Department of Health and Human Services 

National Institutes of Health 

MONITORING ADHERENCE TO THE 

NIH POLICY ON THE INCLUSION 

OF WOMEN AND MINORITIES 

AS SUBJECTS IN CLINICAL RESEARCH 

 

Comprehensive Report: Tracking of Human Subjects Research 

As Reported in Fiscal Year 2003 and Fiscal Year 2004 

NIH Tracking/Inclusion Committee

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

Office of Research on Women’s Health

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

National Heart, Lung, and Blood Institute

Angela C. Bates, M.B.A.

Office of Research on Women’s Health

Carlos E. Caban, Ph.D.

Liaison, Office of Extramural Research

Kim Jarema

Liaison, Office of Intramural Research 

2005 

Table of Contents

PART I Comprehensive Report 

Page

Background Information and Current Activities 

Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities 1 

as Subjects in Clinical Research 

 Summary Report of NIH Inclusion Data Reported in FY2003 & FY2004 13-14 

Aggregate Data Tables 

 

NIH Wide Clinical Research Reported in FY2004, FY2003

Table 1. Overview of NIH Extramural and Intramural Clinical Research: Number of 15 

 Protocols and Enrollment by Sex, Reported In FY 2003 

Table 2. Overview of NIH Extramural and Intramural Clinical Research: Number of 16 

 Protocols and Enrollment by Sex, Reported In FY2004 

Table 3. Overview of NIH Extramural and Intramural Clinical Research: Number of Sex 17 

 Specific Protocols, and Domestic versus Foreign Protocols, Reported in FY 2003 

Table 4. Overview of NIH Extramural and Intramural Clinical Research: Number of Sex 18 

 Specific Protocols, and Domestic versus Foreign Protocols, Reported in FY2004 

Table 5. Overview of NIH Extramural and Intramural Clinical Research: Enrollment by Sex, 19 

 and Domestic versus Foreign Enrollment, Reported in FY 2003 

Table 6. Overview of NIH Extramural and Intramural Clinical Research: Enrollment by Sex, 20 

 and Domestic versus Foreign Enrollment, Reported in FY2004 

Table 7. Summary of NIH Extramural and Intramural Clinical Research Enrollment by 21 

 Race and Ethnicity, Reported in FY2003 & FY2004 

Table 8. Summary of NIH Extramural and Intramural Phase III Clinical Research 22 

 Enrollment by Race and Ethnicity, Reported in FY2003 & FY2004 

Table 9. Aggregate Enrollment Data for All Extramural Research Protocols 23 

 Reported in FY2003: Percent Analysis 

Table 10. Aggregate Enrollment Data for All Extramural Research Protocols 25 

 Reported in FY2004: Percent Analysis 

Table 11. Aggregate Enrollment Data for Extramural Phase III Research 27 

 Reported in FY2003: Percent Analysis 
Table 12. Aggregate Enrollment Data for Extramural Phase III Research Protocols 29 

Reported in FY2004: Percent Analysis 

Table 13. Aggregate Enrollment Data for Intramural Research Protocols 31 

Reported in FY2003: Percent Analysis 

Table 14. Aggregate Enrollment Data for Intramural Research Protocols 33 

Reported in FY2004: Percent Analysis 

Table 15. Aggregate Enrollment Data for Intramural Phase III Research Protocols 35 

Reported in FY2003: Percent Analysis 

Table 16. Aggregate Enrollment Data for Intramural Phase III Research Protocols 37 

Reported in FY2004: Percent Analysis 

Domestic and Foreign Clinical Research Reported in FY 2003 and 2004

Table 17. Domestic Enrollment: Aggregate Data, NIH Domestic Research Protocols 39 

Reported in FY2003: Percent Analysis 

Table 18. Domestic Enrollment: Aggregate Data for NIH Domestic Research Protocols 41 

Reported in FY2004: Percent Analysis 

Table 19. Foreign Enrollment: Aggregate Data, NIH Foreign Research Protocols 43 

Reported in FY2003: Percent Analysis 

Table 20. Foreign Enrollment: Aggregate Data, NIH Foreign Research Protocols 45 

Reported in FY2004: Percent Analysis 

Table 21. Summary Ethnicity Enrollment Report: No. of Hispanics or Latinos 47 

Reported in FY2003 & FY2004: Percent Analysis 

Appendices

Appendix A Explanation of Gender and Minority Codes .................................................................... 51 

 

Appendix B NIH Tracking and Inclusion Committee Members .......................................................... 53 

Appendix C Internet Homepage: Inclusion of Women and Minorities Policy Implementation ........... 59 

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

Subjects in Clinical Research - Amended, October, 2001................................................ 63 

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

Research............................................................................................................................ 79 

Appendix F NIH Inclusion Tables for Target and Enrollment Data .................................................... 92 

Appendix G Updates to Public Health Service Grant Application (PHS 398)...................................... 97 

Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research

Historical Background

The establishment and implementation of policies for the inclusion of women and minorities in clinical 

research funded by the National Institutes of Health (NIH) has its origins in the women=s health 

movement. Following the issuance of the report of the Public Health Service Task Force on Women=s 

Health in 1985, the NIH established a policy in 1986 for the inclusion of women in clinical research. This 

policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and 

Contracts in 1987. Later that year, minority and other scientists at the NIH recognized the need to address 

the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a policy

encouraging the inclusion of minorities in clinical studies was first published. 

In July 1989, an NIH Memorandum on Inclusion stated that research solicitations should encourage 

inclusion of women and minorities and require a rationale if excluded, and that executive secretaries of 

scientific review groups should ensure that responsiveness to policy would be addressed and indicated in 

summary statements. In 1990, the Congressional Caucus for Women=s Issues requested the U.S. General 

Accounting Office (GAO) to conduct an investigation into the implementation of the guidelines for the 

inclusion of women by NIH. This report, in Congressional testimony, indicated that the implementation 

of the policy for the inclusion of women was slow, not well communicated, that gender analysis was not 

implemented, and that the impact of this policy could not be determined. The GAO testimony also 

indicated that there were differences in the implementation of the policy recommending the inclusion of 

minorities, and that not all Institutes and Centers (ICs) factored adherence to these policies into the 

scientific merit review. 

In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made 

what had previously been policy into Public Law, through a section in the NIH Revitalization Act of 1993 

(PL 103-43)

1

, entitled Women and Minorities as Subjects in Clinical Research. In 1994, the NIH revised 

its inclusion policy to meet this mandate that women and minorities must be included in all of its clinical 

research studies. The Revitalization Act essentially reinforced the existing NIH policies, but with four 

major differences: 

# that NIH ensure that women and minorities and their subpopulations be included in all 

clinical research; 

# that women and minorities and their subpopulations be included in Phase III clinical trials 

in numbers adequate to allow for valid analyses of differences in intervention effect; 

# that cost is not allowed as an acceptable reason for excluding these groups; and, 

# that NIH initiate programs and support for outreach efforts to recruit and retain women 

and minorities and their subpopulations as participants in clinical studies 

Revised inclusion guidelines developed in response to this law were published in the Federal Register2

 in 

March 1994, and they became effective in September 1994. The result was that NIH could not and would 

not fund any grant, cooperative agreement or contract or support any intramural project to be conducted 

or funded in Fiscal Year 1995 and thereafter which did not comply with this policy. NIH=s administrative 

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

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

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

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

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

1 
inclusion of women or minorities; or 3) does not realistically address recruitment and retention. For NIHdefined Phase III clinical trials, the Scientific Review Group (SRG) also evaluates the description of plans 

to conduct analyses, as appropriate, to address differences in the intervention effect by sex/gender and/or 

racial/ethnic groups. Applications with unacceptable inclusion plans receive an unacceptable gender or 

minority code, resulting in a bar-to-funding. Such clinical research studies cannot be funded until NIH 

staff is assured of compliance from the investigators. This may involve changes related to study design. 

Sometimes applicants are able to remedy the deficiencies found during initial review by providing 

additional information about the intended enrollment demographics. Research awards covered by this 

policy require the grantee to report annually on enrollment of women and men, and on the race and 

ethnicity of research participants so that accrual can be monitored. Annual progress reports submitted by

the grantee contain information on research progress which includes research participant enrollment, 

retention, and when available, preliminary and/or final analyses including analyses by sex/gender and 

race/ethnicity.

Strategies to ensure uniform implementation of the revised guidelines across the NIH were developed 

through the establishment and deliberations of an NIH Tracking and Inclusion Committee made up of 

representatives of the directors of each of the ICs. This trans-NIH committee, convened by the Office of 

Research on Women=s Health (ORWH) and co-chaired with a senior IC official, meets on a regular basis, 

focusing on consistent and widespread adherence to the NIH guidelines by all the ICs. Working in 

collaboration with the Office of Extramural Research (OER), the Office of Intramural Research (OIR), 

and other components of the NIH, the ORWH coordinates the activity of developing and establishing data 

collection and reporting methodologies to ensure uniform standards and definitions in the reporting of 

data on women and minority participants in NIH-funded clinical research. 

To ensure NIH-wide adherence to the revised inclusion guidelines, in 1994 NIH conducted extensive 

training on the revised inclusion guidelines for more than 1,000 NIH staff members with review, program, 

grants management, and/or contract management responsibilities. Additionally, four publications were 

distributed to further reinforce adherence to the revised inclusion guidelines.(5-8) NIH staff, in turn, 

clarified the requirements to applicants, reviewers, and other members of the research community. NIH 

staff members, reviewers, and applicants received written guidance about the requirements that outlined, 

in great detail, the circumstances under which it may be acceptable to use study populations deficient in 

women or minority participants, pointing out that the justification must be compelling and the scientific 

objectives of the research must be maintained. Training was especially important light of 1990 GAO 

findings that an earlier policy was inconsistently applied and had not been well communicated or 

understood within the NIH or in the research community. 

A variety of outreach activities were initiated to explain the revised policy to the scientific research 

community and to clear up common misunderstandings about the new requirements. Recognizing the 

importance of both recruitment and retention of human subject volunteers, NIH issued several articles(9-10)

and an outreach notebook, entitled Outreach Notebook for the NIH Guidelines on Inclusion of Women 

and Minorities as Subjects in Clinical Research, that outlines elements of outreach processes, offers 

practical suggestions, and provides references to additional sources of information. The outreach 

notebook is available on the Office of Research on Women=s Health Website 

http://www4.od.nih.gov/orwh/outreach.pdf. It also includes the full text of the 1994 implementation 

guidelines as well as a questions and answers document to provide more detailed policy guidance and 

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

on ARecruitment and Retention of Women in Clinical Studies."

