IMPLEMENTATION OF THE

NIH GUIDELINES ON THE

INCLUSION OF

WOMEN AND MINORITIES

AS SUBJECTS IN

CLINICAL RESEARCH

Comprehensive Report

(Fiscal Year 1997 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

Angela Bates

Office of Research on Women’s Health

Larry Fanning

Office of Extramural Research

Systems Quality Assurance Interface Branch

Second Revision May 2000

Includes additional data tables from the May 2000 General Accounting Office Report
TABLE OF CONTENTS 

Implementation of the Revised NIH Guidelines on the Inclusion of Women

and Minorities as Subjects in Clinical Research

Table 1. Level of Compliance with Inclusion Policy in New Extramural Grant Applications

as Assessed During Scientific Peer Review for fiscal years 1994-1997

Table 2. Extramural Competing Awards that Required the Lifting of a

Bar-to-Funding for fiscal years 1994-1997

Table 3. Reasons Why Extramural Awards Required a Lifting of the

Bar-to-Funding for fiscal years 1994-1997 

Table 4A. Inclusion by Sex in All Research Studies Active in FY1994

Table 4B. Inclusion by Sex in All Research Studies Active in FY1995

Table 4C. Inclusion by Sex in All Research Studies Active in FY1996

Table 4D. Inclusion by Sex in All Research Studies Funded in FY1997*

Table 4D-1. Examples of Single Sex Extramural Research Studies

FY1997 Data

Table 97A. Aggregate enrollment data for all extramural research protocols 

funded in FY1997

Table 7B. Aggregate enrollment data for all extramural research protocols

funded in FY1997 (Distribution of Participants by Number)

Table 97C. Aggregate enrollment data for all extramural research protocols

funded in FY1997 (Distribution of Participants by Percentage)

Table 97D. Aggregate enrollment data for extramural Phase III protocols

funded in FY1997

Table 97E. Aggregate enrollment data for extramural Phase III protocols

funded in FY1997 (Distribution of Participants by Number)

Table 97F. Aggregate enrollment data for extramural Phase III protocols

funded in FY1997 (Distribution of Participants by Percentage)

Table 97G. Aggregate enrollment data for intramural research protocols

conducted at the Warren G. Magnuson Clinical Center in FY1997

Table 97H. Aggregate enrollment data for intramural research protocols

conducted at the Warren G. Magnuson Clinical Center

in FY1997 (Distribution of Participants by Number)
Table 97I. Aggregate enrollment data for intramural research protocols

conducted at the Warren G. Magnuson Clinical Center funded

in FY1997 (Distribution of Participants by Percentage)

Table 97J. Aggregate enrollment data for intramural research protocols

conducted off-site in FY1997

Table 97K. Aggregate enrollment data for intramural research protocols

conducted off-site in FY1997 (Distribution of Participants by Number)

Table 97L. Aggregate enrollment data for intramural research protocols

conducted off-site in FY1997 (Distribution of Participants by Percentage)

General Accounting Office (GAO) Report Data Tables

Table 1. Aggregate Enrollment for NIH Extramural and Intramural

Research for FY1997 (By Percentage)

Table 2. Aggregate Enrollment for NIH Extramural Research

Excluding Male-Only & Female-Only Protocols FY1997 (By Percentage)

Table 3. Aggregate Enrollment of Female Minorities in NIH

Extramural and Intramural Research FY1997 (By Percentage)

Appendices

Appendix A

Explanation of Gender/Minority Codes

Appendix B

1999 Tracking/Inclusion Committee
Implementation of the Revised NIH Policy on the Inclusion

of Women and Minorities as Subjects in Clinical Research

In 1994, the NIH revised its inclusion policy to meet the specific mandate of the NIH Revitalization Act of 1993

(PL 103-43) 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 Register in March

1994, and they became effective in September 1994 for proposals submitted after June 1, 1994.

Strategies to ensure that the implementation of the revised guidelines is 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 Institutes and Centers (IC). This trans-NIH committee meets on a regular basis,

focusing on consistent and widespread adherence to the NIH guidelines by all the institutes and centers. Working

in collaboration with the Office of Extramural Research, the Office of Intramural Research, and other components

of the NIH, the Office of Research on Women’s Health 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 volunteers in NIH-funded research.

