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

 

NIH Tracking/Inclusion Committee

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

Office of Research on Women’s Health

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

National Heart, Lung, and Blood Institute

Angela C. Bates, M.B.A.

Office of Research on Women’s Health

Carlos E. Caban, Ph.D. 

Liaison, Office of Extramural Research

Kim Jarema 

Liaison, Office of Intramural Research 

May 2004 

Comprehensive Report: 

Tracking of Human Subjects Research 

Reported in FY 2002 and FY 2003 
Table of Contents

Background Information and Current Activities 

Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in 

Clinical Research ............................................................................................................................. 1 

Summary Report of NIH Inclusion Data 

(Funded in FY 2001 & Reported in FY 2002) and (Funded in FY 2002 & Reported in FY 2003) .......... 13 

Aggregate Data Tables Page

 (Available at http://www4.od.nih.gov/orwh/DataTables_FY2002-2003.pdf ) 

Table A. Level of Compliance with Inclusion Policy in New Extramural Grant Applications as 

Assessed During Scientific Peer Review for the Fiscal Period 2002-2003 ...................... 15 

Table B. Extramural Research Awards Funded for the Fiscal Period 2002-2003:

Bars to Funding and Resolutions...................................................................................... 16 

Table C. Inclusion by Sex in All Research Studies Active and Funded in FY 2001 & Reported 

in FY 2003 ........................................................................................................................ 17 

Table C-1. Examples of Single Sex Extramural Research Studies 

Funded in FY 2003 ........................................................................................................... 18 

Table 1. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2002 

& Reported in FY 2003 ...............................................................................................19-20 

Table 1A. Percent Analysis for All Extramural Research Protocols Funded in FY2002 

 & Reported in FY2003................................................................................................21-22 

Table 2. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2001 

& Reported in FY 2002 ...............................................................................................23-24 

Table 3. Aggregate Enrollment Data for All Extramural Research Protocols Excluding 

Male-Only & Female-Only Protocols Funded in FY 2002 & Reported in FY 2003...25-26 

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

Male-Only & Female-Only Protocols Funded in FY 2001 & Reported in FY 2002...27-28 

Table 5. Aggregate Enrollment Data for Extramural Phase III Protocols Funded in FY 2002 

& Reported in FY 2003 ...............................................................................................29-30 

Table 5A. Percent Analysis for Extramural Phase III Protocols Funded in FY2002 & Reported in 

FY2003...............................................................................................................31-32 

Table 6. Aggregate Enrollment Data for Extramural Phase III Protocols Funded in FY 2001 

& Reported in FY 2002 ...............................................................................................33-34 

Table 7. Aggregate Enrollment Data for Phase III Research Protocols Excluding 

Male-Only & Female-Only Protocols Funded in FY 2002 & Reported in FY 2003...35-36 

Table 8. Aggregate Enrollment Data for Phase III Research Protocols Excluding 

Male-Only & Female-Only Protocols Funded in FY 2001 & Reported in FY 2002...37-38

Table 9. Aggregate Enrollment Data for Intramural Research Protocols 

Funded in FY 2002 and Reported in FY 2003.............................................................39-40 

Table 10. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2001 and 

Reported in FY 2002 (Includes On-site and Off-site) .................................................41-42 

1 
Table of Contents - continued

Page

Appendix A Explanation of Gender and Minority Codes .................................................................... 45 

 

Appendix B NIH Tracking and Inclusion Committee Members .......................................................... 47 

Appendix C Internet Homepage: Inclusion of Women and Minorities Policy Implementation ........... 52 

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

Subjects in Clinical Research - Amended, October, 2001................................................ 54 

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

Research............................................................................................................................ 69 

Appendix F NIH Inclusion Tables for Target and Enrollment Data .................................................... 81 

2 
Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research

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=s administrative 

procedures allow consideration of applications through a peer-review system. During initial peer review, 

the Scientific Review Group (SRG) evaluates the proposed enrollment of each project involving human 

subjects and determines whether the plan to include women and minority subjects is scientifically

acceptable. The implementation plan determines that an application may be unacceptable if it: 1) fails to 

provide sufficient information about target enrollment; 2) does not adequately justify limited or lack of 

inclusion of women or minorities; or 3) does not realistically address recruitment and retention. For NIH1 
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 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 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, 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://www4.od.nih.gov/orwh/outreach.pdf. 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 ARecruitment and Retention of Women in Clinical Studies."

2 
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 

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 Research3

. It concludes 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. 

3 
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 NIH-defined 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. (See Appendix F) 

4 
` 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 NIH-defined 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 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. 

Implementation of Training Activities Ensuring Compliance with the Policy 

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. Since August 2000, several training initiatives have been 

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 in October 2000. This 

symposium focused on the updated human subjects policy and the way in which it would 

be implemented. The training session included a question and answer session that 

provided an opportunity to emphasize the importance of the policy and the importance of 

reviewer evaluation of the changes related to valid analyses in Phase III clinical trials. 

About 450 were in attendance, 400 viewed the session at satellite centers and another 175 

participated through videocast. The training materials are permanently archived in the 

5 
training materials for NIH staff at: 

http://odoerdb2.od.nih.gov/oer/training/esa/human_subjects/esa_hs_symposium.htm. 

# An additional training session regarding a Grants Policy Update: Humans and Animals 

was held. Several hundred additional extramural and intramural researchers were trained. 

The inclusion of human subjects in clinical research studies was included among the 

topics addressed during the session. The training materials may be found at the following 

web address: 

http://odoerdb2.od.nih.gov/oer/training/esa/grants_policy_update/esa_grants_policy_upd

ate.htm.

# The NIH Tracking and Inclusion Committee held a training session for all NIH program

and grants management staff to discuss with members of the technical team, data entry

and collection issues regarding the current population tracking system and IMPAC II as 

well as offer suggestions for the development of the new population tracking module. 

# NIH issued the newly revised Applications for a DHHS Public Health Service Grant 

(PHS 398, rev. 5/01). The instructions in the PHS 398 (rev. 5/01) describe the 

requirements for designing Phase III clinical trails to provide valid analysis by sex/gender 

and race/ethnicity. These instructions continue to be the most frequently accessed NIH 

documents by the research, review, and NIH staff communities. 

# A videocast training session was held on “Sex/Gender and Minority Inclusion in Clinical 

Research.” This session was developed for all program, grants management, review and 

contract staff who administer clinical research and provided information on the updated 

policies and procedures on sex/gender and minority inclusion. A comprehensive training 

manual explaining the new policies and procedures was developed as a training resource. 

The training session and manual is electronically available for all NIH staff. 

# An additional training session, “Inclusion of Children, Women, and Minorities: What 

SRA’s and Reviewers Need to Know!” was held for the Center for Scientific Review on 

the updated policies and procedures on sex/gender and minority inclusion. This session 

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. 

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: 

# In 2002, NIH staff presented “Sex/Gender and Minority Inclusion in NIH Clinical 

Research: What Investigators Need to Know!”, an hour workshop on the revised 

inclusion policy and OMB requirements at two NIH Regional Seminar meetings. Each 

6 
meeting involved 400 extramural scientists and administrators. An additional presentation 

was made to faculty and students at the NIH Warren G. Magnusen Clinical Center. 

# The slide show for “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. 

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

# The Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as 

Subjects in Clinical Research was revised and published in the fall of 2002. The revised 

Outreach Notebook, available to the research community and NIH staff, discusses the 

elements of Outreach, the updated 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://www4.od.nih.gov/orwh 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 Questions and Answers section of the Outreach Notebook for the NIH 

Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research has 

been revised as a separate document called Frequently Asked Questions (FAQs) for the 

Inclusion , Recruitment and Retention of Women and Minority Subjects in Clinical 

Research. This document 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://www4.od.nih.gov/orwh 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. Initial 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 an NIH computerized 

tracking system since fiscal year 1994 and tracking the inclusion of women and minorities in clinical 

trials has been implemented in all ICs. The NIH Tracking and Inclusion Committee continues to work on

ways to refine and improve data collection methods and the quality of the data entered by each IC into 

this system. The NIH Subcommittee Reviewing Inclusion Issues also collected comments on the tracking 

system used prior to 2000 and identified issues relating to data entry, including quality control and the 

7 
mechanisms of data entry. 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 for NIH staff, creates clear and timely NIH reports on inclusion data, 

incorporates the 1997 OMB Office of Management and Budget (OMB) standards for the classification of 

federal data on race and ethnicity, and is consistent with the newly revised PHS Form 398 and PHS Form

2590 (revised May, 2001). 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 new system, recommend improvements and modifications, and provide feedback related to system

use. The re-engineered population tracking system continues to be refined based on input from the NIH 

user community. 

# In May 2002, NIH published an on-line users guide and began offering 2-hour Population 

Tracking System demonstrations to accompany the launch of the new system. 

# Since July 2002, 3-hour, in-depth, hands-on training sessions have been provided to NIH 

staff on the use of the new population tracking system. Training materials for the handson course are available electronically to NIH staff as resource material. 

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

about gaps in enrollment and to design studies to respond to those questions. Aggregate data are reported 

annually by Fiscal Year (FY). 

New Method Implemented Beginning with Data for Funding in FY2001 and Reported in FY 2002

The data tables for FY 2002 (reported in FY 2003) are produced from the current NIH population 

tracking system that stores and reports data based on the fiscal year in which data are reported to NIH as 

part of the annual progress report. The FY 2002 (reported in FY 2003) tables reflect data submitted to 

NIH in FY 2003 as part of the annual progress report and reflects cumulative enrollment through FY 2002 

and through the time when the progress report was submitted to NIH. In addition, the FY 2002 (reported 

in FY 2003) tables describe data using both the 1977 and 1997 OMB standards for reporting data on race 

and ethnicity. The 1997 OMB standards involve a number of changes including: collecting and reporting 

information on ethnicity and race separately; using the new definitions and categories for ethnicity and 

race; allowing respondents the option of selecting more than one race; and reporting the number of 

respondents who selected more than one race, as well as the number selecting only one racial category.