2 
In June 1994, the ORWH convened a meeting of Institutional Review Board (IRB) chairs to discuss their 

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

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

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

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

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

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

recruitment of minority subjects. Other participants, however, noted that their worst fears about the 1994

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

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

for better outreach and for sharing information about effective recruitment strategies. Many noted the 

importance of considering community concerns, particularly those of minority populations who may feel 

that they are not included in enough research studies or who do not receive research results after 

participating in studies. 

Continuing Implementation and Monitoring Activities: 2000 to the Present 

Following a Congressional request for an assessment of NIH=s progress in implementing the1994 

guidelines on including women in clinical research, the GAO issued another report in May, 2000, entitled 

Women=s Health - NIH Has Increased Its Efforts to Include Women in Research3

. It concluded that in the 

past decade, NIH has made significant progress in implementing a strengthened policy on including 

women in clinical research and highlighted several examples: 

# NIH issued guidelines to implement the 1993 NIH Revitalization Act and conducted 

extensive training for scientists and reviewers; 

# the review process for extramural research treats the inclusion of women and minorities 

as a matter of scientific merit, affecting a proposal=s eligibility for funding; 

# the intramural research program now implements the inclusion policy; 

# NIH maintains a centralized inclusion tracking data system which serves as a tool for 

monitoring the implementation of the inclusion policy; and 

# in fiscal year 1997, more that 62% of participants in NIH-funded clinical research studies 

were women; minority women were also well represented, however, the proportion of 

Hispanic women enrolled was below their proportion in the general population. 

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

following: 

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

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

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

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

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

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

training on the requirements and purpose of the system. 

3 
Immediately following the release of this report, an NIH Subcommittee Reviewing Inclusion Issues was 

formed, consisting of representatives from several ICs, ORWH, OER, and OIR, to reexamine NIH=s 

system for tracking data on the inclusion of women and minorities in clinical research, recommend any

necessary changes to improve its accuracy and performance, and reiterate the NIH policy. Several actions 

resulted to clarify the requirement for NIH-defined Phase III clinical trials to include women and minority

groups, if scientifically appropriate, and for analysis of sex/gender and/or racial/ethnic differences to be 

planned and conducted by investigators engaged in NIH-funded research. These included: 

# In October 2001, the NIH Policy and Guidelines on the Inclusion of Women and 

Minorities as Subjects in Clinical Research and Amended Notice to the Guide for 

Grants and Contracts were updated and posted on the Internet with links to the 

ORWH home page and NIH web page, Inclusion of Women and Minorities Policy 

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

These documents supercede the 1994 Federal Register notice 

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

notice in the NIH Guide to Grants and Contracts 

(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). These updated 

versions incorporate the definition of clinical research as reported in the 1997 Report of 

the NIH Director=s Panel on Clinical research and the Office of Management and Budget 

(OMB) Directive 15 racial and ethnic categories to be used when reporting population 

data. They also provide additional guidance on reporting analyses of sex/gender and 

racial/ethnic differences in intervention effects for NIH-defined Phase III clinical trials 

(See Appendix E). 

` The 1997 Report of the NIH Director=s Panel on Clinical research defined clinical 

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

subjects (or on material of human origin such as tissues, specimens and 

cognitive phenomena) for which an investigator (or colleague) directly 

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

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

Patient-oriented research includes: (a) mechanisms of human disease, (b) 

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

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

research and health services research 

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

` The 1997 Office of Management and Budget (OMB) Directive 15 minimum

standards for maintaining, collecting and reporting data on race and ethnicity

were incorporated into the updated Guide Notice for Grants and Contracts. The 

primary differences from the previous categories were: (1) the Hispanic 

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

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

Pacific Islander population data; and 3) respondents are given the option of 

selecting more than one race. (See Appendix E) 

4 
` An NIH Guide Notice was posted on the Internet with a link to the web page, 

Inclusion of Women and Minorities Policy Implementation at: 

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

that NIH-defined Phase III clinical trials must be designed and conducted in a 

manner sufficient to allow for a valid analysis of whether the variables being studied 

affect women or members of minority groups differently than other subjects. 

# A new term and condition of award statement was developed and applied to awards made 

after October 1, 2000 that have NIH-defined Phase III clinical trials. This statement 

indicates that a description of plans to conduct analyses, as appropriate, by sex/gender 

and/or racial/ethnic groups must be included in clinical trial protocols and the results of 

subset analyses must be reported to NIH in Progress Reports, Competitive Renewal 

Applications (or Contract Renewals/Extensions) and in the required Final Progress 

Report. 

# Effective October 1, 2000, language was incorporated in the NIH solicitations for grant 

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

Applications (RFAs), and Request for Proposals (RFPs)] that stated the requirements for 

NIH-defined Phase III clinical trials clarifying the requirements that: a) all applications or 

proposals and/or protocols must provide a description of plans to conduct analyses, as 

appropriate, to address differences by sex/gender and/or racial/ethnic groups, including 

subgroups if applicable, and b) all investigators must report accrual, and conduct and 

report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 

# In April 2001, guidelines and instructions for reviewers and Scientific Review 

Administrators (SRAs) were developed to emphasize and clarify the need to review 

research proposals that are classified as NIH-defined Phase III clinical trials for both 

inclusion requirements and issues related to analyses by sex/gender and/or race/ethnicity. 

Instructions were developed for the proper documentation to include in summary

statements to address adherence to these policies. 

# 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. 

Several training initiatives were implemented: 

 As part of an NIH Symposium: Human Subjects Update, the revised policy on

inclusion of women and minorities and the revised NIH Instructions to Reviewers 

Guidelines for Evaluating the Inclusion of Women and Minorities as Subjects in 

Clinical Research were used as the basis for a required training session for NIH 

staff. The revised 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.ht

m. 

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

Animals was held in December, 2000 where several hundred additional 

extramural and intramural researchers were trained. Additional training materials 

addressing the inclusion of human subjects can be found at the following web 

address: 

5 
http://odoerdb2.od.nih.gov/oer/training/esa/grants_policy_update/esa_grants_poli

cy_update.htm.

 Additional training sessions were held for all NIH program and grants 

management staff 

# The PHS 398 Grant Application was significantly revised to provide additional 

instructions about the Women and Minorities Inclusion Policy and the revised form will 

be mandatory beginning May 10, 2005. 

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

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

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

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

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

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

# Reviewers are instructed about the policy through instructions provided with review 

materials as well as by orientation from the Scientific Review Administrator at the 

beginning of each SRG meeting. Additionally, a training session, “Inclusion of Children, 

Women, and Minorities: What SRA’s and Reviewers Need to Know!” was held for the 

Center for Scientific Review and highlighted the requirements and issues for scientific 

review staff. 

# The Clinical Center now has available a web-based educational module for the 

comprehensive training programs for intramural and other research investigators. All 

principal investigators are required to complete the Clinical Research Training Course 

for Intramural Investigators or equivalent prior to implementing a protocol and 

consideration is being given to making this a requirement for all investigators. 

# In 2003, the ORWH sponsored a workshop entitled, “Science Meets Reality: Recruitment 

and Retention of Women in Clinical Studies, and the Critical Role of Relevance.” This 

workshop discussed lessons learned, continuing challenges and emerging ethical and 

policy issues concerning the recruitment and retention of women and other participants in 

clinical studies over the past decade. 

The Office of Extramural Research (OER) has made available existing training materials on the 

Population tracking system website on the NIH Intranet. Information include: the training workbook, 

“Sex/Gender and Minority Inclusion in Clinical Research”, a series of quick tips and case examples as

well as the Help section of the Population Tracking module itself. A training subcommittee of the full 

NIH Tracking and Inclusion committee has been established to develop new training documents and 

methods of training for NIH staff and the extramural research community. 

Major changes have been made to the Population tracking system to help NIH staff in monitoring 

compliance with the NIH Inclusion policy. For example, the Population Tracking Grant Snapshot report 

was revised to provide easy access for NIH staff to the population data. Additionally, several Population 

Inclusion reports were added to the NIH Query View Report (QVR) system, thus providing broader 

access to the data. As well, user roles were revised and expanded to all the Division of Extramural 

Activities Support (DEAS) staff to assist in the data entry functions. 

6 
Communication and Outreach Efforts to the Scientific Community 

In addition to training NIH staff on the updated guidelines for monitoring the inclusion of women and 

minorities in clinical research and the purpose of the new tracking system, NIH staff is providing outreach 

to the scientific community to help increase understanding of the revised inclusion policy and OMB 

requirements. These include: 

# The slide show for “Sex/Gender and Minority Inclusion in NIH Clinical Research: What 

Investigators Need to Know!” was made available to Institute and Center staff to assist 

them in working with the extramural community. This information was also presented at 

regional meetings attended by extramural scientists and administrators, faculty and 

students. 

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

Subjects in Clinical Research was published in the fall of 2002 and is available to the 

research community and NIH staff. This publication discusses the elements of 

recruitment and retention, the NIH inclusion policy, 1997 OMB requirements for 

reporting race and ethnicity data, as well as information for application submission, peer 

review, and funding. The publication is posted on the ORWH website 

http://www4.od.nih.gov/orwh as well as on the NIH website for the inclusion of women 

and minorities policy implementation at: 

http://grants1.nih.gov/grants/funding/women_min/women_min.htm .

# In addition, the Frequently Asked Questions (FAQs) for the Inclusion , Recruitment and 

Retention of Women and Minority Subjects in Clinical Research complements the 

Outreach Notebook and provides additional guidance to researchers and NIH staff in a 

user friendly format. The FAQs is posted on the ORWH website 

http://www4.od.nih.gov/orwh as well as on the NIH website for the inclusion of women 

and minorities policy implementation at: 

http://grants1.nih.gov/grants/funding/women_min/women_min.htm. 

These training and outreach efforts are designed to improve understanding of the sex/gender and minority

inclusion policy and assist investigators and NIH staff to appropriately address these issues throughout 

the research grant and contract process. Investigators are instructed to address women and minority

inclusion issues in the development of their applications and proposals for clinical research. 

Monitoring Compliance: Extramural and Intramural Population Data Analysis 

When assessing inclusion data, enrollment figures should not be directly compared to the national 

census figures. The goal of the NIH policy is not to satisfy any quotas for proportional representation, 

but rather to conduct biomedical and behavioral research in such a manner that the scientific knowledge 

acquired will be generalizable to the entire population of the United States. The numbers of women or 

minority subgroups included in a particular study depends upon the scientific question addressed in the 

study and the prevalence among women and minority subpopulations of the disease, disorder, or 

condition under investigation. Initial Review Groups are instructed to focus on scientific considerations 

when assessing the planned enrollment for a particular study. 

