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 2004 and Fiscal Year 2005 

 

NIH Tracking/Inclusion Committee

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

Office of Research on Women’s Health 

Office of the Director 

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, O.D. 

Carlos E. Caban, Ph.D.

Liaison, Office of Extramural Research, O.D. 

Kim Jarema

Liaison, Office of Intramural Research 

2006 

Table of Contents

Page

Historical Summary and Current Activities 

Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities 3 

as Subjects in Clinical Research 

 Summary Report of NIH Inclusion Data 13-20 

Summary Data Tables: FY2005 and Eleven-Year Trend Reports

NIH Wide Clinical Research Performed in 2004 and Reported in FY2005

Table 1. Summary of NIH Clinical Research Reported in FY2005: Total Number of 

 Protocols and Enrollment by Sex and Domestic versus Foreign Protocols 21 

 

Table 2. Overview of NIH Extramural and Intramural Clinical Research Reported in FY2005: 

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

 Protocols 22 

Table 3. Summary of NIH Phase III Clinical Research Reported in FY2005: 

 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 FY2005: Number of Sex-Specific Protocols and Enrollment, and Domestic 

 versus Foreign Protocols 24 

Trend Summary Reports: FY1995-2005

Table 5. Eleven-Year Trend for Protocol and Enrollment Data 25 

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

 Clinical Research reported in FY1995-2005: Enrollment by Race and Ethnicity 27 

Table 7. Eleven Year Minority Trend Summary of NIH Phase III Extramural and Intramural 30 

 Clinical Research Reported in FY1995-2005: 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 FY2002-2005: Enrollment Using U.S. Race and 

 Ethnicity Categories 33 

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

 Clinical Research Reported in FY2002-2005: Enrollment Using U.S. Race and 

 Ethnicity Categories 35 

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

 Clinical Research Reported in FY2002-2005: Enrollment Using U.S. Race and 

1
 Ethnicity Categories 37 

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

 Clinical Research Reported in FY2002-2005: Enrollment Using U.S. Race and 

 Ethnicity Categories 39 

Appendices

Appendix A Historical Narrative on the Implementation of the NIH Inclusion Policy ....................... 43 

Appendix B Explanation of Gender and Minority Codes .................................................................... 55 

 

Appendix C NIH Tracking and Inclusion Committee Member ............................................................ 57 

Appendix D Internet Homepage: Inclusion of Women and Minorities Policy Implementation ........... 63 

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

Subjects in Clinical Research - Amended, October, 2001................................................ 67 

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

Research............................................................................................................................ 83 

Appendix G NIH Inclusion Tables for Target and Enrollment Data .................................................... 95 

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

 Ethnicity.......................................................................................................................... 101 

Appendix I FY2005 Aggregate Extramural and Intramural Data Tables ............................................ 105 

2
Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research 

Historical Perspectives

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 

3
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. 

 

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. 

4
Training to ensure compliance with this policy was provided to NIH program and review officials, grants 

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

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

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

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 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/noticefiles/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 provide 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 

5
Inclusion in NIH Clinical Research: What Investigators Need to Know!” was developed for NIH staff to 

assist them in working with the extramural community. 

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. 

6
Format Changes for Reporting Race and Ethnicity Data

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. 

7
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: Enrollment by RACE 

American Indian/Alaska Native X 

Asian X 

Black or African American X 

Hawaiian/Pacific Islander X 

White 

More Than One Race X 

Unknown/Other 

 

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 

 

* Hispanic Totals Included in Part A 

* 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: 

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 

8
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 

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 

9
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 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: 

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

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

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

100.html 

3. 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 

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

10
Aggregate Enrollment Data Tables 

For Extramural and Intramural 

Research Protocols 

Fiscal Year 2005 Summary Reports 

11-year Trend Summary Reports 

11
12
Summary Report of NIH Inclusion Data

NIH AGGREGATE POPULATION DATA REPORTED IN FY2004 and FY2005 

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 FY2004 and FY2005 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 FY2004 and FY2005 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 2004 and 2005 

In FY2004 there were 14,512 extramural and intramural clinical research protocols, including Phase III 

and other clinical studies, of which 10,125 protocols reported human subject participation as noted in this 

report’s trend summary tables. Of these, 96.4% were domestic protocols and 3.6% were foreign protocols. 

Approximately 18.9 million participants were enrolled in extramural and intramural research protocols of 

which 75.9% were domestic participants and 24.1% were foreign participants. Of the 18.9 million 

participants, 57.5% were women, 40.9% were men and 1.5% did not provide sex identification. Further, 

35.8% of the total participants, and 24.1% of the Domestic-only participants, were reported as minorities 

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

Correspondingly, 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 1) 

While the number of participants in all extramural and intramural clinical research decreased (18.9M in 

FY2004 and 15.7M in FY2005), there was no significant change in the ratio of women and men (57.5%F 

and 40.9%M in FY2004; and 60.4%F and 37.8%M in FY2005). Two large studies involving 

approximately 3M participants, that ended in FY2004 and therefore were not included in the FY2005 

figures, accounted for the decreased number of participants reported. 

13
NIH Defined Phase III Clinical Research: FY2004 and FY2005

In FY2004 there were 692 extramural and intramural Phase III clinical research protocols, of which 576 

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

94.7% were domestic protocols and 5.3% were foreign protocols. Approximately 516,360 participants 

were enrolled in extramural and intramural Phase III research protocols of which 90.5% were domestic 

participants and 9.5% were foreign participants. Of the 516,360 participants, 55.5% were women, 44.2% 

were men and 0.2% did not provide sex identification. Further, 27% of the total participants, and 25.4% 

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

OMB categories for race and ethnicity. (Table 7) 

According to the trend summaries in this report, of the 296 extramural and intramural Phase III research 

protocols that report following the 1977 OMB standards in FY2004, minority representation was highest 

for Blacks (not Hispanic) at 12.9% and lowest for American Indian/Alaska Natives at 0.4%. Hispanics 

represented approximately 8.7%, Asian/Pacific Islanders were 5% and Whites (not Hispanic) 70.2% 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 FY 2004, there were 277 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 26.2% and lowest for Hawaiian/Pacific 

Islanders 0.4%. Asians represented 2.6%, American Indian/Alaska Natives 0.8% and Whites 64% of 

participants. Participants identifying as More Than One Race were 2.6% of the total number of 

participants. In addition, 3.4% did not identify a race category. Of the 277 extramural and intramural 

Phase III research protocols designating an ethnicity in FY2004, 87.3 % of total participants identified as 

“Not Hispanic”, 8.0 % of the total participants identified as “Hispanic or Latino”, and 4.7% 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 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 Domesticonly participants, in Phase III clinical research were reported as minorities following the 1997 OMB 

categories for race and ethnicity. (Table 3) 

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) 

Moreover, 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 

14
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) 

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

decreased (516,360 in FY2004 and 493,000 in FY2005), there was no significant change in the ratio of 

women and men (55.5% F and 44.2%M in FY2004; and 59%F and 40%M in FY2005). 

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

EXTRAMURAL CLINICAL RESEARCH: Fiscal Years 2004 and 2005 

In FY2004 there were 12,795 extramural clinical research protocols, including Phase III and other clinical 

studies, of which 8,734 protocols reported human subject participation as noted in this report’s trend 

summary tables. Approximately 16.9 million participants were enrolled in extramural research protocols 

of which 58.6% were women, 39.8% were men and 1.6% did not provide sex identification. (Table 11) 

Correspondingly, 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. Of these, 

82.7% were domestic protocols and 2.9% were foreign protocols. Approximately 13.8 million participants 

were enrolled in extramural research protocols of which 70.2% of the total enrollment is domestic 

participants and 17.5% of the total enrollment is foreign participants. Of the 13.8 million participants, 

62.1% were women, 36.1% were men and 1.9% did not provide sex identification. Further, 42.3% of the 

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

2 and Table 3A) 

While the number of participants in all extramural clinical research decreased (16.8 million in FY2004 

and 13.8 million in FY2005), there was no significant change in the ratio of women and men (58.6%F and 

39.8%M in FY2004; and 62%F and 36%M in FY2005). 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. Two large studies involving approximately 3M participants, that 

ended in FY2004 and therefore were not included in the FY2005 figures, accounted for the decreased 

number of participants reported. 

NIH Defined Phase III Extramural Clinical Research: FY2004 and FY2005

In FY2004 there were 650 extramural Phase III clinical research protocols, of which 500 protocols 

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

482,325 participants were enrolled in extramural Phase III research protocols of which 56% were women, 

44% were men and 0.02% did not provide sex identification. (Table C04 and Table 15 from the 2005 

report) 

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. (Table 15 from the 2005 

report)

According to trend summaries in this report, in FY 2004, there were 266 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 24.3% and lowest for 

15
Hawaiian/Pacific Islanders 0.3%. Asians represented 2.46%, American Indian/Alaska Natives 0.8% and 

Whites 66.5% of participants. Participants identifying as More Than One Race were 2.6% of the total 

number of participants. In addition, 3.06 % did not identify a race category. Of the 266 extramural Phase 

III research protocols designating an ethnicity in FY 2004, 86.38 % of total participants identified as “Not 

Hispanic”, 8.53 % of the total participants identified as “Hispanic or Latino”, and 5.08 % of the total 

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

participants is also provided separately. (Table 15 from the 2005 report) 

Correspondingly, 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. (Table 4 and Appendix Table 

5A) 

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

minority representation was highest for Blacks (not Hispanic) at 18 and lowest for American 

Indian/Alaska Natives at 0.38%. Hispanics represented approximately 7.2%, Asian/Pacific Islanders were 

1.81% 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. (Appendix Table 5A)

Furthermore, 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. (Appendix Table5A) 

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

(500 in FY2004 and 511 in FY2005), there was no significant change in the ratio of women and men 

(56%F and 44%M in FY2004; and 59.5%F and 39.5%M in FY2005). 

INTRAMURAL CLINICAL RESEARCH: Fiscal Years 2004 and 2005 

Substantial numbers of women and minorities were included in NIH intramural studies in FY 2004 and 

FY2005. 

In FY2004 there were 1,717 intramural clinical research protocols, including Phase III and other clinical 

studies, of which 1,391 protocols reported human subject participation. Approximately 1.94 million 

participants were enrolled in intramural research protocols of which 48.4% were women, 50.1% were 

men and 1.5% did not provide sex identification. (Table C04 and Table 11 from the 2005 report) 

In FY 2004, approximately 1.9 million participants were reported in all intramural research including 

Phase III clinical trials, and other clinical studies. Of the 951 intramural research protocols that report data 

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

10.5% and lowest for American Indian/Alaska Natives at 0.9%. Blacks (not-Hispanic) represented 5.6%, 

16
For 440 intramural clinical research studies that reported data following the current 1997 OMB standards 

in FY 2004, the largest racial minority group was Blacks at 9.14% and the smallest racial minority group 

was Hawaiian/Pacific Islanders at .01%. Asians represented 4.2%, American Indian/Alaska Natives 1.1% 

and Whites 78.7% of participants in all intramural clinical research. Approximately 0.2% of participants 

reported More Than One Race as their racial category. In addition, 6.70 % did not identify a race 

category. Of the 440 intramural research protocols following the current 1997 OMB standards designating 

an ethnicity in FY2004, 95.7 % of total participants identified as “Not Hispanic”, 2.83 % of the total 

participants identified as “Hispanic or Latino”, and 1.48 % of the total participants did not identify an 

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

separately. (Table 19 from the 2005 report) 

Correspondingly, 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. (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. (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. (Appendix Table 7A) 

There was no significant change in the ratio of women and men or the number of participants in all 

intramural clinical research. 

NIH Defined Phase III Intramural Clinical Research: FY2004 and FY2005

In FY2004 there were 37 intramural Phase III clinical research protocols reporting human subject 

participation. Approximately 34,035 participants were enrolled in intramural Phase III research protocols 

of which 50.2% were women, 49.8% were men and 0% did not provide sex identification. (Table 23 from 

the 2005 report) 

17
Correspondingly, 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. (Table 

4 and Appendix Table 9A) 

There was no significant change in the ratio of women and men or the number of participants in Phase III 

intramural clinical research. 

18
TREND REPORT ON NIH AGGREGATE POPULATION DATA: FY1995 – FY2005 

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 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. 

Table 5 is an 11-year summary report showing a steady increase in protocols and enrollment data 

collected. The number of protocols with enrollment increased from 3,188 in FY2005 to 10,233 in FY2005 

– a 3.2 fold increase. Reported enrollment increased from approximately 1 million (FY1995) to 15.7 

million (FY2005) – a 15.4 fold increase; minority enrollment increased from 0.37 million (FY1995) to 

6.2 million (FY2005) – a 16.7 increase in minority representation in NIH clinical research. Over the last 

three to 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 (FY1995) to 12.7 million (FY2005) – a 1.2 fold increase. Foreign 

enrollment increased from 0.9 million (FY1995) to 3 million (FY2005) – a 3.2 fold increase. Overall, the 

total enrollment has increased with domestic participation averaging between 80-91% and foreign 

participation averaging between 8.5-24%. In FY2005, domestic and foreign enrollment was 80.6% and 

19.4% 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 52% and 64%, male participation in all extramural and intramural research averaged between 

36% and 45%. Overall minority participation in all extramural and intramural clinical research averaged 

between 31% and 40%. Table 6E provides a comparison of domestic and foreign participation between 

FY2002 and FY2005. 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 27.4% 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, 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% and 75% and male participation in NIHfunded Phase III extramural and intramural clinical research averaged between 28% and 44%. Overall 

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

between 2% and 31%. Table 7E provides a comparison of domestic and foreign participation between 

FY2002 and FY2005. The vast majority of protocols are domestic (75% and 96%) of the total clinical 

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

24% of the total clinical research protocols with enrollment. Table 7F shows domestic and foreign 

enrollment for the five-year period. Domestic minority enrollment varied between 20.9% and 25.4% of 

total domestic participation, while foreign minority enrollment in NIH-funded Phase III clinical research 

19
varied between 48.4% and 80.4% of total foreign participation. Comparing both domestic and foreign 

enrollment over the five year period shows that the small percentage of foreign protocols (5.5%) account 

for a significant proportion (28.7%) of the total minority 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 62% while male 

participation averaged 36%. (Table 8) For NIH-funded Phase III extramural and intramural clinical 

research, domestic participants enrolled in domestic protocols, female participation averaged 57% while 

male participation averaged 42%. (Table 9) For all extramural and intramural clinical research, foreign 

participants enrolled in foreign protocols, female participation varied from 39% to 58% while male 

participation varied from 40% to 60%. (Table 10) For NIH-funded Phase III extramural and intramural 

clinical research, foreign participants enrolled in foreign protocols, female participation varied from 47% 

to 57% while male participation varied from 42% to 53%. (Table 11)

20
1A. PROTOCOLS REPORTED

Total All Clinical 

Studies* Domestic % Foreign %

Protocols with Enrollment 10,233 9,862 96.4% 371 3.6%

% 69.2% 69.4% 62.7%

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted 4,565 4,344 95.2% 221 4.8%

30.8% 30.6% 37.3%

Total Number of Protocols 14,798 14,206 96.0% 592 4.0%

% 100.0% 100.0% 100.0%

Table 1A Comments: 

Total Number of Protocols

1. The total number of protocols reported in the NIH database in FY2005 was 14,798; of these, 10,233(69.2%) reported subject enrollment.

2. Subsequent Tables reporting "Enrollment Reported" are based on the 10,233 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 (14,206; 96.0%); of these, 9,862 (69.4%) reported domestic subject enrollment.

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

1B. ENROLLMENT REPORTED

Total All Clinical 

Studies* Domestic % Foreign %

Females Enrolled 9,503,922 7,887,209 83.0% 1,616,713 17.0%

% 60.4% 62.3% 53.0%

Males Enrolled 5,941,907 4,515,242 76.0% 1,426,665 24.0%

% 37.8% 35.6% 46.7%

Sex of Subjects is Unknown 276,923 267,407 96.6% 9,516 3.4%

% 1.8% 2.1% 0.3%

Total Subjects Enrolled 15,722,752 12,669,858 80.6% 3,052,894 19.4%

% 100.0% 100.0% 100.0%

Table 1B Comments:

Total Enrollment Reported

1. The total "Enrollment Reported" in the NIH database in FY2005 was 15, 722, 752 subjects in 10,233 protocols with enrollment.

2. Females made up 60.4% (9.5M) of the total subjects enrolled, while Males made up 37.8%(5.9M), with 1.8% (.277M) unknown.

Total Domestic Enrollment Reported

4. The total Domestic Enrollment reported was 12,669,858 (80.6%).

5. Females made up 62.3%(7.9M) of the domestic subjects enrolled, while Males made up 35.6%(4.5M), with 2.1%(.267M) unknown.

1C. MINORITY ENROLLMENT 

REPORTED

Total All Clinical 

Studies* Domestic % Foreign %

Minority Total** 6,245,436 3,468,864 55.5% 2,776,572 44.5%

39.7% 27.4% 90.9%

Table 1C Comments. 

1. Minorities made up 39.7% of total subjects enrolled.

2. Minorities made up 27.4%(3.47M) of the Domestic Enrollment.

* 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.

3. The Total Minority Enrollment was made up of 55.5% Domestic and 44.5% Foreign enrollment. The small percentage of 

foreign protocols account for a significant proportion (44.5%) of the Total Minority Enrollment, as shown by comparing both 

domestic and foreign enrollment data. 

Table 1. Summary of NIH Clinical Research Reported In FY2005 :Total Number of Protocols and Enrollment By Sex, and 

Domestic versus Foreign Protocols

* 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.

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100% 21
2A. PROTOCOLS REPORTED

Total All Clinical 

Studies Extramural % Intramural % Extramural % Intramural %

Number of Protocols reporting females only 1,326 1,156 87.2% 124 9.4% 40 3.0% 6 0.5%

% 9.0% 9.2% 7.3% 8.0% 6.6%

Number of Protocols reporting males only 559 450 80.5% 97 17.4% 9 1.6% 3 0.5%

% 3.8% 3.6% 5.7% 1.8% 3.3%

Number of Other Protocols with Enrollment (excluding 

females only and males only protocols) 8,348 6,857 82.1% 1,178 14.1% 251 3.0% 62 0.7%

% 56.4% 54.8% 69.1% 50.1% 68.1%

Total Number of Protocols with Enrollment 10,233 8,463 82.7% 1,399 13.7% 300 2.9% 71 0.7%

% 69.2% 68% 82.1% 59.9% 78.0%

Number of Protocols with zero enrollment. Enrollment 

data has not yet been submitted. 4,565 4,039 88.5% 305 6.7% 201 4.4% 20 0.4%

% 30.8% 32.3% 17.9% 40.1% 22.0%

Total Number of Protocols 14,798 12,502 84.5% 1,704 11.5% 501 3.4% 91 0.6%

% 100.0% 100.0% 100.0% 100.0% 100.0%

Table 2A Comments

Total Number of Protocols with Enrollment

 90.2% were Extramural projects(1,156+40); 9.8% were NIH intramural projects(124+6)

 96.6% were Domestic protocols(1,156+124); 0.4% were Foreign protocols(40+6).

 85.1% were Extramural projects(450+9); 14.9% were NIH intramural projects(97+3)

 97.8% were Domestic protocols(450+97); 0.2% were Foreign protocols(9+3).

 82.1% were Extramural projects(6,857+251); 17.9% were NIH intramural projects(1,178+62)

 96.2% were Domestic protocols(6,857+1,178); 3.8% were Foreign protocols(251+62).

2B. ENROLLMENT REPORTED

Total All Clinical 

Studies Extramural % Intramural % Extramural % Intramural %

In Protocols reporting females only 3,469,692 3,073,956 88.6% 166,709 4.8% 130,092 3.7% 98,938 2.9%

% 22.1% 27.9% 10.2% 4.7% 32.8%

In Protocols reporting males only 317,697 241,871 76.1% 25,513 8.0% 25,218 7.9% 25,120 7.9%

% 2.0% 2.2% 1.6% 0.9% 8.3%

In Protocols excluding female-only and men-only 

enrollment protocols 11,935,363 7,714,690 64.6% 1,447,119 12.1% 2,596,372 21.8% 177,154 1.5%

% 75.9% 69.9% 88.3% 94.4% 58.8%

Enrollment Totals for all studies 15,722,752 11,030,517 70.2% 1,639,341 10.4% 2,751,682 17.5% 301,212 1.9%

% 100.0% 100.0% 100.0% 100.0% 100.0%

Table 2B Comments

Total Enrollment

1. In Female Only Protocols: There were approximately 3.47M females, representing 22.1% of total enrollment.

 92.3% (3.20M)were in Extramural projects; 7.7% (.266M) were in NIH intramural projects

 93.4% (3.24M) were in Domestic protocols; 6.6% (.229M) were in Foreign protocols.

2. In Male Only Protocols: There were approximately 317,697 males, representing 2.0% of total enrollment.

 84.1% (267,089) were in Extramural projects; 15.9%(50,633) were in NIH intramural projects

 84.2% (267,384) were in Domestic protocols; 15.8% (50,338) were in Foreign protocols.

3. In Other Protocols: There were approximately 11,935,363 subjects, representing 75.9% of total enrollment

 86.4% (10.31M) were in Extramural projects;13.6% (1.62M) were in NIH intramural projects

 76.8% (9.16M) were in Domestic protocols; 23.2%(2.77M) were in Foreign protocols

2C. MINORITY ENROLLMENT REPORTED** Extramural % Intramural % Extramural % Intramural %

Minority Totals for all studies 6,245,436 3,235,752 51.8% 233,112 3.7% 2,597,525 41.6% 179,047 2.9%

% 39.7% 29.3% 14.2% 94.4% 59.4%

Table 2C. Comments

Minority Enrollment

1. Total Minority Enrollment was 39.7% (6.25M) of Total Enrollment (15.72M).

 Total Minority enrollment, Extramural protocols(5.83M), was 37.1% of Total Enrollment(15.72M) and 93.3% of Total Minority Enrollment (6.25M)

 Total Minority enrollment, Intramural Projects(412,159), was 2.6% of Total Enrollment (15.72M) and 6.6% of Total Minority Enrollment (6.25M)

2. Total Minority Enrollment, Domestic only(3.47M), was 27.4% of total Domestic Enrollment (12.67M) and 55.5% of Total Minority Enrollment (6.25M)

3. Total Minority Enrollment, Foreign only (2.78M), was 91.1% of Total Foreign Enrollment (3.05M) and 44.5% of Total Minority Enrollment (6.25M)

**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. 

4. Approximately 70% of the total number of protocols reported enrollment; the remaining protocols have not yet submitted their first annual enrollment data.

Domestic Foreign

Domestic Foreign

3. Other Protocols: There were 8,348 protocols with enrollment excluding female only and male only protocols, representing 81.6%(8,348/10,233) of protocols with 

enrollment, and 56.4 % of the Total Number of Protocols.

1. Female Only: There were 1,326 protocols reporting females only, representing 13.0 %(1,326/10,233) of protocols with enrollment, and 9.0% of the Total Number of 

Protocols.

2. Male Only: There were 559 protocols reporting males only, representing 5.5%(559/10,233) of protocols with enrollment, and 3.8% of the Total Number of Protocols.

