Department of Health and Human Services 

National Institutes of Health 

MONITORING ADHERENCE TO THE 

NIH POLICY ON THE INCLUSION 

OF WOMEN AND MINORITIES 

AS SUBJECTS IN CLINICAL RESEARCH 

 

Comprehensive Report: Tracking of Human Subjects Research 

Funded in Fiscal Year 2000 (Reported in FY 2000) and 

Fiscal Year 2001 (Reported in FY 2002) 

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

Della Hann, Ph.D.

Office of Extramural Research 

JUNE 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 2000 & Reported in FY 2000) and (Funded in FY 2001 & Reported in FY 2002) .......... 13 

Aggregate Data Tables Page

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

Assessed During Scientific Peer Review for the Fiscal Period 2000-2002 ...................... 15 

Table B. Extramural Research Awards Funded for the Fiscal Period 2000-2002:

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

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

in FY 2002 ........................................................................................................................ 17 

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

Funded in FY 2001 and Reported in FY 2002.................................................................. 18 

Table 1. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2001 

& Reported in FY 2002 ...............................................................................................19-20 

Table 2. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2000 

& Reported in FY 2000 .................................................................................................... 21 

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

Male-Only & Female-Only Protocols Funded in FY 2001 & Reported in FY 2002...22-23 

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

Male-Only & Female-Only Protocols Funded in FY 2000 & Reported in FY 2000........ 24 

Table 5. Aggregate Enrollment Data for Extramural Phase III Protocols Funded in FY 2001 

& Reported in FY 2002 ...............................................................................................25-26 

Table 6. Aggregate Enrollment Data for Extramural Phase III Protocols Funded in FY 2000 

& Reported in FY 2000 .................................................................................................... 27 

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

Male-Only & Female-Only Protocols Funded in FY 2001 & Reported in FY 2002...28-29 

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

Male-Only & Female-Only Protocols Funded in FY 2000 & Reported in FY 2000........ 30

Table 9. Aggregate Enrollment Data for Intramural Research Protocols 

Funded in FY 2001 and Reported in FY 2002.............................................................31-32 

Table 10. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2000 and 

Reported in FY 2000 (Includes On-site and Off-site) ...................................................... 33 
Table of Contents - continued

Page

Appendix A Explanation of Gender and Minority Codes .................................................................... 37 

 

Appendix B NIH Tracking and Inclusion Committee Members .......................................................... 39 

Appendix C Responses to the General Accounting Office (GAO) Report: AWomen=s Health: 

NIH Has Increased Its Efforts To Include Women in Research@ 

GAO/HEHS-00-96, September 2002................................................................................ 45 

Appendix D Internet Homepage: Inclusion of Women and Minorities Policy Implementation ........... 53 

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

Subjects in Clinical Research - Amended, October, 2001................................................ 57 

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

Research............................................................................................................................ 73 

Appendix G NIH Inclusion Tables for Target and Enrollment Data .................................................... 85 
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 in December, 2000. 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.

# In December 2000, 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. 

# In July 2001, 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. 

# In January 2002, 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. 

# In May 2002, 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: 

6 
# 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 

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. 

# 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 the existing 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 

7 
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 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. To date, 

ten 2-hour sessions have been conducted with one session archived for subsequent staff 

training. 

# Since July 2002, eight 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 

hands-on course are available electronically to NIH staff as resource material. 

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

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

years will allow for longitudinal examination of trends and continued monitoring of compliance. 

Aggregate data are reported annually by Fiscal Year (FY). 

New Method for Data Funded in FY 2001 and Reported in FY 2002

The data tables included in this report mark an important transition in the way the inclusion data are 

described and reported. Data tables for FY 2000 are the final tables produced from the old NIH tracking 

system which stored and reported cumulative enrollment data based on the fiscal year of performance, 

i.e., the fiscal year that the data were collected by the researcher. Also, the FY 2000 tables relied on a 

single reporting format based on the 1977 OMB categories and standards for reporting data on race and 

ethnicity. 

In contrast, the data tables for FY 2001 (reported in FY 2002) are the first tables produced from the new 

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. Using this new strategy, the FY 2001 (reported in 

FY 2002) tables reflect data submitted to NIH in FY 2002 as part of the annual progress report and 

reflects cumulative enrollment through FY 2001 and through the time when the progress report was 

submitted to NIH. In addition, the FY 2001 (reported in FY 2002) tables are the first to describe data 

using both the 1977 and 1997 OMB standards for reporting data on race and ethnicity. The new 1997 

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 number of changes in reporting the FY 2001 (reported in FY 2002) data in many ways precludes the 

comparison of the FY 2000 data with the FY 2001 (reported in FY 2002) data. The introduction of the 

8 
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 2001 (reported in FY 2002) data reflect recent 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 

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. 

In addition, the section of this report entitled, “Part II: Biennial Institute and Center Advisory Council 

Reports Certifying Compliance with Inclusion Guidelines, Spring 2003,” provides statements from the 

Advisory Councils of each IC resulting from discussions and certification of the compliance of each IC 

with the NIH overall inclusion policies. 

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 2000 & Reported in FY 2000 

Summary Report of NIH Inclusion Data

NIH Aggregate Extramural and Intramural Population Data 

Funded in FY 2000 & Reported in FY 2000 and Funded in FY 2001 & Reported in FY 2002 

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

in FY 2001 and FY 2000. Previous inclusion reports and aggregate enrollment figures for FY 1994

through FY 2000 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 2000 (reported in FY 2000) and FY 2001 (reported in FY 2002) 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, more than 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 

2001, more than 95% 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 2001 (reported in FY 2002) show 

that approximately 67.2% of the subjects were women. Of the 670 extramural Phase III research protocols 

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

Black (not Hispanic) subjects (14.8%) and lowest for American Indian/Alaska Native at 0.36%. Hispanic 

subjects comprised approximately 10.9%, Asian/Pacific Islander subjects were 5.59% and White (not 

Hispanic) subjects were 65.62%. 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, 87 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 

(13.8%) and lowest for Hawaiian/Pacific Islander (0.37%). Asian subjects comprised 5.11% of 

participants, American Indian/Alaska Native subjects were 0.37% and White subjects were 73.6%. 0.7%

of the participants identified More Than One Race for their racial category. Of the 87 extramural Phase III

research protocols designating an ethnicity, 90.45% of the subjects identified a racial category and an 

ethnicity of not Hispanic. Whereas, 3.70% identified a racial category and an ethnic category of 

Hispanic/Latino. 5.85% participants identified a racial category but did not report an ethnicity or 

Unknown ethnicity.

Aggregate enrollment data funded and reported in FY 2000 were submitted following the 1977 OMB 

standards. Table 6 shows for extramural Phase III trials funded in FY 2000 (reported in FY 2000), 

approximately 70.9% of the subjects were women an increase of 7.6% from FY 1999. Among minority

subjects,1

 representation in Phase III trials [Table 6] was highest for Black (not Hispanic) subjects 

(12.1%) and lowest for American Indians/Alaskan Natives subjects (0.7%) a decrease of 0.5% and 0.1% 

respectively. Asian/Pacific Islanders subjects were 1.9% of the extramural Phase III subjects for FY 

2000 a decrease of 2.9% from FY 1999; Hispanic subjects were 5.6% a decrease of 0.5%; and White (not 

Hispanic) subjects were 72.7% an increase of 5% from FY 1999. Over nine million subjects were 

included in the research projects as funded and reported in FY 2000 [Table 2]. 