NIH has monitored aggregate demographic data for study populations through the existing NIH 

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

in clinical studies has been implemented in all ICs. The NIH Tracking and Inclusion Committee 

7 
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. In May 2002, the NIH successfully deployed a new population 

tracking system for monitoring the inclusion of women and minorities in clinical research. This system

provides easier data entry and project monitoring for NIH staff, creates clear and timely NIH reports on 

inclusion data, incorporates the 1997 OMB Office of Management and Budget (OMB) standards for the 

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

398 and PHS Form 2590 (revised May, 2001). Following the implementation of the population tracking 

module, an eRA Population Tracking User Group consisting of representatives from several ICs, was 

formed to evaluate the system, recommend improvements and modifications, and provide continuous 

feedback related to system use. The re-engineered population tracking system continues to be refined 

based on input from the NIH user community. 

# NIH has published an on-line users guide and began offering 2-hour Population Tracking 

System demonstrations as well as in-depth, hands-on training sessions on the use of the 

population tracking system. 

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

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

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

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

reporting requirements adhered to by the extramural community and outlined in the NIH Implementation 

Guidelines on the Inclusion of Women and Minority Subjects in Research Studies. The Clinical Center 

Medical Executive Committee (MEC) has taken a leading role in assuring that investigators conducting 

clinical research protocols in the Clinical Center are trained and competent in the conduct of clinical 

research. To this end, the MEC designed and endorsed the Standards for Clinical Research within the 

NIH Intramural Research Program. This set of standards, endorsed by the Clinical Center's Board of 

Governors and the NIH Institute Directors, sets forth guidelines for the infrastructure, training, education, 

and monitoring required for safe and effective conduct of clinical research. The Clinical Center is also 

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

Format Changes for Reporting Race and Ethnicity Data Beginning in FY 2002

The 1997 Office of Management and Budget (OMB) Directive 15 minimum standards for maintaining,

collecting and reporting data on race and ethnicity directs changes in how data are reported to NIH. The 

FY 2003 and FY 2004 tables describe data using both the 1977 and 1997 OMB standards for reporting 

data on race and ethnicity. Implementation of the 1997 OMB standards involved a number of changes 

including collecting and reporting information on race and ethnicity separately (Hispanic/Latinos are 

considered an ethnicity and reported separately from racial data); using the new definitions and categories 

for ethnicity and race (a separate racial category for Asian population data and Hawaiian/Pacific Islander 

data); and allowing respondents the option of selection more than one race or only one race. 

The 1997 OMB reporting format does not allow aggregation of ethnic and racial data with similar data 

collected under the 1977 OMB standards because the categories and methods for collecting the data are 

fundamentally different. Changes in the standardization of definitions and business rules across the NIH 

for improving the data entered in the population tracking system are reflected in data reported beginning

in FY2002. This transition period makes comparisons with prior FY 2002 data difficult. However, 

implementation of these changes will improve the consistency and comparability for future reporting. 

8 
Conclusion and Current Status 

NIH staff continue to monitor, document, and work with grantees and contractors to ensure compliance 

with the inclusion policy. Program Officials provide technical assistance to investigators as they develop 

their applications and proposal throughout the application process. Review Officials introduce and discuss 

with reviewers the Guidelines/Instructions for reviewing the Inclusion of Women and Minorities in 

Clinical Research as well as the instructions and requirements for designing Phase III Clinical Trials in 

order that valid analyses can be conducted for sex/gender and ethnic/racial differences. At the time of 

award and submission of progress reports, program officials monitor and verify that inclusion policy

requirements are met. When new and competing continuation applications that are selected for payment 

are deficient in meeting policy requirements, grants management staff and program officials will withhold

funding until the principal investigator has satisfactorily addressed the policy requirements. 

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

Reports Certifying Compliance with Inclusion Guidelines, Spring 2005,” provides statements from the 

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

with the NIH overall inclusion policies. 

Finally, the dedication and tireless commitment of the IC representatives to the NIH

Tracking and Inclusion Committee must be acknowledged with appreciation for their

efforts.

VWP

9 
References

1. Public Law 103-43. National Institutes of Health Revitalization Act of 1993. 42 USC 289 

(a)(1). 

2. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical 

Research, 59 Fed. Reg. 14508-14513 (1994). 

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

(GAO/HEHS-00-96, May, 2000). 

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

Clinical Research, NIH Guide for Grants and Contracts, Amended 2001. 

5. Hayunga, E.G.,Costello, M. D. Pinn, V. W., ADemographics of Study Populations@,

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

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

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

7. Hayunga, E. G. and Pinn V. W., ANIH Response to Researchers= Concerns@, Applied 

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

8. LaRosa, J. H., Seto, B., Caban, C. E., Hayunga, E. G., AIncluding Women and Minorities 

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

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

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

10. Pinn, V. W., AThe Role of the NIH=s Office of Research on Women=s Health@, Academic 

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

11. Gallin, J, (2002). Principles and Practices of Clinical Research: Chapter 11 NIH Policy 

on the Inclusion of Women and Minorities as Subjects of Clinical Research, Academic 

Press, San Diego, California, pp 146-157. 

For Additional Information on the implementation of the inclusion policy, please visit: 

1. NIH Office of Extramural Research Inclusion of Women and Minorities Policy Implementation Website: 

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

2. Revitalization Act of 1993, 42 USC 289 (a)(1):

http://grants.nih.gov/grants/guide/notice-files/not94-100.html

3. NIH Policy on Reporting Racial and Ethnicity Data: Subjects in Clinical Research, NIH Guide for Grants 

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

4. Office of Research on Women=s Health Website: http://www4.od.nih.gov/orwh/fy97-98trkg.pdf

10 
Aggregate Enrollment Data Tables 

For Extramural and Intramural 

Research Protocols 

Fiscal Years 2003 & 2004 

11
12
Summary Report of NIH Inclusion Data

NIH Aggregate Extramural and Intramural Population Data Reported in FY 2003 and FY 2004 

Tables 1 to 29 provide aggregate enrollment data for extramural and intramural research protocols funded 

in FY 2003 and FY 2004. Previous inclusion reports and aggregate enrollment figures for women, men 

and minority groups for FY 1994 to the present can be found on the ORWH website at 

http://od.nih.gov/orwh/inclusion.html. For this Biennial Report, the FY 2003 and FY2004 data tables 

have been reformatted and some tables may vary slightly from prior reported summary data. Some 

additional data has been presented. 

Analysis of the FY 2003 and FY 2004 inclusion data show that substantial numbers of women, nonminority men, and minorities have been included as research subjects in Phase III clinical trials and other 

human subject research studies, in both intramural and extramural programs. 

EXTRAMURAL RESEARCH: Fiscal Years 2003 and 2004

In FY 2003, over 12 million participants were reported for all extramural clinical research, including 

Phase III clinical trials and other clinical studies. A snapshot of the aggregate enrollment data shows that 

approximately 60% were women, 39.9% were men, and 0.9% did not identify a sex/gender. (Table 9) 

Correspondingly, in FY 2004, over 16 million participants were reported for all extramural clinical 

research, including Phase III clinical trials and other clinical studies, an increase of about 4 million 

participants. Of the 16 million participants, approximately 58.6% were women, 39.8% were men, and 

1.6% did not provide sex identification. (Table 11) While the number of participants in clinical research

significantly increased, there was no substantial percentage change in the ratio of women and men. 

However, when sex-specific studies were excluded the proportions of women and men in all clinical 

research were proportional to the percentages of the general population. (See Tables 10 & 12)

Aggregate enrollment data reported in FY 2003 for extramural Phase III trials show that approximately

55.4% of the participants were women. Of the 635 extramural Phase III research protocols that continue 

to report following the 1977 OMB standards, minority representation was highest for Blacks (not 

Hispanic) at 11.6% and lowest for American Indian/Alaska Natives at 0.4%. Hispanics comprised 

approximately 6.7%, Asian/Pacific Islanders 1.83% and Whites (not Hispanic) 77.2% of the participants. 

The categories Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 

OMB standards and therefore, no data were reported in these categories. (Table 13) 

In FY 2003 there were 196 extramural Phase III research protocols reporting data following the current 

1997 OMB standards for reporting race and ethnicity. Accordingly, minority representation by race was 

highest for Blacks at 28.3% and lowest for Hawaiian/Pacific Islanders at 0.2%. Asians represented 2.71%, 

American Indian/Alaska Natives 0.53% and White 57.1%. 1.04% of the participants identified More Than 

One Race for their racial category. Of the 196 extramural Phase III research protocols designating an 

ethnicity in FY 2003, 77.5% identified a racial category and an ethnicity of not Hispanic. Whereas, 9.71% 

identified a racial category and an ethnic category of Hispanic/Latino. 13.7% of participants identified a 

racial category but did not report an ethnicity. (Table 13) 

Aggregate enrollment data for extramural Phase III trials reported in FY 2004 show that approximately

55.9% were women. Of the 273 extramural Phase III research protocols that continue to report following 

the 1977 OMB standards, minority representation was highest for Blacks (not Hispanic) at 12.9% and 

lowest for American Indian/Alaska Natives at 0.4%. Hispanics represented approximately 7%, 

Asian/Pacific Islanders were 1.9% and Whites (not Hispanic) 76% of the participants. The categories 

13
Hawaiian/Pacific Islander and More Than One Race were not designations with the 1977 OMB standards 

and therefore, no data were reported in these categories. (Table 15) 

In FY 2004, there were 266 extramural Phase III research protocols reporting data following the current 

1997 OMB standards for reporting race and ethnicity. Accordingly, minority representation by race was 

highest for Blacks at 24.3% and lowest for Hawaiian/Pacific Islanders 0.3%. Asians represented 2.46%, 

American Indian/Alaska Natives 0.8% and Whites 66.5% of participants. Participants identifying as More 

Than One Race were 2.6% of the total number of participants. Of the 266 extramural Phase III research 

protocols designating an ethnicity in FY 2004, 86.4% identified a racial category and an ethnicity of not 

Hispanic. Whereas, 8.5% identified a racial category and an ethnic category of Hispanic/Latino. 5% of 

participants identified a racial category but did not report an ethnicity. (Table 15) 

INTRAMURAL RESEARCH: Fiscal Years 2003 and 2004

Substantial numbers of women and minorities were included in NIH intramural studies in FY 2003 and 

FY2004. In FY 2003, approximately 1.8 million participants were reported in all intramural research 

including Phase III clinical trials, and other clinical studies. Approximately 47.5% were women, 51.7% 

were men and 0.8% did not identify their sex. Of the 951 intramural research protocols that continue to 

report data following the 1977 OMB standards, minority representation was highest for Asian/Pacific 

