramural research protocols. 

Approximately 32.15% (150,442) of participants in aggregate Phase III Extramural research (467,954) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African American at 19.7% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 19.4% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.21%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 0.4%.

Ethnicity: 

11.14% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 62.16% (2nd hightest category is White at 24.3%)

Smallest identified racial group is Hawaiian/Pacific Islander at 0.14%.

Of the 28,285 participants, 64.96% are women and 34.1% are men. 

4.41% of participants identified 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 FY2005 and Reported 

in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 422

Females 131,697 48,873 37.11%

% 47.88% 47.78%

Males 137,942 52,832 38.30%

% 50.16% 51.65%

Unknown 5,389 593 11.00%

% 1.96% 0.58%

TOTAL 275,028 102,298 37.20%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 288

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

2,377 11,417 19,578 180 35,842 1,271 17,427 88,092 64,267 7,953 15,872 88,092

1.25% 6.01% 10.31% 0.09% 18.88% 0.67% 9.18% 46.40% 33.85% 4.19% 8.36% 46.40%

2.70% 12.96% 22.22% 0.20% 40.69% 1.44% 19.78% 100.00% 72.95% 9.03% 18.02% 100.00%

57.29% 42.13% 50.55% 40.18% 44.44% 43.29% 48.64% 46.40% 45.75% 46.02% 49.47% 46.40%

Male

1,766 15,640 18,931 267 43,846 1,618 14,442 96,510 75,008 9,056 12,446 96,510

0.93% 8.24% 9.97% 0.14% 23.10% 0.85% 7.61% 50.83% 39.51% 4.77% 6.56% 50.83%

1.83% 16.21% 19.62% 0.28% 45.43% 1.68% 14.96% 100.00% 77.72% 9.38% 12.90% 100.00%

42.56% 57.71% 48.88% 59.60% 54.36% 55.11% 40.31% 50.83% 53.39% 52.41% 38.79% 50.83%

Unknown

6 42 221 1 969 47 3,962 5,248 1,209 271 3,768 5,248

0.00% 0.02% 0.12% 0.00% 0.51% 0.02% 2.09% 2.76% 0.64% 0.14% 1.98% 2.76%

0.11% 0.80% 4.21% 0.02% 18.46% 0.90% 75.50% 100.00% 23.04% 5.16% 71.80% 100.00%

0.14% 0.15% 0.57% 0.22% 1.20% 1.60% 11.06% 2.76% 0.86% 1.57% 11.74% 2.76%

Total

4,149 27,099 38,730 448 80,657 2,936 35,831 189,850 140,484 17,280 32,086 189,850

2.19% 14.27% 20.40% 0.24% 42.48% 1.55% 18.87% 100.00% 74.00% 9.10% 16.90% 100.00%

2.19% 14.27% 20.40% 0.24% 42.48% 1.55% 18.87% 100.00% 74.00% 9.10% 16.90% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

1087 14 247 14 2,070 191 4,330 7,953 41,223

6.29% 0.08% 1.43% 2.72% 11.98% 1.11% 25.06% 46.02% 21.71%

13.67% 0.18% 3.11% 7.33% 26.03% 2.40% 54.44% 100.00% 46.80%

54.30% 43.75% 42.81% 53.85% 46.74% 37.16% 44.64% 46.02% 47.12%

Male 

915 17 330 12 2,342 322 5,118 9,056 45,682

5.30% 0.10% 1.91% 2.33% 13.55% 1.86% 29.62% 52.41% 24.06%

10.10% 0.19% 3.64% 3.73% 25.86% 3.56% 56.52% 100.00% 47.33%

45.70% 53.13% 57.19% 46.15% 52.88% 62.65% 52.76% 52.41% 52.21%

Unknown 

0 1 0 0 17 1 252 271 586

0.00% 0.01% 0.00% 0.00% 0.10% 0.01% 1.46% 1.57% 0.31%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 11.17%

0.00% 3.13% 0.00% 0.00% 0.38% 0.19% 2.60% 1.57% 0.67%

TOTAL

2,002 32 577 26 4,429 514 9,700 17,280 87,491

11.59% 0.19% 3.34% 0.15% 25.63% 2.97% 56.13% 100.00% 46.08%

11.59% 0.19% 3.34% 5.06% 25.63% 2.97% 56.13% 100.00% 46.08%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

123
Table 6A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 134

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

167 919 4,172 2,392 34,784 1,171 43,605 7,650

0.20% 1.08% 4.90% 2.81% 40.84% 1.37% 51.19% 8.98%

0.38% 2.11% 9.57% 5.49% 79.77% 2.69% 100.00% 17.54%

49.26% 53.46% 53.51% 48.30% 51.34% 44.64% 51.19% 51.66%

Male

172 798 3,620 2,560 32,940 1,342 41,432 7,150

0.20% 0.94% 4.25% 3.01% 38.67% 1.58% 48.64% 8.39%

0.42% 1.93% 8.74% 6.18% 79.50% 3.24% 100.00% 17.26%

50.74% 46.42% 46.43% 51.70% 48.62% 51.16% 48.64% 48.29%

Unknown

0 2 5 0 24 110 141 7

0.000% 0.00% 0.01% 0.00% 0.03% 0.13% 0.17% 0.01%

0.00% 1.42% 3.55% 0.00% 17.02% 78.01% 100.00% 4.96%

0.00% 0.12% 0.06% 0.00% 0.04% 4.19% 0.17% 0.05%

Total

339 1,719 7,797 4,952 67,748 2,623 85,178 14,807

0.40% 2.02% 9.15% 5.81% 79.54% 3.08% 100.00% 17.38%

0.40% 2.02% 9.15% 5.81% 79.54% 3.08% 100.00% 17.38%

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: Reference Table 4A

Sex/Gender: 

There were 580 PhaseIII Extramural protocols of which 115 (19.8%) were female-only protocols and 43 (7.4%) were male-only protocols.

Excluding sex-specific studies, the number of males (137,942 or 50.16%) exceeds the number of females (131,697 or 47.88%) enrolled in Phase III Extramural research protocols. 

Excluding sex-specific studies, the number of minority males (52,832 or 51.65%) exceeds the number of females (48,873 or 47.78%) enrolled in Phase III Extramural research protocols. 

Approximately 37.2% (102.298) of participants in aggregate Phase III Extramural research excluding sex-specific studies (275,028) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 42.5% following the 1997 OMB standards and 79.54% following the 1977 OMB standards.

Largest identified racial minority group is Black at 20.4% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 9.15% following the 1997 OMB standards. 

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.24%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.4%.

Ethnicity: 

9.1% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 56.13 % (2nd hightest category is White at 25.63%)

Smallest identified racial group is Hawaiian/Pacific Islander at 0.15%

Of the 17,280 participants, 52.4% are men and 46.02% are women. 

5.8% of participants identified as Hispanic according to the 1977 OMB standards. 

124
 Table 7A. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 1,523

Females 1,002,855 267,477 26.67%

% 55.42% 65.76%

Males 778,113 138,214 17.76%

% 43.00% 33.98%

Unknown 28,516 1,068 3.75%

% 1.58% 0.26%

TOTAL 1,809,484 406,759 22.48%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 933

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

3,493 95,368 39,985 453 551,324 9,154 41,585 741,362 671,853 43,387 26,122 741,362

0.26% 7.06% 2.96% 0.03% 40.81% 0.68% 3.08% 54.88% 49.74% 3.21% 1.93% 54.88%

0.47% 12.86% 5.39% 0.06% 74.37% 1.23% 5.61% 100.00% 90.62% 5.85% 3.52% 100.00%

64.53% 82.09% 59.60% 46.94% 51.57% 82.06% 51.37% 54.88% 54.50% 77.94% 41.91% 54.88%

Male

1,898 20,806 27,102 512 515,941 2,001 23,292 591,552 560,511 12,278 18,763 591,552

0.14% 1.54% 2.01% 0.04% 38.19% 0.15% 1.72% 43.79% 41.49% 0.91% 1.39% 43.79%

0.32% 3.52% 4.58% 0.09% 87.22% 0.34% 3.94% 100.00% 94.75% 2.08% 3.17% 100.00%

35.06% 17.91% 40.39% 53.06% 48.26% 17.94% 28.77% 43.79% 45.47% 22.06% 30.10% 43.79%

Unknown

22 1 7 0 1,819 0 16,074 17,923 475 3 17,445 17,923

0.00% 0.00% 0.00% 0.00% 0.13% 0.00% 1.19% 1.33% 0.04% 0.00% 1.29% 1.33%

0.12% 0.01% 0.04% 0.00% 10.15% 0.00% 89.68% 100.00% 2.65% 0.02% 97.33% 100.00%

0.41% 0.00% 0.01% 0.00% 0.17% 0.00% 19.86% 1.33% 0.04% 0.01% 27.99% 1.33%

Total

5,413 116,175 67,094 965 1,069,084 11,155 80,951 1,350,837 1,232,839 55,668 62,330 1,350,837

0.40% 8.60% 4.97% 0.07% 79.14% 0.83% 5.99% 100.00% 91.26% 4.12% 4.61% 100.00%

0.40% 8.60% 4.97% 0.07% 79.14% 0.83% 5.99% 100.00% 91.26% 4.12% 4.61% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

37 30 912 33 19,590 1,620 21,165 43,387 189,208

0.07% 0.05% 1.64% 1.12% 35.19% 2.91% 38.02% 77.94% 14.01%

0.09% 0.07% 2.10% 2.04% 45.15% 3.73% 48.78% 100.00% 25.52%

0.00% 0.00% 0.00% 0.00% 0.00% 54.84% 73.46% 77.94% 75.19%

Male 

27 11 791 22 2,448 1,334 7,645 12,278 62,412

0.05% 0.02% 1.42% 0.74% 4.40% 2.40% 13.73% 22.06% 4.62%

0.22% 0.09% 6.44% 1.65% 19.94% 10.86% 62.27% 100.00% 10.55%

0.00% 0.00% 0.00% 0.00% 0.00% 45.16% 26.53% 22.06% 24.80%

Unknown 

0 0 0 0 0 0 3 3 33

0.00% 0.00% 0.00% 0.00% 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% 0.18%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.01%

TOTAL

64 41 1,703 55 22,038 2,954 28,813 55,668 251,653

0.11% 0.07% 3.06% 0.10% 39.59% 5.31% 51.76% 100.00% 18.63%

0.11% 0.07% 3.06% 1.86% 39.59% 5.31% 51.76% 100.00% 18.63%

0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00% 100.00%

125
Table 7A

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 590

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

7,919 42,026 19,460 8,864 175,124 8,100 261,493 78,269

1.73% 9.16% 4.24% 1.93% 38.18% 1.77% 57.01% 17.07%

3.03% 16.07% 7.44% 3.39% 66.97% 3.10% 100.00% 29.93%

0.00% 46.07% 59.08% 55.81% 61.57% 42.39% 57.01% 50.46%

Male

7,142 49,155 13,480 6,025 106,927 3,832 186,561 75,802

1.56% 10.72% 2.94% 1.31% 23.31% 0.84% 40.68% 16.53%

3.83% 26.35% 7.23% 3.23% 57.31% 2.05% 100.00% 40.63%

0.00% 53.89% 40.92% 37.93% 37.59% 20.05% 40.68% 48.87%

Unknown

0 40 1 994 2,380 7,178 10,593 1035

0.000% 0.01% 0.00% 0.22% 0.52% 1.57% 2.31% 0.23%

0.00% 0.38% 0.01% 9.38% 22.47% 67.76% 100.00% 9.77%

0.00% 0.04% 0.00% 6.26% 0.84% 37.56% 2.31% 0.67%

Total

15,061 91,221 32,941 15,883 284,431 19,110 458,647 155,106

3.28% 19.89% 7.18% 3.46% 62.02% 4.17% 100.00% 33.82%

3.28% 19.89% 7.18% 3.46% 62.02% 4.17% 100.00% 33.82%

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/Rthnicity (Column Total)

Data Table Comments: 

Sex/Gender: 

More females (1,002,855 or 55.4%) than males (778,113 or 43%) are enrolled in aggregate Intramural research protocols. 