To ensure universal adherence to the new inclusion guidelines, NIH conducted extensive training on the revised

inclusion guidelines for more than 1,000 NIH staff members with review, program, grants management, 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 findings by the U.S. General Accounting Office (GAO) that an earlier policy was inconsistently applied and

had not been well communicated or understood within the NIH or in the research community.

Recognizing the importance of both recruitment and retention of human subject volunteers, NIH issued an outreach

notebook 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 which was prepared in order 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.”
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. For example, 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.

The policy and procedures for meeting the new requirements have been fully implemented. Studies that do not meet

the standards are identified through the scientific review process. The level of compliance is high, and activities will

continue to ensure adherence to the revised guidelines.

NIH is now able to monitor demographic data for study populations on an NIH-wide basis through a computerized

tracking system. Analysis of data for which NIH-wide data are available (FY1997) show 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 FY1997, more than 93% of

applications involving human subjects met the inclusion requirement as submitted [Table 1].

Aggregate enrollment data for extramural Phase III clinical trials funded in FY1997 show that approximately 74.8%

of the subjects were women. Among minority subjects,1

 representation in Phase III clinical trials [Table 97D] was

highest for Black (not Hispanic) subjects (14%) and lowest for American Indians/Alaskan Natives subjects (1.6%).

 Asian/Pacific Islanders subjects were 1.7% of the extramural Phase III subjects; Hispanic subjects were 5.4%; and

White (not Hispanic) subjects were 75.1%. Over six million subjects were included in the research for which data

were collected in the tracking system from among all extramural research active in FY1997. This snapshot of

aggregate enrollment data for FY1997 extramural studies [Table 97A] shows that approximately 62% of the subjects

were women, approximately 37% were men, and approximately 1% were not identified by sex/gender. 

Substantial numbers of women and minorities were also included in NIH intramural protocols conducted at the

Warren G. Magnuson Clinical Center in FY1997 [Table 97G]. Data showed 49.6% of intramural subjects were

women and 50.4% were men. Among minority subjects, representation in intramural protocols conducted at the

Clinical Center was highest for Black (not Hispanic) subjects (11%) and lowest for American Indian/Alaskan native

subjects (0.1%). Asian/Pacific Islander subjects were 4.3% of the subjects in this intramural research; Hispanic

subjects were 3.2%; and White (not Hispanic) subjects were 80.1%. 

 

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

Directive No. 15.
When assessing inclusion data, enrollment figures should not be directly compared to the national census figures.

The goal of the NIH policy is not to satisfy any quotas for proportional representation, but rather to conduct

biomedical and behavioral research in such a manner that the scientific knowledge acquired will be generalizable

to the entire population of the United States. The numbers of women or minority subgroups included in a particular

study depends upon the scientific question addressed in the study and the prevalence among women and minority

subpopulations of the disease, disorder, or condition under investigation. Initial Review Groups are instructed to

focus on scientific considerations when assessing the planned enrollment for a particular study. 

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

in enrollment, to design studies to respond to those questions that allow for longitudinal examination of trends and

continued monitoring of compliance. An application that fails to meet the standards for inclusion receives an

unacceptable gender or minority code, which results in an administrative bar-to-funding (Appendix A). For most

of the awards that were initially barred, the applicants were able to remedy the deficiencies found during initial

review by providing additional information. In some instances, studies may have met the inclusion requirement but

the justification was not apparent to the reviewers. In such cases, it is each applicant's responsibility to submit a

complete research plan and to provide convincing justification before review.

NIH’s administrative procedures allow further consideration of such applications during the second level of review.

The program staff has the flexibility to work with an applicant and resolve problems within the time constraints of

the review-council cycle. In some cases, the program staff may find lack of inclusion in an individual study to be

justified if that same scientific question is addressed elsewhere for other populations so that, when viewed in their

entirety, the combined studies fulfill the inclusion requirement. Similar procedures are in place for projects funded

through contracts.