 

 1Racial and ethnic categories are in accord with the Office of Management and Budget (OMB) Directive No. 15. 

13 
Over nine million subjects were included in the research projects covered by the tracking system in FY 

2001 (reported in FY 2002). A snapshot of the aggregate enrollment data [Table 1] shows that 

approximately 68.1% of the subjects were women, approximately 31.2% were men, and approximately

0.7% did not identify a sex/gender. Extramural studies funded and reported in FY 2000 [Table 2] show 

that approximately 61.3% of the subjects were women, approximately 38.4% were men, and 

approximately 0.4% did not provide sex/gender identification. Overall, the number of women

participants increased by 7%, the number of men decreased by 7% and the number of subjects that did not 

identify their sex/gender decreased by 0.3% comparatively. However, when sex-specific studies were 

excluded for FY 2001 (reported in FY 2002), the proportions of subjects were proportional to the 

percentages of the general population, 49.5% women and 49.7% men respectively. 

The Tracking and Inclusion Committee conducted an analysis of the FY 1999 and FY 2000 extramural 

and Phase III research protocols and noted differences in the numbers and percentages of subjects that 

identified their race/ethnicity in those that did not identify their sex/gender. In response to these findings, 

committee representatives reviewed their institute’s data and reconvened the committee to discuss 

possible explanations. In many cases, the changes in percentages between FY 1999 and FY 2000 were 

attributable to the ending of previously reported studies where enrollments ranged from 20,000 to 300,000 

participants per study. Although other new studies were launched in FY 2000, enrollment for these new 

studies is just beginning. Another reason for the fluctuations between FY 1999 and FY 2000 enrollment 

percentages is the improved reporting and corrections of errors by investigators. In addition, 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.” 

Intramural studies funded and reported in FY 2000 [Table 10] show that approximately 45.8% of 

intramural subjects were women and approximately 53.8% were men. Among minority subjects, 

representation in intramural studies was highest for Asian/Pacific Islander subjects (20.6%) and lowest for 

American Indian/Alaskan native subjects (0.9%). Black – (not Hispanic) subjects represented 

approximately 5.7% of the subjects; Hispanic subjects 2.6%; and White (not Hispanic) subjects 

represented 66.5% of the intramural research study population. Approximately two million subjects were

included in the tracking system from intramural research projects in FY 2000. 

Substantial numbers of women and minorities were also included in NIH intramural studies in FY 2001 

(reported in FY 2002) [Table 9]. Approximately 46.3% of intramural subjects were women and 

approximately 53% were men. Among minority subjects, representation in intramural studies was highest 

for Asian/Pacific Islander subjects (23.59%) and lowest for American Indian/Alaskan native subjects 

(0.89%). Black (not Hispanic) subjects represented approximately 5.68% of the subjects; Hispanic 

subjects 2.42%; and White (not Hispanic) subjects represented 63.39% of the intramural research study 

population. Approximately two million subjects were included in the tracking system from intramural 

research projects in FY 2001.

14 
Council Dates Jan-00 May-00 Aug-00 Oct-00 Jan-01 May-01 Aug-01 Oct-01 Jan-02 M

Total Number of ApplicationsReviewed (#) 13,195 14,967 906 13,716 13,521 14,419 917 14,277 14,372 Number of Applications with Human Subjects (#) 5,255 6,160 406 5,772 5,512 6,068 585 5,936 5,836 

(#) 4,967 5,825 390 5,465 5,244 5,702 562 5,559 5,446 

(%) 94.51% 94.56% 96.05% 94.68% 95.14% 93.97% 96.07% 93.65% 93.32% 9

(#) 115 119 8 112 99 143 5 142 168 

(%) 2.18% 1.93% 1.97% 1.94% 1.80% 2.36% 0.85% 2.39% 2.88% 

(#) 30 25 0 28 14 29 6 23 31 

(%) 0.57% 0.40% 0.00% 0.48% 0.25% 0.48% 1.03% 0.39% 0.53% 

(#) 143 191 16 167 155 194 12 212 191 

(%) 2.72% 3.10% 3.94% 2.89% 2.81% 3.20% 2.05% 3.57% 3.27% 

(#) 258 310 16 279 254 337 17 354 359 

(%) 4.90% 5.03% 3.94% 4.83% 4.61% 5.55% 2.91% 5.96% 6.15% 

(#) 173 216 8 195 169 223 18 235 222 

(%) 3.29% 3.51% 1.97% 3.38% 3.07% 3.68% 3.08% 3.96% 3.80% 

(#) 288 335 16 307 268 366 23 377 390 

(%) 5.48% 5.44% 3.94% 5.32% 4.86% 6.03% 3.93% 6.35% 6.68% 

Total Number (percent) ofunacceptable Applications assubmittedNumber (percent) of Applications with unacceptable sex/gender-only inclusionNumber (percent) of Applications with both unacceptable minority AND sex/gender inclusionTotal Number (percent) ofApplications with unacceptableminority inclusionTotal Number (percent) ofApplications with unacceptablesex/gender inclusion

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

 During Scientific Peer Review for the Fiscal Period 2000-2002

Number (percent) of Applications approved by IRG as submittedNumber (percent) of Applications with unacceptable minority-only inclusion

15 
Council Dates Jan-00 May-00 Aug-00 Oct-00 Jan-01 May-01 Aug-01 Oct-01 Jan-02 M

Total number of awards (#) 4,415 4,960 307 4,389 4,441 4,892 348 4,495 4,480 Number of awards involving Human Subjects (#) 1,633 1,964 129 1,683 1,649 1,896 200 1,697 1,676 

(#) 1,582 1,893 124 1,632 1,599 1,821 188 1,644 1,625 

(%) 96.87% 96.38% 96.12% 96.96% 96.97% 96.04% 94.00% 96.88% 96.96% 

(#) 18 27 1 23 18 25 7 26 19 

(%) 1.10% 1.37% 0.77% 1.36% 1.09% 1.32% 3.50% 1.53% 1.13% 

(#) 13 708 430 4 5 

(%) 0.79% 0.35% 0.00% 0.47% 0.24% 0.16% 0.00% 0.24% 0.30% 

(#) 20 37 4 20 28 47 5 23 27 

(%) 1.22% 1.88% 3.10% 1.18% 1.70% 2.48% 2.50% 1.36% 1.61% 

(#) 38 64 5 43 46 72 12 49 46 

(%) 2.32% 3.25% 3.87% 2.55% 2.79% 3.80% 6.00% 2.89% 2.74% 

(#) 33 44 4 28 32 50 5 27 32 

(%) 2.02% 2.24% 3.10% 1.66% 1.94% 2.64% 2.50% 1.59% 1.91% 

(#) 51 71 5 51 50 75 12 53 51 

(%) 3.12% 3.61% 3.87% 3.03% 3.03% 3.96% 6.00% 3.12% 3.04% 

Table B. Extramural Research Awards Funded for the Fiscal Period 2000-2002: Bars-To-Funding a