More minority females (267,477 or 65.76%) than minority males (138,214 or 33.4%) are enrolled in aggregate Intramural research protocols. 

Approximately 22.5% (406.759) of participants in aggregate Intramural research (1809,484) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Asians at 8.6% following the 1997 OMB standards.

Largest identified racial minority group is Asian/ Pacific Islander at 19.9% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.07%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 3.2%.

Ethnicity: 

4.12% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 51.76% (2nd hightest category is White at 39.6%)

Smallest identified racial group is Asian at 0.07%.

Of the 55,668 participants, 77.9% are women and 22% are men. 

3.46% of participants identified 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 FY2005 and Reported 

in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 1,297

Females 676,551 131,308 19.41%

% 46.54% 48.91%

Males 748,722 136,094 18.18%

% 51.50% 50.69%

Unknown 28,516 1,068 3.75%

% 1.96% 0.40%

TOTAL 1,453,789 268,470 18.47%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 764

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

2,125 18,314 29,291 406 364,099 2,219 21,327 437,781 406,576 10,204 21,001 437,781

0.21% 1.80% 2.87% 0.04% 35.72% 0.22% 2.09% 42.95% 39.89% 1.00% 2.06% 42.95%

0.49% 4.18% 6.69% 0.09% 83.17% 0.51% 4.87% 100.00% 92.87% 2.33% 4.80% 100.00%

52.56% 46.94% 53.12% 44.47% 42.56% 52.58% 35.34% 42.95% 43.26% 45.53% 36.89% 42.95%

Male

1,896 20,699 25,843 507 489,647 2,001 22,948 563,541 532,854 12,207 18,480 563,541

0.19% 2.03% 2.54% 0.05% 48.04% 0.20% 2.25% 55.29% 52.28% 1.20% 1.81% 55.29%

0.34% 3.67% 4.59% 0.09% 86.89% 0.36% 4.07% 100.00% 94.55% 2.17% 3.28% 100.00%

46.90% 53.06% 46.87% 55.53% 57.23% 47.42% 38.03% 55.29% 56.69% 54.46% 32.46% 55.29%

Unknown

22 1 7 0 1,819 0 16,074 17,923 475 3 17,445 17,923

0.00% 0.00% 0.00% 0.00% 0.18% 0.00% 1.58% 1.76% 0.05% 0.00% 1.71% 1.76%

0.12% 0.01% 0.04% 0.00% 10.15% 0.00% 89.68% 100.00% 2.65% 0.02% 97.33% 100.00%

0.54% 0.00% 0.01% 0.00% 0.21% 0.00% 26.64% 1.76% 0.05% 0.01% 30.65% 1.76%

Total

4,043 39,014 55,141 913 855,565 4,220 60,349 1,019,245 939,905 22,414 56,926 1,019,245

0.40% 3.83% 5.41% 0.09% 83.94% 0.41% 5.92% 100.00% 92.22% 2.20% 5.59% 100.00%

0.40% 3.83% 5.41% 0.09% 83.94% 0.41% 5.92% 100.00% 92.22% 2.20% 5.59% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

15 4 867 11 1828 1,583 5,896 10,204 60,079

0.07% 0.02% 3.87% 0.38% 8.16% 7.06% 26.30% 45.53% 5.89%

0.15% 0.04% 8.50% 0.69% 17.91% 15.51% 57.78% 100.00% 13.72%

35.71% 26.67% 52.42% 33.33% 42.81% 54.27% 43.73% 45.53% 49.62%

Male 

27 11 787 22 2442 1,334 7,584 12,207 60,972

0.12% 0.05% 3.51% 0.75% 10.89% 5.95% 33.84% 54.46% 5.98%

0.22% 0.09% 6.45% 1.65% 20.00% 10.93% 62.13% 100.00% 10.82%

64.29% 73.33% 47.58% 66.67% 57.19% 45.73% 56.25% 54.46% 50.36%

Unknown 

0 0 0 0 0 0 3 3 33

0.00% 0.00% 0.00% 0.00% 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% 0.18%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.02% 0.01% 0.03%

TOTAL

42 15 1,654 33 4,270 2,917 13,483 22,414 121,084

0.19% 0.07% 7.38% 0.15% 19.05% 13.01% 60.15% 100.00% 11.88%

0.19% 0.07% 7.38% 1.13% 19.05% 13.01% 60.15% 100.00% 11.88%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

127
Table 8A. Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 533

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

7,913 40,553 16,129 6,634 163,845 3,696 238,770 71,229

1.82% 9.33% 3.71% 1.53% 37.71% 0.85% 54.95% 16.39%

3.31% 16.98% 6.76% 2.78% 68.62% 1.55% 100.00% 29.83%

52.56% 45.19% 55.72% 48.63% 60.14% 25.14% 54.95% 48.33%

Male

7,141 49,151 12,815 6,015 106,229 3,830 185,181 75,122

1.64% 11.31% 2.95% 1.38% 24.45% 0.88% 42.62% 17.29%

3.86% 26.54% 6.92% 3.25% 57.36% 2.07% 100.00% 40.57%

47.44% 54.77% 44.27% 44.09% 38.99% 26.05% 42.62% 50.97%

Unknown

0 40 1 994 2,380 7,178 10,593 1035

0.000% 0.01% 0.00% 0.23% 0.55% 1.65% 2.44% 0.24%

0.00% 0.38% 0.01% 9.38% 22.47% 67.76% 100.00% 9.77%

0.00% 0.04% 0.00% 7.29% 0.87% 48.82% 2.44% 0.70%

Total

15,054 89,744 28,945 13,643 272,454 14,704 434,544 147,386

3.46% 20.65% 6.66% 3.14% 62.70% 3.38% 100.00% 33.92%

3.46% 20.65% 6.66% 3.14% 62.70% 3.38% 100.00% 33.92%

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: Reference Table 2A

Sex/Gender: 

There were 1,523 Intramural protocols of which 130 (8.54%) were female-only protocols and 96 (6.3%) were male-only protocols.

Excluding sex-specific studies, the number of males (748,722 or 51.5%) exceeds the number of females (676,551 or 46.54%) enrolled in Intramural research protocols. 

Excluding sex-specific studies, the number of minority males (136,094 or 50.7%) exceeds the number of females (131,308 or 48.9%) enrolled in Intramural research protocols. 

Approximately 18.5% (268,470) of participants in aggregate Intramural research excluding sex-specific studies (1,453,789) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 83.94% following the 1997 OMB standards and 62.7% following the 1977 OMB standards.

Largest identified racial minority group is Black at 5.4% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 20.65% following the 1977 OMB standards. 

According to the 1997 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.4%.

According to the 1977 OMB standards, the smallest identified racial minority group is Hispanic at 3.14%.

Ethnicity: 

2.22% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 60.15 % (2nd hightest category is White at 19%)

Smallest identified racial group is Asian at 0.07%

Of the 22,414 participants, 45.53% are women and 54.46% are men. 

3.13% of participants identified as Hispanic according to the 1977 OMB standards. 

128
Table 9A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 44

Females 16,988 9,609 56.56%

% 53.97% 56.51%

Males 14,488 7,395 51.04%

% 46.03% 43.49%

Unknown 0 0 0.00%

% 0.00% 0.00%

TOTAL 31,476 17,004 54.02%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 27

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

8 89 493 1 5,179 265 3,725 9,760 5,769 2,526 1,466 9,761

0.05% 0.56% 3.11% 0.01% 32.71% 1.67% 23.53% 61.65% 36.44% 15.96% 9.26% 61.65%

0.08% 0.91% 5.05% 0.01% 53.06% 2.72% 38.17% 100.00% 59.10% 25.88% 15.02% 100.00%

40.00% 45.41% 64.70% 100.00% 57.03% 55.44% 70.38% 61.65% 57.36% 91.89% 48.45% 61.65%

Male

12 107 269 0 3,902 213 1,568 6,071 4,288 223 1,560 6,071

0.08% 0.68% 1.70% 0.00% 24.65% 1.35% 9.90% 38.35% 27.08% 1.41% 9.85% 38.35%

0.20% 1.76% 4.43% 0.00% 64.27% 3.51% 25.83% 100.00% 70.63% 3.67% 25.70% 100.00%

60.00% 54.59% 35.30% 0.00% 42.97% 44.56% 29.62% 38.35% 42.64% 8.11% 51.55% 38.35%

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

20 196 762 1 9,081 478 5,293 15,831 10,057 2,749 3,026 15,832

0.13% 1.24% 4.81% 0.01% 57.36% 3.02% 33.43% 100.00% 63.52% 17.36% 19.11% 100.00%

0.13% 1.24% 4.81% 0.01% 57.36% 3.02% 33.43% 100.00% 63.52% 17.36% 19.11% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

0 0 0 0 0 0 2,526 2,526 3,382

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 91.89% 91.89% 21.36%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 34.65%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 91.89% 91.89% 80.41%

Male 

0 0 0 0 0 0 223 223 824

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 8.11% 8.11% 5.20%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 13.57%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 8.11% 8.11% 19.59%

Unknown 

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%

TOTAL

0 0 0 0 0 0 2,749 2,749 4,206

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 26.57%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 26.57%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00%

129
Table 9A

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 17

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

126 5,993 77 31 996 5 7,228 6,227

0.81% 38.31% 0.49% 0.20% 6.37% 0.03% 46.20% 39.80%

1.74% 82.91% 1.07% 0.43% 13.78% 0.07% 100.00% 86.15%

0.00% 48.67% 33.92% 38.27% 35.19% 29.41% 46.20% 48.66%

Male

50 6,321 150 50 1,834 12 8,417 6,571

0.32% 40.40% 0.96% 0.32% 11.72% 0.08% 53.80% 42.00%

0.59% 75.10% 1.78% 0.59% 21.79% 0.14% 100.00% 78.07%

0.00% 51.33% 66.08% 61.73% 64.81% 70.59% 53.80% 51.34%

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

176 12,314 227 81 2,830 17 15,645 12,798

1.12% 78.71% 1.45% 0.52% 18.09% 0.11% 100.00% 81.80%

1.12% 78.71% 1.45% 0.52% 18.09% 0.11% 100.00% 81.80%

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 females (16,988 or 53.97%) than males (14,488 or 46%) are enrolled in aggregate Intramural research protocols. 