Table 2: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2005: Number of Sex Specific Protocols and 

Enrollment, and Domestic versus Foreign Protocols 

Domestic Foreign

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 22
3A. PROTOCOLS REPORTED

Total of Phase III 

Clinical Trials* Domestic % Foreign %

Protocols with Enrollment 547 517 94.5% 30 5.5%

% 82.3% 83.7% 63.8%

Protocols with zero enrollment. Enrollment 

data has not yet been submitted. 118 101 85.6% 17 14.4%

17.7% 16.3% 36.2%

Total Number of Protocols 665 618 92.9% 47 7.1%

% 100.0% 100.0% 100.0%

Table 3A Comments:

Total Number of Protocols

2. Subsequent Tables reporting "Enrollment Reported" are based on the 665 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 (618; 92.9%); of these 517(83.7%) reported domestic subject enrollment.

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

3B. ENROLLMENT REPORTED

Total of Phase III 

Clinical Trials* Domestic % Foreign %

Females Enrolled 290,977 261,589 89.9% 29,388 10.1%

% 59.0% 59.7% 53.3%

Males Enrolled 197,300 174,137 88.3% 23,163 11.7%

% 40.0% 39.8% 42.0%

Sex of Subjects is Unknown 4,723 2,176 46.1% 2,547 53.9%

% 1.0% 0.5% 4.6%

Total Subjects Enrolled 493,000 437,902 88.8% 55,098 11.2%

% 100.0% 100.0% 100.0%

Table 3B Comments:

Total Enrollment Reported

1. The total "Enrollment Reported" in NIH Defined Phase III Protocols in the NIH database in FY2005 was 493,300 subjects in 547 protocols with enrollment.

2. Females made up 59.0% (290,977) of the total subjects enrolled, while Males made up 40.0%(197,300), with 1.0%(4,723) unknown.

Total Domestic Enrollment Reported

4. The total Domestic Enrollment reported was 437,902(88.8%).

5. Females made up 59.7%(261,589) of the domestic subjects enrolled, while Males made up 39.8%(174,137), with 0.5%(2,176) unknown.

3C. MINORITY ENROLLMENT 

REPORTED**

Total of Phase III 

Clinical Trials* Domestic % Foreign %

Minority Total for all Phase III studies 154,191 109,910 71.3% 44,281 28.7%

31.3% 25.1% 80.4%

Table 3C Comments. Minority Enrollment Reported.

1. Minorities made up 31.3% of total subjects enrolled.

2. Minorities made up 25.1%(109,910) of the Domestic Enrollment (437,902).

3. The Total Minority Enrollment was made up of 71.3% Domestic and 28.7% Foreign enrollment. 

* 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. 

Table 3. Summary of NIH Phase III Clinical Research Reported In FY2005: Number of Protocols and Enrollment by 

Sex, and Domestic versus Foreign Protocols

1. The total number of NIH defined Phase III Clinical protocols reported in the NIH database in FY2005 was 665; of these, 547(82.3%) 

reported subject enrollment.

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 23
4A. PROTOCOLS REPORTED

Total of Phase 

III Clinical 

Trials* Extramural % Intramural % Extramural % Intramural %

Protocols reporting women only 127 120 94.5% 1 0.8% 6 4.7% 0 0.0%

% 19.1% 20.7% 2.6% 14.3% 0.0%

Protocols reporting men only 34 29 85.3% 4 11.8% 1 2.9% 0 0.0%

% 5.1% 5.0% 10.3% 2.4% 0.0%

Other Protocols with Enrollment (excluding women

only and men only protocols) 386 335 86.8% 28 7.3% 20 5.2% 3 0.8%

% 58.0% 57.9% 71.8% 47.6% 60.0%

Total Number of Protocols with Enrollment 547 484 88.5% 33 6.0% 27 4.9% 3 0.5%

% 82.3% 84% 84.6% 64.3% 60.0%

Phase III Protocols with zero enrollment. 

Enrollment data has not yet been submitted. 118 95 80.5% 6 5.1% 15 12.7% 2 1.7%

% 17.7% 16.4% 15.4% 35.7% 40.0%

Total Number of Phase III Protocols 665 579 87.1% 39 5.9% 42 6.3% 5 0.8%

% 100.0% 100.0% 100.0% 100.0% 100.0%

Table 4A Comments

Total Number of Protocols with Enrollment

 99.2% were Extramural projects(126); 0.8% were NIH intramural projects(1)

 95.3% were Domestic protocols(121); 4.7% were Foreign protocols(6).

 88.2% were Extramural projects(30); 11.8% were NIH intramural projects(4)

 97.0% were Domestic protocols(33); 3.0% were Foreign protocols(1).

 92.0% were Extramural projects(355); 8.0% were NIH intramural projects(31)

 94.0% were Domestic protocols(363); 6.0% were Foreign protocols(23).

4B. ENROLLMENT REPORTED 

Total of Phase 

III Clinical 

Trials* Extramural % Intramural % Extramural % Intramural %

Protocols reporting women only 157,329 149,953 95.3% 1 0.0% 7,375 4.7% 0 0.0%

% 31.9% 35.4% 0.0% 17.5% 0.0%

Protocols reporting men only 56,191 54,050 96.2% 46 0.1% 2,095 3.7% 0 0.0%

% 11.4% 12.8% 0.3% 5.0% 0.0%

Protocols excluding female-only and men-only 

enrollment protocols 279,480 219,775 78.6% 14,077 5.0% 32,708 11.7% 12,920 4.6%

% 56.7% 51.9% 99.7% 77.5% 100.0%

Total Subjects Enrolled 493,000 423,778 86.0% 14,124 2.86% 42,178 8.56% 12,920 2.6%

% 100.0% 100.0% 100.0% 100.0% 100.0%

Table 4B Comments

Total Enrollment

1. In Female Only Protocols: There were approximately 157,329 females, representing 31.9% of total enrollment.

 99.9% (157,328)were in Extramural projects; .01% (1) were in NIH intramural projects

 95.3% (149,954) were in Domestic protocols; 4.7% (7,375) were in Foreign protocols.

2. In Male Only Protocols: There were approximately 56,191 males, representing 11.4% of total enrollment.

 99.9% (56,145) were in Extramural projects; 0.1%(46) were in NIH intramural projects

 96.3% (54,096) were in Domestic protocols; 3.7% (2,095) were in Foreign protocols.

3. In Other Protocols: There were approximately 279,480 subjects, representing 56.7% of total enrollment

 90.3% (252,483) were in Extramural projects; 9.7% (26,997) were in NIH intramural projects

 83.7% (233,852) were in Domestic protocols; 16.3%(45,628) were in Foreign protocols

4C. MINORITY ENROLLMENT REPORTED**

Total of Phase 

III Clinical 

Trials* Extramural % Intramural % Extramural % Intramural %

Minority Total for all Phase III studies 154,191 107,513 69.7% 2,397 1.6% 31,943 20.7% 12,338 8.0%

% 31.3% 25.4% 17.0% 75.7% 95.5%

Table 4C. Comments

Minority Enrollment

1. Total Minority Enrollment was 31.3% (154,191) of Total Enrollment (493,000).

 Total Minority enrollment, Extramural protocols(139,456), was 28.3% of Total Enrollment(493,000) and 90.4% of Total Minority Enrollment (154,191)

 Total Minority enrollment, Intramural Projects(14,735), was 3.0% of Total Enrollment (493,000) and 9.6% of Total Minority Enrollment (154,191)

2. Total Minority Enrollment, Domestic only(109,910), was 23.6% of total Domestic Enrollment (465,956) and 71.3% of Total Minority Enrollment (154,191)

3. Total Minority Enrollment, Foreign only(44,281), was 80.3% of Total Foreign Enrollment (55,098) and 28.7% of Total Minority Enrollment (154,191)

**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. 

* 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 t

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

1. Female Only: There were 127 protocols reporting females only, representing 23.20 %(127/547) of protocols with enrollment, and 19.1% of the Total Number of Protocols.

2. Male Only: There were 34 protocols reporting males only, representing 6.2%(34/547) of protocols with enrollment, and 5.1% of the Total Number of Protocols.

3. Other Protocols: There were 386 protocols with enrollment excluding female only and male only protocols, representing 70.6%(386/547) of protocols with enrollment, and 58.0 % 

of the Total Number of Protocols.

Domestic Foreign

Table 4. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2005: Number of Sex Specific Protocols and Enrollment, and 

Domestic versus Foreign Protocols

Domestic Foreign

Domestic Foreign

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 24
5A. Eleven Year Increases in Protocols and Enrollment Data

FY Reported 1995 2005

Relative 

Increase, 

2005 / 1995

Total Protocols 

with enrollment 3,188 10,233 3.2

Total Enrollment 1,021,493 15,722,752 15.4

Total Minorities 374,433 6,245,436 16.7

% of Minority 36.7% 39.7% 1.1

FY Reported 2002 2005

Relative 

Increase, 

2005 / 2002

Total DOMESTIC 

Enrollment data 10,192,401 12,669,858 1.2

Total FOREIGN 

Enrollment 946,083 3,052,894 3.2

Table 5A Comments:

1. There was a 3.2 fold increase in protocols with enrollment reported from 1995 to 2005, from 3,188 protocols to 10,233 protocols.

2. There was a 15.4 fold increase in enrollment reported from 1995 to 2005, from approximately 1.0M to 15.7 M.

3. There was a 16.7 fold increase in minority enrollment from 1995 to 2005, from approximately 0.37M to 6.2 M.

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

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%

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%

Table 5B Comments:

2. The total number of protocols reported with enrollment have leveled off at about 10,000 over the last 3-5 years. 

3. The vast majority of protocols were for domestic studies for 2002-2005, increasing slightly from 94.6% to 96.4% of protocols.

25

* Protocol Form. 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 2002-2005, data have been reported using both Old and New 

Forms. See Appendix table "Minority Data Definitions" for details.

1. Table 5B and 5B Graph provide the number of OLD and NEW protocols year by year (1995-2005) and the distribution between domestic 

and foreign protocols for years 2002-2005.

Total Protocols by Year Reported

Table 5. Eleven Year Trends for Protocol and Enrollment Data: 1995-2005*

Note: The arrow in the graph indicates that the old Form was used until 2001 reports, and both the OLD and NEW FORMS were used for 

2002-2005 reports. 

Old

Old + New

5B. Eleven Year Summary of Total Protocols Reported in FY 1995-2005

4. Domestic and Foreign data were reported for FY 2002-2005, and showed 1.2 fold increase in domestic enrollment 

(from 10.2M to 12.7M) and a 3.2 fold increase in foreign enrollment (from 0.95M to 3.0M).

0

2,000

4,000

6,000

8,000

10,000

12,000

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Number of Protocols

with Enrollment data

(Old + New Forms):

Number of 

DOMESTIC Protocols

with Enrollment data

Number of FOREIGN

Protocols with

Enrollment data

OLD FORM OLD+NEW FORMS

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
5C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2005

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%

Percent Comparison of Domestic and Foreign Enrollment

Table 5C Comments:

26

*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. 

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

domestic enrollment has decreased to approximately 80% as the foreign enrollment has increased to approximately 20%.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

Percent DOMESTIC

Enrollment

Percent FOREIGN

Enrollment

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
6A. ELEVEN 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)

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% 100.0% 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%

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

Note: The arrow in the graphs indicates that the old Form was used until 2001 reports, and both the OLD and NEW FORMS were used for 2002-2005 reports. 

Table 6A Comments:

27

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.

Table 6. Eleven Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY1995-2005: Enrollment by Race and Ethnicity 

Subtotal: All Subjects 

Enrolled by US Minority 

Categories

1. Table 6A summarizes enrollment by sex/gender and minority race/ethnicity categories for the eleven year reporting period (1995-2005). 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). 

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Subtotal: All

Subjects

Enrolled by US

Minority

Categories

OLD FORM OLD+NEW FORMS

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

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

Males

Females

OLD FORM OLD+NEW FORMS

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
NOTE 2: Data from Tables 6B, 6C and 6D are combined to provide the summary data in Table 6A.

FY 

Reported FY Funded

American 

Indian/ Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic, Not 

White White Unknown/O

ther Total 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%

ORIENTATION TO TABLES 6C and 6D.

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

Total of All Subjects by Race

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%

FY 

Reported FYFunded

American 

Indian/ Alaska 

Native

Asian

Black or 

African 

American

Hawaiian /Pacific 

Islander White More Than 

One Race

Unknown/Ot

her

Total Hispanic 

or Latino** 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%

* These totals must agree.

**These totals must agree.

28

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

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

Total of All Subjects by Ethnicity

1. The New Form consists of Parts A and B (Tables 6C and 6D) for reporting years 2002-2005. This Form is provided as part of the annual progress report

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.

Subtotal Using US 

Minority Categories 

(shaded): NEW FORM 

Parts A+B

Subtotal Using US 

Minority Categories 

(shaded): OLD FORM 

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 

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

Form, and separate reporting for Foreign and Domestic Data. 

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

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
6E. Comparison of Domestic and Foreign Enrollment and Protocols with Total Enrollment for the period FY2002-2005

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 

DOMESTIC 

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%

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

Table 6 E Comments:

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

FY 

Reported FY Funded

FOREIGN 

Minority 

Enrollment

Foreign 

Total 

Enrollment

DOMESTIC 

Minority 

Enrollment

Domestic Total 

Enrollment

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%

NOTE MINORITY % WILL NOT ADD TO 100%

Table 6F Comments:

29

3. The Total Minority Enrollment reported in FY2005 was 55.5% Domestic and 44.5 % Foreign (see Table 1). The small percentage of foreign protocols 

account for a significant proportion (44.5%) of the Total Minority Enrollment, as shown by comparing both domestic and foreign enrollment data. A25

ENROLLMENT PROTOCOLS

Percentage Comparison of Domestic Minority Enrollment to Total 

Domestic Enrollment for FY 2002-2005

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.

Percentage Comparison of Foreign Minority Enrollment to Total Foreign Enrollment for 

FY 2002-2005

6F. Comparison of Domestic and Foreign Minority Participation for FY 2002-2005

3. The vast majority of protocols are domestic protocols (approximately 94-96%), while foreign protocols make up approximately 4-6% of total protocols.

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

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2005.

1. Domestic Minority Enrollment has varied from 24.1% to 27.4% of Total Domestic Enrollment.

0

2,000

4,000

6,000

8,000

10,000

12,000

2002 2003 2004 2005

Number of DOMESTIC

Protocols 

Number of FOREIGN

Protocols 

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

Percent

DOMESTIC

Enrollment 

Percent

FOREIGN

Enrollment 

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

2002 2003 2004 2005

Thousands

FOREIGN

Minority

Enrollment

DOMESTIC

Minority

Enrollment

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

FOREIGN

Minority

Enrollment

Foreign

Total

Enrollment

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

DOMESTIC

Minority

Enrollment

Domestic Total

Enrollment

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
Note: Phase III Data for years 1994-2001 is presented only by Extramural Phase III trials data

FY 

Reported

FY 

Funded Females Males Unknown

Total All 

Subjects 

(Old + New 

Forms)

Number of 

Protocols 

with 

Enrollment 

data (Old + 

New Forms):

1995 1994 171,181 108,324 19,818 299,323 560

% 57.2% 36.2% 6.6% 100.0%

1996 1995 264,755 203,698 21,210 489,663 608

% 54.1% 41.6% 4.3% 100.0%

1997 1996 264,755 203,698 21,210 489,663 608

% 54.1% 41.6% 4.3% 100.0%

1998 1997 228,417 74,389 2,705 305,511 320

% 74.8% 24.3% 0.9% 100.0%

1999 1998 339,533 163,950 1,446 504,929 578

% 67.2% 32.5% 0.3% 100.0%

2000 1999 313,952 180,705 1,086 495,743 589

% 63.3% 36.5% 0.2% 100.0%

2001 2000 412,379 168,085 1,273 581,737 645

% 70.9% 28.9% 0.2% 100.0%

2002 2001 278,876 195,090 781 474,747 754

% 58.7% 41.1% 0.2% 100.0%

2003 2002 294,950 239,403 1,914 536,267 852

% 55.0% 44.6% 0.4% 100.0%

2004 2003 301,353 242,913 1,101 545,367 573

% 55.3% 44.5% 0.2% 100.0%

2005 2004 290,977 197,300 4,723 493,000 547

59.0% 40.0% 1.0% 100.0%

Total Phase III Enrollment by Year Reported Sex/Gender Phase III Enrollment by Year Reported

Note: The arrow in the graphs indicates that the old Form was used until 2001 reports, and both the OLD and NEW FORMS were used for 2002-2005 reports. 

Table 7A Comments:

30

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.

120,339

23.4%

27.6%

24.7%

150,456

132,302

24.3%

117,873

20.3%

111,269

28.0%

7A. Phase III ELEVEN YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER AND MINORITY CATEGORIES IN ALL PROTOCOLS 

(Old + New Forms)

22.6%

110,669

80,562

26.9%

154,191

31.3%

1. Table 7A summarizes enrollment by sex/gender and minority race/ethnicity categories for the eleven year reporting period (1995-

2005). 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). 

Table 7: Eleven Year Minority Trend Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in 

FY1995-2005: Enrollment by Race and Ethnicity

110,000

22.5%

69,599

Subtotal: All 

Subjects Enrolled by 

US Minority 

Categories

22.8%

141,449

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Subtotal:

All

Subjects

Enrolled

by US

Minority

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

Unknown

Males

Females

OLD FORM OLD+NEW FORMS

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

Number 

Protocols with 

Enrollment 

data (Old 

Form):

1995 1994 5,358 2,740 52,433 20,031 172,773 45,988 299,323 560

% 1.8% 0.9% 17.5% 6.7% 57.7% 15.4% 100.0%

1996 1995 4,235 40,126 46,838 19,470 321,445 57,549 489,663 608

% 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0%

1997 1996 4,235 40,126 46,838 19,470 321,445 57,549 489,663 608

% 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0%

1998 1997 5,030 5,324 42,805 16,440 229,534 6,378 305,511 320

% 1.6% 1.7% 14.0% 5.4% 75.1% 2.1% 100.0%

1999 1998 3,685 20,276 76,921 40,567 336,703 26,777 504,929 578

% 0.7% 4.0% 15.2% 8.0% 66.7% 5.3% 100.0%

2000 1999 3,726 24,017 62,512 30,084 335,824 39,580 495,743 589

% 0.8% 4.8% 12.6% 6.1% 67.7% 8.0% 100.0%

2001 2000 4,079 11,132 70,110 32,552 422,802 41,062 581,737 645

% 0.7% 1.9% 12.1% 5.6% 72.7% 7.1% 100.0%

2002 2001 1,645 20,560 51,991 29,636 315,543 12,228 431,603 660

% 0.4% 4.8% 12.0% 6.9% 73.1% 2.8% 100.0%

2003 2002 1,689 20,038 49,255 29,066 337,654 16,615 454,317 656

% 0.4% 4.4% 10.8% 6.4% 74.3% 3.7% 100.0%

2004 2003 1,505 18,807 45,285 32,974 265,764 14,050 378,385 296

% 0.4% 5.0% 12.0% 8.7% 70.2% 3.7% 100.0%

2005 2004 1,319 17,740 39,402 21,829 231,492 4,507 316,289 210

% 0.4% 5.6% 12.5% 6.9% 73.2% 1.4% 100.0%

ORIENTATION TO TABLES 7C and 7D.

2. Table 7C displays the New Form Part A for reporting separate race and ethnicity data

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

% 0.4% 1.9% 10.8% 0.1% 80.3% 1.3% 5.3% 100.0% 84.0% 3.8% 12.3% 100.0%

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%

7D. Phase III New Form Part B: 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/Pac

ific Islander White More Than One Race

Unknown/Oth

er

Total 

Hispanic or 

Latino**

Number of 

Protocols with 

Enrollment 

data (New 

Form):

2002 2001 49 22 31 4 660 304 560 1,630 94

% 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0%

2003 2002 37 70 186 23 2,115 203 5,197 7,831 196

% 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0%

2004 2003 269 59 193 26 7,264 3,052 2,572 13,435 277

% 2.0% 0.4% 1.4% 0.2% 54.1% 22.7% 19.1% 100.0%

2005 2004 759 42 446 45 3,667 423 5,015 10,397 337

% 7.3% 0.4% 4.3% 0.4% 35.3% 4.1% 48.2% 100.0%

* These totals must agree

** These totals must agree

31

22.6%

110,669

22.6%

141,449

28.0%

24.3%

120,339

73,901

Total of All Subjects by Race

103,832

54,405

7C. Phase III New Form Part A: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race and Ethnicity 

20.3%

110,669

69,599

117,873

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 (below the dark row) are from the new Population Tracking System that was deployed with data reported in FY 2002, and allows separate reporting using the Old 

Form and the New Form, and separate reporting for Foreign and Domestic Data. 

22.8%

80,290

25.4%

7,437

32,254

Subtotal Using US 

Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

Total of All Subjects by Ethnicity

1. The New Form consists of Parts A and B (Tables 7C and 7D) for reporting years 2002-2005. This Form is provided as part of the annual progress report.

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.

98,571

26.1%

24.1%

100,048

22.0%

Subtotal Using US 

Minority 

Categories 

(shaded): OLD 

FORM 

80,562

26.9%

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
7E. Comparison of Domestic and Foreign Phase III Enrollment and Protocols with Enrollment for the period FY2002-2005

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 

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%

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

Table 7 E Comments:

1. The Total Enrollment, Total Domestic, and Total Foreign enrollment increase from FY2002-2005.

2. The Domestic enrollment decreased to approximately 88.8%, while the Foreign enrollment increased to approximately 11%.

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

FY 

Reported

FY 

Funded

FOREIGN 

Phase III 

Minority 

Enrollment

FOREIGN 

Phase III 

Total 

Enrollment

DOMESTIC 

Phase III 

Minority 

Enrollment

DOMESTIC 

Phase III 

Total 

Enrollment

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%

Table 7F Comments:

32

1. Domestic Minority Enrollment has varied from 20.9% to 25.4% of Total Domestic Enrollment.

3. The Total Minority Enrollment reported in FY2005 was 71.3% Domestic and 28.7 % Foreign (see Table 3). The small percentage of foreign protocols 

(5.5%)account for a significant proportion (28.7%) of the Total Minority Enrollment, as shown by comparing both domestic and foreign enrollment data. 

2. Foreign Minority Enrollment has varied from 48.4% to 80.4% 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.

ENROLLMENT PROTOCOLS

3. The vast majority of protocols are domestic protocols (approximately 94-96%), while foreign protocols make up approximately 4-6% of total protocols.

Percentage Comparison of Phase III Foreign Minority Enrollment to Total Foreign 

Phase III Enrollment for FY 2002-2005

Percentage Comparison of Phase III Domestic Minority to Total Domestic Phase III 

Enrollment for FY 2002-2005

7F. Phase III Foreign and Domestic Minority Comparison for FY 2002-2005

Number of Minority Participants in Phase III Clinical Studies for 

FY2002-2005

0

20

40

60

80

100

120

140

2002 2003 2004 2005

Thousands

FOREIGN

Phase III

Minority

Enrollment

DOMESTIC

Phase III

Minority

Enrollment

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

DOMESTIC

Phase III Minority

Enrollment

DOMESTIC

Phase III Total

Enrollment

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

FOREIGN Phase

III Total

Enrollment

FOREIGN Phase

III Minority

Enrollment

0

100

200

300

400

500

600

700

800

900

2002 2003 2004 2005

Number of 

DOMESTIC Protocols 

Number of FOREIGN

Protocols 

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005

Percent

DOMESTIC

Enrollment 

Percent

FOREIGN

Enrollment

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

Reported

FY 

Funded Females Males

Unknown 

sex

Total 

Domestic 

Subjects (Old 

+ New 

Forms)

Number of

Domestic 

Protocols 

with 

Enrollment 

data (Old + 

New 

Forms):

2002 2001 6,583,087 3,506,787 59,995 10,149,869 2,754,820 8,425

% 64.9% 34.6% 0.6% 100.0% 27.1%

2003 2002 7,392,404 4,393,496 125,457 11,911,357 2,935,363 9,578

% 62.1% 36.9% 1.1% 100.0% 24.6%

2004 2003 8,881,299 5,199,765 278,729 14,359,793 3,464,356 9,760

% 61.8% 36.2% 1.9% 100.0% 24.1%

2005 2004 7,887,209 4,515,242 267,407 12,669,858 3,468,864 9,862

62.3% 35.6% 2.1% 100.0% 27.4%

Table 8A Comments:

2. There were approximately an average of 26% domestic minority subjects enrolled in domestic protocols from 2002-2005.

3. Total domestic enrollment ranged from 10.1M to 12.7M during these 4 years.

4. The number of domestic protocols increased from 8,425 to 9,862 in 2005.

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).