In compliance with the provisions of the NIH Revitalization Act, the Advisory Council of each IC has reviewed IC

procedures for implementation of NIH guidelines for the inclusion of women and minorities in clinical research. In

1999, Advisory Councils reported that all ICs were in compliance with the NIH Implementation Guidelines, which

included analysis of FY1997 data.

Reports from the Advisory Councils,2

 describing individual IC procedures for the implementation of the guidelines

and data on inclusion of women and minorities in human subject research included the following observations:

• Scientific Review Groups (SRGs) and scientific program staff were found to be diligent and rigorous

in implementing the policies and procedures for meeting the requirements of the NIH guidelines.

• Institute review, program, and grants management staff have attended the extensive training sessions

on the inclusion guidelines conducted by NIH. Institute staff, in turn, explain the requirements to

applicants, reviewers, and other members of the research community. 

• Health scientist administrators (program) review progress reports for funded grants to ensure continued

compliance as approved in the initial grant application. 

• Advisory Council members continue to be kept aware of the inclusion requirements. During Council

meetings, Advisory Council members are informed of concerns regarding the inclusion requirements

identified in the review of grant applications.

Inclusion of Women and Minorities in Clinical Research - Future Directions 

Future endeavors include efforts to expand the analysis of demographic data collected for clinical studies in order

to determine ongoing and changing trends in enrollment and assess their meaning. Target data for Phase III Clinical

Trials are being collected, and ways to assess this data in a meaningful manner are under discussion.

 

 2Copies of certifications are available in the Office of the Director, NIH and the Office of Research on

Women’s Health.
The issue of reporting foreign populations has made clear the occasional need to develop points of clarification

for tracking population data. More than two-thirds of the ICs that fund research involving foreign populations

reported them the same way they did U.S. populations, i.e., a breakdown by gender/ethnicity in the population

matrix found in the PHS 398 form. Of the remainder, some reported them as other/unknown, others used an

exception code, and still others are not funding studies with foreign subjects.

The Application for a PHS Grant (Form PHS 398) states, “The NIH policy is that women and members of minority

groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects

involving human subjects, unless a clear and compelling rationale shows that inclusion is inappropriate with respect

to the health of the subjects or the purpose of the research.” Therefore:

• Tracking foreign populations ensures compliance with the policy. 

• Tracking foreign populations provides unique opportunities to collect data on subpopulations where

knowledge gaps exist. In fact, subpopulations are the focus of many current foreign grants.

• Reporting foreign populations as other/unknown or excluding them could create the impression that NIH

is intentionally skewing data to hide non-compliance with the policy.

The NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research state:

For foreign awards, the NIH policy on inclusion of women in research conducted outside the U.S. is the same

as that for research conducted in the U.S.

However, with regard to the population of the foreign country, the definition of the minority groups may be

different than 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.

These issues were resolved with a decision to use a flag to identify foreign populations in the NIH Tracking System.

 This would provide flexibility in reporting aggregate data: domestic data alone, domestic and foreign data combined,

or foreign data alone.

When aggregate data includes foreign participants, it is now recommended that reports contain an asterisk and

footnote. The footnote should state that the data include subjects from foreign countries; therefore, it cannot be

determined with complete accuracy that demographic classifications on foreign participants correspond exactly with

minority classifications used for U.S. subjects.

ORWH and the NIH will also continue to meet new challenges related to the recruitment and retention of women

and minorities in clinical studies, particularly with regard to expanded community outreach and legal, ethical, and

social implications. Issues involving special populations of women will continue to receive attention. Finally,

ORWH will work with the ICs and broader scientific communities to determine how to better facilitate sex and

gender analysis of data from NIH supported research, as required by the NIH Revitalization Act of 1993, in published

reports of research outcomes.
Table 1. Level of Compliance with Inclusion Policy in New Extramural Grant A

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-9Total Number of ApplicationsReviewed (#) 12,886 14,027 424 12,832 12,028 12,125 846 11,760 12,0Number of Applications with HumanSubjects (#) 5,101 5,359 162 5,260 4,521 4,676 374 4,653 4,5Number (percent) of applicationsapproved by IRG as submitted (#) 4,707 4,986 157 4,914 4,218 4,385 360 4,359 4,2