More minority females (9,609 or 56.5%) than minority males (7,395 or 43.5%) are enrolled in aggregate Intramural research protocols. 

Approximately 54% (17,004) of participants in aggregate Intramural research (31,476) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African American at 4.8% following the 1997 OMB standards.

Largest identified racial minority group is Asian/ Pacific Islander at 78.7% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.01%.

According to the 1977 OMB standards, the smallest identified racial minority group is Hispanic at 0.5%.

Ethnicity: 

17.36% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown/Other at 100%

Of the 2,749 participants, 91.9% are women and 8.1% are men. 

0.52% of participants identified 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 FY2005 and 

Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 37

Females 14,745 7,368 49.97%

% 50.75% 49.99%

Males 14,310 7,370 51.50%

% 49.25% 50.01%

Unknown 0 0 0.00%

% 0.00% 0.00%

TOTAL 29,055 14,738 50.72%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 22

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

8 89 492 1 5,176 265 1,486 7,517 5,765 286 1,466 7,517

0.06% 0.66% 3.62% 0.01% 38.10% 1.95% 10.94% 55.33% 42.44% 2.11% 10.79% 55.33%

0.11% 1.18% 6.55% 0.01% 68.86% 3.53% 19.77% 100.00% 76.69% 3.80% 19.50% 100.00%

40.00% 45.41% 64.65% 100.00% 57.04% 55.44% 48.66% 55.33% 57.36% 56.19% 48.45% 55.33%

Male

12 107 269 0 3,899 213 1,568 6,068 4,285 223 1,560 6,068

0.09% 0.79% 1.98% 0.00% 28.70% 1.57% 11.54% 44.67% 31.54% 1.64% 11.48% 44.67%

0.20% 1.76% 4.43% 0.00% 64.26% 3.51% 25.84% 100.00% 70.62% 3.68% 25.71% 100.00%

60.00% 54.59% 35.35% 0.00% 42.96% 44.56% 51.34% 44.67% 42.64% 43.81% 51.55% 44.67%

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

20 196 761 1 9,075 478 3,054 13,585 10,050 509 3,026 13,585

0.15% 1.44% 5.60% 0.01% 66.80% 3.52% 22.48% 100.00% 73.98% 3.75% 22.27% 100.00%

0.15% 1.44% 5.60% 0.01% 66.80% 3.52% 22.48% 100.00% 73.98% 3.75% 22.27% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

0 0 0 0 0 0 286 286 1,141

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.19% 56.19% 8.40%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 15.18%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.19% 56.19% 58.07%

Male 

0 0 0 0 0 0 223 223 824

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.81% 43.81% 6.07%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 13.58%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.81% 43.81% 41.93%

Unknown 

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%

TOTAL

0 0 0 0 0 0 509 509 1,965

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 14.46%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 14.46%

100.00% 100.00% 100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00%

131
Table 10A. Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 15

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

126 5,993 77 31 996 5 7,228 6,227

0.81% 38.74% 0.50% 0.20% 6.44% 0.03% 46.72% 40.25%

1.74% 82.91% 1.07% 0.43% 13.78% 0.07% 100.00% 86.15%

72.00% 48.68% 37.02% 39.24% 37.15% 31.25% 46.72% 48.75%

Male

49 6,318 131 48 1,685 11 8,242 6,546

0.32% 40.84% 0.85% 0.31% 10.89% 0.07% 53.28% 42.31%

0.59% 76.66% 1.59% 0.58% 20.44% 0.13% 100.00% 79.42%

28.00% 51.32% 62.98% 60.76% 62.85% 68.75% 53.28% 51.25%

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

175 12,311 208 79 2,681 16 15,470 12,773

1.13% 79.58% 1.34% 0.51% 17.33% 0.10% 100.00% 82.57%

1.13% 79.58% 1.34% 0.51% 17.33% 0.10% 100.00% 82.57%

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: Reference Table 4A

Sex/Gender: 

There were 44 PhaseIII Intramural protocols of which 3 (6.8%) were female-only protocols and 4 (9.1%) were male-only protocols.

Excluding sex-specific studies, the number of females (14,745 or 50.75%) exceeds the number of males (14,310 or 49.25%) enrolled in PhaseIII Intramural research protocols. 

Excluding sex-specific studies, the number of minority males (7,370 or 50.01%) exceeds the number of females (7,368 or 49.99%) enrolled in Phase III Intramural research protocols. 

Approximately 50.72% (14,7389) of participants in aggregate PhaseIII Intramural research excluding sex-specific studies (29,055) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 66.8 % following the 1997 OMB standards .

Largest identified racial minority group is Asian/ Pacific Islander at 79.58% following the 1977 OMB standards.

Largest identified racial minority group is Black or African American at 5.6% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is Hispanic at 0.51%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.01%.

Ethnicity: 

3.75% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 100%

Of the 509 participants, 56.2% are women and 43.8% are men. 

0.5% of participants identified as Hispanic according to the 1977 OMB standards. 

132
Table 11A. DOMESTIC Aggregate Enrollment Data for Extramural and Intramural Research Protocols Funded in FY2005 and 

Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of 

Protocols with 

Enrollment Data: 

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 10,294

Females 7,684,453 2,200,474 28.64%

% 67.26% 66.66%

Males 3,566,577 1,075,138 30.14%

% 31.22% 32.57%

Unknown 174,671 25,523 14.61%

% 1.53% 0.77%

TOTAL 11,425,701 3,301,135 28.89%

Total % 100% 100.00%

Number of Protocols 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data: 8,933

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/Ot

her Total Not 

Hispanic

Hispanic or 

Latino

Unknown 

/Not 

Reported

Total

Female

78,746 622,637 710,350 21,249 4,690,433 106,926 679,820 6,910,161 5,763,444 534,174 612,543 6,910,161

0.77% 6.10% 6.96% 0.21% 45.97% 1.05% 6.66% 67.72% 56.48% 5.24% 6.00% 67.72%

1.14% 9.01% 10.28% 0.31% 67.88% 1.55% 9.84% 100.00% 83.41% 7.73% 8.86% 100.00%

70.91% 65.78% 68.82% 60.47% 68.52% 59.98% 64.41% 67.72% 68.74% 67.06% 59.89% 67.72%

Male

31,668 320,088 313,187 13,828 2,111,033 67,559 278,483 3,135,846 2,561,151 254,802 319,893 3,135,846

0.31% 3.14% 3.07% 0.14% 20.69% 0.66% 2.73% 30.73% 25.10% 2.50% 3.14% 30.73%

1.01% 10.21% 9.99% 0.44% 67.32% 2.15% 8.88% 100.00% 81.67% 8.13% 10.20% 100.00%

28.52% 33.81% 30.34% 39.35% 30.84% 37.90% 26.39% 30.73% 30.55% 31.99% 31.28% 30.73%

Unknown

634 3,888 8,662 65 43,494 3,790 97,133 157,666 59,765 7,580 90,321 157,666

0.01% 0.04% 0.08% 0.00% 0.43% 0.04% 0.95% 1.55% 0.59% 0.07% 0.89% 1.55%

0.40% 2.47% 5.49% 0.04% 27.59% 2.40% 61.61% 100.00% 37.91% 4.81% 57.29% 100.00%

0.57% 0.41% 0.84% 0.18% 0.64% 2.13% 9.20% 1.55% 0.71% 0.95% 8.83% 1.55%

Total

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

1.09% 9.28% 10.12% 0.34% 67.08% 1.75% 10.34% 100.00% 82.17% 7.81% 10.02% 100.00%

1.09% 9.28% 10.12% 0.34% 67.08% 1.75% 10.34% 100.00% 82.17% 7.81% 10.02% 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/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW 

FORM 

Parts A+B

Female 

8,011 4,415 11,785 968 275,061 27,943 205,991 534,174 2,020,960

1.01% 0.55% 1.48% 1.97% 34.53% 3.51% 25.86% 67.06% 19.81%

1.50% 0.83% 2.21% 3.46% 51.49% 5.23% 38.56% 100.00% 29.25%

0.00% 0.00% 0.00% 0.00% 0.00% 56.85% 62.58% 67.06% 67.20%

Male 

7,472 2,117 8,042 526 99169 20,619 116,857 254,802 962,356

0.94% 0.27% 1.01% 1.07% 12.45% 2.59% 14.67% 31.99% 9.43%

2.93% 0.83% 3.16% 2.55% 38.92% 8.09% 45.86% 100.00% 30.69%

0.00% 0.00% 0.00% 0.00% 0.00% 41.95% 35.50% 31.99% 32.00%

Unknown 

15 8 43 11 600 588 6,315 7,580 23,954

0.00% 0.00% 0.01% 0.02% 0.08% 0.07% 0.79% 0.95% 0.23%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 15.19%

0.00% 0.00% 0.00% 0.00% 0.00% 1.20% 1.92% 0.95% 0.80%

TOTAL

15,498 6,540 19,870 1,505 374,830 49,150 329,163 796,556 3,007,270

1.95% 0.82% 2.49% 3.06% 47.06% 6.17% 41.32% 100.00% 29.47%

1.95% 0.82% 2.49% 3.06% 47.06% 6.17% 41.32% 100.00% 29.47%

0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00% 100.00%

133
Table 11 A

Number of Protocols 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards with Enrollment Data: 1,361

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

10,542 31,260 92,934 44,778 565,910 28,868 774,292 179,514

0.86% 2.56% 7.60% 3.66% 46.31% 2.36% 63.36% 14.69%

1.36% 4.04% 12.00% 5.78% 73.09% 3.73% 100.00% 23.18%

0.00% 60.46% 62.70% 60.26% 65.30% 46.96% 63.36% 61.09%

Male

9,009 20,205 54,657 28,911 298,197 19,752 430,731 112,782

0.74% 1.65% 4.47% 2.37% 24.40% 1.62% 35.25% 9.23%

2.09% 4.69% 12.69% 6.71% 69.23% 4.59% 100.00% 26.18%

0.00% 39.08% 36.87% 38.90% 34.41% 32.13% 35.25% 38.38%

Unknown

77 236 633 623 2,576 12,860 17,005 1569

0.006% 0.02% 0.05% 0.05% 0.21% 1.05% 1.39% 0.13%

0.45% 1.39% 3.72% 3.66% 15.15% 75.62% 100.00% 9.23%

0.00% 0.46% 0.43% 0.84% 0.30% 20.92% 1.39% 0.53%

Total

19,628 51,701 148,224 74,312 866,683 61,480 1,222,028 293,865

1.61% 4.23% 12.13% 6.08% 70.92% 5.03% 100.00% 24.05%

1.61% 4.23% 12.13% 6.08% 70.92% 5.03% 100.00% 24.05%

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/Rthnicity (Column Total)

Data Table Comments: 

Sex/Gender: 

More females (7,864,453 or 67.26%) than males (3,566,577 or 31.22%) are enrolled in aggregate Domestic extramural and intramural research protocols. 

