National Institutes of Health

MONITORING ADHERENCE TO THE NIH

POLICY ON THE INCLUSION OF 

WOMEN AND MINORITIES

AS SUBJECTS IN 

CLINICAL RESEARCH

Comprehensive Report

(Fiscal Year 1998 & 1999 Tracking Data)

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

Virginia W. Hartmuller, Ph.D.

Office of Research on Women’s Health

(Currently with NCI as of June 16, 2001)

Angela Bates

Office of Research on Women’s Health

Larry Fanning

Office of Extramural Research

Systems Quality Assurance Interface Branch

FINAL VERSION - November 2001
TABLE OF CONTENTS

 Page

Part I - Comprehensive Report

Background and Current Activities

Monitoring Adherence to the NIH Policy on the Inclusion of 

Women and Minorities as Subjects in Clinical Research ....................... . 1

Aggregate Data Tables

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

Applications as Assessed During Scientific Peer Review ...................... 9-10

Table B. Extramural Awards That Required the Lifting of a Bar-to Funding .................. 11-12

Table C. Inclusion by Sex in All Research Studies Active and Funded in FY1998 

and FY1999 ....................... ....................... .......... 13-15

Table 1. Aggregate Enrollment Data for All Extramural Research Protocols Funded in Fy1998 ..... 17

Table 2. Aggregate Enrollment Data for All Extramural Research Protocols Funded in FY1999 .... 17

Table 3. Aggregate Enrollment Data for All Extramural Research Protocols

Excluding Male-only & Female-only Protocols Funded in FY1998 ............... 19

Table 4. Aggregate Enrollment Data for All Extramural Research Protocols

Excluding Male-only & Female-only Protocols Funded in FY1999 ............... 19

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

in FY1998 ....................... ....................... ............. 21

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

in FY1999 ....................... ....................... ............. 21

Table 7. Aggregate Enrollment Data for Phase III Research Protocols

Excluding Male-only & Female-only Protocols Funded in FY1998 ............... 23

Table 8. Aggregate Enrollment Data for Phase III Research Protocols

Excluding Male-only & Female-only Protocols Funded in FY1999 ............... 23

Table 9. Aggregate Enrollment Data for Intramural Research Protocols Conducted 

On-site and Off-site in FY 1998 ....................... ................... 25

Table 10. Aggregate Enrollment Data for Intramural Research Protocols Conducted 

On-site and Off-site in FY1999 ....................... .................... 25

Appendices

Appendix A

Explanation of Gender/Minority Codes ....................... .................... 27

Appendix B

2001 Tracking/Inclusion Committee Membership Lists ....................... ...... 29

Appendix C

Responses to the General Accounting Office (GAO) Report: “Women’s Health: 

NIH Has Increased Its Efforts To Include Women in Research” 

GAO/HEHS-00-96, August 2000 ....................... .................. 35

i
TABLE OF CONTENTS (continued)

 Page

Appendix D

Homepage: Inclusion of Women and Minorities Policy Implementation ................. 47

Appendix E

Amendment: NIH Policy and Guidelines on the Inclusion of Women and 

Minorities as Subjects in Clinical Research - October, 2001 .................... 51

Appendix F

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

Subjects in Clinical Research - Amended, October, 2001 ....................... 55

Appendix G

NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research .......... 71

Appendix H

NIH Inclusion Tables for Target and Enrollment Data (Old and New Data Tables) ......... 83

Appendix I

NIH Instructions to Reviewers for Evaluating Research Involving Human

Subjects in Grant and Cooperative Agreement Applications .................... 89

Appendix J

Subcommittee Reviewing Inclusion Issues: Summary Report on Actions to the 

NIH Tracking and Inclusion Committee ....................... ............ 105

ii
1

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 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
2

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 NIH-defined Phase III clinical trials, the Scientific Review Group (SRG) also evaluates the

description of plans to conduct analyses, as appropriate, to address differences in the intervention effect

by sex/gender and/or racial/ethnic groups. Applications with unacceptable inclusion plans 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

requiring 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 by sex/gender and race/ethnicity.

Strategies to ensure that the implementation of these revised guidelines was uniform 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 the participation of women and minority participants in NIH-funded clinical

research.

To ensure universal 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, explained the requirements to applicants, reviewers, and other members of the research

community. NIH staff members, reviewers, and applicants received written guidance about the

requirements. This guidance outlined, in great detail, the circumstances under which it may be acceptable

to use study populations deficient in women or minority participants, pointing out that the justification

must be compelling and the scientific objectives of the research must be maintained. Training was

especially important in response to 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
 

1Racial and ethnic categories are in accord with the Office of Management and Budget (OMB)

Directive No. 15.

3

some of the more commonly asked questions. The ORWH also has available a full report of its workshop

on “Recruitment and Retention of Women in Clinical Studies."

In June 1994, the ORWH convened a meeting of Institutional Review Board (IRB) chairs to discuss their

role in implementing the revised policy. In 1996, ORWH reconvened these IRB chairs, along with

representative members of the ORWH Recruitment and Retention Task Force, other experts, and

representatives from NIH ICs, to discuss their experiences in implementing the 1994 guidelines. In these

meetings, investigators expressed a number of lingering concerns, most notably whether it was realistic

for the law to declare that cost is not a factor in designing clinical studies. Participants also raised

questions about inclusion of women of childbearing potential, liability in clinical trials, and barriers to

the recruitment of minority subjects. Other participants, however, noted that their worst fears about the

1994 guidelines did not materialize, in part because NIH focused on scientific considerations when

developing its policy. They reported improved collaboration among institutions and emphasized the

continued need for better outreach and for sharing information about effective recruitment strategies. 

Many noted the importance of considering community concerns, particularly those of minority

populations who may feel that they are not included in enough research studies or who do not receive

research results after participating in studies.

 

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 IC into this system. Aggregate data is reported annually by Fiscal Year (FY). This report contains

data for FY1998 and FY1999 and FY2000 data is currently being completed. Tables 1 to 10 provide

aggregate enrollment data for extramural and intramural research protocols funded in FY1998 and

FY1999. Aggregate enrollment figures FY1994 - 1997 for women and men and minority groups may be

found on the ORWH website at http://www4.od.nih.gov/orwh/fy97-98trkg.pdf. Following the format of

the aggregate extramural data tables, the aggregate intramural data for on-site and off-site research

protocols are combined on a single table rather than separate data tables for on-site and off-site research

protocols. 

Analysis of the FY1999 inclusion data shows that substantial numbers of both women 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. During FY1999, more than 93% of applications

involving human subjects met the inclusion requirements as submitted to the Initial Review Group [see

Table A]. Of the remaining applications, approximately 7% were found to have unacceptable plans for

inclusion at the time they were originally submitted. Of these, the applications that were otherwise

considered acceptable for payment, were required to submit an acceptable plan for inclusion prior to

funding [see Table B].

Aggregate enrollment data for extramural Phase III trials funded in FY1999 show that approximately

63.3% of the subjects were women. Among minority subjects,1 representation in Phase III trials [Table 6]

was highest for Black (not Hispanic) subjects (12.6%) and lowest for American Indians/Alaskan Natives

subjects (0.8%). Asian/Pacific Islanders subjects were 4.8% of the extramural Phase III subjects;

Hispanic subjects were 6.1%; and White (not Hispanic) subjects were 67.7%. Over six million subjects
4

were included in the research for which data were collected in the tracking system from among all

extramural research active in FY 1999. This snapshot of aggregate enrollment data for FY 1999

extramural studies [Table 6] shows that approximately 61.6% of the subjects were women,

approximately 37.7% were men, and approximately 0.6% were not identified by sex/gender. 

Substantial numbers of women and minorities were also included in NIH intramural studies in FY 1999

[Table 10]. Approximately 47.3% of intramural subjects were women and approximately 51.8% were

men. Among minority subjects, representation in intramural studies was highest for Asian/Pacific

Islander subjects (20.5%) and lowest for American Indian/Alaskan native subjects (0.9%). Black - Not

Hispanic subjects represented approximately 4.6% of the subjects; Hispanic subjects 1.7%; and White

(not Hispanic) subjects represented 67.8% of the intramural research study population. Over two million

subjects were included in the research for which data were collected in the tracking system from among

intramural research active in FY 1999.

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 proactive 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 the safe and effective conduct of clinical research and,

the Clinical Center is actively engaged in outreach to minority groups to encourage participation in

intramural clinical research. 

Current 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. The conclusions of

this report showed that in the past decade, NIH made significant progress in implementing a strengthened

policy on including women in clinical research and highlighted several examples, including:

# 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.
5

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

following:

# that the requirement be implemented that Phase III clinical trials be designed and carried

out to allow for the valid analysis of differences between women and men and

communicate this requirement to applicants as well as requiring peer review groups to

determine whether each proposed Phase III clinical trial is required to have such a study

design, and that summary statements document the decision of the initial reviewers; and

# that the NIH staff who transmit data to the inclusion tracking data system receive

ongoing training on the requirements and purpose of the system.

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

formed, comprised 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 the accuracy and performance of the system, and reiterate the NIH policy

(See Appendix J). Four 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/noticefiles/not94-100.html) and the August 2000 notice in the NIH Guide to Grants and

Contracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). 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 Appendices E and F). 

# In June 2001, clarified the definition for Clinical Research as reported in the 1997 Report

of the NIH Director’s Panel on Clinical research. 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

# The Office of Management and Budget (OMB) Directive 15 categories for reporting racial

and ethnic population data were incorporated into the updated Guide Notice for Grants and

Contracts. The primary difference from the previous categories were: (1) the Hispanic
6

population are considered an ethnicity and reported separately from other racial data; and

(2) there is a separate racial category for Asian population data and Hawaiian and Pacific

Islander population data (See Appendix G). 

# On August 2, 2000, an NIH Guide Notice was posted on the Internet with a link to the web

page, Inclusion of Women and Minorities Policy Implementation at:

http://grants.nih.gov/grants/funding/women_min/women_min.htm. This restated that NIHdefined Phase III clinical trials must be designed and conducted in a manner sufficient to

allow for a valid analysis of whether the variables being studied affected 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. 

# 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 (See Appendix I)

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

occurred:

# 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
7

through videocast. The training materials are permanently archived in the 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 where several hundred more extramural and intramural researchers

were trained. It included a section regarding the inclusion of human subjects in clinical

research studies. The training materials may be found at the following web address:

http://odoe rdb2.od .nih.gov/oer/training/esa/gran ts_policy_ update/esa _grants_p olicy_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 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 is

currently being revised and will be published this fall as Frequently Asked Questions

(FAQs) on the NIH website for the inclusion of women and minorities policy

implementation at: http://grants.nih.gov/grants/funding/women_min/women_min.htm as

well as on the ORWH website http://www4.od.nih.gov/orwh/fy97-98trkg.pdf. These FAQs

are being developed and reviewed by members of the Tracking and Inclusion Committee to

provide additional guidance to researchers and NIH staff on implementing the inclusion

policy for women and minorities in clinical research, the new reporting requirements for

inclusion data, and information for submitting an application, application submission, peer

review and funding.