Number (percent) of awards where minority-only bar-to-funding wasremoved by program staff (M_U)Number (percent) of awards involvingHuman Subjects that met the inclusion requirements as submittedTotal Number (percent) of awardswhere bar-to-funding was removedNumber (percent) of awards where sex/gender-only bar-to-funding was removed by program staff (G_U)Number (percent) of awards where both minority AND sex/gender bar-tofunding were removed by program 

staffTotal Number (percent) of awardswhere minority bar-to-funding was removed by program staffTotal Number (percent) of awardswhere sex/gender bar-to-funding wasremoved by program staff

16 
Phase III

trials* On-Site

Protocols reporting women only 181 868 92 35

Protocols reporting men only 62 378 64 16

Protocols reporting both men and 

women 473 5,312 832 164

Protocols reporting men, women, and

unknown *** 37 328 - 40

Protocols reporting sex composition as

unknown only 2 37 - 6

Protocols reporting men and unknown - 6 - 1

Protocols reports women and unknown 2 7 - 2

Early Stage studies where enrollment

data has not yet been submitted 130 3,569 175 78

Totals 887 10,505 1,163 342

*** Many studies may be generic.

Extramural Studies Intramural Studies

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

 Funded in FY 2001 & Reported in FY 2002

* 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.

Other Clinical

trials** Off-Site

17
Osteoporopic Fractures in Men (MR OS)

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

Evaluation and Treatment of Pain

Gene Environment Cancer Prevention

Mechanisms Linking Depression To Cardiovascular Risk

Gene Expression in Normal & Diseased Muscle Development

Spit Tobacco (ST) Cessation: Rural High School Males

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

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

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 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

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 

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

 Funded in FY 2001 and Reported in FY 2002

Decision Delay in Women with Acute Myocardial Infarction

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

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

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

18
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

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 or Latino U

R

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

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%

Table 1. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2001 and Reported 

Total of All Subjects by Race

Female

Male

Unknown

Total

Number of Protocolswith Enrollment Data: Number of Protocolswith Enrollment Data: 

*Categories not in uprovided here for coOMB Standards.

Total

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

Total of All Subjects 

Female

Male

Unknown

19 
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 protocLargest identified racial group is White at 58.66% following the 1977 OMB standards and 60.21% following the 1997 OMB staAccording 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 (0.6%According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.5%).

Table 1. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY 2001 and Reported 

More participants identified a race and no Hispanic/Latino ethnicity (70.8%) than a Hispanic or Latino ethnicity (7%).

20 
# % # % # % # % # % # 

Female 45,828 0.80% 728,385 12.30% 650,459 10.90% 422,476 7.10% 3,797,984 63.90% 295,742 Male 42,000 1.10% 372,842 10.00% 436,833 11.70% 345,394 9.30% 2,243,973 60.30% 280,166 Unknown 205 0.60% 2,779 7.90% 4,128 11.70% 1,827 5.20% 10,053 28.60% 16,167 Total 88,033 0.90% 1,104,006 11.40% 1,091,420 11.30% 769,697 7.90% 6,052,010 62.40% 592,075 

Table 2. Aggregate Enrollment Data for All Extramural Research Protocols 

American Indians 

and Alaska

Asian and Pacific 

Islanders Black - Not Hispanic Hispanic White - Not Hispanic Other a

Unkno

Largest identified racial minority group is Asian/Pacific Islanders at 1,104,006 or 11.4%.Smallest identified racial minority group is American Indian/Alaska Natives at 88,033 or 0.9%.

 Funded in FY 2000 and Reported in FY 2000*

Number of Protocols: 8,785

* Data reported following the 1977 OMB standards for reporting race and ethnicity.

FY 00 Data Table Comments:

More females (5,940,874 or 61.3%) than males (3,721,208 or 38.4%) are enrolled in aggregate Extramural ReseaLargest identified racial group is White, non-Hispanic at 6,052,010 or 62.4%.

21 
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

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 Hispanic or Latino 

27,471 73,888 199,564 8,231 745,791 12,665 86,501 1,154,111 805,206 86,756 

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 79,388 

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 1,732 

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 1,600,576 167,876 

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%

Number of Protocols with Enrollment Data: 

Table 3. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and Female-O

Female

Male

Unknown *Categories not 

are provided he

Total 1997 OMB Stan

Number of Protocols with Enrollment Data: 

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

 Funded in FY 2001 and Reported in FY 2002

Total of All Subjects by Race

Total

Total of All Subject

Female

Male

Unknown

22 
Data Table Comments:

Table 3. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and Female-O

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 extprotocols are closely representative of the general population.Largest identified racial group is White at 51.5% following the 1977 OMB standards and 64.4% following the 1997 OMB stan

 Funded in FY 2001 and Reported in FY 2002

More participants identified a race and no Hispanic/Latino ethnicity (72.7%) than a Hispanic or Latino ethnicity (7.63%). According 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%According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.97%). 

23 
#%#% #%#% # % # % 

Female 40,261 1.10% 354,982 9.90% 459,924 12.80% 345,866 9.60% 2,183,755 60.80% 205,104 5.70% Male 40,567 1.20% 345,952 9.80% 421,657 12.00% 333,218 9.50% 2,105,264 59.80% 274,424 7.80% Unknown 205 0.60% 2,779 7.90% 4,128 11.70% 1,827 5.20% 10,053 28.60% 16,167 46.00% Total 81,033 1.10% 703,713 9.80% 885,709 12.40% 680,911 9.50% 4,299,072 60.20% 495,695 6.90% 

FY 00 Data Table Comments:Table 4. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only & Fema Funded in FY 2000 and Reported in FY 2000*

American Indians

and Alaska

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic White - Not Hispanic

Largest identified racial minority group is Black - Not Hispanic at 885,709 or 12.4%.Smallest identified racial minority group is American Indian/Alaska Native at 81,033 or 1.1%.

Other and

Unknown 

There were 8,785 protocols of which 975 were women only protocols and 360 were men only protocols.Largest identified racial group is White, non-Hispanic at 4,299,072 or 60.2%.Number of Protocols: 5,897* Data reported following the 1977 OMB standards for reporting race and ethnicity. 24 
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 U

R

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%

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

Female

Male

Unknown

 Funded in FY 2001 and Reported in FY 2002

Total

Number of Protocolswith Enrollment

*Categories not iprovided here fo1997 OMB Stand

Number of Protocols

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

Total of All Subjects by Race

Total

Total of All Subject

Female

Male

Unknown

25 
Data Table Comments:

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

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

 Funded in FY 2001 and Reported in FY 2002

More participants identified a race and no Hispanic/Latino ethnicity (90.4%) than a Hispanic or Latino ethnicity (3.7%).Largest identified racial group is White at 65.6% following the 1977 OMB standards and 73.6% following the 1997 OMB sLargest 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 (According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.02%)

26 
# % # % # % # % # % # % 

Female 2,521 0.60% 8,920 2.20% 46,303 11.20% 20,889 5.10% 309,289 75.00% 24,457 5Male 1,558 0.90% 2,205 1.30% 23,606 14.00% 11,606 6.90% 113,068 67.30% 16,042 9Unknown 0 0.00% 7 0.50% 201 15.80% 57 4.50% 445 35.00% 563 44Total 4,079 0.70% 11,132 1.90% 70,110 12.10% 32,552 5.60% 422,802 72.70% 41,062 7Number of Protocols : 645* Data reported following the 1977 OMB standards for reporting race and ethnicity.