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

Number (percent) of applications withunacceptable minority inclusion (#) 175 131 1 126 146 115 4 129 1

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

Number (percent) of applications withunacceptable sex/gender inclusion (#) 33 29 2 22 21 23 1 14 

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

Number (percent) of applications withboth unacceptable minority AND (#) 186 213 2 198 136 153 9 151 1

(%)

Total Number (percent) of applicationswith unacceptable minority inclusion (#) 361 344 3 324 282 268 13 280 2

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

Total Number (percent) of applicationswith unacceptable sex/gender inclusion (#) 219 242 4 220 157 176 10 165 1

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

Total number (percent) unacceptableapplications as submitted (#) 394 373 5 346 303 291 14 294 3

(%) 7.72% 6.96% 3.09% 6.58% 6.70% 6.22% 3.74% 6.32% 6.84
Table 2. Extramural Competing Awards that Required the Lifting of a Bar-To-F

Council Dates Jan-95 May-95 Aug-95 Oct-95 Jan-96 May-96 Aug-96 Oct-96 Jan-9Total number of awards (#) 3,476 3,902 129 3,344 3,548 3,759 228 3,378 3,8Number of awards involving human subjects (#) 1,287 1,421 51 1,263 1,260 1,352 92 1,254 1,3Number (percent) of awards involvinghuman subjects that met the inclusionrequirements as submitted (#) 1,224 1,330 50 1,189 1,178 1,277 89 1,198 1,3

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

Number (percent) of awards where minorityonly bar-to-funding was removed by programstaff (M_U) (#) 29 26 22 43 29 0 22 

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

Number (percent) of awards wheresex/gender only bar-to-funding was removedby program staff (G_U) (#) 3 6 3 3 3 0 3 

(%) 0.23% 0.42% 0.00% 0.24% 0.24% 0.22% 0.00% 0.24% 0.57

Number (percent) of awards where bothminority AND sex/gender bar-to-funding wasremoved by program staff (#) 31 59 1 49 36 43 3 31 

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

Total number (percent) of awards whereminority bar-to-funding was removed byprogram staff (#) 60 85 1 71 79 72 3 53 

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

Total number (percent) of awards wheresex/gender bar-to-funding was removed byprogram staff (#) 34 65 1 52 39 46 3 34 

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

Total number (percent) of awards where barto-funding was removed (#) 63 91 1 74 82 75 3 56 

(%) 4.90% 6.40% 1.96% 5.86% 6.51% 5.55% 3.26% 4.47% 6.38
Table 3. Reasons Why Extramural Awards Required a Lifting of the Bar-to-

Council Dates Jan-95 May-95 Aug-95 Oct-95 Jan-96 May-96 Aug-96 Oct-96 Jan-97 Additional information 37 75 1 43 50 49 2 30 43 Study design modification 3 1 0 4 5 3 0 7 8 Overall portfolio balance 0 0 0 1 2 0 0 2 4 Error in Initial Coding 2 2 0 7 7 1 0 5 2 Other: Existing cohort 0 0 0 2 1 0 0 1 2  Unidentified tissue specimens 3 5 1 0 0 5  Cadavers 1 0 0 0 1 0 0 0 0  Specified/Noted in Comments 1 0 1 1 0 0 0 0  Records Unavailable 7 4 1 0 4 1 1 5 Total Identified Reasons 50 83 1 62 72 58 3 46 69  *Difference in Totals 13 8 0 12 10 17 0 10 19 Total Bar-to-Funding includingFellowship Awards 63 91 1 74 82 75 3 56 88 * Information from NICHD pending.
Table 4A. Inclusion by Sex in All Research Studies

Active in FY1994

Extramural Studies Intramural Studies

Phase III

trials**

Other clinical

research*** (On Site)

Protocols reporting women only 96 192 121

Protocols reporting men only 14 96 130

Protocols reporting both women and men 334 1,566 492

Protocols involving men, women and

Unknown*** 92 80

Sex composition reported as Unknown 9 26

Protocols reporting men and Unknown 8 3

Protocols reporting women and Unknown 10 2

Early Stage studies where enrollment data

has not yet been collected 35 329 474

Data Not Available 8 92 0

Totals 606 2,386 1,217

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

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

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

comparing two or more existing treatments.