The introduction of the 1997 OMB reporting format does not allow aggregation 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. Also, the FY 2002 (reported in FY 2003) data reflect 

current changes in the standardization of definitions and business rules across the NIH for improving the 

data entered in the population tracking system. While this transition period makes comparisons with prior 

FY data difficult, implementation of these changes will improve the consistency and comparability with 

future reporting. 

A review of intramural inclusion data indicates that the intramural research program is 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 

8 
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. The Clinical Center is also 

actively engaged in outreach to minority groups to encourage participation in intramural clinical research. 

Conclusion 

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. 

9 
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., ADemographics of Study Populations@,

Applied Clinical Trials, Vol. 6, No. 1, p. 41-45, 1997. 

6. Hayunga, E. G. and Pinn V. W., AImplementing the 1994 NIH Guidelines@, Applied 

Clinical Trials, Vol. 5, No. 10, p. 34-40, 1996. 

7. Hayunga, E. G. and Pinn V. W., ANIH 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., AIncluding Women and Minorities 

in Clinical Research@, Applied Clinical Trials, Vol. 4, No. 5, p. 31-38, 1995. 

9. McCarthy, C. R., AHistorical Background of Clinical Trials Involving Women and 

Minorities@, Academic Medicine, Vol. 69, No. 9, p. 695-698, 1994. 

10. Pinn, V. W., AThe 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: 

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://www4.od.nih.gov/orwh/fy97-98trkg.pdf

10 
Aggregate Enrollment Data Tables 

For Extramural and Intramural 

Research Protocols 

Funded in Fiscal Year 2001 & Reported in FY 2002 

Funded in Fiscal Year 2002 & Reported in FY 2003 

Pages 15-42 available at 

http://www4.od.nih.gov/orwh/DataTables_FY2002-2003.pdf 

11 
12 
Summary Report of NIH Inclusion Data

NIH Aggregate Extramural and Intramural Population Data 

Funded in FY 2001 & Reported in FY 2002 and Funded in FY 2002 & Reported in FY 2003 

Tables 1 to 10 provide aggregate enrollment data for extramural and intramural research protocols funded 

in FY 2002 and FY 2003. Previous inclusion reports and aggregate enrollment figures for FY 1994

through FY2002 for women, men and minority groups may be found on the ORWH website at 

http://od.nih.gov/orwh/inclusion.html. 

Analysis of the FY 2001 (reported in FY 2002) and FY 2002 (reported in FY 2003) inclusion data show 

that substantial numbers of women, non-minority men, and minorities have been included as research 

subjects in Phase III clinical trials and other human subject research studies, in both intramural and 

extramural programs. Overall, approximately 94% of applications involving human subjects met the 

inclusion requirements as submitted to the Initial Review Group [see Table A]. Of those selected for 

award in FY 2002, more than 96% were determined to have met the inclusion requirements as submitted. 

All of the remaining 4% of applications were required to address and to resolve satisfactorily any issues 

pertaining to the inclusion requirements prior to funding [see table B]. 

Aggregate enrollment data for extramural Phase III trials funded in FY 2002 (reported in FY 2003) show 

that approximately 55.8% of the subjects were women. Of the 628 extramural Phase III research protocols 

that continue to report following the 1977 OMB standards, minority representation was highest for Black 

(not Hispanic) subjects (11.6%) and lowest for American Indian/Alaska Native at 0.4%. Hispanic subjects 

comprised approximately 10%, Asian/Pacific Islander subjects were 1.84% and White (not Hispanic) 

subjects were 77.2%. The categories Hawaiian/Pacific Islander and More Than One Race were not 

designations with the 1977 OMB standards and therefore, no data were reported in these categories. 

Accordingly, 205 extramural Phase III research protocols submitted data following the 1997 OMB 

standards for reporting race and ethnicity. Minority representation by race was highest for Black subjects 

(28.23%) and lowest for Hawaiian/Pacific Islander (0.2%). Asian subjects comprised 3.99% of 

participants, American Indian/Alaska Native subjects were 0.51% and White subjects were 55.4%. 1.54%

of the participants identified More Than One Race for their racial category. Of the 205 extramural Phase 

III research protocols designating an ethnicity, 76.9% of the subjects identified a racial category and an 

ethnicity of not Hispanic. Whereas, 10% identified a racial category and an ethnic category of 

Hispanic/Latino. 13.1% participants identified a racial category but did not report an ethnicity or 

Unknown ethnicity.

Over 12 million subjects were included in the research projects covered by the tracking system in FY 

2002 (reported in FY 2003). A snapshot of the aggregate enrollment data [Table 1] shows that 

approximately 60.7% of the subjects were women, approximately 38.3% were men, and approximately

0.9% did not identify a sex/gender. Extramural studies funded in FY 2002 (reported in FY2003) [Table 

2] show that approximately 68.1% of the subjects were women, approximately 31.2% were men, and 

approximately 0.7% did not provide sex/gender identification. Overall, the number of women

participants decreased by 7.4%, the number of men increased by 7.1% and the number of subjects that did 

not identify their sex/gender increased by 0.2% comparatively. However, when sex-specific studies were 

excluded for FY 2002 (reported in FY 2003), the proportions of subjects were proportional to the 

percentages of the general population, 50.6% women and 48.1% men respectively. 

Changes in percentages between FY 2002 and FY 2003 were attributable to the ending of previously

reported studies where enrollments ranged from 20,000 to 300,000 participants per study. Although other 

13 
new studies have been launched in FY 2002, enrollment for these new studies is just beginning. Another 

reason for the fluctuations between FY 2002 and FY 2003 enrollment percentages is the improved 

reporting and corrections of errors by investigators. Recognizing that information on sex/gender and 

ethnicity/race is obtained voluntarily from study participants, some participants will elect not to report 

this information, i.e. the data are recorded as “Unknown.” 

Approximately 1.8 million subjects were included in the tracking system from intramural research 

projects in FY 2002 (reported in FY2003). Intramural studies funded and reported in FY 2003 [Table 9]

show that approximately 47.5% of intramural subjects were women and approximately 51.6% were men. 

Among minority subjects, representation in intramural studies was highest for Asian subjects at 10.5% 

and lowest for American Indian/Alaskan native subjects (1.01%) following the 1977 OMB standards. 

Hispanic subjects represented approximately 3.12%; Black subjects 5.65%; and White (not Hispanic) 

subjects represented 40.5% of the intramural research study population following the 1977 OMB 

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

with the 1977 OMB standards and therefore, no data were reported in these categories. 

Likewise, 156 intramural research protocols submitted data following the 1997 OMB standards for 

reporting race and ethnicity. Minority representation was highest for Black subjects (17.34%) and lowest 

for Hawaiian/Pacific Islander subjects (0.03%). Asian subjects comprised 5.81% of participants and 

White subjects were 70.5% of the intramural participants. Of the 156 intramural research protocols 

designating an ethnicity, 5.26% identified themselves as Hispanic/Latino. 92.8% of the subjects identified 

their ethnicity as not Hispanic and 1.91% participants identified a racial category but did not report an 

ethnicity or Unknown ethnicity. 

Aggregate data tables available at http://www4.od.nih.gov/orwh/DataTables_FY2002-2003.pdf 

14 
15 
APPENDICES 
44
45

Appendix A

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 AU@ (unacceptable) code it automatically receives a bar-to-funding as well. If the 

bar is removed, the AU@ is converted to AR@ to designate that change in status. 
46
47

Appendix B 

NIH Tracking and Inclusion Committee Members 

- Full Committee 
48
49 

NIH Tracking and Inclusion Committee 

List of Members 

Year 2002-2003 (updated 3/30/2004)

Office of the Director

Yvonne Maddox 

Office of Research on Women=s Health

Vivian Pinn (Co-Chair), Angela Bates, Lisa Begg, Joyce Rudick

Office of Extramural Research

Carlos Caban*, Melissa Hirsch, Dan Hall 

Office of Acquisition, Management and Procurement 

 Zaiga Tums, Barbara Levy, Joann Wingard

National Cancer Institute

Margaret Holmes*, Diane Bronzert, Marilyn Gaston, Joe Harford, Kim Witherspoon 

National Eye Institute

Lore Anne McNicol*, William Darby 

National Heart, Lung, and Blood Institute

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

National Human Genome Research Institute

Karen DeLeon*, Susan Saylor 

National Institute on Aging 

Miriam Kelty *, Karen Bashir 

National Institute on Alcohol Abuse and Alcoholism

Dorita Sewell *, Carmen Richardson 

National Institute of Allergy and Infectious Diseases

Marie Parker*, Lai Tan , Diane Adger-Johnson, Susan Schafer, Christine Beachley, Joyce Woodford, 

Diane Yerg, Martin Gutierrez 

National Institute of Arthritis and Musculoskeletal and Skin Diseases

 Charisse Lamar*, Julia Freeman 

National Institute of Child Health and Human Development

 Michael Whalin,*, Sandra Occhipinti

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
50 

List of Members, continued...