FY 00 Data Comments:

Substantial numbers of women and minorities are enrolled in Phase III research protocols funded in 2000.There were more females (412,379 or70.9%) than males (168,085 or 28.9%) enrolled in Phase III research protocols.Among minority subjects, the largest racial minority group is Black, non-Hispanic at 70,110 or 12%.Smallest identified racial group is American Indian/Alaska Natives at 4,079 or 0.7%.

Table 6. Aggregate Enrollment Data for Extramural Phase III Protocols 

 Funded in FY 2000 and Reported in FY 2000*

American Indians 

and Alaska

Asian and Pacific

Islanders

Black - Not 

Hispanic Hispanic White - Not Hispanic Other and Unknown

27 
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 U

R

51 226 1,615 4 4,441 144 633 7,114 5,768 461 

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 31 

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%

Table 7. Aggregate Enrollment Data for Extramural Phase III Protocols Excluding Male-Only and Female-O

Female

Male

Unknown *Categories not 

are provided her1997 OMB Stand

Number of Protocols with Enrollment

Total

 Funded in FY 2001 and Reported in FY 2002

Total of All Subject

Female

Male

Unknown

Total

Total of All Subjects by Race

Number of Protocols 

28 with Enrollment
Data Table Comments:

Table 7. 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 extramurprotocols are closely representative of the general population.More participants identified a race and no Hispanic/Latino ethnicity (83.3%) than a Hispanic or Latino ethnicity (5.3%). Largest identified racial group is White at 66.4% following the 1977 OMB standards and 60.8% following the 1997 OMB stanLargest identified racial minority group is Black at 15.9% following the 1977 OMB standards and 17.8% following the 1997 OAccording to the 1977 OMB standards, the smallest identified racial minority group is American Indian/Alaskan Native (0.4%According to the 1997 OMB standards, the smallest identified racial minority group is Hawaiian/Pacific Islander at (0.05%).

29 
#%#%#%#%

#

% # %

F

e

m

ale 1,383 1.10% 1,750 1.30%

21,977 16.90% 10,567 8.10% 74,761 57.50% 19,541 15.00% 

Mal

e 1,526 1.00% 2,096 1.40%

21,469 13.80% 11,125 7.20% 103,862 66.90% 15,145 9.80% 

Unknown 0 0.00% 7 0.50% 201 15.80% 57 4.50% 445 35.00% 563 44.20% T

otal

2,909 1.00% 3,853 1.30%

43,647 15.20%

21,749 7.60% 179,068 62.50% 35,249 12.30% 

T

able 8. A

ggregate 

E

nrollm

ent Data for Extramural Phase III Research Protocols 

Exclu

din

g

MaleO

nly

& F

emale O

nly Protocols F

u

n

d

e

d in F

Y 2000 and Rep

orted in F

Y 2000*

Black - Not 

Hispanic Hispanic White -

N

ot

Hispanic

Other and 

Unknown 

Asian and Pacific Islanders Am

erican Indians

and Alaska

Largest identified r

acial minority gr

oup is Black - Not Hispanic at 43,647 or 15.2%.

Sm

allest identified racial minority group is A

meric

an Indian/Alaska Nati

v

e at 2,909 or 1.0%.

* Data reported f

ollowing the 1977 O

MB standards f

or reporting race and ethnicity.

Number of Protocols: 444There w

ere 645 protocols of

which 121 w

ere w

o

m

en onl

y pr

otocols and 3

4 w

ere men onl

y protocols.

Largest identified r

acial group is White, non-Hispanic at 179,068 or 6

2.5%.

FY 0

0 Data Tabl

e Comments

30 
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 Hispanic or Latino 

0 0 0 0 0 0 0 0 0 0 

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

0 0 0 0 0 0 0 0 0 0 

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

0 0 0 0 0 0 0 0 0 0 

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

0 0 0 0 0 0 0 0 0 0 

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

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

46.32% 53.00% 0.68% 100%

Number of Protocolswith Enrollment

Table 9. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2001 and Reporte

Female

Male

Unknown *Categories n

are provided 

Total 1997 OMB S

Number of Protocolswith Enrollment

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

Total of All Subjects by Race

Total

Total of All Subj

Female

Male

Unknown

31 
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%Table 9. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2001 and Reported iDifferences in the enrollment of males and females is attributed primarily toimprovements in reporting procedures 

sex/gender declaration and recording at enrollment.There were more males (1,049,173 or 53%) than females (917,024 or 46.3%) enrolled in aggregate intramural reThe racial minority group with the largest increase in enrollment is Asian/Pacific Islander - an increase of 50% fro

32 
#%#% #%# % # %#%

Female 9,042 1.00% 198,427 22.90% 53,713 6.20% 29,928 3.40% 546,363 62.90% 30,475 3.50

Male 7,991 1.10% 192,775 18.90% 54,470 5.30% 19,392 1.90% 715,671 70.20% 29,380 2.90Unknown 1 0.00% 71 0.80% 22 0.20% 131 1.40% 405 4.30% 8,758 93.30Total 17,034 0.90% 391,273 20.60% 108,205 5.70% 49,451 2.60% 1,262,439 66.50% 68,613 3.60

Other and 

Unknown 

The large Asian/Pacific Islander population is due in part to a large clinical study being conducted in Vietnam.

Asian and Pacific 

Islanders

Smallest identified racial minority group is American Indian/Alaskan Native at 17,034 or 0.9%.

FY 00 Data Comments 

There were more males (1,019,679 or 53.8%) than females (867,948 or 45.8%) enrolled in aggregate Intramural research protocoDifferences in the enrollment of males and females are attributed primarily to improvements in reporting procedures. (ie, ensuring 

sex/gender declaration and recording at enrollment).The racial minority group with the largest increase in enrollment is Hispanic - an increase of 75% from FY99 to FY00.

Table 10. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY 2000 and Repo

The number of Black - Not Hispanic enrollees increased by 8% from FY99 to FY00.Largest identified racial minority group is Asian/Pacific Islanders at 391,273 or 20.6%.* Data reported following the 1977 OMB standards for reporting race and ethnicity.Number of Protocols: 1,427

 (Includes On-site and Off-site)* 

American Indians

and Alaska Natives

Black - Not 

Hispanic Hispanic White - Not Hispanic

33 

35 

APPENDICES 
36 
37 

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-tofunding as well. If the bar is removed, the AU@ is converted to AR@ to designate that change in 

status. 
38 
39 

Appendix B 

NIH Tracking and Inclusion Committee Members 

- Full Committee 
40 
41 

NIH Tracking and Inclusion Committee 

List of Members 

Year 2001-2002 (updated 3/23/2003)

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

Della Hann*, Larry Fanning, Donna Frahm, Dan Hall 

Office of Acquisition, Management and Procurement 

 Zaiga Tums, Barbara Levy, Joann Wingard

National Cancer Institute

Marvin Kalt*, Diane Bronzert, Marilyn Gaston, Joe Harford, Margaret Holmes, 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 Hajos*, Susan Saylor 

National Institute on Aging 

Miriam Kelty *, Karen Bashir, Taylor Harden 

National Institute on Alcohol Abuse and Alcoholism

Lorraine Gunzerath *; Dorita Sewell 

National Institute of Allergy and Infectious Diseases

Marie Parker*, Lai Tan *, Diane Adger-Johnson, Susan Schafer, Wallace Robinson, 

Joyce Woodford, Diane Yerg 

National Institute of Arthritis and Musculoskeletal and Skin Diseases

 Christine Densmore*, 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
42 

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

Margo Adesanya*, Trenita Davis, Maria Canto

National Institute of Diabetes, Digestive and Kidney Disorders

Beth Paterson *, Patricia Robuck, Donna James

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

Mary Lou Prince *, Mary Blehar, Ernesto Marquez, Pamela Wexler, Sue Kennel 

National Institute of Neurological Disorders and Stroke

 Mary Ellyn Michel*, Connie Atwell, Gladys Melendez-Bohler, Frances Yee 

National Institute of Nursing Research

Carole Hudgings *, Robin Gruber 

National Library of Medicine

Rita Richey *, Dwight Mowery 

Warren G. Magnuson Clinical Center

Kim Jarema *, Dee Koziol 

National Center for Complementary and Alternative Medicine

 Jennifer Tisch, Linda Rich * 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
43 

List of Members, continued...