*** Human subject studies that are not Phase III clinical trials.

  Many studies may be generic.

Overall data is incomplete.
Table 4B. Inclusion by Sex in All Research Studies

Active in FY1995

Extramural Studies Intramural Studies

Phase III

trials** 

Other clinical

research*** (On Site)

Protocols reporting women only 89 582 121

Protocols reporting men only 14 241 113

Protocols reporting both women and men 350 3,248 470

Protocols involving men, women and

Unknown  105 310

Sex composition reported as Unknown 5 84

Protocols reporting men and Unknown 7 10

Protocols reporting women and Unknown 9 18

Early Stage studies where enrollment data

has not yet been collected 39 1,404 513

Data Not Available 12 335 0

Totals 630 6,232 1,217

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

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

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

comparing two or more existing treatments.

*** Human subject studies that are not Phase III clinical trials.

  Many studies may be generic.
Table 4C. Inclusion by Sex in All Research Studies

Active in FY1996

Extramural Studies Intramural Studies

Phase III

trials** 

Other clinical

research*** On-site

Protocols reporting women only 29 603 118

Protocols reporting men only 10 182 123

Protocols reporting both women and men 166 3,406 457

Protocols involving men, women and

Unknown  14 245

Sex composition reported as Unknown 0 72

Protocols reporting men and Unknown 0 5

Protocols reporting women and Unknown 1 12

Early Stage studies where enrollment data

has not yet been collected 58 1,307 393

Data Not Available 11 235 0

Totals 289 6,067 1,091

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

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

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

intervention or comparing two or more existing treatments.

*** Human subject studies that are not Phase III clinical trials.

**** Many studies may be generic.
Table 4D. Inclusion by Sex in All Research Studies

Funded in FY1997*

Extramural Studies Intramural Studies

Phase III

trials**

Other clinical

research*** On-site

Protocols reporting women only 45 689 98

Protocols reporting men only 7 232 92

Protocols reporting both women and men 181 3,606 450

Protocols involving men, women and

Unknown**** 8 209

Sex composition reported as Unknown 5 65

Protocols reporting men and Unknown 1 3

Protocols reporting women and Unknown 0 3

Early Stage studies where enrollment data

has not yet been collected 51 1,295 446

Data Not Available 18 264 0

Totals 316 6,366 1,086

*Note change in data collection for FY1997 to include research studies funded in FY97.

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

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

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

comparing two or more existing treatments.

*** Human subject studies that are not Phase III clinical trials.

**** Many studies may be generic.
Table 4D-1 Examples of Single Sex Extramural Research Studies

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

Nutritional and Hormonal Biomarkers in Prostate Cancer

Testosterone and Bone Mineral Density in Elderly Men

Bone Loss in Vertebral Fractures in Older Men

Head Injury & Alzheimer's Disease

Genetic Epidemiology of Alzheimer's Disease in Twins

Epidemiology of Male Infertility - Cryptorchidism

Medical Therapy for BPH - Data Coordinating Center

HIV Prevention Intervention for Young Men

Dietary Etiologies of Heart Disease and Cancer

Managing Uncertainty in Stage B Prostate Cancer

Comprehensive HBP Care for Young Urban Black Men

Follow-up Study of Neurological Risks in Amateur Boxers

Serum Albumin, Orthostatic Hypotension in Frail Old Men

GU Sites in Men

Psychophysiology of Visible and Invisible Trauma

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

Breast Cancer Surveillance in a Defined Population

Osteoporotic Fractures

Women's Health and Aging Study

Cesarean Section Reduction in Primigravid Patients

Diet, Activity and Adolescent Weight Changes

Alternative Interventions for Battered Women

Trial of Vitamin E, Beta-Carotene and Aspirin in Women

Genetic Epidemiology of Blood Lipids and Obesity

Endogenous Estrogen & Coronary Heart Disease in Women

Women's Health Initiative

Risk Factors for Cardiovascular Disease in Women

Cross Ethnic Nursing Study of Weight Management in Women

Women's Estrogen for Stroke Trial (West)