National Institute on Deafness and Other Communication Disorders

Julie Gulya*, Sue Hamilton, Karen Boone, Lana Shekim

National Institute of Dental and Craniofacial Research

Richard Mowery*, Trenita Davis

National Institute of Diabetes, Digestive and Kidney Disorders

Patricia Robuck*, Lauren Meskill, Donna James, Todd Le

National Institute on Drug Addiction

Jack Manischewitz *, Mark Swieter 

National Institute of Environmental Health Sciences

Martha Barnes * 

National Institute of General Medical Sciences

John Matala *, Alison Cole 

National Institute of Mental Health

Michelle Parker*, Catherine Roca, Mary Lou Prince, Ernesto Marquez, Pamela Wexler, Sue Kennel 

National Institute of Neurological Disorders and Stroke

 Mary Ellyn Michel*, Connie Atwell, Frances Yee 

National Institute of Nursing Research

Janice Phillips*, Christian Shaw 

National Library of Medicine

Rita Richey *, Dwight Mowery 

Warren G. Magnuson Clinical Center

Kim Jarema *, Dee Koziol 

National Center for Complementary and Alternative Medicine

 April Bowers* 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
51 

List of Members, continued...

National Center for Research Resources

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

Fogarty International Center

Laura Rowe*, Aron Primack 

Center for Scientific Review 

Anita Miller Sostek* 

Office of Intramural Research

Alan Sandler 

National Center for Minority Health and Health Disparities

Eric Bailey*, John Ruffin, Tommy Broadwater 

National Institute of Biomedical Imaging and Bioengineering

Meredith Temple*, Tinera Fobbs, Yinka Abu 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee 
52 

Appendix C 

Internet Homepage: 

Inclusion of Women and Minorities Policy Implementation 

http://grants.nih.gov/grants/funding/women_min/women_min.htm
53 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

NATIONAL INSTITUTES OF HEALTH 

Office of Extramural Research 

Inclusion of Women and Minorities Policy Implementation 

Current Policy Documents and References:

• 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. 

• 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. 5/01) and PHS 2590 (rev. 5/01) 

instructions and forms. 

• Inclusion Table (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. 

• Women's Inclusion as Participants in Research - Page from the Office of Research on Women's Health (ORWH) 

Web site. 

• Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical 

Research - To help investigators to understand and comply with the NIH's inclusion policies, the ORWH collaborated 

in the preparation and publication of this Notebook, available here in Adobe Acrobat (PDF) format. This publication 

contains two appendices. Appendix A summarizes the inclusion guidelines; Appendix B contains sample questions 

and answers to assist investigators in preparing their applications in accordance with the inclusion guidelines. 

OUTREACH NOTEBOOK (Pages 1-39 of PDF file) 

INCLUSION GUIDELINES (Pages 40-51 of PDF file) 

QUESTIONS AND ANSWERS (Pages 52-87 of PDF file) 

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. 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 
54 

Appendix D 

NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as 

Subjects in Clinical Research 

(Amended, October, 2001) 
55 

NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND 

MINORITIES AS SUBJECTS IN CLINICAL RESEARCH BB 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/noticefiles/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 ). 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 NIH-defined 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. Patientoriented 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: 

(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: 
56 

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) 

(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 
57 

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 NIH-supported 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-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 
58 

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. 

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 
59 

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 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, 
60 

• 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 
61 

• 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 

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 HealthDivision of Acquisition Policy and EvaluationOffice of Acquisition Management 

and Policy6100 Executive Boulevard, Room 6C01Phone: 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 the purpose of evaluating 
62 

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, nonpharmacologic, 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 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 
63 

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 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 
64 

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: 

Dr. Marvin Kalt 

National Cancer Institute 

Executive Plaza North 

6116 Executive Boulevard, Suite 8001 

Bethesda, MD 20892 

Telephone: (301) 496-5147 

Email: kaltm@dea.nci.nih.gov

Dr. Lore Anne McNicol 

National Eye Institute 

Executive Plaza South 

6120 Executive Boulevard, Room 350 

Rockville, MD 20892 

Telephone: (301) 496-5301 

Email: loreanne.mcnicol@nei.nih.gov
65 

Ms. Sharry Palagi 

National Heart, Lung and Blood Institute 

Building 31 

31 Center Drive, Room 5A-07 

Bethesda, MD 20892 

Telephone: (301) 402-3424 

Email: palagis@nih.gov

Dr. Miriam Kelty 

National Institute on Aging 

Gateway Building 

7201 Wisconsin Avenue, Room 2C218 

Bethesda, MD 20892 

Telephone: (301) 496-9322 

Email: keltyM@nia.nih.gov

Dr. Lorraine Gunzerath 

National Institute on Alcohol Abuse and Alcoholism 

Willco Building 

6000 Executive Boulevard, Suite 409 

Rockville, MD 20892 

Telephone: (301) 443-2369 

Email: lgunzera@mail.nih.gov 

Dr. John McGowan 

National Institute of Allergy and Infectious Diseases 

6700 B Rockledge 6700 Rockledge Drive 

Bethesda, MD 20817 

Telephone: (301) 496-7291 

Email: jm80c@nih.gov 

Dr. Julia Freeman 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

Natcher Building 

Building 45, Room 5AS19F 

Bethesda, MD 20892 

Telephone: (301) 594-4543 

Email: freemanj@ep.niams.nih.gov

Dr. Susan Streufert 

National Institute of Child Health and Human Development 

6100 Executive Boulevard 

Building 61EB, Room 4A05 

Bethesda, MD 20892 

Telephone: (301) 435-6856 

Email: streufes@mail.nih.gov 
66 

Dr. Julie Gulya 

National Institute on Deafness and Other Communication Disorders 

Executive Plaza South 

6120 Executive Boulevard, Room 400D-7 

Rockville, MD 20892 

Telephone: (301) 435-4085 

Email: gulyaj@ms.nidcd.nih.gov

Dr. Norman S. Braveman 

National Institute on Dental and Craniofacial Research 

Natcher Building 

Building 45, Room 4AN24C 

Bethesda, MD 20892 

Telephone: (301) 594-2089 

Email: BravemanN@de45.nidr.nih.gov 

Dr. Robert Hammond 

National Institute of Diabetes and Digestive and Kidney Diseases 

2 Democracy Boulevard, Room 715 

Bethesda, MD 20892 

Telephone: (301) 594-8834 

Email: hammondr@extra.niddk.nih.gov

Dr. Teresa Levitin 

National Institute on Drug Abuse 

Neuroscience Building 

6001 Executive Boulevard, Room 3158 

Bethesda, MD 20852 

Telephone: (301) 443-2755 

Email: tlevitin@nida.nih.gov

 

Dr. Anne P. Sassaman 

National Institute of Environmental Health Sciences 

P.O. Box 12233, MD EC-30 

Research Triangle Park, NC 27709 

Telephone: (919) 541-7723 

Email: sassaman@niehs.nih.go 

Dr. Alison Cole 

National Institute of General Medical Sciences 

Natcher Building 

Building 45, Room 2AS49K 

Bethesda, MD 20892 

Telephone: (301) 594-1826 

Email: colea@nigms.nih.gov
67 

Dr. Richard Nakamura 

National Institute of Mental Health 

Neuroscience Building 

6001 Executive Boulevard, Room 8235 

Bethesda, MD 20852 

Telephone: (301) 443-3675 

Email: rnakamur@mail.nih.gov

Dr. Mary Ellen Michel 

National Institute of Neurological Disorders and Stroke 

Neuroscience Building 

6001 Executive Boulevard, Room 2227 

Bethesda, MD 20892- 9525 

Telephone: (301) 496-1447 

Email: michelm@ninds.nih.gov 

Dr. Mark Guyer 

National Human Genome Research Institute 

Building 31 

31 Center Drive, Room B2B07 

Bethesda, MD 20892 

Telephone: (301) 496-7531 

Email: guyerm@exchange.nih.gov

Dr. Carole Hudgings 

National Institute of Nursing Research 

Natcher Building 

45 Center Drive, Room 3AN-12 

Bethesda, MD 20892 

Telephone: (301) 594-5976 

Email: carole_hudgings@nih.gov

Dr. Christine Goertz 

National Center for Complementary and Alternative Medicine 

Building 31 

31 Center Drive, Room 5B-58 

Telephone: (301) 402-1030 

Email: GoertzC@od.nih.gov

Dr. Geoffrey Cheung 

National Center for Research Resources 

Rockledge Centre I 

6705 Rockledge Dr, Rm 6118 

Bethesda, MD 20817 

Telephone: (301) 435-0768 

Email: cheungg@ncrr.ncrr.nih.gov
68 

Dr. Kenneth Bridbord 

Fogarty International Center 

Building 31 

31 Center Drive, Room B2C39 

Bethesda, MD 20892 

Telephone: (301) 496-2516 

Email: bridbordk@ficod.fic.nih.gov

Dr. Meredith Temple 

National Institute of Biomedical Imaging and Bioengineering 

6707 Democracy Boulevard, Room 980 

Bethesda, MD 20892 

Telephone: (301) 451-4792 

Email: templem@mail.nih.gov 

Dr. Eric Bailey 

National Center for Minority Health and Health Disparities 

2 Democracy Boulevard, Suite 800 

Bethesda, MD 20817 

Telephone: (301) 402-1366 

Email: baileye@od.nih.gov 
69 

Appendix E 

NIH Policy on 

Reporting Race and Ethnicity Data: 

Subjects in Clinical Research 
70 
71 

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: 
72 

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 ASpanish origin@ can also be used in addition to AHispanic 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 

AHaitian@ or ANegro@ can be used in addition to ABlack 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 Anumber 

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. 
73 

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. 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. 

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. 

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 
74 

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 

ATargeted/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 ATargeted/Planned Enrollment Table@ for a New Application 

and the AInclusion 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. 

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 Aadd up@? 