Throughout and following training, Program Officials continue to monitor, verify and document at the time

of an award that policy requirements, including sex/gender analysis, are met and, when annual progress

reports are submitted, they will continue to determine and document whether there is ongoing compliance

with these policy requirements. In addition, Review Officials will introduce and discuss with reviewers the

Guidelines/Instructions for reviewing Phase III clinical trials and the requirements for sufficient sample size

to conduct valid analyses by sex/gender. When new and continuing applications are deficient in meeting

the policy requirements, grants management and program officials will withhold funding until the Principal

Investigator (PI) has satisfactorily addressed the policy requirements. 

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. Improvements were recommended for the development of a new electronic database for grant

administration and management which will include a user-friendly computerized information system for

collecting and reporting inclusion data. In preparation for the launch of the new system, further training of
8

NIH staff responsible for monitoring and entering population data fromNIH-funded investigators, will be

undertaken. 

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. Updated: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in

Clinical Research, NIH Guide for Grants and Contracts, (October, 2001).

5. Hayunga, E. G.,Costello, M. D. Pinn, V. W., “Demographics of Study Populations”, Applied

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

6. Hayunga, E. G. and Pinn V. W., “Implementing the 1994 NIH Guidelines”, Applied Clinical

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

7. Hayunga, E. G. and Pinn V. W., “NIH Response to Researchers’ Concerns”, Applied Clinical

Trials, Vol. 5, No. 11, p. 59-64, 1996.

8. LaRosa, J. H., Seto, B., Caban, C. E., Hayunga, E. G., “Including Women and Minorities in Clinical

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

9. McCarthy, C. R., “Historical Background of Clinical Trials Involving Women and Minorities”,

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

10. Pinn, V. W., “The Role of the NIH’s Office of Research on Women’s Health”, Academic

Medicine, Vol. 69, No. 9, p. 698-702, 1994.

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.go v/grants/funding /women_ min/wome n_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 P olicy on Re porting Ra cial and Eth nicity Data: Su bjects in Clinic al Researc h, NIH G uide for G rants

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

4. Office of Re search on W omen’s H ealth We bsite: http://www4.od.nih.gov/orwh/fy97-98trkg.pdf
9

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

 Applications as Assessed During Scientific Peer Review

Council Dates Jan-95 May-95 Aug-95 Oct-95 Jan-96 May-96 Aug-96 Oct-96 Jan-97 May-97 Aug-97 Oct-97

Total Number of Applications Reviewed (#) 12,886 14,027 424 12,832 12,028 12,125 846 11,760 12,037 12,082 505 12,402

Number of Applications with Human

Subjects (#) 5,101 5,359 162 5,260 4,521 4,676 374 4,653 4,562 4,704 271 4,671

Number (percent) of applications

approved by IRG as submitted

(#)

4,707 4,986 157 4,914 4,218 4,385 360 4,359 4,250 4,379 259 4,382

(%) 92.28% 93.04% 96.91% 93.42% 93.30% 93.78% 96.26% 93.68% 93.16% 93.09% 95.57% 93.81%

Numb er (percen t) of applicatio ns with

unacceptable minority inclusion 

(#)

175 131 1 126 146 115 4 129 134 115 2 104

(%) 3.43% 2.44% 0.62% 2.40% 3.23% 2.46% 1.07% 2.77% 2.94% 2.44% 0.74% 2.23%

Numb er (percen t) of applicatio ns with

unacceptable sex/gender inclusion (#) 33 29 2 22 21 23 1 14 17 20 6 20

(%) 0.65% 0.54% 1.23% 0.42% 0.46% 0.49% 0.27% 0.30% 0.37% 0.43% 2.21% 0.43%

Numb er (percen t) of applicatio ns with

both unacceptable minority AND

sex/gender inclusion

(#)

186 213 2 198 136 153 9 151 161 190 4 165

(%)

Total Number (percent) of applications

with unacceptable minority inclusion (#) 361 344 3 324 282 268 13 280 295 305 6 269

(%) 7.08% 6.42% 1.85% 6.16% 6.24% 5.73% 3.48% 6.02% 6.47% 6.48% 2.21% 5.76%

Total Number (percent) of applications

with unacceptable sex/gender inclusion (#) 219 242 4 220 157 176 10 165 178 210 10 185

(%) 4.29% 4.52% 2.47% 4.18% 3.47% 3.76% 2.67% 3.55% 3.90% 4.46% 3.69% 3.96%

Total num ber (perc ent) unacce ptable

applications as submitted

(#) 394 373 5 346 303 291 14 294 312 325 12 289

(%) 7.72% 6.96% 3.09% 6.58% 6.70% 6.22% 3.74% 6.32% 6.84% 6.91% 4.43% 6.19%
10

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

Applications as Assessed During Scientific Peer Review (continued)

Council Dates Jan-98 May-98 Aug-98 Oct-98 Jan-99 May-99 Aug-99 Oct-99 Jan-00 May-00 Aug-00 Oct-00

Total Number of Applications Reviewed (#) 11,149 12,918 589 12,484 12,603 14,340 700 13,965 13,195 14,967 906 13,716

Number of Applications with Human

Subjects (#) 4,252 5,005 295 4,849 4,940 5,603 451 5,560 5,255 6,160 406 5,772

Number (percent) of applications

approved by IRG as submitted (#) 3,977 4,705 276 4,530 4,635 5,246 413 5,242 4,967 5,825 390 5,465

(%) 93.53% 94.01% 93.56% 93.42% 93.83% 93.63% 91.57% 94.28% 94.51% 94.56% 96.05% 94.68%

Numb er (percen t) of applicatio ns with

unacceptable minority inclusion (#) 114 118 7 120 133 115 20 133 115 119 8 112

(%) 2.68% 2.36% 2.37% 2.47% 2.69% 2.05% 4.43% 2.39% 2.18% 1.93% 1.97% 1.94%

Numb er (percen t) of applicatio ns with

unacceptable sex/gender inclusion (#) 27 24 3 26 20 28 5 23 30 25 0 28

(%) 0.63% 0.48% 1.02% 0.54% 0.40% 0.50% 1.11% 0.41% 0.57% 0.40% 0.00% 0.48%

Numb er (percen t) of applicatio ns with

both unacceptable minority AND

sex/gender inclusion

(#)

134 158 9 173 152 214 13 162 143 191 16 167

(%)

Total Number (percent) of applications

with unacceptable minority inclusion (#) 248 276 16 293 285 329 33 295 258 310 16 279

(%) 5.83% 5.51% 5.42% 6.04% 5.77% 5.87% 7.32% 5.31% 4.90% 5.03% 3.94% 4.83%
11

Table B. Extramural Awards that Required the Lifting of a Bar-To-Funding

Council Dates Jan-95 May-95 Aug-95 Oct-95 Jan-96 May-96 Aug-96 Oct-96 Jan-97 May-97 Aug-97 Oct-97

Total number of awards (#) 3,476 3,902 129 3,344 3,548 3,759 228 3,378 3,874 3,958 222 3,817

Number of awards involving human

subjects (#) 1,287 1,421 51 1,263 1,260 1,352 92 1,254 1,394 1,470 106 1,401

Number (percent) of awards involving

human subjects that met the inclusion

(#)

1,224 1,330 50 1,189 1,178 1,277 89 1,198 1,305 1,374 101 1,324

(%) 95.10% 93.60% 98.04% 94.14% 93.49% 94.45% 96.74% 95.53% 93.62% 93.47% 95.28% 94.50%

Number (percent) of awards where

minority o nly bar-to-funding was

removed by program staff (M_U) 

(#)

29 26 22 43 29 0 22 38 47 0 24

(%) 2.25% 1.83% 0.00% 1.74% 3.41% 2.14% 0.00% 1.75% 2.73% 3.20% 0.00% 1.71%

Number (percent) of awards where

sex/gend er only bar-to-funding was

removed by program staff (G_U)

(#)

3 6 3 3 3 0 3 8 5 4 10

(%) 0.23% 0.42% 0.00% 0.24% 0.24% 0.22% 0.00% 0.24% 0.57% 0.34% 3.77% 0.71%

Numb er (percen t) of awards w here both

minority AND sex/gender bar-to-funding

was remo ved by pro gram staff

(#)

31 59 1 49 36 43 3 31 43 44 1 43

(%) 2.41% 4.15% 1.96% 3.88% 2.86% 3.18% 3.26% 2.47% 3.08% 2.99% 0.94% 3.07%

Total numb er (percent) of award s where

minority bar-to-funding was removed by

progra m staff 

(#)

60 85 1 71 79 72 3 53 81 91 1 67

(%) 4.66% 5.98% 1.96% 5.62% 6.27% 5.33% 3.26% 4.23% 5.81% 6.19% 0.94% 4.78%

Total numb er (percent) of award s where

sex/gender bar-to-funding was removed

by prog ram staff 

(#)

34 65 1 52 39 46 3 34 51 49 5 53

(%) 2.64% 4.57% 1.96% 4.12% 3.10% 3.40% 3.26% 2.71% 3.66% 3.33% 4.72% 3.78%

Total number (percent) of awards where

bar-to-funding was removed (#)

63 91 1 74 82 75 3 56 89 96 5 77

(%) 4.90% 6.40% 1.96% 5.86% 6.51% 5.55% 3.26% 4.47% 6.38% 6.53% 4.72% 5.50%
12

Table B. Extramural Awards that Required the Lifting of a Bar-To-Funding (continued)

Council Dates Jan-98 May-98 Aug-98 Oct-98 Jan-99 May-99 Aug-99 Oct-99 Jan-00 May-00 Aug-00 Oct-00

Total number of awards (#) 3,863 4,363 209 4,019 4,247 4,824 298 4,278 4,415 4,960 307 4,389

Number of awards involving human

subjects (#) 1,431 1,594 104 1,442 1,625 1,832 156 1,616 1,633 1,964 129 1,683

Number (percent) of awards involving

human subjects that met the inclusion

requirements as submitted

(#)

1,368 1,524 98 1,370 1,556 1,753 143 1,552 1,582 1,893 124 1,632

(%) 95.60% 95.61% 94.23% 95.01% 95.75% 95.69% 91.67% 96.04% 96.87% 96.38% 96.12% 96.96%