National Center for Research Resources

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

Fogarty International Center

Aron Primack*, Kathleen Michels, Janice Solomon 

Center for Scientific Review 

Elliot Postow *, Anita Miller Sostek 

Office of Intramural Research

Alan Sandler 

National Center for Minority Health and Health Disparaties

Eric Bailey*, John Ruffin, Tommy Broadwater 

National Institute of Biomedical Imaging and Bioengineering

Meredith Temple*, Joan Harmon, Mollie Sourwine, Yinka Abu 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee 
44 
45 

Appendix C 

Responses to the General Accounting Office (GAO) 

Report: AWomen=s Health: NIH Has Increased Its 

Efforts to Include Women in Research@

GAO/HEHS-00-96, September 2002 
46 
47 

Status Report on Actions Taken on General Accounting Office (GAO) Report, 

AWomen=s Health: NIH Has Increased Its Efforts to Include Women in Research@, 

GAO/HEHS-00-96, September 2002

This document represents a status report of actions taken by the National Institutes of Health in 

response to the second recommendation of the May 2000 General Accounting Office Report, 

AWomen=s Health: NIH Has Increased Its Efforts to Include Women in Research.@ 

RECOMMENDATION #2

To improve the accuracy of NIH=s tracking data on the inclusion of women and minorities, 

we recommend that the Director of the NIH ensure that the NIH staff who transmit data to 

the tracking system receive ongoing training on the requirements and purpose of the 

system.

NIH STATEMENT: The launch of a new electronic database for grant review, 

management and administration, which would include a computerized system for 

standardizing and collecting inclusion data, would occur before the end of the calendar 

year 2000. 

CURRENT STATUS: 

The NIH population tracking system for monitoring the inclusion of women and minorities in 

clinical research was successfully deployed in May 2002. This system provides easier data entry 

and project monitoring for NIH staff, creates clear and timely NIH reports on inclusion data, 

incorporates the 1997 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). The re-engineered population tracking system continues 

to be refined based on input from the NIH user community. 

Several training efforts have been conducted to assist staff in using the new system. In January 

2002, NIH conducted and archived a videocast training session on the updated policies and 

procedures on sex/gender and minority inclusion. This session was mandatory for all NIH 

program, grants management and review staff involved in the administration of clinical research. 

To accompany the training course, a comprehensive training manual explaining the new polices 

and procedures was developed as a training resource and remains available electronically for all 

NIH staff. In May 2002, NIH provided a second session for the Center for Scientific Review that 

highlighted the requirements and issues for scientific review staff. 

Also in May, NIH published an on-line users guide and began offering 2-hour demonstrations to 

accompany the launch of the new system. To date, ten 2-hour sessions have been conducted with 

one session archived as a videocast session for subsequent staff training. Since July 2002, an 
48 

additional eight 3-hour, in-depth, hands-on training sessions have been provided to NIH staff. 

The training materials for the hands-on course will be available electronically to NIH staff in 

mid-September. Additional demonstration sessions and hands-on training sessions will be 

offered in Fall 2002/Winter 2003. All training materials are available to NIH staff via 

http://imacii.nih.gov.

In addition to launching the new system and providing staff training, NIH has been providing 

outreach to the scientific community to help increase their understanding of the revised inclusion 

policy and OMB requirements. To date, staff have participated in two NIH Regional Seminar 

meetings (each involving approximately 400 extramural scientists and administrators), presented 

to the NIH Clinical Center faculty and students, and developed a resource slide show on the 

inclusion policy and OMB requirements that can be used by Institute staff when working with 

the extramural community. 

 

The NIH continues to provide training to intramural and other research investigators through its 

comprehensive training programs. These ongoing programs include: Clinical Research Training 

Course for Intramural Investigators; Introduction to the Principles and Practice of Clinical 

Research; Principles of Clinical Pharmacology; Ethical and Regulatory Aspects of Human 

Subjects Research; Computer Based Training for the Protection of Human Subject Research; 

and Computer Based Training Course for NIH IRB Members. 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. As a result, a web-based educational module is now available 

on-line. The curriculums for the Clinical Research Programs provide guidance on the NIH 

policies related to clinical research and continue to be evaluated. 

To capture and report data on women and minorities, the NIH intramural program uses 

centralized systems within the hospital from which data are abstracted and reported. This 

information is self-reported by the patient and is centrally collected and entered into the 

hospital=s information systems by the Admission staff at the time of the patient=s visit to the 

Clinical Center. Modifications to the hospital=s systems were made to comply with the updated 

OMB Directive 15, and training was provided to the necessary staff. The data will be analyzed in 

the near future to determine if there is a need for additional training programs. NIH is currently 

working on reporting intramural program FY2002 inclusion data and future inclusion data using 

the new population tracking system. 
49 

Status of Activities on GAO Report on Women=s Health (GAO/HEHS-00-96, May 2000) 

Activity Due Date Status Date 

Completed

Notice in NIH Guide to 

Grants & Contracts - clarifies 

policy for gender analyses for 

Phase III clinical trials 

8/1/2000 Completed - link from Women 

and Minorities Web Page at: 

http://grants.nih.gov/grants/fun

ding/women_min/women_min.

htm

8/2/2000 

Language incorporated in 

NIH solicitations for grant 

applications and contract 

proposals (PA/RFA/RFP)

indicating requirements for 

applications and reporting for 

Phase III clinical trials 

Effective 

10/1/2000 

Completed document 8/2/2000 

A new Terms and 

Conditions for Awards will 

be included in all grant, 

cooperative agreement, & 

contract awards containing 

Phase III clinical trials

Effective 

10/1/2000 

Completed document 8/2/2000 

Guidelines/instructions for 

reviewers & SRAs developed 

clarifying the need to review 

research proposals containing 

Phase III clinical trials. 

Documentation required in 

summary statements 

addressing adherence to these 

policies 

10/26/2000 Completed document

http://grants.nih.gov/grants/peer

/hs_review_inst.pdf

02/2001 

Train NIH program & review 

officials and grants & 

contracts management staff on 

Fall 2000 Symposium training session for 

extramural staff (450) occurred 

on10/16 on new policies and 

10/16/00 
Status of Activities on GAO Report on Women=s Health (GAO/HEHS-00-96, May 2000) 

Activity Due Date Status Date 

Completed

updated policy for Phase III 

clinical trials (workshops, 

presentations at professional 

meetings & advisory 

committees; web-site didactic 

instructions; & on-line Q&A 

and fact sheets)

procedures regarding human 

subjects. An additional 400 

individuals viewed the 

symposium in satellite centers 

and 175 additional NIH staff 

utilized a VideoCast system.