More minority females (2,200,474 or 66.66%) than minority males (1,075,138 or 32.57 %) are enrolled in aggregate Domestic extramural and intramural 

research protocols. 

Approximately 28.89% (3,301,135) of participants in aggregate Domestic extramural and intramural research (11,425,701) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Unknown at 10.34% and Black or African American at 10.12 % following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 12.13% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.34%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 1.61%.

Ethnicity: 

7.81% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is White at 47.06% (2nd hightest category is Unknown at 41.32%)

Smallest identified racial group is Asian at 0.82%.

Of the 796,556 participants, 67.06% are women and 31.99% are men. 

6.08% of participants identified as Hispanic according to the 1977 OMB standards. 

134
Table 12A. DOMESTIC Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 8,851

Females 6,905,294 2,076,882 30.08%

% 69.25% 66.94%

Males 2,914,327 1,000,359 34.33%

% 29.23% 32.24%

Unknown 151,816 25,490 16.79%

% 1.52% 0.82%

TOTAL 9,971,437 3,102,731 31.12%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 8,064

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

75,255 615,029 672,362 20,798 4,209,239 99,445 656,904 6,349,032 5,243,492 507,943 597,597 6,349,032

0.83% 6.75% 7.38% 0.23% 46.20% 1.09% 7.21% 69.69% 57.55% 5.58% 6.56% 69.69%

1.19% 9.69% 10.59% 0.33% 66.30% 1.57% 10.35% 100.00% 82.59% 8.00% 9.41% 100.00%

71.24% 66.09% 69.33% 60.85% 71.33% 58.44% 65.76% 69.69% 71.17% 66.80% 60.84% 69.69%

Male

29,770 311,727 288,796 13,316 1,650,108 66,926 258,911 2,619,554 2,065,110 244,872 309,572 2,619,554

0.33% 3.42% 3.17% 0.15% 18.11% 0.73% 2.84% 28.75% 22.67% 2.69% 3.40% 28.75%

1.14% 11.90% 11.02% 0.51% 62.99% 2.55% 9.88% 100.00% 78.83% 9.35% 11.82% 100.00%

28.18% 33.50% 29.78% 38.96% 27.96% 39.33% 25.92% 28.75% 28.03% 32.20% 31.52% 28.75%

Unknown

612 3,888 8,655 65 41,788 3,790 83,200 141,998 59,404 7,577 75,017 141,998

0.01% 0.04% 0.09% 0.00% 0.46% 0.04% 0.91% 1.56% 0.65% 0.08% 0.82% 1.56%

0.43% 2.74% 6.10% 0.05% 29.43% 2.67% 58.59% 100.00% 41.83% 5.34% 52.83% 100.00%

0.58% 0.42% 0.89% 0.19% 0.71% 2.23% 8.33% 1.56% 0.81% 1.00% 7.64% 1.56%

Total

105,637 930,644 969,813 34,179 5,901,135 170,161 999,015 9,110,584 7,368,006 760,392 982,186 9,110,584

1.16% 10.21% 10.64% 0.38% 64.77% 1.87% 10.97% 100.00% 80.87% 8.35% 10.78% 100.00%

1.16% 10.21% 10.64% 0.38% 64.77% 1.87% 10.97% 100.00% 80.87% 8.35% 10.78% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

7,976 4,385 11,555 936 255,664 27,870 199,557 507,943 1,938,110

1.05% 0.58% 1.52% 1.91% 33.62% 3.67% 26.24% 66.80% 21.27%

1.57% 0.86% 2.27% 3.36% 50.33% 5.49% 39.29% 100.00% 30.53%

51.67% 67.47% 59.59% 64.51% 72.40% 56.86% 63.25% 66.80% 67.32%

Male 

7,445 2,106 7,793 504 96840 20,558 109,626 244,872 917,001

0.98% 0.28% 1.02% 1.03% 12.74% 2.70% 14.42% 32.20% 10.07%

3.04% 0.86% 3.18% 2.45% 39.55% 8.40% 44.77% 100.00% 35.01%

48.23% 32.40% 40.19% 34.73% 27.43% 41.94% 34.75% 32.20% 31.85%

Unknown 

15 8 43 11 600 588 6312 7,577 23,922

0.00% 0.00% 0.01% 0.02% 0.08% 0.08% 0.83% 1.00% 0.26%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 16.85%

0.10% 0.12% 0.22% 0.76% 0.17% 1.20% 2.00% 1.00% 0.83%

TOTAL

15,436 6,499 19,391 1,451 353,104 49,016 315,495 760,392 2,879,033

2.03% 0.85% 2.55% 0.19% 46.44% 6.45% 41.49% 100.00% 31.60%

2.03% 0.85% 2.55% 2.96% 46.44% 6.45% 41.49% 100.00% 31.60%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

135
Table 12A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 787

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

2,626 24,727 73,822 37,597 396,237 21,253 556,262 138,772

0.31% 2.87% 8.58% 4.37% 46.03% 2.47% 64.62% 16.12%

0.47% 4.45% 13.27% 6.76% 71.23% 3.82% 100.00% 24.95%

57.46% 61.04% 63.67% 59.99% 66.73% 49.03% 64.62% 62.04%

Male

1,867 15,545 41,492 24,454 195,007 16,408 294,773 83,358

0.22% 1.81% 4.82% 2.84% 22.65% 1.91% 34.24% 9.68%

0.63% 5.27% 14.08% 8.30% 66.15% 5.57% 100.00% 28.28%

40.85% 38.38% 35.79% 39.02% 32.84% 37.86% 34.24% 37.26%

Unknown

77 236 632 623 2,568 5,682 9,818 1,568

0.009% 0.03% 0.07% 0.07% 0.30% 0.66% 1.14% 0.18%

0.78% 2.40% 6.44% 6.35% 26.16% 57.87% 100.00% 15.97%

1.68% 0.58% 0.55% 0.99% 0.43% 13.11% 1.14% 0.70%

Total

4,570 40,508 115,946 62,674 593,812 43,343 860,853 223,698

0.53% 4.71% 13.47% 7.28% 68.98% 5.03% 100.00% 25.99%

0.53% 4.71% 13.47% 7.28% 68.98% 5.03% 100.00% 25.99%

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 females (6,905,204 or 69.2%) than males (2,914,327 or 29.2%) are enrolled in aggregate Domestic extramural research protocols. 

More minority females (2,076,882 or 66.9%) than minority males (1,000,359 or 32.24 %) are enrolled in aggregate Domestic extramural research protocols. 

Approximately 31.12% (3,102,731) of participants in aggregate Domestic extramural research (9,971,437) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African American at 10.64 % following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 13.5% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.4%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 0.53%.

Ethnicity: 

8.35% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is White at 46.44% (2nd hightest category is Unknown at 41.5%)

Smallest identified racial group is Hawaiian/Pacific Islander at 0.19%.

Of the 760,392 participants, 64.62% are women and 34.24% are men. 

7.28% of participants identified as Hispanic according to the 1977 OMB standards. 

136
Table 13A. DOMESTIC Aggregate Enrollment Data for Intramural Research Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 1,443

Females 779,159 123,592 15.86%

% 53.58% 62.29%

Males 652,250 74,779 11.46%

% 44.85% 37.69%

Unknown 22,855 33 0.14%

% 1.57% 0.02%

TOTAL 1,454,264 198,404 13.64%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 869

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

3,491 7,608 37,988 451 481,194 7,481 22,916 561,129 519,952 26,231 14,946 561,129

0.32% 0.70% 3.48% 0.04% 44.02% 0.68% 2.10% 51.33% 47.57% 2.40% 1.37% 51.33%

0.62% 1.36% 6.77% 0.08% 85.75% 1.33% 4.08% 100.00% 92.66% 4.67% 2.66% 100.00%

64.52% 47.64% 60.89% 46.83% 50.98% 92.20% 40.62% 51.33% 51.16% 72.53% 36.84% 51.33%

Male

1,898 8,361 24,391 512 460,925 633 19,572 516,292 496,041 9,930 10,321 516,292

0.17% 0.76% 2.23% 0.05% 42.17% 0.06% 1.79% 47.23% 45.38% 0.91% 0.94% 47.23%

0.37% 1.62% 4.72% 0.10% 89.28% 0.12% 3.79% 100.00% 96.08% 1.92% 2.00% 100.00%

35.08% 52.36% 39.10% 53.17% 48.84% 7.80% 34.69% 47.23% 48.81% 27.46% 25.44% 47.23%

Unknown

22 0 7 0 1706 0 13,933 15,668 361 3 15,304 15,668

0.00% 0.00% 0.00% 0.00% 0.16% 0.00% 1.27% 1.43% 0.03% 0.00% 1.40% 1.43%

0.14% 0.00% 0.04% 0.00% 10.89% 0.00% 88.93% 100.00% 2.30% 0.02% 97.68% 100.00%

0.41% 0.00% 0.01% 0.00% 0.18% 0.00% 24.69% 1.43% 0.04% 0.01% 37.72% 1.43%

Total

5,411 15,969 62,386 963 943,825 8,114 56,421 1,093,089 1,016,354 36,164 40,571 1,093,089