Detection of Presymptomatic Alzheimer's Disease by FMRI

Women's Estrogen for Stroke Trial

Diagnosis of Perinatal HIV Infection in Puerto Rico

Persistence or Transience of HPV Infection in Women

Urine Screening Test to Detect Bacteruiuria in Pregnancy

Women's Interagency HIV Study

Connective Tissue Role in Urinary Stress Incontinence

Infant Mortality in Rural Yunnan, China
Table 97A. Aggregate Enrollment Data for All Extramural Research Protoc

 Funded in FY1997

American Indians

and Alaska Natives

Asian and Pacific

Islanders Black - Not Hispanic Hispanic White - Not Hispanic

Other a

Unknow

# % # % # % #% # % # 

Female 42,502 1.1% 577,432 15.4% 647,444 17.2% 290,735 7.7% 1,980,881 52.7% 220,332 Male 28,072 2.9% 292,246 12.9% 384,330 17.0% 195,618 8.7% 1,212,955 53.7% 144,418 Unknown 432 0.7% 1,185 1.9% 3,533 5.8% 3,945 6.5% 20,157 33.0% 31,882 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 Number of Protocols: 6,799Comments:More females (3,759,326 or 61.9%) than males (2,257,326 or 37.1%) are enrolled in aggregate Extramural Research protocols.Largest identified racial group is White, non-Hispanic at 52.9%.Largest identified racial minority group is Black, non-Hispanic at 17%.Smallest identified racial minority group is American Indian/Alaskan Natives at 1.6%.
Aggregate Enrollment Data for Extramural Research Protocols

Funded in FY 1997

Table 97B. Distribution of Participants (Numbers)

American

Indians and

Alaska Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 42,502 577,432 647,444 290,735 1,980,881 220,332 3,759,326

Male 28,072 292,246 384,330 195,618 1,212,955 144,418 2,257,639

Unknown 432 1,185 3,533 3,945 20,157 31,882 61,134

Total 71,006 870,863 1,035,307 490,298 3,213,993 396,632 6,078,099

Table 97C. Distribution of Participants (Percentage)

American

Indians and

Alaska Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 1.1% 15.4% 17.2% 7.7% 52.7% 5.9% 61.9%

Male 1.2% 12.9% 17.0% 8.7% 53.7% 6.4% 37.1%

Unknown 0.7% 1.9% 5.8% 6.5% 33.0% 52.2% 1.0%

Total 1.2% 14.3% 17.0% 8.1% 52.9% 6.5% 100.0%
Table 97D. Aggregate Enrollment Data for Extramural Phase III Protocols

Funded in FY1997

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown 

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

Female 2,902 1.3% 4,490 2.0% 26,402 11.6% 10,013 4.4% 181,603 79.5% 3,007 1.3% Male 2,127 2.9% 834 1.1% 16,256 21.9% 6,423 8.6% 47,829 64.3% 920 1.2% Unknown 1 0.0% 0 0.0% 147 5.4% 4 0.1% 102 3.8% 2,451 90.6% 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% Number of Protocols : 320Comments:Substantial numbers of women and minorities were enrolled in Phase III research protocols funded in 1997.

There were more females (228,417 or 74.8%) than males (74,389 or 24.3%) enrolled in Phase III research protocols.Among minority subjects, the largest racial minority group is Black, non-Hispanic at 42,805 or 14.0%.Smallest identified racial group is American Indian/Alaska Natives at 5,030 or 1.6%.
Aggregate Enrollment Data for Extramural Phase III Protocols

Funded in FY1997

Table 97E. Distribution of Participants (Numbers)

American

Indians

and Alaska

Natives

Asian and

Pacific

Islander

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 2,902 4,490 26,402 10,013 181,603 3,007 228,417