An additional training session 

regarding a Grants Policy 

Update: Humans and 

Animals targeting extramural 

and intramural research,

program and grants 

management, and review staff. 

Video tapes and web-video 

access from the 10/16 and 

12/11 training are available to 

NIH staff. 

Frequently Asked Questions 

document. 

Training of Extramural and 

Intramural staff at December 

2000 Full Tracking and 

Inclusion Committee Meeting. 

Sex/Gender and Minority 

Inclusion in Clinical Research: 

Staff Training Workshop (over 

400 participants; videocast and 

archived; available online to 

NIH staff. 

12/11/00 

7/5/2001 

12/11/00 

1/2/2002 

Intramural Training on 

Updated Policies and 

Population Tracking System 

Ongoing Required for all PI=s. The NIH 

Clinical Center continues to 

provide training to intramural 

and other PI through 

comprehensive training 

programs; Computer-based 

Revised: 

Spring/Fall 

2002

50 
Status of Activities on GAO Report on Women=s Health (GAO/HEHS-00-96, May 2000) 

Activity Due Date Status Date 

Completed

training; web-based modules 

available on-line. 

ORWH & OER work together 

to ensure NIH staff are wellinformed about data collection 

requirements of current 

tracking system

No end date Continuing Ongoing 

NIH develop specific 

tracking/inclusion module to 

interface w/ IMPAC2 system. 

12/31/2000 System Deployed May 2002 

NIH staff training on tracking 

system module to interface w/ 

IMPAC2 system. 

6/2002 NIH wide system training June 

2002 

- (10) 2 hr demonstration 

sessions (archived and 

videocast) 

- (8) 3 hr hands-on training 

sessions 

Ongoing 

Training on current NIH 

Tracking System to members 

of Full Tracking & Inclusion 

Committee. 

12/11/2000 OER conducted training on the 

current tracking system at the 

12/11 Full Tracking & 

Inclusion Committee meeting. 

12/11/2000 

51 
52 
53 

Appendix D 

Internet Homepage: 

Inclusion of Women and Minorities Policy 

Implementation 

http://grants.nih.gov/grants/funding/women_min/women_min.htm
54 
55 

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 
56 
57 

Appendix E 

NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as 

Subjects in Clinical Research 

(Amended, October, 2001) 
58 
59 

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/notice-files/not94-100.html ) and the August 2000 notice in 

the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD00-048.html ). It incorporates the definition of clinical research as reported in the 1997 Report of 

the NIH Director==s Panel on Clinical research. Also, this notice provides additional guidance on 

reporting analyses of sex/gender and racial/ethnic differences in intervention effects for NIHdefined Phase III clinical trials. The guidelines ensure that all NIH-funded clinical research will 

be carried out in a manner sufficient to elicit information about individuals of both sexes/genders 

and diverse racial and ethnic groups and, particularly in NIH-defined Phase III clinical trials, to 

examine differential effects on such groups. Since a primary aim of research is to provide 

scientific evidence leading to a change in health policy or standard of care, it is imperative to 

determine whether the intervention or therapy being studied affects women or men or members 

of minority groups and their subpopulations differently. 

In June 2001, NIH adopted the definition of clinical research as: (1) Patient-oriented research. 

Research conducted with human subjects (or on material of human origin such as tissues, 

specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts 

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

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

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

technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health 

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

EFFECTIVE DATE: This amended policy is effective immediately and applies to all grants and 

cooperative agreements currently active and to be awarded. Contract solicitations issued as of 

October 2001 must adhere to the amended policy. 

I. LEGISLATIVE BACKGROUND 

The NIH Revitalization Act of 1993, PL 103-43, signed into law on June 10, 1993, directed the 

NIH to establish guidelines for inclusion of women and minorities in clinical research. 

The statute states that: 

In conducting or supporting clinical research for the purposes of this title, the Director of NIH 

shall ... ensure that (a) women are included as subjects in each project of such research; and (b) 

members of minority groups are included in such research. 492B(a)(1) 

The statute further directed the NIH to establish guidelines to specify: 
60 

(a) the circumstances under which the inclusion of women and minorities as subjects in projects 

of clinical research is inappropriate YY; (b) the manner in which clinical trials are required to be 

designed and carried out YY; and (c) the operation of outreach programs YY 492B(d)(1) 

The statute defines "clinical research" to include "clinical trials" and states that: 

In the case of any clinical trial in which women or members of minority groups will be included 

as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner 

sufficient to provide for valid analysis of whether the variables being studied in the trial affect 

women or members of minority groups, as the case may be, differently than other subjects in the 

trial. 492B(c) 

Specifically addressing the issue of minority groups, the statute states that: 

The term "minority group" includes subpopulations of minority groups. The Director of NIH 

shall, through the guidelines established...define the terms "minority group" and "subpopulation" 

for the purposes of the preceding sentence. 492B(g)(2) 

The statute speaks specifically to outreach and states that: 

The Director of NIH, in consultation with the Director of the Office of Research on Women's 

Health and the Director of the Office of Research on Minority Health, shall conduct or support 

outreach programs for the recruitment of women and members of minority groups as subjects in 

the projects of clinical research. 492B(a)(2) 

The statute includes a specific provision pertaining to the cost of clinical research and, in 

particular clinical trials. 

(A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in 

the trial is (sic) not a permissible consideration in determining whether such inclusion is 

inappropriate. 492B(d)(2) 

(ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of 

such inclusion in the project is (sic) not a permissible consideration in determining whether such 

inclusion is inappropriate unless the data regarding women or members of minority groups, 

respectively, that would be obtained in such project (in the event that such inclusion were 

required) have been or are being obtained through other means that provide data of comparable 

quality. 492B(d)(2) 

Exceptions to the requirement for inclusion of women and minorities are stated in the statute, as 

follows: 

The requirements established regarding women and members of minority groups shall not apply 

to the project of clinical research if the inclusion, as subjects in the project, of women and 

members of minority groups, respectively- 

(1) is inappropriate with respect to the health of the subjects; (2) is inappropriate with respect to 

the purpose of the research; or (3) is inappropriate under such other circumstances as the 

Director of NIH may designate. 492B(b) 
61 

(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not 

required if there is substantial scientific data demonstrating that there is no significant difference 

between- 

(i) the effects that the variables to be studied in the trial have on women or members of minority 

groups, respectively; and 

(ii) the effects that the variables have on the individuals who would serve as subjects in the trial 

in the event that such inclusion were not required. 492B(d)(2) 

II. POLICY 

A. Inclusion of Women and Minorities as Subjects in Clinical Research 

It is the policy of NIH that women and members of minority groups and their subpopulations 

must be included in all NIH-funded clinical research, unless a clear and compelling rationale and 

justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion 

is inappropriate with respect to the health of the subjects or the purpose of the research. 

Exclusion under other circumstances may be made by the Director, NIH, upon the 

recommendation of an Institute/Center Director based on a compelling rationale and justification. 