The numbers in several parts of the two tables must be the same. In both the ATargeted/Planned Enrollment 

Table@ for a New Application and the AInclusion Enrollment Report @ for Continuation Applications, Competing 

Supplement Applications, and Annual Progress Reports, the sum in AEthnic Category: Total of All Subjects@

must equal the sum in ARacial Categories: Total of All Subjects.@ In addition, the ARacial Categories: Total 

Hispanics or Latinos@ in Part B of the AInclusion Enrollment Report Table@ must equal the Total Hispanic or 
75 

Latino number reported in Part A of the AInclusion 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 selfidentification 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 AAEthnic 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 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? 
76 

Investigators are encouraged to design their data collection instruments in ways that allow respondent selfidentification 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 BB 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 self-reporting 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. 

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: 

Dr. Marvin Kalt 

National Cancer Institute 

Executive Plaza North 

6116 Executive Boulevard, Suite 8001 

Bethesda, MD 20892 

Telephone: (301) 496-5147 

Email: kaltm@dea.nci.nih.gov 

Dr. Lore Anne McNicol 

National Eye Institute 

Executive Plaza South 

6120 Executive Boulevard, Room 350 

Rockville, MD 20892 

Telephone: (301) 496-5301 

Email: loreanne.mcnicol@nei.nih.gov
77 

Ms. Sharry Palagi 

National Heart, Lung and Blood Institute 

Building 31 

31 Center Drive, Room 5A-07 

Bethesda, MD 20892 

Telephone: (301) 402-3424 

Email: palagis@nih.gov

Dr. Miriam Kelty 

National Institute on Aging 

Gateway Building 

7201 Wisconsin Avenue, Room 2C218 

Bethesda, MD 20892 

Telephone: (301) 496-9322 

Email: keltyM@nia.nih.gov

Dr. Lorraine Gunzerath 

National Institute on Alcohol Abuse and Alcoholism 

Willco Building 

6000 Executive Boulevard, Suite 409 

Rockville, MD 20892 

Telephone: (301) 443-2369 

Email: lgunzera@mail.nih.gov 
78 

Dr. John McGowan 

National Institute of Allergy and Infectious Diseases 

6700 B Rockledge 6700 Rockledge Drive 

Bethesda, MD 20817 

Telephone: (301) 496-7291 

Email: jm80c@nih.gov 

Dr. Julia Freeman 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

Natcher Building 

Building 45, Room 5AS19F 

Bethesda, MD 20892 

Telephone: (301) 594-4543 

Email: freemanj@ep.niams.nih.gov 

Dr. Susan Streufert 

National Institute of Child Health and Human Development 

6100 Executive Boulevard 

Building 61EB, Room 4A05 

Bethesda, MD 20892 

Telephone: (301) 435-6856 

Email: streufes@mail.nih.gov 

Dr. Julie Gulya 

National Institute on Deafness and Other Communication Disorders 

Executive Plaza South 

6120 Executive Boulevard, Room 400D-7 

Rockville, MD 20892 

Telephone: (301) 435-4085 

Email: gulyaj@ms.nidcd.nih.gov

Dr. Norman S. Braveman 

National Institute on Dental and Craniofacial Research 

Natcher Building 

Building 45, Room 4AN24C 

Bethesda, MD 20892 

Telephone: (301) 594-2089 

Email: BravemanN@de45.nidr.nih.gov 

Dr. Robert Hammond 

National Institute of Diabetes and Digestive and Kidney Diseases 

2 Democracy Boulevard, Room 715 

Bethesda, MD 20892 

Telephone: (301) 594-8834 

Email: hammondr@extra.niddk.nih.gov
79 

Dr. Teresa Levitin 

National Institute on Drug Abuse 

Neuroscience Building 

6001 Executive Boulevard, Room 3158 

Bethesda, MD 20852 

Telephone: (301) 443-2755 

Email: tlevitin@nida.nih.gov

Dr. Anne P. Sassaman 

National Institute of Environmental Health Sciences 

P.O. Box 12233, MD EC-30 

Research Triangle Park, NC 27709 

Telephone: (919) 541-7723 

Email: sassaman@niehs.nih.gov 

Dr. Alison Cole 

National Institute of General Medical Sciences 

Natcher Building 

Building 45, Room 2AS49K 

Bethesda, MD 20892 

Telephone: (301) 594-1826 

Email: colea@nigms.nih.gov

Dr. Richard Nakamura 

National Institute of Mental Health 

Neuroscience Building 

6001 Executive Boulevard, Room 8235 

Bethesda, MD 20852 

Telephone: (301) 443-3675 

Email: rnakamur@mail.nih.gov

Dr. Mary Ellen Michel 

National Institute of Neurological Disorders and Stroke 

Neuroscience Building 

6001 Executive Boulevard, Room 2227 

Bethesda, MD 20892- 9525 

Telephone: (301) 496-1447 

Email: michelm@ninds.nih.gov 

Dr. Mark Guyer 

National Human Genome Research Institute 

Building 31 

31 Center Drive, Room B2B07 

Bethesda, MD 20892 

Telephone: (301) 496-7531 

Email: guyerm@exchange.nih.gov
80 

Dr. Carole Hudgings 

National Institute of Nursing Research 

Natcher Building 

45 Center Drive, Room 3AN-12 

Bethesda, MD 20892 

Telephone: (301) 594-5976 

Email: carole_hudgings@nih.gov

Dr. Christine Goertz 

National Center for Complementary and Alternative Medicine 

Building 31 

31 Center Drive, Room 5B-58 

Telephone: (301) 402-1030 

Email: GoertzC@od.nih.gov

Dr. Geoffrey Cheung 

National Center for Research Resources 

Rockledge Centre I 

6705 Rockledge Dr, Rm 6118 

Bethesda, MD 20817 

Telephone: (301) 435-0768 

Email: cheungg@ncrr.ncrr.nih.gov

Dr. Kenneth Bridbord 

Fogarty International Center 

Building 31 

31 Center Drive, Room B2C39 

Bethesda, MD 20892 

Telephone: (301) 496-2516 

Email: bridbordk@ficod.fic.nih.gov

Dr. Meredith Temple 

National Institute of Biomedical Imaging and Bioengineering 

6707 Democracy Boulevard, Room 980 

Bethesda, MD 20892 

Telephone: (301) 451-4792 

Email: templem@mail.nih.gov 

Dr. Eric Bailey 

National Center for Minority Health and Health Disparities 

2 Democracy Boulevard, Suite 800 

Bethesda, MD 20817 

Telephone: (301) 402-1366 

Email: baileye@od.nih.gov 
81 

APPENDIX F 

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 
82 
83 

Old Table for Target & Enrollment Data Collection 
84 

New Table for Target Data Collection
New Table for Enrollment Data Collection

85 
Council Dates Jan-02 May-02 Aug-02 Oct-02 Jan-03 May-03 

Total Number of Applications Reviewed (#) 14,372 16,020 1,370 16,868 16,227 19,572 Number of Applications with Human Subjects (#) 5,836 6,892 733 7,005 6,550 8,340 Number (percent) of Applications approved by IRG as submitted (#) 5,447 6,438 683 6,572 6,229 7,875 

(%) 93.33% 93.41% 93.18% 93.82% 95.10% 94.42% 

Number (percent) of Applications with unacceptable minority-only inclusion (#) 168 167 21 171 127 170 

(%) 2.88% 2.42% 2.86% 2.44% 1.94% 2.04% 

Number (percent) of Applications with unacceptable sex/gender-only inclusion (#) 31 30 1 34 30 42 

(%) 0.53% 0.44% 0.14% 0.49% 0.46% 0.50% 

Number (percent) of Applications with both unacceptable minority AND sex/gender 

inclusion (#) 190 257 28 228 164 253 

(%) 3.26% 3.73% 3.82% 3.25% 2.50% 3.03% 

Total Number (percent) of Applications with unacceptable minority inclusion (#) 358 424 49 399 291 423 

(%) 6.13% 6.15% 6.68% 5.70% 4.44% 5.07% 

Total Number (percent) of Applications with unacceptable sex/gender inclusion (#) 221 287 29 262 194 295 

(%) 3.79% 4.16% 3.96% 3.74% 2.96% 3.54% 

Total Number (percent) of unacceptable Applications as submitted (#) 389 454 50 433 321 465 

(%) 6.67% 6.59% 6.82% 6.18% 4.90% 5.58% 

Table A. Level of Compliance with Inclusion Policy in New Extramural Grant Applications as A During Scientific Peer Review for the Fiscal Period 2001-2003
Council Dates Jan-02 May-02 Aug-02 Oct-02 Jan-03 Ma

Total number of awards (#) 4,517 5,103 399 4,613 4,850 5Number of awards involving Human Subjects (#) 1,704 2,041 220 1,718 1,822 2Number (percent) of awards involving Human Subjects that met the inclusion requirements as submitted (#) 1,653 1,964 207 1,672 1,778 2

(%) 97.01% 96.23% 94.09% 97.32% 97.59% 97.4

Number (percent) of awards where minority-only bar-tofunding was removed by program staff (M_U) (#) 19 32 3 20 14 

(%) 1.12% 1.57% 1.36% 1.16% 0.77% 1.0

Number (percent) of awards where sex/gender-only bar-to-funding was removed by program staff (G_U) (#) 5 6 0 7 7 

(%) 0.29% 0.29% 0.00% 0.41% 0.38% 0.4

Number (percent) of awards where both minority AND 

sex/gender bar-to-funding were removed by program staff (#) 27 39 10 19 23 

(%) 1.58% 1.91% 4.55% 1.11% 1.26% 1.0

Total Number (percent) of awards where minority barto-funding was removed by program staff (#) 46 71 13 39 37 

(%) 2.70% 3.48% 5.91% 2.27% 2.03% 2.