33

Table 8. DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research Reported in FY2002-

2005: Enrollment Using U.S. Race/Ethnicity Categories

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

studies continuing from the prior year; (2) the addition of new studies reported; (3) and the subtraction of studies that are 

no longer reported.

NOTE 1: Summary Totals for Domestic Protocols are shown in Table 8A. Table 8A includes Subtotals from OLD FORM (Table 8B) and NEW 

Form (Table 8C and 8D).

NOTE 2: The shaded portions of the Tables A, B, C and D show the race/ethnicity categories that are identified as minority categories.

NOTE 3: 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 allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data. 

1. There were approximately an average of 62% females, 36% males and 2% of unknown sex enrolled in domestic protocols from 2002-2005.

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

Subtotal: Domestic 

Subjects Enrolled by 

US Minority 

Categories

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

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 5,783

% 0.8% 12.4% 11.1% 6.3% 64.2% 5.2% 100.0%

2003 2002 36,238 249,420 455,329 264,336 3,100,815 266,339 4,372,477 4,478

% 0.8% 5.7% 10.4% 6.0% 70.9% 6.1% 100.0%

2004 2003 28,953 196,647 322,078 194,762 2,273,619 157,464 3,173,523 2,702

% 0.9% 6.2% 10.1% 6.1% 71.6% 5.0% 100.0%

2005 2004 22,375 89,119 210,465 126,351 1,245,337 93,239 1,786,886 1,736

% 1.3% 5.0% 11.8% 7.1% 69.7% 5.2% 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/

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%

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

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 2,642

% 0.7% 0.3% 7.3% 0.1% 42.3% 3.4% 45.9% 100.0%

2003 2002 3,756 1,950 13,345 678 349,844 23,560 208,885 602,018 5,100

% 0.6% 0.3% 2.2% 0.1% 58.1% 3.9% 34.7% 100.0%

2004 2003 6,293 5,026 12,498 2,037 356,575 51,031 287,091 720,551 7,058

% 0.9% 0.7% 1.7% 0.3% 49.5% 7.1% 39.8% 100.0%

2005 2004 22,057 7,810 19,282 1,981 362,707 36,503 270,798 721,138 8,126

% 3.1% 1.1% 2.7% 0.3% 50.3% 5.1% 37.6% 100.0%

** These totals must agree

34

1,005,323

23.0%

8B. OLD FORM: Total of All Domestic Subjects Reported Using the 1977 OMB Standards in a combined race/ethnicity 

format

Domestic Subtotal 

Using US Minority 

Categories 

(shaded): OLD 

FORM 

* These totals must agree

Domestic Subtotal 

Using US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

1,930,040

25.6%

1,849,868

30.6%

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

742,440

23.4%

448,310

8C. NEW FORM: Inclusion Enrollment Report (Total of All Domestic Subjects Reported Using the 1997 OMB Standards for

Separate Race and Ethnicity Formats)

27.8%

2,721,916

25.1%

904,952

22.1%

3,020,554

24.3%

Part A: TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race

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

Reported

FY 

Funded Females Males Unknown

Total 

Domestic 

Subjects 

(Old + New 

Forms)

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%

Table 9A Comments:

2. There were approximately an average of 23.5% domestic minority subjects enrolled in domestic Phase III protocols from 2002-2005.

3. Total domestic Phase III enrollment ranged from 437,902 to 496,241during these 4 years.

4. The number of domestic Phase III protocols ranged from 643 to 517 in 2005.

35

Table 9. DOMESTIC PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in 

FY2002-2005:Enrollment Using U.S. Race/Ethnicity Categories 

NOTE 1: Summary Totals for Domestic Protocols are shown in Table 9A. Table 9A includes Subtotals from OLD FORM (Table 9B) and NEW 

Form (Table 9Cand 9D).

NOTE 2: The shaded portions of the Tables A, B, C and D show the race/ethnicity categories that are identified as minority categories.

NOTE 3: 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 allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data. 

1. There were approximately an average of 57% females, 42% males and 0.3% of unknown sex enrolled in domestic protocols from 2002-2005.

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.

9A . SUMMARY TOTALS: DOMESTIC SUBJECTS IN Phase III DOMESTIC PROTOCOLS (Old + New Forms)

Subtotal: Domestic 

Subjects Enrolled 

by US Minority 

Categories

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

Number of 

Domestic 

Protocols 

with 

Enrollment 

data (Old 

Form):

2002 2001 1,586 8,291 49,184 27,912 305,964 10,670 403,607 494

% 0.4% 2.1% 12.2% 6.9% 75.8% 2.6% 100.0%

2003 2002 1,612 7,610 48,975 25,567 322,600 8,538 414,902 468

% 0.4% 1.8% 11.8% 6.2% 77.8% 2.1% 100.0%

2004 2003 1,504 6,739 45,233 31,967 262,671 6,447 354,561 286

% 0.4% 1.9% 12.8% 9.0% 74.1% 1.8% 100.0%

2005 2004 1,319 5,488 39,401 20,646 229,235 4,493 300,582 205

% 0.4% 1.8% 13.1% 6.9% 76.3% 1.5% 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/

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%

9D. NEW FORM 

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 

Domestic 

Protocols 

with 

Enrollment 

data (New 

Form):

2002 2001 49 21 31 4 660 304 560 1,629 88

% 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0%

2003 2002 37 70 186 23 2,113 203 5,196 7,828 175

% 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0%

2004 2003 269 59 193 26 7,262 482 2,572 10,863 263

% 2.5% 0.5% 1.8% 0.2% 66.9% 4.4% 23.7% 100.0%

2005 2004 371 42 446 45 3,663 423 4,783 9,773 312

% 3.8% 0.4% 4.6% 0.5% 37.5% 4.3% 48.9% 100.0%

** These totals must agree

36

9B. OLD FORM: Total of All Phase III Domestic Subjects Reported Using the 1977 OMB Standards in a combined 

race/ethnicity format

Domestic Subtotal 

Using US Minority 

Categories 

(shaded): OLD 

FORM 

86,973

21.5%

83,764

20.2%

85,443

24.1%

66,854

22.2%

9C. NEW FORM: Inclusion Enrollment Report (Total of All Phase III Domestic Subjects Reported Using the 1997 OMB 

Standards for Separate Race and Ethnicity Formats)

Part A: TOTAL ENROLLMENT REPORT: Number of Phase III Subjects Enrolled to Date (Cumulative) by Ethnicity and Race

35.6%

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

Domestic Subtotal 

Using US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

5,988

31.4%

* These totals must agree

40,370

28.5%

43,056

14.7%

Part B: Hispanic Enrollment Report: Number of Phase III Hispanics or Latinos Enrolled to Date 

25,612

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

Table 10AComments:

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 4 years.

4. The number of foreign protocols ranged from 638 in 2003 to 371 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)

37

Table 10. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Clinical Research Reported in FY2002-2005: 

Enrollment Using U.S. Race/Ethnicity Categories

NOTE 1: Summary Totals for Domestic Protocols are shown in Table 10A. Table 10A includes Subtotals from OLD FORM (Table 10B) and NEW Form 

(Table 10C and 10D).

NOTE 2: The shaded portions of the Tables A, B, C and D show the race/ethnicity categories that are identified as minority categories.

NOTE 3: 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 

allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data. 

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.

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%.

10A. SUMMARY TOTALS: FOREIGN SUBJECTS IN FOREIGN PROTOCOLS (Old + New Forms)

Subtotal: Foreign 

Subjects Enrolled by 

US Minority 

Categories

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
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 69 468,958 21,407 19,075 143,768 3,565 656,842 380

% 0.0% 71.4% 3.3% 2.9% 21.9% 0.5% 100.0%

2003 2002 341 481,122 17,097 24,187 137,469 12,562 672,778 425

% 0.1% 71.5% 2.5% 3.6% 20.4% 1.9% 100.0%

2004 2003 434 110,405 20,110 19,560 74,910 14,666 240,085 80

% 0.2% 46.0% 8.4% 8.1% 31.2% 6.1% 100.0%

2005 2004 0 165,479 19,150 8,621 21,752 9,166 224,168 50

% 0.0% 73.8% 8.5% 3.8% 9.7% 4.1% 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/

Not 

Reported

*Total of All 

Subjects by 

Ethnic 

Category

2002 2001 3,271 180,022 68,071 14,013 19,970 741 3,153 289,241 278,618 6,064 4,559 289,241

% 1.1% 62.2% 23.5% 4.8% 6.9% 0.3% 1.1% 100.0% 96.3% 2.1% 1.6% 100.0%

2003 2002 2,018 1,842,941 62,572 14,501 253,745 5,324 7,018 2,188,119 2,158,933 9,623 19,563 2,188,119

% 0.1% 84.2% 2.9% 0.7% 11.6% 0.2% 0.3% 100.0% 98.7% 0.4% 0.9% 100.0%

2004 2003 193 3,860,259 99,728 11,507 292,142 14,056 46,157 4,324,042 4,275,684 35,788 12,570 4,324,042

% 0.0% 89.3% 2.3% 0.3% 6.8% 0.3% 1.1% 100.0% 98.9% 0.8% 0.3% 100.0%

2005 2004 1,171 2,390,404 125,305 10,293 187,697 18,857 94,999 2,828,726 2,683,871 52,801 92,054 2,828,726

% 0.0% 84.5% 4.4% 0.4% 6.6% 0.7% 3.4% 100.0% 94.9% 1.9% 3.3% 100.0%

10D. NEW FORM

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 1,461 0 4 0 1,659 683 175 3,982 102

% 36.7% 0.0% 0.1% 0.0% 41.7% 17.2% 4.4% 100.0%

2003 2002 1,644 3 1,222 0 632 4,528 1,594 9,623 213

% 17.1% 0.0% 12.7% 0.0% 6.6% 47.1% 16.6% 100.0%

2004 2003 115 14 12,778 0 4,537 11,878 6,466 35,788 285

% 0.3% 0.0% 35.7% 0.0% 12.7% 33.2% 18.1% 100.0%

2005 2004 682 6 164 0 26,161 14,664 11,124 52,801 321

% 1.3% 0.0% 0.3% 0.0% 49.5% 27.8% 21.1% 100.0%

** These totals must agree

38

10B. 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 

522,747

77.7%

150,509

62.7%

FOREIGN Subtotal 

Using US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

1,929,582

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

92.6%

* These totals must agree

509,509

77.6%

193,250

86.2%

267,952

88.2%

10C. NEW FORM: Inclusion Enrollment Report (Total of All FOREIGN Subjects Reported Using the 1997 OMB Standards for 

Separate Race and Ethnicity Formats)

2,583,315

91.3%

Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

3,996,746

92.4%

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

Table 11A Comments:

3. Total Phase III foreign enrollment increased from 30,311 to 55,098 during these 4 years.

4. The number of Phase III foreign protocols dropped from 209 in 2003 to 30 in 2005.

39

Table 11. FOREIGN PROTOCOLS: Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in 

FY2002-2005: Enrollment Using U.S. Race/Ethnicity Categories

NOTE 2: The shaded portions of the Tables A, B, C and D show the race/ethnicity categories that are identified as minority categories.

NOTE 1: Summary Totals for Domestic Protocols are shown in Table 11A. Table 11A includes Subtotals from OLD FORM (Table 11B) and NEW 

Form (Table 11C and 11D).

NOTE 3: 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 allows separate reporting using the Old Form and the New Form, and separate reporting for Foreign and Domestic Data. 

1. The percent females varied from 47.4% to 56.7% in Phase III foreign protocols from 2002-2005; 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 80.4% from 2002 to 2005.

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.

11A. SUMMARY TOTALS: FOREIGN SUBJECTS IN in Phase III Clinical Research FOREIGN PROTOCOLS 

(Old + New Forms)

Subtotal: Foreign 

Subjects Enrolled 

by US Minority 

Categories

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

FY 

Reported FY Funded

American 

Indian or 

Alaska 

Native

Asian

Black or 

African 

American

Native 

Hawaiian 

or Pacific 

Islander

White More Than 

One Race

Unknown 

or Not 

Reported

*Total of All 

Subjects by 

Racial 

Categories 

(New Form)

Not 

Hispanic

**Hispanic 

or Latino

Unknown

/Not 

Reported

*Total of All 

Subjects by 

Ethnic 

Category

2002 2001 0 1 1,448 0 113 0 753 2,315 1,562 0 753 2,315

% 0.0% 0.0% 62.5% 0.0% 4.9% 0.0% 32.5% 100.0% 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%

11D. NEW FORM

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%

** These totals must agree

40

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

combined race/ethnicity format

FOREIGN Subtotal 

Using US Minority 

Categories 

(shaded): OLD 

FORM 

16,859

60.2%

16,284

41.3%

13,128

55.1%

13,436

85.5%

11C. NEW FORM: Inclusion Enrollment Report (Total of All FOREIGN Subjects Reported in Phase III Clinical Research Using 

the 1997 OMB Standards for Separate Race and Ethnicity Formats)

Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled in Phase III Clinical Research to Date 

7,643

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

FOREIGN Subtotal 

Using US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B

30,845

78.3%

* These totals must agree

76.5%

23,998

94.8%

1,449

62.6%

Note: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.
41

APPENDICES 

Page

Appendix A Full Historical Narrative on the Implementation of the NIH Inclusion Policy..............43 

Appendix B Explanation of Gender and Minority Codes ..................................................................55 

Appendix C NIH Tracking and Inclusion Committee Members........................................................57 

Appendix D Internet Homepage: Inclusion of Women and Minorities – Policy Implementation .....63 

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

Subjects in Clinical Research – Amended, October 2001 .............................................67 

Appendix F NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research ......83 

Appendix G NIH Inclusion Tables for Target and Enrollment Data..................................................95 

Appendix H Comparison of 1977 and 1997 OMB Standards for Classification for Reporting 

 Race and Ethnicity .......................................................................................................101 

Appendix I FY2005 Aggregate Extramural and Intramural Data Tables .......................................105 
42
43

Appendix A 

Historical Narrative on the 

Implementation of the 

NIH Inclusion Policy 
44
45

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 
46

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 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. 

47
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 

48
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 

49
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. 

50
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 

51
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 

52
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. 

53
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

54
55

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. 
56
57

Appendix C 

NIH Tracking and Inclusion Committee Members 

- Full Committee 
58
59

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, Lisa Begg, Joyce Rudick

Office of Extramural Research

Carlos Caban*, Viktoriya Anufriyeva, Maria Koshy 

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 

National Institute on Alcohol Abuse and Alcoholism

Dorita Sewell*, Van Van 

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* 

National Institute of Child Health and Human Development

 Eugene Hayunga*, Sandi Delcore

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
60

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, Donna James, 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 

National Institute of Nursing Research

Paul Cotton *, Christine Shaw 

National Library of Medicine

Hua-Chuan Sim * 

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
61

List of Members, continued...

National Center for Research Resources

Sheila McClure*, Delores Lee, Patricia Newman, Stephen Seidel, Louise Ramm 

Fogarty International Center

Aron Primack* 

Center for Scientific Review 

Anita Miller Sostek* 

National Center for Minority Health and Health Disparaties

 Derrick Tabor*, Ivy Chan 

National Institute of Biomedical Imaging and Bioengineering

Andrea Brooks*, Anthony Dempsey 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee 
62
63

Appendix D 

Internet Homepage: 

Inclusion of Women and Minorities Policy 

Implementation 

http://grants.nih.gov/grants/funding/women_min/women_min.htm
64
65

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. 
66

• 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 
67

Appendix E 

NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as 

Subjects in Clinical Research 

(Amended, October, 2001) 
68
69

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: 
70

(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) 
71

(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-
72

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. 
73

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 
74

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 
75

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 
76

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 
77

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 
78

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
79

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
80

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
81

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
82

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
83

Appendix F 

NIH Policy on 

Reporting Race and Ethnicity Data: 

Subjects in Clinical Research 
84
85

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: 
86

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. 
87

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. 
88

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. 
89

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 
90

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. 
91

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 
92

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
93

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
94

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 

95
96
Old Table for Target & Enrollment Data Collection 

97
New Table for Target Data Collection

98
New Table for Enrollment Data Collection

99
100
Appendix H 

Comparison of 1977 and 1997 OMB Classifications 

For Reporting Race and Ethnicity 

101
102
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* 

 

103
Part B: Hispanic Enrollment by RACE 

 American Indian/Alaska Native* 

 Asian* 

 Black or African American* 

 Hawaiian/Pacific Islander* 

 White (Hispanic) X 

 More Than One Race* 

 Unknown/Other (Hispanic) X 

Racial Categories: Total of Hispanics or Latinos** 

 

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

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

Note 1. Hispanics are defined by country of origin, and may be identified as belonging to any one, or more than one, race 

category. 

Note 2. The OLD FORM uses the 1977 OMB combined Race and Ethnicity Format, which has mutually 

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

Note 3. The NEW FORM uses the 1997 OMB Race and Ethnicity Categories, with separate reporting for 

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

Ethnic Category and by Race Category. Part B of the NEW FORM therefore provides a distribution of only 

"Hispanics or Latinos" by the five main Race categories. Since minority categories are defined to include both

"Hispanic or Latino ethnicity" and non-white racial categories when providing summary totals of minorities, it is 

necessary to add White Hispanics" and "Unknown/Other Hispanics" based on their ethnicity to the non-white 

racial categories. 

104
Appendix I

Aggregate Extramural and Intramural Data Tables 

Funded in FY2004 and Reported in FY2005

105
Table of Contents: Fiscal Year 2005 Aggregate Data Tables 

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

 Funded in FY2004 and Reported in FY2005: Percent Analysis 108 

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

 Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis 110 

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

 FY2004 and Reported in FY2005: Percent Analysis 112 

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

Male-Only and Female-Only Protocols Funded in FY2004 and Reported in 

FY2005: Percent Analysis 114 

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

in FY2004 and Reported in FY2005: Percent Analysis 116 

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

 Male-Only and Female-Only Research Protocols Funded in FY2004 and 

 Reported in FY2005: Percent Analysis 118 

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

 FY2004 and Reported in FY2005: Percent Analysis 120 

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

 Male-Only and Female-Only Protocols Funded in FY2004 and Reported in 

 FY2005: Percent Analysis 122 

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

 Funded in FY2004 and Reported in FY2005: Percent Analysis 124 

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

 Male-Only and Female-Only Research Protocols Funded in FY2004 and 

 Reported in FY2005: Percent Analysis 126 

Domestic and Foreign Clinical Research Reported in FY 2003 and 2004

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

 Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis 128 

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

 Funded in FY2004 and Reported in FY2005: Percent Analysis 130 

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

 Funded in FY2004 and Reported in FY2005: Percent Analysis 132 

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

 Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis 134 

106
Table 15A. Domestic: Aggregate Enrollment Data for Intramural Phase III Researc

Protocols Funded in FY2004 and Reported in FY2005: Percent Analys

h 

is 136 

able 16A. ural Research 

Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis 138 

Analysis 

T Foreign: Aggregate Enrollment Data for Extramural and Intram

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

Funded in FY2004 and Reported in FY2005: Percent Analysis 140 

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

Funded in FY2004 and Reported in FY2005: Percent 142 

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

 Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis 144 

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

 Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis 146 

107
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 9,503,922 3,714,289 39.08% 10,233

% 60.45% 59.47%

Males 5,941,907 2,493,792 41.97%

% 37.79% 39.93%

Unknown 276,923 37,356 13.49%

% 1.76% 0.60%

TOTAL 15,722,752 6,245,437 39.72%

Total % 100% 100.00% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 8,447

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

269,164 1,598,780 863,143 30,490 4,837,167 109,736 683,644 8,392,124 7,214,587 511,731 665,806 8,392,124

1.96% 11.66% 6.29% 0.22% 35.28% 0.80% 4.99% 61.20% 52.62% 3.73% 4.86% 61.20%

3.21% 19.05% 10.29% 0.36% 57.64% 1.31% 8.15% 100.00% 85.97% 6.10% 7.93% 100.00%

92.11% 52.48% 63.55% 57.22% 63.04% 59.98% 61.83% 61.20% 61.12% 66.12% 58.73% 61.20%

22,333 1,441,120 474,386 21,827 2,691,434 72,109 338,312 5,061,521 4,421,319 255,280 384,922 5,061,521

0.16% 10.51% 3.46% 0.16% 19.63% 0.53% 2.47% 36.91% 32.24% 1.86% 2.81% 36.91%

0.44% 28.47% 9.37% 0.43% 53.17% 1.42% 6.68% 100.00% 87.35% 5.04% 7.60% 100.00%

7.64% 47.31% 34.93% 40.96% 35.08% 39.41% 30.60% 36.91% 37.46% 32.98% 33.96% 36.91%

718 6,470 20,733 969 144,289 1,108 83,766 258,053 168,258 6,928 82,867 258,053

0.01% 0.05% 0.15% 0.01% 1.05% 0.01% 0.61% 1.88% 1.23% 0.05% 0.60% 1.88%

0.28% 2.51% 8.03% 0.38% 55.91% 0.43% 32.46% 100.00% 65.20% 2.68% 32.11% 100.00%

0.25% 0.21% 1.53% 1.82% 1.88% 0.61% 7.58% 1.88% 1.43% 0.90% 7.31% 1.88%

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

2.13% 22.22% 9.91% 0.39% 55.96% 1.33% 8.06% 100.00% 86.09% 5.64% 8.27% 100.00%

2.13% 22.22% 9.91% 0.39% 55.96% 1.33% 8.06% 100.00% 86.09% 5.64% 8.27% 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 

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

18,244 5,693 12,224 1,273 268,670 29,134 176,493 511,731 3,316,476

2.36% 0.74% 1.58% 2.49% 34.71% 3.76% 22.80% 66.12% 24.19%

3.57% 1.11% 2.39% 4.37% 52.50% 5.69% 34.49% 100.00% 39.52%

80.23% 72.84% 62.86% 64.26% 69.09% 56.94% 62.60% 66.12% 59.18%

4,354 2,062 7,061 659 117,005 21,276 102,863 255,280 2,251,643

0.56% 0.27% 0.91% 1.29% 15.12% 2.75% 13.29% 32.98% 16.42%

1.71% 0.81% 2.77% 3.10% 45.83% 8.33% 40.29% 100.00% 44.49%

19.15% 26.38% 36.31% 33.27% 30.09% 41.58% 36.49% 32.98% 40.18%

141 61 161 49 3,199 756 2,561 6,928 35,758

0.02% 0.01% 0.02% 0.10% 0.41% 0.10% 0.33% 0.90% 0.26%

2.04% 0.88% 2.32% 6.48% 46.17% 10.91% 36.97% 100.00% 13.86%

0.62% 0.78% 0.83% 2.47% 0.82% 1.48% 0.91% 0.90% 0.64%

22,739 7,816 19,446 1,981 388,874 51,166 281,917 773,939 5,603,877

2.94% 1.01% 2.51% 3.87% 50.25% 6.61% 36.43% 100.00% 40.87%

2.94% 1.01% 2.51% 3.87% 50.25% 6.61% 36.43% 100.00% 40.87%

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

108

Female 

Male 

Unknown 

TOTAL

Table 1A. Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Number of Protocols with 

Enrollment Data: 

Total

Total Number of Protocols 

with Enrollment Data: 

Male

Unknown

Total of All Subjects by Ethnicity

Total of All Subjects by Race

Total of All Subjects by Race

Female
1,786

American 

Indian/ 

Alaska Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

11,837 170,391 132,806 82,779 677,824 36,161 1,111,798 397,813

0.59% 8.47% 6.60% 4.12% 33.70% 1.80% 55.28% 19.78%

1.06% 15.33% 11.95% 7.45% 60.97% 3.25% 100.00% 35.78%

52.90% 66.93% 57.84% 61.33% 53.49% 35.31% 55.28% 62.01%

10,422 83,995 96,547 51,185 584,294 53,943 880,386 242,149

0.52% 4.18% 4.80% 2.55% 29.05% 2.68% 43.78% 12.04%

1.18% 9.54% 10.97% 5.81% 66.37% 6.13% 100.00% 27.50%

46.58% 32.99% 42.05% 37.92% 46.11% 52.68% 43.78% 37.74%

116 212 262 1,008 4,971 12,301 18,870 1,598

0.006% 0.01% 0.01% 0.05% 0.25% 0.61% 0.94% 0.08%

0.61% 1.12% 1.39% 5.34% 26.34% 65.19% 100.00% 8.47%

0.52% 0.08% 0.11% 0.75% 0.39% 12.01% 0.94% 0.25%

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

1.11% 12.66% 11.42% 6.71% 63.01% 5.09% 100.00% 31.90%

1.11% 12.66% 11.42% 6.71% 63.01% 5.09% 100.00% 31.90%

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

Data Table Comments: 

Sex/Gender: 

More females (9,503,922 or 60.5%) than males (5,941,907 or 37.8%) are enrolled in aggregate extramural and intramural research protocols. 