Cost is not an acceptable reason for exclusion except when the study would duplicate data from 

other sources. Women of childbearing potential should not be routinely excluded from 

participation in clinical research. This policy applies to research subjects of all ages in all NIHsupported clinical research studies. 

The inclusion of women and members of minority groups and their subpopulations must be 

addressed in developing a research design or contract proposal appropriate to the scientific 

objectives of the study/contract. The research plan/proposal should describe the composition of 

the proposed study population in terms of sex/gender and racial/ethnic group, and provide a 

rationale for selection of such subjects. Such a plan/proposal should contain a description of the 

proposed outreach programs for recruiting women and minorities as participants. 

B. NIH-defined Phase III Clinical Trials: Planning, Conducting, and Reporting of Analyses for 

Sex/Gender and Race/Ethnicity Differences. 

When an NIH-defined Phase III clinical trial is proposed, evidence must be reviewed to show 

whether or not clinically important sex/gender and race/ethnicity differences in the intervention 

effect are to be expected. This evidence may include, but is not limited to, data derived from 

prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology 

studies, and observational, natural history, epidemiology and other relevant studies. 

Investigators must consider the following when planning, conducting, analyzing, and reporting 

an NIH-Defined Phase III clinical trial. Based on prior studies, one of the three situations below 

will apply: 

1. Prior Studies Support the Existence of Significant Differences 

If the data from prior studies strongly support the existence of significant differences of clinical 

or public health importance in intervention effect based on sex/gender, racial/ethnic, and relevant 

subpopulation comparisons, the primary question(s) to be addressed by the proposed NIH-
62 

defined Phase III clinical trial and the design of that trial must specifically accommodate this. 

For example, if men and women are thought to respond differently to an intervention, then the 

Phase III clinical trial must be designed to answer two separate primary questions, one for men 

and the other for women, with adequate sample size for each. 

The Research Plan (for grant applications) or Proposal (for contract solicitations) must include a 

description of plans to conduct analyses to detect significant differences in intervention effect 

(see DEFINITIONS - Significant Difference) by sex/gender, racial/ethnic groups, and relevant 

subpopulations, if applicable. The final protocol(s) approved by the Institutional Review Board 

(IRB) must include these plans for analysis. The award will require that for each funded 

protocol, investigators must report in their annual Progress Report cumulative subject accrual 

and progress in conducting analyses for sex/gender and race/ethnicity differences. If final 

analyses of sex/gender and race/ethnicity are not available at the time of the Final Progress 

Report or Competing Continuation for the grant, a justification and plan ensuring completion and 

reporting of the analyses are required. If final analyses are required as part of the contract, these 

analyses must be included as part of the deliverables. These requirements will be cited in the 

terms and conditions of all awards for grants, cooperative agreements and contracts supporting 

NIH-defined Phase III clinical trials. 

Inclusion of the results of sex/gender, race/ethnicity and relevant subpopulations analyses is 

strongly encouraged in all publication submissions. If these analyses reveal no differences, a 

brief statement to that effect, indicating the groups and/or subgroups analyzed, will suffice. 

2. Prior Studies Support No Significant Differences 

If the data from prior studies strongly support no significant differences of clinical or public 

health importance in intervention effect based on sex/gender, racial/ethnic and/or relevant 

subpopulation comparisons, then sex/gender and race/ethnicity will not be required as subject 

selection criteria. However, the inclusion and analysis of sex/gender and/or racial/ethnic 

subgroups is still strongly encouraged. 

3. Prior Studies Neither Support nor Negate Significant Differences 

If the data from prior studies neither strongly support nor strongly negate the existence of 

significant differences of clinical or public health importance in intervention effect based on 

sex/gender, racial/ethnic, and relevant subpopulation comparisons, then the NIH-defined Phase 

III clinical trial will be required to include sufficient and appropriate entry of sex/gender and 

racial/ethnic participants, so that valid analysis of the intervention effects can be performed. 

However, the trial will not be required to provide high statistical power for these comparisons. 

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 
63 

required as part of the contract, these analyses must be included as part of the deliverables. These 

requirements will be cited in the terms and conditions of all awards for grants, cooperative 

agreements and contracts supporting NIH-defined Phase III clinical trials. 

Inclusion of the results of sex/gender, race/ethnicity and relevant subpopulations analyses is 

strongly encouraged in all publication submissions. If these analyses reveal no differences, a 

brief statement to that effect, indicating the groups and/or subgroups analyzed, will suffice. 

For all three situations, cost is not an acceptable reason for exclusion of women and minorities 

from clinical trials. 

III. ROLES AND RESPONSIBILITIES 

While this policy applies to all applicants/offerors for NIH-supported clinical research, certain 

individuals and groups have special roles and responsibilities with regard to its implementation. 

1. NIH Staff 

The NIH staff provide educational opportunities for the extramural and intramural communities 

concerning this policy; monitor its implementation during the development, review, award and 

conduct of research; and manage the NIH research portfolio to comply with the policy. 

2. Principal Investigators 

Principal investigators should assess the theoretical and/or scientific linkages between 

sex/gender, race/ethnicity, and their topic of study. Following this assessment, the principal 

investigator and the applicant/offeror institution will address the policy in each application and 

proposal, providing the required information on inclusion of women and minorities and their 

subpopulations in clinical research projects, and any required justifications for exceptions to the 

policy. 

For foreign awards and domestic awards with a foreign component, the NIH policy on inclusion 

of women and minority groups in research is the same as that for research conducted in the U.S. 

If there is scientific rationale for examining subpopulation group differences within the foreign 

population, investigators should consider designing their studies to accommodate these 

differences. 

Investigators and their staff(s) are urged to develop appropriate and culturally sensitive outreach 

programs and activities commensurate with the goals of the study or objectives of the contract. 

The objective should be to actively recruit and retain the most diverse study population 

consistent with the purposes of the research project. Indeed, the purpose should be to establish a 

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 
64 

Asked Questions document, are located at the following URL: 

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

3. Institutional Review Boards (IRBs) 

It is the responsibility of the IRBs to address the ethical issues as outlined in Section IV(2) for 

Principal Investigators. As the IRBs implement the regulation for the protection of human 

subjects as described in Title 45 CFR Part 46, "Protection of Human Subjects", 

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm they must also attend to the 

guidelines for the inclusion of women and minorities and their subpopulations in clinical 

research. They should take into account the Food and Drug Administration's "Guidelines for the 

Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs," Vol. 58 

Federal Register 39406 http://www.fda.gov/cder/guidance/old036fn.pdf. 

4. Peer Review Groups 

In conducting peer review for scientific and technical merit, appropriately constituted initial 

review groups (including study sections), technical evaluation groups, and intramural review 

panels are instructed, as follows: 

• to evaluate the proposed plan for the inclusion of minorities and both genders for 

appropriate representation or to evaluate the proposed justification when 

representation is limited or absent, 

• to evaluate the proposed exclusion of minorities and women on the basis that a 

requirement for inclusion is inappropriate with respect to the health of the subjects, 

• to evaluate the proposed exclusion of minorities and women on the basis that a 

requirement for inclusion is inappropriate with respect to the purpose of the research, 

• to determine whether the design of clinical trials is adequate to measure differences 

when warranted, 

• to evaluate the plans for valid analysis for NIH-defined Phase III clinical trials, 

• to evaluate the plans for recruitment/outreach for study participants, and 
65 

• 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
66 

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 an experimental intervention in comparison with a standard or control 

intervention or comparing two or more existing treatments. Often the aim of such investigation is 

to provide evidence leading to a scientific basis for consideration of a change in health policy or 

standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral 

interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials 

and other population-based intervention trials are also included. 

