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 1997 & 1998 Tracking Data)

NIH Tracking/Inclusion Committee

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

National Heart, Lung, and Blood Institute

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

Office of Research on Women s Health

Virginia W. Hartmuller, Ph.D.

Office of Research on Women s Health

Angela Bates

Office of Research on Women s Health

Larry Fanning

Office of Extramural Research

Systems Quality Assurance Interface Branch

September 1, 2000
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 human

subject 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 volunteers 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 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. Research awards covered by this policy required the grantee

to report annually on enrollment of women and men, and on the race and ethnicity of research participants. 

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
2

methodologies to ensure uniform standards and definitions in the reporting of data on the participation of women

and minority volunteers in NIH-funded 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. 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 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. This outreach notebook also includes the full text of the 1994 implementation guidelines as well

as a questions and answers document to provide more detailed policy guidance and some of the more commonly

asked questions. The ORWH also has available a full report of its workshop on Recruitment and Retention of

Women in Clinical Studies." 

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

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

members of the ORWH Recruitment and Retention Task Force, other experts, and representatives from NIH ICs,

to discuss their experiences in implementing the 1994 guidelines. In these meetings, investigators expressed a

number of lingering concerns, most notably whether it was realistic for the law to declare that cost is not a factor

in designing clinical studies. Participants also raised questions about inclusion of women of childbearing

potential, liability in clinical trials, and barriers to the recruitment of minority subjects. Other participants,

however, noted that their worst fears about the 1994 guidelines did not materialize, in part because NIH focused

on scientific considerations when developing its policy. They reported improved collaboration among institutions

and emphasized the continued need for better outreach and for sharing information about effective recruitment

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

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

results after participating in studies.

NIH s administrative procedures allow consideration of applications through a peer-review system. During initial

peer review, the Scientific Review Group (SRG) evaluates the proposed enrollment of each project involving

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

acceptable. An application may be judged to 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 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. 
3

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) and the most recent report available is for FY1998. Appendix A

contains Tables 1 to 8 that provide aggregate enrollment data for extramural and intramural research protocols

funded in FY1997 and FY1998. 

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 a 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.

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. 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:

% On August 2, 2000, an NIH Guide Notice was posted on the Internet and a link is available from a

new 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 approved on August 2, 2000 to

be 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
4

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 will be incorporated in the NIH solicitations for grant

applications and contract proposals [Program Announcements (PAs), Request for Applications

(RFAs), and Request for Proposals (RFPs)] stating the requirements for NIH-defined Phase III

clinical trials. This clarifies 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) are being

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 are being developed for the proper

documentation to include in summary statements to address adherence to these policies.

Following completion of the updated guidelines and instructions, training to ensure compliance with this policy

will be provided to NIH program and review officials, grants and contracts management staff and current and

prospective research investigators. This training will be through workshops for NIH staff as well as for the

extramural community, presentations at professional meetings and advisory committees, web-site didactic

instructions and on line question and answer fact sheets. Program Officials will 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 determine and document whether there is continuing compliance with these policy

requirements. 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 computerized information system, resulting in NIH undertaking the

development of a new electronic database for grant review, management and administration, which will include a

computerized system for standardizing and collecting inclusion data. NIH is currently developing and

implementing this system. It is anticipated that the launch of the new system, together with staff training, will

occur by the end of calendar year 2000.

These actions to document the requirement for inclusion, including valid analysis of sex/gender and/or

race/ethnicity differences in NIH-defined Phase III clinical trials, are being implemented to respond to

recommendations made in the May, 2000 GAO report. A new computer system for tracking inclusion data will

also facilitate consistency in data collection and appropriate training for staff who enter data will occur following

its development. 
5

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 (1994).

3. Women s Health: NIH Has Increased Its Efforts to Include Women in Research (GAO/HEHS-00-

96, May, 2000).
6

Appendix A

Aggregate Enrollment Data for Extramural and Intramural Research Protocols

Funded by NIH in Fiscal Year 1997 and Fiscal Year 1998
7

Table 1 (1997). Aggregate Enrollment Data for All Extramural Research Protocols 

Funded in FY1997

American Indians

and Alaska

Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic

Hispan ic White - Not

Hispan ic

Other and

Unknown

Total

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

Fema le 42,502 1.1% 577,432 15.4% 647,444 17.2% 290,735 7.7% 1,980,881 52.7% 220,332 5.9% 3,759,326 61.9%

Male 28,072 2.9% 292,246 12.9% 384,330 17.0% 195,618 8.7% 1,212,955 53.7% 144,418 6.4% 2,257,639 37.1%

Unknown 432 0.7% 1,185 1.9% 3,533 5.8% 3,945 6.5% 20,157 33.0% 31,882 52.2% 61,134 1.0%

Total 71,006 1.6% 870,863 14.3% 1,035,307 17.0% 490,298 8.1% 3,213,993 52.9% 396,632 6.5% 6,078,099 100.0%