Total Number (percent) of awards where sex/gender bar-to-funding was removed by program staff (#) 32 45 10 26 30 

(%) 1.88% 2.20% 4.55% 1.51% 1.65% 1.4

Total Number (percent) of awards where bar-to-funding was removed (#) 51 77 13 46 44 

(%) 2.99% 3.77% 5.91% 2.68% 2.41% 2.5

Table B. Extramural Research Awards Funded for the Fiscal Period 2002-2003: Bars-To-Funding 
Phase III 

trials*

Other Clinical 

trials**

On-Site Off-Site

Protocols reporting women only 186 1131 84 40

Protocols reporting men only 81 441 78 17

Protocols reporting both men 

and women 528 6037 904 190

Protocols reporting men, 

women, and unknown 35 379 5 28

Protocols reporting sex 

composition as unknown only 1 55 0 6

Protocols reporting men and 

unknown 0 20 1

Protocols reports women and 

unknown 2 80 2

Early Stage studies where 

enrollment data has not yet been 

submitted 122 3869 0 0

Totals 955 11922 1071 284

*** Many studies may be generic.

Extramural Studies Intramural Studies

Table C. Inclusion by Sex in All Research Studies Active and 

 Funded in FY2002 and Reported in FY2003

* According to the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical 

Research, Phase III clinical investigations usually involve several hundred or more human subjects, for 

the purpose of evaluating an experimental intervention in comparison with standard or control 

intervention or comparing two or more existing treatments.

** Human subject studies that are not Phase III trials.
Decision Delay in Women with Acute Myocardial Infarction

Carpel tunnel Syndrome Diagnosis and Treatment Trial

Methadone and Bupernorphine: Ante and Post-Partum

Gestational Diabetes: Diagnostic Criteria and Outcomes

Insulin and the Polycystic Ovary Syndrome

Calcium and Vitamin D Malnutrition in Elderly Women

Women's Antioxidant Cardiovascular Study

HCV and Progression of HIV and HAART Response in 

Parathyroid Hormone in Addition to Alendronate for 

Chronic Life Stress And Incident Asthma In Adult Women

Psychobiology of Eating Behavior in Eating Disorders

Treatment of Women with Depression and Sexual Abuse

Raloxifene and Alendronate Comparison in Postmenopausal 

Risk Factors for Uterine Fibroids: A Case Control

Cognitive Behavioral Therapy for Vulvodynia

Pathogenesis of health Disparities in Preterm Birth

Risk Of Change In Women With Polycystic Ovary Syndrome

Effects of Partner Violence Victimization in Drug-Use

Etanercept Therapy for Sjogren's Syndrome

Exercise Training in Obesity-Prone Black and White Women

Placental Glucose Transport in Diabetic Pregnancies

Risk factors for Physical Disability in Aging Women

A Clinical Trial to Determine the Worth of Tamoxifen

Low Fat Diet and Breast Cancer Recurrence - Outcome Trial

Prevention of HIV and STDs in Drug-Using Women

Spit Tobacco (ST) Cessation: Rural High School Males

Examples of Studies of Selected Protocols that include Female-Only Human Subjects

Brief Intervention to Prevent Prenatal Alcohol Use

The Biological Basis of Alcohol-Induced Brain Damage

Osteoporopic Fractures in Men

Molecular Epidemiology of Testicular Carcinoma

Genetic Predisposition to Noise Induced Hearing Loss

Evaluation and Treatment of Pain

Gene Environment Cancer Prevention

Mechanisms Linking Depression To Cardiovascular Risk

Gene Expression in Normal & Diseased Muscle Development

High dose Chemotherapy and combination anti-HIV Therapy 

Physicians Health Study II: Prevention Trial of Vitamins

Parenting psychotherapy for drug-dependent fathers

HIV Risk and Club Drugs among MSM

Examples of Studies of Selected Protocols that include Male-Only Human Subjects

Osteoporopic Fractures in Men (MR OS)

Table C-1. Examples of Single Sex Extramural Research Studies

 Funded in FY 2002 and Reported in FY 2003
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/

Other Total

9,040 288,674 233,746 139,103 1,171,556 81,921 1,924,040

0.28% 8.93% 7.23% 0.00% 4.30% 36.23% 0.00% 2.53% 59.49%

7,183 244,143 138,232 84,976 746,750 56,812 1,278,096

0.22% 7.55% 4.27% 0.00% 2.63% 23.09% 0.00% 1.76% 39.52%

2,059 7,082 2,521 1,299 7,032 11,847 31,840

0.06% 0.22% 0.08% 0.00% 0.04% 0.22% 0.00% 0.37% 0.98%

18,282 539,899 374,499 225,378 1,925,338 150,580 3,233,976

0.57% 16.69% 11.58% 0.00% 6.97% 59.53% 0.00% 4.66% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White More Than One Race Unknown/ Other Total Not Hispanic Hispa

or Lat

42,491 759,689 610,265 15,952 3,503,273 55,890 744,551 5,732,111 4,646,305 381

0.45% 8.10% 6.51% 0.17% 37.36% 0.60% 7.94% 61.12% 49.54% 4

18,087 1,084,087 339,345 14,523 1,850,378 43,192 207,811 3,557,423 3,148,264 226

0.19% 11.56% 3.62% 0.15% 19.73% 0.46% 2.22% 37.93% 33.57% 2

1,383 1,713 7,829 5,772 14,936 448 56,525 88,606 20,872 2

0.01% 0.02% 0.08% 0.06% 0.16% 0.00% 0.60% 0.94% 0.22% 0

61,961 1,845,489 957,439 36,247 5,368,587 99,530 1,008,887 9,378,140 7,815,441 609

0.66% 19.68% 10.21% 0.39% 57.25% 1.06% 10.76% 100.00% 83.34% 6

TOTAL TOTAL TOTAL OVERALLFemales 7,656,151 Males 4,835,519 Unknown 120,446 Total 12,612,116

60.70% 38.34% 0.96% 100%

Total

New Form: Total of All Subjects Reported Using the 1997 OMB Standards

Total of All S

Female

Male

Unknown

Table 1: Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY2002 and Reported 

Total of All Subjects by Race

Female

Male

Unknown

Total *Categor

provided OMB Sta

Number of Protocowith Enrollment DaNumber of Protocowith Enrollment Da
Data Table Comments:

More females (7,656,151 or 60.7%) than males (4,835,519 or 38.34%) are enrolled in aggregate extramural research protocoLargest identified racial group is White at 59.53% following the 1977 OMB standards and 57.25% following the 1997 OMB staAccording to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native at (0.6%According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.4%). 

Table 1: Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY2002 and Reported 

6.5% of participants identified their ethnicity as Hispanic or Latino. Largest identified racial minority group is Asian at 16.69% following the 1977 OMB standards and 19.68% following the 1997 O
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards

American 

Indian/ 

Alaska 

Native

Asian Black

Hawaiian/ 

Pacific 

Islander

Hispanic White

More 

Than One 

Race

Unknown/

Other Total

9,040 288,674 233,746 139,103 1,171,556 81,921 1,924,040

0.28% 8.93% 7.23% 4.30% 36.23% 2.53% 59.49%

0.47% 15.00% 12.15% 7.23% 60.89% 4.26% 100.00%

49.45% 53.47% 62.42% 61.72% 60.85% 54.40% 59.49%

7,183 244,143 138,232 84,976 746,750 56,812 1,278,096

0.22% 7.55% 4.27% 2.63% 23.09% 1.76% 39.52%

0.56% 19.10% 10.82% 6.65% 58.43% 4.45% 100.00%

39.29% 45.22% 36.91% 37.70% 38.79% 37.73% 39.52%

2,059 7,082 2,521 1,299 7,032 11,847 31,840

0.06% 0.22% 0.08% 0.04% 0.22% 0.37% 0.98%

6.47% 22.24% 7.92% 4.08% 22.09% 37.21% 100.00%

11.26% 1.31% 0.67% 0.58% 0.37% 7.87% 0.98%

18,282 539,899 374,499 225,378 1,925,338 150,580 3,233,976

0.57% 16.69% 11.58% 6.97% 59.53% 4.66% 100.00%

0.57% 16.69% 11.58% 6.97% 59.53% 4.66% 100.00%

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

Female

Male

Table 1A: Percent Analysis for All Extramural Research Protocols Funded in FY2002 Reported in FY2

Unknown

Total

Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total)

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New form)Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total)
American 

Indian/ 

Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White

More 

Than One 

Race

Unknown/

Other Total Not Hispanic Hispan

or Latin

42,491 759,689 610,265 15,952 3,503,273 55,890 744,551 5,732,111 4,646,305 381,1

0.45% 8.10% 6.51% 0.17% 37.36% 0.60% 7.94% 61.12% 49.54% 4.0

0.74% 13.25% 10.65% 0.28% 61.12% 0.98% 12.99% 100.00% 81.06% 6.65

68.58% 41.16% 63.74% 44.01% 65.26% 56.15% 73.80% 61.12% 59.45% 62.5

18,087 1,084,087 339,345 14,523 1,850,378 43,192 207,811 3,557,423 3,148,264 226,4