Male 2,127 834 16,256 6,423 47,829 920 74,389

Unknown 1 0 147 4 102 2,451 2,705

Total 5,030 5,324 42,805 16,440 229,534 6,378 305,511

Table 97F. Distribution of Participants (Percentage)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 1.3% 2.0% 11.6% 4.4% 79.5% 1.3% 74.8%

Male 2.9% 1.1% 21.9% 8.6% 64.3% 1.2% 24.3%

Unknown 0.0% 0.0% 5.4% 0.1% 3.8% 90.6% 0.9%

Total 1.6% 1.7% 14.0% 5.4% 75.1% 2.1% 100.0%
Table 97G. Aggregate Enrollment Data for Intramural Research Protocols

Conducted at the Warren G. Magnuson Clinical Center

Funded in FY1997

American

Indians and

Alaska Natives

Asian and

Pacific Islanders Black - Not Hispanic Hispanic White - Not Hispanic Other and Unknown 

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

Female 8 0.1% 309 4.3% 887 12.4% 257 3.6% 5,578 78.2% 97 1.4% Male 13 0.2% 308 4.2% 699 9.6% 207 2.9% 5,954 82.1% 73 1.0% Unknown 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% 1Number of Protocols: 642Comments:Women and men have about equal participation in aggregate Intramural Research protocols.Largest identified racial group is White, Not-Hispanic at 11,532 or 80.1%.Largest identified racial minority group is Black, Not-Hispanic at 1,586 or 11.0%.Smallest identified racial minority group is American Indian/Alaska Native at 21 or 0.1%.Clinical Center is engaged in outreach to minority groups to encourage participation.
Aggregate Enrollment Data for Intramural Research Protocols Conducted

at the Warren G. Magnuson Clinical Center

Funded in FY1997

Table 97H. Distribution of Participants (Number)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 8 309 887 257 5,578 97 7,136

Male 13 308 699 207 5,954 73 7,254

Unknown 0 000000

Total 21 617 1,586 464 11,532 170 14,390

Table 97I. Distribution of Participants (Percentage)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 0.1% 4.3% 12.4% 3.6% 78.2% 1.4% 49.6%

Male 0.2% 4.2% 9.6% 2.9% 82.1% 1.0% 50.4%

Unknown 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%

Total 0.1% 4.3% 11.0% 3.2% 80.1% 1.2% 100.0%
Table 97J. Aggregate Enrollment Data for Intramural Research Protocol

Conducted Off-Site in FY 1997

American Indians

and Alaska

Natives

Asian and Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown 

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

Female 1,579 0.33% 186,222 38.82% 29,354 6.12% 5,737 1.20% 248,139 51.73% 8,637 1.8Male 1,508 0.33% 178,514 39.50% 15,343 3.39% 6,527 1.44% 239,614 53.01% 10,481 2.3Unknown 11,843 21.76% 814 1.50% 14,628 26.87% 1,431 2.63% 481 0.88% 25,235 46.3Total 14,930 1.51% 365,550 37.07% 59,325 6.02% 13,695 1.39% 488,234 49.51% 44,353 4.5Total Number of Protocols: 161Comments:More females (479,668 or 48.6%) than males (451,987 or 45.8%) in aggregate Intramural Research ProtocolsAmong the minority groups, the largest identified racial group is Asian/Pacific Islander at 365,550 or 37.1%.More males (10,481 or 2.32%) than females (8,637 or 1.80%) have not identified a racial group.Smallest identified racial group is Hispanic at 13,695 or 1.39%.
Aggregate Enrollment Data for Intramural Research Protocols

Conducted Off-Site in FY1997

Table 97K. Distribution of Participants (Number)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 1,579 186,222 29,354 5,737 248,139 8,637 479,668

Male 1,508 178,514 15,343 6,527 239,614 10,481 451,987

Unknown 11,843 814 14,628 1,431 481 25,235 54,432

Total 14,930 365,550 59,325 13,695 488,234 44,353 986,087

Table 97L. Distribution of Participants (Percentage)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black - Not

Hispanic Hispanic

White - Not

Hispanic

Other and

Unknown Total

Female 0.33% 38.82% 6.12% 1.20% 51.73% 1.80% 48.64%

Male 0.33% 39.50% 3.39% 1.44% 53.01% 2.32% 45.84%

Unknown 21.76% 1.50% 26.87% 2.63% 0.88% 46.36% 5.52%

Total 1.51% 37.07% 6.02% 1.39% 49.51% 4.50% 100.00%
Additional General Accounting Office (GAO) Report Tables

GAO Report Table 1

Aggregate Enrollment for

NIH Extramural and Intramural Research

FY1997 (By Percentage)

Gender Extramural Intramural

All

Phase III

Only On-site Off-Site

Female 61.9% 74.8% 49.6% 50.0%

Male 37.1% 24.3% 50.4% 39.9%

Unknown 1.0% 0.9% 0.0% 10.1%

GAO Report Table 2

Aggregate Enrollment for NIH Extramural Research

Excluding Male-Only & Female-only Protocols

FY 1997 (By Percentage)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black -

Not

Hispanic Hispanic

White -

Not

Hispanic

Other and

Unknown Total

Female 1.6% 9.6% 20.8% 10.5% 51.6% 5.9% 52.1%

Male 1.3% 12.5% 17.2% 8.9% 53.7% 6.4% 46.6%

Unknown 0.7% 1.9% 5.8% 6.5% 33.0% 52.2% 1.3%

GAO Report Table 3

Aggregate Enrollment of FEMALE MINORITIES

in NIH Extramural and Intramural Research 

FY 1997 (By Percentage)

American

Indians and

Alaska

Natives

Asian and

Pacific

Islanders

Black -

Not

Hispanic Hispanic

White -

Not

Hispanic

Other and

Unknown Total

All Extramural 1.1% 15.4% 17.2% 7.7% 52.7% 5.9% 61.9%

Phase III

Extramural 1.3% 2.0% 11.6% 4.4% 79.5% 1.3% 74.8%

On-Site

Intramural 0.1% 4.3% 12.4% 3.6% 78.2% 1.4% 49.6%

Off-Site

Intramural 0.2% 55.3% 3.8% 0.5% 38.4% 1.8% 50.0%

* Based on special request from the May 2000 GAO Report.
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-to-funding. If the bar is

removed, the “U” is converted to “R” to designate that change in status.
Appendix B

NIH Tracking and Inclusion Committee Members

IC Members

NCI Diane Bronzert, Jane Cassidy, Otis Brawley, Marilyn Gaston, Karen Bashir, George Alexander,

Marvin Kalt

NCRR Dolores Lee, Barbara Perrone, Louise Ramm, Jan Heffernan, Geoff Cheung

NEI Jack McLaughlin, Lore Ann McNicol

NHGRI Monique Mansoura

NHLBI Carl Roth, Sharry Palagi, Barbara Liu, Ralph Van Wey, Bill Wagner, Janita Coen

NIA Miriam Kelty, David Reiter

NIAAA Anne Phillips, Carmen Richardson, Nancy Brennan

NIAID Joan Kondratick, Diane Yerg, Lai Tan, Milton Hernandez, Susan Marshall

NIAMS Joanne Odenkirchen, Julia Freeman

NICHD Darlene Levenson, Douglas Shawver, Yvonne Maddox

NIDA Jack Manischewitz, Mark Sweiter

NIDCD Julie Gulya, Lynnette Hemsley, Beth Ansel, Susa Hamilton

NIDDK Walter Stolz, Beth Paterson

NIDCR Norman Braveman, Patricia Bryant

NIEHS Martha Barnes

NIGMS Alison Cole, Marcia Hahn

NIMH Mary Blehar, Sherman Ragland, Charles Havekost

NINDS Mary Graham, Constance Atwell, Mary Ellen Cheung, Mark Hallet

NINR Carole Hudgings, Robin Gruber

NLM Dwight Mowery, John Seachrist

FIC Kathleen Michels

CC Jerry King, Kai Lakeman

OIR Alan Sandler, Deloris Mills

ORWH Vivian Pinn, Virginia Hartmuller, Angela Bates