More minority females (3,714,289 or 59.5%) than minority males (2,493,792 or 39.9%) are enrolled in aggregate extramural and intramural research protocols. 

Minority:

Approximately 39.7% (6,245,437) of participants in aggregate extramural and intramural research (15,722,752) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 63% following the 1977 OMB standards and 56% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 12.6% following the 1977 OMB standards.

Largest identifiec racial minority group is Asians at 22.2% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 1.1%.

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

Ethnicity: 

5.64% 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 50.3%

Smallest identified racial group is Asian at 1%

Of the 773,939 participants, 66.1% are women and 33% are men. 

6.7% of participants identified as Hispanic according to the 1977 OMB standards. 

109

Number of Protocols with 

Enrollment Data: 

Legend

Female

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

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 290,977 85,015 29.22% 547

% 59.02% 55.14%

Males 197,300 66,589 33.75%

% 40.02% 43.19%

Unknown 4,723 2,587 54.77%

% 0.96% 1.68%

TOTAL 493,000 154,191 31.28%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 337

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

1,531 5,122 24,512 206 47,828 1,637 4,467 85,303 75,266 6,164 3,872 85,302

0.87% 2.90% 13.87% 0.12% 27.07% 0.93% 2.53% 48.27% 42.59% 3.49% 2.19% 48.27%

1.79% 6.00% 28.74% 0.24% 56.07% 1.92% 5.24% 100.00% 88.23% 7.23% 4.54% 100.00%

70.75% 55.72% 48.69% 44.59% 47.24% 53.44% 43.56% 48.27% 48.05% 59.29% 40.07% 48.27%

629 4,032 23,303 256 53,144 1,422 4,005 86,791 78,594 4,214 3,983 86,791

0.36% 2.28% 13.19% 0.14% 30.07% 0.80% 2.27% 49.11% 44.48% 2.38% 2.25% 49.11%

0.72% 4.65% 26.85% 0.29% 61.23% 1.64% 4.61% 100.00% 90.56% 4.86% 4.59% 100.00%

29.07% 43.86% 46.29% 55.41% 52.49% 46.43% 39.06% 49.11% 50.17% 40.53% 41.21% 49.11%

4 38 2,523 0 266 4 1,782 4,617 2,790 18 1,809 4,617

0.00% 0.02% 1.43% 0.00% 0.15% 0.00% 1.01% 2.61% 1.58% 0.01% 1.02% 2.61%

0.09% 0.82% 54.65% 0.00% 5.76% 0.09% 38.60% 100.00% 60.43% 0.39% 39.18% 100.00%

0.18% 0.41% 5.01% 0.00% 0.26% 0.13% 17.38% 2.61% 1.78% 0.17% 18.72% 2.61%

2,164 9,192 50,338 462 101,238 3,063 10,254 176,711 156,650 10,396 9,664 176,710

1.22% 5.20% 28.49% 0.26% 57.29% 1.73% 5.80% 100.00% 88.65% 5.88% 5.47% 100.00%

1.22% 5.20% 28.49% 0.26% 57.29% 1.73% 5.80% 100.00% 88.65% 5.88% 5.47% 100.00%

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

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

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

709 30 234 31 1,859 223 3,079 6,165 37,946

6.82% 0.29% 2.25% 7.33% 17.88% 2.14% 29.61% 59.30% 21.47%

11.50% 0.49% 3.80% 13.90% 30.15% 3.62% 49.94% 100.00% 44.48%

93.41% 71.43% 52.47% 68.89% 50.70% 52.72% 61.40% 59.30% 51.35%

49 12 212 14 1,804 199 1,924 4,214 33,370

0.47% 0.12% 2.04% 3.31% 17.35% 1.91% 18.51% 40.53% 18.88%

1.16% 0.28% 5.03% 7.04% 42.81% 4.72% 45.66% 100.00% 38.45%

6.46% 28.57% 47.53% 31.11% 49.20% 47.04% 38.36% 40.53% 45.16%

1 0 0 0 4 1 12 18 2,585

0.01% 0.00% 0.00% 0.00% 0.04% 0.01% 0.12% 0.17% 1.46%

5.56% 0.00% 0.00% 0.00% 22.22% 5.56% 66.67% 100.00% 55.99%

0.13% 0.00% 0.00% 0.00% 0.11% 0.24% 0.24% 0.17% 3.50%

759 42 446 45 3,667 423 5,015 10,397 73,901

7.30% 0.40% 4.29% 10.64% 35.27% 4.07% 48.24% 100.00% 41.82%

7.30% 0.40% 4.29% 10.64% 35.27% 4.07% 48.24% 100.00% 41.82%

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

Total of All Subjects by Race

Female 

Male 

Unknown 

TOTAL

Female

Male

Unknown

Total

Table 2A. Aggregate Enrollment Data for Extramural and Intramural Phase III Research Protocols Funded in FY2004 and Reported in 

FY2005: Percent Analysis

Number of Protocols with 

Enrollment Data: 

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

Total Number of Protocols 

with Enrollment Data: 

110
210

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

885 9,930 23,422 12,832 155,978 2,627 205,674 47,069

0.28% 3.14% 7.41% 4.06% 49.32% 0.83% 65.03% 14.88%

0.43% 4.83% 11.39% 6.24% 75.84% 1.28% 100.00% 22.89%

67.10% 55.98% 59.44% 58.78% 67.38% 58.29% 65.03% 58.62%

433 7,810 15,979 8,997 75,505 1,785 110,509 33,219

0.14% 2.47% 5.05% 2.84% 23.87% 0.56% 34.94% 10.50%

0.39% 7.07% 14.46% 8.14% 68.32% 1.62% 100.00% 30.06%

32.83% 44.02% 40.55% 41.22% 32.62% 39.61% 34.94% 41.37%

1 0 1 0 9 95 106 2

0.000% 0.00% 0.00% 0.00% 0.00% 0.03% 0.03% 0.00%

0.94% 0.00% 0.94% 0.00% 8.49% 89.62% 100.00% 1.89%

0.08% 0.00% 0.00% 0.00% 0.00% 2.11% 0.03% 0.00%

1,319 17,740 39,402 21,829 231,492 4,507 316,289 80,290

0.42% 5.61% 12.46% 6.90% 73.19% 1.42% 100.00% 25.39%

0.42% 5.61% 12.46% 6.90% 73.19% 1.42% 100.00% 25.39%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in extramural Phase III research protocols reported in FY2005. 

More females (290,977 or 59%) than males (197,300 or 40%) are enrolled in aggregate extramural and intramural Phase III research protocols. 

More minority females (85,015 or 55.1%) than minority males (66,589 or 43.2%) are enrolled in aggregate extramural and intramural Phase III research protocols. 

Minority: 

Approximately 30% (139,456) of participants in aggregate extramural Phase III research (465,956) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 73.2% following the 1977 OMB standards and 57.3% following the 1997 OMB standards.

Largest identified racial minority group is Black at 12.5% following the 1977 OMB standards and 28.5% following the 1997 OMB standards.

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

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0.3%.

Ethnicity: 

5.8% 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 White at 35.3%

Smallest identified racial group is Asian at 0.4%

Of the 10,397 participants, 59.3% are women and 40.5% are men. 

6.9% of participants identified as Hispanic according to the 1977 OMB standards. 

111

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)

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

Male

Unknown

Total

Legend

Number of Protocols with 

Enrollment Data: 

Female
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 8,558,998 3,459,235 40.42% 8,763

% 62.10% 59.30%

Males 4,961,653 2,337,451 47.11%

% 36.00% 40.07%

Unknown 261,548 36,591 13.99%

% 1.90% 0.63%

TOTAL 13,782,199 5,833,277 42.32%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 7,710

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

266,313 1,581,873 836,332 29,778 4,402,423 101,234 661,349 7,879,302 6,725,464 500,537 653,301 7,879,302

2.10% 12.46% 6.59% 0.23% 34.68% 0.80% 5.21% 62.07% 52.98% 3.94% 5.15% 62.07%

3.38% 20.08% 10.61% 0.38% 55.87% 1.28% 8.39% 100.00% 85.36% 6.35% 8.29% 100.00%

92.48% 52.52% 63.83% 57.99% 64.75% 58.59% 62.34% 62.07% 62.09% 66.51% 58.86% 62.07%

20,940 1,423,812 453,090 20,605 2,252,000 70,444 319,035 4,559,926 3,939,661 245,060 375,205 4,559,926

0.16% 11.22% 3.57% 0.16% 17.74% 0.55% 2.51% 35.92% 31.04% 1.93% 2.96% 35.92%

0.46% 31.22% 9.94% 0.45% 49.39% 1.54% 7.00% 100.00% 86.40% 5.37% 8.23% 100.00%

7.27% 47.27% 34.58% 40.13% 33.12% 40.77% 30.07% 35.92% 36.37% 32.57% 33.80% 35.92%

718 6,470 20,728 969 144,278 1,108 80,503 254,774 166,373 6,927 81,474 254,774

0.01% 0.05% 0.16% 0.01% 1.14% 0.01% 0.63% 2.01% 1.31% 0.05% 0.64% 2.01%

0.28% 2.54% 8.14% 0.38% 56.63% 0.43% 31.60% 100.00% 65.30% 2.72% 31.98% 100.00%

0.25% 0.21% 1.58% 1.89% 2.12% 0.64% 7.59% 2.01% 1.54% 0.92% 7.34% 2.01%

287,971 3,012,155 1,310,150 51,352 6,798,701 172,786 1,060,887 12,694,002 10,831,498 752,524 1,109,980 12,694,002

2.27% 23.73% 10.32% 0.40% 53.56% 1.36% 8.36% 100.00% 85.33% 5.93% 8.74% 100.00%

2.27% 23.73% 10.32% 0.40% 53.56% 1.36% 8.36% 100.00% 85.33% 5.93% 8.74% 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 

American 

Indian/ 

Alaska 

Native

Asian

Black or 

African 

American

Hawaiian 

/Pacific 

Islander

White More Than 

One Race

Unknown 

/Other Total

Using US 

Minority 

Categories 

Female 18,231 5,666 12,192 1,251 267,973 27,818 167,406 500,537 3,250,909

% 2.42% 0.75% 1.62% 2.57% 35.61% 3.70% 22.25% 66.51% 25.61%

3.64% 1.13% 2.44% 4.50% 53.54% 5.56% 33.45% 100.00% 41.26%

80.26% 72.77% 62.86% 63.89% 69.05% 57.24% 63.41% 66.51% 59.25%

Male 4,343 2,059 7,044 658 116,900 20,029 94,027 245,060 2,199,818

% 0.58% 0.27% 0.94% 1.35% 15.53% 2.66% 12.49% 32.57% 17.33%

1.77% 0.84% 2.87% 3.29% 47.70% 8.17% 38.37% 100.00% 48.24%

19.12% 26.44% 36.31% 33.61% 30.12% 41.21% 35.62% 32.57% 40.10%

Unknown 141 61 161 49 3,199 756 2,560 6,927 35,752

% 0.02% 0.01% 0.02% 0.10% 0.43% 0.10% 0.34% 0.92% 0.28%

2.04% 0.88% 2.32% 6.48% 46.18% 10.91% 36.96% 100.00% 14.03%

0.62% 0.78% 0.83% 2.50% 0.82% 1.56% 0.97% 0.92% 0.65%

TOTAL 22,715 7,786 19,397 1,958 388,072 48,603 263,993 752,524 5,486,479

% 3.02% 1.03% 2.58% 4.03% 51.57% 6.46% 35.08% 100.00% 43.22%

3.02% 1.03% 2.58% 4.03% 51.57% 6.46% 35.08% 100.00% 43.22%

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

Unknown

Total

Table 3A. Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis

Total Number of Protocols with 

Enrollment Data: 

Male

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Ethnicity

Female

Total of All Subjects by Race

Total of All Subjects by Race

112
1,053

American 

Indian/ 

Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

3,084 54,240 98,598 52,404 452,596 18,774 679,696 208,326

0.28% 4.98% 9.06% 4.82% 41.59% 1.73% 62.46% 19.14%

0.45% 7.98% 14.51% 7.71% 66.59% 2.76% 100.00% 30.65%

58.84% 60.31% 61.49% 57.40% 64.24% 50.98% 62.46% 60.07%

2,042 35,517 61,487 38,587 249,418 14,676 401,727 137,633

0.19% 3.26% 5.65% 3.55% 22.92% 1.35% 36.92% 12.65%

0.51% 8.84% 15.31% 9.61% 62.09% 3.65% 100.00% 34.26%

38.96% 39.49% 38.35% 42.27% 35.40% 39.85% 36.92% 39.69%

115 175 250 299 2,561 3,374 6,774 839

0.011% 0.02% 0.02% 0.03% 0.24% 0.31% 0.62% 0.08%

1.70% 2.58% 3.69% 4.41% 37.81% 49.81% 100.00% 12.39%

2.19% 0.19% 0.16% 0.33% 0.36% 9.16% 0.62% 0.24%

5,241 89,932 160,335 91,290 704,575 36,824 1,088,197 346,798

0.48% 8.26% 14.73% 8.39% 64.75% 3.38% 100.00% 31.87%

0.48% 8.26% 14.73% 8.39% 64.75% 3.38% 100.00% 31.87%

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

Data Table Comments: 

Sex/Gender: 

More females (8,558,998 or 62.1%) than males (4,961,653 or 36%) are enrolled in aggregate extramural research protocols. 

More minority females (3,459,235 or 59.3%) than minority males (2,337,451 or 40%) are enrolled in aggregate extramural research protocols. 

Minority:

Approximately 42.3% (5,833,277) of participants in aggregate extramural research (13,782,199) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 64.8% following the 1977 OMB standards and 53.6% following the 1997 OMB standards.

Largest identified racial minority group is Black at 14.7% following the 1977 OMB standards and 23.7% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.5%.

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

Ethnicity: 

5.9% 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 51.5% 

Smallest identified racial group is Asian at 1%

Of the 752,524 participants, 66.5% are women and 32.5% are men. 

8.4% of participants identified as Hispanic according to the 1977 OMB standards. 

113

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Legend

Female

Male

Unknown

Total

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 5,354,950 2,451,014 45.77% 7,108

% 51.93% 51.94%

Males 4,694,564 2,231,374 47.53%

% 45.53% 47.29%

Unknown 261,548 36,591 13.99%

% 2.54% 0.78%

TOTAL 10,311,062 4,718,979 45.77%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 6,243

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

23,366 1,359,742 575,979 23,622 2,561,178 78,066 313,628 4,935,581 4,366,027 267,900 301,754 4,935,681

0.25% 14.28% 6.05% 0.25% 26.90% 0.82% 3.29% 51.83% 45.85% 2.81% 3.17% 51.83%

0.47% 27.55% 11.67% 0.48% 51.89% 1.58% 6.35% 100.00% 88.46% 5.43% 6.11% 100.00%

52.26% 49.99% 55.90% 52.36% 52.49% 52.62% 47.98% 51.83% 52.53% 52.18% 43.24% 51.83%

20,629 1,353,932 433,581 20,520 2,174,357 69,171 259,570 4,331,760 3,778,566 238,565 314,629 4,331,760

0.22% 14.22% 4.55% 0.22% 22.83% 0.73% 2.73% 45.49% 39.68% 2.51% 3.30% 45.49%

0.48% 31.26% 10.01% 0.47% 50.20% 1.60% 5.99% 100.00% 87.23% 5.51% 7.26% 100.00%

46.14% 49.77% 42.08% 45.49% 44.56% 46.63% 39.71% 45.49% 45.46% 46.47% 45.09% 45.49%

718 6,470 20,728 969 144,278 1,108 80,503 254,774 166,373 6,927 81,474 254,774

0.01% 0.07% 0.22% 0.01% 1.52% 0.01% 0.85% 2.68% 1.75% 0.07% 0.86% 2.68%

0.28% 2.54% 8.14% 0.38% 56.63% 0.43% 31.60% 100.00% 65.30% 2.72% 31.98% 100.00%

1.61% 0.24% 2.01% 2.15% 2.96% 0.75% 12.31% 2.68% 2.00% 1.35% 11.67% 2.68%

44,713 2,720,144 1,030,288 45,111 4,879,813 148,345 653,701 9,522,115 8,310,966 513,392 697,857 9,522,215

0.47% 28.57% 10.82% 0.47% 51.25% 1.56% 6.87% 100.00% 87.28% 5.39% 7.33% 100.00%

0.47% 28.57% 10.82% 0.47% 51.25% 1.56% 6.87% 100.00% 87.28% 5.39% 7.33% 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 

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

4,016 1,921 7,623 667 121,270 22,199 110,204 267,900 2,292,249

0.78% 0.37% 1.48% 1.56% 23.62% 4.32% 21.47% 52.18% 24.07%

1.50% 0.72% 2.85% 3.00% 45.27% 8.29% 41.14% 100.00% 46.44%

48.02% 47.64% 52.04% 48.83% 50.95% 51.88% 53.97% 52.18% 51.73%

4,206 2,050 6,863 650 113,527 19,831 91,438 238,565 2,102,798

0.82% 0.40% 1.34% 1.52% 22.11% 3.86% 17.81% 46.47% 22.08%

1.76% 0.86% 2.88% 3.28% 47.59% 8.31% 38.33% 100.00% 48.54%

50.29% 50.84% 46.86% 47.58% 47.70% 46.35% 44.78% 46.47% 47.46%

141 61 161 49 3,199 756 2,560 6,927 35,752

0.03% 0.01% 0.03% 0.11% 0.62% 0.15% 0.50% 1.35% 0.38%

2.04% 0.88% 2.32% 6.48% 46.18% 10.91% 36.96% 100.00% 14.03%

1.69% 1.51% 1.10% 3.59% 1.34% 1.77% 1.25% 1.35% 0.81%

8,363 4,032 14,647 1,366 237,996 42,786 204,202 513,392 4,430,799

1.63% 0.79% 2.85% 3.19% 46.36% 8.33% 39.78% 100.00% 46.53%

1.63% 0.79% 2.85% 3.19% 46.36% 8.33% 39.78% 100.00% 46.53%

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

114

Total Number of Protocols 

with Enrollment Data: 

Male

Total of All Subjects by Race

Female 

Male 

Unknown 

TOTAL

Table 4A. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and Female-Only ProtocolsFunded in 

FY2004 and Reported in FY2005: Percent Analysis

Total

Total of All Subjects by Ethnicity

Unknown

Total of All Subjects by Race

Female
865

American 

Indian/ 

Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

2,052 41,279 72,665 42,769 244,940 15,664 419,369 158,765

0.26% 5.23% 9.21% 5.42% 31.05% 1.99% 53.16% 20.12%

0.49% 9.84% 17.33% 10.20% 58.41% 3.74% 100.00% 37.86%

50.48% 54.02% 56.55% 54.00% 52.36% 47.46% 53.16% 55.09%

1,898 34,955 55,583 36,140 220,262 13,966 362,804 128,576

0.24% 4.43% 7.05% 4.58% 27.92% 1.77% 45.99% 16.30%

0.52% 9.63% 15.32% 9.96% 60.71% 3.85% 100.00% 35.44%

46.69% 45.75% 43.26% 45.63% 47.09% 42.32% 45.99% 44.62%

115 175 250 299 2,561 3,374 6,774 839

0.015% 0.02% 0.03% 0.04% 0.32% 0.43% 0.86% 0.11%

1.70% 2.58% 3.69% 4.41% 37.81% 49.81% 100.00% 12.39%

2.83% 0.23% 0.19% 0.38% 0.55% 10.22% 0.86% 0.29%

4,065 76,409 128,498 79,208 467,763 33,004 788,947 288,180

0.52% 9.68% 16.29% 10.04% 59.29% 4.18% 100.00% 36.53%

0.52% 9.68% 16.29% 10.04% 59.29% 4.18% 100.00% 36.53%

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

Data Table Comments: 

Sex/Gender: 

Excluding sex-specific studies, the number of females (5,354,950 or 52%) exceeds the number of males (4,694,564 or 45.5%) enrolled in extramural research protocols. 

Excluding sex-specific studies, the number of minority females (2,451,014 or 52%) exceeds the number of males (2,231,374 or 47.3%) enrolled in extramural research protocols. 

Minority: 

Approximately 45.7% (4,718,979) of participants in aggregate extramural research excluding sex-specific studies (10,311,062) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 59.3% following the 1977 OMB standards and 51.3% following the 1997 OMB standards.

Largest identified racial minority group is Black at 16.3% following the 1977 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 28.6% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.5%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander and American Indian/Alaska Native at 0.5%.

Ethnicity: 

5.4% 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 White at 46.3%

Smallest identified racial group is Asian at 0.8%

Of the 204,202 participants, 52.2% are women and 46.5% are men. 

10% of participants identified as Hispanic according to the 1977 OMB standards. 