0.19% 11.56% 3.62% 0.15% 19.73% 0.46% 2.22% 37.93% 33.57% 2.4

0.51% 30.47% 9.54% 0.41% 52.01% 1.21% 5.84% 100.00% 88.50% 6.36

29.19% 58.74% 35.44% 40.07% 34.47% 43.40% 20.60% 37.93% 40.28% 37.1

1,383 1,713 7,829 5,772 14,936 448 56,525 88,606 20,872 2,2

0.01% 0.02% 0.08% 0.06% 0.16% 0.00% 0.60% 0.94% 0.22% 0.02

1.56% 1.93% 8.84% 6.51% 16.86% 0.51% 63.79% 100.00% 23.56% 2.54

2.23% 0.09% 0.82% 15.92% 0.28% 0.45% 5.60% 0.94% 0.27% 0.3

61,961 1,845,489 957,439 36,247 5,368,587 99,530 1,008,887 9,378,140 7,815,441 609,8

0.66% 19.68% 10.21% 0.39% 57.25% 1.06% 10.76% 100.00% 83.34% 6.5

0.66% 19.68% 10.21% 0.39% 57.25% 1.06% 10.76% 100.00% 83.34% 6.50

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.0

New Form: Total of All Subjects Reported Using the 1997 OMB Standards

Table 1A: Percent Analysis for All Extramural Research Protocols Funded in FY2002 Reported in FY2

Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total)

Male

Unknown

Total

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New form)Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total)

Total of All Subjects by Race Total of All Sub

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

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/O

ther Total

16,559 405,345 354,133 205,747 1,797,249 149,706 2,928,739

0.57% 13.84% 12.09% 7.03% 61.37% 5.11% 61.60%

11,611 349,340 234,725 143,848 984,407 76,193 1,800,124

0.65% 19.41% 13.04% 7.99% 54.69% 4.23% 37.86%

53 509 971 1,119 7,357 15,846 25,855

0.20% 1.97% 3.76% 4.33% 28.45% 61.29% 0.54%

28,223 755,194 589,829 350,714 2,789,013 241,745 4,754,718

0.59% 15.88% 12.41% 7.38% 58.66% 5.08% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White More Than One Race Unknown/ Other Total Not Hispanic Hispanic o

Latino 

51,173 271,731 371,468 8,554 1,946,559 18,376 641,925 3,309,786 2,237,035 208,844 

1.55% 8.21% 11.22% 0.26% 58.81% 0.56% 19.39% 75.15% 67.59% 6.31% 

26,272 79,857 168,857 7,981 698,010 12,267 62,019 1,055,263 813,756 81,853 

2.49% 7.57% 16.00% 0.76% 66.15% 1.16% 5.88% 23.96% 77.11% 7.76% 

289 2,461 7,451 5,101 6,972 312 16,418 39,004 21,161 1,732 

0.74% 6.31% 19.10% 13.08% 17.88% 0.80% 42.09% 0.89% 54.25% 4.44% 

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

1.77% 8.04% 12.44% 0.49% 60.21% 0.70% 16.36% 100.00% 69.75% 6.64% 

TOTAL TOTAL TOTAL OVERALLFemales 6,238,525 Males 2,855,387 Unknown 64,859 Total 9,158,771

68.12% 31.18% 0.71% 100%

Male

Unknown

Total

Total of All Subjects by Race Total of All Subj

Female

Unknown *Categories 

but are provwith the 199

Total

Number of Protocols 

New Form: Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data: 

Table 2. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2001 and Reporte

Number of Protocols with Enrollment Data: 

Female

Male
Data Table Comments:

More females (6,238,525 or 68.12%) than males (2,855,387 or 31.18%) are enrolled in aggregate extramural research protoLargest identified racial group is White at 58.66% following the 1977 OMB standards and 60.21% following the 1997 OMB sAccording to the 1977 OMB standards, the largest identified racial minority group is Asians (15.88%). According to the 1997 OMB standards, the largest identified racial minority group is Blacks at (12.44%). According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native at (0.According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.5%). 7% of participants identified their ethnicity as Hispanic or Latino. 

Table 2. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2001 and Reporte
 Excluding Male-Only and Female-Only ProtocolsFunded in FY2002 and Reported in FY2003

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

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/O

ther Total

7,600 252,055 155,225 88,670 657,232 70,746 1,231,528

0.32% 10.61% 6.54% 3.73% 27.67% 2.98% 51.85%

6,945 238,520 127,005 81,248 622,193 35,696 1,111,607

0.29% 10.04% 5.35% 3.42% 26.20% 1.50% 46.80%

2,059 7,082 2,521 1,299 7,032 11,847 31,840

0.09% 0.30% 0.11% 0.05% 0.30% 0.50% 1.34%

16,604 497,657 284,751 171,217 1,286,457 118,289 2,374,975

0.70% 20.95% 11.99% 7.21% 54.17% 4.98% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White More Than One Race Unknown/ Other Total Not Hispanic Hispa

or Lat

19,433 702,652 398,067 14,420 2,135,257 45,357 247,379 3,562,565 3,099,235 242,

0.27% 9.91% 5.62% 0.20% 30.12% 0.64% 3.49% 50.26% 43.72% 3.4

17,802 1,049,877 326,199 14,454 1,787,209 41,580 200,330 3,437,451 3,041,215 219,

0.25% 14.81% 4.60% 0.20% 25.21% 0.59% 2.83% 48.49% 42.90% 3.1

1,383 1,713 7,829 5,772 14,936 448 56,525 88,606 20,872 2,

0.02% 0.02% 0.11% 0.08% 0.21% 0.01% 0.80% 1.25% 0.29% 0.0

38,618 1,754,242 732,095 34,646 3,937,402 87,385 504,234 7,088,622 6,161,322 464,

0.54% 24.75% 10.33% 0.49% 55.55% 1.23% 7.11% 100.00% 86.92% 6.5

TOTAL TOTAL TOTAL OVERALLFemales 4,794,093 Males 4,549,058 Unknown 120,446 Total 9,463,597

50.66% 48.07% 1.27% 100%

Total of All Subjects by Race

Total

Total of All S

Female

Male

Unknown

Number of Protocowith Enrollment DaNumber of Protocowith Enrollment Da

Table 3: Aggregate Enrollment Data for Extramural Research Protocols 

Female

Male

Unknown *Categor

provided 

Total OMB Sta

New Form: Total of All Subjects Reported Using the 1997 OMB Standards
 Excluding Male-Only and Female-Only ProtocolsFunded in FY2002 and Reported in FY2003

Data Table Comments:

6.55 of participants identified their ethnicity as Hispanic or Latino. Largest identified racial minority group is Asian at 20.95% following the 1977 OMB standards and 24.8% following the 1997 OAccording to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native (0.7%)According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.497%). 

Table 3: Aggregate Enrollment Data for Extramural Research Protocols 

There were 8,886 protocols of which 1,317 were female-only protocols and 522 were male-only protocols. Excluding sex-specific studies, the number of females (4,794,093 or 50.6%) to males (4,549,058 or 48.1%) enrolled in extramLargest identified racial group is White at 54.2% following the 1977 OMB standards and 55.5% following the 1997 OMB stand
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

*More 

Than One 

Race

Unknown/O

ther Total

12,476 361,471 258,829 144,161 850,748 78,036 1,705,721

0.73% 21.19% 15.17% 8.45% 49.88% 4.57% 49.48%

11,269 345,810 226,443 139,031 919,272 73,583 1,715,408

0.66% 20.16% 13.20% 8.10% 53.59% 4.29% 49.77%

53 509 971 1,119 7,357 15,846 25,855

0.20% 1.97% 3.76% 4.33% 28.45% 61.29% 0.75%

23,798 707,790 486,243 284,311 1,777,377 167,465 3,446,984

0.69% 20.53% 14.11% 8.25% 51.56% 4.86% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White More Than One Race Unknown/ Other Total Not Hispanic Hispan

or Latin

27,471 73,888 199,564 8,231 745,791 12,665 86,501 1,154,111 805,206 86,7

2.38% 6.40% 17.29% 0.71% 64.62% 1.10% 7.50% 52.47% 69.77% 7.52

26,096 75,650 162,359 7,958 664,642 11,541 58,129 1,006,375 774,209 79,3

2.59% 7.52% 16.13% 0.79% 66.04% 1.15% 5.78% 45.75% 76.93% 7.89

289 2,461 7,451 5,101 6,972 312 16,418 39,004 21,161 1,7

0.74% 6.31% 19.10% 13.08% 17.88% 0.80% 42.09% 1.77% 54.25% 4.44

53,856 151,999 369,374 21,290 1,417,405 24,518 161,048 2,199,490 1,600,576 167,8

2.45% 6.91% 16.79% 0.97% 64.44% 1.11% 7.32% 100.00% 72.77% 7.63

TOTAL TOTAL TOTAL OVERALLFemales 2,859,832 Males 2,721,783 Unknown 64,859 Total 5,646,474

50.65% 48.20% 1.15% 100%

Female

Male

Unknown

Total

Table 4. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and Female-O Funded in FY 2001 and Reported in FY 2002

Number of Protocols with Enrollment Data

Female

Male

Unknown *Categorie

provided h

Total 1997 OMB 

Number of Protocols 

New Form: Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data

Total of All Subjects by Race Total of All Sub
Data Table Comments:

According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.97%). 7.63% of participants identified their ethnicity as Hispanic or Latino.Largest identified racial group is White at 51.5% following the 1977 OMB standards and 64.4% following the 1997 OMB staAccording to the 1977 OMB standards, the largest identified racial minority group is Asian (20.53%). According to the 1997 OMB standards, the largest identified racial minority group is Blacks at (16.8%). According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native (0.7%

Table 4. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and Female-O Funded in FY 2001 and Reported in FY 2002

There were 7,693 protocols of which 1,049 were female-only protocols and 440 were male-only protocols. Excluding sex-specific studies, the number of females (2,859,832 or 50.65%) to males (2,721,783 or 48.20%) enrolled in exprotocols are closely representative of the general population.
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ 

Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/

Other Total

1,040 4,843 30,110 16,236 193,734 4,580 250,543

0.24% 1.11% 6.92% 3.73% 44.51% 1.05% 57.57%

648 3,152 20,571 12,680 142,250 4,355 183,656

0.15% 0.72% 4.73% 2.91% 32.68% 1.00% 42.20%

0 0 1 84 20 918 1,023

0.00% 0.00% 0.00% 0.02% 0.00% 0.21% 0.24%

1,688 7,995 50,682 29,000 336,004 9,853 435,222

0.39% 1.84% 11.65% 6.66% 77.20% 2.26% 100.00%

American 

Indian/ 

Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White

More 

Than One 

Race

Unknown/

Other Total Not Hispanic Hisp

or L

160 1,708 12,752 75 18,090 765 2,680 36,230 27,495 

0.20% 2.18% 16.31% 0.10% 23.13% 0.98% 3.43% 46.33% 35.16% 

238 1,414 9,316 78 25,231 437 4,290 41,004 32,586 

0.30% 1.81% 11.91% 0.10% 32.26% 0.56% 5.49% 52.43% 41.67% 

0 2 10 0 46 1 910 969 55 

0.00% 0.00% 0.01% 0.00% 0.06% 0.00% 1.16% 1.24% 0.07% 

398 3,124 22,078 153 43,367 1,203 7,880 78,203 60,136 

0.51% 3.99% 28.23% 0.20% 55.45% 1.54% 10.08% 100.00% 76.90% 1

TOTAL TOTAL TOTAL OVERAL

L

Females 286,773 Males 224,660 Unknown 1,992 Total 513,425

55.85% 43.76% 0.39% 100%

Total of All Subjects by Race

 Funded in FY2002 and Reported in FY2003

Total of All 

Female

*Categare pro1997 O

Number of Protowith Enrollment Number of Protowith Enrollment 

Total

Table 5: Aggregate Enrollment Data for Extramural Phase III Research Protocols 

Female

Male

Unknown

Total

Unknown

New Form: Total of All Subjects Reported Using the 1997 OMB Standards

Male
Data Table Comments:

10% of participants identified their ethnicity as Hispanic or Latino. Largest identified racial group is White at 77.2% following the 1977 OMB standards and 55.5% following the 1997 OLargest identified racial minority group is Black at 11.6% following the 1977 OMB standards and 28.2% following the According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan NativAccording to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0

Table 5: Aggregate Enrollment Data for Extramural Phase III Research Protocols  Funded in FY2002 and Reported in FY2003

Substantial numbers of women and minorities are enrolled in Phase III research protocols funded in FY2002 and repMore females (286,733 or 55.8%) than males (224,660 or 43.7%) are enrolled in aggregate extramural research pro
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards

American 

Indian/ 

Alaska 

Native

Asian Black

Hawaiian/ 

Pacific 

Islander

Hispanic White More Than One Race Unknown/ Other Total

1,040 4,843 30,110 16,236 193,734 4,580 250,543

0.24% 1.11% 6.92% 3.73% 44.51% 1.05% 57.57%

0.42% 1.93% 12.02% 6.48% 77.33% 1.83% 100.00%

61.61% 60.58% 59.41% 55.99% 57.66% 46.48% 57.57%

648 3,152 20,571 12,680 142,250 4,355 183,656

0.15% 0.72% 4.73% 2.91% 32.68% 1.00% 42.20%

0.35% 1.72% 11.20% 6.90% 77.45% 2.37% 100.00%

38.39% 39.42% 40.59% 43.72% 42.34% 44.20% 42.20%

0 0 1 84 20 918 1,023

0.00% 0.00% 0.00% 0.02% 0.00% 0.21% 0.24%

0.00% 0.00% 0.10% 8.21% 1.96% 89.74% 100.00%

0.00% 0.00% 0.00% 0.29% 0.01% 9.32% 0.24%

1,688 7,995 50,682 29,000 336,004 9,853 435,222

0.39% 1.84% 11.65% 6.66% 77.20% 2.26% 100.00%

0.39% 1.84% 11.65% 6.66% 77.20% 2.26% 100.00%

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

Female

Male

Unknown

Total

Legend

Bold: % of Total No. of Participants in Research Protocols (Old or New form)Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total)

Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total)

Table 5A: Percent Analysis of Phase III Research Protocols Funded in FY2002 and Reported in FY2003 
American 

Indian/ 

Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White More Than One Race Unknown/ Other Total Not Hispanic H

o

160 1,708 12,752 75 18,090 765 2,680 36,230 27,495 

0.20% 2.18% 16.31% 0.10% 23.13% 0.98% 3.43% 46.33% 35.16% 

0.44% 4.71% 35.20% 0.21% 49.93% 2.11% 7.40% 100.00% 75.89% 

40.20% 54.67% 57.76% 49.02% 41.71% 63.59% 34.01% 46.33% 45.72% 

238 1,414 9,316 78 25,231 437 4,290 41,004 32,586 

0.30% 1.81% 11.91% 0.10% 32.26% 0.56% 5.49% 52.43% 41.67% 

0.58% 3.45% 22.72% 0.19% 61.53% 1.07% 10.46% 100.00% 79.47% 

59.80% 45.26% 42.20% 50.98% 58.18% 36.33% 54.44% 52.43% 54.19% 

0 2 10 0 46 1 910 969 55 

0.00% 0.00% 0.01% 0.00% 0.06% 0.00% 1.16% 1.24% 0.07% 

0.00% 0.21% 1.03% 0.00% 4.75% 0.10% 93.91% 100.00% 5.68% 

0.00% 0.06% 0.05% 0.00% 0.11% 0.08% 11.55% 1.24% 0.09% 

398 3,124 22,078 153 43,367 1,203 7,880 78,203 60,136 

0.51% 3.99% 28.23% 0.20% 55.45% 1.54% 10.08% 100.00% 76.90% 

0.51% 3.99% 28.23% 0.20% 55.45% 1.54% 10.08% 100.00% 76.90% 

100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 1

Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total)

Female

Male

Total of All Subjects by Race Total of A

Total

Unknown

New Form: Total of All Subjects Reported Using the 1997 OMB Standards

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total)

Table 5A: Percent Analysis of Phase III Research Protocols Funded in FY2002 and Reported in FY2003 

Legend

Bold: % of Total No. of Participants in Research Protocols (Old or New form)
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/ 

Pacific 

Islander

Hispanic White More Than One Race Unknown/ Other Total

1,307 24,958 55,358 44,705 229,803 7,658 363,789

0.36% 6.86% 15.22% 12.29% 63.17% 2.11% 67.14%

619 6,603 24,674 14,466 125,634 5,338 177,334

0.35% 3.72% 13.91% 8.16% 70.85% 3.01% 32.73%

0 2 33 8 95 547 685

0.00% 0.29% 4.82% 1.17% 13.87% 79.85% 0.13%

1,926 31,563 80,065 59,179 355,532 13,543 541,808

0.36% 5.83% 14.78% 10.92% 65.62% 2.50% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White

More 

Than One 

Race

Unknown/

Other Total Not Hispanic Hispanic or Latino 

81 385 2,834 4 15,027 274 859 19,464 17,697 781 

0.42% 1.98% 14.56% 0.02% 77.20% 1.41% 4.41% 52.50% 90.92% 4.01% 

57 1,508 2,287 4 12,244 151 1,099 17,350 15,695 560 

0.33% 8.69% 13.18% 0.02% 70.57% 0.87% 6.33% 46.80% 90.46% 3.23% 

0 1 2 0 14 1 241 259 140 31 

0.00% 0.39% 0.77% 0.00% 5.41% 0.39% 93.05% 0.70% 54.05% 11.97% 

138 1,894 5,123 8 27,285 426 2,199 37,073 33,532 1,372 

0.37% 5.11% 13.82% 0.02% 73.60% 1.15% 5.93% 100.00% 90.45% 3.70% 

TOTAL TOTAL TOTAL OVERALLFemales 383,253 Males 194,684 Unknown 944 Total 578,881

66.21% 33.63% 0.16% 100%

Female

Male

Unknown

Total

Number of Protocols 

New Form: Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Data

Total of All Subjects by Race Total of All Subj

Male

Unknown *Categories 

provided her

Total OMB Standa

Table 6. Aggregate Enrollment Data for Extramural Phase III Research Protocols  Funded in FY 2001 and Reported in FY 2002

Number of Protocols with Enrollment Data

Female
Data Table Comments:

3.7% of participants identified their ethnicity as Hispanic or Latino. Largest identified racial group is White at 65.6% following the 1977 OMB standards and 73.6% following the 1997 OMB stLargest identified racial minority group is Black at 14.8% following the 1977 OMB standards and 13.8% following the 1997 According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native at (0According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.02%)

Table 6. Aggregate Enrollment Data for Extramural Phase III Research Protocols  Funded in FY 2001 and Reported in FY 2002

Substantial numbers of women and minorities are enrolled in Phase III research protocols funded in FY2001 and reported More females (383,253 or 66.2%) than males (194,684 or 33.6%) are enrolled in aggregate extramural research protocols
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ 

Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/

Other Total

476 1,485 15,439 10,543 61,405 2,074 91,422

0.23% 0.71% 7.35% 5.02% 29.25% 0.99% 43.55%

486 1,895 15,235 10,474 86,485 2,906 117,481

0.23% 0.90% 7.26% 4.99% 41.20% 1.38% 55.96%

0 0 1 84 20 918 1,023

0.00% 0.00% 0.00% 0.04% 0.01% 0.44% 0.49%

962 3,380 30,675 21,101 147,910 5,898 209,926

0.46% 1.61% 14.61% 10.05% 70.46% 2.81% 100.00%

New Form: Total of All Subjects Reported Using the 1997 OMB Standards 

American 

Indian/ 

Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White

More 

Than One 

Race

Unknown/

Other Total Not Hispanic Hisp

or L

92 1,585 8,744 61 14,093 503 2,294 27,372 19,308 

0.14% 2.49% 13.76% 0.10% 22.17% 0.79% 3.61% 43.06% 30.37% 

190 1,239 8,694 78 21,023 297 3,707 35,228 27,624 

0.30% 1.95% 13.68% 0.12% 33.07% 0.47% 5.83% 55.42% 43.46% 

0 2 10 0 46 1 910 969 55 

0.00% 0.00% 0.02% 0.00% 0.07% 0.00% 1.43% 1.52% 0.09% 

282 2,826 17,448 139 35,162 801 6,911 63,569 46,987 

0.44% 4.45% 27.45% 0.22% 55.31% 1.26% 10.87% 100.00% 73.91% 1

TOTAL TOTAL TOTAL OVERAL

L

Females 118,794 Males 152,709 Unknown 1,992 Total 273,495

43.44% 55.84% 0.73% 100%

Total

 Excluding Male-Only and Female-Only Protocols Funded in FY2002 and Reported in FY2003

Total of All 

Female

Male

Unknown

Total

Total of All Subjects by Race

Number of Protocwith Enrollment D

Table 7: Aggregate Enrollment Data for Extramural Phase III Protocols

Female

Male

Unknown *Categ

provideOMB S

Number of Protocwith Enrollment D
Data Table Comments:

10.16% of participants identified their ethnicity as Hispanic or Latino. Largest identified racial group is White at 70.5% following the 1977 OMB standards and 55.3% following the 1997 OMLargest identified racial minority group is Black at 14.6% following the 1977 OMB standards and 27.4% following the According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.2

Table 7: Aggregate Enrollment Data for Extramural Phase III Protocols Excluding Male-Only and Female-Only Protocols Funded in FY2002 and Reported in FY2003

There were 833 protocols of which 186 were female-only protocols and 81 were male-only protocols. 

Excluding sex-specific studies, the number of females (118,794 or 43.4%) to males (152,709 or 55.8%) enrolled in exare closely representative of the general population.
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/

Other Total

554 5,107 19,887 12,857 75,234 3,147 116,786

0.47% 4.37% 17.03% 11.01% 64.42% 2.69% 44.57%

580 5,693 21,856 13,621 98,692 4,105 144,547

0.40% 3.94% 15.12% 9.42% 68.28% 2.84% 55.17%

0 2 33 8 95 547 685

0.00% 0.29% 4.82% 1.17% 13.87% 79.85% 0.26%

1,134 10,802 41,776 26,486 174,021 7,799 262,018

0.43% 4.12% 15.94% 10.11% 66.42% 2.98% 100.00%

New Form: Total of All Subjects Reported Using the 1997 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White

More 

Than One 

Race

Unknown/

Other Total Not Hispanic Hispanic or Latino 

51 226 1,615 4 4,441 144 633 7,114 5,768 46

0.72% 3.18% 22.70% 0.06% 62.43% 2.02% 8.90% 42.03% 81.08% 6.48% 

54 1,300 1,403 4 5,839 148 805 9,553 8,194 402 

0.57% 13.61% 14.69% 0.04% 61.12% 1.55% 8.43% 56.44% 85.77% 4.21% 

0 1 2 0 14 1 241 259 140 3

0.00% 0.39% 0.77% 0.00% 5.41% 0.39% 93.05% 1.53% 54.05% 11.97% 

105 1,527 3,020 8 10,294 293 1,679 16,926 14,102 894 

0.62% 9.02% 17.84% 0.05% 60.82% 1.73% 9.92% 100.00% 83.32% 5.28% 

TOTAL TOTAL TOTAL OVERALLFemales 123,900 Males 154,100 Unknown 944 Total 278,944

44.42% 55.24% 0.34% 100%

Female

Male

Unknown

Total

Number of Protocols with Enrollment Data

Total of All Subjects by Race Total of All Subj

Male

Unknown *Categories 

provided her

Total OMB Standa

Table 8. Aggregate Enrollment Data for Extramural Phase III Protocols Excluding Male-Only and Female-O Funded in FY 2001 and Reported in FY 2002

Number of Protocols with Enrollment Data

Female
Data Table Comments:

5.3% of participants identified their ethnicity as Hispanic or Latino. Largest identified racial group is White at 66.4% following the 1977 OMB standards and 60.8% following the 1997 OMB stLargest identified racial minority group is Black at 15.9% following the 1977 OMB standards and 17.8% following the 1997 According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native (0.4According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.05%)

Table 8. Aggregate Enrollment Data for Extramural Phase III Protocols Excluding Male-Only and Female-O Funded in FY 2001 and Reported in FY 2002

There were 757 protocols of which 181 were female-only protocols and 62 were male-only protocols. Excluding sex-specific studies, the number of females (123,900 or 44.4%) to males (154,100 or 55.2%) enrolled in extramare closely representative of the general population.
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/

Other Total

9,511 128,639 52,418 227,889 393,786 57,453 869,696

0.52% 7.03% 2.86% 12.45% 21.51% 3.14% 47.50%

8,896 63,520 50,943 418,626 346,942 57,058 945,985

0.49% 3.47% 2.78% 22.86% 18.95% 3.12% 51.67%

0 41 10 200 870 14,165 15,286

0.00% 0.00% 0.00% 0.01% 0.05% 0.77% 0.83%

18,407 192,200 103,371 646,715 741,598 128,676 1,830,967

1.01% 10.50% 5.65% 35.32% 40.50% 7.03% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White

More 

Than One 

Race

Unknown/

Other Total Not Hispanic Hispanic or Latino 

2 75 312 1 1,024 3 107 1,524 1,388 9

0.06% 2.42% 10.07% 0.03% 33.06% 0.10% 3.45% 49.21% 44.82% 3.20% 

10 105 225 0 1,161 3 69 1,573 1,487 6

0.32% 3.39% 7.27% 0.00% 37.49% 0.10% 2.23% 50.79% 48.01% 2.07% 

00 0 000 00 0 

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

12 180 537 1 2,185 6 176 3,097 2,875 16

0.39% 5.81% 17.34% 0.03% 70.55% 0.19% 5.68% 100.00% 92.83% 5.26% 

TOTAL TOTAL TOTAL OVERALLFemales 871,220 Males 947,558 Unknown 15,286 Total 1,834,064

47.50% 51.66% 0.83% 100%

Total of All Subjects by Race

Total

Total of All Subj

Female

Male

Unknown

Number of Protocols with Enrollment DataNumber of Protocols with Enrollment Data

Table 9: Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2002 and Reported 

Female

Male

Unknown *Categories 

are provided 

Total 1997 OMB S

New Form: Total of All Subjects Reported Using the 1997 OMB Standards
Data Table Comments:

Table 9: Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2002 and Reported 

There were more males (947,558 or 51.6%) than females (871,220 or 47.5%) enrolled in aggregate intramural research pDifferences in the enrollment of males and females is attributed primarily to improvements in reporting procedures (e.g. edeclaration and recording at enrollment.5.3% of participants identified their ethnicity as Hispanic or Latino. According to the 1977 OMB standards, the largest identified racial minority group is Hispanics at (35.32%). According to the 1997 OMB standards, the largest identified racial minority group is Blacks at (17.34%). According to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native (1According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.03%
Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

American 

Indian/ Alaska 

Native

Asian Black

* 

Hawaiian/ 

Pacific 

Islander

Hispanic White

* More 

Than One 

Race

Unknown/

Other Total

9,127 272,304 55,114 27,293 518,632 34,554 917,024

1.00% 29.69% 6.01% 2.98% 56.56% 3.77% 46.32%

8,491 194,723 57,250 20,458 735,946 32,305 1,049,173

0.81% 18.56% 5.46% 1.95% 70.15% 3.08% 53.00%

2 75 41 192 461 12,745 13,516

0.01% 0.55% 0.30% 1.42% 3.41% 94.30% 0.68%

17,620 467,102 112,405 47,943 1,255,039 79,604 1,979,713

0.89% 23.59% 5.68% 2.42% 63.39% 4.02% 100.00%

American 

Indian/ Alaska 

Native

Asian Black

Hawaiian/

Pacific 

Islander

White More Than One Race Unknown/ Other Total Not Hispanic Hispan

or Latin

00 0 0 0 0 00 0

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00

00 0 0 0 0 00 0

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00

00 0 0 0 0 00 0

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00

00 0 0 0 0 00 0

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00

TOTAL TOTAL TOTAL OVERALLFemales 917,024 Males 1,049,173 Unknown 13,516 Total 1,979,713

46.32% 53.00% 0.68% 100%

Male

Unknown

Total

Total of All Subjects by Race Total of All Su

Female

Unknown *Categorie

provided h

Total OMB Stan

Number of Protoco

New Form: Total of All Subjects Reported Using the 1997 OMB Standards with Enrollment Da

Table 10. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2001 and Report

Number of Protocowith Enrollment Da

Female

Male
Data Table Comments:

Largest identified racial minority group is Asians at 467,102 or 23.6%.Smallest identified racial minority group is American Indian/Alaska Native at 17,620 or 0.9%There were more males (1,049,173 or 53%) than females (917,024 or 46.3%) enrolled in aggregate intramural Differences in the enrollment of males and females is attributed primarily toimprovements in reporting procedusex/gender declaration and recording at enrollment.The racial minority group with the largest increase in enrollment is Asian/Pacific Islander - an increase of 50% Table 10. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2001 and Report