Islanders at 10.5% and lowest for American Indian/Alaska Natives at 1%. Blacks (not Hispanic) 

represented approximately 5.6%; Hispanics 3.2%; and Whites (not Hispanic) 72.6% of the intramural 

research study population. The categories Hawaiian/Pacific Islander and More Than One Race were not 

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

(Table 17) 

For all intramural clinical research studies that reported data following the current 1997 OMB standards 

in FY 2003, the largest racial minority group was Blacks at 17.3% and the smallest racial minority group 

was Hawaiian/Pacific Islanders at .03%. Asians represented 5.8%, American Indian/Alaska Natives 0.4% 

and Whites 70.5% of participants in all intramural clinical research. Approximately 0.2% of participants 

reported More Than One Race as their racial category. Of the 156 intramural research protocols reporting 

data following the current 1997 OMB standards and designating an ethnicity in FY 2003, 92.8%

identified a racial category and an ethnicity of not Hispanic. Whereas, 5.3% identified a racial category

and an ethnic category of Hispanic/Latino and 1.9% of participants identified a racial category but did not 

report an ethnicity. (Table 17) 

In FY 2004, approximately 1.9 million participants were reported in all intramural research including 

Phase III clinical trials, and other clinical studies. Of the 951 intramural research protocols that continue 

to report data following the 1977 OMB standards, minority representation was highest for Asian/Pacific 

Islanders at 10.5% and lowest for American Indian/Alaska Natives at 0.9%. Blacks (not-Hispanic) 

represented 5.6%, Hispanics 4%; and Whites (not Hispanic) 72% of the intramural research study

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

with the 1977 OMB standards and therefore, no data were reported in these categories. (Table 19) 

For all intramural clinical research studies that reported data following the current 1997 OMB standards 

in FY 2004, the largest racial minority group was Blacks at 9.14% and the smallest racial minority group 

was Hawaiian/Pacific Islanders at .01%. Asians represented 4.2%, American Indian/Alaska Natives 1.1% 

and Whites 78.7% of participants in all intramural clinical research. Approximately 0.2% of participants 

reported More Than One Race as their racial category. Of the 440 intramural research protocols following 

the current 1997 OMB standards designating an ethnicity in FY 2004, 95.7% identified a racial category

and an ethnicity of not Hispanic. Whereas, 2.8% identified a racial category and an ethnic category of 

Hispanic/Latino and 1.5% of participants identified a racial category but did not report an ethnicity.

(Table 19) 

14
Table 1. Overview of NIH Extramural and Intramural Clinical Research: 

 Number of Protocols and Enrollment by Sex, Reported In FY 2003 

Protocols Reported** 

Clinical Studies 

 (Not NIH Defined 

Phase III) 

NIH Defined 

Phase III Clinical 

Trials* 

Total All 

Clinical 

Studies 

Protocols with Enrollment 9,352 864 10,216

% 71.6% 88.4% 72.8%

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted 3,712 113 3,825

 28.4% 11.6% 27.2%

Total Number of Protocols 13,064 977 14,041

% 100.0% 100.0% 100.0%

 

Enrollment Reported 

Clinical Studies 

 (Not NIH Defined 

Phase III) 

NIH Defined 

Phase III Clinical 

Trials 

Total All 

Clinical 

Studies 

Females Enrolled 8,220,593 293,888 8,514,481

% 57.7% 55.1% 57.6%

Males Enrolled 5,883,897 237,599 6,121,496

% 41.3% 44.5% 41.4%

Sex of Subjects is Unknown 134,285 1,992 136,277

% 0.9% 0.4% 0.9%

Total Subjects Enrolled 14,238,775 533,479 14,772,254

% 100.0% 100.0% 100.0%

An NIH-defined Phase III 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 controlled 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. 

Source: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, October

2001.

15
Table 2. Overview of NIH Extramural and Intramural Clinical Research: 

 Number of Protocols and Enrollment by Sex, Reported In FY 2004 

Protocols Reported 

Clinical Studies 

(Not NIH Defined 

Phase III) 

NIH Defined 

Phase III 

Clinical Trials*

Total All 

Clinical 

Studies 

Protocols with Enrollment 9,549 576 10,125

% 69.1% 83.2% 69.8%

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted 4,271 116 4,387

 30.9% 16.8% 30.2%

Total Number of Protocols 13,820 692 14,512

% 100.0% 100.0% 100.0%

Enrollment Reported 

Clinical Studies 

(Not NIH Defined 

Phase III) 

NIH Defined 

Phase III 

Clinical Trials 

Total All 

Clinical 

Studies 

Females Enrolled 10,602,296 286,801 10,889,097

% 57.6% 55.5% 57.5%

Males Enrolled 7,513,411 228,481 7,741,892

% 40.8% 44.2% 40.9%

Sex of Subjects is Unknown 291,853 1,078 292,931

% 1.6% 0.2% 1.5%

Total Subjects Enrolled 18,407,560 516,360 18,923,920

% 100.0% 100.0% 100.0%

An NIH-defined Phase III 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 controlled 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. 

Source: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, October 2001. 

16
Table 3. Overview of NIH Extramural and Intramural Clinical Research: Number of Sex Specific 

 Protocols, and Domestic versus Foreign Protocols, Reported in FY2003 

Protocols Tracked 

Clinical Studies

(Not NIH Defined

Phase III) 

NIH Defined

Phase III 

Clinical Trials* 

Total All 

Clinical 

Studies 

Protocols reporting women only 1,215 189 1,404

% 9.3% 19.3% 10.0%

Protocols reporting men only 530 84 614

% 4.1% 8.6% 4.4%

Other Protocols with Enrollment (excluding 

women only and men only protocols) 7,607 591 8,198

% 58.2% 60.5% 58.4%

Protocols with zero enrollment. Enrollment data 

has not yet been submitted. 3,712 113 3,825

% 28.4% 11.6% 27.2%

Total Number of Protocols 13,064 977 14,041

% 100.0% 100.0% 100.0%

Domestic and Foreign Protocols Tracked 

Domestic Protocols with Enrollment 8,922 656 9,578

% 68.3% 67.1% 68.2%

Domestic Protocols with Zero Enrollment 3,532 106 3,638

% 27.0% 10.8% 25.9%

 Subtotal: Total Domestic Protocols 12,454 762 13,216

% 95.3% 78.0% 94.1%

Foreign Protocols with Enrollment 430 208 638

% 3.3% 21.3% 4.5%

Foreign Protocols with Zero Enrollment. 180 7 187

% 1.4% 0.7% 1.3%

 Subtotal: Total Foreign Protocols 610 215 825

% 4.7% 22.0% 5.9%

Total Number of All Protocols Tracked** 13,064 977 14,041

% 100.0% 100.0% 100.0%

* An NIH-defined Phase III 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 controlled 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. 

Source: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, October 2001. 

* *Enrollment for Domestic and Foreign sites are reported as separate protocols. Totals are not corrected for 37studies

that have both Domestic and Foreign enrollment sites/protocols. 

17
Table 4. Overview of NIH Extramural and Intramural Clinical Research: Number of Sex Specific 

 Protocols, and Domestic versus Foreign Protocols, Reported in FY2004 

Protocols Tracked 

Clinical Studies 

(Not NIH Defined 

Phase III) 

NIH Defined 

Phase III 

Clinical Trials* 

Total All 

Clinical 

Studies 

Protocols reporting women only 1,323 147 1,470

% 9.6% 21.2% 10.1%

Protocols reporting men only 477 34 511

% 3.5% 4.9% 3.5%

Other Protocols with Enrollment (excluding 

women only and men only protocols) 7,749 395 8,144

% 56.1% 57.1% 56.1%

Protocols with zero enrollment. Enrollment data 

has not yet been submitted. 4,271 116 4,387

% 30.9% 16.8% 30.2%

Total Number of Protocols 13,820 692 14,512

% 100.0% 100.0% 100.0%

Domestic and Foreign Protocols Tracked 

Domestic Protocols with Enrollment 9,207 553 9,760

% 66.6% 79.9% 67.3%

Domestic Protocols with Zero Enrollment 4,090 102 4,192

% 29.6% 14.7% 28.9%

 Subtotal: Total Domestic Protocols 13,297 655 13,952

% 96.2% 94.7% 96.1%

Foreign Protocols with Enrollment 342 23 365

% 2.5% 3.3% 2.5%

Foreign Protocols with Zero Enrollment. 181 14 195

% 1.3% 2.0% 1.3%

 Subtotal: Total Foreign Protocols 523 37 560

% 3.8% 5.3% 3.9%

Total Number of All Protocols Tracked** 13,820 692 14,512

% 100.0% 100.0% 100.0%

An NIH-defined Phase III 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 controlled 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. 

Source: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, October 2001.

* *Enrollment for Domestic and Foreign sites are reported as separate protocols. Totals are not corrected 

for 55 studies that have both Domestic and Foreign enrollment sites/protocols. 

18
Table 5. Overview of NIH Extramural and Intramural Clinical Research: 

 Enrollment by Sex, and Domestic versus Foreign Enrollment, 

 Reported in FY 2003 

Enrollment Reported 

Clinical Studies 

(Not NIH Defined 

Phase III) 

NIH Defined 

Phase III 

Clinical Trials* 

Total All 

Clinical 

Studies 

Protocols reporting women only 2,881,338 163,220 3,044,558

% 20.2% 30.6% 20.6%

Protocols reporting men only 280,002 71,985 351,987

% 2.0% 13.5% 2.4%

Protocols excluding female-only and menonly enrollment protocols 11,077,435 298,274 11,375,709

% 77.8% 55.9% 77.0%

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted. 0 0 0

% 0.0% 0.0% 0.0%

Enrollment Totals for all studies 14,238,775 533,479 14,772,254

% 100.0% 100.0% 100.0%

Enrollment Reported by Domestic or Foreign Site

Domestic Enrollment 11,427,288 484,069 11,911,357

% 80.3% 90.7% 80.6%

Foreign Enrollment 2,811,487 49,410 2,860,897

% 19.7% 9.3% 19.4%

Enrollment Totals for All Studies 14,238,775 533,479 14,772,254

% 100.0% 100.0% 100.0%

An NIH-defined Phase III 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 controlled 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. Source: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, October

2001.

19
Table 6. Overview of NIH Extramural and Intramural Clinical Research: 

 Enrollment by Sex, and Domestic versus Foreign Enrollment, 

 Reported in FY 2004 

Enrollment Reported 

Clinical Studies 

(Not NIH Defined 

Phase III) 

NIH Defined 

Phase III 

Clinical Trials* 

Total All 

Clinical 

Studies 

Protocols reporting women only 3,096,486 160,148 3,256,634

% 16.8% 31.0% 17.2%

Protocols reporting men only 172,720 72,762 245,482

% 0.9% 14.1% 1.3%

Protocols excluding female-only and menonly enrollment protocols 15,138,354 283,450 15,421,804

% 82.2% 54.9% 81.5%

Protocols with zero enrollment. 

Enrollment data has not yet been 

submitted. 0 0 0

% 0.0% 0.0% 0.0%

Enrollment Totals for all studies 18,407,560 516,360 18,923,920

% 100.0% 100.0% 100.0%

Enrollment Reported by Domestic or Foreign Site

Domestic Enrollment 13,892,559 467,234 14,359,793

% 75.5% 90.5% 75.9%

Foreign Enrollment 4,515,001 49,126 4,564,127

% 24.5% 9.5% 24.1%

Enrollment Totals for All Studies 18,407,560 516,360 18,923,920

% 100.0% 100.0% 100.0%

An NIH-defined Phase III 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 controlled 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. Source: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, October

2001.

20











































64 
65
66
67

APPENDICES 

Page

Appendix A Explanation of Gender and Minority Codes 69 

Appendix B NIH Track and Inclusion Committee Members 71 

Appendix C Internet Homepage: Inclusion of Women and Minority Policy Implementation 77 

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

 Subjects in Clinical Research – Amended, October, 2001 81 

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

 Research 97 

Appendix F NIH Inclusion Tables for Target and Enrollment Data 109 

Appendix G Updates to PHS398 115 
68
69

Appendix A

Explanation of Sex and Minority Codes

G1A Includes both genders, scientifically acceptable. 

G2A Includes only women, scientifically acceptable. 

G3A Includes only men, scientifically acceptable. 

G4A Gender representation unknown, scientifically acceptable. 

G1U Includes both genders, but scientifically unacceptable. 

G2U Includes only women, scientifically unacceptable. 

G3U Includes only men, scientifically unacceptable. 

G4U Gender representation unknown, scientifically unacceptable. 

M1A Includes minorities and non-minorities, scientifically acceptable. 

M2A Includes only minorities, scientifically acceptable. 

M3A Includes only non-minorities, scientifically acceptable. 

M4A Minority representation unknown, scientifically acceptable. 

M1U Includes minorities and non-minorities, but scientifically unacceptable. 

M2U Includes only minorities, scientifically unacceptable. 

M3U Includes only non-minorities, scientifically unacceptable. 

M4U Minority representation unknown, scientifically unacceptable. 

When an application receives a AU@ (unacceptable) code it automatically receives a bar-tofunding as well. If the bar is removed, the AU@ is converted to AR@ to designate that change in 

status. 
70
71

Appendix B 

NIH Tracking and Inclusion Committee Members 

- Full Committee 
72
73 

NIH Tracking and Inclusion Committee 

2005 List of Members 

Office of the Director

Office of Research on Women=s Health

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

Office of Extramural Research

Carlos Caban*, Viktoriya Anufriyeva, Maria Koshy 

Office of Acquisition, Management and Procurement 

 Barbara Levy

National Cancer Institute

Margaret Holmes*, Marilyn Gaston, Kim Witherspoon, Lisa Krueger, Clarissa Douglass 

National Eye Institute

Lore Anne McNicol*, William Darby, Donald Everett 

National Heart, Lung, and Blood Institute

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

National Human Genome Research Institute

Bettie Graham*, Pam Sellman 

National Institute on Aging 

Miriam Kelty *, Karen Bashir, Kate Nagy 

National Institute on Alcohol Abuse and Alcoholism

Dorita Sewell*, Carmen Richardson 

National Institute of Allergy and Infectious Diseases

Diane Adger-Johnson*, Susan Schafer, Diane Yerg, Martin Gutierrez 

National Institute of Arthritis and Musculoskeletal and Skin Diseases

 Madeline Turkeltaub*, Charisse Lamar 

National Institute of Child Health and Human Development

 Eugene Hayunga*, Sandi Delcore

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
74 

List of Members, continued...

National Institute on Deafness and Other Communication Disorders

Julie Gulya*, Lana Shekim

National Institute of Dental and Craniofacial Research

Richard Mowery *, Trenita Davis

National Institute of Diabetes, Digestive and Kidney Disorders

Patricia Robuck*, Lauren Meskill, Donna James

National Institute on Drug Addiction

Christie Baxter* 

National Institute of Environmental Health Sciences

Martha Barnes * 

National Institute of General Medical Sciences

Lori Burge *, Alison Cole 

National Institute of Mental Health

Catherine Roca *, Pamela Wexler, Sue Kennel, Ernesto Marquez, Dawn Corbett 

National Institute of Neurological Disorders and Stroke

 Frances Yee *, Kristy Woolbert 

National Institute of Nursing Research

Alexis Bakos *, Christine Shaw 

National Library of Medicine

Dwight Mowery * 

Warren G. Magnuson Clinical Center

Kim Jarema *, Dee Koziol 

National Center for Complementary and Alternative Medicine

 April Bowers * 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee
75 

List of Members, continued...

National Center for Research Resources

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

Fogarty International Center

Aron Primack* 

Center for Scientific Review 

Anita Miller Sostek* 

Office of Intramural Research

Alan Sandler* 

National Center for Minority Health and Health Disparaties

Ivy Chan* 

National Institute of Biomedical Imaging and Bioengineering

Meredith Temple-O Connor*, Tinera Fobbs, Tony Demsey, Casey Goode 

Division of Extramural Activities Support

 Mary Lou Prince*, Dorothy Sanders 

* Indicates the IC Lead Representative to the Tracking and Inclusion Committee 
76 
77 

Appendix C 

Internet Homepage: 

Inclusion of Women and Minorities Policy 

Implementation 

http://grants.nih.gov/grants/funding/women_min/women_min.htm
78 
79 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

NATIONAL INSTITUTES OF HEALTH 

Office of Extramural Research 

Inclusion of Women and Minorities Policy Implementation 

Current Policy Documents and References:

• 10/09/2001 NIH Guide Notice - The NIH Policy on the Inclusion of Women and Minorities as 

Subjects in Clinical Research was amended October 2001. Click here for a complete copy of the 

Amended Policy that provides full explanation of the October 2001 policy notice. 

• 08/08/2001 NIH Guide Notice - NIH Policy on Reporting Race and Ethnicity Data: Subjects in 

Clinical Research. This notice provides additional guidance and instruction for using the revised 

minimum standards for maintaining, collecting, and presenting data on race and ethnicity found 

in the PHS 398 (rev. 5/01) and PHS 2590 (rev. 5/01) instructions and forms. 

• Inclusion Table (07/25/2001) - Prior format for reporting sex/gender and race/ethnicity data 

using the 1977 OMB standards for the classification of federal data on race and ethnicity. This 

format is superceded by the Target/Planned Enrollment Table and Inclusion Enrollment Reports 

that use the 1997 OBM standards for the classification of federal data on race and ethnicity. 

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

Women's Health (ORWH) Web site. 

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

Subjects in Clinical Research - To help investigators to understand and comply with the NIH's 

inclusion policies, the ORWH collaborated in the preparation and publication of this Notebook, 

available here in Adobe Acrobat (PDF) format. This publication contains two appendices. 

Appendix A summarizes the inclusion guidelines; Appendix B contains sample questions and 

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

guidelines. 

OUTREACH NOTEBOOK (Pages 1-39 of PDF file) 

INCLUSION GUIDELINES (Pages 40-51 of PDF file) 

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

Historical Documents and References: 

• 08/02/2000 NIH Guide Notice - NIH Guidelines on The Inclusion of Women and Minorities 

as Subjects in Clinical Research - Updated August 2, 2000. Changes to the Guidelines, 

Sections 'III.B. NIH Phase III Clinical Trials' and 'V. Definitions' are highlighted in bold type. 

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

Research - Updated August 2, 2000 - A complete text of the Updated Guidelines, with 

changes to the Guidelines, Sections 'III.B. NIH Phase III Clinical Trials' and 'V. Definitions' 

highlighted in bold type. The list of NIH Contacts has also been updated. 

• 03/18/1994 NIH Guide Notice - NIH Guidelines on The Inclusion of Women and Minorities 

as Subjects in Clinical Research. 

Weblink: http://grants.nih.gov/grants/funding/women_min/women_min.htm
80 
81 

Appendix D 

NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as 

Subjects in Clinical Research 

(Amended, October, 2001) 
82 
83 

NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND 

MINORITIES AS SUBJECTS IN CLINICAL RESEARCH BB Amended, 

October, 2001. 

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

Minorities as Subjects in Clinical Research is available at 

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

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

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

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

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

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

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

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

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

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

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

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

of minority groups and their subpopulations differently. 

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

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

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

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

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

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

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

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

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

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

October 2001 must adhere to the amended policy. 

I. LEGISLATIVE BACKGROUND 

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

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

The statute states that: 

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

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

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

The statute further directed the NIH to establish guidelines to specify: 
84 

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

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

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

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

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

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

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

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

trial. 492B(c) 

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

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

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

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

The statute speaks specifically to outreach and states that: 

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

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

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

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

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

particular clinical trials. 

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

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

inappropriate. 492B(d)(2) 

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

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

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

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

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

quality. 492B(d)(2) 

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

follows: 

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

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

members of minority groups, respectively- 

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

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

Director of NIH may designate. 492B(b) 
85 

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

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

between- 

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

groups, respectively; and 

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

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

II. POLICY 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

proposed outreach programs for recruiting women and minorities as participants. 

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

Sex/Gender and Race/Ethnicity Differences. 

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

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

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

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

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

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

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

will apply: 

1. Prior Studies Support the Existence of Significant Differences 

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

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

subpopulation comparisons, the primary question(s) to be addressed by the proposed NIH-
86 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NIH-defined Phase III clinical trials. 

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

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

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

2. Prior Studies Support No Significant Differences 

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

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

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

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

subgroups is still strongly encouraged. 

3. Prior Studies Neither Support nor Negate Significant Differences 

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

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

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

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

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

However, the trial will not be required to provide high statistical power for these comparisons. 
87 

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

description of plans to conduct valid analysis (see DEFINITIONS - Valid Analysis) by 

sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable. The final protocol(s) 

approved by the Institutional Review Board (IRB) must include these plans for analysis. The 

award will require that for each funded protocol, investigators must report in their annual 

Progress Report cumulative subject accrual and progress in conducting analyses for sex/gender 

and race/ethnicity differences. If final analyses of sex/gender and race/ethnicity are not available 

at the time of the Final Progress Report or Competing Continuation for the grant, a justification 

and plan ensuring completion and reporting of the analyses are required. If final analyses are 

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

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

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

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

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

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

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

from clinical trials. 

III. ROLES AND RESPONSIBILITIES 

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

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

1. NIH Staff 

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 
88 

relationship between the investigator(s) and staff(s) and populations and community(ies) of 

interest such that mutual benefit is derived for participants in the study. Investigator(s) should 

take precautionary measures to ensure that ethical issues are considered, such that there is 

minimal possibility of coercion or undue influence in the incentives or rewards offered in 

recruiting into or retaining participants in studies. 

To assist investigators and potential study participants, NIH staff have prepared educational 

materials, including a notebook titled the, "NIH Outreach Notebook On the Inclusion of Women 

and Minorities in Biomedical and Behavioral Research." The notebook as well as the Frequently 

Asked Questions document, are located at the following URL: 

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

3. Institutional Review Boards (IRBs) 

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

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

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

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

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

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

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

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

4. Peer Review Groups 

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

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

panels are instructed, as follows: 

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

appropriate representation or to evaluate the proposed justification when 

representation is limited or absent, 

• 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 
89 

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

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

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

Or contact: 

National Institutes of HealthDivision of Acquisition Policy and EvaluationOffice of Acquisition 

Management and Policy6100 Executive Boulevard, Room 6C01Phone: 301-496-6014Fax: 301- 

402-1199 

5. NIH Advisory Councils 

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

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

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

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

with the provisions of the statute. 

6. Institute/Center Directors 

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

7. NIH Director 

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

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

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

subjects, the purpose of the research, or costs. 

IV. DEFINITIONS

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

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

drawn directly from the statute, are defined below. 

A. Clinical Research 

Clinical research is defined as: 

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

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

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

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

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

trials, and (d) development of new technologies, (2) Epidemiologic and behavioral studies, (3) 

Outcomes research and health services research. 

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

B. NIH-defined Clinical Trial 

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

Phase III clinical investigation, usually involving several hundred or more human subjects, for 
90 

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

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

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

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

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

and other population-based intervention trials are also included. 

C. Valid Analysis 

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

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

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

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

ensuring a valid analysis of the question of interest are: 

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

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

process such as randomization, 

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

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

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

D. Significant Difference 

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

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

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

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

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

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

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

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

significant. 

E. Racial and Ethnic Categories 

1. Minority Groups 

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

racial, ethnic, and/or cultural heritage. 

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 
91 

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

constructs and should not be interpreted as anthropological in nature. 

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

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

designed in a way that they can be aggregated into these required categories. Using respondent 

self-report or self-identification to collect an individual==s data on ethnicity and race, 

investigators should use two separate questions with ethnicity information collected first 

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

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

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

Hispanic or Latino. 

The following definitions apply for ethnic categories. 

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

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

addition to "Hispanic or Latino." 

Not Hispanic or Latino 

The following definitions apply for racial categories. 

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

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

attachment. 

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

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

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

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

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

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

American." 

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

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

2. Majority Group 

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

North Africa. 

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

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

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

differing racial and ethnic categories. 

3. Subpopulations 
92 

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

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

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

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

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

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

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

scientific question under study. 

F. Outreach Strategies 

These are outreach efforts by investigators and their staff(s) to appropriately recruit and retain 

populations of interest into research studies. Such efforts should represent a thoughtful and 

culturally sensitive plan of outreach and generally include involvement of other individuals and 

organizations relevant to the populations and communities of interest, e.g., family, religious 

organizations, community leaders and informal gatekeepers, and public and private institutions 

and organizations. The objective is to establish appropriate lines of communication and 

cooperation to build mutual trust and cooperation such that both the study and the participants 

benefit from such collaboration. 

V. NIH CONTACTS FOR MORE INFORMATION 

The following senior extramural staff from the NIH Institutes and Centers may be contacted for 

further information about the policy and relevant Institute/Center programs: 

 Dr. Marvin Kalt 

National Cancer Institute 

Executive Plaza North 

6116 Executive Boulevard, Suite 8001 

Bethesda, MD 20892 

Telephone: (301) 496-5147 

Email: kaltm@dea.nci.nih.gov

Dr. Lore Anne McNicol 

National Eye Institute 

Executive Plaza South 

6120 Executive Boulevard, Room 350 

Rockville, MD 20892 

Telephone: (301) 496-5301 

Email: loreanne.mcnicol@nei.nih.gov

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
93 

Dr. Miriam Kelty 

National Institute on Aging 

Gateway Building 

7201 Wisconsin Avenue, Room 2C218 

Bethesda, MD 20892 

Telephone: (301) 496-9322 

Email: keltyM@nia.nih.gov

Dr. Lorraine Gunzerath 

National Institute on Alcohol Abuse and Alcoholism 

Willco Building 

6000 Executive Boulevard, Suite 409 

Rockville, MD 20892 

Telephone: (301) 443-2369 

Email: lgunzera@mail.nih.gov 

Dr. John McGowan 

National Institute of Allergy and Infectious Diseases 

6700 B Rockledge 6700 Rockledge Drive 

Bethesda, MD 20817 

Telephone: (301) 496-7291 

Email: jm80c@nih.gov 

Madeline Turkeltaub RN, Ph.D., CRNP, FAAN 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

One Democracy Plaza 

6701 Democracy Blvd., Suite 800 MSC 4872 

Rockville, MD 20857 

Telephone: (301) 451-5888 

Email: MTurkeltaub@mail.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. Lana Shekim 

National Institute on Deafness and Other Communication Disorders 

Executive Plaza South 

6120 Executive Boulevard, Room 400C 

Rockville, MD 20892 

Telephone: (301) 496-5061 

Email: ShekimL@nidcd.nih.gov 
94 

Richard Mowery, Ph.D. 

National Institute on Dental and Craniofacial Research 

Natcher Building 

Building 45, Room 4AS543F MSC 6401 

Bethesda, MD 20892 

Telephone: (301) 594-4848 

Email: mowerich@mail.nih.gov

Patricia Robuck Ph.D., MPH 

National Institute of Diabetes and Digestive and Kidney Diseases 

6707 Democracy Blvd., Room 659 

Bethesda, MD 20817 

Telephone: (301) 480-8300 

Email: pr132q@nih.gov

Dr. Teresa Levitin 

National Institute on Drug Abuse 

Neuroscience Building 

6001 Executive Boulevard, Room 3158 

Bethesda, MD 20852 

Telephone: (301) 443-2755 

Email: tlevitin@nida.nih.gov

 

Dr. Anne P. Sassaman 

National Institute of Environmental Health Sciences 

P.O. Box 12233, MD EC-30 

Research Triangle Park, NC 27709 

Telephone: (919) 541-7723 

Email: sassaman@niehs.nih.go 

Dr. Alison Cole 

National Institute of General Medical Sciences 

Natcher Building 

Building 45, Room 2AS49K 

Bethesda, MD 20892 

Telephone: (301) 594-1826 

Email: colea@nigms.nih.gov

Catherine Roca, M.D. 

National Institute of Mental Health 

Neuroscience Building 

6001 Executive Boulevard, Room 8125 

Bethesda, MD 20852 

Telephone: (301) 443-3488 

Email: rocac@mail.nih.gov
95 

Dr. Frances Yee, Ph.D. 

National Institute of Neurological Disorders and Stroke 

Neuroscience Building 

6001 Executive Boulevard, Room 2227 MSC 9520 

Bethesda, MD 20852-9520 

Telephone: (301) 496-5447 

Email: yeef@ninds.nih.gov

Bettie Graham, Ph.D. 

National Human Genome Research Institute 

5635 Fishers Lane, Suite 4073 MSC 9305 

Rockville, MD 20852 

Telephone: (301) 496-7531 

Email: bettie_graham@mail.nih.gov

 

Barbara Smothers, Ph.D. 

National Institute of Nursing Research 

6701 Democracy Blvd., Suite 710, MSC 4870 

Bethesda, MD 20892 

Telephone: (301) 594-5976 

Email: bs86h@nih.gov

Jonathon Berman, M.D., Ph.D., FAAP 

National Center for Complementary and Alternative Medicine 

6707 Democracy Blvd., Suite 401 

Bethesda, MD, 20892 

Telephone: (301) 594-7105 

Email: bermanjo@mail.nih.gov

Shelia McClure, Ph.D. 

National Center for Research Resources 

6701 Democracy Blvd., Room 932, MSC 4874 

Bethesda, MD 20892-4874 

Telephone: (301) 4451-6536 

Email: mcclursh@mail.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
96 

Anthony Demsey, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

Two Democracy Boulevard, Suite 240 

Bethesda, MD 20892 

Telephone: (301) 402-7039 

Email: demseya@mail.nih.gov 

Derrick Tabor, Ph.D. 

National Center for Minority Health and Health Disparities 

2 Democracy Boulevard, Suite 800 

Bethesda, MD 20817 

Telephone: (301) 402-1366 

Email: tabord@mail.nih.gov
97 

Appendix E 

NIH Policy on 

Reporting Race and Ethnicity Data: 

Subjects in Clinical Research 
98 
99 

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: 
100 

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

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

addition to AHispanic or Latino.@ 

Not Hispanic or Latino 

Racial Categories: 

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

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

attachment. 

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

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

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

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

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

Terms such as AHaitian@ or ANegro@ can be used in addition to ABlack or African American.@ 

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

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

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

North Africa. 

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

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

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

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

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

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

multiple racial categories reported as the Anumber selecting more than one race@; and, (d) the 

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

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

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

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

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

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

detailed categories if doing so would compromise data quality or confidentiality standards. 
101 

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

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

the Inclusion of Women and Minorities (see 

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

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

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

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

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

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

(3) Outcomes research and health services research. 

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

Intramural Projects 

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

Clinical Research: 

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

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

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

the Targeted/Planned Enrollment table 

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

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

for Collecting New/Additional Data: 

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

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

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

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

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

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

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

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

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

Annual Progress Reports (type 5) and Competing Supplement Applications 

In Annual Progress Reports and Competing Supplement Applications, investigators conducting 

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

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

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

sex/gender. 
102 

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

Will be Collected from Human Subjects: 

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

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

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

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

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

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

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

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

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

III. Frequently Asked Questions 

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

OMB standards? 

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

table ATargeted/Planned Enrollment Table@ for New Applications. First, the investigator should 

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

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

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

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

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

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

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

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

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

categories, once data collection commences. 

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

categories do not comply with the new OMB guidelines? 

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

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

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

Enrollment Table@ for a New Application and the AInclusion Enrollment Report@ for 

Continuation Applications, Competing Supplement Applications, and Annual Grant Progress 

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

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

and use the 4/98 Version of the Inclusion Table. 
103 

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

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

Aadd up@? 

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

Enrollment Table@ for a New Application and the AInclusion Enrollment Report @ for 

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

the sum in AEthnic Category: Total of All Subjects@ must equal the sum in ARacial Categories: 

Total of All Subjects.@ In addition, the ARacial Categories: Total Hispanics or Latinos@ in Part B 

of the AInclusion Enrollment Report Table@ must equal the Total Hispanic or Latino number 

reported in Part A of the AInclusion Enrollment Report.@ Footnotes in the tables clearly identify 

which numbers must be the same. 

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

collect data from individuals? 

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

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

data. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

listing the information in an attachment to the required table. 

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

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

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

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

circumstance, investigators should note that the research project was initiated prior to the 
104 

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

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

Inclusion Table. 

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

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

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

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

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

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

the new Inclusion Enrollment Report. 

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

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

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

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

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

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

are relevant to the scientific hypotheses being studied. 

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

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

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

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

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

footnote accompanying the table with foreign data. 

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

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

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

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

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

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

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

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

than one racial designation. 

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

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

http://grants.nih.gov/grants/funding/women_min/women_min.htm. 
105 

The following senior extramural staff from the NIH Institutes and Centers may be contacted for 

further information about the policy and relevant Institute/Center programs: 

Dr. Marvin Kalt 

National Cancer Institute 

Executive Plaza North 

6116 Executive Boulevard, Suite 8001 

Bethesda, MD 20892 

Telephone: (301) 496-5147 

Email: kaltm@dea.nci.nih.gov

Dr. Lore Anne McNicol 

National Eye Institute 

Executive Plaza South 

6120 Executive Boulevard, Room 350 

Rockville, MD 20892 

Telephone: (301) 496-5301 

Email: loreanne.mcnicol@nei.nih.gov

Ms. Sharry Palagi 

National Heart, Lung and Blood Institute 

Building 31 

31 Center Drive, Room 5A-07 

Bethesda, MD 20892 

Telephone: (301) 402-3424 

Email: palagis@nih.gov

Dr. Miriam Kelty 

National Institute on Aging 

Gateway Building 

7201 Wisconsin Avenue, Room 2C218 

Bethesda, MD 20892 

Telephone: (301) 496-9322 

Email: keltyM@nia.nih.gov

Dr. Lorraine Gunzerath 

National Institute on Alcohol Abuse and Alcoholism 

Willco Building 

6000 Executive Boulevard, Suite 409 

Rockville, MD 20892 

Telephone: (301) 443-2369 

Email: lgunzera@mail.nih.gov 

Dr. John McGowan 

National Institute of Allergy and Infectious Diseases 

6700 B Rockledge 6700 Rockledge Drive 

Bethesda, MD 20817 

Telephone: (301) 496-7291 
106 

Email: jm80c@nih.gov 

Madeline Turkeltaub RN, Ph.D., CRNP, FAAN 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

One Democracy Plaza 

6701 Democracy Blvd., Suite 800 MSC 4872 

Rockville, MD 20857 

Telephone: (301) 451-5888 

Email: MTurkeltaub@mail.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. Lana Shekim 

National Institute on Deafness and Other Communication Disorders 

Executive Plaza South 

6120 Executive Boulevard, Room 400C 

Rockville, MD 20892 

Telephone: (301) 496-5061 

Email: ShekimL@nidcd.nih.gov 

Richard Mowery, Ph.D. 

National Institute on Dental and Craniofacial Research 

Natcher Building 

Building 45, Room 4AS543F MSC 6401 

Bethesda, MD 20892 

Telephone: (301) 594-4848 

Email: mowerich@mail.nih.gov

Patricia Robuck Ph.D., MPH 

National Institute of Diabetes and Digestive and Kidney Diseases 

6707 Democracy Blvd., Room 659 

Bethesda, MD 20817 

Telephone: (301) 480-8300 

Email: pr132q@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

 
107 

Dr. Anne P. Sassaman 

National Institute of Environmental Health Sciences 

P.O. Box 12233, MD EC-30 

Research Triangle Park, NC 27709 

Telephone: (919) 541-7723 

Email: sassaman@niehs.nih.go 

Dr. Alison Cole 

National Institute of General Medical Sciences 

Natcher Building 

Building 45, Room 2AS49K 

Bethesda, MD 20892 

Telephone: (301) 594-1826 

Email: colea@nigms.nih.gov

Catherine Roca, M.D. 

National Institute of Mental Health 

Neuroscience Building 

6001 Executive Boulevard, Room 8125 

Bethesda, MD 20852 

Telephone: (301) 443-3488 

Email: rocac@mail.nih.gov

Dr. Frances Yee, Ph.D. 

National Institute of Neurological Disorders and Stroke 

Neuroscience Building 

6001 Executive Boulevard, Room 2227 MSC 9520 

Bethesda, MD 20852-9520 

Telephone: (301) 496-5447 

Email: yeef@ninds.nih.gov

Bettie Graham, Ph.D. 

National Human Genome Research Institute 

5635 Fishers Lane, Suite 4073 MSC 9305 

Rockville, MD 20852 

Telephone: (301) 496-7531 

Email: grahambj@mail.nih.gov

Barbara Smothers, Ph.D. 

National Institute of Nursing Research 

6701 Democracy Blvd., Suite 710, MSC 4870 

Bethesda, MD 20892 

Telephone: (301) 594-5976 

Email: bs86h@nih.gov

Jonathon Berman, M.D., Ph.D., FAAP 

National Center for Complementary and Alternative Medicine 

6707 Democracy Blvd., Suite 401 

Bethesda, MD, 20892 
108 

Telephone: (301) 594-7105 

Email: bermanjo@mail.nih.gov

Shelia McClure, Ph.D. 

National Center for Research Resources 

6701 Democracy Blvd., Room 932, MSC 4874 

Bethesda, MD 20892-4874 

Telephone: (301) 4451-6536 

Email: mcclursh@mail.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

Anthony Demsey, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

Two Democracy Boulevard, Suite 240 

Bethesda, MD 20892 

Telephone: (301) 402-7039 

Email: demseya@mail.nih.gov 

Derrick Tabor, Ph.D. 

National Center for Minority Health and Health Disparities 

2 Democracy Boulevard, Suite 800 

Bethesda, MD 20817 

Telephone: (301) 402-1366 

Email: tabord@mail.nih.gov
APPENDIX F 

NIH Inclusion Tables for Target and Enrollment Data 

- Old Table for Target & Enrollment Data Collection 

- New Table for Target Data Collection 

- New Table for Enrollment Data Collection 

109 
110 
Old Table for Target & Enrollment Data Collection 

111 
New Table for Target Data Collection

112 
New Table for Enrollment Data Collection

113 
114 
Appendix G 

Updates to PHS398

Competing - Public Health Service Grant 

Application 

115 
Grant Application 

U.S. DEPAR HUMAN

PUBLIC HEALTH SERVICE 

PHS 398 (Revised 9/2004)

See the 11/2/2004 NIH Guide Notice

TMENT OF HEALTH AND

SERVICES 

 for important changes to this version.

All notable changes made to PHS 398 form pages are listed at the bottom of this page

(Updated 3/16/2005).

Downloadable Instructions and Form Files 

Some of the MS Word and PDF files are large and may take a few minutes to download. 

PHS 398 Instructions 

This edition of the PHS 398 has been reorganized into three distinct parts, each of which 

is available as a separate file in the MS Word and PDF versions. Principal investigators 

and institutions will need to use all three parts of the instructions in order to prepare a 

complete and acceptable application. 

PHS 398 Instructions Files - Part I, II, and 

III 

Part I, Instructions MS 

Word PDF

Part II, Human Subjects Research Supplement MS 

Word PDF

Flash

or 

HTML

116 
Part III, Policy, Assurances, Definitions MS 

Word PDF

If the links between the three parts do not function properly when using the MS Word 

and PDF versions of these instructions, save the three files to your hard drive (see Saving 

Files Locally), rather than opening them in your browser. Be sure that the three files are 

saved to the same folder/directory.

PHS 398 Fillable Forms 

The links below allow for downloading of individual and combined form files in MS 

Word and PDF formats. Please see the Adobe Acrobat or PDF Forms section of the 

"Help Downloading Files" page for information on using the fillable PDF forms. 

Fillable Individual PHS 398 Forms 

MS

ion, Performance Sites, 

Form Page 1: Face Page Word PDF

Form Page 2: Descript

Key Personnel, Other Significan

and Human Embryonic S

t Contributors, d

tem Cells 

MS Wor PDF

Form Page 3: Research Grant Table of Contents MS Word PDF

Form Page 4: Detailed Budget for Initial Budget MS Word Period PDF

Form Page 5: Budget for Entire Proposed Period

of Support MS Word PDF

Modular Budget Format Page MS Word PDF

Modular Budget Sample: Same Modules MS Word PDF

Modular Budget Sample: Variable Modules MS Word PDF

Biographical Sketch Format Page MS Word PDF

Biographical Sketch Sample MS Word PDF

Resources Format Page MS Word PDF

Checklist Form Page MS Word PDF

Personal Data Form Page MS Word PDF

Continuation Page MS Word PDF

Targeted/Planned Enrollment Table Format Page MS Word

rt For d PDF

Mailing Address an

Word

Personnel Report Format Page MS Word

PDF

Inclusion Enrollment Repo mat Page MS Wor

d RFA Labels MS Word PDF

Other Support Format Page: Example MS PDF

PDF

Fillable Research Career Development 

117 
Award Forms 

Substitute Form Page 3: Research Career 

Development Award Table of Contents MS Word PDF

Research Career Development Award Reference 

Guidelines 

MS Word PDF

Fillable Institutional National Research

Service Award (NRSA) Forms 

Substitute Table of Contents for Institutional MS Word NRSA 

Substitute Detailed Budget for Initial Budget 

Period Direct Costs MS Word PDF

PDF

Substitute Budget for Entire Proposed Period of 

Su

MS Word

pport Direct Costs 

Fillable Small Business Innovation

Research (SBIR)/ 

Small Business Technology Transfer 

(STTR) Forms 

Full Set of SBIR and STTR Forms (Phase I and 

Phase II) 

Does NOT include Continuation Page, 

Biographical Sketch, or any Sample pages, all of 

which may be downloaded below.

MS Word PDF

Development) MS Word PDF

Combined PHS 398 Forms File

Does NOT include the Biographical Sketch page, 

Continuation Page, or any of the Sample/Example 

pages (Biosketch Sample, Other Support Sample).

See Individual Form

Form Files rm Fil

For Questions Related to: 

grantsinfo@nih.gov or 301-435-0714. 

orms: visit the PHS Forms Help ,Technical 

eacetech.com/phsform

• Technical Problems With F Desk

FAQs at http://www.p

PDF

 

STTR Research Institution Budget Form Page MS Word PDF

Continuation Page MS Word PDF

Biographical Sketch Format Page MS Word PDF

Biographical Sketch Sample MS Word PDF

Budget Sample - SBIR (STTR Under 

file links above. 

Combined 

PHS 398 

(MS Word) 

Combined 

PHS 398

Fo es

(PDF)

• Application Procedures/Forms Submission: contact GrantsInfo at 

s. 

118 
Note: Other softw

other sources; how

are packages for completing these applications may be available from

ever, it is essential that the type size and format specifications are met. 

e delayed, cation e returned to

: Reference to these software packages neither constitutes nor should be 

inferred to be an endorsement or recommendation of any product, service, or enterprise 

ncy of the United States Government, 

overnment. No warranties are st plied. 

Otherwise, application processing may b

the applicant without review. 

or the appli may b

Disclaimer

by the National Institutes of Health, any other age

or any employee of the United States G ated or im

• Revisions h

typefaces (Arial, Helvetica, Palatino L

provide clear

pe or Georg now a

tions that in consor

costs; and to clarify format requirem

material may be two-sided). See th

revisions made

to improve usability (3/16/05). 

• Revisions h

some form

Supplement, to further address NIH im

re

changes in content have been

changes have been made in the PHS 398

ple. Minor revisions and

format no longer applies to SBIR/STT

• Significant PHS 398, P Huma

Research Supplement, to

research involving coded private information or biological specimens

changes in content h ple. Minor revisions and

changes have been made in th

Resear

arts I and II orm P

ring of item e Research Plan has 

been revised (12/30/04). 

• Page numbering on Form Page 2 and F

to Page 2 and Page 3. Be sure to numb

(11/23/04). 

Notable Changes Made to PHS 398 

ave been made in the PHS 398 to specify additional acceptable font 

inoty ia are cceptable); to

er budget guidance for applica clude tium F&A 

ents for Appendix material (Appendix

e NIH Guide Notice for details regarding 

. Minor formatting revisions have been made to pages 

ave been made in the PHS 398, Part II, Human Subjects Research 

plementation of OHRP Guidance on 

search involving coded private information or biological specimens. Notable 

marked in pur formatting 

, Parts I and III (1/20/05). 

• Chapter V of the PHS 398 has been revised to reflect that the modular budget 

R grant applications (1/14/05). 

revisions have been made in the art II, n Subjects 

address NIH implementation of OHRP Guidance on 

. Notable 

ave been marked in pur formatting 

e PHS 398, P I. On F age 3, 

ch Grant Table of Contents, the orde s in th

orm tinue changed

er al pli ntially

d format specifications (11/17/04). 

• New PHS 398 (Rev. 9/04) instructions and forms posted 11/02/2004. See the 

Page 2-con

l pages in ap

d has been

cation seque

• Clarification of font an

11/2/2004 NIH Guide Notice for important details regarding changes made to 

this version. 

119 
Revis

Now A

ed PHS 398 (DHHS Public Health Service Grant Application) 

vailable 

Notice

Key Da

Release Date: November 02, 2004 

Issued by

National Institutes of Health (NIH), (http://www.nih.gov/

Number: NOT-OD-05-006 

tes

) 

EFFECTIVE

Grant” (PHS 3 ed for

submission/rec r after May 

10, 2005 must ns

using the previ HS 398 will be accepted through May 9, 2005. 

However, after this date, applications submitted using instructions and forms other than the PHS 

398 (rev 9/ )

The newly rev ms.htm

DATE: The newly revised “Application for a DHHS Public Health Service

98, rev. 9/04) instructions and forms are now available and will be accept

eipt dates on or after December 1, 2004. All applications received on o

use the new instructions and forms. During the transition period, applicatio

ous version (rev. 5/01) of the P

04 will be returned to the applicant. 

ised instructions and forms are available at http://grants.nih.gov/grants/for

ilable on the website continue to be provided in two formats—MS Word an

dobe Acrobat Reader Software. Free Adobe Software may be

. 

The forms ava d PDFfillable using A accessed at 

http://www.adobe.com/products/acrobat/readstep.html. Applicants are strongly encoura

uctions and forms via the Internet because they provide valuable

ged to

access the instr links to current

policy documents and allow easy navigation of the instructions. This is particularly important 

with this ve io , contact

GrantsInfo@n

rs n due to the interactive format of the instructions. For further information

ih.gov. 

SBIR/STTR ap ubmission 

date may use th

Chapter IV of s SBIR/STTR Grant Solicitation. However, applicants 

who wish to use the new forms should use the following set of instructions (MS Word

plicants who are preparing an application for the December 1, 2004 s

e previous PHS 398 version (rev. 05/01) in accordance with instructions in

the PHS 2004-2 Omnibu

 / PDF). in 

accordance with instructions in Chapter IV of the PHS 2004-2 Omnibus SBIR/STTR Grant

Solicitation. The PHS 2005-2 Omnibus Solicitation, with updated instructions, will be released

on or around January 14, 2005. 

As in the past, applicants should read the instructions carefully. The following is a list of notable 

changes. 

Notable Changes to the PHS 398 (rev. 9/04): 

This edition of the PHS 398 has been extensively rewritten with a focus on clarity and special 

emphasis on simplicity and plain language. 

120 
Overall Format Changes 

The format has been organized into three distinct, but integrally linked, parts: 

• Part I: Instructions for Preparing the Application 

lude only instructional material related to the preparation, 

ission and review of your application. 

s have been revised to incorporate appropriate policy 

nformation pertaining to policies, assurances, definitions and 

r information is now found in Part III: Policies, Assurances, Definitions and Other 

arch

• Efforts have been made to inc

subm

• When applicable, instruction

changes. However, detailed i

othe

Information. 

• Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Rese

Plan 

• This section includes instructions for preparing the human subjects section of the research 

plan (Section e) and related policies related to Human Subjects Research. 

• This section is also organized in a question/answer format to guide application writers 

through the decision making process regarding the involvement of human subjects in the 

proposed research. 

• Part III: Policies, Assurances, Definitions and Other Information 

• This section contains non-instructional information relating to policies and assurances, 

incorporates all policy changes since the last (5/01) PHS398 revision, and includes links 

from Part I (“Instructions”) as necessary. 

• Definitions have been harmonized with those used in the NIH Grants Policy Statement . 

• This section also includes a description of various grant mechanisms that NIH uses to 

fund research

Changes of Note to Specific PHS 398 Form/Format Pages: 

Face Page: 

• Title—Form field length has been increased to 81 characters 

• eRA Commons User Name field has been added. This data item is currently optional 

• Human Subjects Research box has been modified to include a new data element for 

m

Clinical Trials. 

• The IPF option data field in block 9 has been eliminated 

Form Page 2: 

• Now 2 pages (Form Page 2 & Form Page 2-continued with 5 distinct sections—

Description, Performance Sites, Key Personnel, Other Significant Contributors, and Ste

Cells. 

121 
• Description/Abstract : Instructions have been added requiring the PI to succinctly (2-3 

sentences) describe the relevance of the proposed research to public health. Plain 

• Key Personnel Section : A field has been added for the eRA Commons User Name. This 

• Other Significant Contributors: This is a new field that allows the PI to identify 

cified measurable effort. (Biographical 

be

• 

rojects that involve human embryonic stem cells has now been requested 

as a separate form field. A link to the Human Embryonic Stem Cell Registry is provided. 

Pages 4 and 5: Budget pages have been modified to implement the broader application of 

the policy on Direct Cost Limitations (e.g., excluding consortium/contractual F&A costs when 

determ

“Conso Subtotal 

Dir

Modular Budget Format Page : The budget data fields have been modified to implement the 

new policy on Direct Cost Limitations. Specifically, users must now separate the Consortium

vised to implement the new 

policy. 

Biogra

This da

Per n

Social formation remains voluntary, it is hoped that by 

limiting the data to only the last four digits, individuals will be more receptive to providing it. 

te identification, referral, and

review of applications and for management of PHS grant programs. 

Key Personnel Report Format Page: The request for a Social Security Number is now limited 

to t l

Ch l

. 

• Foreign Application: Two distinct options are now provided 1) Grants at Foreign 

ns or 2) Domestic Grants with Significant Foreign Involvement. This data area 

also includes a text entry section to list countries involved. 

Specifi

language is suggested. 

new data item is currently optional. 

individuals who have committed to contribute to the scientific development or execution

of the project but are not committing any spe

sketches will be required for these individuals; Other Support information will not

required.) 

Human Embryonic Stem Cells: Previously embedded in the Description, information 

pertaining to p

Form

ining eligibility for any application with a direct cost limitation.) Specifically, the 

rtium/Contractual Direct Costs” budget row has been moved to above the “

ect Costs” line. Instructions have been revised to implement the new policy. 

F&A costs from the other Direct Costs. Instructions have also been re

phical Sketch Format Page : A field has been added for the eRA Commons User Name. 

ta item is currently optional. 

so al Data Page: Applicants are now requested to provide only the last four digits of the 

Security Number. While providing this in

This vital information continues provide the agency with accura

he ast four digits.

eck ist Form Page: 

• A field has been added for “Change in Grantee Institution”

Institutio

c Changes of Note to the PHS398 Instructions 

122 
• T F

Researc and

guidanc when.”

• F t

• NIH ed to better accommodate interdisciplinary, 

tran t

• Instru

new po en

determ

• Research Plan instructions now include a distinct section on Resource Sharing. 

• R e

• 

• Changed requirement in Career Award Instructions for Checklist Page. This page is now 

ections

e Final Progress

Report. 

of Grants Policy

Office of Policy for Extramural Research Administration 

Bethesda, MD 20892 

he oreword now contains general information about the NIH Extramural Research and 

h Training Programs, including useful “Quick References”, contacts within HHS

e for “whom to contact

on Size Requirement: NIH now requires the use of Arial-11 or Helvetica-11 point font. 

Peer Review Criteria have been updat

sla ional, and clinical projects.

ctions for Modular and Non-Modular Budgets and have been revised to implement the 

licy on Direct Cost Limitations; e.g., excluding consortium/contractual F&A costs wh

ining eligibility for any application with a direct cost limitation. 

es arch Career Development Award Instructions: 

Added clarifying instructions for completing sections of Form Page 2 

required at time of submission. 

• Institutional Training Grant Instructions: Added clarifying instructions for completing s

of Form Page 2 

• SBIR/STTR Instructions: Clarification has been added on the preparation of th

Inquiries on any changes to the forms and instructions may be directed to: 

Division

National Institutes of Health 

6705 Rockledge Drive, Suite 350 

Telephone: (301) 435-0938 

FAX: (301) 435-3059 

Email: GrantsPolicy@od.nih.gov 

Updated Instructions to the PHS 398 (DHHS Public Health Service Grant Applications) Now

Available 

123 
124