115

Number of Protocols with 

Enrollment Data: 

Female

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

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Male

Unknown

Total

Legend

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 277,315 77,657 28.00% 511

% 59.52% 55.69%

Males 183,918 59,212 32.19%

% 39.47% 42.46%

Unknown 4,723 2,587 54.77%

% 1.01% 1.86%

TOTAL 465,956 139,456 29.93%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 319

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

1,523 5,033 24,029 205 42,662 1,372 4,043 78,867 69,520 5,879 3,468 78,867

0.92% 3.04% 14.54% 0.12% 25.81% 0.83% 2.45% 47.71% 42.05% 3.56% 2.10% 47.71%

1.93% 6.38% 30.47% 0.26% 54.09% 1.74% 5.13% 100.00% 88.15% 7.45% 4.40% 100.00%

71.04% 55.95% 48.45% 44.47% 46.29% 53.08% 43.20% 47.71% 47.41% 59.44% 39.43% 47.71%

617 3,925 23,047 256 49,237 1,209 3,534 81,825 74,314 3,993 3,518 81,825

0.37% 2.37% 13.94% 0.15% 29.78% 0.73% 2.14% 49.50% 44.95% 2.42% 2.13% 49.50%

0.75% 4.80% 28.17% 0.31% 60.17% 1.48% 4.32% 100.00% 90.82% 4.88% 4.30% 100.00%

28.78% 43.63% 46.47% 55.53% 53.42% 46.77% 37.76% 49.50% 50.68% 40.37% 40.00% 49.50%

4 38 2,523 0 266 4 1,782 4,617 2,790 18 1,809 4,617

0.00% 0.02% 1.53% 0.00% 0.16% 0.00% 1.08% 2.79% 1.69% 0.01% 1.09% 2.79%

0.09% 0.82% 54.65% 0.00% 5.76% 0.09% 38.60% 100.00% 60.43% 0.39% 39.18% 100.00%

0.19% 0.42% 5.09% 0.00% 0.29% 0.15% 19.04% 2.79% 1.90% 0.18% 20.57% 2.79%

2,144 8,996 49,599 461 92,165 2,585 9,359 165,309 146,624 9,890 8,795 165,309

1.30% 5.44% 30.00% 0.28% 55.75% 1.56% 5.66% 100.00% 88.70% 5.98% 5.32% 100.00%

1.30% 5.44% 30.00% 0.28% 55.75% 1.56% 5.66% 100.00% 88.70% 5.98% 5.32% 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 

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

709 30 234 31 1,859 223 2,793 5,879 36,814

7.17% 0.30% 2.37% 7.33% 18.80% 2.25% 28.24% 59.44% 22.27%

12.06% 0.51% 3.98% 13.90% 31.62% 3.79% 47.51% 100.00% 46.68%

93.41% 71.43% 52.47% 68.89% 50.70% 52.72% 61.96% 59.44% 51.16%

49 12 212 14 1,804 199 1,703 3,993 32,561

0.50% 0.12% 2.14% 3.31% 18.24% 2.01% 17.22% 40.37% 19.70%

1.23% 0.30% 5.31% 7.04% 45.18% 4.98% 42.65% 100.00% 39.79%

6.46% 28.57% 47.53% 31.11% 49.20% 47.04% 37.78% 40.37% 45.25%

1 0 0 0 4 1 12 18 2,585

0.01% 0.00% 0.00% 0.00% 0.04% 0.01% 0.12% 0.18% 1.56%

5.56% 0.00% 0.00% 0.00% 22.22% 5.56% 66.67% 100.00% 55.99%

0.13% 0.00% 0.00% 0.00% 0.11% 0.24% 0.27% 0.18% 3.59%

759 42 446 45 3,667 423 4,508 9,890 71,960

7.67% 0.42% 4.51% 10.64% 37.08% 4.28% 45.58% 100.00% 43.53%

7.67% 0.42% 4.51% 10.64% 37.08% 4.28% 45.58% 100.00% 43.53%

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

116

Total Number of Protocols 

with Enrollment Data: 

Male

Total of All Subjects by Race

Female 

Male 

Unknown 

TOTAL

Table 5A. Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Total

Total of All Subjects by Ethnicity

Unknown

Total of All Subjects by Race

Female
192

American 

Indian/ 

Alaska Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

759 3,937 23,347 12,800 154,983 2,622 198,448 40,843

0.25% 1.31% 7.77% 4.26% 51.55% 0.87% 66.01% 13.59%

0.38% 1.98% 11.76% 6.45% 78.10% 1.32% 100.00% 20.58%

66.40% 72.54% 59.59% 58.86% 67.78% 58.37% 66.01% 60.51%

383 1,490 15,831 8,947 73,667 1,775 102,093 26,651

0.13% 0.50% 5.27% 2.98% 24.50% 0.59% 33.96% 8.86%

0.38% 1.46% 15.51% 8.76% 72.16% 1.74% 100.00% 26.10%

33.51% 27.46% 40.41% 41.14% 32.22% 39.51% 33.96% 39.49%

1 0 1 0 9 95 106 2

0.000% 0.00% 0.00% 0.00% 0.00% 0.03% 0.04% 0.00%

0.94% 0.00% 0.94% 0.00% 8.49% 89.62% 100.00% 1.89%

0.09% 0.00% 0.00% 0.00% 0.00% 2.11% 0.04% 0.00%

1,143 5,427 39,179 21,747 228,659 4,492 300,647 67,496

0.38% 1.81% 13.03% 7.23% 76.06% 1.49% 100.00% 22.45%

0.38% 1.81% 13.03% 7.23% 76.06% 1.49% 100.00% 22.45%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in extramural Phase III research protocols reported in FY2005. 

More females (277,315 or 59.5%) than males (183,918 or 39.5%) are enrolled in aggregate extramural Phase III research protocols. 

More minority females (77,657 or 55.7%) than minority males (59,212 or 42.5%) are enrolled in aggregate extramural Phase III research protocols. 

Minority:

Approximately 30% (139,456) of participants in aggregate extramural Phase III research (465,956) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 76% following the 1977 OMB standards and 55.75% following the 1997 OMB standards.

Largest identified racial minority group is Black at 13% following the 1977 OMB standards and 30% following the 1997 OMB standards.

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

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0.3%.

Ethnicity: 

6% 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 37.8%

Smallest identified racial group is Asian at 0.4%

Of the 9,890 participants, 59.4% are women and 40.4% are men. 

7.2% of participants identified as Hispanic according to the 1977 OMB standards. 

117

Number of Protocols with 

Enrollment Data: 

Female

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

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Male

Unknown

Total

Legend

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 119,987 49,235 41.03% 355

% 47.52% 50.07%

Males 127,773 46,515 36.40%

% 50.61% 47.30%

Unknown 4,723 2,587 54.77%

% 1.87% 2.63%

TOTAL 252,483 98,337 38.95%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 227

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

1,160 2,620 20,752 138 26,391 1,002 1,602 53,665 47,985 3,070 2,610 53,665

0.96% 2.16% 17.14% 0.11% 21.80% 0.83% 1.32% 44.33% 39.64% 2.54% 2.16% 44.33%

2.16% 4.88% 38.67% 0.26% 49.18% 1.87% 2.99% 100.00% 89.42% 5.72% 4.86% 100.00%

65.72% 44.84% 47.63% 36.80% 43.15% 46.35% 25.91% 44.33% 44.88% 46.17% 34.85% 44.33%

601 3,185 20,291 237 34,505 1,156 2,798 62,773 56,140 3,562 3,071 62,773

0.50% 2.63% 16.76% 0.20% 28.50% 0.95% 2.31% 51.85% 46.38% 2.94% 2.54% 51.85%

0.96% 5.07% 32.32% 0.38% 54.97% 1.84% 4.46% 100.00% 89.43% 5.67% 4.89% 100.00%

34.05% 54.51% 46.58% 63.20% 56.42% 53.47% 45.26% 51.85% 52.51% 53.56% 41.00% 51.85%

4 38 2,523 0 266 4 1,782 4,617 2,790 18 1,809 4,617

0.00% 0.03% 2.08% 0.00% 0.22% 0.00% 1.47% 3.81% 2.30% 0.01% 1.49% 3.81%

0.09% 0.82% 54.65% 0.00% 5.76% 0.09% 38.60% 100.00% 60.43% 0.39% 39.18% 100.00%

0.23% 0.65% 5.79% 0.00% 0.43% 0.19% 28.83% 3.81% 2.61% 0.27% 24.15% 3.81%

1,765 5,843 43,566 375 61,162 2,162 6,182 121,055 106,915 6,650 7,490 121,055

1.46% 4.83% 35.99% 0.31% 50.52% 1.79% 5.11% 100.00% 88.32% 5.49% 6.19% 100.00%

1.46% 4.83% 35.99% 0.31% 50.52% 1.79% 5.11% 100.00% 88.32% 5.49% 6.19% 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 

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

410 14 130 19 1,404 139 954 3,070 28,030

6.17% 0.21% 1.95% 5.62% 21.11% 2.09% 14.35% 46.17% 23.15%

13.36% 0.46% 4.23% 13.67% 45.73% 4.53% 31.07% 100.00% 52.23%

89.32% 53.85% 38.35% 57.58% 44.60% 41.12% 41.35% 46.17% 47.38%

48 12 209 14 1,740 198 1,341 3,562 28,551

0.72% 0.18% 3.14% 4.14% 26.17% 2.98% 20.17% 53.56% 23.59%

1.35% 0.34% 5.87% 7.07% 48.85% 5.56% 37.65% 100.00% 45.48%

10.46% 46.15% 61.65% 42.42% 55.27% 58.58% 58.13% 53.56% 48.26%

1 0 0 0 4 1 12 18 2,585

0.02% 0.00% 0.00% 0.00% 0.06% 0.02% 0.18% 0.27% 2.14%

5.56% 0.00% 0.00% 0.00% 22.22% 5.56% 66.67% 100.00% 55.99%

0.22% 0.00% 0.00% 0.00% 0.13% 0.30% 0.52% 0.27% 4.37%

459 26 339 33 3,148 338 2,307 6,650 59,166

6.90% 0.39% 5.10% 9.76% 47.34% 5.08% 34.69% 100.00% 48.88%

6.90% 0.39% 5.10% 9.76% 47.34% 5.08% 34.69% 100.00% 48.88%

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

118

Total Number of Protocols 

with Enrollment Data: 

Male

Total of All Subjects by Race

Female 

Male 

Unknown 

TOTAL

Table 6A. Aggregate Enrollment Data for Extramural Phase III Protocols, Excluding Male-Only and Female-Only Protocols Funded in FY2004 

and Reported in FY2005: Percent Analysis

Total

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Ethnicity

Unknown

Total of All Subjects by Race

Female
128

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

219 1,125 11,852 8,009 44,069 1,048 66,322 21,205

0.17% 0.86% 9.02% 6.09% 33.53% 0.80% 50.46% 16.13%

0.33% 1.70% 17.87% 12.08% 66.45% 1.58% 100.00% 31.97%

47.00% 52.45% 53.87% 55.01% 48.95% 47.14% 50.46% 54.13%

246 1,020 10,149 6,549 45,956 1,080 65,000 17,964

0.19% 0.78% 7.72% 4.98% 34.97% 0.82% 49.46% 13.67%

0.38% 1.57% 15.61% 10.08% 70.70% 1.66% 100.00% 27.64%

52.79% 47.55% 46.13% 44.99% 51.04% 48.58% 49.46% 45.86%

1 0 1 0 9 95 106 2

0.001% 0.00% 0.00% 0.00% 0.01% 0.07% 0.08% 0.00%

0.94% 0.00% 0.94% 0.00% 8.49% 89.62% 100.00% 1.89%

0.21% 0.00% 0.00% 0.00% 0.01% 4.27% 0.08% 0.01%

466 2,145 22,002 14,558 90,034 2,223 131,428 39,171

0.35% 1.63% 16.74% 11.08% 68.50% 1.69% 100.00% 29.80%

0.35% 1.63% 16.74% 11.08% 68.50% 1.69% 100.00% 29.80%

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

Data Table Comments: 

Sex/Gender: 

Excluding sex-specific studies, the number of females (119,987or 47.5%) exceeds the number of males(127,773 or 50.6%)enrolled in extramural Phase III research protocols. 

Excluding sex-specific studies, the number of minority females (49,235or 50.7%) exceeds the number of male (46,515 or 47.3%) enrolled in extramural Phase III research protocols. 

Minority: 

Approximately 38.9% (98,337) of participants in aggregate extramural Phase III research excluding sex-specific studies (252,483) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 68.5% following the 1977 OMB standards and 50.5% following the 1997 OMB standards.

Largest identified racial minority group is Black at 16.7% following the 1977 OMB standards and 36% following the 1997 OMB standards.

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

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.3%.

Ethnicity: 

5.5% 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 47.3%

Smallest identified racial group is Asian at 0.4%

Of the 6,650 participants, 46.2% are women and 53.5% are men. 

11% of participants identified as Hispanic according to the 1977 OMB standards. 

119

Number of Protocols with 

Enrollment Data: 

Female

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

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Male

Unknown

Total

Legend

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 944,924 255,053 26.99% 1,470

% 48.69% 62.34%

Males 980,254 153,341 15.64%

% 50.51% 37.48%

Unknown 15,375 765 4.98%

% 0.79% 0.19%

TOTAL 1,940,553 409,159 21.08%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 737

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

2,851 16,907 26,811 712 434,744 8,502 22,295 512,822 489,123 11,194 12,505 512,822

0.28% 1.67% 2.64% 0.07% 42.84% 0.84% 2.20% 50.54% 48.06% 1.10% 1.23% 50.39%

0.56% 3.30% 5.23% 0.14% 84.77% 1.66% 4.35% 100.00% 95.38% 2.18% 2.44% 100.00%

67.18% 54.16% 55.73% 36.81% 49.73% 83.62% 49.73% 50.54% 50.29% 52.27% 52.95% 50.39%

1,393 14,308 21,296 1,222 439,434 1,665 19,277 498,595 481,658 10,220 9,717 501,595

0.14% 1.41% 2.10% 0.12% 43.31% 0.16% 1.90% 49.14% 47.33% 1.00% 0.95% 49.29%

0.28% 2.87% 4.27% 0.25% 88.13% 0.33% 3.87% 100.00% 96.03% 2.04% 1.94% 100.00%

32.82% 45.84% 44.26% 63.19% 50.27% 16.38% 43.00% 49.14% 49.52% 47.72% 41.15% 49.29%

0 0 5 0 11 0 3,263 3,279 1,885 1 1,393 3,279

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.32% 0.32% 0.19% 0.00% 0.14% 0.32%

0.00% 0.00% 0.15% 0.00% 0.34% 0.00% 99.51% 100.00% 57.49% 0.03% 42.48% 100.00%

0.00% 0.00% 0.01% 0.00% 0.00% 0.00% 7.28% 0.32% 0.19% 0.00% 5.90% 0.32%

4,244 31,215 48,112 1,934 874,189 10,167 44,835 1,014,696 972,666 21,415 23,615 1,017,696

0.42% 3.08% 4.74% 0.19% 86.15% 1.00% 4.42% 100.00% 95.58% 2.10% 2.32% 100.00%

0.42% 3.08% 4.74% 0.19% 86.15% 1.00% 4.42% 100.00% 95.58% 2.10% 2.32% 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 

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

13 27 32 22 692 1,317 9,091 11,194 65,566

0.06% 0.13% 0.15% 0.86% 3.23% 6.15% 42.45% 52.27% 6.46%

0.12% 0.24% 0.29% 1.67% 6.18% 11.77% 81.21% 100.00% 12.79%

54.17% 90.00% 65.31% 95.65% 86.93% 51.37% 50.71% 52.27% 57.31%

11 3 17 1 104 1,247 8,837 10,220 48,825

0.05% 0.01% 0.08% 0.04% 0.49% 5.82% 41.27% 47.72% 4.81%

0.11% 0.03% 0.17% 0.08% 1.02% 12.20% 86.47% 100.00% 9.79%

45.83% 10.00% 34.69% 4.35% 13.07% 48.63% 49.29% 47.72% 42.68%

0 0 00 0 0 1 1 6

0.00% 0.00% 0.00% 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% 100.00% 0.18%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 0.01%

24 30 49 23 796 2,564 17,929 21,415 114,397

0.11% 0.14% 0.23% 0.90% 3.72% 11.97% 83.72% 100.00% 11.27%

0.11% 0.14% 0.23% 0.90% 3.72% 11.97% 83.72% 100.00% 11.27%

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

120

Unknown 

TOTAL

Total of All Subjects by Race

Female 

Male 

Male

Table 7A. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent Analysis

Total

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Ethnicity

Unknown

Total of All Subjects by Race

Total Number of 

Protocols with 

Enrollment Data: 

Female
733

American 

Indian/ 

Alaska Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

8,753 116,151 34,208 30,375 225,228 17,387 432,102 189,487

0.95% 12.59% 3.71% 3.29% 24.41% 1.88% 46.82% 20.53%

2.03% 26.88% 7.92% 7.03% 52.12% 4.02% 100.00% 43.85%

51.09% 70.54% 49.38% 69.54% 40.04% 26.51% 46.82% 64.28%

8,380 48,478 35,060 12,598 334,876 39,267 478,659 104,516

0.91% 5.25% 3.80% 1.37% 36.29% 4.25% 51.87% 11.33%

1.75% 10.13% 7.32% 2.63% 69.96% 8.20% 100.00% 21.84%

48.91% 29.44% 50.61% 28.84% 59.53% 59.88% 51.87% 35.46%

1 37 12 709 2,410 8,927 12,096 759

0.000% 0.00% 0.00% 0.08% 0.26% 0.97% 1.31% 0.08%

0.01% 0.31% 0.10% 5.86% 19.92% 73.80% 100.00% 6.27%

0.01% 0.02% 0.02% 1.62% 0.43% 13.61% 1.31% 0.26%

17,134 164,666 69,280 43,682 562,514 65,581 922,857 294,762

1.86% 17.84% 7.51% 4.73% 60.95% 7.11% 100.00% 31.94%

1.86% 17.84% 7.51% 4.73% 60.95% 7.11% 100.00% 31.94%

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

Data Table Comments: 

Sex/Gender: 

More males (980,254 or 50.5%) than females (944,924 or 48.7%) are enrolled in aggregate intramural research protocols. 

In contrast, more minority females (255,053 or 62.3%) than minority males (153,341 or 37.5%) are enrolled in aggregate intramural research protocols. 

Minority: 

Approximately 21% (409,159) of participants in aggregate intramural research (1,940,553) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 61% following the 1977 OMB standards and 86.2% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 17.8% following the 1977 OMB standards.

Largest identifiec racial minority group is Black at 4.7% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0.9%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0.2%.

Ethnicity: 

2.1% 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/Other at 83.72% 

Smallest identified racial group is American Indian/Alaskan Native at 0.1%

Of the 21,415 participants, 52.3% are women and 47.7% are men. 

4.7% of participants identified as Hispanic according to the 1977 OMB standards. 

121

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

Number of Protocols with 

Enrollment Data: 

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Legend

Female

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Male

Unknown

Total
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 679,277 135,432 19.94% 1,240

% 41.82% 46.51%

Males 929,621 154,995 16.67%

% 57.23% 53.23%

Unknown 15,375 765 4.98%

% 0.95% 0.26%

TOTAL 1,624,273 291,192 17.93%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 594

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

1,579 15,435 24,797 675 309,106 1,737 15,099 368,428 352,745 7,770 7,913 368,428

0.21% 2.07% 3.32% 0.09% 41.41% 0.23% 2.02% 49.36% 41.67% 0.92% 0.93% 43.53%

0.43% 4.19% 6.73% 0.18% 83.90% 0.47% 4.10% 100.00% 95.74% 2.11% 2.15% 100.00%

53.15% 47.30% 54.21% 35.64% 49.66% 51.06% 40.48% 49.36% 43.56% 43.62% 41.96% 43.53%

1,392 17,198 20,940 1,219 313,382 1,665 18,936 374,732 455,138 10,042 9,552 474,732

0.19% 2.30% 2.81% 0.16% 41.98% 0.22% 2.54% 50.20% 53.77% 1.19% 1.13% 56.09%

0.37% 4.59% 5.59% 0.33% 83.63% 0.44% 5.05% 100.00% 95.87% 2.12% 2.01% 100.00%

46.85% 52.70% 45.78% 64.36% 50.34% 48.94% 50.77% 50.20% 56.21% 56.37% 50.65% 56.09%

0 0 5 0 11 0 3,263 3,279 1,885 1 1,393 3,279

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.44% 0.44% 0.22% 0.00% 0.16% 0.39%

0.00% 0.00% 0.15% 0.00% 0.34% 0.00% 99.51% 100.00% 57.49% 0.03% 42.48% 100.00%

0.00% 0.00% 0.01% 0.00% 0.00% 0.00% 8.75% 0.44% 0.23% 0.01% 7.39% 0.39%

2,971 32,633 45,742 1,894 622,499 3,402 37,298 746,439 809,768 17,813 18,858 846,439

0.40% 4.37% 6.13% 0.25% 83.40% 0.46% 5.00% 100.00% 95.67% 2.10% 2.23% 100.00%

0.40% 4.37% 6.13% 0.25% 83.40% 0.46% 5.00% 100.00% 95.67% 2.10% 2.23% 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 

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

7 2 9 1 94 1,294 6,363 7,770 50,680

0.04% 0.01% 0.05% 0.04% 0.53% 7.26% 35.72% 43.62% 6.79%

0.09% 0.03% 0.12% 0.08% 1.21% 16.65% 81.89% 100.00% 13.76%

38.89% 40.00% 34.62% 50.00% 47.47% 50.92% 42.36% 43.62% 49.75%

1.00%

11 3 17 1 104 1,247 8,659 10,042 51,177

0.06% 0.02% 0.10% 0.04% 0.58% 7.00% 48.61% 56.37% 6.86%

0.11% 0.03% 0.17% 0.08% 1.04% 12.42% 86.23% 100.00% 13.66%

61.11% 60.00% 65.38% 50.00% 52.53% 49.08% 57.64% 56.37% 50.24%

0 0 00 0 0 1 1 6

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% 100.00% 100.00% 0.18%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.01%

18 5 26 2 198 2,541 15,023 17,813 101,863

0.10% 0.03% 0.15% 0.08% 1.11% 14.26% 84.34% 100.00% 13.65%

0.10% 0.03% 0.15% 0.08% 1.11% 14.26% 84.34% 100.00% 13.65%

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

122

Female

Total Number of Protocols 

with Enrollment Data: 

Male

Female 

Male 

Unknown 

Unknown

Table 8A. Aggregate Enrollment Data for Intramural Research Protocols Excluding Male-Only and Female-Only Protocols Funded in FY2004 

and Reported in FY2005: Percent Analysis

Number of Protocols with 

Enrollment Data: 

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

Total

Total of All Subjects by Race

TOTAL
646

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

8,739 39,190 29,011 7,812 212,728 13,369 310,849 84,752

1.12% 5.04% 3.73% 1.00% 27.35% 1.72% 39.96% 10.90%

2.81% 12.61% 9.33% 2.51% 68.43% 4.30% 100.00% 27.26%

51.05% 44.69% 45.75% 37.02% 38.73% 34.05% 39.96% 44.76%

8,379 48,471 34,386 12,582 334,104 16,967 454,889 103,818

1.08% 6.23% 4.42% 1.62% 42.95% 2.18% 58.48% 13.35%

1.84% 10.66% 7.56% 2.77% 73.45% 3.73% 100.00% 22.82%

48.95% 55.27% 54.23% 59.62% 60.83% 43.21% 58.48% 54.83%

1 37 12 709 2,410 8,927 12,096 759

0.000% 0.00% 0.00% 0.09% 0.31% 1.15% 1.56% 0.10%

0.01% 0.31% 0.10% 5.86% 19.92% 73.80% 100.00% 6.27%

0.01% 0.04% 0.02% 3.36% 0.44% 22.74% 1.56% 0.40%

17,119 87,698 63,409 21,103 549,242 39,263 777,834 189,329

2.20% 11.27% 8.15% 2.71% 70.61% 5.05% 100.00% 24.34%

2.20% 11.27% 8.15% 2.71% 70.61% 5.05% 100.00% 24.34%

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

Data Table Comments: 

Sex/Gender: 

Excluding sex-specific studies, the number of males (929,621 or 57.2%) exceeds the number of females (679,277 or 41.8%) enrolled in intramural research protocols. 