Number (percent) of awards where

minority o nly bar-to-funding was

removed by program staff (M_U) 

(#)

30 17 3 30 21 31 5 25 18 27 1 23

(%) 2.10% 1.07% 2.88% 2.08% 1.29% 1.69% 3.21% 1.55% 1.10% 1.37% 0.77% 1.36%

 Number (percent) of awards where

sex/gend er only bar-to-funding was

removed by program staff (G_U)

(#)

9 7 1 8 9 9 2 4 13 7 0 8

(%) 0.63% 0.44% 0.96% 0.55% 0.55% 0.49% 1.28% 0.25% 0.79% 0.35% 0.00% 0.47%

Numb er (percen t) of awards w here both

minority AND sex/gender bar-to-funding

was remo ved by pro gram staff

(#)

24 46 2 34 39 39 6 35 20 37 4 20

(%) 1.68% 2.89% 1.92% 2.36% 2.40% 2.13% 3.85% 2.17% 1.22% 1.88% 3.10% 1.18%

 Total numb er (percent) of award s where

minority bar-to-funding was removed by

progra m staff 

(#)

54 63 5 64 60 70 11 60 38 64 5 43

(%) 3.77% 3.95% 4.81% 4.44% 3.69% 3.82% 7.05% 3.71% 2.32% 3.25% 3.87% 2.55%

 Total numb er (percent) of award s where

sex/gender bar-to-funding was removed

by prog ram staff 

(#)

33 53 3 42 48 48 8 39 33 44 4 28

(%) 2.31% 3.32% 2.88% 2.91% 2.95% 2.62% 5.13% 2.41% 2.02% 2.24% 3.10% 1.66%

Total number (percent) of awards where

bar-to-funding was removed (#) 63 70 6 72 69 79 13 64 51 71 5 51

(%) 4.40% 4.39% 5.77% 4.99% 4.25% 4.31% 8.33% 3.96% 3.12% 3.61% 3.87% 3.03%
13

Table C. Inclusion by Sex in All Research Studies 

Receiving Funding in FY1998

Extramural Studies Intramural Studies

Phase III

trials*

Other clinical

research** On-site Off-site

Protocols reporting women only 74 669 96 23

Protocols reporting men only 18 235 59 15

Protocols reporting both women

and men 368 3,730 804 130

Protocols involving men, women

and Unknown*** 38 221 18

Sex composition reported as

Unknown 2 45 12

Protocols reporting men and

Unknown 2 1 1

Protocols reporting women and

Unknown 1 6

Early Stage studies where

enrollment data has not yet been

collected 75 1,462 136 44

Totals 578 6,369 1,095 243

* According to the NIH Guidelines on the Inclusion of Women and M inorities 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 stand ard or control intervention or c omparing two or m ore existing treatments.

** Human subject studies that are no t Phase III trials.

*** Many studies may be generic.
14

Table C. Inclusion by Sex in All Research Studies 

Receiving Funding in FY1999

Extramural Studies Intramural Studies

Phase III

trials*

Other clinical

research** On-site Off-site

Protocols reporting women only 114 774 90 36

Protocols reporting men only 34 294 64 14

Protocols reporting both women

and men 369 4,329 848 155

Protocols involving men, women

and Unknown*** 24 260 26

Sex composition reported as

Unknown 2 57 10

Protocols reporting men and

Unknown 2 6 1

Protocols reporting women and

Unknown 0 8 1

Early Stage studies where

enrollment data has not yet been

collected 44 1,631 128 69

Totals 589 7,359 1,130 312

* According to the NIH Guidelines on the Inclusion of Women and M inorities 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 stand ard or control intervention or c omparing two or m ore existing treatments.

** Human subject studies that are no t Phase III trials.

*** Many studies may be generic.
15

Examples of Single Sex Extramural Research Studies

Examples of Studies of Selected Protocols That Include Male-Only Human Subjects

Managing Uncertainty in Advanced Prostate Cancer

Long Term Lithium for Aggressive Conduct Disorder

Dietary Fat Modulation of Androgen Metabolism in Men

Aging and Skeletal Muscle Fatty Acid Metabolism

Nutritional and Hormonal Biomarkers in Prostate Cancer

Head Injury & Alzheimer's Disease

Genetic Epidemiology of Alzheimer's Disease in Twins

Epidemiology of Male Infertility - Cryptorchidism

Medical Therapy for Benigh Prostatic Hyperplasia (BPH) - Data Coordinating Center

HIV Prevention Intervention for Young Men

Managing Uncertainty in Stage B Prostate Cancer

Comprehensive High Blood Pressure (HBP) Care for Young Urban Black Men

Serum Albumin, Orthostatic Hypotension in Frail

Psychophysiology of Visible and Invisible Trauma

 Examples of Studies of Selected Protocols That Include Female-Only Human Subjects

Divalproex Sodium/Placebo in Bronchopulmonary Dysplasia (BPD)

Hormone Replacement and Metabolic Cardiovascular Risk

Detection of Presymptomatic Alzheimer Disease by functional Magnetic Resonance Imaging (fMRI) 

Breastfeeding Services for Low Birth Weight (LBW) Infants-Outcomes and Cost

Epidemiology of Osteoporosis in Systemic Lupus Erythematosus (SLE)

Trials of Prevention of Cognitive Decline in Women

Breast Cancer Surveillance in a Defined Population

Diet, Activity and Adolescent Weight Changes

Women's Health Initiative

Cross Ethnic Nursing Study of Weight Management in Women

Women's Estrogen for Stroke Trial (WEST)

Persistence or Transience of HPV Infection in Women

Urine Screening Test to Detect Bacteriuria in Pregnancy

Infant Mortality in Rural Yunnan, China
16

Table 1 (1998) Aggregate Enrollment Data for All Extramural Research Protocols

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 29,959 0.7% 803,076 18.5% 660,702 15.2% 298,867 6.9% 2,330,017 53.7% 216,288 5.0% 4,338,909 67.0%

Male 24,081 1.2% 192,455 9.2% 341,128 16.4% 191,350 9.2% 1,210,602 58.1% 124,463 6.0% 2,084,079 32.2%

Unknown 1,620 2.8% 7,470 13.0% 2,176 3.8% 14,909 25.9% 10,092 17.5% 21,350 37.1% 57,617 0.9%

Total 55,660 0.9% 1,003,001 15.5% 1,004,006 15.5% 505,126 7.8% 3,550,711 54.8% 362,101 5.6% 6,480,605 100.0%

Number of Protocols: 6,947

Table 2 (1999) Aggregate Enrollment Data for All Extramural Research Protocols

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 33,991 0.7% 829,502 18.2% 653,412 14.4% 313,065 6.9% 2,468,041 54.2% 254,403 5.6% 4,552,414 61.6%

Male 29,707 1.1% 247,475 8.9% 451,895 16.2% 221,781 8.0% 1,633,898 58.6% 202,372 7.3% 2,787,128 37.7%

Unknown 288 0.6% 855 1.9% 4,179 9.3% 16,084 35.6% 5,820 12.9% 17,913 39.7% 45,139 0.6%

Total 63,986 0.9% 1,077,832 14.6% 1,109,486 15.0% 550,930 7.5% 4,107,759 55.6% 474,688 6.4% 7,384,681 100.0%

Number of Protocols: 7,948
17

Aggregate Enrollment Data for All Extramural Research Protocols

FY98 Data Table Comments:

More females (4,338,909 or 67.0%) than males (2,084,079 or 32.2%) are enrolled in aggregate Extramural Research protocols.

Largest identified racial group is White, Not-Hispanic at 54.8%.

Largest identified racial minority groups are Black, Not-Hispanic at 15.5% and Asian/Pacific Islanders at 15.5%.

Smallest identified racial minority group is American Indian/Alaska Natives at 0.9%.

FY99 Data Table Comments:

More females (4,552,414 or 61.6%) than males (2,787,128 or 37.7) are enrolled in aggregate Extramural Research protocols.

Largest identified racial group is White, Not-Hispanic at 55.6%.

Largest identified racial minority groups is Black, Not-Hispanic at 15.0%.

Smallest identified racial minority group is American Indian/Alaska Natives at 0.9%.

The large Asian/Pacific Islander accrual reflects a number of NCI-supported epidemiology studies conducted in Asia, Hawaii and 

 California
18

Table 3 (1998) Aggregate Enrollment Data for All Extramural Research 

Protocols Excluding Male-Only & Female-Only Protocols Funded in FY1998

American Indians and

Alaska Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 26,567 1.0% 185,719 7.3% 500,707 19.7% 249,381 9.8% 1,433,509 56.5% 140,221 5.5% 2,536,104 55.0%

Male 23,915 1.2% 166,962 8.3% 334,357 16.6% 189,162 9.4% 1,179,768 58.5% 122,281 6.1% 2,016,445 43.7%

Unknown 1,620 2.8% 7,470 13.0% 2,176 3.8% 14,909 26.0% 10,092 17.6% 21,114 36.8% 57,381 1.2%

Total 52,102 1.1% 360,151 7.8% 837,240 18.2% 453,452 9.8% 2,623,369 56.9% 283,616 6.2% 4,609,930 100.0%

Number of Protocols: 4,413

Table 4 (1999) Aggregate Enrollment Data for All Extramural Research 

Protocols Excluding Male-Only & Female-Only Protocols Funded in FY1999

American Indians and

Alaska Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 29,853 1.2% 167,725 6.8% 504,250 20.4% 258,584 10.4% 1,318,085 53.2% 197,183 8.0% 2,475,680 50.1%

Male 29,459 1.2% 159,956 6.6% 420,593 17.3% 216,121 8.9% 1,402,815 57.8% 197,582 8.1% 2,426,526 49.1%

Unknown 288 0.7% 855 1.9% 4,179 9.5% 16,084 36.5% 5,820 13.2% 16,840 38.2% 44,066 0.9%

Total 59,600 1.2% 328,536 6.6% 929,022 18.8% 490,789 9.9% 2,726,720 55.1% 411,605 8.3% 4,946,272 100.0%

Number of Protocols: 5,049
19

Aggregate Enrollment Data for All Extramural Research Protocols Excluding Male-Only

& Female-Only Protocols 

FY98 Data Table Comments:

There were 6,947 protocols of which 743 were women-only protocols, 253 were men-only protocols and 1,538 were early stage

studies where enrollment data have not yet been collected. 

The remaining 4,413 protocols include both females (55%) and males (43%).

Largest identified racial group is White, Not-Hispanic at 2,623,369 or 56.9%.

Largest identified racial minority group is Black - Not Hispanic at 837,240 or 18.2%

Smallest identified racial minority group is American Indian/Alaska Native at 52,102 or 1.1%.

FY99 Data Table Comments:

There were 7,948 extramural protocols of which 888 were women-only protocols, 328 were men-only protocols and 1,683 were early

stage studies where enrollment data have not yet been collected. 

The remaining 5,049 protocols include both females (50%) and males (49%).

Largest identified racial group is White, Not-Hispanic at 2,726,720 or 55.1%.

Largest identified racial minority group is Black - Not Hispanic at 929,022 or 18.8%.

Smallest identified racial minority group is American Indian/Alaska Native at 59,600 or 1.2%.
20

Table 5 (1998) Aggregate Enrollment Data for Extramural Phase III Protocols 

Funded in FY1998

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic White - N ot Hispan ic Other and Unknown Total

# % # % # % # % # % # % # %

Female 2,195 0.6% 11,796 3.5% 50,052 14.7% 24,008 7.1% 235,271 69.3% 16,211 4.8% 339,533 67.2%

Male 1,480 0.9% 8,477 5.2% 26,456 16.1% 16,291 9.9% 100,802 61.5% 10,444 6.4% 163,950 32.5%

Unknown 10 0.7% 3 0.2% 413 28.6% 268 18.5% 630 43.6% 122 8.4% 1,446 0.3%

Total 3,685 0.7% 20,276 4.0% 76,921 15.2% 40,567 8.0% 336,703 66.7% 26,777 5.3% 504,929 100.0%

Number of Protocols : 578

Table 6 (1999) Aggregate Enrollment Data for Extramural Phase III Protocols 

Funded in FY1999

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic White - N ot Hispan ic Other and Unknown Total

# % # % # % # % # % # % # %

Female 2,132 0.7% 13,314 4.2% 37,827 12.0% 17,097 5.4% 221,098 70.4% 22,484 7.2% 313,952 63.3%

Male 1,590 0.9% 10,697 5.9% 24,605 13.6% 12,950 7.2% 114,416 63.3% 16,447 9.1% 180,705 36.5%

Unknown 4 0.4% 6 0.6% 80 7.4% 37 3.4% 310 28.5% 649 59.8% 1,086 0.2%

Total 3,726 0.8% 24,017 4.8% 62,512 12.6% 30,084 6.1% 335,824 67.7% 39,580 8.0% 495,743 100.0%

Number of Protocols : 589
21

Aggregate Enrollment Data for Extramural Phase III Protocols

FY98 Data Comments:

Substantial numbers of women and minorities are enrolled in Phase III research protocols funded in 1998. 

There were more females (339,533 or 67.2%) than males (163,950 or 32.5%) enrolled in Phase III research protocols.

Among minority subjects, the largest racial minority group is Black, Not-Hispanic at 76,921 or 15.2%. 

Smallest identified racial group is American Indian/Alaska Natives at 3,685 or 0.7%.

FY99 Data Comments:

Substantial numbers of women and minorities are enrolled in Phase III research protocols funded in 1999. 

There were more females (313,952 or 63.3%) than males (180,705 or 36.5%) enrolled in Phase III research protocols.

Among minority subjects, the largest racial minority group is Black, Not-Hispanic at 62,512 or 12.6%. 

Smallest identified racial group is American Indian/Alaska Natives at 3,726 or 0.8%.
22

Table 7 (1998) Aggregate Enrollment Data for Extramural Phase III Research

Protocols Excluding Male-Only & Female-Only Protocols Funded in FY1998

American Indians and

Alaska Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 1,408 1.0% 7,856 5.3% 26,145 17.8% 16,419 11.2% 81,669 55.5% 13,528 9.2% 147,025 47.7%

Male 1,468 0.9% 8,441 5.3% 25,587 16.0% 16,148 10.1% 97,724 61.2% 10,393 6.5% 159,761 51.8%

Unknown 10 0.7% 3 0.2% 413 28.6% 268 18.5% 630 43.6% 122 8.4% 1,446 0.5%

Total 2,886 0.9% 16,300 5.3% 52,145 16.9% 32,835 10.7% 180,023 58.4% 24,043 7.8% 308,232 100.0%

Number of Protocols: 411

Table 8 (1999) Aggregate Enrollment Data for Extramural Phase III Research

Protocols Excluding Male-Only & Female-Only Protocols Funded in FY1999

American Indians and

Alaska Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 1,422 1.1% 9,070 6.9% 22,144 16.9% 10,939 8.3% 68,168 51.9% 19,571 14.9% 131,314 45.9%

Male 1,557 1.0% 10,109 6.6% 21,097 13.7% 11,589 7.5% 94,761 61.4% 15,099 9.8% 154,212 53.8%

Unknown 4 0.5% 6 0.7% 80 9.3% 37 4.3% 310 36.0% 423 49.2% 860 0.3%

Total 2,983 1.0% 19,185 6.7% 43,321 15.1% 22,565 7.9% 163,239 57.0% 35,093 12.3% 286,386 100.0%

Number of Protocols: 396
23

Aggregate Enrollment Data for Extramural Phase III Research Protocols 

Excluding Male-Only & Female-Only Protocols

FY98 Data Table Comments

There were 578 protocols of which 74 were women-only protocols, 18 were men-only protocols and 75 protocols were early stage

studies where enrollment data have not yet been collected. 

The remaining 411 protocols include both females (47%) and males (51%).

Largest identified racial group is White, Not-Hispanic at 180,025 or 58.4%

Largest identified racial minority group is Black - Not Hispanic at 52,145 or 16.9%.

Smallest identified racial minority group is American Indian/Alaska Native at 2,886 or 0.9%.

FY99 Data Table Comments

There were 589 protocols of which 114 were women-only protocols, 34 were men-only protocols and 45 protocols were early stage

studies where enrollment data have not yet been collected.

The remaining 396 protocols include both females (46%) and males (53%).

Largest identified racial group is White, Not-Hispanic at 163,239 or 57.0%.

Largest identified racial minority group is Black - Not Hispanic at 43,321 or 15.1%.

Smallest identified racial minority group is American Indian/Alaska Native at 2,983 or 1.0%.
24

Table 9 (1998). Aggregate Enrollment Data for Intramural Research Protocols 

Funded in FY1998 (Includes On-site and Off-site)

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 8,304 1.1% 232,972 30.5% 42,459 5.6% 10,205 1.3% 446,675 58.5% 22,782 3.0% 763,397 50.8%

Male 7,460 1.2% 192,976 30.7% 34,406 5.5% 11,145 1.8% 368,736 58.7% 13,266 2.1% 627,989 41.8%

Unknown 12 0.0% 73 0.1% 339 0.3% 84 0.1% 104,844 93.4% 6,894 6.1% 112,246 7.5%

Total 15,776 1.0% 426,021 28.3% 77,204 5.1% 21,434 1.4% 920,255 61.2% 42,942 2.9% 1,503,632 100.0%

Number of Protocols: 1,338

Table 10 (1999). Aggregate Enrollment Data for Intramural Research Protocols 

Funded in FY1999 (Includes On-site and Off-site)

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

# % # % # % # % # % # % # %

Female 9,910 1.0% 242,790 23.5% 55,288 5.4% 20,863 2.0% 654,775 63.4% 49,002 4.7% 1,032,628 47.3%

Male 8,810 0.8% 204,676 18.1% 44,756 4.0% 16,588 1.5% 823,213 72.7% 33,894 3.0% 1,131,937 51.8%

Unknown 22 0.1% 94 0.5% 239 1.2% 27 0.1% 3,195 16.1% 16,274 82.0% 19,851 0.9%

Total 18,742 0.9% 447,560 20.5% 100,283 4.6% 37,478 1.7% 1,481,183 67.8% 99,170 4.5% 2,184,416 100.0%

Number of Protocols: 1,442
25

Aggregate Enrollment Data for Intramural Research Protocols

FY98 Data Comments:

There were more females (763,397 or 50.8%) than males (627,989 or 41.8%) enrolled in aggregate Intramural research protocols.

Largest identified racial minority group is Asian/Pacific Islanders at 426,021 or 28.3%.

Smallest identified racial minority group is American Indian/Alaska Native at 15,731 or 1.1%.

FY99 Data Comments

There were more males (1,131,937 or 51.8%) than females (1,032,628 or 47.3%) enrolled in aggregate Intramural research protocols.

Differences in the enrollment of males and females is attributed primarily to improvements in reporting procedures. (ie, ensuring

gender declaration and recording at enrollment).

The racial minority group with the largest increase in enrollment is Hispanic - an increase of 75% from FY98 to FY99. 

The number of Black - Not Hispanic enrollees increased by 30% from FY98 to FY99.

Largest identified racial minority group is Asian/Pacific Islanders at 446,918 or 20.6%.

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

Smallest identified racial minority group is American Indian/Alaska Native at 18,692 or 0.9%.

Patient enrollment in the intramural research program at the Warren Grant Magnuson Clinical Cener increased by 45% in FY99

compared to FY98. 
26

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 “U” (unacceptable) code it automatically receives a bar-tofunding as well. If the bar is removed, the “U” is converted to “R” to designate that change in

status. 
27

Appendix B

NIH Tracking and Inclusion Committee Members

- Full Committee

- Subcommittee Reviewing Inclusion Issues
28

NIH Tracking and Inclusion Committee

List of Members

Year 2000-2001

Office of the Director

Yvonne Maddox

Office of Research on Women’s Health

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

Hartmuller, Kay Anderson, Marietta Anthony

Office of Extramural Research

Della Hann*, Larry Fanning, Carlos Caban, Carla Flora, Vicki Fadeley, Donna

Frahm, Sherry Zucker, Jan Heffernan, Chuck Selden, Belinda Seto, Jim Tucker,

Rene Edwards, Aileen Kelly

National Cancer Institute

Marvin Kalt*, Diane Bronzert, Marilyn Gaston, Joe Harford, Michaele Christian, Paulette

Gray, Karen Bashir, George Alexander, Ann Carpenter, Otis Brawley

National Eye Institute

Lore Anne McNicol*, Jack McLaughlin, William Darby

National Heart, Lung, and Blood Institute

Carl Roth (Co-Chair), Barbara Liu, Nancy Morris, Sharry Palagi, Ralph Van Wey, Juanita

Coen 

National Human Genome Research Institute

Monique Mansoura *, Joy Boyer, Emily Linde, Peggy McKoy

National Institute on Aging

Miriam Kelty *, Karen Bashir, Taylor Harden, David Reiter

National Institute on Alcohol Abuse and Alcoholism

Lorraine Gunzerath *; Mary Westcott, Carmen Richardson, Deborah Hendry

National Institute of Allergy and Infectious Diseases

Lai Tan *, Diane Adger-Johnson, Susan Schafer, Waquita Smith, Joyce Woodford, Diane

Yerg, Milton Hernandez, Joan Kondratick

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Christine Densmore *, Julia Freeman, Marcia Hahn, Kristen Ehrenspeck, Joanne

Odenkirchen

* Indicates the IC Lead Representative to the Tracking a nd Inclusion Committee
29

List of Members, continued...

National Institute of Child Health and Human Development

Darlene Levenson *, Douglas Shawver, Yvonne Maddox, Sandra Occipinti

National Institute on Deafness and Other Communication Disorders

Julie Gulya*, Sue Hamilton, Lynnette Hemsley, Jackie Jones

National Institute of Dental and Craniofacial Research

Norman Braveman *, Maryann Redford, Susan Hamilton, Trenita Davis

National Institute of Diabetes, Digestive and Kidney Disorders

Beth Paterson *, Patricia Robuck, Walter Stolz

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, Judit Camacho, Marcia Hahn

National Institute of Mental Health

Mary Lou Prince *, Mary Blehar, William Radcliffe, Pamela Wexler, Tracy Soto

National Institute of Neurological Disorders and Stroke

Meredith Temple *, Connie Atwell, Gladys Melendez-Bohler, Mary Beth Cheung, James

Washington, Mary Graham

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, Kai Lakeman, Kim Hunt, Jerry King

National Center for Complementary and Alternative Medicine

Carol Fitzpatrick*, Eugene Hayunga, Dean Batten, Victoria Putprush, Joan Talley,

Maliaka Pinkney

* Indicates the IC Lead Representative to the Tracking a nd Inclusion Committee
30

List of Members, continued...

National Center for Research Resources

Louise Ramm *, Delores Lee, Patricia Newman, Stephen Seidel, Geoffrey Cheung

Fogarty International Center

Kathleen Michels *, Janice Solomon

Center for Scientific Review

Elliot Postow *

Office of Intramural Research

Alan Sandler

National Center for Minority Health and Health Disparaties

Eric Bailey*, John Ruffin

National Institute of Biomedical Imaging and Bioengineering

Joan Harmon *

* Indicates the IC Lead Representative to the Tracking a nd Inclusion Committee
31

Subcommittee Reviewing Inclusion Issues

List of Members

Year 2000-2001

Miriam Kelty, Chair, National Institute of Aging

Virginia Hartmuller, Office of Research on Women’s Health

Angela Bates, Office of Research on Women’s Health

Vickie Fadeley, Office of Extramural Research

Larry Fanning, Office of Extramural Research

Carla Flora, Office of Extramural Research

Donna Frahm, Office of Extramural Research

Carlos Caban, Office of Extramural Research

Renee Edwards, Center for Information Technology

Aileen Kelly, Center for Information Technology

Zaiga Tums, Office of Acquisition Management and Policy

Barbara Levy, Office of Acquisition Management and Policy

Mary Ellen Cheung, National Institute on Neurological Disorders

Meredith Temple, National Institute on Neurological Disorders

Darlene Levenson, National Institute on Child Health and Human Development

Jack Manischewitz, National Institute on Drug Addiction

Sharry Palagi, National Heart, Lung, and Blood Institute

Lai Tan, National Institute of Allergy and Infectious Diseases

Beth Paterson, National Institute of Diabetes, Digestive and Kidney Disorders

Kim Jarema, Warren G. Magnuson Clinical Center

Dee Koziol, Warren G. Magnuson Clinical Center

Margaret Holmes, National Cancer Insitute

Kim Witherspoon, National CancerInstitute

Martha Barnes, National Institute of Environmental Health Sciences
32

Appendix C

Responses to the General Accounting Office (GAO) Report: “Women’s Health:

NIH Has Increased Its Efforts to Include Women in Research”

GAO/HEHS-00-96, August 2001
33

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

“Women’s Health: NIH Has Increased Its Efforts to Include Women in Research”,

GAO/HEHS-00-96, August 2001

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

response to recommendations of the May 2000 General Accounting Office Report, “Women’s

Health: NIH Has Increased Its Efforts to Include Women in Research.” 

RECOMMENDATION #1

To strengthen the capacity of biomedical research to produce health information

applicable to all segments of the population, we recommend that the director of NIH ensure

that the agency implements the requirement that Phase III clinical trials be designed and

carried out to allow for valid analysis of differences by sex as fully as it implements other

elements of the inclusion policy. Specifically, we recommend that NIH appropriately

communicate this requirement to applicants, that peer review groups explicitly determine

whether each Proposed Phase III clinical study is required to have such a study design, and

that Summary Statements document the initial reviewer’s decision. 

# NIH STATEMENT: Language in the NIH Guide Notice of August 1, 2000 would be

incorporated in the IC guidelines and instructions for the submission and review of

applications and proposals, to be effective October 1, 2000.

CURRENT STATUS:

The NIH policy on the inclusion of women and minorities as subjects in clinical research was

updated in August, 2000 for active grants, cooperative agreements, and contracts and applied

to all new grant, cooperative agreement, and contract submissions beginning in October,

2000. The updated policy can be accessed at the following NIH Grants Policy website

address: http://grants.nih.gov/grants/funding/women_min/women_min.htm. The NIH Guide

for Grants and Contracts serves, in lieu of the Federal Register’s compliance with the

Administrative Procedures Act, as the official publication of NIH policies, procedures, and

availability of funds. Researchers can access this information from the NIH Grants website

through the URL: http://grants.nih.gov/grants/policy/policy.htm. The NIH website is one of

the most frequently accessed sites by researchers and by the public and is used for both

administrative announcements and reporting of more general scientific issues.

Beginning with the October, 2000 receipt date, grant, cooperative agreement, and contract

submissions requesting support for an NIH-defined Phase III clinical trial must adhere to this

updated policy which specifies when a valid analysis by sex/gender and race/ethnicity of the

intervention effect is required. All applications or proposals and/or protocols for a Phase III

clinical trial require the research design and inclusion plan not only to describe the

composition of the proposed study population but also to address differences by sex/gender

and race/ethnicity describe plans to conduct valid analyses to address these differences. The
34

final protocol approved by the Institutional Review Board must include these plans for

analysis. 

In addition to the general announcements for all applicants, special steps have been taken to

reinforce the NIH policy. As of October, 2000, investigators who respond to a Request for

Applications (RFA), a Program Announcement (PA), or a Request for Proposals (RFP) are

required to adhere to the specific requirements for NIH-defined Phase III clinical trials. The

revision requires the inclusion of a description of plans to conduct analyses to address

sex/gender and racial/ethnic differences and instructions that all investigators must report

accrual of subjects and conduct as well as report analyses by sex/gender and/or racial/ethnic

group differences. Once the research study has been completed, analyses by sex/gender

and/or racial/ethnic differences are to be submitted to the NIH as part of the final progress

report. 

Relevant information for inclusion of women and minorities in clinical research studies may

also be accessed through the Inclusion of Women and Minorities Policy Implementation web

page at the following URL:

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

# NIH STATEMENT: Guidelines/Instructions for reviewers and SRAs would be

developed that would emphasize and clarify the need to review research proposals

containing NIH-defined Phase III clinical trials for both inclusion requirements and

those related to sex/gender. Instructions were to be provided on the proper

documentation to be included in summary statements to address adherence to these

policies.

CURRENT STATUS:

In February 2001, NIH issued new “NIH Instructions to Reviewers for Evaluating Research

Involving Human Subjects in Grant and Cooperative Agreement Applications” as part of its

commitment to the protection of human subjects from research risks and to the inclusion of

women, minorities, and children in clinical research. These instructions consolidate

information and instructions for reviewers concerning new, revised, or existing NIH policies

for human subject protection, data and safety monitoring plans, and inclusion of women,

minorities and children in clinical research. These instructions are available on the NIH

website: http://grants.nih.gov/grants/peer/hs_review_inst.pdf . In the instruction document,

the Scientific Review Groups are instructed that they must evaluate applications on these

factors independently of any other review by Institutional Review Boards, NIH staff, or

others. 

The instructions emphasize the importance of a thorough evaluation of the requirements for

inclusion of women and minorities in clinical research applications submitted to the NIH. 

They specifically describe the requirements that clinical trials be designed to provide for valid

analysis by sex/gender and race/ethnicity. The instructions remind reviewers that failure to

address the issues related to inclusion of women and minorities adequately, must have a

negative impact on the priority scores assigned for scientific and technical merit. Moreover,
35

the designation of an unacceptable plan for the inclusion of women and minorities results in a

bar-to-funding by the NIH until the deficiencies are resolved. 

# NIH STATEMENT: Following completion of these actions, training would be provided

to program and review official and grants and contracts management staff.

CURRENT STATUS:

Since August 2000, several training initiatives have occurred and are ongoing. 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 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. Some 450 NIH staff were in attendance, 400 viewed

the remote session at satellite centers and another 175 participated through videocast. The

training materials are permanently archived in the 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 where several hundred more extramural and intramural researchers

were provided updated instructions about inclusion of human subjects in clinical research

studies. 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_update.htm

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 are the most frequently accessed NIH documents by the

research, review, and NIH staff communities. 

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 is

currently being revised and will be published this fall as Frequently Asked Questions (FAQs)

on the NIH website for the inclusion of women and minorities policy implementation at:

http://grants.nih.gov/grants/funding/women_min/women_min.htm. These FAQs are being

developed and reviewed by members of the NIH-wide Tracking and Inclusion Committee.

They provide additional guidance to researchers and NIH staff on implementing the inclusion

policy for women and minorities in clinical research, the new reporting requirements for

inclusion data, and information for submitting an application, peer review and funding. 
36

# NIH STATEMENT: Program Officials would monitor, verify, and document, at time of

award, whether policy requirements are met and, when annual progress reports are

submitted, will determine and document whether compliance has continued. 

CURRENT STATUS:

Throughout and following training on these actions, Program Officials continue to monitor,

verify and document, at time of award, whether policy requirements are met. At the time

annual progress reports are submitted, they continue to determine and document whether

there is ongoing compliance. When applications or proposals are deficient in meeting the

policy requirements, grants and contracts management staff along with program officials will

withhold funding until the Principal Investigator has satisfactorily addressed the policy

requirements.

Advisory Councils of each Institute and Center (IC) prepare biennial reports describing the

manner in which they have complied with the inclusion guidelines mandated by law in the

NIH Revitalization Act of 1993, Public Law 103-43, Section 485B (2)(f). In December, 2000,

the Office of Research on Women’s Health (ORWH) requested each IC Director to address

compliance with the inclusion guidelines in their report submitted to members at their

January or February, 2001 Advisory Council meetings. As of August 2001, ORWH has

received reports from the ICs to be included in the 2000 Biennial Report Certifying

Compliance with the NIH Policy on the Inclusion of Women and Minorities as Subjects in

Clinical Research. In their reports, ICs were asked to address procedures used to ensure

compliance with the May 2000 GAO recommendations, including the requirements that

clinical trials be designed to provide for a valid analysis of sex/gender and racial/ethnic

differences.

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.

5. 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.
37

CURRENT STATUS:

The data tracking system for monitoring inclusion of women and minorities in clinical

research is going through significant re-engineering. This re-engineering is driven by three

main issues: (1) the need to develop a system that provides easy-to-use data entry and project

monitoring by staff; (2) the ability to create clear, accurate, and timely NIH reports on

inclusion data; and (3) the need to incorporate the 1997 OMB Directive 15 - standards for the

classification of federal data on race and ethnicity. 

The re-engineering of the NIH electronic tracking system was begun by OER in 2000. This

system now includes a web-based set of tools that provides user-friendly access and data

entry by NIH staff. In addition, the new system is part of the NIH enterprise data system,

IMPAC II, and as such will be integral to extramural research grant administration that

includes grant review, grants management and program operations. The new system will

incorporate data reported using the new classifications in OMB Directive 15 and is consistent

with the instructions and forms provided in the newly revised PHS 398 and 2590 (rev. 5/01). 

The design of the new system is currently being reviewed and accepted by NIH committees

representing tracking and inclusion, grants management, health services administration,

electronic research administration, and extramural policy and management. Development

and testing of the new system is expected to continue through April 2002, with full

deployment in May 2002. Analyses of inclusion data reported in FY2002 will be conducted

with the new system. After completion of the re-engineered electronic database by OER, the

ORWH will collaborate with OER and the Division of Workforce Development to develop

training on the new system prior to its full implementation.
38

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

Activity Due Date Status Date

Completed

39

Train NIH program & review

officials and grants &

contracts management staff on

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)

Fall 2000 Symposium training session for

extramural staff (450) occurred

on10/16 on new policies and

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 as needed.

Frequently Asked Questions

document drafted

Training of Extramural and

Intramural staff at December

2000 Full Tracking and

Inclusion Committee Meeting. 

10/16/00

12/11/00

12/11/00

ORWH & OER work together

to ensure NIH staff are wellinformed about data collection

requirements of current

tracking system

No end date Continuing
Status of Activities on GAO Report on Women’s Health (GAO/HEHS-00-96, May 2000)

Activity Due Date Status Date

Completed

40

NIH develop specific

tracking/inclusion module to

interface w/ IMPAC2 system.

12/31/2000 CIT/OER proposal for

Sex/Gender and Minority

Population Tracking System

Development submitted on

10/27. Requirements analysis

started 10/31 - to be completed

by 12/15.

NIH staff training on tracking

system module to interface w/

IMPAC2 system.

Begin

training

when

system

developed 

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
41

Appendix D

Internet Homepage: 

Inclusion of Women and Minorities Policy Implementation

http://grants.nih.gov/grants/funding/women_min/women_min.htm
42

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.
43

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
44

Appendix E

Amendment

NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as Subjects in 

Clinical Research - October, 2001
45

AMENDMENT: NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN

AND MINORITIES 

AS SUBJECTS IN CLINICAL RESEARCH - OCTOBER, 2001

Release Date: October 9, 2001

NOTICE: NOT-OD-02-001

National Institutes of Health

The National Institutes of Health policy on the Inclusion of Women and Minorities as Subjects in

Clinical Research has been amended. A complete copy of the amended policy may be found on

the "Inclusion of Women and Minorities Policy Implementation" web site:

http://grants.nih.gov/grants/funding/women_min/women_min.htm. The October 2001 policy

provides a consolidated, concise, and clear document of the updates and changes to the NIH

policies to implement the original legislation (PL 103-43), 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). 

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.

The amended policy incorporates the following four points: 

1. The definition of clinical research as reported in the "1997 Report of the NIH Director’’s Panel

on Clinical Research" is used to implement the NIH policy on the inclusion of women and

minorities as subjects in clinical research. 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

2. Racial and ethnic categories have been updated in order to comply with the new standards issued

by the Office of Management and Budget (OMB) in Directive No. 15

http://www.whitehouse.gov/omb/fedreg/ombdir15.html. This directive defines the 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.
46

3. Language governing NIH-defined Phase III clinical trials has been clarified in order to be

consistent with the mandate for the inclusion of women and minorities as subjects in clinical

research (PL103-43), the new PHS 398 form and OMB Directive 15. The amended policy

provides additional guidance on the analyses and reporting of analyses of sex/gender, 

racial/ethnic and relevant subpopulation differences in intervention effects for NIH-defined Phase III

clinical trials. 

4. Roles and responsibilities of NIH staff and the extramural community have been updated with

regard to the implementation of the NIH policy on the inclusion of women and minorities as

subjects in clinical research. While this policy applies to all applicants/offerors for NIH-fundeded

clinical research, certain individuals and groups have special roles and responsibilities with

regard to its implementation.
47

Appendix F

NIH Policy and Guidelines on the Inclusion 

of Women and Minorities as Subjects in Clinical Research 

Amended, October, 2001
48

NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND

MINORITIES AS SUBJECTS IN CLINICAL RESEARCH –– Amended,

October, 2001.

NOTE: Additional information concerning the NIH Policy on Inclusion of Women and Minorities as

Subjects in Clinical Research is available at

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

SUMMARY: This notice updates the NIH policy on the inclusion of women and minorities as

subjects in clinical research. It supercedes the 1994 Federal Register notice

(http://grants.nih.gov/grants/guide/notice-files/not94-100.html) and the August 2000 notice in the

NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-

048.html). It incorporates the definition of clinical research as reported in the 1997 Report of the

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

reporting analyses of sex/gender and racial/ethnic differences in intervention effects for 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) 
49

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

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

of clinical research is inappropriate ......; 

(b) the manner in which clinical trials are required to be designed and carried out ......; and 

(c) the operation of outreach programs ...... 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) 
50

(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 NIH-supported clinical research studies.

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

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

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

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

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

the proposed outreach programs for recruiting women and minorities as participants. 

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

Sex/Gender and Race/Ethnicity Differences.

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

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

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

derived from prior animal studies, clinical observations, metabolic studies, genetic studies,

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

studies.

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

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

below will apply:

1. Prior Studies Support the Existence of Significant Differences

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

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

relevant subpopulation comparisons, the primary question(s) to be addressed by the proposed

NIH-defined Phase III clinical trial and the design of that trial must specifically accommodate

this. For example, if men and women are thought to respond differently to an intervention,
51

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 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
52

conditions of all awards for grants, cooperative agreements and contracts supporting NIHdefined 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 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)
53

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:

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

appropriate representation or to evaluate the proposed justification when representation is

limited or absent, 

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

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

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

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

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

warranted,

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

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

to include these criteria as part of the scientific assessment and evaluation. 

The review instructions for grants are available on line at the following URL:

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

For contracts, the contracting officer will provide instructions for contract reviewers. Further

information on instructions for contracts may be obtained at the following URL:

http://oa.od.nih.gov/oamp/index.html. 

Or contact:

National Institutes of Health

Division of Acquisition Policy and Evaluation

Office of Acquisition Management and Policy

6100 Executive Boulevard, Room 6C01

Phone: 301-496-6014

Fax: 301- 402-1199
54

5. NIH Advisory Councils

In addition to other responsibilities for review of projects where the peer review groups have

raised questions about the appropriate inclusion of women and minorities, the Advisory

Council/Board of each Institute/Center shall prepare biennial reports, for inclusion in the

overall NIH Director's biennial report, describing the manner in which the Institute/Center

has complied with the provisions of the statute.

6. Institute/Center Directors

Institute/Center Directors and their staff shall ensure compliance with the policy.

7. NIH Director

The NIH Director may approve, on a case-by-case basis, the exclusion of projects, as

recommended by the Institute/Center Director, that may be inappropriate to include within

the requirements of these guidelines on the basis of circumstances other than the health of the

subjects, the purpose of the research, or costs. 

IV. DEFINITIONS

Throughout the section of the statute pertaining to the inclusion of women and minorities, terms

are used which require definition for the purpose of implementing these guidelines. These

terms, drawn directly from the statute, are defined below.

A. Clinical Research

Clinical research is defined as:

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

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

colleague) directly interacts with human subjects. Excluded from this definition are in vitro

studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented

research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical

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

(3) Outcomes research and health services research.

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

B. NIH-defined Clinical Trial

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

Phase III clinical investigation, usually involving several hundred or more human subjects,

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

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

investigation is to provide evidence leading to a scientific basis for consideration of a change

in health policy or standard of care. The definition includes pharmacologic, nonpharmacologic, and behavioral interventions given for disease prevention, prophylaxis,

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

also included.
55

C. Valid Analysis

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

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

Valid analysis can and should be conducted for both small and large studies. A valid analysis

does not need to have a high statistical power for detecting a stated effect. The principal

requirements for ensuring a valid analysis of the question of interest are:

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

racial/ethnic groups to the intervention and control groups by an unbiased process such as

randomization,

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

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

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

D. Significant Difference

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

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

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

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

significance. Statistical significance depends upon the amount of information in the data set.

With a very large amount of information, one could find a statistically significant, but clinically

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

could find a large difference of potential importance that is not statistically significant.

E. Racial and Ethnic Categories

1. Minority Groups

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

racial, ethnic, and/or cultural heritage.

The Office of Management and Budget (OMB) Directive No. 15

http://www.whitehouse.gov/omb/fedreg/ombdir15.html defines minimum standards for

maintaining, collecting and presenting data on race and ethnicity for all Federal reporting. NIH is

required to use these definitions to allow comparisons to other federal databases, especially the

census and national health databases. The categories in this classification are social-political

constructs and should not be interpreted as anthropological in nature. 

When an investigator is planning data collection on race and ethnicity, these categories shall be

used. The collection of greater detail is encouraged. However, more detailed items should be

designed in a way that they 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
56

followed by the option to select more than one racial designation. Respondents shall be offered

the opportunity to select more than one racial designation. When data are collected separately,

provision shall be made to report the number of respondents in each racial category who are

Hispanic or Latino. 

The following definitions apply for ethnic categories.

Hispanic or Latino - a person of Cuban, Mexican, Puerto Rican, South or Central American, or

other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in

addition to "Hispanic or Latino."

Not Hispanic or Latino

The following definitions apply for racial categories.

American Indian or Alaska Native - a person having origins in any of the original peoples of

North, Central, or South America, and who maintains tribal affiliations or community

attachment.

Asian - a person having origins in any of the original peoples of the Far East, Southeast Asia, or

the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia,

Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine

Islands have been recorded as Pacific Islanders in previous data collection strategies.)

Black or African American - a person having origins in any of the black racial groups of Africa.

Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American."

Native Hawaiian or Other Pacific Islander - a person having origins in any of the original

peoples of Hawaii, Guam, Samoa, or other Pacific Islands. 

2. Majority Group

White - a person having origins in any of the original peoples of Europe, the Middle East, or

North Africa.

NIH recognizes the diversity of the U.S. population and that changing demographics are reflected

in the changing racial and ethnic composition of the population. The terms "minority groups" and

"minority subpopulations" are meant to be inclusive, rather than exclusive, of differing racial and

ethnic categories.

3. Subpopulations

Each racial and ethnic group contains subpopulations that are delimited by geographic origins,

national origins and/or cultural differences. It is recognized that there are different ways of

defining and reporting racial and ethnic subpopulation data. The subpopulation to which an

individual is assigned depends on self-reporting of specific origins and/or cultural heritage.

Attention to subpopulations also applies to individuals who self identify with more than one race

or ethnicity. Researchers should be cognizant of the possibility that these racial/ethnic

combinations may have biomedical, behavioral, and/or social-cultural implications related to the

scientific question under study.
57

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

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
58

Dr. Eleanor Hanna

National Institute on Alcohol Abuse and Alcoholism

Willco Building

6000 Executive Boulevard, Suite 514

Rockville, MD 20892

Telephone: (301) 594-6231

Email: ehanna1@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

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
59

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.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. Meredith Temple

National Institute of Neurological Disorders and Stroke

Neuroscience Building 

6001 Executive Boulevard, Room 2227

Bethesda, MD 20892- 9525

Telephone: (301) 496-1447 

Email: templem@ninds.nih.gov
60

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

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. Joan T. Harmon

National Institute of Biomedical Imaging and Bioengineering

Room 697

6707 Democracy Boulevard

Bethesda, MD 20892

Telephone: (301) 594-8813

Email: joan_harmon@nih.gov
61

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
62

Appendix G

NIH Policy on 

Reporting Race and Ethnicity Data: 

Subjects in Clinical Research
63

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: 
64

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or

other Spanish culture or origin, regardless of race. The term “Spanish origin” can also be used in

addition to “Hispanic or Latino.” 

Not Hispanic or Latino 

Racial Categories: 

American Indian or Alaska Native: A person having origins in any of the original peoples of

North, Central, or South America, and who maintains tribal affiliations or community

attachment. 

Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or

the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia,

Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine

Islands have been recorded as Pacific Islanders in previous data collection strategies.) 

Black or African American: A person having origins in any of the black racial groups of Africa.

Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.” 

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples

of Hawaii, Guam, Samoa, or other Pacific Islands. 

White: A person having origins in any of the original peoples of Europe, the Middle East, or

North Africa. 

Using respondent self-report or self-identification to collect an individual’s data on ethnicity and

race, investigators should use two separate questions with ethnicity information collected first

followed by the option to select more than one racial designation. 

When reporting these data in the aggregate, investigators should report: (a) the number of

respondents in each ethnic category; (b) the number of respondents who selected only one

category for each of the five racial categories; (c) the total number of respondents who selected

multiple racial categories reported as the “number selecting more than one race”; and, (d) the

number of respondents in each racial category who are Hispanic or Latino. Investigators may

provide the detailed distributions, including all possible combinations, of multiple responses to

the racial designations as additional information. However, more detailed items should be

designed in a way that they can be aggregated into the required categories for reporting purposes.

NIH is required to use these definitions to allow comparisons to other federal databases,

especially the census and national health databases. Federal agencies will not present data on

detailed categories if doing so would compromise data quality or confidentiality standards. 

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
65

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. 

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
66

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

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

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

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

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

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

III. Frequently Asked Questions 

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

OMB standards? 

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

table “Targeted/Planned Enrollment Table” for New Applications. First, the investigator should

report the anticipated total number of males and females to be enrolled by Ethnicity (Hispanic or

Latino, Not Hispanic or Latino). Then, the investigator should report the anticipated total number

of males and females by Racial Categories (American Indian or Alaska Native, Asian, Native

Hawaiian or Other Pacific Islander, Black or African American, White). The total number of

subjects in the Ethnic Category section of the table should equal the total number of subjects in

the Racial Categories section. Investigators do not need to estimate the anticipated number of

individuals reporting multiple racial categories (either total number reporting multiple categories

or number reporting specific combinations) for New Applications. However, the investigator

must follow the OMB guidelines, which include allowing respondents to select multiple race

categories, once data collection commences. 

2. What if my new application involves analyzing secondary data in which the race and ethnicity

categories do not comply with the new OMB guidelines? 

If an investigator is using secondary data sets that do not conform to the new OMB guidelines

and does not plan to collect any new/additional data from the subjects, this should be noted in the

New Application. In this circumstance, the investigator should complete the “Targeted/Planned

Enrollment Table” for a New Application and the “Inclusion Enrollment Report” for

Continuation Applications, Competing Supplement Applications, and Annual Grant Progress

Reports if the data allow. However, if the existing data do not allow accurate correspondence

with the new categories, the investigator should report the information using the prior categories

and use the 4/98 Version of the Inclusion Table. 

3. There are many ways of tabulating the multiple race and ethnicity responses, particularly since

the race and ethnicity categories are not mutually exclusive. Do the numbers I report have to “add

up”? 

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

Enrollment Table” for a New Application and the “Inclusion Enrollment Report ” for

Continuation Applications, Competing Supplement Applications, and Annual Progress Reports,

the sum in “Ethnic Category: Total of All Subjects” must equal the sum in “Racial Categories:
67

Total of All Subjects.” In addition, the “Racial Categories: Total Hispanics or Latinos” in Part B

of the “Inclusion Enrollment Report Table” must equal the Total Hispanic or Latino number

reported in Part A of the “Inclusion Enrollment Report.” Footnotes in the tables clearly identify

which numbers must be the same. 

4. Can I use the Targeted/Planned Enrollment Table or the Enrollment Inclusion Report to collect

data from individuals? 

Neither the Targeted/Planned Enrollment Tablet nor the Enrollment Inclusion Report should be

used for collecting data from individuals. These tables are only to be used for reporting aggregate

data. 

To collect data from an individual respondent, investigators should use respondent self-report or

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

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

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

Origin and Race”” section of the Personal Data Form Page in the PHS 398 (rev. 5/01)

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

5. Can I ask more detailed questions about ethnicity and race than these guidelines indicate? 

The revised OMB guidelines provide minimal standards for data collection. Indeed, researchers

are encouraged to explore collecting additional types of information on race and ethnicity that

will provide additional insights into the relationships between race and ethnicity and health. For

example, after asking the ethnicity and then the race questions, researchers may opt to ask study

participants who choose multiple categories to identify the group that they identify with

primarily. Further questions identifying membership in subpopulations within the ethnic and

racial categories provided by OMB may also be considered. The scientific question being

addressed in the study should guide investigators’ decisions regarding collection of any

additional information on ethnicity or race. Information on subpopulations may be reported by

listing the information in an attachment to the required table. 

6. I have already begun data collection and my categories do not comply with the new OMB

standards. Do I need to change my questions on race and ethnicity in the middle of the study? 

If data collection has already begun, we do not expect investigators to change their questions on

race and ethnicity prior to the completion of the study. For Annual Progress Reports, in this

circumstance, investigators should note that the research project was initiated prior to the

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? 
68

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

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

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

the new Inclusion Enrollment Report. 

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

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

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

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

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

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

are relevant to the scientific hypotheses being studied. 

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

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

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

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

two separate tables –– one for domestic data and one for foreign data, with an asterisk and

footnote accompanying the table with foreign data. 

9. How do the 1997 OMB revised standards differ from the previous standards? 

OMB issued the previous standards for maintaining, collecting, and presenting data on race and

ethnicity in 1977. The minimum acceptable categories were: American Indian or Alaska Native;

Asian or Pacific Islander; Black, not of Hispanic origin; Hispanic; White, not of Hispanic origin. 

The 1997 OMB revised standards now include two ethnic categories (Hispanic or Latino or Not

Hispanic or Latino) and five racial categories (American Indian or Alaska Native, Asian, Black

or African American, Native Hawaiian or Other Pacific Islander, and White). When using selfreporting or self-identification to collect data on ethnicity and race, investigators should use two

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

than one racial designation. 

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

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

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

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
69

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. Eleanor Hanna

National Institute on Alcohol Abuse and Alcoholism

Willco Building

6000 Executive Boulevard, Suite 514

Rockville, MD 20892

Telephone: (301) 594-6231

Email: ehanna1@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
70

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

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
71

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. Meredith Temple

National Institute of Neurological Disorders and Stroke

Neuroscience Building 

6001 Executive Boulevard, Room 2227

Bethesda, MD 20892- 9525

Telephone: (301) 496-1447 

Email: templem@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
72

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. Joan T. Harmon

National Institute of Biomedical Imaging and Bioengineering

Room 697

6707 Democracy Boulevard

Bethesda, MD 20892

Telephone: (301) 594-8813

Email: joan_harmon@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 H

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
74

OLD TABLE - TARGET/ENROLLMENT DATA
75

NEW TABLE - TARGET DATA
76

NEW TABLE - ENROLLMENT DATA
77

Appendix I

NIH Instructions to Reviewers for 

Evaluating Research Involving Human Subjects 

in Grant and Cooperative Agreement Applications
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79
80
81
82
83
84
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87
88
89
90
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Appendix J

Subcommittee Reviewing Inclusion Issues: 

Summary Report on Actions to 

the NIH Tracking and Inclusion Committee
93

Summary Report to the NIH Tracking and Inclusion Committee on the 

Actions of the Subcommittee Review Inclusion Issues

Between 1994 and 2000, a number of changes occurred at the NIH that affected extramural

policies and the subsequent implementation of a tracking system for the inclusion of women and

minorities in clinical research. As a result of these changes and the May 2000 GAO report, the

Chair of the NIH Tracking and Inclusion Committee created an ad hoc Subcommittee composed

of representatives of Institutes and Centers (ICs), the Office on Women’s Health Research

(ORWH), the Office of Extramural Research (OER), and the Office of Intramural Research

(OIR). A list of the subcommittee members follows this report.

The purpose of the subcommittee was to examine NIH’s policy and information system for

tracking data on the inclusion of women and minorities in clinical research, recommend changes

to improve the accuracy and performance of the system, and recommend improvements needed

in the NIH policy.

The NIH Subcommittee Reviewing Inclusion Issues surveyed and collected comments from ICs

on their interpretation and implementation of the inclusion policy and the tracking of inclusion

data. A random sampling of files confirmed that there were inconsistencies in the interpretation

and implementation of the requirements as well as in the collection and reporting of data. Based

on these comments, the Subcommittee identified as immediate issues to be addressed: (1)

updates, clarifications, and implementation of the policies regarding inclusion of women and

minorities as subjects in clinical research including the definition of clinical research and the

clarification of the gender analysis requirements; (2) quality and consistency of data entered and

mechanisms of data entry; and (3) improvements necessary for the computerized information

system. 

The Subcommittee (1) updated the NIH policy on the inclusion of women and minorities as

subjects in clinical research, (2) clarified the NIH definition of clinical research as it pertains to

inclusion issues, (3) clarified the requirements for analysis for sex differences in NIH defined

Phase III clinical trials, and (4) proposed and made substantive recommendations for the design

of a new tracking system that will be fully compatible with the IMPAC II database. In addition,

the subcommittee (5) recommended additional training on the inclusion policy and the proposed

system for NIH staff, (6) incorporated and communicated the Office of Management and Budget

(OMB) Directive 15 racial and ethnic categories into the NIH inclusion policies and guidelines,

(7) prepared and reviewed relevant sections of the new 398/2590 Grant Application Instructions

and Forms, (8) and revised the Frequently Asked Questions section of the Outreach Notebook

used by the extramural community to ensure that the inclusion policy is understood and fully

implemented. 
94

A number of operational details required attention. Our initial activities involved the

clarification of the requirement for NIH-defined Phase III clinical trials to provide analysis of sex

differences. The NIH Policy and Guidelines on the Inclusion of Women and Minorities as

Subjects in Clinical Research updated August 1, 2000 reflected this clarification of requirements

specific to NIH defined Phase III clinical trials. Language was incorporated into the

announcements of research initiatives to the extramural research community (PA/RFA/RFP), and

the Terms and Conditions of Awards to clarify the requirement for Phase III clinical trials to

provide analysis for sex differences. Moreover, the instructions for reviewers and for the

Scientific Review Administrators were updated to emphasize and clarify the need to review

research proposals for inclusion requirements, analyses by sex/gender, the new OMB Directive

15 standards for reporting racial and ethnic data, as well as the proper documentation to be

included in summary statements to address adherence to these policies. 

Once these policy changes were approved by the full tracking and inclusion committee and

governing committees of NIH (Review Policy Committee (RPC); Grants Management Advisory

Committee (GMAC); Acquisition Management Committee (AMC); and Extramural Program

Management Committee (EPMC)), the subcommittee began to outline design requirements for a

new computerized tracking system for the inclusion of women and minorities as subjects in

clinical research. The subcommittee worked closed with the technology team and members from

the Office of Extramural Research (OER) and the Center for Information Technology (CIT). As

well, many of the subcommittee members participated on the Joint Application

Development/Design (JAD) team to design the new tracking system and assisted in the

development of the Initial Critical Design Review (ICDR) document.

The subcommittee also was instrumental in the organization and design of training sessions and

documents for NIH staff and the extramural community. Members worked closely with Dr.

Chuck Selden, the OER Extramural Staff Training Officer, to design and conduct training

sessions on the new/updated inclusion policies and assisted in the training sessions as faculty. As

well, subcommittee members made periodic presentations to the GMAC, POPOF, and EPMC to

keep them abreast of changes and receive input on updates to the inclusion policy. 

In spring 2001, after final approval was given to update the definition of clinical research,

additional updates and clarifications were needed in the inclusion policy. These included the

incorporation of the new OMB Directive 15 standards on reporting race and ethnicity data, and

further specification of the sex/gender analysis required for NIH-defined phase III clinical trials. 

The Subcommittee developed the October 2001 Amended Guidelines that provide a

consolidation of the original legislation (PL 103-43) and the Federal Register notice and provide

a clear and concise reference document for NIH staff and the extramural community. An

abbreviated guide notice, dated October 2001, will be posted in the NIH Guide for Grants and

Contracts with the fully amended policy posted on the OER Inclusion of Women and Minorities

Policy Implementation web site

http://grants.nih.gov/grants/funding/women_min/women_min.htm. Also, the Subcommittee

provided substantive recommendations in the development of the NIH Policy on Reporting Race

and Ethnicity Data: Subjects in Clinical Research (also available through the OER Inclusion of
95

Women and Minorities Policy Implementation web site ) which provides NIH staff and the

extramural community guidance on collecting and reporting data consistent with the new OMB

standards regarding race and ethnicity data. 

In concert with the October 2001 Amended Guidelines, the Frequently Asked Question (FAQ’s)

section of the Outreach Notebook is being updated. These updated FAQ’s will reflect the

Amended Policy, the newly revised 398/2590 application instructions (rev. 5/01), and the new

data tables for collecting target and enrollment data. The FAQ’s will be posted on the ORWH

website and the OER Inclusion of Women and Minorities Policy Implementation website. 

The Subcommittee Reviewing Inclusion Issues has accomplished the three objectives that

constituted it’s charge. A detailed listing of actions completed by the Subcommittee Reviewing

Inclusion Issues, work in progress, and new issues is attached. A final recommendation from the

Subcommittee is that the ongoing activities be monitored by a new subcommittee of the NIH

Tracking and Inclusion Committee. 
Page 96

Actions Taken by Subcommittee Reviewing Inclusion Issues

October 2001

Actions Completed

1. Updates to NIH Policy and Guidelines on Inclusion 

a. A Notice was announced on August 2, 2000 in the NIH Guide to Grants and Contracts, 

which reiterated and clarified the policy for inclusion and restated that Phase III clinical

trials must be designed and conducted in a manner sufficient to allow for a valid analysis

to determine whether differences exist in intervention effect for women or members of

minority groups. This notice would apply to all intramural and extramural research. 

b. A new Terms and Conditions of Award was applied to awards made after October 1, 

2000 that have Phase III clinical trials. 

c. An Amended Notice was prepared for release in October 2001. This document will

essentially replace the Federal Register Notice as a reference and the update from August

2, 2000; it is significantly shortened however it incorporates statute language; change in

language to reflect new OMB standards, insertion of new definition for clinical research (

replace “human subject” references with “clinical research”) and provides further

clarification on sex/gender analysis in NIH-defined phase III clinical trials.

d. Approved by full committee in September 2001 and posted October 2001.

e. Separate 1-page notice of the new guidelines will be placed in electronic version for NIH 

Guide for Grants and Contracts. Posted in October 2001.

2. New Policy and Guidelines on Reporting Data Sex/Gender and Race/Ethnicity 

a. Policy developed by OER; distributed to full tracking committee for comment.

b. Outlines OMB Directive 15 requirements for reporting race and ethnicity data.

c. Includes FAQ questions - new concept to include in policy.

3. Tracking System Module for IMPAC 2 - Initial Design

a. November 2000, proposal developed by CIT and OER

b. December 2000, Joint Application Design (JAD) team formed to discuss

recommendations and design implications.

c. Spring/Summer 2001, Initial design for tracking system module discussed and presented 

to the full tracking committee and NIH functional committees.

4. Training for NIH staff 

a. October 16, 2000, a one-day training session was held on new policies and procedures

regarding human subjects and the inclusion of women and minorities in clinical trials was

addressed.

b. December 11, 2000, a half-day training session was held on additional policy issues

related to the inclusion of women and minorities, including the new OMB reporting

requirements for data on race and ethnicity.

c. December 11, 2000, L. Fanning conducted a training session on the existing population

tracking system for the full committee.

5. Activity Codes that must be tracked 
Page 97

a. Document approved in March 2001.

b. All F’s and T’s and K’s are not to be tracked.

c. Activity Codes will be used for development of exception codes and business rules for

new tracking system.

6. Creation of NIH Website for the Implementation of Policy for Inclusion of Women and 

Minorities as Subjects in Clinical Research 

7. Preparation of GAO Status Reports 

8. SRA Reviewer Instructions 

(website-- http://grants.nih.gov/grants/peer/hs_review_inst.pdf) 

a. Document approved and published on Website in April 2001(website)

b. New definition for Clinical research and Phase III clinical trials included

9. Definitions and Communication 

 a. NIH definition for Phase III Clinical Trials

 b. NIH definition for Clinical Research

 c. Racial/Ethnic Categories and Data Tables

10. Policy: Applications for Phase I toxicity studies will not require the inclusion of target data 

tables. (see attachment I) - Recommendation Approved by Full Committee

 a. Motion approved by committee in May 2001.

 b. NCI requested exception for Phase II clinical studies.

11. New 398/2590 Application Instructions and Forms 

 a. Issue: The form does not include a field to identify whether a study is “clinical research”.

Of great concern to NIH staff. Comments given to OER. Context changes to reflect

clinical research instead of the words “human subjects”.

Work in Progress

1. Update to the Frequently Asked Questions (FAQ) Document 

a. Needs to be posted on Women and Minorities Home Page

b. Questions to reflect new 398 and Amendment to the Inclusion Policy

c. Reflects additions and changes since the release of the May 2000 GAO report

d. Document has been approved in concept by full committee; will pass by committee for

final approval.

e. Anticipated posting October 2001.

2. Update to the Outreach Notebook 

a. Needs to be finalized and posted on Women and Minorities Home Page

b. Separate committee chaired by Taylor Harden

3. Exception Categories 
Page 98

a. Exception codes reduced from 11 to 6 or 7.

b. Explanations provided for each code. 

c. New codes provide a separate acronym to be used and correlate with old code, if

appropriate.

d. Recommend addition of a code to cover “parent projects” where the data is stored in subprojects or protocols. This code will need to be re-assessed when JAD conducts beta

testing.

e. Question regarding interpretation and implementation of exception categories remains. 

4. Tracking System

a. Interim MS Excel spreadsheets to be developed for IC’s to use when entering data

reported in FY 02.

b. No FY 02 data should be entered into the old system.

c. JAD to be re-convened Fall 01 to refine, design and assist in beta testing.

d. New system to be deployed April/May 02.

New Issues

1. Transition of Subcommittee to Steering Committee - Recommendation

a. Committee has addressed the recommendation of the GAO

b. Steering to assume Subcommittee committee functions to monitor and make

recommendations regarding the inclusion policy and new population tracking system. 

2. Training NIH staff and extramural community

a. In the Fall 2001, need to develop training materials and organize training sessions 

regarding the revised inclusion policy, new forms and tables for reporting data on 

women and minorities, the new data tracking codes, and the new IMPAC II tracking 

module. Should include written information, verbal presentations, and web-based

tutorials for NIH staff and extramural community.

b. Develop a list of important meetings and associated NIH staff to provide training to

extramural community.

c. Develop training