0.50% 1.46% 5.71% 0.09% 86.34% 0.74% 5.16% 100.00% 92.98% 3.31% 3.71% 100.00%

0.50% 1.46% 5.71% 0.09% 86.34% 0.74% 5.16% 100.00% 92.98% 3.31% 3.71% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

35 30 230 32 19,397 73 6,434 26,231 82,850

0.10% 0.08% 0.64% 23.88% 53.64% 0.20% 17.79% 72.53% 7.58%

0.13% 0.11% 0.88% 43.84% 73.95% 0.28% 24.53% 100.00% 14.76%

56.45% 73.17% 48.02% 59.26% 89.28% 54.48% 47.07% 72.53% 64.61%

Male 

27 11 249 22 2,329 61 7,231 9,930 45,355

0.07% 0.03% 0.69% 16.42% 6.44% 0.17% 20.00% 27.46% 4.15%

0.27% 0.11% 2.51% 36.07% 23.45% 0.61% 72.82% 100.00% 8.78%

43.55% 26.83% 51.98% 40.74% 10.72% 45.52% 52.90% 27.46% 35.37%

Unknown 

0 0 0 0 0 0 3 3 32

0.00% 0.00% 0.00% 0.00% 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% 0.20%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.02% 0.01% 0.02%

TOTAL

62 41 479 54 21,726 134 13,668 36,164 128,237

0.17% 0.11% 1.32% 0.15% 60.08% 0.37% 37.79% 100.00% 11.73%

0.17% 0.11% 1.32% 40.30% 60.08% 0.37% 37.79% 100.00% 11.73%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

137
Table 13A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 574

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

7,916 6,533 19,112 7,181 169,673 7,615 218,030 40,742

2.19% 1.81% 5.29% 1.99% 46.98% 2.11% 60.37% 11.28%

3.63% 3.00% 8.77% 3.29% 77.82% 3.49% 100.00% 18.69%

52.57% 58.37% 59.21% 61.70% 62.18% 41.99% 60.37% 58.06%

Male

7,142 4,660 13,165 4,457 103,190 3,344 135,958 29,424

1.98% 1.29% 3.65% 1.23% 28.57% 0.93% 37.64% 8.15%

5.25% 3.43% 9.68% 3.28% 75.90% 2.46% 100.00% 21.64%

47.43% 41.63% 40.79% 38.30% 37.82% 18.44% 37.64% 41.93%

Unknown

0 0 1 0 8 7,178 7,187 1

0.000% 0.00% 0.00% 0.00% 0.00% 1.99% 1.99% 0.00%

0.00% 0.00% 0.01% 0.00% 0.11% 99.87% 100.00% 0.01%

0.00% 0.00% 0.00% 0.00% 0.00% 39.58% 1.99% 0.00%

Total

15,058 11,193 32,278 11,638 272,871 18,137 361,175 70,167

4.17% 3.10% 8.94% 3.22% 75.55% 5.02% 100.00% 19.43%

4.17% 3.10% 8.94% 3.22% 75.55% 5.02% 100.00% 19.43%

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 females (779,159 or 53.6%) than males (652,250 or 44.85%) are enrolled in aggregate Domestic Intramural research protocols. 

More minority females (123,592 or 62.3%) than minority males (74,779 or 37.7%) are enrolled in aggregate Domestic Intramural research protocols. 

Approximately 13.6% (198,404) of participants in aggregate Domestic Intramural research (1,454,264) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African American at 5.7% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 8.94% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.09%.

According to the 1977 OMB standards, the smallest identified racial minority group is Asian/ Pacific Islander at 3.1%.

Ethnicity: 

3.31% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is White at 60% (2nd hightest category is Unknown at 37.8%)

Smallest identified racial group is Asian at 0.11%.

Of the 36,164 participants, 72.5% are women and 27.5% are men. 

3.2% of participants identified as Hispanic according to the 1977 OMB standards. 

138
Table 14A. DOMESTIC Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 524

Females 251,055 51,855 20.65%

% 65.02% 64.32%

Males 130,852 28,473 21.76%

% 33.89% 35.32%

Unknown 4,209 294 6.99%

% 1.09% 0.36%

TOTAL 386,116 80,622 20.88%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 333

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

1,742 2,223 13,021 261 51,745 1,999 16,115 87,106 64,148 6,921 16,037 87,106

0.98% 1.25% 7.34% 0.15% 29.18% 1.13% 9.09% 49.13% 36.18% 3.90% 9.04% 49.13%

2.00% 2.55% 14.95% 0.30% 59.40% 2.29% 18.50% 100.00% 73.64% 7.95% 18.41% 100.00%

64.42% 43.45% 57.59% 49.34% 47.26% 55.54% 48.46% 49.13% 48.70% 53.07% 49.29% 49.13%

Male

961 2,890 9,562 268 57,642 1,595 13,215 86,133 67,451 5,866 12,816 86,133

0.54% 1.63% 5.39% 0.15% 32.51% 0.90% 7.45% 48.58% 38.04% 3.31% 7.23% 48.58%

1.12% 3.36% 11.10% 0.31% 66.92% 1.85% 15.34% 100.00% 78.31% 6.81% 14.88% 100.00%

35.54% 56.49% 42.29% 50.66% 52.64% 44.32% 39.74% 48.58% 51.20% 44.98% 39.39% 48.58%

Unknown

1 3 25 0 109 5 3,927 4,070 135 254 3,681 4,070

0.00% 0.00% 0.01% 0.00% 0.06% 0.00% 2.21% 2.30% 0.08% 0.14% 2.08% 2.30%

0.02% 0.07% 0.61% 0.00% 2.68% 0.12% 96.49% 100.00% 3.32% 6.24% 90.44% 100.00%

0.04% 0.06% 0.11% 0.00% 0.10% 0.14% 11.81% 2.30% 0.10% 1.95% 11.31% 2.30%

Total

2,704 5,116 22,608 529 109,496 3,599 33,257 177,309 131,734 13,041 32,534 177,309

1.53% 2.89% 12.75% 0.30% 61.75% 2.03% 18.76% 100.00% 74.30% 7.35% 18.35% 100.00%

1.53% 2.89% 12.75% 0.30% 61.75% 2.03% 18.76% 100.00% 74.30% 7.35% 18.35% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Ot

her Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

370 30 262 28 3122 381 2,728 6,921 25,096

2.84% 0.23% 2.01% 3.93% 23.94% 2.92% 20.92% 53.07% 14.15%

5.35% 0.43% 3.79% 7.35% 45.11% 5.50% 39.42% 100.00% 28.81%

80.79% 63.83% 51.68% 70.00% 56.31% 53.51% 47.58% 53.07% 54.76%

Male 

88 17 245 12 2418 330 2,756 5,866 20,450

0.67% 0.13% 1.88% 1.69% 18.54% 2.53% 21.13% 44.98% 11.53%

1.50% 0.29% 4.18% 3.64% 41.22% 5.63% 46.98% 100.00% 23.74%

19.21% 36.17% 48.32% 30.00% 43.61% 46.35% 48.07% 44.98% 44.62%

Unknown 

0 0 0 0 4 1 249 254 287

0.00% 0.00% 0.00% 0.00% 0.03% 0.01% 1.91% 1.95% 0.16%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 7.05%

0.00% 0.00% 0.00% 0.00% 0.07% 0.14% 4.34% 1.95% 0.63%

TOTAL

458 47 507 40 5,544 712 5,733 13,041 45,833

3.51% 0.36% 3.89% 0.31% 42.51% 5.46% 43.96% 100.00% 25.85%

3.51% 0.36% 3.89% 5.62% 42.51% 5.46% 43.96% 100.00% 25.85%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

139
Table 14A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 191

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

633 3,599 15,770 6,757 133,513 3,677 163,949 26,759

0.30% 1.72% 7.55% 3.24% 63.94% 1.76% 78.52% 12.82%

0.39% 2.20% 9.62% 4.12% 81.44% 2.24% 100.00% 16.32%

77.20% 81.06% 78.47% 71.65% 79.30% 65.00% 78.52% 76.92%

Male

187 839 4,323 2,674 34,824 1,872 44,719 8,023

0.09% 0.40% 2.07% 1.28% 16.68% 0.90% 21.42% 3.84%

0.42% 1.88% 9.67% 5.98% 77.87% 4.19% 100.00% 17.94%

22.80% 18.90% 21.51% 28.35% 20.68% 33.09% 21.42% 23.06%

Unknown

0 2 5 0 24 108 139 7

0.000% 0.00% 0.00% 0.00% 0.01% 0.05% 0.07% 0.00%

0.00% 1.44% 3.60% 0.00% 17.27% 77.70% 100.00% 5.04%

0.00% 0.05% 0.02% 0.00% 0.01% 1.91% 0.07% 0.02%

Total

820 4,440 20,098 9,431 168,361 5,657 208,807 34,789

0.39% 2.13% 9.63% 4.52% 80.63% 2.71% 100.00% 16.66%

0.39% 2.13% 9.63% 4.52% 80.63% 2.71% 100.00% 16.66%

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 females (251,055 or 65%) than males (130,852 or 33.9%) are enrolled in aggregate Phase III Domestic extramural research protocols. 

More minority females (51,855 or 64.3%) than minority males (28,473 or 35.3%) are enrolled in aggregate Phase III Domestic extramural research protocols. 

Approximately 20.9% (80,622) of participants in aggregate PhaseIII Domestic extramural research (386,116) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African Americanat 12.75 % following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 9.63% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.3%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 0.4%.

Ethnicity: 

7.35% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknow at 43.96% (2nd hightest category is White at 42.51%)

Smallest identified racial group is Hawaiian/Pacific Islander at 0.3%.

Of the 13,041 participants, 53% are women and 45% are men. 

4.52% of participants identified as Hispanic according to the 1977 OMB standards. 

140
Table 15A. DOMESTIC Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 40

Females 7,412 1,339 18.07%

% 52.27% 55.51%

Males 6,769 1,073 15.85%

% 47.73% 44.49%

Unknown 0 0 0.00%

% 0.00% 0.00%

TOTAL 14,181 2,412 17.01%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 24

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/Pa

cific 

Islander

White More Than 

One Race

Unknown/Oth

er Total Not Hispanic Hispanic or Latino

Unknown 

/Not 

Reported

Total

Female

8 89 433 1 5,179 265 179 6,154 5,709 286 159 6,154

0.07% 0.83% 4.01% 0.01% 48.02% 2.46% 1.66% 57.06% 52.93% 2.65% 1.47% 57.06%

0.13% 1.45% 7.04% 0.02% 84.16% 4.31% 2.91% 100.00% 92.77% 4.65% 2.58% 100.00%

40.00% 45.41% 65.71% 100.00% 57.03% 55.44% 51.00% 57.06% 57.35% 56.19% 49.23% 57.06%

Male

12 107 226 0 3,902 213 172 4,632 4,245 223 164 4,632

0.11% 0.99% 2.10% 0.00% 36.18% 1.97% 1.59% 42.94% 39.36% 2.07% 1.52% 42.94%

0.26% 2.31% 4.88% 0.00% 84.24% 4.60% 3.71% 100.00% 91.65% 4.81% 3.54% 100.00%

60.00% 54.59% 34.29% 0.00% 42.97% 44.56% 49.00% 42.94% 42.65% 43.81% 50.77% 42.94%

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

20 196 659 1 9,081 478 351 10,786 9,954 509 323 10,786

0.19% 1.82% 6.11% 0.01% 84.19% 4.43% 3.25% 100.00% 92.29% 4.72% 2.99% 100.00%

0.19% 1.82% 6.11% 0.01% 84.19% 4.43% 3.25% 100.00% 92.29% 4.72% 2.99% 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/Pa

cific 

Islander

White More Than 

One Race

Unknown/Oth

er Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

0 0 0 0 0 0 286 286 1,082

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.19% 56.19% 10.03%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.58%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.19% 56.19% 58.08%

Male 

0 0 0 0 0 0 223 223 781

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.81% 43.81% 7.24%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 16.86%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.81% 43.81% 41.92%

Unknown 

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%

TOTAL

0 0 0 0 0 0 509 509 1,863

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.27%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.27%

100.00% 100.00% 100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00%

141
Table 15A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 16

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

126 23 77 31 996 5 1,258 257

3.71% 0.68% 2.27% 0.91% 29.34% 0.15% 37.05% 7.57%

10.02% 1.83% 6.12% 2.46% 79.17% 0.40% 100.00% 20.43%

71.59% 35.38% 33.92% 38.27% 35.19% 31.25% 37.05% 46.81%

Male

50 42 150 50 1,834 11 2,137 292

1.47% 1.24% 4.42% 1.47% 54.02% 0.32% 62.95% 8.60%

2.34% 1.97% 7.02% 2.34% 85.82% 0.51% 100.00% 13.66%

28.41% 64.62% 66.08% 61.73% 64.81% 68.75% 62.95% 53.19%

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

176 65 227 81 2,830 16 3,395 549

5.18% 1.91% 6.69% 2.39% 83.36% 0.47% 100.00% 16.17%

5.18% 1.91% 6.69% 2.39% 83.36% 0.47% 100.00% 16.17%

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 females (7,412 or 52.3%) than males (6,769 or 47.7%) are enrolled in aggregate Phase III Domestic extramural research protocols. 

More minority females (1,339 or 55.5%) than minority males (1,073 or 44.5%) are enrolled in aggregate Phase III Domestic extramural research protocols. 

Approximately 17% (2,412) of participants in aggregate PhaseIII Domestic extramural research (14,181) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African American at 6.11 % following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 6.7% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.01%.

According to the 1977 OMB standards, the smallest identified racial minority group is Asian/ Pacific Islander at 1.1%.

Ethnicity: 

4.72% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknow at 100%

Of the 509 participants, 56.2% are women and 43.8% are men. 

2.4% of participants identified as Hispanic according to the 1977 OMB standards. 

142
Table 16A. FOREIGN Aggregate Enrollment Data for Extramural and Intramural Research Protocols Funded in FY2005 and Reported in 

FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of 

Protocols with 

Enrollment Data: 

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex 464

Females 1,788,820 1,618,146 90.46%

% 52.53% 52.42%

Males 1,605,628 1,464,176 91.19%

% 47.15% 47.43%

Unknown 10,781 4,859 45.07%

% 0.32% 0.16%

TOTAL 3,405,229 3,087,181 90.66%

Total % 100% 100.00%

Number of Protocols 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data: 434

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

17,120 1,322,684 111,823 1,576 131,689 71,659 86,056 1,742,607 1,537,817 142,023 62,767 1,742,607

0.52% 40.06% 3.39% 0.05% 3.99% 2.17% 2.61% 52.77% 46.57% 4.30% 1.90% 52.77%

0.98% 75.90% 6.42% 0.09% 7.56% 4.11% 4.94% 100.00% 88.25% 8.15% 3.60% 100.00%

56.10% 52.56% 51.03% 47.50% 53.96% 50.01% 59.31% 52.77% 52.59% 55.10% 52.15% 52.77%

Male

13,295 1,193,722 105,226 1,740 110,891 71,494 55,659 1,552,027 1,384,103 114,318 53,606 1,552,027

0.40% 36.15% 3.19% 0.05% 3.36% 2.17% 1.69% 47.00% 41.92% 3.46% 1.62% 47.00%

0.86% 76.91% 6.78% 0.11% 7.14% 4.61% 3.59% 100.00% 89.18% 7.37% 3.45% 100.00%

43.56% 47.43% 48.02% 52.44% 45.44% 49.90% 38.36% 47.00% 47.34% 44.35% 44.54% 47.00%

Unknown

104 183 2,091 2 1477 126 3,390 7,373 1,965 1,415 3,993 7,373

0.00% 0.01% 0.06% 0.00% 0.04% 0.00% 0.10% 0.22% 0.06% 0.04% 0.12% 0.22%

1.41% 2.48% 28.36% 0.03% 20.03% 1.71% 45.98% 100.00% 26.65% 19.19% 54.16% 100.00%

0.34% 0.01% 0.95% 0.06% 0.61% 0.09% 2.34% 0.22% 0.07% 0.55% 3.32% 0.22%

Total

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

0.92% 76.21% 6.64% 0.10% 7.39% 4.34% 4.39% 100.00% 88.55% 7.81% 3.65% 100.00%

0.92% 76.21% 6.64% 0.10% 7.39% 4.34% 4.39% 100.00% 88.55% 7.81% 3.65% 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

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B

Female 

16,665 54 996 294 20,359 68,345 35,310 142,023 1,580,531

6.47% 0.02% 0.39% 0.22% 7.90% 26.52% 13.70% 55.10% 47.87%

11.73% 0.04% 0.70% 0.43% 14.34% 48.12% 24.86% 100.00% 90.70%

0.00% 0.00% 0.00% 0.00% 0.00% 50.13% 75.84% 55.10% 52.65%

Male 

12,816 46 846 394 22,158 67,981 10,077 114,318 1,417,712

4.97% 0.02% 0.33% 0.29% 8.60% 26.37% 3.91% 44.35% 42.93%

11.21% 0.04% 0.74% 0.58% 19.38% 59.47% 8.81% 100.00% 91.35%

0.00% 0.00% 0.00% 0.00% 0.00% 49.87% 21.64% 44.35% 47.22%

Unknown 

95 1 0 0 148 0 1,171 1,415 3,825

0.04% 0.00% 0.00% 0.00% 0.06% 0.00% 0.45% 0.55% 0.12%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 51.88%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 2.52% 0.55% 0.13%

TOTAL

29,576 101 1,842 688 42,665 136,326 46,558 257,756 3,002,068

11.47% 0.04% 0.71% 0.50% 16.55% 52.89% 18.06% 100.00% 90.92%

11.47% 0.04% 0.71% 0.50% 16.55% 52.89% 18.06% 100.00% 90.92%

0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00% 100.00%

143
Table 16A

Number of Protocols 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards with Enrollment Data: 30

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

20 35,535 369 1,691 7,963 635 46,213 37,615

0.02% 34.43% 0.36% 1.64% 7.71% 0.62% 44.77% 36.44%

0.04% 76.89% 0.80% 3.66% 17.23% 1.37% 100.00% 81.39%

0.00% 44.37% 50.97% 39.47% 48.68% 36.26% 44.77% 44.19%

Male

0 44,510 355 1,599 6,023 1,114 53,601 46,464

0.00% 43.12% 0.34% 1.55% 5.83% 1.08% 51.93% 45.01%

0.00% 83.04% 0.66% 2.98% 11.24% 2.08% 100.00% 86.68%

0.00% 55.58% 49.03% 37.32% 36.82% 63.62% 51.93% 54.59%

Unknown

0 40 0 994 2,372 2 3,408 1,034

0.000% 0.04% 0.00% 0.96% 2.30% 0.00% 3.30% 1.00%

0.00% 1.17% 0.00% 29.17% 69.60% 0.06% 100.00% 30.34%

0.00% 0.05% 0.00% 23.20% 14.50% 0.11% 3.30% 1.21%

Total

20 80,085 724 4,284 16,358 1,751 103,222 85,113

0.02% 77.59% 0.70% 4.15% 15.85% 1.70% 100.00% 82.46%

0.02% 77.59% 0.70% 4.15% 15.85% 1.70% 100.00% 82.46%

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 females (1,788,820 or 52.53%) than males (1,605,628 or 47.15%) are enrolled in aggregate Foreign extramural and intramural research protocols. 

More minority females (1,618,146 or 52.42%) than minority males (1464,176 or 47.43 %) are enrolled in aggregate Foreign extramural and intramural research protocols. 

Approximately 90.66% (3,087,181) of participants in aggregate Foreign extramural and intramural research (3,405,229) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Asian at 76.21% and Black or African American at 6.64% following the 1997 OMB standards.

Largest identified racial minority group is Asian/ Pacific Islander at 77.59% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.1%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 0.02%.

Ethnicity: 

7.81% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is More Than One Race at 52.89% (2nd hightest category is Unknown at 18.06%)

Smallest identified racial group is Asian at 0.04%.

Of the 257,756 participants, 55.10% are women and 44.35% are men. 

4.15% of participants identified as Hispanic according to the 1977 OMB standards. 

144
Table 17A. FOREIGN Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent 

Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 1,565,124 1,474,261 94.19% 384

% 51.32% 51.21%

Males 1,479,765 1,400,741 94.66%

% 48.52% 48.66%

Unknown 5,120 3,824 74.69%

% 0.17% 0.13%

TOTAL 3,050,009 2,878,826 94.39%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 370

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

17,118 1,234,924 109,826 1,574 61,559 69,986 67,387 1,562,374 1,385,916 124,867 51,591 1,562,374

0.56% 40.57% 3.61% 0.05% 2.02% 2.30% 2.21% 51.32% 45.53% 4.10% 1.69% 51.32%

1.10% 79.04% 7.03% 0.10% 3.94% 4.48% 4.31% 100.00% 88.71% 7.99% 3.30% 100.00%

56.09% 51.11% 51.22% 47.47% 51.82% 49.91% 55.89% 51.32% 51.19% 52.41% 52.32% 51.32%

Male

13,295 1,181,277 102,515 1,740 55,875 70,126 51,939 1,476,767 1,319,633 111,970 45,164 1,476,767

0.44% 38.80% 3.37% 0.06% 1.84% 2.30% 1.71% 48.51% 43.35% 3.68% 1.48% 48.51%

0.90% 79.99% 6.94% 0.12% 3.78% 4.75% 3.52% 100.00% 89.36% 7.58% 3.06% 100.00%

43.57% 48.89% 47.81% 52.47% 47.03% 50.00% 43.08% 48.51% 48.74% 47.00% 45.80% 48.51%

Unknown

104 182 2,091 2 1,364 126 1,249 5,118 1,851 1,415 1,852 5,118

0.00% 0.01% 0.07% 0.00% 0.04% 0.00% 0.04% 0.17% 0.06% 0.05% 0.06% 0.17%

2.03% 3.56% 40.86% 0.04% 26.65% 2.46% 24.40% 100.00% 36.17% 27.65% 36.19% 100.00%

0.34% 0.01% 0.98% 0.06% 1.15% 0.09% 1.04% 0.17% 0.07% 0.59% 1.88% 0.17%

Total

30,517 2,416,383 214,432 3,316 118,798 140,238 120,575 3,044,259 2,707,400 238,252 98,607 3,044,259

1.00% 79.38% 7.04% 0.11% 3.90% 4.61% 3.96% 100.00% 88.93% 7.83% 3.24% 100.00%

1.00% 79.38% 7.04% 0.11% 3.90% 4.61% 3.96% 100.00% 88.93% 7.83% 3.24% 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

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

Female 

16,663 54 314 293 20,166 66,798 20,579 124,867 1,474,173

6.99% 0.02% 0.13% 0.22% 8.46% 28.04% 8.64% 52.41% 48.42%

13.34% 0.04% 0.25% 0.44% 16.15% 53.50% 16.48% 100.00% 94.35%

56.34% 53.47% 50.81% 0.00% 47.62% 50.03% 65.49% 52.41% 51.21%

Male 

12,816 46 304 394 22,039 66,708 9,663 111,970 1,400,655

5.38% 0.02% 0.13% 0.30% 9.25% 28.00% 4.06% 47.00% 46.01%

11.45% 0.04% 0.27% 0.59% 19.68% 59.58% 8.63% 100.00% 94.85%

43.34% 45.54% 49.19% 0.00% 52.05% 49.97% 30.75% 47.00% 48.66%

Unknown 

95 1 0 0 140 0 1,179 1,415 3,824

0.04% 0.00% 0.00% 0.00% 0.06% 0.00% 0.49% 0.59% 0.13%

6.71% 0.07% 0.00% 0.00% 9.89% 0.00% 83.32% 100.00% 74.72%

0.32% 0.99% 0.00% 0.00% 0.33% 0.00% 3.75% 0.59% 0.13%

TOTAL

29,574 101 618 687 42,345 133,506 31,421 238,252 2,878,652

12.41% 0.04% 0.26% 0.29% 17.77% 56.04% 13.19% 100.00% 94.56%

12.41% 0.04% 0.26% 0.51% 17.77% 56.04% 13.19% 100.00% 94.56%

100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00%

145
Table 17A

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 14

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

17 42 21 8 2,512 150 2,750 88

0.30% 0.73% 0.37% 0.14% 43.69% 2.61% 47.83% 1.53%

0.62% 1.53% 0.76% 0.29% 91.35% 5.45% 100.00% 3.20%

0.00% 73.68% 34.43% 20.51% 52.36% 19.28% 47.83% 50.57%

Male

0 15 40 31 2,286 626 2,998 86

0.00% 0.26% 0.70% 0.54% 39.76% 10.89% 52.14% 1.50%

0.00% 0.50% 1.33% 1.03% 76.25% 20.88% 100.00% 2.87%

0.00% 26.32% 65.57% 79.49% 47.64% 80.46% 52.14% 49.43%

Unknown

0 0 0 0 0 2 2 0

0.000% 0.00% 0.00% 0.00% 0.00% 0.03% 0.03% 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% 0.26% 0.03% 0.00%

Total

17 57 61 39 4,798 778 5,750 174

0.30% 0.99% 1.06% 0.68% 83.44% 13.53% 100.00% 3.03%

0.30% 0.99% 1.06% 0.68% 83.44% 13.53% 100.00% 3.03%

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 females (1,565,124 or 51.3%) than males (1,479,765 or 48.5%) are enrolled in aggregate foreign extramural research protocols. 

More minority females (1,474,261 or 51.2%) than minority males (1,400,741 or 48.7%) are enrolled in aggregate foreign extramural research protocols. 

Approximately 94.4% (2,878,826) of participants in aggregate foreign extramural research (3,050,009) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Asians at 79% following the 1997 OMB standards.

Largest identified racial minority group is Black or African American at 1.06% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.1%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/ Alaska Native at 0.3%.

Ethnicity: 

7.8% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is More Than One Race at 56.04% (2nd hightest category is White at 17.8%)

Smallest identified racial group is Asian at 0.04%.

Of the 238,252 participants, 52.41% are women and 47% are men. 

0.7% of participants identified as Hispanic according to the 1977 OMB standards. 

146
Table 18A. FOREIGN Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols 

with Enrollment Data: 

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 223,696 143,883 64.32% 80

% 62.97% 69.06%

Males 126,863 64,431 50.79%

% 35.71% 30.92%

Unknown 4,661 41 0.88%

% 1.31% 0.02%

TOTAL 355,220 208,355 58.66%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 64

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

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian/P

acific 

Islander

White More Than 

One Race

Unknown 

/Other Total Not Hispanic

Hispanic or 

Latino

Unknown 

/Not 

Reported

Total

Female

2 87,760 1,997 2 70,130 1,673 18,669 180,233 151,901 17,156 11,176 180,233

0.00% 34.05% 0.77% 0.00% 27.21% 0.65% 7.24% 69.93% 58.93% 6.66% 4.34% 69.93%

0.00% 48.69% 1.11% 0.00% 38.91% 0.93% 10.36% 100.00% 84.28% 9.52% 6.20% 100.00%

100.00% 87.58% 42.42% 100.00% 55.99% 55.01% 76.11% 69.93% 70.17% 87.96% 51.36% 69.93%

Male

0 12,445 2,711 0 55,016 1,368 3,720 75,260 64,470 2,348 8,442 75,260

0.00% 4.83% 1.05% 0.00% 21.34% 0.53% 1.44% 29.20% 25.01% 0.91% 3.28% 29.20%

0.00% 16.54% 3.60% 0.00% 73.10% 1.82% 4.94% 100.00% 85.66% 3.12% 11.22% 100.00%

0.00% 12.42% 57.58% 0.00% 43.92% 44.99% 15.17% 29.20% 29.78% 12.04% 38.80% 29.20%

Unknown

0 1 0 0 113 0 2,141 2,255 114 0 2,141 2,255

0.00% 0.00% 0.00% 0.00% 0.04% 0.00% 0.83% 0.87% 0.04% 0.00% 0.83% 0.87%

0.00% 0.04% 0.00% 0.00% 5.01% 0.00% 94.94% 100.00% 5.06% 0.00% 94.94% 100.00%

0.00% 0.00% 0.00% 0.00% 0.09% 0.00% 8.73% 0.87% 0.05% 0.00% 9.84% 0.87%

Total

2 100,206 4,708 2 125,259 3,041 24,530 257,748 216,485 19,504 21,759 257,748

0.00% 38.88% 1.83% 0.00% 48.60% 1.18% 9.52% 100.00% 83.99% 7.57% 8.44% 100.00%

0.00% 38.88% 1.83% 0.00% 48.60% 1.18% 9.52% 100.00% 83.99% 7.57% 8.44% 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/P

acific 

Islander

White More Than 

One Race

Unknown 

/Other Total

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

FORM Parts 

A+B

Female 

4 0 682 1 193 1,547 14,729 17,156 106,356

0.02% 0.00% 3.50% 0.04% 0.99% 7.93% 75.52% 87.96% 41.26%

0.02% 0.00% 3.98% 0.06% 1.12% 9.02% 85.85% 100.00% 59.01%

100.00% 0.00% 55.54% 0.00% 62.66% 54.86% 97.27% 87.96% 86.18%

Male 

0 0 546 0 115 1,273 414 2,348 17,053

0.00% 0.00% 2.80% 0.00% 0.59% 6.53% 2.12% 12.04% 6.62%

0.00% 0.00% 23.25% 0.00% 4.90% 54.22% 17.63% 100.00% 22.66%

0.00% 0.00% 44.46% 0.00% 37.34% 45.14% 2.73% 12.04% 13.82%

Unknown 

0 0 0 0 0 0 0 0 1

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% 0.04%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

TOTAL

4 0 1,228 1 308 2,820 15,143 19,504 123,410

0.02% 0.00% 6.30% 0.01% 1.58% 14.46% 77.64% 100.00% 47.88%

0.02% 0.00% 6.30% 0.04% 1.58% 14.46% 77.64% 100.00% 47.88%

100.00% 0.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Table 18A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 16

147
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

3 35,493 348 1,683 5,451 485 43,463 37,527

0.00% 36.41% 0.36% 1.73% 5.59% 0.50% 44.59% 38.50%

0.01% 81.66% 0.80% 3.87% 12.54% 1.12% 100.00% 86.34%

0.00% 43.80% 52.49% 51.77% 53.54% 20.68% 44.59% 44.18%

Male

0 45,495 315 1,568 3,737 488 51,603 47,378

0.00% 46.67% 0.32% 1.61% 3.83% 0.50% 52.94% 48.61%

0.00% 88.16% 0.61% 3.04% 7.24% 0.95% 100.00% 91.81%

0.00% 56.15% 47.51% 48.23% 36.70% 20.81% 52.94% 55.77%

Unknown

0 40 0 0 994 1,372 2,406 40

0.000% 0.04% 0.00% 0.00% 1.02% 1.41% 2.47% 0.04%

0.00% 1.66% 0.00% 0.00% 41.31% 57.02% 100.00% 1.66%

0.00% 0.05% 0.00% 0.00% 9.76% 58.51% 2.47% 0.05%

Total

3 81,028 663 3,251 10,182 2,345 97,472 84,945

0.00% 83.13% 0.68% 3.34% 10.45% 2.41% 100.00% 87.15%

0.00% 83.13% 0.68% 3.34% 10.45% 2.41% 100.00% 87.15%

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/Rthnicity (Column Total)

Data Table Comments: 

Sex/Gender: 

More females (223,696 or 62.97%) than males (126,863 or 35.7%) are enrolled in aggregate foreign intramural research protocols. 

More minority females (143.883 or 69.06%) than males (64,431 or 30.9%) are enrolled in aggregate foreign intramural research protocols. 

Approximately 58.9% (208,355) of participants in aggregate foreign intramural research (355,220) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Asians at 38.9% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islanders at 83.1% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native and Hawaiian/Pacific Islander at 0%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native at 0.0%.

Ethnicity: 

7.57% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown /Other at 77.7 % (2nd hightest category is More Than One Race at 14.5%)

Smallest identified racial group is Aian at 0%.

Of the 19.504 participants,87.9% are women and 12% are men. 

3.34% of participants identified as Hispanic according to the 1977 OMB standards. 

148
Table 19A. FOREIGN Aggregate Enrollment Data for Phase III Extramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent 

Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols with 

Enrollment Data: 

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 46,022 38,939 84.61% 56

% 56.24% 55.77%

Males 34,636 30,582 88.30%

% 42.32% 43.80%

Unknown 1,180 299 25.34%

% 1.44% 0.43%

TOTAL 81,838 69,820 85.31%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 49

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

1,064 13,456 13,998 3 5,218 22 9,766 43,527 31,451 11,452 624 43,527

1.39% 17.58% 18.29% 0.00% 6.82% 0.03% 12.76% 56.88% 41.10% 14.96% 0.82% 56.88%

2.44% 30.91% 32.16% 0.01% 11.99% 0.05% 22.44% 100.00% 72.26% 26.31% 1.43% 100.00%

55.82% 49.75% 51.07% 60.00% 64.48% 13.02% 82.10% 56.88% 51.93% 75.12% 87.27% 56.88%

Male

837 13,553 13,216 1 2,015 105 2,094 31,821 28,042 3,775 4 31,821

1.09% 17.71% 17.27% 0.00% 2.63% 0.14% 2.74% 41.58% 36.64% 4.93% 0.01% 41.58%

2.63% 42.59% 41.53% 0.00% 6.33% 0.33% 6.58% 100.00% 88.12% 11.86% 0.01% 100.00%

43.91% 50.11% 48.22% 20.00% 24.90% 62.13% 17.60% 41.58% 46.30% 24.76% 0.56% 41.58%

Unknown

5 39 196 1 860 42 35 1,178 1,074 17 87 1,178

0.01% 0.05% 0.26% 0.00% 1.12% 0.05% 0.05% 1.54% 1.40% 0.02% 0.11% 1.54%

0.42% 3.31% 16.64% 0.08% 73.01% 3.57% 2.97% 100.00% 91.17% 1.44% 7.39% 100.00%

0.26% 0.14% 0.72% 20.00% 10.63% 24.85% 0.29% 1.54% 1.77% 0.11% 12.17% 1.54%

Total

1,906 27,048 27,410 5 8,093 169 11,895 76,526 60,567 15,244 715 76,526

2.49% 35.34% 35.82% 0.01% 10.58% 0.22% 15.54% 100.00% 79.15% 19.92% 0.93% 100.00%

2.49% 35.34% 35.82% 0.01% 10.58% 0.22% 15.54% 100.00% 79.15% 19.92% 0.93% 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

Subtotal Using US 

Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

Female 

1,014 1 108 0 1,256 1 9,072 11,452 38,871

6.65% 0.01% 0.71% 0.00% 8.24% 0.01% 59.51% 75.12% 50.79%

8.85% 0.01% 0.94% 0.00% 10.97% 0.01% 79.22% 100.00% 89.30%

54.84% 33.33% 50.70% 0.00% 94.58% 100.00% 76.56% 75.12% 55.76%

Male 

835 1 105 0 59 0 2,775 3,775 30,546

5.48% 0.01% 0.69% 0.00% 0.39% 0.00% 18.20% 24.76% 39.92%

22.12% 0.03% 2.78% 0.00% 1.56% 0.00% 73.51% 100.00% 95.99%

45.16% 33.33% 49.30% 0.00% 4.44% 0.00% 23.42% 24.76% 43.81%

Unknown 

0 1 0 0 13 0 3 17 299

0.00% 0.01% 0.00% 0.00% 0.09% 0.00% 0.02% 0.11% 0.39%

0.00% 5.88% 0.00% 0.00% 76.47% 0.00% 17.65% 100.00% 25.38%

0.00% 33.33% 0.00% 0.00% 0.98% 0.00% 0.03% 0.11% 0.43%

TOTAL

1,849 3 213 0 1,328 1 11,850 15,244 69,716

12.13% 0.02% 1.40% 0.00% 8.71% 0.01% 77.74% 100.00% 91.10%

12.13% 0.02% 1.40% 0.00% 8.71% 0.01% 77.74% 100.00% 91.10%

100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00%

149
Table 19A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 7

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

16 34 13 5 2,327 100 2,495 68

0.30% 0.64% 0.24% 0.09% 43.81% 1.88% 46.97% 1.28%

0.64% 1.36% 0.52% 0.20% 93.27% 4.01% 100.00% 2.73%

0.00% 73.91% 43.33% 41.67% 51.33% 14.81% 46.97% 65.38%

Male

0 12 17 7 2,206 573 2,815 36

0.00% 0.23% 0.32% 0.13% 41.53% 10.79% 52.99% 0.68%

0.00% 0.43% 0.60% 0.25% 78.37% 20.36% 100.00% 1.28%

0.00% 26.09% 56.67% 58.33% 48.67% 84.89% 52.99% 34.62%

Unknown

0 0 0 0 0 2 2 0

0.000% 0.00% 0.00% 0.00% 0.00% 0.04% 0.04% 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% 0.30% 0.04% 0.00%

Total

16 46 30 12 4,533 675 5,312 104

0.30% 0.87% 0.56% 0.23% 85.34% 12.71% 100.00% 1.96%

0.30% 0.87% 0.56% 0.23% 85.34% 12.71% 100.00% 1.96%

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 females (46,022 or 56.2%) than males (34,636 or 42.3%) are enrolled in aggregate Phase III foreign extramural research protocols. 

More minority females (38,939 or 55.8%) than minority males (30,582 or 43.8%) are enrolled in aggregate Phase III foreign extramural research protocols. 

Approximately 85.3% (69,820) of participants in aggregate PhaseIII foreign extramural research (81,838) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African Americanat 35.8 % following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islanders at0.87% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0%.

According to the 1977 OMB standards, the smallest identified racial minority group is Hispanic at 0.23%.

Ethnicity: 

19.92% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknown at 77.74% (2nd hightest category is American Indian/Alaska Native at 12.13%)

Smallest identified racial group is Hawaiian/Pacific Islander at 0%.

Of the 15,244 participants, 75% are women and 24% are men. 

0.23% of participants identified as Hispanic according to the 1977 OMB standards. 

150
Table 20A. FOREIGN Aggregate Enrollment Data for Phase III Intramural Research Protocols Funded in FY2005 and Reported in FY2006: Percent 

Analysis

I. SUMMARY TOTALS: Old Form + New Form

Total Number of Protocols with 

Enrollment Data: 

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 9,577 8,270 86.35% 4

% 55.37% 56.67%

Males 7,718 6,322 81.91%

% 44.63% 43.33%

Unknown 0 0 0.00%

% 0.00% 0.00%

TOTAL 17,295 14,592 84.37%

Total % 100% 100.00%

Number of Protocols with 

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards Enrollment Data: 3

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 60 0 0 0 3,547 3,607 60 2,240 1,307 3,607

0.00% 0.00% 1.19% 0.00% 0.00% 0.00% 70.29% 71.48% 1.19% 44.39% 25.90% 71.48%

0.00% 0.00% 1.66% 0.00% 0.00% 0.00% 98.34% 100.00% 1.66% 62.10% 36.24% 100.00%

0.00% 0.00% 58.25% 0.00% 0.00% 0.00% 71.76% 71.48% 58.25% 100.00% 48.35% 71.48%

Male

0 0 43 0 0 0 1,396 1,439 43 0 1,396 1,439

0.00% 0.00% 0.85% 0.00% 0.00% 0.00% 27.67% 28.52% 0.85% 0.00% 27.67% 28.52%

0.00% 0.00% 2.99% 0.00% 0.00% 0.00% 97.01% 100.00% 2.99% 0.00% 97.01% 100.00%

0.00% 0.00% 41.75% 0.00% 0.00% 0.00% 28.24% 28.52% 41.75% 0.00% 51.65% 28.52%

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 0 103 0 0 0 4,943 5,046 103 2,240 2,703 5,046

0.00% 0.00% 2.04% 0.00% 0.00% 0.00% 97.96% 100.00% 2.04% 44.39% 53.57% 100.00%

0.00% 0.00% 2.04% 0.00% 0.00% 0.00% 97.96% 100.00% 2.04% 44.39% 53.57% 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

Subtotal Using US 

Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

Female 

0 0 0 0 0 0 2,240 2,240 2,300

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 45.58%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 63.76%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 98.16%

Male 

0 0 0 0 0 0 0 0 43

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.85%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 2.99%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 1.84%

Unknown 

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%

TOTAL

0 0 0 0 0 0 2,240 2,240 2,343

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 46.43%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 46.43%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00%

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Table 20A Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 1

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 5,970 0 0 0 0 5,970 5,970

0.00% 48.74% 0.00% 0.00% 0.00% 0.00% 48.74% 48.74%

0.00% 100.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

0.00% 48.74% 0.00% 0.00% 0.00% 0.00% 48.74% 48.74%

Male

0 6,279 0 0 0 0 6,279 6,279

0.00% 51.26% 0.00% 0.00% 0.00% 0.00% 51.26% 51.26%

0.00% 100.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

0.00% 51.26% 0.00% 0.00% 0.00% 0.00% 51.26% 51.26%

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

0 12,249 0 0 0 0 12,249 12,249

0.00% 100.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

0.00% 100.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00%

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 females (9,577 or 55.4%) than males (7,718 or 44.6%) are enrolled in aggregate Phase III foreign intamural research protocols. 

More minority females (8,270or 56.7%) than minority males (6,322 or 43.3%) are enrolled in aggregate PhaseIII foreign intramural research protocols. 

Approximately 84.4% (14,592) of participants in aggregate Phase III foreign intramural research (17,295) are classified as U.S. minorities. 

Race: White doesn’t rank as a top racial category. 

Largest identified racial minority group is Black or African American at 2.04% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islanders at 100% following the 1977 OMB standards.

According to the 1997 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native, Asian, Hawaiian/Pacific Islander at 0%.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native, Black or African American, Hispanic at 0.04%.

Ethnicity: 

44.4% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

Largest identified racial group is Unknow/Other at 100% 

Of the 2,240 participants, 100% are women 

0% of participants identified as Hispanic according to the 1977 OMB standards. 

152