Excluding sex-specific studies, the number of minority males (154,995 or 53.2%) exceeds the number of females (135,432 or 47.5%) enrolled in intramural research protocols. 

Minority: 

Approximately 18% (291,192) of participants in aggregate intramural research excluding sex-specific studies (1,624,273) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 70.6% following the 1977 OMB standards and 83.4% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 11.3% following the 1977 OMB standards.

Largest identified racial minority group is Blacks at 6.1% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native at 2.2%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.3%.

Ethnicity: 

2.1% 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/Other at 84.3% 

Smallest identified racial group is Asian at 0.10%

Of the 17,813 participants, 43.6% are women and 56.4% are men. 

2.7% of participants identified as Hispanic according to the 1977 OMB standards. 

123

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

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

Number of Protocols with 

Enrollment Data: 

Female
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 13,662 7,358 53.86% 36

% 50.52% 49.87%

Males 13,382 7,377 55.13%

% 49.48% 50.00%

Unknown 0 0 0%

% 0.00% 0.00%

TOTAL 27,044 14,753 54.55%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 18

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

8 89 483 1 5,166 265 424 6,436 5,746 286 404 6,436

0.07% 0.78% 4.24% 0.01% 45.31% 2.32% 3.72% 56.45% 50.39% 2.51% 3.54% 56.45%

0.12% 1.38% 7.50% 0.02% 80.27% 4.12% 6.59% 100.00% 89.28% 4.44% 6.28% 100.00%

40.00% 45.41% 65.36% 100.00% 56.94% 55.44% 47.37% 56.45% 57.31% 56.41% 46.49% 56.45%

12 107 256 0 3,907 213 471 4,966 4,280 221 465 4,966

0.11% 0.94% 2.25% 0.00% 34.27% 1.87% 4.13% 43.55% 37.54% 1.94% 4.08% 43.55%

0.24% 2.15% 5.16% 0.00% 78.67% 4.29% 9.48% 100.00% 86.19% 4.45% 9.36% 100.00%

60.00% 54.59% 34.64% 0.00% 43.06% 44.56% 52.63% 43.55% 42.69% 43.59% 53.51% 43.55%

0 0 00 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%

20 196 739 1 9,073 478 895 11,402 10,026 507 869 11,402

0.18% 1.72% 6.48% 0.01% 79.57% 4.19% 7.85% 100.00% 87.93% 4.45% 7.62% 100.00%

0.18% 1.72% 6.48% 0.01% 79.57% 4.19% 7.85% 100.00% 87.93% 4.45% 7.62% 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 

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

0 0 0 0 0 0 286 286 1,132

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.41% 56.41% 9.93%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.59%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.41% 56.41% 58.32%

0 0 0 0 0 0 221 221 809

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.59% 43.59% 7.10%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 16.29%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.59% 43.59% 41.68%

0 0 00 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 0 0 0 0 0 507 507 1,941

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.02%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.02%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00%

124

Female

TOTAL

Total Number of 

Protocols with 

Enrollment Data: 

Male

Unknown

Table 9A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Number of Protocols with 

Enrollment Data: 

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

Total

Total of All Subjects by Race

Female 

Male 

Unknown 
18

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): OLD 

FORM 

126 5,993 75 32 995 5 7,226 6,226

0.81% 38.31% 0.48% 0.20% 6.36% 0.03% 46.20% 39.80%

1.74% 82.94% 1.04% 0.44% 13.77% 0.07% 100.00% 86.16%

71.59% 48.67% 33.63% 39.02% 35.12% 33.33% 46.20% 48.66%

50 6,320 148 50 1,838 10 8,416 6,568

0.32% 40.40% 0.95% 0.32% 11.75% 0.06% 53.80% 41.99%

0.59% 75.10% 1.76% 0.59% 21.84% 0.12% 100.00% 78.04%

28.41% 51.33% 66.37% 60.98% 64.88% 66.67% 53.80% 51.34%

0 0 00 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%

176 12,313 223 82 2,833 15 15,642 12,794

1.13% 78.72% 1.43% 0.52% 18.11% 0.10% 100.00% 81.79%

1.13% 78.72% 1.43% 0.52% 18.11% 0.10% 100.00% 81.79%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in intramural Phase III research protocols reported in FY2005. 

More males (13,382 or 49.4%) than females (13,662 or 50.5%) are enrolled in aggregate intramural Phase III research protocols. 

More minority males (7,377 or 50%) than minority females (7,358 or 49.9%) are enrolled in aggregate intramural Phase III research protocols. 

Minority: 

Approximately 54.5% (14,735) of participants in aggregate intramural Phase III research (27,044) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 18% following the 1977 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 78.7% following the 1977 OMB standards.

Largest identified racial minority group is Black at 79.6% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is Hispanic at 0.5%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.1%.

Ethnicity: 

4.5% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

All participants identified their racial category as Unknown/Other (100%)

Of the 507 participants, 56.4% are women and 43.6% are men. 

0.5% of participants identified as Hispanic according to the 1977 OMB standards. 

125

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

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

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)

Male

Number of Protocols with 

Enrollment Data: 

Legend

Female
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 13,661 7,358 53.86% 31

% 50.60% 49.97%

Males 13,336 7,368 55.25%

% 49.40% 50.03%

Unknown 0 0 0%

% 0.00% 0.00%

TOTAL 26,997 14,726 54.55%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 14

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

8 89 483 1 5,165 265 424 6,435 5,745 286 404 6,435

0.07% 0.78% 4.24% 0.01% 45.39% 2.33% 3.73% 56.55% 50.48% 2.51% 3.55% 56.55%

0.12% 1.38% 7.51% 0.02% 80.26% 4.12% 6.59% 100.00% 89.28% 4.44% 6.28% 100.00%

40.00% 45.41% 65.36% 100.00% 57.05% 55.44% 47.48% 56.55% 57.42% 56.52% 46.54% 56.55%

12 107 256 0 3,888 213 469 4,945 4,261 220 464 4,945

0.11% 0.94% 2.25% 0.00% 34.17% 1.87% 4.12% 43.45% 37.44% 1.93% 4.08% 43.45%

0.24% 2.16% 5.18% 0.00% 78.62% 4.31% 9.48% 100.00% 86.17% 4.45% 9.38% 100.00%

60.00% 54.59% 34.64% 0.00% 42.95% 44.56% 52.52% 43.45% 42.58% 43.48% 53.46% 43.45%

0 0 000 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%

20 196 739 1 9,053 478 893 11,380 10,006 506 868 11,380

0.18% 1.72% 6.49% 0.01% 79.55% 4.20% 7.85% 100.00% 87.93% 4.45% 7.63% 100.00%

0.18% 1.72% 6.49% 0.01% 79.55% 4.20% 7.85% 100.00% 87.93% 4.45% 7.63% 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 

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

0 0 0 0 0 0 286 286 1,132

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.52% 56.52% 9.95%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.59%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.52% 56.52% 58.35%

0 0 0 0 0 0 220 220 808

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.48% 43.48% 7.10%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 16.34%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.48% 43.48% 41.65%

0 0 000 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 0 0 0 0 0 506 506 1,940

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.05%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.05%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00% 126

Female

Total Number of 

Protocols with 

Enrollment Data: 

Male

Female 

Male 

Unknown 

TOTAL

Unknown

Table 10A. Aggregate Enrollment Data for Intramural Phase III Research Protocols Excluding Male-Only and Female-Only Protocols 

Funded in FY2004 and Reported in FY2005: Percent Analysis

Number of Protocols with 

Enrollment Data: 

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

Total

Total of All Subjects by Race
17

American 

Indian/ Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

126 5,993 75 32 995 5 7,226 6,226

0.81% 38.37% 0.48% 0.20% 6.37% 0.03% 46.27% 39.87%

1.74% 82.94% 1.04% 0.44% 13.77% 0.07% 100.00% 86.16%

72.00% 48.68% 34.25% 39.51% 35.33% 33.33% 46.27% 48.69%

49 6,318 144 49 1,821 10 8,391 6,560

0.31% 40.46% 0.92% 0.31% 11.66% 0.06% 53.73% 42.01%

0.58% 75.29% 1.72% 0.58% 21.70% 0.12% 100.00% 78.18%

28.00% 51.32% 65.75% 60.49% 64.67% 66.67% 53.73% 51.31%

0 0 000 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%

175 12,311 219 81 2,816 15 15,617 12,786

1.12% 78.83% 1.40% 0.52% 18.03% 0.10% 100.00% 81.87%

1.12% 78.83% 1.40% 0.52% 18.03% 0.10% 100.00% 81.87%

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

Data Table Comments: 

Sex/Gender: 

Excluding sex-specific studies, the number of females (13,661 or 50.6%) exceeds the number of males (13,336 or 49.4%) enrolled in intramural Phase III research protocols. 

Excluding sex-specific studies, the number of minority males (7,368 or 5%) exceeds the number of females (7,358 or 49.9%) enrolled in intramural Phase III research protocols. 

Minority: 

Approximately 54.5% (14,726) of participants in aggregate intramural Phase III research excluding sex-specific studies (26,997) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 18% following the 1977 OMB standards and 79.5% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 78.8% following the 1977 OMB standards.

Largest identified racial minority group is Black at 6.5% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is Hispanic at 0.5%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.01%.

Ethnicity: 

4.5% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

All participants identified their racial category as Unknown/Other (100%)

Of the 506 participants, 56.5% are women and 43.5% are men. 

0.52% of participants identified as Hispanic according to the 1977 OMB standards. 

127

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

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

Number of Protocols with 

Enrollment Data: 

Legend

Female
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 7,887,209 2,239,359 28.39% 9,862

% 62.25% 64.56%

Males 4,515,242 1,197,772 26.53%

% 35.64% 34.53%

Unknown 267,407 31,733 11.87%

% 2.11% 0.91%

TOTAL 12,669,858 3,468,864 27.38%

Total % 100% 100.00%

8,126

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

268,433 377,242 796,332 25,420 4,727,660 99,879 633,550 6,928,516 5,838,120 472,003 618,393 6,928,516

2.47% 3.47% 7.32% 0.23% 43.44% 0.92% 5.82% 63.66% 53.64% 4.34% 5.68% 63.66%

3.87% 5.44% 11.49% 0.37% 68.23% 1.44% 9.14% 100.00% 84.26% 6.81% 8.93% 100.00%

92.23% 57.51% 64.59% 59.13% 63.16% 60.87% 62.68% 63.66% 64.01% 65.45% 59.37% 63.66%

21,948 272,478 420,262 16,674 2,613,499 63,121 294,813 3,702,795 3,119,173 242,408 341,214 3,702,795

0.20% 2.50% 3.86% 0.15% 24.01% 0.58% 2.71% 34.02% 28.66% 2.23% 3.14% 34.02%

0.59% 7.36% 11.35% 0.45% 70.58% 1.70% 7.96% 100.00% 84.24% 6.55% 9.22% 100.00%

7.54% 41.54% 34.09% 38.78% 34.92% 38.47% 29.17% 34.02% 34.20% 33.61% 32.76% 34.02%

663 6,239 16,363 899 144,034 1,096 82,367 251,661 163,000 6,727 81,934 251,661

0.01% 0.06% 0.15% 0.01% 1.32% 0.01% 0.76% 2.31% 1.50% 0.06% 0.75% 2.31%

0.26% 2.48% 6.50% 0.36% 57.23% 0.44% 32.73% 100.00% 64.77% 2.67% 32.56% 100.00%

0.23% 0.95% 1.33% 2.09% 1.92% 0.67% 8.15% 2.31% 1.79% 0.93% 7.87% 2.31%

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

2.67% 6.03% 11.33% 0.40% 68.78% 1.51% 9.29% 100.00% 83.80% 6.63% 9.57% 100.00%

2.67% 6.03% 11.33% 0.40% 68.78% 1.51% 9.29% 100.00% 83.80% 6.63% 9.57% 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 

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

17,785 5,691 12,143 1,273 245,474 21,254 168,383 472,003 1,981,163

2.47% 0.79% 1.68% 3.49% 34.04% 2.95% 23.35% 65.45% 18.20%

3.77% 1.21% 2.57% 5.99% 52.01% 4.50% 35.67% 100.00% 28.59%

80.63% 72.87% 62.98% 64.26% 67.68% 58.23% 62.18% 65.45% 65.59%

4,182 2,058 6,978 659 114,174 14,501 99,856 242,408 1,008,513

0.58% 0.29% 0.97% 1.81% 15.83% 2.01% 13.85% 33.61% 9.27%

1.73% 0.85% 2.88% 4.54% 47.10% 5.98% 41.19% 100.00% 27.24%

18.96% 26.35% 36.19% 33.27% 31.48% 39.73% 36.87% 33.61% 33.39%

90 61 161 49 3,059 748 2,559 6,727 30,878

0.01% 0.01% 0.02% 0.13% 0.42% 0.10% 0.35% 0.93% 0.28%

1.34% 0.91% 2.39% 6.55% 45.47% 11.12% 38.04% 100.00% 12.27%

0.41% 0.78% 0.83% 2.47% 0.84% 2.05% 0.94% 0.93% 1.02%

22,057 7,810 19,282 1,981 362,707 36,503 270,798 721,138 3,020,554

3.06% 1.08% 2.67% 5.43% 50.30% 5.06% 37.55% 100.00% 27.75%

3.06% 1.08% 2.67% 5.43% 50.30% 5.06% 37.55% 100.00% 27.75%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 128

Total

Total of All Subjects by Race

Female 

Total of All Subjects by Race

Male 

Unknown 

TOTAL

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

Table 11A. DOMESTIC Aggregate Enrollment Data for Extramural and Intramural Research Protocols Funded in FY2004 and Reported in 

FY2005: Percent Analysis

Male

Unknown

Total of All Subjects by Ethnicity

Number of Protocols with 

Enrollment Data: 

Female

Total Number of Protocols 

with Enrollment Data: 
1,736

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

11,837 47,628 120,247 78,484 668,855 31,642 958,693 258,196

0.66% 2.67% 6.73% 4.39% 37.43% 1.77% 53.65% 14.45%

1.23% 4.97% 12.54% 8.19% 69.77% 3.30% 100.00% 26.93%

52.90% 53.44% 57.13% 62.12% 53.71% 33.94% 53.65% 57.59%

10,422 41,316 89,956 47,565 573,886 49,302 812,447 189,259

0.58% 2.31% 5.03% 2.66% 32.12% 2.76% 45.47% 10.59%

1.28% 5.09% 11.07% 5.85% 70.64% 6.07% 100.00% 23.29%

46.58% 46.36% 42.74% 37.65% 46.08% 52.88% 45.47% 42.22%

116 175 262 302 2,596 12,295 15,746 855

0.006% 0.01% 0.01% 0.02% 0.15% 0.69% 0.88% 0.05%

0.74% 1.11% 1.66% 1.92% 16.49% 78.08% 100.00% 5.43%

0.52% 0.20% 0.12% 0.24% 0.21% 13.19% 0.88% 0.19%

22,375 89,119 210,465 126,351 1,245,337 93,239 1,786,886 448,310

1.25% 4.99% 11.78% 7.07% 69.69% 5.22% 100.00% 25.09%

1.25% 4.99% 11.78% 7.07% 69.69% 5.22% 100.00% 25.09%

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

Data Table Comments: 

Sex/Gender: 

More females (7,887,209 or 62.3%) than males (4,515,242 or 35.6%) are enrolled in aggregate domestic extramural and intramural research protocols. 

More minority females (2,239,359 or 65%) than minority males (1,197,772 or 34.5%) are enrolled in aggregate domestic extramural and intramural research protocols. 

Minority: 

Approximately 27.3% (3,468,864) of participants in aggregate domestic extramural and intramural research (12,669,858) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 69.7% following the 1977 OMB standards and 68.8% following the 1997 OMB standards.

Largest identified racial minority group is Black at 11.8% following the 1977 OMB standards and 11.3% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 1.3%.

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

Ethnicity: 

6.6% 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 50.3% 

Smallest identified racial group is Asian at 1.08%

Of the721,138 participants, 64.5% are women and 33.6% are men. 

7% of participants identified as Hispanic according to the 1977 OMB standards. 

129

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Legend

Female

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Unknown

Total

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 7,129,143 2,112,671 29.63% 8,463

% 64.63% 65.29%

Males 3,646,098 1,091,370 29.93%

% 33.05% 33.73%

Unknown 255,276 31,711 12.42%

% 2.31% 0.98%

TOTAL 11,030,517 3,235,752 29.33%

Total % 100% 100.00%

7,435

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

265,582 369,568 772,181 24,715 4,338,645 92,764 614,305 6,477,760 5,405,237 464,086 608,437 6,477,760

2.66% 3.70% 7.73% 0.25% 43.43% 0.93% 6.15% 64.85% 54.11% 4.65% 6.09% 64.85%

4.10% 5.71% 11.92% 0.38% 66.98% 1.43% 9.48% 100.00% 83.44% 7.16% 9.39% 100.00%

92.60% 57.69% 64.89% 60.18% 64.71% 59.24% 63.33% 64.85% 65.43% 65.88% 59.45% 64.85%

20,563 264,803 401,454 15,453 2,221,683 62,743 276,535 3,263,234 2,695,237 233,606 334,391 3,263,234

0.21% 2.65% 4.02% 0.15% 22.24% 0.63% 2.77% 32.67% 26.98% 2.34% 3.35% 32.67%

0.63% 8.11% 12.30% 0.47% 68.08% 1.92% 8.47% 100.00% 82.59% 7.16% 10.25% 100.00%

7.17% 41.34% 33.74% 37.63% 33.14% 40.07% 28.51% 32.67% 32.62% 33.16% 32.67% 32.67%

663 6,239 16,358 899 144,026 1,096 79,227 248,508 161,118 6,726 80,664 248,508

0.01% 0.06% 0.16% 0.01% 1.44% 0.01% 0.79% 2.49% 1.61% 0.07% 0.81% 2.49%

0.27% 2.51% 6.58% 0.36% 57.96% 0.44% 31.88% 100.00% 64.83% 2.71% 32.46% 100.00%

0.23% 0.97% 1.37% 2.19% 2.15% 0.70% 8.17% 2.49% 1.95% 0.95% 7.88% 2.49%

286,808 640,610 1,189,993 41,067 6,704,354 156,603 970,067 9,989,502 8,261,592 704,418 1,023,492 9,989,502

2.87% 6.41% 11.91% 0.41% 67.11% 1.57% 9.71% 100.00% 82.70% 7.05% 10.25% 100.00%

2.87% 6.41% 11.91% 0.41% 67.11% 1.57% 9.71% 100.00% 82.70% 7.05% 10.25% 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 

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

17,772 5,664 12,111 1,251 244,782 21,222 161,284 464,086 1,930,876

2.52% 0.80% 1.72% 3.43% 34.75% 3.01% 22.90% 65.88% 19.33%

3.83% 1.22% 2.61% 5.89% 52.74% 4.57% 34.75% 100.00% 29.81%

80.66% 72.80% 62.97% 63.89% 67.64% 58.23% 63.23% 65.88% 65.85%

4,171 2,055 6,961 658 114,070 14,475 91,216 233,606 970,302

0.59% 0.29% 0.99% 1.81% 16.19% 2.05% 12.95% 33.16% 9.71%

1.79% 0.88% 2.98% 4.55% 48.83% 6.20% 39.05% 100.00% 29.73%

18.93% 26.41% 36.19% 33.61% 31.52% 39.72% 35.76% 33.16% 33.09%

90 61 161 49 3,059 748 2,558 6,726 30,872

0.01% 0.01% 0.02% 0.13% 0.43% 0.11% 0.36% 0.95% 0.31%

1.34% 0.91% 2.39% 6.55% 45.48% 11.12% 38.03% 100.00% 12.42%

0.41% 0.78% 0.84% 2.50% 0.85% 2.05% 1.00% 0.95% 1.05%

22,033 7,780 19,233 1,958 361,911 36,445 255,058 704,418 2,932,050

3.13% 1.10% 2.73% 5.37% 51.38% 5.17% 36.21% 100.00% 29.35%

3.13% 1.10% 2.73% 5.37% 51.38% 5.17% 36.21% 100.00% 29.35%

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

130

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

Female 

Male 

Unknown 

Total

Total of All Subjects by Race

TOTAL

Table 12A. DOMESTIC Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Number of Protocols with 

Enrollment Data: 

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

Female

Male

Unknown

Total Number of Protocols 

with Enrollment Data: 
1,028

American 

Indian/ Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

3,084 39,788 88,897 50,026 450,942 18,646 651,383 181,795

0.30% 3.82% 8.54% 4.81% 43.32% 1.79% 62.57% 17.46%

0.47% 6.11% 13.65% 7.68% 69.23% 2.86% 100.00% 27.91%

58.84% 60.80% 60.85% 57.56% 64.34% 51.12% 62.57% 59.86%

2,042 25,478 56,956 36,592 247,334 14,462 382,864 121,068

0.20% 2.45% 5.47% 3.52% 23.76% 1.39% 36.78% 11.63%

0.53% 6.65% 14.88% 9.56% 64.60% 3.78% 100.00% 31.62%

38.96% 38.93% 38.98% 42.10% 35.29% 39.65% 36.78% 39.86%

115 175 250 299 2,561 3,368 6,768 839

0.011% 0.02% 0.02% 0.03% 0.25% 0.32% 0.65% 0.08%

1.70% 2.59% 3.69% 4.42% 37.84% 49.76% 100.00% 12.40%

2.19% 0.27% 0.17% 0.34% 0.37% 9.23% 0.65% 0.28%

5,241 65,441 146,103 86,917 700,837 36,476 1,041,015 303,702

0.50% 6.29% 14.03% 8.35% 67.32% 3.50% 100.00% 29.17%

0.50% 6.29% 14.03% 8.35% 67.32% 3.50% 100.00% 29.17%

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

Data Table Comments: 

Sex/Gender: 

More females (7,129,143 or 64.6%) than males (3,646,098 or 33%) are enrolled in aggregate domestic extramural research protocols. 

More minority females (2,112,671 or 65.3%) than minority males (1,091,370 or 33.7%) are enrolled in aggregate domestic extramural research protocols. 

Minority:

Approximately 29.3% (3,235,752) of participants in aggregate domestic extramural research (11,030,517) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 67.3% following the 1977 OMB standards and 67.1% following the 1997 OMB standards.

Largest identified racial minority group is Black at 14.3% following the 1977 OMB standards and 11.9% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native at 0.5%.

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

Ethnicity: 

7.1% 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 White at 51.4%

Smallest identified racial group is Asian at 1.1%.

Of the 704,418 participants, 65.8% are women and 33.1% are men. 

8.4% of participants identified as Hispanic according to the 1977 OMB standards. 