Number of Protocols: 6,799

Table 2 (1998). Aggregate Enrollment Data for All Extramural Research Protocols 

Funded in FY1998

American Indians

and Alaska

Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic Hispan ic

White - Not

Hispan ic

Other and

Unknown Total

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

Fema le 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
8

Table 3 (1997). Aggregate Enrollment Data for Extramural Phase III Protocols 

Funded in FY1997

American Indians

and Alaska

Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic Hispan ic

White - Not

Hispan ic

Other and

Unknown Total

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

Fema le 2,902 1.3% 4,490 2.0% 26,402 11.6% 10,013 4.4% 181,603 79.5% 3,007 1.3% 228,417 74.8%

Male 2,127 2.9% 834 1.1% 16,256 21.9% 6,423 8.6% 47,829 64.3% 920 1.2% 74,389 24.3%

Unknown 1 0.0% 0 0.0% 147 5.4% 4 0.1% 102 3.8% 2,451 90.6% 2,705 0.9%

Total 5,030 1.6% 5,324 1.7% 42,805 14.0% 16,440 5.4% 229,534 75.1% 6,378 2.1% 305,511 100.0%

Number of Protocols : 320

Table 4 (1998). Aggregate Enrollment Data for Extramural Phase III Protocols 

Funded in FY1998

American Indians

and Alaska

Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic Hispan ic

White - Not

Hispan ic

Other and

Unknown Total

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

Fema le 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
9

Table 5 (1997). Aggregate Enrollment Data for Intramural Research Protocols 

Conducted at the Warren G. Magnuson Clinical Center Funded in FY1997

American Indians

and Alaska

Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic Hispan ic

White - Not

Hispan ic

Other and

Unknown Total

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

Fema le 8 0.1% 309 4.3% 887 12.4% 257 3.6% 5,578 78.2% 97 1.4% 7,136 49.6%

Male 13 0.2% 308 4.2% 699 9.6% 207 2.9% 5,954 82.1% 73 1.0% 7,254 50.4%

Unknown 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0%

Total 21 0.1% 617 4.3% 1,586 11.0% 464 3.2% 11,532 80.1% 170 1.2% 14,390 100.0%

Number of Protocols: 642

Table 6 (1998). Aggregate Enrollment Data for Intramural Research Protocols 

Conducted at the Warren G. Magnuson Clinical Center Funded in FY1998

American Indians

and Alaska

Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic Hispan ic

White - Not

Hispan ic

Other and

Unknown Total

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

Fema le 97 0.3% 1,181 3.4% 3,941 11.5% 1,152 3.4% 27,281 79.7% 593 1.7% 34,245 49.8%

Male 95 0.3% 1,242 3.6% 3,160 9.1% 955 2.8% 28,601 82.7% 515 1.5% 34,568 50.2%

Unknown 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0%

Total 192 0.3% 2,423 3.5% 7,101 10.3% 2,107 3.1% 55,882 81.2% 1,108 1.6% 68,813 100.0%

Number of Protocols: 1,093
10

Table 7 (1997). Aggregate Enrollment Data for Intramural Research Protocols 

Conducted Off-Site in FY 1997

American Indians

and Alaska Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic Hispan ic

White - Not

Hispan ic

Other and

Unknown Total

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

Fema le 1,579 0.33% 186,222 38.82% 29,354 6.12% 5,737 1.20% 248,139 51.73% 8,637 1.80% 479,668 48.64%

Male 1,508 0.33% 178,514 39.50% 15,343 3.39% 6,527 1.44% 239,614 53.01% 10,481 2.32% 451,987 45.84%

Unknown 11,843 21.76% 814 1.50% 14,628 26.87% 1,431 2.63% 481 0.88% 25,235 46.36% 54,432 5.52%

Total 14,930 1.51% 365,550 37.07% 59,325 6.02% 13,695 1.39% 488,234 49.51% 44,353 4.50% 986,087 100.00%

Number of Protocols: 161

Table 8 (1998). Aggregate Enrollment Data for Intramural Research Protocols 

Conducted Off-Site and Funded in FY1998

American Indians

and Alaska Natives

Asian an d Pacific

Islanders

Black - Not

Hispan ic

Hispan ic White - Not

Hispan ic

Other and Unknown Total

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

Fema le 8,194 1.1% 231,562 32.1% 37,547 5.2% 8,819 1.2% 413,164 57.3% 22,102 3.1% 721,388 50.9%

Male 7,333 1.3% 191,397 32.7% 30,460 5.2% 9,959 1.7% 332,807 56.9% 12,700 2.2% 584,656 41.2%

Unknown 12 0.0% 73 0.1% 339 0.3% 84 0.1% 104,844 93.4% 6,894 6.1% 112,246 7.9%

Total 15,539 1.1% 423,032 29.8% 68,346 4.8% 18,862 1.3% 850,815 60.0% 41,696 2.9% 1,418,290 100.0%

Number of Protocols: 243