C. Valid Analysis 

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

yield the correct estimate of the difference in outcomes between two groups of subjects. Valid 

analysis can and should be conducted for both small and large studies. A valid analysis does not 

need to have a high statistical power for detecting a stated effect. The principal requirements for 

ensuring a valid analysis of the question of interest are: 

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

different racial/ethnic groups to the intervention and control groups by an unbiased 

process such as randomization, 

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

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

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

D. Significant Difference 

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

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

commonly used "statistically significant difference," which refers to the event that, for a given 

set of data, the statistical test for a difference between the effects in two groups achieves 

statistical significance. Statistical significance depends upon the amount of information in the 

data set. With a very large amount of information, one could find a statistically significant, but 

clinically small difference that is of very little clinical importance. Conversely, with less 

information one could find a large difference of potential importance that is not statistically 

significant. 

E. Racial and Ethnic Categories 

1. Minority Groups 

A minority group is a readily identifiable subset of the U.S. population that is distinguished by 

racial, ethnic, and/or cultural heritage. 
67 

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 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 
68 

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 

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
69 

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 
70 

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
71 

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
72 

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 
73 

Appendix F 

NIH Policy on 

Reporting Race and Ethnicity Data: 

Subjects in Clinical Research 
74 
75 

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: 
76 

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. 
77 

II. Guidance on Reporting Ethnicity/Race and Sex/Gender in Clinical Research 

NIH requires all grants, contracts, and intramural projects conducting clinical research to address 

the Inclusion of Women and Minorities (see 

http://grants.nih.gov/grants/funding/women_min/women_min.htm). NIH defines clinical 

research as: (1) Patient-oriented research. Research conducted with human subjects (or on 

material of human origin such as tissues, specimens and cognitive phenomena) for which an 

investigator (or colleague) directly interacts with human subjects. Excluded from this definition 

are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patientoriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) 

clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. 

(3) Outcomes research and health services research. 

New Applications (type 1), Competing Continuations (type 2), Requests for Proposals, and 

Intramural Projects 

Submitting Applications or Proposals Involving the Collection of New/Additional Data in 

Clinical Research: 

Investigators are instructed to provide plans for the total number of subjects proposed for the 

study and to provide the distribution by ethnic/racial categories and sex/gender. This information 

must be reported using the newly revised categories and according to the new format provided in 

the Targeted/Planned Enrollment table 

http://grants.nih.gov/grants/funding/phs398/enrollment.pdf 

Submitting Applications or Proposals Using Existing Data in Clinical Research with No Plans 

for Collecting New/Additional Data: 

Investigators are instructed to provide plans for the total number of subjects proposed for the 

study and to provide the distribution by ethnic/racial categories and sex/gender. Under these 

circumstances, investigators are not required to re-contact subjects solely to comply with the 

newly revised categories. If the existing data on ethnicity and race allows accurate 

correspondence with the new categories, the investigator can use the format in the 

Targeted/Planned Enrollment table. However, if the existing data do not allow accurate 

correspondence with the new categories, information may be reported using the former 

categories and according to the format in the 4/98 Version of the Inclusion Table 

http://grants.nih.gov/grants/funding/women_min/InclusionOld_Form.pdf 

Annual Progress Reports (type 5) and Competing Supplement Applications 

In Annual Progress Reports and Competing Supplement Applications, investigators conducting 

clinical research are required to provide the cumulative total enrollment of subjects to-date (as 

well as any proposed additions to the Targeted/Planned enrollment in the case of Competing 

Supplement Applications) and to present the distribution by ethnic/racial categories and 

sex/gender. 
78 

If Data Collection is Ongoing, Such that New Subjects Will be Enrolled and/or Additional Data 

Will be Collected from Human Subjects: 

Investigators may choose to report ethnicity/race and sex/gender sample composition using 

EITHER the format in the former 4/98 Version of the Inclusion Table OR the new Inclusion 

Enrollment Report http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf [Note: If 

investigators with on-going data collection choose to report information using the new Inclusion 

Enrollment Report, they must continue to use this format for the remaining years of the project.] 

If Data Collection is Complete, Such that No New/Additional Subject Contact is Planned: 

Investigators may EITHER continue to report using the former categories and according to the 

4/98 Version of the Inclusion Table, OR, if data allow accurate correspondence with the new 

categories, use the format in the new Inclusion Enrollment Report. 

III. Frequently Asked Questions 

1. What categories should I use in my application to estimate race and ethnicity, given the new 

OMB standards? 

Investigators should use the categories described in the PHS 398 instructions and listed in the 

table 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. 
79 

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 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 

self-identification and use two separate questions. The first question should be about ethnicity, 

followed by a question that provides the option of selecting one or more racial designations. An 

example of a format for collecting information from an individual can be found in the 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 
80 

implementation of the new reporting guidelines. If the data do not accurately correspond with the 

new categories, the investigator may continue to use the format in the 4/98 Version of the 

Inclusion Table. 

7. I began data collection prior to the new standards, but my race and ethnicity questions comply 

with the new standards. I submitted my original estimates of the study composition using the old 

standards. How should I present the data in the progress report? 

If you began your data collection prior to the implementation of the new standards but your 

questions on race and ethnicity comply with the new standards, the choice is left up to the 

investigator as to how to present the data for Annual Progress Reports. We suggest completion of 

the new Inclusion Enrollment Report. 

8. How should I report race and ethnicity data when my research involves a foreign population? 

Investigators are encouraged to design their data collection instruments in ways that allow 

respondent self-identification of their racial and ethnic affiliation. However, these items should 

be designed in a way that they can be aggregated into the required categories. Also, the 

investigator can report on any racial/ethnic subpopulations by listing this information in an 

attachment to the required table. This may be particularly useful when distinctive subpopulations 

are relevant to the scientific hypotheses being studied. 

When completing the tables, investigators should asterisk and footnote the table indicating that 

data includes foreign participants. If the aggregated data only includes foreign participants, the 

investigator should provide information in one table with an asterisk and footnote. However, if 

the study includes both domestic and foreign participants, we suggest the investigator complete 

two separate tables 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 selfreporting or self-identification to collect data on ethnicity and race, investigators should use two 

separate questions with ethnicity information collected first followed by the option to select more 

than one racial designation. 

Additional Information and NIH Contacts Additional information on NIH policy regarding the 

Inclusion of Women and Minorities in Clinical Research can be found at the website 

http://grants.nih.gov/grants/funding/women_min/women_min.htm. 
81 

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

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 
82 

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
83 

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
84 

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 
APPENDIX G 

NIH Inclusion Tables for Target and Enrollment Data 

- Old Table for Target & Enrollment Data 

Collection 

- New Table for Target Data Collection 

- New Table for Enrollment Data Collection 

85 
86 
Old Table for Target & Enrollment Data Collection 

87 
New Table for Target Data Collection

88 
New Table for Enrollment Data Collection

89 
90