131

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 758,066 126,688 16.71% 1,399

% 46.24% 54.35%

Males 869,144 106,402 12.24%

% 53.02% 45.64%

Unknown 12,131 22 0.18%

% 0.74% 0.01%

TOTAL 1,639,341 233,112 14.22%

Total % 100% 100.00%

691

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

2,851 7,674 24,151 705 389,015 7,115 19,245 450,756 432,883 7,917 9,956 450,756

0.32% 0.86% 2.70% 0.08% 43.54% 0.80% 2.15% 50.45% 48.45% 0.89% 1.11% 50.45%

0.63% 1.70% 5.36% 0.16% 86.30% 1.58% 4.27% 100.00% 96.03% 1.76% 2.21% 100.00%

67.30% 50.00% 56.21% 36.60% 49.82% 94.96% 47.33% 50.45% 50.41% 47.35% 55.16% 50.45%

1,385 7,675 18,808 1,221 391,816 378 18,278 439,561 423,936 8,802 6,823 439,561

0.16% 0.86% 2.11% 0.14% 43.85% 0.04% 2.05% 49.20% 47.45% 0.99% 0.76% 49.20%

0.32% 1.75% 4.28% 0.28% 89.14% 0.09% 4.16% 100.00% 96.45% 2.00% 1.55% 100.00%

32.70% 50.00% 43.78% 63.40% 50.18% 5.04% 44.95% 49.20% 49.37% 52.64% 37.80% 49.20%

0 0 5 0 8 0 3,140 3,153 1,882 1 1,270 3,153

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.35% 0.35% 0.21% 0.00% 0.14% 0.35%

0.00% 0.00% 0.16% 0.00% 0.25% 0.00% 99.59% 100.00% 59.69% 0.03% 40.28% 100.00%

0.00% 0.00% 0.01% 0.00% 0.00% 0.00% 7.72% 0.35% 0.22% 0.01% 7.04% 0.35%

4,236 15,349 42,964 1,926 780,839 7,493 40,663 893,470 858,701 16,720 18,049 893,470

0.47% 1.72% 4.81% 0.22% 87.39% 0.84% 4.55% 100.00% 96.11% 1.87% 2.02% 100.00%

0.47% 1.72% 4.81% 0.22% 87.39% 0.84% 4.55% 100.00% 96.11% 1.87% 2.02% 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 

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

13 27 32 22 692 32 7,099 7,917 50,287

0.08% 0.16% 0.19% 0.13% 4.14% 0.19% 42.46% 47.35% 5.63%

0.16% 0.34% 0.40% 0.28% 8.74% 0.40% 89.67% 100.00% 11.16%

54.17% 90.00% 65.31% 95.65% 86.93% 55.17% 45.10% 47.35% 56.82%

11 3 17 1 104 26 8,640 8,802 38,211

0.07% 0.02% 0.10% 0.01% 0.62% 0.16% 51.67% 52.64% 4.28%

0.12% 0.03% 0.19% 0.01% 1.18% 0.30% 98.16% 100.00% 8.69%

45.83% 10.00% 34.69% 4.35% 13.07% 44.83% 54.89% 52.64% 43.17%

0 0 00 0 0 1 1 6

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% 100.00% 100.00% 0.19%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.01%

24 30 49 23 796 58 15,740 16,720 88,504

0.14% 0.18% 0.29% 0.14% 4.76% 0.35% 94.14% 100.00% 9.91%

0.14% 0.18% 0.29% 0.14% 4.76% 0.35% 94.14% 100.00% 9.91%

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

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

Female 

Male 

Unknown 

Total

Total of All Subjects by Race

TOTAL

Table 13A. DOMESTIC Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Number of Protocols with 

Enrollment Data: 

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

Female

Male

Unknown

Total Number of Protocols 

with Enrollment Data: 

132
708

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

8,753 7,840 31,350 28,458 217,913 12,996 307,310 76,401

1.17% 1.05% 4.20% 3.82% 29.22% 1.74% 41.20% 10.24%

2.85% 2.55% 10.20% 9.26% 70.91% 4.23% 100.00% 24.86%

51.09% 33.11% 48.71% 72.17% 40.02% 22.90% 41.20% 52.83%

8,380 15,838 33,000 10,973 326,552 34,840 429,583 68,191

1.12% 2.12% 4.42% 1.47% 43.78% 4.67% 57.59% 9.14%

1.95% 3.69% 7.68% 2.55% 76.02% 8.11% 100.00% 15.87%

48.91% 66.89% 51.27% 27.83% 59.97% 61.38% 57.59% 47.16%

1 0 12 3 35 8,927 8,978 16

0.000% 0.00% 0.00% 0.00% 0.00% 1.20% 1.20% 0.00%

0.01% 0.00% 0.13% 0.03% 0.39% 99.43% 100.00% 0.18%

0.01% 0.00% 0.02% 0.01% 0.01% 15.73% 1.20% 0.01%

17,134 23,678 64,362 39,434 544,500 56,763 745,871 144,608

2.30% 3.17% 8.63% 5.29% 73.00% 7.61% 100.00% 19.39%

2.30% 3.17% 8.63% 5.29% 73.00% 7.61% 100.00% 19.39%

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

Data Table Comments: 

Sex/Gender: 

More males (869,144 or 53%) than females (758,066 or 46.2%) are enrolled in aggregate domestic intramural research protocols. 

More minority females (126,688 or 54.3%) than minority males (106,402 or 45.6%) are enrolled in aggregate domestic intramural research protocols. 

Minority: 

Approximately 14.2% (233,112) of participants in aggregate domestic intramural research (1,639,341) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 73% following the 1997 OMB standards and 87.4% following the 1997 OMB standards.

Largest identified racial minority group is Black at 8.6% following the 1977 OMB standards and 4.8% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 2.3%.

According to the 1997 OMB standards, the smallest identified racial minority groups is Hawaiian/Pacific Islander at 0.2%.

Ethnicity: 

1.9% 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 4.8% 

Remaining participants identified the racial category of Unknown/Other at 94.1%

Of the 16,720 participants, 47.4% are women and 52.6% are men. 

5.3% of participants identified as Hispanic according to the 1977 OMB standards. 

133

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 254,207 62,328 24.52% 484

% 59.99% 57.97%

Males 167,395 45,137 26.96%

% 39.50% 41.98%

Unknown 2,176 48 2.21%

% 0.51% 0.04%

TOTAL 423,778 107,513 25.37%

Total % 100% 100.00%

296

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

1,142 2,266 13,013 205 36,005 1,372 3,642 57,645 48,950 5,266 3,429 57,645

0.90% 1.79% 10.28% 0.16% 28.44% 1.08% 2.88% 45.54% 38.67% 4.16% 2.71% 45.54%

1.98% 3.93% 22.57% 0.36% 62.46% 2.38% 6.32% 100.00% 84.92% 9.14% 5.95% 100.00%

65.07% 47.97% 54.81% 44.47% 42.56% 53.08% 41.69% 45.54% 45.08% 56.83% 39.27% 45.54%

609 2,455 10,708 256 48,320 1,209 3,311 66,868 59,392 3,982 3,494 66,868

0.48% 1.94% 8.46% 0.20% 38.17% 0.96% 2.62% 52.82% 46.92% 3.15% 2.76% 52.82%

0.91% 3.67% 16.01% 0.38% 72.26% 1.81% 4.95% 100.00% 88.82% 5.96% 5.23% 100.00%

34.70% 51.97% 45.11% 55.53% 57.12% 46.77% 37.90% 52.82% 54.69% 42.97% 40.01% 52.82%

4 3 19 0 264 4 1,782 2,076 249 18 1,809 2,076

0.00% 0.00% 0.02% 0.00% 0.21% 0.00% 1.41% 1.64% 0.20% 0.01% 1.43% 1.64%

0.19% 0.14% 0.92% 0.00% 12.72% 0.19% 85.84% 100.00% 11.99% 0.87% 87.14% 100.00%

0.23% 0.06% 0.08% 0.00% 0.31% 0.15% 20.40% 1.64% 0.23% 0.19% 20.72% 1.64%

1,755 4,724 23,740 461 84,589 2,585 8,735 126,589 108,591 9,266 8,732 126,589

1.39% 3.73% 18.75% 0.36% 66.82% 2.04% 6.90% 100.00% 85.78% 7.32% 6.90% 100.00%

1.39% 3.73% 18.75% 0.36% 66.82% 2.04% 6.90% 100.00% 85.78% 7.32% 6.90% 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 

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

329 30 234 31 1,858 223 2,561 5,266 22,417

3.55% 0.32% 2.53% 7.33% 20.05% 2.41% 27.64% 56.83% 17.71%

6.25% 0.57% 4.44% 13.90% 35.28% 4.23% 48.63% 100.00% 38.89%

88.68% 71.43% 52.47% 68.89% 50.72% 52.72% 59.89% 56.83% 54.40%

41 12 212 14 1,801 199 1,703 3,982 18,741

0.44% 0.13% 2.29% 3.31% 19.44% 2.15% 18.38% 42.97% 14.80%

1.03% 0.30% 5.32% 7.04% 45.23% 5.00% 42.77% 100.00% 28.03%

11.05% 28.57% 47.53% 31.11% 49.17% 47.04% 39.83% 42.97% 45.48%

1 0 0 0 4 1 12 18 46

0.01% 0.00% 0.00% 0.00% 0.04% 0.01% 0.13% 0.19% 0.04%

5.56% 0.00% 0.00% 0.00% 22.22% 5.56% 66.67% 100.00% 2.22%

0.27% 0.00% 0.00% 0.00% 0.11% 0.24% 0.28% 0.19% 0.11%

371 42 446 45 3,663 423 4,276 9,266 41,204

4.00% 0.45% 4.81% 10.64% 39.53% 4.57% 46.15% 100.00% 32.55%

4.00% 0.45% 4.81% 10.64% 39.53% 4.57% 46.15% 100.00% 32.55%

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 134

Table 14A. DOMESTIC Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2004 and Reported in 

FY2005: Percent Analysis

Female

Male

Unknown

Total Number of Protocols 

with Enrollment Data: 

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

Total

Total of All Subjects by Race

Female 

Male 

Unknown 

TOTAL

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Race Total of All Subjects by Ethnicity
188

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown/

Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): OLD 

FORM 

759 3,934 23,347 11,871 154,032 2,619 196,562 39,911

0.26% 1.32% 7.86% 3.99% 51.83% 0.88% 66.14% 13.43%

0.39% 2.00% 11.88% 6.04% 78.36% 1.33% 100.00% 20.30%

66.40% 72.53% 59.59% 57.73% 68.03% 58.49% 66.14% 60.19%

383 1,490 15,830 8,693 72,361 1,770 100,527 26,396

0.13% 0.50% 5.33% 2.93% 24.35% 0.60% 33.83% 8.88%

0.38% 1.48% 15.75% 8.65% 71.98% 1.76% 100.00% 26.26%

33.51% 27.47% 40.41% 42.27% 31.96% 39.53% 33.83% 39.81%

1 0 1 0 9 89 100 2

0.000% 0.00% 0.00% 0.00% 0.00% 0.03% 0.03% 0.00%

1.00% 0.00% 1.00% 0.00% 9.00% 89.00% 100.00% 2.00%

0.09% 0.00% 0.00% 0.00% 0.00% 1.99% 0.03% 0.00%

1,143 5,424 39,178 20,564 226,402 4,478 297,189 66,309

0.38% 1.83% 13.18% 6.92% 76.18% 1.51% 100.00% 22.31%

0.38% 1.83% 13.18% 6.92% 76.18% 1.51% 100.00% 22.31%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in foreign extramural Phase III research protocols reported in FY2005. 

More females (254,207 or 59.9%) than males (167,395 or 39.5%) are enrolled in aggregate domestic extramural Phase III research protocols. 

More minority females (62,328 or 57.9%) than minority males (45,137 or 4%) are enrolled in aggregate domestic extramural Phase III research protocols. 

Minority:

Approximately 25.4% (107,513) of participants in aggregate domestic extramural Phase III research (423,778) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 76.2% following the 1977 OMB standards and 66.8% following the 1997 OMB standards.

Largest identified racial minority group is Black at 13.2% following the 1977 OMB standards and 18.7% following the 1997 OMB standards. 

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

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

Ethnicity: 

7.3% 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 39.5%

Smallest identified racial group is Asian at 0.5%

Of the 9,266 participants, 56.8% are women and 43% are men. 

6.9% of participants identified as Hispanic according to the 1977 OMB standards. 

135

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex /Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 7,382 1,336 18.10% 33

% 52.27% 55.74%

Males 6,742 1,061 15.74%

% 47.73% 44.26%

Unknown 0 0 0%

% 0.00% 0.00%

TOTAL 14,124 2,397 16.97%

Total % 100% 100.00%

16

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

8 89 431 1 5,166 265 166 6,126 5,694 286 146 6,126

0.07% 0.83% 4.02% 0.01% 48.14% 2.47% 1.55% 57.09% 53.06% 2.67% 1.36% 57.09%

0.13% 1.45% 7.04% 0.02% 84.33% 4.33% 2.71% 100.00% 92.95% 4.67% 2.38% 100.00%

40.00% 45.41% 66.31% 100.00% 56.94% 55.44% 53.04% 57.09% 57.30% 56.41% 50.87% 57.09%

12 107 219 0 3,907 213 147 4,605 4,243 221 141 4,605

0.11% 1.00% 2.04% 0.00% 36.41% 1.98% 1.37% 42.91% 39.54% 2.06% 1.31% 42.91%

0.26% 2.32% 4.76% 0.00% 84.84% 4.63% 3.19% 100.00% 92.14% 4.80% 3.06% 100.00%

60.00% 54.59% 33.69% 0.00% 43.06% 44.56% 46.96% 42.91% 42.70% 43.59% 49.13% 42.91%

0 0 0 0 0 0 0 00 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%

20 196 650 1 9,073 478 313 10,731 9,937 507 287 10,731

0.19% 1.83% 6.06% 0.01% 84.55% 4.45% 2.92% 100.00% 92.60% 4.72% 2.67% 100.00%

0.19% 1.83% 6.06% 0.01% 84.55% 4.45% 2.92% 100.00% 92.60% 4.72% 2.67% 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 

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

0 0 0 0 0 0 286 286 1,080

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.41% 56.41% 10.06%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.63%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 56.41% 56.41% 58.32%

0 0 0 0 0 0 221 221 772

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.59% 43.59% 7.19%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 16.76%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 43.59% 43.59% 41.68%

0 0 000 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 0 0 0 0 0 507 507 1,852

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.26%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 17.26%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00%

136

Total Number of 

Protocols with 

Enrollment Data: 

Table 15A. DOMESTIC Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2004 and Reported in 

FY2005: Percent Analysis

Total of All Subjects by Race

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

Total

Number of Protocols 

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

Female

Male

Unknown

TOTAL

Female 

Male 

Unknown 
17

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

126 23 75 32 995 5 1,256 256

3.71% 0.68% 2.21% 0.94% 29.33% 0.15% 37.02% 7.54%

10.03% 1.83% 5.97% 2.55% 79.22% 0.40% 100.00% 20.38%

71.59% 35.94% 33.63% 39.02% 35.12% 33.33% 37.02% 46.97%

50 41 148 50 1,838 10 2,137 289

1.47% 1.21% 4.36% 1.47% 54.17% 0.29% 62.98% 8.52%

2.34% 1.92% 6.93% 2.34% 86.01% 0.47% 100.00% 13.52%

28.41% 64.06% 66.37% 60.98% 64.88% 66.67% 62.98% 53.03%

0 0 000 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%

176 64 223 82 2,833 15 3,393 545

5.19% 1.89% 6.57% 2.42% 83.50% 0.44% 100.00% 16.06%

5.19% 1.89% 6.57% 2.42% 83.50% 0.44% 100.00% 16.06%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in domestic intramural Phase III research protocols reported in FY2005. 

More females (7,382 or 52.2%) than males (6,742 or 47.7%) are enrolled in aggregate domestic intramural Phase III research protocols. 

More minority females (1,136or 55.7%) than minority males (1,061or 44.3%)are enrolled in aggregate domestic intramural Phase III research protocols. 

Minority: 

Approximately 17% (2,397) of participants in aggregate domestic intramural Phase III research (14,124) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 83.5% following the 1977 OMB standards and 84.5% following the 1997 OMB standards.

Largest identified racial minority group is Black at 6.6% following the 1977 OMB standards and 6.1% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is Asian/Pacific Islander at 1.9%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at 0.01%.

Ethnicity: 

4.7% of participants identified their ethnicity as Hispanic or Latino following the 1997 OMB standards. 

For participants reporting ethcnicity as Hispanic/Latino: 

All participants identified their racial category as Unknown/Other (100%)

Of the 507 participants, 56.4% are women and 43.5% are men. 

2.4% of participants identified as Hispanic according to the 1977 OMB standards. 

137

Unknown

Total

Number of Protocols 

with Enrollment Data: 

Female

Male

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

Typeface: Percentage of Total No. of Participants sorted 

by Race/Rthnicity (Column Total)

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Bold: Percentage of Total No. of Participants in 

Research Protocols (Old or New Form)

Legend
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 1,616,713 1,474,926 91.23% 371

% 52.96% 53.12%

Males 1,426,665 1,296,016 90.84%

% 46.73% 46.68%

Unknown 9,516 5,623 59.09%

% 0.31% 0.20%

TOTAL 3,052,894 2,776,565 90.95%

Total % 100% 100.00%

II. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 321

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

731 1,221,535 66,811 5,070 109,507 9,857 50,097 1,463,608 1,376,467 39,728 47,413 1,463,608

0.03% 43.18% 2.36% 0.18% 3.87% 0.35% 1.77% 51.74% 48.66% 1.40% 1.68% 51.74%

0.05% 83.46% 4.56% 0.35% 7.48% 0.67% 3.42% 100.00% 94.05% 2.71% 3.24% 100.00%

62.43% 51.10% 53.32% 49.26% 58.34% 52.27% 52.73% 51.74% 51.29% 75.24% 51.51% 51.74%

385 1,168,638 54,124 5,153 77,935 8,988 43,503 1,358,726 1,302,146 12,872 43,708 1,358,726

0.01% 41.31% 1.91% 0.18% 2.76% 0.32% 1.54% 48.03% 46.03% 0.46% 1.55% 48.03%

0.03% 86.01% 3.98% 0.38% 5.74% 0.66% 3.20% 100.00% 95.84% 0.95% 3.22% 100.00%

32.88% 48.89% 43.19% 50.06% 41.52% 47.66% 45.79% 48.03% 48.52% 24.38% 47.48% 48.03%

55 231 4,370 70 255 12 1,399 6,392 5,258 201 933 6,392

0.00% 0.01% 0.15% 0.00% 0.01% 0.00% 0.05% 0.23% 0.19% 0.01% 0.03% 0.23%

0.86% 3.61% 68.37% 1.10% 3.99% 0.19% 21.89% 100.00% 82.26% 3.14% 14.60% 100.00%

4.70% 0.01% 3.49% 0.68% 0.14% 0.06% 1.47% 0.23% 0.20% 0.38% 1.01% 0.23%

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

0.04% 84.50% 4.43% 0.36% 6.64% 0.67% 3.36% 100.00% 94.88% 1.87% 3.25% 100.00%

0.04% 84.50% 4.43% 0.36% 6.64% 0.67% 3.36% 100.00% 94.88% 1.87% 3.25% 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 

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

459 2 81 0 23,191 7,881 8,114 39,728 1,335,309

0.87% 0.00% 0.15% 0.00% 43.92% 14.93% 15.37% 75.24% 47.21%

1.16% 0.01% 0.20% 0.00% 58.37% 19.84% 20.42% 100.00% 91.23%

67.30% 33.33% 49.39% 0.00% 88.65% 53.74% 72.94% 75.24% 51.69%

172 4 83 0 2,830 6,775 3,008 12,872 1,243,126

0.33% 0.01% 0.16% 0.00% 5.36% 12.83% 5.70% 24.38% 43.95%

1.34% 0.03% 0.64% 0.00% 21.99% 52.63% 23.37% 100.00% 91.49%

25.22% 66.67% 50.61% 0.00% 10.82% 46.20% 27.04% 24.38% 48.12%

51 0 0 0 140 8 2 201 4,880

0.10% 0.00% 0.00% 0.00% 0.27% 0.02% 0.00% 0.38% 0.17%

25.37% 0.00% 0.00% 0.00% 69.65% 3.98% 1.00% 100.00% 76.35%

7.48% 0.00% 0.00% 0.00% 0.54% 0.05% 0.02% 0.38% 0.19%

682 6 164 0 26,161 14,664 11,124 52,801 2,583,315

1.29% 0.01% 0.31% 0.00% 49.55% 27.77% 21.07% 100.00% 91.32%

1.29% 0.01% 0.31% 0.00% 49.55% 27.77% 21.07% 100.00% 91.32%

100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00%

138

Total Number of Protocols 

with Enrollment Data: 

Female 

Male 

Unknown 

TOTAL

Total

Total of All Subjects by Race

Table 16A. FOREIGN Aggregate Enrollment Data for Extramural and Intramural Research Protocols Funded in FY2004 and Reported in 

FY2005: Percent Analysis

Male

Unknown

Total of All Subjects by Ethnicity

Number of Protocols with 

Enrollment Data: 

Female

Total of All Subjects by Race
50

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

0 122,763 12,559 4,295 8,969 4,519 153,105 139,617

0.00% 54.76% 5.60% 1.92% 4.00% 2.02% 68.30% 62.28%

0.00% 80.18% 8.20% 2.81% 5.86% 2.95% 100.00% 91.19%

0.00% 74.19% 65.58% 49.82% 41.23% 49.30% 68.30% 72.25%

0 42,679 6,591 3,620 10,408 4,641 67,939 52,890

0.00% 19.04% 2.94% 1.61% 4.64% 2.07% 30.31% 23.59%

0.00% 62.82% 9.70% 5.33% 15.32% 6.83% 100.00% 77.85%

0.00% 25.79% 34.42% 41.99% 47.85% 50.63% 30.31% 27.37%

0 37 0 706 2,375 6 3,124 743

0.000% 0.02% 0.00% 0.31% 1.06% 0.00% 1.39% 0.33%

0.00% 1.18% 0.00% 22.60% 76.02% 0.19% 100.00% 23.78%

0.00% 0.02% 0.00% 8.19% 10.92% 0.07% 1.39% 0.38%

0 165,479 19,150 8,621 21,752 9,166 224,168 193,250

0.00% 73.82% 8.54% 3.85% 9.70% 4.09% 100.00% 86.21%

0.00% 73.82% 8.54% 3.85% 9.70% 4.09% 100.00% 86.21%

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

Data Table Comments: 

Sex/Gender: 

More females (1,616,713 or 52.9%) than males (1,426,665 or46.7%) are enrolled in aggregate foreign extramural and intramural research protocols. 

More minority females (1,414,926 or 52.9%) than minority males (1,296,016 or 46.7%) are enrolled in aggregate foreign extramural and intramural research protocols. 

Minority: 

Approximately 91% (2,776,565) of participants in aggregate foreign extramural and intramural research (3,052,894) are classified as U.S. minorities. 

Race: White doesn't rank as top racial category.

Largest identified racial minority group is Asian/Pacific Islander at 73.8% following the 1977 OMB standards.

Largest identified racial minority group is Asians at 84.5% following the 1997 OMB standards. 

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native at 0.04% and 0% following the 1997 OMB standards.

Ethnicity: 

1.8% 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 White at 49.5%

Smallest identified racial group is Hawaiian/Pacific Islander at 0%

Of the 52,801 participants, 75.2% are women and 24.4% are men. 

3.9% of participants identified as Hispanic according to the 1977 OMB standards. 

139

Italics: Percentage of Total No. of Participants Sorted by 

Sex/Gender (Row Total)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Legend

Female

Bold: Percentage of Total No. of Participants in Research 

Protocols (Old or New Form)

Unknown

Total

Number of Protocols with 

III. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 1,429,855 1,346,564 94.17% 300

% 51.96% 51.84%

Males 1,315,555 1,246,081 94.72%

% 47.81% 47.97%

Unknown 6,272 4,880 77.81%

% 0.23% 0.19%

TOTAL 2,751,682 2,597,525 94.40%

Total % 100% 100.00%

275

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

731 1,212,305 64,151 5,063 63,778 8,470 47,044 1,401,542 1,320,227 36,451 44,864 1,401,542

0.03% 44.83% 2.37% 0.19% 2.36% 0.31% 1.74% 51.82% 48.82% 1.35% 1.66% 51.82%

0.05% 86.50% 4.58% 0.36% 4.55% 0.60% 3.36% 100.00% 94.20% 2.60% 3.20% 100.00%

62.85% 51.12% 53.39% 49.23% 67.60% 52.34% 51.80% 51.82% 51.37% 75.77% 51.87% 51.82%

377 1,159,009 51,636 5,152 30,317 7,701 42,500 1,296,692 1,244,424 11,454 40,814 1,296,692

0.01% 42.85% 1.91% 0.19% 1.12% 0.28% 1.57% 47.95% 46.01% 0.42% 1.51% 47.95%

0.03% 89.38% 3.98% 0.40% 2.34% 0.59% 3.28% 100.00% 95.97% 0.88% 3.15% 100.00%

32.42% 48.87% 42.97% 50.09% 32.13% 47.59% 46.80% 47.95% 48.42% 23.81% 47.19% 47.95%

55 231 4,370 70 252 12 1,276 6,266 5,255 201 810 6,266

0.00% 0.01% 0.16% 0.00% 0.01% 0.00% 0.05% 0.23% 0.19% 0.01% 0.03% 0.23%

0.88% 3.69% 69.74% 1.12% 4.02% 0.19% 20.36% 100.00% 83.87% 3.21% 12.93% 100.00%

4.73% 0.01% 3.64% 0.68% 0.27% 0.07% 1.40% 0.23% 0.20% 0.42% 0.94% 0.23%

1,163 2,371,545 120,157 10,285 94,347 16,183 90,820 2,704,500 2,569,906 48,106 86,488 2,704,500

0.04% 87.69% 4.44% 0.38% 3.49% 0.60% 3.36% 100.00% 95.02% 1.78% 3.20% 100.00%

0.04% 87.69% 4.44% 0.38% 3.49% 0.60% 3.36% 100.00% 95.02% 1.78% 3.20% 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 

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

459 2 81 0 23,191 6,596 6,122 36,451 1,320,033

0.95% 0.00% 0.17% 0.00% 48.21% 13.71% 12.73% 75.77% 48.81%

1.26% 0.01% 0.22% 0.00% 63.62% 18.10% 16.80% 100.00% 94.18%

67.30% 33.33% 49.39% 0.00% 88.65% 54.25% 68.52% 75.77% 51.68%

172 4 83 0 2,830 5,554 2,811 11,454 1,229,516

0.36% 0.01% 0.17% 0.00% 5.88% 11.55% 5.84% 23.81% 45.46%

1.50% 0.03% 0.72% 0.00% 24.71% 48.49% 24.54% 100.00% 94.82%

25.22% 66.67% 50.61% 0.00% 10.82% 45.68% 31.46% 23.81% 48.13%

51 0 0 0 140 8 2 201 4,880

0.11% 0.00% 0.00% 0.00% 0.29% 0.02% 0.00% 0.42% 0.18%

25.37% 0.00% 0.00% 0.00% 69.65% 3.98% 1.00% 100.00% 77.88%

7.48% 0.00% 0.00% 0.00% 0.54% 0.07% 0.02% 0.42% 0.19%

682 6 164 0 26,161 12,158 8,935 48,106 2,554,429

1.42% 0.01% 0.34% 0.00% 54.38% 25.27% 18.57% 100.00% 94.45%

1.42% 0.01% 0.34% 0.00% 54.38% 25.27% 18.57% 100.00% 94.45%

100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00%

140

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

Female 

Male 

Unknown 

Total

Total of All Subjects by Race

TOTAL

Table 17A. FOREIGN Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Number of Protocols with 

Enrollment Data: 

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

Female

Male

Unknown

Total Number of Protocols 

with Enrollment Data: 
25

American 

Indian/ 

Alaska 

Native

Asian/ 

Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

0 14,452 9,701 2,378 1,654 128 28,313 26,531

0.00% 30.63% 20.56% 5.04% 3.51% 0.27% 60.01% 56.23%

0.00% 51.04% 34.26% 8.40% 5.84% 0.45% 100.00% 93.71%

0.00% 59.01% 68.16% 54.38% 44.25% 36.78% 60.01% 61.56%

0 10,039 4,531 1,995 2,084 214 18,863 16,565

0.00% 21.28% 9.60% 4.23% 4.42% 0.45% 39.98% 35.11%

0.00% 53.22% 24.02% 10.58% 11.05% 1.13% 100.00% 87.82%

0.00% 40.99% 31.84% 45.62% 55.75% 61.49% 39.98% 38.44%

0 0 00 0 6 6 0

0.000% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 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% 1.72% 0.01% 0.00%

0 24,491 14,232 4,373 3,738 348 47,182 43,096

0.00% 51.91% 30.16% 9.27% 7.92% 0.74% 100.00% 91.34%

0.00% 51.91% 30.16% 9.27% 7.92% 0.74% 100.00% 91.34%

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

Data Table Comments: 

Sex/Gender: 

More females (1,429,855 or 51.9%) than males (1,315,555 or 47.8%) are enrolled in aggregate foreign extramural research protocols. 

More minority females (1,346,564 or 51.8%) than minority males (1,246,081 or 47.9%) are enrolled in aggregate foreign extramural research protocols. 

Minority: 

Approximately 94.4% (2,597,525) of participants in aggregate foreign extramural research (2,751,682) are classified as U.S. minorities. 

Race:

Largest identified racial minority group is Asians at 87.7% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islanders at 51.9% following the 1977 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native at 0%.

According to the 1997 OMB standards, the smallest identified racial minority group is American Indian/Alaska Native at 0.04%.

Ethnicity: 

1.78% 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 54.4%

Smallest identified racial group is Hawaiian/Pacific Islander at 0%.

Of the 48,106 participants, 75.7% are women and 23.8% are men. 

9.3% of participants identified as Hispanic according to the 1977 OMB standards. 

141

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 186,858 128,365 68.70% 71

% 62.04% 71.69%

Males 111,110 49,939 44.95%

% 36.89% 27.89%

Unknown 3,244 743 22.90%

% 1.08% 0.41%

TOTAL 301,212 179,047 59.44%

Total % 100% 100.00%

46

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

0 9,233 2,660 7 45,729 1,387 3,050 62,066 56,240 3,277 2,549 62,066

0.00% 7.43% 2.14% 0.01% 36.81% 1.12% 2.46% 49.96% 45.27% 2.64% 2.05% 49.96%

0.00% 14.88% 4.29% 0.01% 73.68% 2.23% 4.91% 100.00% 90.61% 5.28% 4.11% 100.00%

0.00% 48.94% 51.67% 87.50% 48.99% 51.87% 73.11% 49.96% 49.35% 69.80% 45.80% 49.96%

8 9,633 2,488 1 47,618 1,287 999 62,034 57,722 1,418 2,894 62,034

0.01% 7.75% 2.00% 0.00% 38.33% 1.04% 0.80% 49.94% 46.47% 1.14% 2.33% 49.94%

0.01% 15.53% 4.01% 0.00% 76.76% 2.07% 1.61% 100.00% 93.05% 2.29% 4.67% 100.00%

100.00% 51.06% 48.33% 12.50% 51.01% 48.13% 23.95% 49.94% 50.65% 30.20% 51.99% 49.94%

0 0 0 0 3 0 123 126 3 0 123 126

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.10% 0.10% 0.00% 0.00% 0.10% 0.10%

0.00% 0.00% 0.00% 0.00% 2.38% 0.00% 97.62% 100.00% 2.38% 0.00% 97.62% 100.00%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 2.95% 0.10% 0.00% 0.00% 2.21% 0.10%

8 18,866 5,148 8 93,350 2,674 4,172 124,226 113,965 4,695 5,566 124,226

0.01% 15.19% 4.14% 0.01% 75.15% 2.15% 3.36% 100.00% 91.74% 3.78% 4.48% 100.00%

0.01% 15.19% 4.14% 0.01% 75.15% 2.15% 3.36% 100.00% 91.74% 3.78% 4.48% 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 

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

0 0 0 0 0 1,285 1,992 3,277 15,279

0.00% 0.00% 0.00% 0.00% 0.00% 27.37% 42.43% 69.80% 12.30%

0.00% 0.00% 0.00% 0.00% 0.00% 39.21% 60.79% 100.00% 24.62%

0.00% 0.00% 0.00% 0.00% 0.00% 51.28% 91.00% 69.80% 52.88%

0 0 0 0 0 1,221 197 1,418 13,614

0.00% 0.00% 0.00% 0.00% 0.00% 26.01% 4.20% 30.20% 10.96%

0.00% 0.00% 0.00% 0.00% 0.00% 86.11% 13.89% 100.00% 21.95%

0.00% 0.00% 0.00% 0.00% 0.00% 48.72% 9.00% 30.20% 47.12%

0 0 00 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 0 0 0 0 2,506 2,189 4,695 28,893

0.00% 0.00% 0.00% 0.00% 0.00% 53.38% 46.62% 100.00% 23.26%

0.00% 0.00% 0.00% 0.00% 0.00% 53.38% 46.62% 100.00% 23.26%

0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 100.00% 100.00% 100.00%

142

Table 18A. FOREIGN Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2004 and Reported in FY2005: Percent 

Analysis

Female

Male

Unknown

Total Number of 

Protocols with Enrollment 

Data: 

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

Total

Total of All Subjects by Race

Female 

Male 

Unknown 

TOTAL

Number of Protocols with 

Enrollment Data: 

Total of All Subjects by Race Total of All Subjects by Ethnicity
25

American 

Indian/ Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown/

Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

0 108,311 2,858 1,917 7,315 4,391 124,792 113,086

0.00% 61.20% 1.61% 1.08% 4.13% 2.48% 70.51% 63.90%

0.00% 86.79% 2.29% 1.54% 5.86% 3.52% 100.00% 90.62%

0.00% 76.82% 58.11% 45.13% 40.61% 49.80% 70.51% 75.31%

0 32,640 2,060 1,625 8,324 4,427 49,076 36,325

0.00% 18.44% 1.16% 0.92% 4.70% 2.50% 27.73% 20.52%

0.00% 66.51% 4.20% 3.31% 16.96% 9.02% 100.00% 74.02%

0.00% 23.15% 41.89% 38.25% 46.21% 50.20% 27.73% 24.19%

0 37 0 706 2,375 0 3,118 743

0.000% 0.02% 0.00% 0.40% 1.34% 0.00% 1.76% 0.42%

0.00% 1.19% 0.00% 22.64% 76.17% 0.00% 100.00% 23.83%

0.00% 0.03% 0.00% 16.62% 13.18% 0.00% 1.76% 0.49%

0 140,988 4,918 4,248 18,014 8,818 176,986 150,154

0.00% 79.66% 2.78% 2.40% 10.18% 4.98% 100.00% 84.84%

0.00% 79.66% 2.78% 2.40% 10.18% 4.98% 100.00% 84.84%

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

Data Table Comments: 

Sex/Gender: 

More females (186,858 or 62%) than males (111,110 or 37%) are enrolled in aggregate foreign intramural research protocols. 

More minority females (128,365 or 71.7%) than minority males (49,939 or 27.9%) are enrolled in aggregate foreign intramural research protocols. 

Minority: 

Approximately 59.4% (179,047) of participants in aggregate foreign intramural research (301,212) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 75.1% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 79.6% following the 1977 OMB standards.

Largest identified racial minority group is Asian at 15.2% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0%.

According to the 1997 OMB standards, the smallest identified racial minority groups are Hawaiian/Pacific Islander and American Indian/Alaska Native at 0.01%.

Ethnicity: 

3.8% 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 53.4% 

Remaining participants identified the racial category of Unknown/Other at 46.6%

Of the 4,695 participants, 69.8% are women and 30.2% are men. 

10.2% of participants identified as Hispanic according to the 1977 OMB standards. 

143

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 23,108 15,329 66.34% 27

% 54.79% 47.99%

Males 16,523 14,075 85.18%

% 39.17% 44.06%

Unknown 2,547 2,539 99.69%

% 6.04% 7.95%

TOTAL 42,178 31,943 75.73%

Total % 100% 100.00%

23

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

381 2,767 11,016 0 6,657 0 401 21,222 20,570 613 39 21,222

0.98% 7.15% 28.45% 0.00% 17.19% 0.00% 1.04% 54.81% 53.13% 1.58% 0.10% 54.81%

1.80% 13.04% 51.91% 0.00% 31.37% 0.00% 1.89% 100.00% 96.93% 2.89% 0.18% 100.00%

97.94% 64.77% 42.60% 0.00% 87.87% 0.00% 64.26% 54.81% 54.08% 98.24% 61.90% 54.81%

8 1,470 12,339 0 917 0 223 14,957 14,922 11 24 14,957

0.02% 3.80% 31.87% 0.00% 2.37% 0.00% 0.58% 38.63% 38.54% 0.03% 0.06% 38.63%

0.05% 9.83% 82.50% 0.00% 6.13% 0.00% 1.49% 100.00% 99.77% 0.07% 0.16% 100.00%

2.06% 34.41% 47.72% 0.00% 12.10% 0.00% 35.74% 38.63% 39.23% 1.76% 38.10% 38.63%

0 35 2,504 0 2 0 0 2,541 2,541 0 0 2,541

0.00% 0.09% 6.47% 0.00% 0.01% 0.00% 0.00% 6.56% 6.56% 0.00% 0.00% 6.56%

0.00% 1.38% 98.54% 0.00% 0.08% 0.00% 0.00% 100.00% 100.00% 0.00% 0.00% 100.00%

0.00% 0.82% 9.68% 0.00% 0.03% 0.00% 0.00% 6.56% 6.68% 0.00% 0.00% 6.56%

389 4,272 25,859 0 7,576 0 624 38,720 38,033 624 63 38,720

1.00% 11.03% 66.78% 0.00% 19.57% 0.00% 1.61% 100.00% 98.23% 1.61% 0.16% 100.00%

1.00% 11.03% 66.78% 0.00% 19.57% 0.00% 1.61% 100.00% 98.23% 1.61% 0.16% 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 

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

380 0 0 0 1 0 232 613 14,397

60.90% 0.00% 0.00% 0.00% 0.16% 0.00% 37.18% 98.24% 37.18%

61.99% 0.00% 0.00% 0.00% 0.16% 0.00% 37.85% 100.00% 67.84%

97.94% 0.00% 0.00% 0.00% 25.00% 0.00% 100.00% 98.24% 46.81%

8 0 0 0 3 0 0 11 13,820

1.28% 0.00% 0.00% 0.00% 0.48% 0.00% 0.00% 1.76% 35.69%

72.73% 0.00% 0.00% 0.00% 27.27% 0.00% 0.00% 100.00% 92.40%

2.06% 0.00% 0.00% 0.00% 75.00% 0.00% 0.00% 1.76% 44.93%

0 0 0 0 0 0 0 0 2,539

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 6.56%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 99.92%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 8.26%

388 0 0 0 4 0 232 624 30,756

62.18% 0.00% 0.00% 0.00% 0.64% 0.00% 37.18% 100.00% 79.43%

62.18% 0.00% 0.00% 0.00% 0.64% 0.00% 37.18% 100.00% 79.43%

100.00% 0.00% 0.00% 0.00% 100.00% 0.00% 100.00% 100.00% 100.00%

144

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

Female 

Male 

Unknown 

Total

Total of All Subjects by Race

TOTAL

Table 19A. FOREIGN Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2004 and Reported in FY2005: 

Percent Analysis

Number of Protocols with 

Enrollment Data: 

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

Female

Male

Unknown

Total Number of Protocols 

with Enrollment Data: 
4

American 

Indian/ Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

0 3 0 929 951 3 1,886 932

0.00% 0.09% 0.00% 26.87% 27.50% 0.09% 54.54% 26.95%

0.00% 0.16% 0.00% 49.26% 50.42% 0.16% 100.00% 49.42%

0.00% 100.00% 0.00% 78.53% 42.14% 21.43% 54.54% 78.52%

0 0 1 254 1306 5 1,566 255

0.00% 0.00% 0.03% 7.35% 37.77% 0.14% 45.29% 7.37%

0.00% 0.00% 0.06% 16.22% 83.40% 0.32% 100.00% 16.28%

0.00% 0.00% 100.00% 21.47% 57.86% 35.71% 45.29% 21.48%

0 0 00 0 6 6 0

0.000% 0.00% 0.00% 0.00% 0.00% 0.17% 0.17% 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% 42.86% 0.17% 0.00%

0 3 1 1,183 2,257 14 3,458 1,187

0.00% 0.09% 0.03% 34.21% 65.27% 0.40% 100.00% 34.33%

0.00% 0.09% 0.03% 34.21% 65.27% 0.40% 100.00% 34.33%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in foreign extramural Phase III research protocols reported in FY2005.

More females (23,108 or 54.8%) than males (16,523 or 39.17%) are enrolled in aggregate foreign extramural Phase III research protocols. 

More minority females (15,329 or 47.9%) than minority males (14,075 or 44.1%) are enrolled in aggregate foreign extramural Phase III research protocols. 

Minority: 

Approximately 76% (31,943) of participants in aggregate foreign extramural Phase III research (42,178) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 65.2% following the 1977 OMB standards.

Largest identified racial minority group is Hispanic at 34.2% following the 1977 OMB standards. 

Largest identified racial minority group is Black at 66.8% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0%.

Ethnicity: 

1.6% 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 37.8%

Smallest identified racial group is White at 0.6%

Of the 624 participants, 98.25% are women and 1.8% are men. 

34.2% of participants identified as Hispanic according to the 1977 OMB standards. 

145

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
4

American 

Indian/ Alaska 

Native

Asian/ Pacific 

Islander

Black or 

African 

American

Hispanic White Unknown 

/Other Total

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

0 3 0 929 951 3 1,886 932

0.00% 0.09% 0.00% 26.87% 27.50% 0.09% 54.54% 26.95%

0.00% 0.16% 0.00% 49.26% 50.42% 0.16% 100.00% 49.42%

0.00% 100.00% 0.00% 78.53% 42.14% 21.43% 54.54% 78.52%

0 0 1 254 1306 5 1,566 255

0.00% 0.00% 0.03% 7.35% 37.77% 0.14% 45.29% 7.37%

0.00% 0.00% 0.06% 16.22% 83.40% 0.32% 100.00% 16.28%

0.00% 0.00% 100.00% 21.47% 57.86% 35.71% 45.29% 21.48%

0 0 00 0 6 6 0

0.000% 0.00% 0.00% 0.00% 0.00% 0.17% 0.17% 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% 42.86% 0.17% 0.00%

0 3 1 1,183 2,257 14 3,458 1,187

0.00% 0.09% 0.03% 34.21% 65.27% 0.40% 100.00% 34.33%

0.00% 0.09% 0.03% 34.21% 65.27% 0.40% 100.00% 34.33%

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

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in foreign extramural Phase III research protocols reported in FY2005. 

More females (23,108 or 54.8%) than males (16,523 or 39.17%) are enrolled in aggregate foreign extramural Phase III research protocols. 

More minority females (15,329 or 47.9%) than minority males (14,075 or 44.1%) are enrolled in aggregate foreign extramural Phase III research protocols. 

Minority: 

Approximately 76% (31,943) of participants in aggregate foreign extramural Phase III research (42,178) are classified as U.S. minorities. 

Race: 

Largest identified racial group is White at 65.2% following the 1977 OMB standards.

Largest identified racial minority group is Hispanic at 34.2% following the 1977 OMB standards. 

Largest identified racial minority group is Black at 66.8% following the 1997 OMB standards.

According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaska native at 0%.

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific islander at 0%.

Ethnicity: 

1.6% 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 37.8%

Smallest identified racial group is White at 0.6%

Of the 624 participants, 98.25% are women and 1.8% are men. 

34.2% of participants identified as Hispanic according to the 1977 OMB standards. 

145

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Rthnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols with 

Enrollment Data: 
I. SUMMARY TOTALS: Old Form + New Form

Sex 

/Gender

Total 

Enrollment

Minority 

Enrollment

Total % 

Minority

% Minority 

by Sex

Females 6,280 6,022 95.89% 3

% 48.61% 48.81%

Males 6,640 6,316 95.12%

% 51.39% 51.19%

Unknown 0 0 0%

% 0.00% 0.00%

TOTAL 12,920 12,338 95.50%

Total % 100% 100.00%

2

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

0 0 52 0 0 0 258 310 52 0 258 310

0.00% 0.00% 7.75% 0.00% 0.00% 0.00% 38.45% 46.20% 7.75% 0.00% 38.45% 46.20%

0.00% 0.00% 16.77% 0.00% 0.00% 0.00% 83.23% 100.00% 16.77% 0.00% 83.23% 100.00%

0.00% 0.00% 58.43% 0.00% 0.00% 0.00% 44.33% 46.20% 58.43% 0.00% 44.33% 46.20%

0 0 37 0 0 0 324 361 37 0 324 361

0.00% 0.00% 5.51% 0.00% 0.00% 0.00% 48.29% 53.80% 5.51% 0.00% 48.29% 53.80%

0.00% 0.00% 10.25% 0.00% 0.00% 0.00% 89.75% 100.00% 10.25% 0.00% 89.75% 100.00%

0.00% 0.00% 41.57% 0.00% 0.00% 0.00% 55.67% 53.80% 41.57% 0.00% 55.67% 53.80%

0 0 0 0 0 0 0 00 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%

0 0 89 0 0 0 582 671 89 0 582 671

0.00% 0.00% 13.26% 0.00% 0.00% 0.00% 86.74% 100.00% 13.26% 0.00% 86.74% 100.00%

0.00% 0.00% 13.26% 0.00% 0.00% 0.00% 86.74% 100.00% 13.26% 0.00% 86.74% 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 

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

0 0 00 0 0 0 0 52

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 7.75%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 16.77%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 58.43%

0 0 00 0 0 0 0 37

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 5.51%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 10.25%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 41.57%

0 0 00 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 0 00 0 0 0 0 89

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 13.26%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 13.26%

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00%

146

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

Female 

Male 

Unknown 

Total

Total of All Subjects by Race

TOTAL

Table 20A. FOREIGN Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2004 and Reported in FY2005: 

Percent Analysis

Number of Protocols with 

Enrollment Data: 

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

Female

Male

Unknown

Total Number of 

Protocols with 

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 

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%

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%

0 0 00 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%

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%

Data Table Comments: 

Sex/Gender: 

Substantial numbers of women and minorities are enrolled in intramural Phase III research protocols reported in FY2005. 

More males (6,640 or 51.4%) than females (6,280 or 48.6%) are enrolled in aggregate foreign intramural Phase III research protocols. 

More minority males (6,316 or 51.2%) than minority females (6,022 or 48.8%) are enrolled in aggregate foreign intramural Phase III research protocols. 

Minority:

Approximately 95% (12,338) of participants in aggregate foreign intramural Phase III research (12,920) are classified as U.S. minorities. 

Race: 

Largest identified racial group is Unknown/Other at 86.7% following the 1997 OMB standards.

Largest identified racial minority group is Asian/Pacific Islander at 100% following the 1977 OMB standards (1 study).

Largest identified racial minority group is Black at 13.3% following the 1997 OMB standards. 

Ethnicity: 

0% of participants identified their ethnicity as Hispanic or Latino following the 1977 and 1997 OMB standards. 

147

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)

Male

Typeface: Percentage of Total No. of Participants sorted by 

Race/Ethnicity (Column Total)

Unknown

Total

Legend

Female

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

Number of Protocols 

with Enrollment Data: