O UTREACH

N OTEBOOK

For the Inclusion, Recruitment and 

Retention of Women and 

Minority Subjects in Clinical Research

Hispanic or Latino ï Not Hispanic or Latino ï American Indian/Alaskan Native ï Asian ï Native Hawaiian or Other Pacific Islander ï Caucasian ïBlack or African American ï Hispanic or Latino ï Not Hispanic or Latino ï American Indian/Alaskan Native ï Asian ï Native Hawaiian or Other Pacific

Islander ï Caucasian ïBlack or African American ï Hispanic or Latino ï Not Hispanic or Latino ï American Indian/Alaskan Native ï Asian

U.S. DEPARTMENT OF HEALTH

AND HUMAN SERVICES

National Institutes of Health

Office of the Director
Outreach Notebook 

for the Inclusion, Recruitment 

and Retention of Women 

and Minority Subjects in 

Clinical Research

National Institutes of Health

Office of Research on Womenís Health

Office of Extramural Research

NIH Outreach Notebook Committee

NIH Tracking and Inclusion Committee

Principal Investigators’ Notebook

HOW TO USE THIS NOTEBOOK

December 2002

Dear Principal Investigator:

The information in this notebook may be of assistance to you and your research team 

in fulfilling your responsibilities for proper conduct of clinical research under applicable 

federal laws and regulations, and implementation of the updated 2001 NIH Guidelines on 

the Inclusion of Women and Minorities as Subjects in Clinical Research. This notebook serves 

as a complement to the updated NIH Guidelines on the Inclusion of Women and Minorities 

as Subjects in Clinical Research.

Outreach efforts for inclusion, recruitment and retention of research subjects necessarily 

span the entire clinical research spectrum, from small observational studies trials to the largest

Phase III clinical trials enrolling thousands. Primary prevention studies involving apparently 

disease-free individuals, as well as secondary and tertiary intervention involving individuals 

with diagnosed diseases, are included, as are studies in which the unit of observation is on the

entire community. The notebook does not mandate that participants from various populations 

be enrolled, nor is it a step-by-step guide through recruitment and retention. Rather, it furnishes

advice on inclusion criteria, provides an overview of key elements in recruitment and retention

processes, and suggests a number of practical applications, including ethical considerations.

Attention to these factors in the design of a research project will assist in the appropriate 

inclusion of women and minorities into studies.

Specific requirements for information needed in a grant application or contract proposal 

will depend on particulars of the study aims, design and other factors. The reader is urged 

to determine these requirements by reading carefully documents included in this book and 

iii
listed in the appendices under the section “Resources Available on the Internet.” This primer 

is an evolving document that will undergo review and revision in the future. Therefore, we 

welcome your comments for future editions of this book.

Sincerely,

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 

and Minority Subjects in Clinical Research iv

Vivian W. Pinn, M.D.

Director 

Office of Research on 

Women’s Health 

Office of the Director 

National Institutes of Health

J. Taylor Harden, Ph.D., 

R.N., FAAN

Outreach Notebook 

Committee Co-Chair 

Assistant to the Director 

for Special Populations 

National Institute on Aging 

National Institutes of Health

Mary C. Blehar, Ph.D.

Outreach Notebook 

Committee Co-Chair

Director, Women’s Mental 

Health Program

National Institute of 

Mental Health 

National Institutes of Health
v

National Institute on Aging

J. Taylor Harden, Co-Chair

National Institute of Mental Health

Mary C. Blehar, Co-Chair

Office of Research on Women’s Health 

Angela Bates

National Institute of Neurological 

Disorders and Stroke 

Gladys Melendez Bohler

Emory University

Otis Brawley

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

Joan McGowan

National Institute on Drug Abuse

Cora Lee Wetherington

NIH OUTREACH NOTEBOOK COMMITTEE

The committee wishes to extend its deepest appreciation to the NIH staff 

and those in the extramural community who contributed to the development 

of this notebook.

ACKNOWLEDGEMENT

The Outreach Committee is indebted to the NIH Tracking and Inclusion Committee and 

the Office of Extramural Research for their work in developing the Sex/Gender and Minority

Inclusion in Clinical Research: Staff Training notebook that served as the prototype for this 

document. A list of the members during the years 2001-2002 follows.

NIH TRACKING AND INCLUSION COMMITTEE 

*Indicates the lead representative from the Institute/Center

vii

Office of the Director

Yvonne Maddox

Office of Research on Women’s Health

Vivian Pinn (Co-Chair), Angela Bates, 

Lisa Begg, Joyce Rudick

Office of Extramural Research

Della Hann*, Larry Fanning, Carlos Caban,

Carla Flora, Vicki Fadeley, Donna Frahm,

Chuck Selden, Belinda Seto, Jim Tucker

Office of Acquisition, Management 

and Procurement

Zaiga Tums, Barbara Levy, Joann Wingard 

Center for Scientific Review

Elliot Postow*

Fogarty International Center

Kathleen Michels*, Janice Solomon

National Cancer Institute

Marvin Kalt*, Margaret Holmes, Diane

Bronzert, Marilyn Gaston, Joe Harford, 

Kim Witherspoon

National Center for Complementary 

and Alternative Medicine

Marguarite Evans*

National Center for Minority Health and 

Health Disparities

Eric Bailey*, John Ruffin

National Center for Research Resources

Louise Ramm*, Delores Lee, 

Patricia Newman, Stephen Seidel

National Eye Institute

Lore Anne McNicol*, Jack McLaughlin

National Heart, Lung, and Blood Institute

Carl Roth (Co-Chair), Barbara Liu, Nancy

Morris, Sharry Palagi, Ralph Van Wey

National Human Genome Research Institute

Monique Mansoura*, Joy Boyer

National Institute on Aging

Miriam Kelty*, Karen Bashir, Taylor Harden

National Institute on Alcohol 

Abuse and Alcoholism

Lorraine Gunzerath*, Mary Westcott

National Institute of Allergy and 

Infectious Diseases

Lai Tan*, Diane Adger-Johnson, 

Susan Schafer, Waquita Smith, 

Joyce Woodford, Diane Yerg
National Institute of Arthritis and 

Musculoskeletal and Skin Diseases

Christine Densmore*, Julia Freeman

National Institute of Biomedical Imaging 

and Bioengineering

Joan Harmon*

National Institute of Child Health 

and Human Development

Darlene Levenson*, Sandra Occhipinti

National Institute on Deafness and Other

Communication Disorders

Julie Gulya*, Sue Hamilton, Lynnette Hemsley

National Institute of Dental and 

Craniofacial Research

Norman Braveman*, Margo Adesanya, 

Trenita Davis, Lorrayne Jackson

National Institute of Diabetes, Digestive 

and Kidney Diseases

Beth Paterson*, Patricia Robuck

National Institute on Drug Abuse

Jack Manischewitz*, Mark Swieter

National Institute of Environmental 

Health Sciences

Martha Barnes*

National Institute of General 

Medical Sciences

John Matala*, Alison Cole

National Institute of Mental Health

Mary Lou Prince*, Mary Blehar, 

Pamela Wexler, Sue Kennell

National Institute of Neurological 

Disorders and Stroke

Meredith Temple*, Mary Ellen Michel, 

Connie Atwell, Gladys Melendez-Bohler

National Institute of Nursing Research

Carole Hudgings*, Robin Gruber

National Library of Medicine

Rita Richey*, Dwight Mowery

Warren G. Magnuson Clinical Center

Kim Jarema*, Dee Koziol

Office of Extramural Research

Della Hann

Office of Research on Women’s Health

Angela Bates

Office of Acquisition, Management and Procurement

Barbara Levy

National Cancer Institute

Kim Witherspoon

National Heart, Lung, and Blood Institute

Sharry Palagi

National Institute of Allergy 

and Infectious Diseases

Susan Schafer, Joyce Woodford

National Institute of Neurological Disorders 

and Stroke

Merideth Temple

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women viii and Minority Subjects in Clinical Research

SEX/GENDER AND MINORITY INCLUSION IN CLINICAL RESEARCH 

TRAINING WORKING GROUP
ix

CONTENTS

Letter to the Principal Investigator ....................................................................................................iii

NIH Outreach Notebook Committee .................................................................................................v

Acknowledgement .............................................................................................................................vii

Section 1

NIH Policies Involving the Inclusion of Women and Minorities: 

Review of the Inclusion Policy ............................................................................................1

I Why, When and What..............................................................................................................3

A Rationale – Why Does NIH Have the Inclusion Policy? .........................................................3

B Congressional Mandate..........................................................................................................4

II Amended Inclusion Policy (October 2001) .............................................................................5

A NIH Definition of Clinical Research.......................................................................................5

B NIH-Defined Phase III Clinical Trials – Further Clarification ................................................5

C New OMB Standards ............................................................................................................8

D Updated Roles and Responsibilities for Implementing the Policy ...............................................9

Section 2

Research Grants: How Does the Amended Policy Impact the 

Way NIH Does Business? .................................................................................................11

I Grant Applicants Pre-submission ..........................................................................................13

A Is It NIH-Defined Clinical Research?...................................................................................13

B Guidance for Principal Investigators .....................................................................................16

C Is It an NIH-Defined Phase III Clinical Trial?......................................................................17

D Implementing the New OMB Standards ...............................................................................18

II Review Considerations ...........................................................................................................20

A Applications That Fail to Address the Policy .........................................................................20

B Evaluation of Inclusion Description and Justifications for Clinical Research Grants...............20

C Evaluation of Inclusion Description and Justifications for NIH-Defined Phase III 

Clinical Trial Applications....................................................................................................23

D Assignment of Sex/Gender and Minority Codes....................................................................25

E Human Subjects Codes vs. Sex/Gender and Minority Codes ................................................28

F NIH-Defined Phase III Clinical Trials Coding .....................................................................29
III Progress Reports.......................................................................................................................29

A Policy Statement...................................................................................................................29

B The Final Progress Report ....................................................................................................29

Section 3

Research Contracts: How Does the Amended Policy Impact the 

Way NIH Does Business? .................................................................................................31

I Acquisition Planning and Proposal Submission ....................................................................33

A Is the Contract for Clinical Research?

(Additional Guidance and Examples)...................................................................................33

B Is the Contract for an NIH-Defined Phase III Clinical Trial?................................................37

C Implementing the New OMB Standards ...............................................................................38

II Technical Review/Evaluation Consideration ........................................................................40

A Evaluation of Inclusion Description and Justifications for Clinical Research 

Contract Proposals...............................................................................................................40

B Evaluation of Inclusion Descriptions and Justifications for NIH-defined Phase III 

Clinical Trial Proposals.........................................................................................................43

C Program/Project Officer Review of the Appropriateness of the Target Data ............................45

D Confirming the Analysis Plans for NIH-Defined Phase III Clinical Trials .............................46

E Human Subjects Comments/Evaluations vs. Sex/Gender and Minority 

Comments/Evaluations.........................................................................................................46

III Gender/Minority Issues – Process of Review and Resolution Is Needed Prior To Award ...........46

A Award Decisions – Contracting Officers...............................................................................46

B Monitoring of Information in Progress Reports......................................................................48

Section 4

Recruitment and Retention of Women and Minorities in Clinical Research: 

Elements of Outreach .......................................................................................................53

I Introduction.............................................................................................................................55

II Background..............................................................................................................................55

III Barriers to Recruitment and Retention of Women and Minorities .......................................56

A Fear and Distrust of the Research Enterprise.........................................................................56

B Lack of Knowledge...............................................................................................................57

C Lack of Transportation .........................................................................................................57

D Interference with Work and/or Family Responsibilities...........................................................57

E Subject Burden as a Result of Participation in a Clinical Study..............................................58

F Financial Costs ....................................................................................................................58

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women x and Minority Subjects in Clinical Research
IV Elements of Outreach..............................................................................................................58

A Element 1: Understand the Study Population........................................................................58

B Element 2: Establish an Explicit Outreach Plan....................................................................63

C Element 3: Achieve Agreement on Research Plans................................................................65

D Element 4: Design and Conduct Evaluations........................................................................66

E Element 5: Establish and Maintain Communication .............................................................69

V Successful Strategies ................................................................................................................71

VI Conclusion...............................................................................................................................75

Section 5

Human Subjects Protections and Inclusion Issues.................................................................77

I What Are the Ethical Principles that Govern My Research?................................................79

A Informed Consent ................................................................................................................80

B Conflict of Interest ...............................................................................................................81

II Data and Safety Monitoring Board (DSMB)..........................................................................82

III Institutional Review Board (IRB)...........................................................................................83

A What is the Role of the IRB? ................................................................................................83

B What are the Criteria for IRB Approval of Research?............................................................84

Section 6

Appendices...........................................................................................................................85

A Glossary....................................................................................................................................87

B Selected References.................................................................................................................93

C Amended NIH Policy and Guidelines on the Inclusion of Women and 

Minorities as Subjects in Clinical Research, Amended October 2001................................103

D NIH Policy on Reporting Population Data by Race and Ethnicity .....................................119

E Inclusion Table, Targeted/Planned Enrollment Table and 

Inclusion Enrollment Report Table ......................................................................................129

F Resources Available on the Internet.....................................................................................135

G Subpart B: Additional Protections for Pregnant Women, Human Fetuses 

and Neonates Involved in Research (45 CFR 46) ...............................................................137

H Powerpoint Slide Show: Sex/Gender and Minority Inclusion 

in NIH Clinical Research .....................................................................................................143

xi

Section 1

NIH Policies Involving the Inclusion 

of Women and Minorities: 

Review of the Inclusion Policy

REVIEW OF THE INCLUSION POLICY

I WHY, WHEN AND WHAT

A Rationale – Why Does NIH Have the Inclusion Policy?

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, 

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 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 they 

were excluded. It also stated that executive secretaries of scientific review groups 

should ensure that responsiveness to this 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 and 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) of NIH factored adherence to these policies into the scientific merit

review (2001 Annual Comprehensive Report: Monitoring Adherence to the NIH Policy on 

the Inclusion of Women and Minorities as Subjects in Clinical Research).

In addition to the concerns and issues raised by the advocacy community and 

Congress, ethical principles in conducting research with human subjects contributed 

to the development of the NIH inclusion policy. The ethical principle of justice highlights the importance for research to balance its burdens and benefits. In terms of the

inclusion of women and minorities as research participants, this speaks to the ethical

importance of ensuring that recruitment is conducted in a manner that is fair to 

women, men and persons from minority populations so that no group is unduly 

burdened and that no group is unduly benefited (McCarthy, 1994).

3
B Congressional Mandate

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

Congress enacted these policies into Public Law through a section in the NIH

Revitalization Act of 1993 (PL 103-43), 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. PL 103-43 essentially reinforced the existing NIH policies, but 

with four major differences. The new law requires that:

1 NIH ensure that women and minorities and their subpopulations be 

included in all human subject research;

2 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;

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

4 NIH initiate programs and support for outreach efforts to recruit and retain 

women and minorities and their subpopulations as volunteers in clinical studies.

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

Federal Register in March 1994, and they became effective in September 1994. The 

result was that NIH would not fund any grant, cooperative agreement or contract, 

or support any intramural project to be conducted or funded in Fiscal Year 1995 and 

thereafter, which did not comply with this policy. Research awards covered by this 

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

and on the race and ethnicity of research participants.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 4 and Minority Subjects in Clinical Research
II AMENDED INCLUSION POLICY (OCTOBER 2001)

In October 2001, NIH amended the Policy on Inclusion of Women and Minorities in 

Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html)

to clarify the policy in regards to definitions, roles and responsibilities.

A NIH Definition of Clinical Research

In June 2001, NIH adopted the definition of clinical research as: 

• Patient-oriented research. Research that is 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: 

mechanisms of human disease, therapeutic interventions, clinical trials, and 

development of new technologies; 

• Epidemiologic and behavioral studies; and 

• Outcomes research and health services research. 

Note: Studies falling under Exemption 4 for human subjects research are not 

considered clinical research by this definition.

B NIH-Defined Phase III Clinical Trials – Further Clarification 

For the purpose of the guidelines 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 control intervention or comparing two or more existing

treatments. Often the aim of such investigation is to provide evidence leading to a 

scientific basis for consideration of a change in health policy or standard of care.

The definition includes pharmacologic, nonpharmacologic and behavioral interventions

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

other population-based intervention trials are also included.

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,

NIH Policies Involving the Inclusion of Women and Minorities: Review of the Inclusion Policy 5

* The term gender refers to the classification of research subjects into either or both of two categories: women 

and men. Sex refers to biological sex, either male or female. For inclusion purposes, biological sex should be 

used, either male or female.
data derived from prior animal studies, clinical observations, metabolic studies, genetic

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

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

reporting an NIH-defined Phase III clinical trial. Based on prior studies, one of the 

three situations below will apply:

1 PRIOR STUDIES SUPPORT THE EXISTENCE OF SIGNIFICANT DIFFERENCES

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

of clinical or public health importance in intervention effect based on sex/gender,

racial/ethnic and relevant subpopulation comparisons, the primary question(s) to be

addressed by the proposed NIH-defined Phase III clinical trial and the design of that

trial must specifically accommodate this. 

For 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 depends

upon the amount of information in the data set. With a very large amount of 

information, one could find a small but statistically significant difference that is 

of very little clinical importance. Conversely, with less information one could 

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

For example, if prior research suggests that men and women 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 technical proposal (for contract 

solicitations) must include a description of plans to conduct analyses to detect 

significant differences in intervention effect 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.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 6 and Minority Subjects in Clinical Research
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 RULE OUT SIGNIFICANT DIFFERENCES

If the data from prior studies neither strongly support nor strongly rule out 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. 

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.

The research plan (for grant applications) or technical proposal (for contract 

solicitations) must include a description of plans to conduct valid analyses by 

sex/gender, racial/ethnic groups and relevant subpopulations, if applicable. The 

final protocol(s) approved by the IRB must include these plans for analysis. The 

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

NIH Policies Involving the Inclusion of Women and Minorities: Review of the Inclusion Policy 7
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 in 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.

C New OMB Standards

Office of Management and Budget (OMB) Directive No. 15 defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all federal

reporting (including NIH). The standards were revised in 1997 and now include two 

ethnic categories, Hispanic or Latino and Not Hispanic or Latino. There are five racial

categories: American Indian or Alaska Native; Asian; Black or African American; 

Native Hawaiian or Other Pacific Islander; and White.

1 DEFINITIONS FOR ETHNIC AND RACIAL CATEGORIES (OMB DIRECTIVE 15)

The categories in this classification are social-political constructs and should not 

be interpreted as being anthropological in nature. NIH is required to use these 

definitions to allow comparisons to other federal databases, especially the census 

and national health databases. Reports of data on race and ethnicity will use 

these categories.

2 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 be used in addition to “Hispanic or Latino.”

Not Hispanic or Latino

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 8 and Minority Subjects in Clinical Research
3 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 affiliation 

or community attachment.

Asian – A person having origins in any of the original peoples of the Far East, 

Southeast Asia or the Indian subcontinent including, for example, Cambodia, 

China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand 

and Vietnam. (Note: Individuals from the Philippine Islands have been recorded 

as Pacific Islanders in previous data collection strategies.)

Black or African American – A person having origins in any of the Black racial 

groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to 

“Black or African American.”

Native Hawaiian or Other Pacific Islander – A person having origins in any 

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

White – A person having origins in any of the original peoples of Europe, the 

Middle East or North Africa.

D Updated Roles and Responsibilities for Implementing the Policy

NIH staff provide educational opportunities for the extramural and intramural 

communities concerning this policy. In addition, staff are charged with monitoring 

the implementation of the policy during the development, review, award and conduct 

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

specific guidance on the roles and reponsibilities of the PI, please refer to Appendix C:

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

Subjects in Clinical Research.

The remaining sections of this workbook provide detailed information on the responsibilities of NIH program, review (including peer reviewers), grants management and 

contracts staff in implementing and ensuring compliance with the inclusion policy. 

Section 2 is devoted to implementation and procedures involving research grants, 

while Section 3 is devoted to implementation and procedures involving research 

contracts. Finally, Section 4 contains a list of resources available on the Internet 

regarding this policy. Although some of the following sections are directed to specific 

staff functional areas, it is important to remember that program, review, grants management and contracts each play a significant role and share in the responsibility 

for ensuring compliance. Understanding the role of your functional area and how 

it coordinates with others is encouraged.

NIH Policies Involving the Inclusion of Women and Minorities: Review of the Inclusion Policy 9

Section 2

Research Grants: 

How Does the Amended Policy Impact 

the Way NIH Does Business?

RESEARCH GRANTS:

HOW DOES THE AMENDED POLICY IMPACT

THE WAY NIH GRANTEES DO BUSINESS?

I GRANT APPLICANTS PRE-SUBMISSION

A Is It NIH-Defined Clinical Research?

The Principal Investigator (PI), in discussions with program staff, should determine 

if the application involves clinical research, as defined by NIH policy (see section 1:II.A. 

in this document). The following discussion provides additional guidance in making 

this determination. 

ADDITIONAL GUIDANCE

Research should be considered clinical research when the protocol involves either 

1 Direct interaction between the investigator (or colleague) and living individuals or 

2 Access to readily identifiable data that links directly to living individuals.

Readily identifiable data include any one of the following pieces of information: 

full name, address, birth date, social security number, financial account number, 

insurance policy number or unique coding that links directly to a living individual. 

Some clinical research issues such as genetics, genetic testing and linkage to families 

are still evolving and present questions regarding the protection of human subjects 

that are the focus of ongoing scientific and ethical debate and discussion. Thus, this 

additional guidance on determining what is NIH clinical research may be updated 

in the future.

The examples can be used to further clarify when studies are or are not considered 

clinical research.

EXAMPLES OF PATIENT-ORIENTED RESEARCH

Case 1 PI proposes to collect specimens from living volunteers and conduct analyses 

on a cell protein process hypothesized as a potential mechanism of disease.

Informed consent is obtained from the subjects, and data are stored with 

some readily identifiable information (i.e., data are easily linked back to 

the subject through subject’s ID).

Is this clinical research? Yes – PI is interacting directly with subjects and 

is collecting and storing readily identifiable data.

13
Case 2 Similar to Case 1, PI proposes to collect specimens from living volunteers 

and conduct analyses on a cell protein process hypothesized as a potential 

mechanism of disease. Informed consent is obtained. However, the data 

are stored with no readily identifiable data (i.e., no subject ID, date or 

other information that can be linked directly to the individual).

Is this clinical research? Yes – PI is directly interacting with subjects. 

Although data are stored in an unlinked manner, the protocol involves 

direct contact with a live individual.

Case 3 PI proposes to obtain stem cells from a company on the NIH registry. The 

company does maintain records that link the cell lines to specific individuals

(i.e., readily identifiable information). However, PI does not need access 

to the identifying information and the donor company is providing documentation that the identifying information will not be disclosed to PI. 

Is this clinical research? No – PI has no interaction with a living person 

and has no access to readily identifiable information.

Case 4 PI proposes to obtain stem cells from a company listed on the NIH registry. 

The company does maintain records that link the cell lines to specific 

individuals (i.e., readily identifiable information). PI does not need 

access to the identifying information. However, PI has no documentation from the company that identifying information will not be disclosed.

Is this clinical research? Yes – PI has no interaction with a living 

person but does have access to readily identifiable information. PI would 

need to obtain a letter from the company assuring that the readily identifiable

data will not be disclosed in order to consider this “not clinical research.”

Case 5 PI proposes to obtain samples from a specimen bank. Because of the nature of

the research question, readily identifiable information (e.g., birth date, home

address) will be needed and will be obtained from the specimen bank. However,

PI has no plans to make contact with a living donor.

Is this clinical research? Yes – Although PI is not directly interacting with 

individuals, PI has readily identifiable data.

Case 6 Similar to Case 5, PI proposes to obtain samples from a specimen bank, but 

the samples will all be from deceased individuals (e.g., brain bank). Readily 

identifiable information is available, and PI proposes to include this in 

the research.

Is this clinical research? No – PI has no interaction with a living individual.

Access to readily identifiable data from deceased individuals is not considered

clinical research.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 14 and Minority Subjects in Clinical Research
EXAMPLES OF EPIDEMIOLOGICAL, BEHAVIORAL, HEALTH SERVICES AND HEALTH OUTCOMES RESEARCH

Case 7 PI proposes to conduct secondary data analysis of epidemiological, behavioral 

or health services research. The initial data collection included readily identifiable information that is now part of the data set. However, PI has no plans 

for using the readily identifiable data or for re-contacting the subjects.

Is this clinical research? Yes – Although PI is not directly interacting with 

individuals, PI has access to readily identifiable data.

Case 8 PI proposes to conduct secondary data analysis of epidemiological, behavioral 

or health services data that are publicly available (e.g., census data) that have

been stored without readily identifiable information in the data set. Also, PI 

will obtain documentation from the owner of the data set that no readily 

identifiable data will be disclosed to PI.

Is this clinical research? No – PI neither interacts with individuals nor has

access to readily identifiable data.

Case 9 Similar to Case 8, PI proposes to conduct secondary data analysis of epidemiological, behavioral or health services data that have been stored without

readily identifiable information in the data set. The owner of the data set, 

however, does have readily identifiable information on the subjects. PI has 

no documentation from the owner of the data set that the readily identifiable

data will not be disclosed.

Is this clinical research? Yes – PI is not interacting with living individuals 

but could have access to readily identifiable data. Documentation would 

be needed from the owner of the data set stating that the readily identifiable information will not be disclosed in order to consider this “not 

clinical research.”

WHAT ABOUT THE HUMAN SUBJECTS EXEMPTIONS?

It is important to remember that an exemption to human subjects protection indicates 

that the research is considered to present low risk of harm to the subjects. It does not 

mean that subjects are not human. Thus, it is possible that low-risk research, which is

exempt from human subjects regulations, may still be considered clinical research. 

Case 10 PI proposes research on normal educational practices and is not recording 

data in such a manner that identifies the human subjects (Human Subjects

Exemption 1 & 2).

Is this clinical research? Yes – PI has direct interaction with living individuals.

Research Grants 15
Case 11 PI proposes research on existing data (biological and/or behavioral) that 

are publicly available and cannot be linked to the subjects (Human 

Subjects Exemption 4).

Is this clinical research? No – PI neither has contact with living 

individuals nor is working with readily identifiable data.

Case 12 PI proposes research to evaluate public benefits programs (Human 

Subjects Exemption 5).

Is this clinical research? Yes – PI is coming into direct contact with 

living individuals.

Case 13 PI proposes taste, food quality evaluations or consumer acceptance studies

(Human Subjects Exemption 6).

Is this clinical research? Yes – PI is coming into direct contact with 

living individuals.

B Guidance for Principal Investigators

IF THE APPLICATION INVOLVES CLINICAL RESEARCH, PI SHOULD KNOW THAT:

a NIH policy requires that women and members of minority groups and their 

subpopulations be included in all NIH-supported clinical research.

b Inclusion must be addressed in developing the research design appropriate to 

the scientific objectives of the study.

c Inclusion is required unless:

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

2) Inclusion is inappropriate for the purpose of the study; or

3) Inclusion is inappropriate for some other reason, for which a compelling 

justification is made.

d Cost is not an acceptable reason for exclusion except when the study would 

duplicate data from other sources.

e Women of childbearing potential should not be excluded routinely from 

participation in clinical research.

f This policy applies to research subjects of all ages.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 16 and Minority Subjects in Clinical Research
In the PHS 398 Instructions (5/01), the inclusion of women and minorities is now 

part of Section E: Human Subjects Research. PIs are instructed to include a section 

heading entitled “Inclusion of Women” and a separate section heading entitled “Inclusion 

of Minorities.” No page limitation applies to this section, but PIs are encouraged to be 

succinct. These sections must provide information on the composition of the proposed

study population in terms of sex/gender and racial/ethnic groups and provide a rationale 

for selection of such subjects in terms of the scientific objectives and proposed study

design. The description should include (but is not limited to) information on the 

population characteristics of the disease or condition under study, national and local

demography, knowledge of the racial/ethnic/cultural characteristics of the population, 

prior experience and collaborations in recruitment and retention of the populations 

and subpopulations to be studied, and the plans, arrangements and letters of commitment from relevant community groups and organizations for the planned study.

These sections must include the following information:

• A description of the subject selection criteria and rationale for selection in terms 

of the scientific objectives and proposed study design.

• A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group.

• The proposed dates of enrollment (beginning and end).

• A description of proposed outreach programs for recruiting women and minorities 

in clinical research as subjects.

• The proposed sample composition using the “5/01 Targeted/Planned Enrollment 

Format Page” and/or the “5/01 Enrollment Report Format Page.” 

If PI believes that the proposed research is not clinical research yet does involve 

human subjects, then PI should justify this position in the Human Subjects section 

of the application. There are no page limitations for this section; therefore PI may 

justify this position in as much detail as deemed appropriate. 

C Is It an NIH-Defined Phase III Clinical Trial?

If the application contains an NIH-defined Phase III clinical trial (as defined in 

Section 2: I.A.1 above), then PI must address whether he/she expects to find clinically

important sex/gender and/or race/ethnicity differences in the intervention effect. The 

discussion may include supporting evidence and/or data derived from prior animal 

studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, 

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

Research Grants 17
The research plan must include one of the following:

• Plans to conduct valid analyses to detect significant differences in intervention 

effect among sex/gender and/or racial/ethnic subgroups (when prior studies 

strongly support these significant differences among subgroups).

or

• Plans to include and analyze sex/gender and/or racial/ethnic subgroups (when prior 

studies strongly support no significant differences in intervention effect between 

subgroups). (Representation of sex/gender and/or racial/ethnic groups as subject 

selection criterion is not required; however, inclusion and analyses are encouraged.)

or

• Plans to conduct valid analyses of the intervention effect in sex/gender and/or

racial/ethnic subgroups without requiring high statistical power for each subgroup 

(when the prior studies neither support nor rule out significant differences in 

intervention effect between subgroups.) 

D Implementing the New OMB Standards

1 IMPACT ON DATA COLLECTION

When an investigator is planning data collection items on ethnicity and race, 

categories identified in the definitions for “Ethnic and Racial Categories (OMB

Directive 15)” should be used. (See item C.3 below). 

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

and race, PI should use two separate questions with ethnicity information, 

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

of this two-question format can be found in the PHS 398 Personal Data Form

(http://grants1.nih.gov/grants/funding/phs398/personal.pdf).

The 5/01 Targeted/Planned Enrollment Table Format Page

(http://grants1.nih.gov/grants/funding/phs398/enrollment.pdf)

and 5/01 Inclusion Enrollment Report Table Format Page

(http://grants1.nih.gov/grants/funding/phs398/enrollment report.pdf) 

are not to be used for data collection from study participants.

2 IMPACT ON REPORTING DATA

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

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

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 18 and Minority Subjects in Clinical Research
only one category for each of the five racial categories; (c) the total number of 

respondents who selected multiple racial categories reported as the “number 

selecting more than one race”; and, (d) the number of respondents in each racial 

category who are Hispanic or Latino. PI may provide the detailed distributions, 

including all possible combinations, of multiple responses to the racial designations 

as a comment section below the data table or as an attachment to the table. 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.

3 THE NEW TARGET AND ENROLLMENT FORMS

PI should provide the following materials in the applications described in bold type.

a New Applications (type 1), Competing Continuations (type 2), and 

Intramural Projects Submitting Applications Involving the Collection 

of New/Additional Data in Clinical Research: 

Investigators should provide plans for the total number of subjects proposed for 

the study, the distribution by ethnic/racial categories and sex/gender, and the 

study title. This information must be reported using the newly revised categories 

in OMB Directive 15 and according to the new format provided in the 5/01

Targeted/Planned Enrollment table. If there is more than one study, a separate 

table should be provided for each study. Any proposed racial/ethnic subpopulations should be listed below the table or as an attachment. 

b New Applications Using Existing Data in Clinical Research with No Plans 

for Collecting New/Additional Data: 

For each study, investigators should provide plans for the total number of subjects

proposed for the study and the distribution by ethnic/racial categories and sex/

gender. Under these circumstances, PIs are not required to re-contact subjects 

solely to comply with the newly revised categories. If the existing data on ethnicity 

and race accurately correspond with the new categories in OMB Directive 15, 

PI can use the format in the 5/01 Targeted/Planned Enrollment table. However, 

if the existing data do not allow accurate correspondence with the new categories,

then PI may report the information using the former categories and according 

to the format in the 4/98 version of the Inclusion Table

http://grants1.nih.gov/grants/funding/women_min/Inclusion Old_Form.pdf

Research Grants 19
II REVIEW CONSIDERATIONS 

A Applications That Fail to Address the Policy

Prior to review, NIH staff should identify applications that fail to address the inclusion 

of women and minorities as subjects in clinical research. Failing to address the policy 

in an application may include either or both of the following:

• No description or section on the inclusion of women 

• No description or section on the inclusion of minorities 

The Scientific Review Administration (SRA) will contact the applicant and request 

that this information be provided prior to review. If applicants do not respond to this

request for additional materials, the application may be deferred for review until the 

additional materials are provided. 

B Evaluation of Inclusion Description and Justifications for Clinical Research Grants

During initial peer review, the Scientific Review Group (SRG) evaluates the proposed

plan for the inclusion of women and minorities for appropriate representation or to 

evaluate the proposed justification when representation is limited or absent for each 

project involving human subjects in clinical research. 

In evaluating inclusion plans, reviewers will provide a brief narrative to answer each 

of the following questions separately for women and minorities:

INCLUSION

• Does the applicant propose a plan for the inclusion of minorities and both 

sexes/genders for appropriate representation?

• How does the applicant address the inclusion of women and members of minority 

groups and their subpopulations in the development of a research design that is 

appropriate to the scientific objectives of the study?

• Does the research plan describe the composition of the proposed study population 

in terms of sex/gender and racial/ethic groups?

• Does the research plan provide a rationale for the selection and composition 

of subjects?

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 20 and Minority Subjects in Clinical Research
EXCLUSION

• Does the applicant propose justification when representation is limited or absent?

• Does the applicant propose exclusion of minorities and women on the basis that a

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

and/or with respect to the purpose of the research?

On the basis of the information provided in the application, reviewers evaluate 

the inclusion plans as “Absent,” “Acceptable” or “Unacceptable.”

SRAs should inform reviewers that when either the sex/gender inclusion plan and/or 

the minority inclusion plan are “Absent,” reviewers should contact the SRA immediately.

The SRA will determine if the application should be deferred for failing to address 

the inclusion policy.

1 EVALUATING SEX/GENDER INCLUSION PLANS

If the plans described in the inclusion of women section are judged “Unacceptable,”

then, the unacceptability must be reflected in the priority score assigned to the 

application. Criteria for unacceptable inclusion plans include:

• Representation that fails to conform to the NIH Policy on the Inclusion of 

Women and Minorities as Subjects in Clinical Research in relation to the 

scientific purpose of the study.

• The application provides insufficient information.

• The application does not adequately justify limited representation.

The sex/gender inclusion plan may be judged “Acceptable” based on one or 

more of the following:

• Both sexes/genders are included in the study in scientifically appropriate numbers.

• One sex/gender is excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their health;

– The research question addressed is relevant to only one sex/gender;

– Evidence from prior research strongly demonstrates no difference between

sexes/genders; or

– Sufficient data already exist with regard to the outcome of comparable studies 

in the excluded sex/gender and duplication is not needed in this study.

Research Grants 21
• One sex/gender is excluded or severely limited because the purpose of the research

constrains the applicant’s selection of study subjects by sex/gender (e.g., uniquely

valuable stored specimens or existing datasets are single sex/gender; very small 

numbers of subjects are involved; or overriding factors dictate selection of subjects,

such as matching of transplant recipients, or availability of rare surgical specimens).

• Sex/gender representation of specimens or existing data sets cannot be accurately

determined (e.g., pooled blood samples, stored specimens or data sets with 

incomplete sex/gender documentation are used), and this does not compromise 

the scientific objectives of the research.

2 EVALUATING MINORITY INCLUSION PLANS

If the plans described in the inclusion of minorities section are judged “Unacceptable,” the unacceptability must be reflected in the priority score assigned to the 

application. Criteria for unacceptable minority inclusion plans include:

• Representation that fails to conform to the NIH Policy on the Inclusion of 

Women and Minorities as Subjects in Clinical Research in relation to the 

scientific purpose of the study.

• The application provides insufficient information.

• The application does not adequately justify limited representation of minority 

groups or subgroups.

• The application does not realistically address recruitment/retention of minority

groups or subgroups.

The minority inclusion plan may be judged “Acceptable” based on one or more 

of the following:

• Minority individuals are included in scientifically appropriate numbers.

• Some or all minority groups or subgroups are excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their health;

– The research question addressed is relevant to only one racial or ethnic group;

– Evidence from prior research strongly demonstrates no differences between 

racial or ethnic groups on the outcome variables;

– A single minority group study is proposed to fill a research gap;

– Significant data already exist with regard to the outcome of comparable studies 

in the excluded racial or ethnic groups and duplication is not needed in this study.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 22 and Minority Subjects in Clinical Research
• Some minority groups or subgroups are excluded or poorly represented because 

the geographical location of the study has only limited numbers of these minority

groups who would be eligible for the study, and the investigator has satisfactorily

addressed this issue in terms of:

– The size of study;

– The relevant characteristics of the disease, disorder or condition;

– The feasibility of making collaboration or consortium or other arrangements 

to include representation.

• Some minority groups or subgroups are excluded or poorly represented because 

the purpose of the research constrains the applicant’s selection of study subjects 

by race or ethnicity (e.g., uniquely valuable cohorts, stored specimens or existing

datasets are of limited minority representation, very small numbers of subjects 

are involved or overriding factors dictate selection of subjects, such as matching 

of transplant recipients or availability of rare surgical specimens).

• Racial or ethnic origins of specimens or existing datasets cannot be accurately 

determined (e.g., pooled blood samples, stored specimens or data sets with 

incomplete racial or ethnic documentation are used) and this does not compromise the scientific objectives of the research.

Note: Elements in evaluating minority inclusion are different from elements in 

the evaluation of sex/gender inclusion. 

C Evaluation of Inclusion Description and Justifications for NIH-Defined 

Phase III Clinical Trial Applications

For NIH-defined Phase III clinical trials, the instructions to reviewers also include 

evaluation of the design and data analysis plans for examining intervention effects 

based on sex/gender and ethnicity/race differences.

1 THE SEX/GENDER INCLUSION PLAN MAY BE JUDGED ìACCEPTABLEî BASED ON ONE OR MORE

OF THE FOLLOWING:

• Available evidence strongly indicates significant sex/gender differences of 

clinical or public health importance in intervention effect and the study 

design is appropriate to answer two separate primary questions – one for 

males and one for females – with adequate sample size for each sex/gender. 

The research plan must include a description of plans to conduct analyses to 

detect significant differences in intervention effect.

Research Grants 23
Remember: 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 depends upon the amount of information in the data set. 

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

significant difference that is of very little clinical importance. Conversely, with 

less information one could find a large difference of potential clinical importance that is not statistically significant.

• Available evidence strongly indicates there is no significant difference of clinical 

or public health importance between males and females in relation to the study 

variables. Representation of both sexes/genders is not required; however, 

inclusion of both sexes/genders is encouraged.

• There is no clear-cut scientific evidence to rule out significant differences of 

clinical or public health importance between males and females in relation to 

the study variables, and the study design includes sufficient and appropriate 

representation of both sexes/genders to permit valid analyses of differential 

intervention effect. The research plan must include a description of plans to 

conduct the valid analysis of the intervention effect.

Remember: For the purpose of this policy, 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.

• One sex/gender is excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their 

health; or

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 24 and Minority Subjects in Clinical Research
– Inclusion of these individuals would be inappropriate with respect to the 

purposes of the research (e.g., the research question addressed is only relevant 

to one sex/gender).

2 THE MINORITY INCLUSION PLAN MAY BE JUDGED ìACCEPTABLEî BASED ON ONE OR MORE

OF THE FOLLOWING:

• Available evidence strongly indicates significant racial or ethnic differences 

of clinical or public health importance in intervention effect, and the study 

design is appropriate to answer separate primary questions for each of the relevant

racial or ethnic subgroups, with adequate sample size for each. The research plan 

must include a description of plans to conduct analyses to detect significant differences 

in intervention effect. (See definition of “significant differences” in Section 2: II.C.1.) 

• Available evidence strongly indicates there are no significant differences of clinical 

or public health importance among racial or ethnic groups or subgroups relation to

the study variables. Minority representation is not required as a subject selection 

criterion; however, inclusion of minority group or subgroup members is encouraged.

• There is no clear-cut scientific evidence to rule out significant differences of 

clinical or public health importance among racial or ethnic groups or subgroups 

in relation to the effects of study variables, and the study design includes sufficient

and appropriate representation of minority groups to permit valid analyses of 

differential intervention effect. The research plan must include a description of plans 

to conduct the valid analysis of the intervention effect in subgroups. (See definition of 

“valid analyses” in Section 2: II.C.1.)

• Some minority groups or subgroups are excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their 

health; or

– Inclusion of these individuals would be inappropriate with respect to the 

purposes of the research (e.g., the research question addressed is not relevant 

to all subgroups).

D Assignment of Sex/Gender and Minority Codes

For single project applications, reviewers assign an overall code as described below. 

For multi-project applications, a code should be assigned to each individual project 

or subproject in an application containing multiple projects or involving distinct 

Research Grants 25
populations or specimen collections. If only one project in a multi-project application

involves clinical research, the codes assigned to that project will apply to the overall 

document; if there is more that one project covered by the policy, reviewers also assign 

an overall code to the entire application as follows:

1 GENDER CODES

Format: Each code is a three-digit alphanumeric string:

• First character G (indicates sex/gender code)

• Second character 1, 2, 3, or 4 (representation proposed in project – see below)

• Third character A or U (acceptable or unacceptable – see below)

Representation Proposed in Project (second character)

1 = both sexes/genders

2 = only women

3 = only men

4 = sex/gender unknown

Gender Codes (first character)

Scientific Acceptability

Gender Representation Acceptable Unacceptable

Both included G1A G1U

Women only G2A G2U

Men only G3A G3U

Unknown G4A G4U

Acceptability/Unacceptability of Representation of Women (third character)

A = Representation is scientifically acceptable and recruitment/retention has 

been realistically addressed, or an acceptable justification for exclusion 

has been provided.

U = Representation is unacceptable. Application fails to conform to NIH policy 

guidelines in relation to the scientific purpose of the study, fails to provide 

sufficient information, does not adequately justify exclusion of women 

subjects, or does not realistically address recruitment/retention.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 26 and Minority Subjects in Clinical Research
2 MINORITY CODES

The inclusion of racial/ethnic groups should be determined by the scientific questions

under examination and their relevance to racial and ethnic groups. Applications should

describe the subgroups that will be included in the research. It is not anticipated that

every study will include all minority groups and subgroups.

In foreign research projects involving clinical research, the definition of minority groups

may be different than in the United States; if there are scientific reasons for examining

minority group or subgroup differences in such settings, studies should be designed to

accommodate such differences.

Format: Each code is a three-digit alphanumeric string:

• First character M (indicated minority code)

• Second character 1, 2, 3, 4, or 5 (representation proposed in project – see below)

• Third character A or U (scientifically acceptable or unacceptable – see below)

Representation Proposed in Project (second character)

1 = minority and non-minority

2 = only minority

3 = only non-minority

4 = minority representation unknown

5 = only foreign subjects in study population (no U.S. subjects). If the study 

population includes both foreign and U.S. study subjects then use codes 1 thru 

4 to describe the U.S. component (do not use code 5).

Acceptability/Unacceptability of Representation of Minorities (third character)

A = Representation is scientifically acceptable and recruitment/retention has been realistically addressed, or an acceptable justification for exclusion has been provided.

U = Representation is unacceptable. Application fails to conform to NIH policy guidelines in relation to the scientific purpose of the study, fails to provide sufficient

information, does not adequately justify exclusion of minority consideration in 

subjects, or does not realistically address recruitment/retention.

Research Grants 27
Minority Codes

Scientific Acceptability

Minority Representation Acceptable Unacceptable

Minorities and Non-minorities included M1A M1U

Minorities only M2A M2U

Non-minorities M3A M3U

Unknown M4A M4U

Foreign M5A M5U

E Human Subjects Codes vs. Sex/Gender and Minority Codes

PIs should remember that the comments and coding in reference to human subjects 

protections are separate from the comments and coding in reference to the inclusion 

of women and minorities in clinical research.

1 HUMAN SUBJECTS RESEARCH CODES

In the human subjects research section of the PHS 398, applicants must address 

the involvement of human subjects and protections from research risk relating to 

their participation in the proposed research plan. Exemption codes are used to claim 

an exemption from the human subjects regulations. Also, reviewers indicate whether

the proposed research raises human subjects concerns (coded as a 44 by the SRA) 

or if no concerns were raised by the reviewers. 

The exemption code and human subjects concern code are indicated on the summary

statement. The coding information is entered into IMPAC II by review staff.

2 SEX/GENDER AND MINORITY REPRESENTATION CODES

Also in the human subjects research section, if the research is clinical research, 

applicants must address the representation and involvement of women and minorities 

in the research. Reviewers evaluate the scientific acceptability of the inclusion plans

and use the gender and minority codes in this evaluation. 

Sex/Gender codes and minority codes are separate from human subject concerns 

and exemptions.

Sex/Gender and minority codes are indicated on the summary statement. 

The coding information is entered into IMPAC II by review staff. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 28 and Minority Subjects in Clinical Research
F NIH-Defined Phase III Clinical Trials Coding

Review also serves a vital role in determining whether the proposed research is:

• Yes – an NIH-defined Phase III clinical trial;

• No – not a Phase III trial, but is clinical research;

• X – not clinical research or is unscored and does not require 

sex/gender and/or minority codes.

Determination of this code is the responsibility of the review staff, based on 

information in the application, discussions at the review meeting, and their 

knowledge of the field. The Phase III clinical trial code is indicated on the 

summary statement. The coding information is entered into IMPAC II by 

review staff.

III PROGRESS REPORTS 

A Policy Statement

Research awards covered by this policy require an annual progress report on enrollment of women and men, and on the race and ethnicity of research participants so 

that accrual can be monitored. Progress reports must contain information on research 

progress, which includes research participant enrollment and retention. Progress and/or

final analyses based on sex/gender, race/ethnicity and relevant subpopulation differences

are encouraged for all clinical research awards and are required for NIH-defined Phase 

III clinical trials. NIH has the authority to delay, withhold, remove expanded authorities or terminate an award that does not comply with the inclusion policy.

B Final Progress Report

A final progress report is required within 90 days of the end of grant support unless 

an extension is issued by the grants management staff. The final progress report for 

clinical research studies is required to include a summary of the final cumulative 

enrollment of subjects by sex/gender and race/ethnicity. 

Research Grants 29
Failure to provide accurate and timely final reports may affect the future funding to 

your organization or awards with the same investigators. NIH has the authority to delay

funding of subsequent awards to the organization or investigator until satisfactory 

information is received. 

For NIH-defined Phase III clinical trials, the final progress report also must include final

analyses of intervention effect by sex/gender and race/ethnicity or provide a justification

and plan for ensuring completion of these analyses and reporting to NIH. Failure to 

provide these analyses may affect the future funding to the organization or awards to 

the PI. NIH has the authority to delay funding of subsequent awards to the organization 

or investigator until satisfactory information is received.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 30 and Minority Subjects in Clinical Research
Section 3

Research Contracts: 

How Does the Amended Policy Impact 

the Way NIH Does Business?

RESEARCH CONTRACTS: 

HOW DOES THE AMENDED POLICY

IMPACT THE WAY NIH DOES BUSINESS?

I ACQUISITION PLANNING AND PROPOSAL SUBMISSION

Program Staff/Project Officers, Contracting Officers and Offerors

A Is the Contract for Clinical Research?

The contract specialist and the program staff/project officer will discuss the 

requirement during the acquisition planning phase to determine whether the 

acquisition is for NIH-defined clinical research. The following provides additional 

guidance in making this determination. 

ADDITIONAL GUIDANCE

Research will be considered “clinical research” when the protocol/acquisition involves

either direct interaction between the investigator (or colleague) and living individuals or access to readily identifiable data that links directly to living individuals.

“Readily identifiable data” includes any one of the following pieces of information: 

full name, address, birth date, social security number, financial account number, 

insurance policy number or unique coding that links directly to a living individual. 

Note: Some clinical research issues such as genetics, genetic testing and linkage to 

families are evolving and present questions regarding the protection of human subjects 

that are the focus of scientific debate and discussion. Thus, this additional guidance 

on determining what is NIH clinical research may be updated in the future.

The following examples further clarify when studies are or are not considered 

clinical research.

EXAMPLES OF PATIENT-ORIENTED RESEARCH

Case 1 The principal investigator (PI) will collect specimens from living volunteers 

and conduct analyses on a cell protein process hypothesized as a potential 

mechanism of disease. Informed consent is obtained from the subjects, and 

data are stored with some readily identifiable information (i.e., data are easily

linked back to the subject through subject’s ID).

Is this clinical research? Yes – PI is interacting directly with subjects and 

is collecting and storing readily identifiable data.

33
Case 2 Similar to Case 1, PI will collect specimens from living volunteers and 

conduct analyses on a cell protein process hypothesized as a potential 

mechanism of disease. Informed consent is obtained. However, the data 

are stored with no readily identifiable data (i.e., no subject ID, date or 

other information that can be linked directly to the individual).

Is this clinical research? Yes – PI is directly interacting with subjects. 

Although data are stored in an unlinked manner, the protocol involves 

direct contact with a live individual.

Case 3 PI will obtain stem cells from a company on the NIH registry. The company 

does maintain records that link the cell lines to specific individuals (i.e., 

readily identifiable information). However, PI does not need access to 

the identifying information and the donor company is providing documentation that the identifying information will not be disclosed to PI. 

Is this clinical research? No – PI has neither interaction with a living 

person nor access to readily identifiable information.

Case 4 PI will obtain stem cells from a company listed on the NIH registry. The 

company does maintain records that link the cell lines to specific individuals (i.e., readily identifiable information). PI does not need access to 

the identifying information. However, PI has no documentation from 

the company that identifying information will not be disclosed.

Is this clinical research? Yes – PI has no interaction with a living person 

but does have access to readily identifiable information. PI would need to 

obtain a letter from the company assuring that the readily identifiable data 

will not be disclosed in order to consider this “not clinical research.”

Case 5 PI will obtain samples from a specimen bank. Because of the nature of the

research, readily identifiable information (e.g., birth date, home address) 

will be needed and will be obtained from the specimen bank. However, 

PI has no plans to make contact with a living donor.

Is this clinical research? Yes – Although PI is not directly interacting 

with individuals, PI has readily identifiable data.

Case 6 Similar to Case 5, PI will obtain samples from a specimen bank, but the 

samples will all be from deceased individuals (e.g., brain bank). Readily 

identifiable information is available, and PI proposes to include this 

in the research.

Is this clinical research? No – PI has no interaction with a living individual.

Access to readily identifiable data from deceased individuals is not considered

clinical research.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 34 and Minority Subjects in Clinical Research
EXAMPLES OF THE EPIDEMIOLOGICAL, BEHAVIORAL, HEALTH SERVICES AND HEALTH OUTCOMES RESEARCH

Case 7 PI will conduct secondary data analysis of epidemiological, behavioral 

or health services research. The initial data collection included readily 

identifiable information that is now part of the data set. However, PI has no

plans for using the readily identifiable data or for re-contacting the subjects.

Is this clinical research? Yes – PI is not directly interacting with 

individuals, but does have access to readily identifiable data.

Case 8 PI will conduct secondary data analysis of epidemiological, behavioral or 

health services data that are publicly available (e.g., census data) that have 

been stored without readily identifiable information in the data set. Also, 

PI will obtain documentation from the owner of the data set that no readily

identifiable data will be disclosed to PI.

Is this clinical research? No – PI neither interacts with individuals nor 

has access to readily identifiable data.

Case 9 Similar to Case 9, PI will conduct secondary data analysis of epidemiological,

behavioral or health services data that have been stored without readily 

identifiable information in the data set. The owner of the data set, however, 

does have readily identifiable information on the subjects. PI has no documentation from the owner of the data set that the readily identifiable data 

will not be disclosed.

Is this clinical research? Yes – PI is not interacting with living individuals 

but could have access to readily identifiable data. Documentation would 

be needed from the owner of the data set stating that the readily identifiable information will not be disclosed in order to consider this “not 

clinical research.”

WHAT ABOUT THE HUMAN SUBJECTS EXEMPTIONS?

It is important to remember that an exemption to human subjects research designates 

that the research is considered to pose a low risk of harm to the subjects. It does not 

mean that subjects are not human. Thus, it is possible that low-risk research, which is 

exempt from human subjects regulations, may still be considered clinical research. 

Case 10 PI will conduct research on normal educational practices and is not 

recording data in such a manner that identifies the human subjects 

(Human Subjects Exemption 1 & 2).

Is this clinical research? Yes – PI has direct interaction with living individuals.

Research Contracts 35
Case 11 PI will conduct research on existing data (biological and/or behavioral) that 

are publicly available and cannot be linked to the subjects (Human Subjects

Exemption 4).

Is this clinical research? No – PI neither has contact with living individuals 

nor is working with readily identifiable data.

Case 12 PI will conduct Departmental research to evaluate public benefits programs

(Human Subjects Exemption 5).

Is this clinical research? Yes – PI has direct contact with living individuals.

Case 13 PI will perform taste, food quality evaluations or consumer acceptance studies

(Human Subjects Exemption 6).

Is this Clinical Research? Yes – PI has direct contact with living individuals.

1 IF THE ACQUISITION IS FOR CLINICAL RESEARCH

If it is determined that the acquisition is for clinical research, then the resultant 

acquisition plan/request for contract will so state and the resultant solicitation/

request for proposals will inform prospective offerors of the following requirements: 

a NIH policy requires that women and members of minority groups and their 

subpopulations be included in all NIH-supported clinical research.

b Inclusion must be addressed in developing the technical proposal appropriate 

to the scientific objectives of the study.

c Inclusion is required unless:

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

2) Inclusion is inappropriate for the purpose of the study; and/or

3) Inclusion is inappropriate for some other reason, for which a justification is made. 

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

data from other sources. 

e Women of childbearing potential should not be excluded routinely from participation

in clinical research. 

f This policy applies to research subjects of all ages.

In a separate section of the technical proposal (entitled “Human Subjects,” and 

which should encompass all human subjects issues) the offeror must provide information on the composition of the proposed study population in terms of sex/gender 

and racial/ethnic groups and provide a rationale for selection of such subjects in 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 36 and Minority Subjects in Clinical Research
terms of the scientific objectives of the acquisition. The description should include 

(but is not limited to) information on the population characteristics of the disease or 

condition under study, national and local demography, knowledge of the racial/ethnic/

cultural characteristics of the population, prior experience in recruitment and retention

of the populations and subpopulations to be studied, and the plans, arrangements and

letters of commitment from relevant community groups and organizations.

This section of the technical proposal must include the following information: 

• A description of the subject selection criteria and rationale for selection in 

response to the statement of work in the request for proposals, or in terms of 

the scientific objectives and proposed study design. 

• A compelling rationale for proposed exclusion of any sex/gender or racial/

ethnic group.

• The proposed dates of enrollment (beginning and end).

• A description of proposed outreach programs for recruiting women and minorities 

in clinical research as subjects.

• The proposed sample composition using the 5/01 “Targeted/Planned Enrollment 

Table” (modified in the NCI Workform 10/01) and/or the 5/01 “Inclusion Enrollment

Report ” (modified in the NCI Workform 10/01). (See NCI RFP workform – 

section J, attachments at http://rcb.cancer.gov/rcb-internet/forms/forms.htm.)

2 IF THE ACQUISITION IS NOT CLINICAL RESEARCH YET INVOLVES HUMAN SUBJECTS

If the offeror believes that the proposed research is not clinical research yet does 

involve human subjects, the offeror must justify this position in the section on 

human subjects in the technical proposal. The offeror must explain its rationale 

in as much detail as deemed appropriate.

B Is the Contract for an NIH-Defined Phase III Clinical Trial?

If the acquisition is for an NIH-defined Phase III clinical trial (see section 1: II.B. in 

this document), the solicitation will inform prospective offerors that the separate section of the technical proposal must contain the elements stated in section 3: I.A.1 

above and address whether the offeror expects to find clinically important sex/gender

and/or race/ethnicity differences in the intervention effect. The proposal may include 

supporting evidence and/or data derived from prior animal studies, clinical observations,

metabolic studies, genetic studies, pharmacology studies, and observational, natural 

history, epidemiology and other relevant studies.

Research Contracts 37
The proposal must include one of the following elements:

• Plans to conduct valid analyses to detect significant differences in intervention 

effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly 

support these significant differences among subgroups.

or

• Plans to include and analyze sex/gender and /or racial/ethnic subgroups when prior 

studies strongly support no significant differences in intervention effect between subgroups.

(Representation of sex/gender and/or racial/ethnic groups as subject selection 

criterion is not required; however, inclusion and analyses are encouraged.)

or

• Plans to conduct valid analyses of the intervention effect in sex/gender and/or

racial/ethnic subgroups (without requiring high statistical power for each subgroup)

when the prior studies neither support nor negate significant differences in intervention 

effect between subgroups.

C Implementing the New OMB Standards 

1 IMPACT ON DATA COLLECTION

When an investigator is planning data collection items on ethnicity and race, 

categories identified in the definitions for ethnic and racial categories (OMB 

Directive 15) should be used. (See item C.3 below.) 

Using 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. 

An example of this two-question format can be found in the PHS 398 Personal 

Data Form (http://grants.nih.gov/grants/funding/phs398/personal.pdf).

The 5/01 Targeted/Planned Enrollment Table (modified in the NCI 

Workform 10/01) and 5/01 Inclusion Enrollment Report (modified 

in the NCI Workform 10/01, Attachment J – http://rcb.cancer.gov/

rcb-internet/forms/forms.htm) are not to be used by the principal 

investigator for data collection from study participants.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 38 and Minority Subjects in Clinical Research
2 IMPACT ON REPORTING DATA

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

number of respondents in each ethnic category; (b) the number of respondents 

who selected only one category for each of the five racial categories; (c) the total 

number of respondents who selected multiple racial categories reported as the 

“number selecting more than one race”; and (d) the number of respondents in each

racial category who are Hispanic or Latino. Investigators may provide the detailed 

distributions, including all possible combinations, of multiple responses to the racial 

designations as additional information. 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.

3 THE NEW TARGET AND ENROLLMENT FORMS

Offerors should provide the following materials in the proposals described in bold type.

a Proposals Involving the Collection of New/Additional Data in Clinical Research

For each study, offerors should provide plans for the total number of subjects proposed, the distribution by ethnic/racial categories and sex/gender, and the study 

title. For each study, a separate table should be provided. This information must 

be reported using the newly revised categories required by OMB Directive 15 and

according to the new format provided in the 5/01 Targeted/Planned Enrollment 

Table (modified in the NCI Workform 10/01) (See NCI RFP Workform at 

http://rcb.cancer.gov/rcb-internet/forms/forms.htm). Any proposed racial/ethnic 

subpopulations should be listed below the Targeted/Planned Enrollment Table.

b Proposals Using Existing Data in Clinical Research with No Plans for 

Collecting New/Additional Data

For each study, offerors should provide plans for the total number of subjects 

proposed and the distribution by ethnic/racial categories and sex/gender. 

Contracting officers or their designees should advise offerors that under these 

circumstances, they are not required to re-contact subjects solely to comply 

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

accurately corresponds with the new categories in OMB Directive 15, the offeror 

can use the format in the 5/01 Targeted/Planned Enrollment Table (modified in 

the NCI Workform 10/01). However, if the existing data do not allow accurate 

correspondence with the new categories, the offeror may report the information 

Research Contracts 39
using the former categories and according to the format in section J of the 

NCI Workform at http://rcb.cancer.gov/rcb-internet/forms/forms.htm in the 

form entitled “Annual Technical Progress Report Format for Each Study.”

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html – NIH Policy 

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

II TECHNICAL REVIEW/EVALUATION CONSIDERATION

SRA, Technical Reviewers and Program Staff/Project Officers

A Evaluation of Inclusion Description and Justifications for Clinical Research 

Contract Proposals

Proposals will be evaluated in accordance with the technical evaluation criteria set forth 

in the solicitation. During initial peer review, the Scientific Review Group (SRG)* 

evaluates the proposed women and minorities inclusion plan for appropriate representation or the proposed justification for limiting or excluding representation. In evaluating 

inclusion plans, reviewers will provide a brief narrative as applicable to answer each 

of the following questions separately for women and minorities:

1 INCLUSION

• Does the offeror propose a plan for the inclusion of minorities and both sexes/

genders for appropriate representation?

• How does the offeror address the inclusion of women and members of minority 

groups and their subpopulations in the development of a proposal that addresses

the requirements of the statement of work, or is appropriate to the scientific 

objectives of the research?

• Does the proposal describe the composition of the proposed study population 

in terms of sex/gender and racial/ethic group?

• Does the proposal provide a rationale for the selection and composition of subjects?

2 EXCLUSION

• Does the offeror propose justification when representation is limited or absent?

• Does the offeror propose exclusion of minorities and women on the basis that 

a requirement for inclusion is inappropriate with respect to the health of the 

subjects and/or with respect to the purpose of the research?

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 40 and Minority Subjects in Clinical Research

* The Scientific Review Group is also known as the Technical Evaluation Group (TEG).
On the basis of the information provided in the proposal, reviewers rate the 

inclusion plans as “Acceptable” or “Unacceptable.”

a Evaluating Sex/Gender Inclusion Plans

If the sex/gender inclusion plan is judged “Unacceptable”, then the narrative 

must explain the rationale. Criteria for unacceptable inclusion plans include:

• Representation that fails to conform to the NIH Policy on the Inclusion of 

Women and Minorities as Subjects in Clinical Research in relation to the 

scientific purpose of the study.

• The proposal provides insufficient information, or discussion regarding inclusion 

of women is absent.

• The proposal does not adequately justify limited representation. 

The sex/gender inclusion plan may be judged “Acceptable” based on one or 

more of the following:

• Both sexes/genders are included in the study in scientifically appropriate numbers.

• One sex/gender is excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their

health;

– The statement of work and/or the proposal in response to the solicitation 

is relevant to only one sex/gender;

– Evidence from prior research strongly demonstrates no difference between

sexes/genders;

– Sufficient data already exist with regard to the outcome of comparable studies 

in the excluded sex/gender and duplication is not needed in this study.

• One sex/gender is excluded or severely limited because the objective of the 

solicitation constrains the offeror’s selection of study subjects by sex/gender 

(e.g., uniquely valuable stored specimens or existing datasets are single sex/

gender; very small numbers of subjects are involved; or overriding factors 

dictate selection of subjects, such as matching of transplant recipients, or 

availability of rare surgical specimens).

• Sex/gender representation of specimens or existing datasets cannot be accurately

determined (e.g., pooled blood samples, stored specimens or datasets with 

incomplete sex/gender documentation are used), and this does not compromise the scientific objectives of the research.

Research Contracts 41
b Evaluating Minority Inclusion Plans

If the minority inclusion plan is judged “Unacceptable”, then the narrative must

explain the rationale. Criteria for unacceptable minority inclusion plans include:

• Representation that fails to conform to the NIH Policy on the Inclusion of

Women and Minorities as Subjects in Clinical Research in relation to the 

scientific purpose of the acquisition.

• The proposal provides insufficient information, or discussion regarding the 

minority inclusion plan is absent.

• The proposal does not adequately justify limited representation of minority 

groups or subgroups.

• The proposal does not realistically address recruitment/retention of minority 

groups or subgroups.

The minority inclusion plan may be judged “Acceptable” based on one or more 

of the following:

• Minority individuals are included in scientifically appropriate numbers.

• Some or all minority groups or subgroups are excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their

health;

– The research required by the statement of work is relevant to only one racial 

or ethnic group; and/or

– Evidence from prior research strongly demonstrates no differences between

racial or ethnic groups on the outcome variables.

• A single minority group study is proposed to fill a research gap.

• Significant data already exists with regard to the outcome of comparable studies 

in the excluded racial or ethnic groups and duplication is not needed in this study.

• Some minority groups or subgroups are excluded or poorly represented because the

geographical location where the work is to be performed has only limited numbers

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 42 and Minority Subjects in Clinical Research
of these minority groups who would be eligible for the study, and the offeror has

satisfactorily addressed this issue in terms of:

– The size of study;

– The relevant characteristics of the disease, disorder or condition; and/or

– The feasibility of making a collaboration or consortium or other arrangements

to include representation.

• Some minority groups or subgroups are excluded or poorly represented because 

the purpose of the acquisition constrains the offeror’s selection of study subjects 

by race or ethnicity (e.g., uniquely valuable cohorts, stored specimens or existing

datasets are of limited minority representation, very small numbers of subjects 

are involved, or overriding factors dictate selection of subjects, such as matching 

of transplant recipients or availability of rare surgical specimens).

• Racial or ethnic origins of specimens or existing datasets cannot be accurately

determined (e.g., pooled blood samples, stored specimens or data sets with 

incomplete racial or ethnic documentation are used) and this does not 

compromise the scientific objectives of the acquisition.

Note: Elements in evaluating minority inclusion are different from elements in 

the evaluation of sex/gender inclusion.

B Evaluation of Inclusion Descriptions and Justifications for NIH-Defined 

Phase III Clinical Trial Proposals

For NIH-defined Phase III clinical trials, the reviewers must also evaluate the design 

and data analysis plans for examining intervention effects based on sex/gender and 

ethnicity/race differences.

The sex/gender inclusion plan may be judged “Acceptable” based on one or more 

of the following criteria:

• Available evidence strongly indicates significant sex/gender differences of clinical or

public health importance in intervention effect and the study design is appropriate 

to answer two separate primary questions – one for males and one for females – with

adequate sample size for each sex/gender. The proposal must include a description of 

plans to conduct analyses to detect significant differences in intervention effect. (See 

definition of “significant differences” in Section 2:II.C.1.)

Research Contracts 43
• Available evidence strongly indicates there is no significant difference of clinical 

or public health importance between males and females in relation to the study 

variables. Representation of both sexes/genders is not required: however, inclusion 

of both sexes/genders is encouraged. Note: The inclusion of both sexes/genders 

may be required by the statement of work; in this case, the proposal must address 

such inclusion.

• There is no clear-cut scientific evidence to rule out significant differences of clinical 

or public health importance between males and females in relation to the study 

variables, and the study design includes sufficient and appropriate representation 

of both sexes/genders to permit valid analyses of differential intervention effect. 

The proposal must include a description of plans to conduct the valid analysis 

of the intervention effect. (See definition of “valid analysis” in section 2:II.C.1.)

• One sex/gender is excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their health, or

– Inclusion of these individuals would be inappropriate with respect to the purposes of

the research (e.g., the research question addressed is only relevant to one sex/gender).

The minority inclusion plan may be judged “Acceptable” based on one or more of 

the following:

• Available evidence strongly indicates significant racial or ethnic differences of clinical 

or public health importance in intervention effect and the proposal is appropriate to

answer separate primary questions for each of the relevant racial or ethnic subgroups,

with adequate sample size for each. Note: This only applies if the sample size is not 

dictated by the statement of work. The proposal must include a description of plans to 

conduct analyses to detect significant differences in intervention effect. (See definition 

of “significant differences” in section 2:II.B.1.)

• Available evidence strongly indicates there are no significant differences of clinical 

or public health importance among racial or ethnic groups or subgroups in relation 

to the study variables. Minority representation is not required as a subject selection 

criterion unless required by the statement of work; however, inclusion of minority 

group or subgroup members is encouraged.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 44 and Minority Subjects in Clinical Research
• There is no clear-cut scientific evidence to rule out significant differences of 

clinical or public health importance among racial or ethnic groups or subgroups 

in relation to the effects of study variables and the proposal includes sufficient and

appropriate representation of minority groups to permit valid analyses of differential

intervention effect. The proposal must include a description of plans to conduct the valid

analysis of the intervention effect in subgroups. (See definition of “valid analyses” in 

section 2:II.B.2)

• Some minority groups or subgroups are excluded from the study because:

– Inclusion of these individuals would be inappropriate with respect to their 

health; or

– Inclusion of these individuals would be inappropriate with respect to the purposes 

of the research (e.g., the statement of work in the solicitation is not relevant to 

all subgroups).

C Program/Project Officer Review of the Appropriateness of the Target Data 

After the SRG/TEG review and comments, it is the responsibility of program/project 

officer staff, in conjunction with the contracting officer, to evaluate the appropriateness of the proposed targeted/planned enrollment data based on their knowledge 

of the field. When reviewing the appropriateness of the proposed target data, NIH 

program/project officer staff may consider and provide a narrative discussion on one 

or more of the following points:

• Does the proposed number/proportions of women/men and different racial groups 

correspond to the population characteristics of the disease and/or is the proposed 

number/proportions in compliance with the requirements of the statement of work?

• Is there a compelling rationale for proposed exclusion of any sex/gender or 

ethnic/racial group?

• Is this a follow-up of a pre-existing cohort that provides unique information/

opportunity about the focus of study? 

See Section 3: III.A.1 regarding discussions with offerors to resolve any issues raised 

by either the SRG/TEG or the program staff/project officer during review of proposed 

target/planned enrollment data.

Research Contracts 45
D Confirming the Analysis Plans for NIH-Defined Phase III Clinical Trials

NIH-defined Phase III clinical trials must include plans for valid analysis of sex/gender 

and ethnicity/race differences. It is the responsibility of program/project officer staff, 

based on the comments from the SRG/TEG and their knowledge of the field, to confirm 

the appropriateness of the proposed plans for conducting sex/gender and/or racial/

ethnic analysis plans for NIH-defined Phase III clinical trials, in conjunction with 

the proposed distribution of sex/gender and race/ethnicity in the target data. 

See Section 3, C.1.a regarding discussions with offerors to resolve any issues raised by

either the SRG/TEG or the program staff/project officer during review of analysis plan.

E Human Subjects Comments/Evaluations vs. Sex/Gender and Minority 

Comments/Evaluations 

It is important for reviewers, SRAs, and program/project officers to remember that 

the comments/evaluations in reference to human subjects protections are separate 

from the comments/evaluations in reference to the inclusion of women and minorities 

in clinical research.

III GENDER/MINORITY ISSUES

Process of Review and Resolution Is Needed Prior to Award

A Award Decisions – Contracting Officers

1 NEGOTIATION AND REVISION

Proposals with unacceptable inclusion plans receive an “Unacceptable” sex/gender 

or minority rating. These proposals may not be funded until NIH is assured of 

acceptability/appropriateness of these plans from the offerors.

Typically, if the proposal is otherwise acceptable, the issues raised by the SRG/TEG 

and program/project officers will be brought to the attention of the offeror during discussions and the offeror will be afforded an opportunity to discuss, clarify or modify 

the plan during the discussions and in its final proposal revision. If the discussion 

results in any changes to the plan or the data in the Targeted/Planned Enrollment 

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

of sex/gender and ethnicity/race differences, the offeror should submit a revised table/

plan and any supporting documentation. The revised table/plan should be included 

as part of the contract file. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 46 and Minority Subjects in Clinical Research
If the plan is still considered “Unacceptable” by the Government after discussions, 

the offeror may not be considered further for award. 

Note: NIH-defined Phase III clinical trials must include plans for valid analysis 

of sex/gender and ethnicity/race differences. It is important for program staff and 

project officers to review and evaluate the adequacy of these plans, in conjunction 

with the proposed distribution of sex/gender and race/ethnicity in the target data, 

and for the contracting officer to discuss/resolve any issues with the offeror prior 

to award. Any substantive changes that result from these discussions should be 

documented in the contract file.

2 CONTRACT AWARD LANGUAGE

At the time of award, the contract shall include the following language:

“Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members 

of minority groups and their subpopulations for each study being performed under 

this contract. This information shall be submitted in the format indicated in the 

attachment entitled, “Inclusion Enrollment Report,” which is set forth in Section J 

of this contract. This format, modified to indicate that it is a final report, shall also 

be used for reporting purposes in the final report. The report shall be submitted in 

accordance with ARTICLE F.1. DELIVERIES of this contract.* In addition, 

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

Subjects in Clinical Research, Amended, October, 2001 applies. If this contract 

is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may 

be found at the following website:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

A description of the plans to conduct analyses, as appropriate, by sex/gender and/or 

racial/ethnic groups shall be included in the clinical trial protocol as approved by the 

IRB, and a description of the progress in the conduct of these analyses, as appropriate, 

must be reported in the annual progress report and the final report. If the analysis 

reveals no subset differences, a brief statement to that effect, indicating the subsets 

analyzed, will suffice. Inclusion of the results of subset analysis is strongly encouraged 

in all publication submissions. The final report must include all final analyses of the 

data on sex/gender and race/ethnicity.”

Research Contracts 47
Note: *For Level of Effort Contracts, replace this sentence with the following. 

“[The first report shall be due__. Thereafter, the report shall be due on or before the

(Working/Calendar) day following each reporting period. The final report shall be 

due on__.]”

B Monitoring of Information in Progress Report 

1 POLICY STATEMENT

Contracts covered by this policy require the contractor 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 

principal investigator must contain information on research progress, including 

research participant enrollment and retention. Progress and/or final analyses based 

on sex/gender and race/ethnicity differences are encouraged for all clinical research 

contracts and are required for all NIH-defined Phase III clinical trials. NIH has the

authority to terminate a contract that does not comply with the inclusion policy in

terms of providing the required reports and/or in meeting its planned enrollment goals.

2 ANNUAL INCLUSION ENROLLMENT REPORT

Contractors must include yearly inclusion enrollment reports that describe 

the actual cumulative accrual of study populations and the sex/gender and 

ethnicity/race distributions.

For most contracts awarded in FY 02, investigators will be completing the 5/01 

Inclusion Enrollment Report that reflects the new OMB standards for reporting 

data on race and ethnicity. The table on the 5/01 Inclusion Enrollment Report 

contains two parts; part A is for all subjects and part B is for Hispanics or Latinos. 

The investigator should provide contract title, total enrollment (from target), 

protocol number (if available), and contract number. For Part A the investigator 

should provide the distribution of subjects by ethnic and racial categories and by sex/

gender according to the format in the 5/01 Inclusion Enrollment Report. Part B should

include information on the race of all Hispanics (or Latinos) enrolled in Part A. If 

there is more than one study, the investigator should provide a separate table for each

study. Also, if a study involves both domestic and foreign populations, separate tables

should be provided – one for domestic and one for foreign. Any table including 

information on foreign populations should be asterisked and footnoted, indicating 

the involvement of foreign participants. For tables containing either domestic or

foreign data, any proposed racial/ethnic subpopulations should be listed below 

the table.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 48 and Minority Subjects in Clinical Research
For progress reports for contracts that began data collection prior to FY02, investigators may report ethnicity/race and sex/gender sample composition using either 

the format in the former “Annual Technical Progress Report Format for Each Study”

found in section J of the NCI Workform at http://rcb.cancer.gov/rcb-internet/forms/

forms.htm, or the new 5/01 Inclusion Enrollment Report (modified in the NCI

Workform 10/01). Deciding which format is acceptable depends on the following:

• The 5/01 Inclusion Enrollment Report (modified in the NCI Workform 10/01)

should be used if the investigator is collecting data from subjects that comply 

with the new OMB Directive 15 standards, i.e., is using, at a minimum, a twoquestion format (with one question asking about ethnicity and the other asking 

about race) and allowing the participant to indicate more than one race.

• The former “Annual Technical Progress Report Format for Each Study” should 

be used if the investigator is still collecting data using the former standards, i.e., 

using a one-question format to ask about ethnicity and race, and not allowing 

participants to select more than one race. 

Note: Trying to “fit” data collected using the former standards into the new format 

is not recommended. The investigator will not have the race information for the

Hispanic/Latino section of the table and will not have data that corresponds to 

the new racial categories. If program staff suspect this may have occurred, they 

should contact the investigator, clarify the appropriate format for the data, and, 

if necessary, receive a revised enrollment table from the investigator.

• Once an investigator begins use the new inclusion enrollment report, they 

must continue using this format for the remaining years of the contract.

In filling out the Inclusion Enrollment report, the investigator should not assume 

or guess a subject’s racial or ethnic affiliation. The investigator should collect the 

data using instruments that allow respondents to select their racial or ethnic 

affiliation separately.

3 PROJECT OFFICER REVIEW OF ANNUAL ENROLLMENT DATA

The project officer will evaluate annual progress reports to determine if sex/gender

and/or minority information has been provided and if recruitment/retention is 

appropriate in accordance with the terms of the contract and is on schedule. 

The progress report will be evaluated for the description of subject recruitment/

retention and study composition. The Inclusion Enrollment report will be 

evaluated for the numerical distribution of subjects by sex/gender and ethnicity/race. 

Research Contracts 49
4 MISSING, INAPPROPRIATE OR INCONSISTENT INFORMATION

If the project officer notes missing information or considers the information in 

either the progress report text, inclusion enrollment report or both to be inappropriate or inconsistent with the proposed target data and/or stage of data collection,

he/she should contact the contracting officer, who will discuss and resolve the issues

with the contractor. A summary of the discussion and resolution should be included 

in the contract file. 

For NIH-defined Phase III clinical trials, the information in the progress report should 

also indicate if any data analysis has begun for the trial and, if so, what progress has

been made in conducting valid analyses for sex/gender and race/ethnicity differences. 

If this information is missing or considered inconsistent with the proposed data 

analysis plan and/or stage of data collection, the project officer should contact the 

contracting officer who will discuss and resolve the issues with the contractor. Also, 

a summary of the discussion and resolution should be included in the contract file.

5 REVIEW OF THE FINAL PROGRESS REPORT

Contractors are required to submit a final progress report no later than the 

expiration date of the contract. (Note: The contract may require a draft report 

at an earlier date). The final progress report for contracts for clinical research 

is required to include a summary of the final cumulative enrollment of subjects 

by sex/gender and race/ethnicity. 

The project officer should review the final progress report and determine if 

the final cumulative enrollment data is appropriate. If the project officer has any 

questions about these data, he/she should notify the contracting officer to contact 

the Principal Investigator to provide any changes. Any changes recorded in the final

progress report. All final accrual of subjects must be entered into the population 

tracking system and designated as “final” data.

Failure to provide accurate and timely final reports may affect the contractor’s past 

performance rating as well as any future funding of contract awards. If the project 

officer identifies such problems with the final report, these problems and potential 

corrective actions should be discussed with the contracting officer, and the project 

officer may also provide information on such problems in the contractor’s past 

performance evaluation. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 50 and Minority Subjects in Clinical Research
For NIH-defined Phase III clinical trials, the final progress report also must 

include final analyses of intervention effect by sex/gender and race/ethnicity. 

Failure to provide these analyses may affect the contractor’s past performance 

rating as well as any future fund of contract awards. If the project officer identifies 

such problems with the final report, the problems and potential corrective actions

should be discussed with the contracting officer and the project officer may also 

provide information regarding such problems in the contractor’s past performance evaluation. 

Research Contracts 51

Section 4

Recruitment and Retention of Women

and Minorities in Clinical Research:

Elements of Outreach

RECRUITMENT AND RETENTION OF WOMEN

AND MINORITIES IN CLINICAL RESEARCH: 

ELEMENTS OF OUTREACH

I INTRODUCTION

For many clinical investigators, the pathway from conceptualization through study 

completion is fraught with delirious highs and dreadful lows. The first challenge, 

getting a study funded, is followed quickly by the challenge of recruiting and retaining 

appropriate sex/gender representation, as well as research participants from diverse population

groups. This section focuses on the successful recruitment, inclusion, and retention of women 

and minority subjects in clinical research. It highlights barriers to participation in clinical

research and provides information on five elements of recruitment and retention that may

assist investigators to best accrue recruitment and retention of women and minorities. It also 

provides a table of selected recruitment and retention strategies and tips. The section closes

with findings pertaining to successful cases of recruitment and retention of women and 

minorities in clinical research. Successful recruitment of diverse population groups often 

begins with culturally and racially sensitive outreach into the communities in which individuals reside. Ideally, community outreach for research purposes should be part of the 

overall goal of the research institution and not solely the province of individual investigators. 

II BACKGROUND

Historically, the typical and usual research participant was a white male. This legacy exists 

for many and varied reasons. History, education, culture, language, income and wealth, 

geography, racial identity, prejudice, paternalism and other social deterrents are implicated 

in the underrepresentation of women and minorities in clinical research (Millon Underwood,

2000; Giuliano et al., 2000). The National Institutes of Health (NIH) continues to ensure 

the recruitment and retention of women and members of minority groups as participants 

in clinical research (Public Law 103-43, 1993). The appropriate representation of women 

and members of minority groups in biomedical and biobehavioral research studies, especially

clinical trials, remains an explicit criterion considered in the review of applications for 

NIH funding (Harden and McFarland, 2000). 

Effective outreach to women and minorities, especially those who are difficult to access 

and often disenfranchised, must incorporate a partnership approach involving participation 

by would-be research subjects, investigators, community-based organizations, and other 

relevant stakeholders in the research process. Recruitment and retention of subjects in 

Recruitment and Retention of Women and Minorities in Clinical Research 55
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 

and Minority Subjects in Clinical Research

clinical research is complex. This section complements the other sections in this Principal

Investigators’ Notebook and other resources available from NIH and is not meant to be a 

comprehensive guide. A goal of this section is to present strategies that are culturally and 

ethnically relevant to women and minorities and to some degree translatable across many 

subgroups of the U.S. population. For more tips on engaging the community and education

activities, see Cancer Clinical Trials: A Resource Guide for Outreach, Education and

Advocacy (http://cancer.gov/clinicaltrials/resources/outreach-education-advocacy or 

call 1-800-4-CANCER).

III BARRIERS TO RECRUITMENT AND RETENTION OF WOMEN AND MINORITIES

Limited data are available on the participation of underrepresented groups in clinical 

research. Lack of participation also may be exacerbated by a perceived mismatch between 

the cultural experiences of principal investigators and potential subjects. However, the 

overall participation rate in clinical trials also is low, ranging from 3 to 20 percent of adults

(Giuliano et al., 2000; Swanson and Ward, 1995). Reasons why so few adults participate 

in clinical research, especially clinical trials, include:

• Fear and distrust of the research enterprise;

• Lack of knowledge;

• Lack of transportation;

• Interference with work and/or family responsibilities;

• Subject burden as a result of participation in a clinical study; and

• Financial costs.

This list is not exhaustive, but it does reflect recurring themes in the literature on 

this subject (NCI Cancer Clinical Trials et. al., 2001; Giuliano et al., 2001; Brown 

et al., 2000; Corbie-Smith et al., 1999; Shavers-Hornaday et al., 1997). Systematically 

addressing each of these six barriers can exert a positive effect on successful recruitment 

and retention of women and minorities. However, failure to address the first two 

barriers – lack of trust and knowledge – will absolutely undermine outreach efforts. 

A Fear and Distrust of the Research Enterprise

From the 1940s through the late 1970s, research was widely viewed as risky to the 

point of death and of most value to scientists (McCarthy, 1994). Fear and distrust of 

the research enterprise are often associated with experiences such as the Nuremberg 

trial (Nuremberg Code, 1949) and the Tuskegee syphilis study (Jones, 1993). In the 

former, 23 Nazi scientists were prosecuted for crimes against humanity; in the latter, 

400 illiterate or low-literacy African American male subjects in Alabama were 

56
systematically denied treatment by an agency of the U.S. government for more than 

30 years. An additional concern perceived by underrepresented groups is the mismatch

between the cultural experiences of the PIs and potential subjects. Recent events – 

like the deaths of three relatively healthy volunteers in studies at The Johns Hopkins

University, University of Pennsylvania, and Case Western Reserve University – have

raised new concerns and remembrances of past events. The belief remains strong in 

minority communities that participating in a clinical trial could actually worsen 

one’s health status or serve to stigmatize the group in which an individual holds 

membership (Corbie-Smith et al., 2002).

B Lack of Knowledge

Lack of information that is usable by individual subjects and clinicians also tends 

to diminish interest and participation in clinical research. Failure to inform primary 

health care providers may be as significant a barrier as is failure to inform participants,

because even a well-informed subject may be powerless to persuade the primary health

provider to refer them to clinical research studies, especially clinical trials. Another 

significant issue is lack of knowledge about informed consent procedures and protections.

For example, some would-be research participants believe that the informed consent 

document protects the research institution and its staff while abridging the rights of 

the individual research participant. 

C Lack of Transportation

When there is no car, and buses and taxis are difficult to access or unaffordable, 

the prospect of traveling to a clinical facility for research purposes may represent 

a formidable obstacle. For example, one would-be research participant decided that, 

at age 80, a bus voucher was insufficient incentive for participation when confronted 

with ice, snow and 34 degree temperatures. For many tribal groups in rural sections of 

the West and Midwest, lack of transportation may be the sole barrier to participation. 

Would-be research participants in underserved and rural areas require additional 

consideration (planning and money) to meet transportation needs.

D Interference with Work and/or Family Responsibilities

For many women and minority group members, work and family are closely linked – 

their job may be their sole link to health care, and loss of employment would mean 

exclusion or dropout from clinical research. Taking leave (annual or sick) to participate 

in research is in conflict with leave that is needed to care for an ill family member. 

Simple monetary incentives will not adequately address this barrier. As caregivers 

for dependent children, grandchildren, or aging parents, some women and minority 

group members clearly have no free hours left in a typical work week.

Recruitment and Retention of Women and Minorities in Clinical Research 57
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 58 and Minority Subjects in Clinical Research

E Subject Burden as a Result of Participation in a Clinical Study

In the current effort to add biological/physiological/genetic variables to many studies 

and surveys, subjects are often burdened with repeated medical tests and trips to clinical research sites. It is incumbent on investigators to be sensitive to issues of physical 

pain, environmental discomforts, and the value of pleasant and encouraging staff.

F Financial Costs 

Poverty can be a major barrier to research participation for women and men alike.

Minority women and men, who tend to be overrepresented in low-income and 

poverty level strata, have little reserve for unpaid research costs. The cost of being 

away from work and family, as well as, insurance coverage or lack of coverage is 

a deterrent.

IV ELEMENTS OF OUTREACH

Five elements of outreach can help investigators to diminish the impact of these barriers 

to recruitment and facilitate success in retaining women and minorities in clinical research. 

These elements are, in most respects, generic principles that can be used to enhance inclusion,

recruitment and retention of research subjects from most population groups. The operational

details may differ when individuals are recruited in hospitals, clinics or other health care centers, rather than from the general community (such as work sites, schools, places of worship),

but the underlying elements are common to all successful outreach efforts. Ideally, successful

outreach would involve representatives of the population of interest in all major phases of the

research process: defining the problem, developing the data collection plan, developing the

recruitment and retention plan, gathering and analyzing data, disseminating the results, and

developing plans to address new issues and problems. Table 1 provides an overview of these

elements of outreach. 

A Element 1: Understand the Study Population

Identify the potential research participants, the medical settings in which they are 

found, and the community in which they reside. This may require an assessment of

racial/ethnic characteristics, socioeconomic status, age, gender, language, education/

literacy levels, community structure, cultural norms and customs, migration patterns,

points of access (sites of intervention), and needs and values of the potential research 

participants, including reasons for seeking health care.
1 WHY IS THIS IMPORTANT?

Working in culturally diverse settings can be challenging for even the most 

experienced clinical investigator. One key to success is to learn as much as 

possible about the groups of interest. Gathering background information about 

the potential study populations, their history and their communities is an essential 

first step, to be followed by periodic updates of this information (NHLBI, 1993a; 

Chen, 1993; NCI, 2001). Note: Investigators should observe that, while suggestions 

are provided in a wide range of subpopulations, the NIH Guidelines do not require 

that every study include every racial and ethnic group. The scientific question must

determine the inclusion criteria.

Recruitment and Retention of Women and Minorities in Clinical Research 59

Table 1. FIVE ELEMENTS OF OUTREACH

ELEMENT 1 Understand the Study Population. Learn about the people you hope to recruit. 

Prior beliefs may need to be changed with a goal of valuing, knowing, trusting,

and understanding would-be participants. Identify the potential research participants, the medical settings in which they are found, and/or the community in 

which they reside. Try to learn something about their cultural norms, migration 

patterns and reasons for seeking health care.

ELEMENT 2 Establish an Explicit Outreach Plan. Establish specific goals for recruiting and 

retaining study participants. Where possible, involve formal and informal 

decision makers from local organizations and institutions, as well as the main 

communication channels in each medical setting or community. Establish lines 

of communication to promote continuing awareness of and trust in the project. 

ELEMENT 3 Achieve Agreement on Research Plans. Confirm that the investigators, medical 

staff, and community all agree on the purpose for design, methodologies, 

implementation, and conduct of the study.

ELEMENT 4 Design and Conduct Evaluations. In cooperation with health care staff, community 

leaders and potential participants, pretest and periodically retest the recruitment 

and retention strategies ñ including resources, incentives and problem-solving 

mechanisms ñ to ensure that they conform with the needs and values of the 

research participants and their communities. Monitor subject accrual on a 

frequent and regular basis and compare results with established goals.

ELEMENT 5 Establish and Maintain Communication. Keeping everyone informed of progress 

and findings, including research staff, health care providers, participants and their 

families and communities. This will increase awareness of the project and demonstrate 

that the participants and community are valuable partners in the scientific process.

Source: Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research, 

NIH Publication No. 97-4160, 1997.
Hospitals and clinics represent a special type of community and should be approached 

as one would any other important community. There may be differences, however. 

For example, research-based alcoholism after-care programs may have to compete 

with established hospital service programs for the same population of patients – and

their personal or insurance payments. Background information on the potential study

populations, especially number of potential minority and women participants, and 

their surroundings is also important.

a Cultural Diversity

Considerable heterogeneity can exist within health care settings and communities.

Socioeconomic, cultural and linguistic characteristics can vary widely, along 

with major differences in health beliefs and practices. Recruitment and retention

strategies must therefore be based on the background information about the particular groups of interest. For example, the label “Southeast Asian” does not take 

into consideration the major differences among Filipino, Hmong, Laotian,

Vietnamese, and Cambodian peoples. The term “American Indian” is used to

describe more than 550 federally recognized tribes (Parker et al., 2002). Similarly,

Hispanic/Latino and African American populations have varying ethnic origins 

and racial characteristics and should not necessarily be considered as constituting 

a single subpopulation.

Country of origin, immigration status, language, and acculturation add to the 

wide diversity within racial and ethnic population groups, and support the need 

to conduct a careful assessment of the population of interest (Johnson et al., 

1992; Hughes et al., 2000). Furthermore, in communities that include illegal 

immigrants or where illegal activities are in evidence, investigators will need 

special skills to evaluate the population.

b Special Issues with Women

The successful recruitment and retention of women in studies requires consideration of several important factors. Women of childbearing potential must 

understand the requirements of the study and decide whether it is appropriate 

for them to participate (e.g., do the benefits outweigh the risks). Even with IRB

approval, the research team must make special efforts to ensure that women who 

are considering participation fully understand the demands of the study and what 

they will be asked to do. Informed consent and understanding are essential. 

Indeed, issues of autonomy are paramount in the decision to participate. 

In some instances, women may or may not wish to share their decision 

to participate in a study with family members or others in the community.

Other factors affect the ability of women of different ages and family statuses 

to participate and should be weighed when designing recruitment and retention

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 60 and Minority Subjects in Clinical Research
strategies. Child care, location of the research site, ease of access and transportation, and time away from work are only a few of these considerations.

c Community and Population Infrastructure

If the research study requires the inclusion of individuals in a particular 

geographical region, investigators must know the infrastructure and the 

characteristics of the health care setting, the different communities within 

the region, and a perspective on the region itself. Is it a rural or an urban 

community? What are the various cultural groups living there? In which 

cities or neighborhoods do each ethnic or cultural group live? What are the 

structure and characteristics of local health care systems and settings?

Investigators also need to gain insights about how community residents, or 

hospital and clinic staff, perceive the research team and its home institution. 

Such information is crucial in identifying potential problems and finding ways 

to avoid or work through them early in the outreach efforts. What is the reputation of the health services/research organization and their local partners in 

the community? Is there a history of responsiveness to and mutual respect for 

the community (state, town, region)?

2 HOW DO I APPROACH IT?

Depending on the study questions and research setting, the assessment process 

requires different kinds of data. Several sources describe orderly assessment 

procedures for learning about the individuals, health care settings, and communities of interest (NCI, 1992; NHLBI, 1993b, Swanson and Ward, 1995).

a Identify Characteristics of the Potential Participants and Setting(s)

• Individual characteristics: age, sex/gender, cultural norms, education, literacy, 

language, health awareness, reasons for seeking medical care, knowledge of 

available health care services, ideas and attitudes about disease, health beliefs 

and practices, beliefs in effectiveness of interventions, beliefs in susceptibility 

of disease, access to health care, sensitivity of health care providers, religious

beliefs, sexual orientation, socioeconomic level, and acculturation patterns.

• Family characteristics: family structure to include fictive kin (e.g., godparents 

and close family friends), number and age of children and other family members, number of parents and head of household, socioeconomic level, beliefs 

and practices, cultural norms, education, literacy, language, health awareness, 

and access to health care.

• Employment characteristics: work patterns (daytime versus night-shift work), 

part versus full-time employment, willingness of employers to grant leave time 

Recruitment and Retention of Women and Minorities in Clinical Research 61
for participation, and willingness of employees to take leave time for participation. How might the research process benefit employers in the community?

• Community characteristics: socioeconomic level, urban or rural background, 

migration patterns, racial and ethnic minority groups and subgroups residing 

in the community, health care delivery systems, civic and religious organizations, and business and community structure.

b Identify Contacts and Points of Access that Potential Participants Might Utilize

• Health care decision makers: physicians (especially referring physicians), nurses,

department chairs, hospital administrators, research committees, and IRBs.

• Community leaders: not only political figures and government officials but 

also clergy, tribal leaders, teachers and principals, leaders of business and 

community groups, media personalities, sports figures, and youth leaders.

• Community businesses and organizations: schools, day-care centers, places 

of worship, colleges and universities including fraternities and sororities, 

hospitals, clinics, nursing homes, women’s and men’s clubs, senior and community centers, private organizations (e.g., American Heart Association and

American Cancer Society), alumni associations, recreational facilities such 

as gyms and local recreational centers, and work sites including grocery and 

clothing stores, hair salons and barber shops, day spas, laundromats, banks, 

cleaners, restaurants, taverns, pharmacies, and fire and police stations.

• Social service agencies: public welfare, child welfare, tribal councils, community action agencies, public housing, community health clinics, mental 

health clinics, and drug treatment centers. 

c Identify Communication Channels

• Formal interpersonal relationships: health care providers, religious leaders, 

community leaders, and school teachers.

• Informal interpersonal relationships: family, friends, and those who are related 

by language or common origins, other researchers in the hospital or clinic, 

former students, and other contacts.

• Mass media: specifically targeting women and minorities such as television,

Internet including web TV, newspapers, magazines, films, and radio.

Language is a vital part of communication, and investigators from outside a 

particular community may not be familiar with the nuances of colloquial 

expressions. Another integral part of this process is a clear understanding of 

the literacy levels of participants. This literacy level must be ascertained for the 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 62 and Minority Subjects in Clinical Research
individual in her or his first language and in English. As a result, special efforts 

may be needed to develop and translate informational materials and other 

instruments so that they are sensitive to the linguistic and cultural differences 

among sexes/genders and members of minority groups e.g., Hispanic/Latino 

subpopulations and Asian subpopulations (Chen et al., 1992a,b). The National 

Adult Literacy Survey provides more information on minority groups and literacy 

(Kirsch et. al., 1993)

In general, the research staff and institution must also be aware of their own 

abilities and limitations in working with the diversity of participants identified 

for the study such as gay men and lesbians, substance abuse populations, 

homeless individuals, AIDS patients, older adults, and minority group 

members (Giachello et al., 1992).

B Element 2: Establish an Explicit Outreach Plan

Having determined the scientific question(s) for investigation and the study design, or 

in response to specific requirements of the Statement of Work in a contract solicitation,

establish a specific plan, goals and objectives for recruiting and retaining study participants. Where possible, involve key community leaders, decision makers, organizations, 

and institutions, as well as the main communication channels in each medical setting 

or community. Establish lines of communication and cooperation to promote continuing

awareness of and trust in the project.

1 WHY IS THIS IMPORTANT?

The development and implementation of effective recruitment and retention 

strategies is a multi-dimensional and evolving process. Outreach strategies that 

are productive in one population or setting may be counterproductive in another. 

For example, a door hanger announcing your research study in a middle-income, 

suburban neighborhood may generate little interest to casual obervers. However, 

in some lower-income, urban areas, a door hanger left undisturbed for several hours 

or days may attract undesired attention. Consequently, it is essential to involve 

the health care setting and/or community early in the design of outreach strategies.

Hospital and/or clinic staff and community leaders and organizations are important

sources of perspective on potential participants. They can provide insights into 

problems in study design that would otherwise become barriers to the successful 

accrual of participants. Forging linkages with these individuals and organizations 

will strengthen lines of communication, establish trust, and promote awareness 

(Mellins et al., 1992).

Recruitment and Retention of Women and Minorities in Clinical Research 63
• Many members of minority groups are skeptical about participating in clinical 

studies. Abuses of the past are well known and have been cited by individuals 

as reasons for refusing to take part in a clinical study. The Tuskeegee syphilis 

study, for example, was a tragic deception well remembered even today. Opinion 

leaders such as political, religious and social leaders can become the primary 

link to these groups and individuals, providing key information, reassurance, 

and building trust.

• Leaders can inform investigators about the social and economic needs of the 

population. For example, the provision of basic social services has been shown 

to be an effective mechanism for overcoming barriers to the recruitment and 

retention of women and underserved populations in AIDS clinical trials in the 

inner cities. When payments or other incentives are offered, however, they 

should not be of such a magnitude as to be coercive. The level at which this 

occurs varies with the characteristics of the population.

• Consultation with hospital or clinic staff and formal and informal community 

leaders may allow investigators to “fine tune” their recruitment and retention 

strategies to reflect differences among individuals and groups of interest. For 

example, Mexicans, Puerto Ricans, Cubans, and Central or South Americans 

may share a common language, but they differ widely in culture and values

(Shumaker et al., 1992).

2 HOW DO I APPROACH IT?

The research questions will guide the development of the recruitment plan. Given 

the desired diversity of subjects and established sample size goals, you are encouraged 

to write a deliberate plan for outreach, recruitment and retention. A recruitment 

coordinator may be very helpful during this phase of the study (see Section D, 

below). The timeline also becomes a critical element in the plan. A familiar refrain 

in research involving minority subjects is that recruitment takes a long time; consequently it is perhaps better to err on the side of a longer recruitment period than 

not. Many mechanisms exist to establish explicit goals for appropriate recruitment 

and retention; several suggestions are presented here:

• Identify recruitment and retention goals as specifically and explicitly as possible, 

with the collaboration of a statistician, hospital or clinic staff and community leaders.

• Involve hospital staff and/or community leaders early in the process. For example,

present the study plans to the community leaders, physicians and others in the 

health care settings. The plan may be presented to the broader community on 

neutral territory such as a local school in a minority community. Consider creating 

a diverse advisory board comprised of racial/ethnic and sex/gender representation

such as study staff, health care providers, where warranted, community members, 

and participants. Incentives should be considered for community members who 

would be advisory board members. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 64 and Minority Subjects in Clinical Research
• Include one or more representative(s) from the research institution, hospital 

or clinic staff as members of the research team to serve as liaisons between the

researchers, the staff and the participants. Ideally, a staff member residing in 

the community of interest would serve a meaningful role as liaison. 

• Offer hospital or clinic staff and/or community organizations opportunities to 

participate at different levels of involvement, from establishing and taking part 

in focus groups, to providing sponsorship for the study, to assisting in recruiting, 

to contributing to the writing or reviewing of proposals. A useful practice to 

follow is that for every scientific paper or report written there is a corresponding 

version for the interested lay community.

• Recruit women and minority investigators and health care staff for the project. 

Racial/ethnic and sex/gender equivalence among staff and participants may enrich

goals for appropriate recruitment and retention. Consider subcontracting specific 

components of the research activities to hospital or clinic staff and/or community

organizations that are well known. Consortium arrangements with research institutions and hospitals with an established history of serving the underrepresented 

groups would be useful in increasing recruitment in clinical research.

C Element 3: Achieve Agreement on Research Plans

Confirm that the investigators, medical and health care staff, and/or community all 

agree on the purpose of design, methodologies, implementation, and conduct of the study.

1 WHY IS THIS IMPORTANT?

Women and minorities must be included in clinical research if scientists are to 

make valid inferences about health and disease in these groups. It is essential that 

investigators strive to build the level of understanding and trust that will lead to 

a productive partnership and successful conduct of the research project.

2 HOW DO I APPROACH IT?

Many mechanisms exist to achieve agreement; several are presented here:

• Consult the hospital or clinic staff and/or the community at every stage of the 

study. It is much easier to achieve agreement on issues if all parties have been

involved from the earliest stages. Mutually beneficial collaboration can be 

achieved and maintained for many years, if the hospitals’, clinics’ and communities’

needs, concerns and recommendations are taken into account. Involve the hospital

or clinic staff and/or community in the planning, as well as the conduct of the

research. Understanding and responding to individual and group concerns can 

lead to more appropriate and useful results. Women and minority groups are likely 

to appreciate and trust investigators with demonstrated collaborative skills. This

process may require substantial time.

Recruitment and Retention of Women and Minorities in Clinical Research 65
• Present the proposed study, complete with rationale and plans for implementing 

it, to those who are expected to recruit subjects or answer public questions. This 

can be accomplished through announcements in public forums, hospital and 

community newsletters and special mailings. Do not use jargon in describing 

the proposed research.

• Create a diverse advisory board that includes key members of hospital or clinic 

staff and community organizations. This can be a very effective mechanism for 

establishing and maintaining a functional study. Not only can an advisory board

guide sensitive and sensible recruitment, it can also assist in understanding and 

reenlisting those who drop out of the study.

• Identify ways of including and rewarding hospital or clinic staff so that they 

find the research satisfying and interesting.

• On an on-going basis, ask diverse advisory boards to review the research 

plans to ensure that incentives are appropriate for the community, no 

undue coercion is used, and materials are appropriate in terms of language 

and literacy levels. 

D Element 4: Design and Conduct Evaluations

Design and implement an evaluation plan to assess how well the recruitment and 

retention strategies are working. In cooperation with community leaders, health care 

staff and potential participants, investigators should pretest and periodically retest 

the recruitment and retention strategies – including resources, incentives and problemsolving mechanisms – to ensure that they conform with the needs and values of the

research participants and their communities. Monitor subject accrual on a frequent 

and regular basis and compare results with established goals.

Study design should include a process for systematically documenting the extent to 

which recruitment and retention objectives were accomplished during a defined 

period of time for a defined population. Such an evaluation will help investigators 

to (1) determine which strategies work well; (2) certify the degree of progress that 

has occurred; and (3) identify elements that are not working. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 66 and Minority Subjects in Clinical Research
1 WHY IS THIS IMPORTANT?

Evaluation is an integral part of developing and planning the recruitment and 

retention strategies (NCI, 1992, 2001). As such, evaluation provides investigators 

with tools for the following tasks:

• Addressing the issues of feasibility: (Can the goals be accomplished with the 

existing staff and resources within the time frame specified?);

• Addressing the issues of accountability to the research institutions, research 

participants and their families, and the community;

• Providing information to encourage the acceptance and response of the community and research participants involved; and

• Providing a feedback mechanism to guide changes in current strategies to 

avoid or counter participant drop out.

2 HOW DO I APPROACH IT?

Depending upon the type of evaluation being conducted, important elements form 

the basis for evaluation. Investigators wishing to learn more about any of the different 

types of evaluation are urged to seek guidance from an expert or consult the 

literature on this subject (Frechtling and Sharp, 1997). Because this can be 

a complex process, only the most general elements are presented here.

a Establish Evaluation Measures

• Study staff: time-line schedules, work performed, and response to participants 

over time.

• Media outreach: publicity, promotion, type and extent of media coverage, 

estimated audience size and demographics, and materials planned and distributed.

• Population response: volume of inquiries, screening participation rates, and 

interviewees’ perceptions of screening and proposed study and staff.

• Enrollment rates: proportion of eligible subjects who agree to participate.

• Continuing functions and response: number of phone calls or meetings with 

community-based organizations, advisory boards, focus groups, and other 

patient or participant groups.

• Compliance: participants’ continuing responses to study protocols and demands.

• Feedback: consultation with and responses from research participants, community leaders, and hospital or clinic staff.

Recruitment and Retention of Women and Minorities in Clinical Research 67
b Use Evaluation Data to Refine the Recruitment and Retention Strategies

• Are some of the objectives not being met? Why?

• Are there strategies or activities that are not succeeding? Why?

• Are more resources required, or can resources be used more efficiently?

• What are the strengths and weaknesses of the strategies or mechanisms 

for retaining study participants?

c Establish an Ongoing, Problem-Solving Mechanism

This mechanism should include not only regularly scheduled meetings with 

participant focus groups and hospital or clinic staff involved in the study, but 

also adequate mechanisms for tracking patients and investigating each patient 

withdrawal to determine if some aspect of the retention strategy is at fault.

Investigators may also need to provide counseling to address the social needs 

that can impede the participation of women and members of minority groups 

in a clinical study (e.g., child care, transportation costs, study site location, 

availability of parking). Above all, investigators must remain flexible within 

the constraints of the study goals and objectives.

d Pretest and Retest

Before initiating the full-scale project, investigators typically find it useful to 

conduct a pilot test of the proposed recruitment and retention strategies. This 

will allow the opportunity to test the feasibility of the planned approach and 

amend it according to feedback from the study population. Potential participants 

can contribute valuable information on the needs, cultures and values of the 

population of interest and the community in which they reside. It is during this 

preliminary test period that the investigator can best determine the most costeffective distribution of resources, including materials, equipment, personnel, 

and time. Based on this information, fiscal and budgetary planning can be finalized 

and problem-solving mechanisms can be put in place (Rand et al., 1992).

Pilot testing can also provide feedback on proposed strategies and incentives, 

such as educational materials, hiring staff from the proposed study population, 

establishing a project office in the community, providing transportation, and 

other compensations (e.g., meals, food coupons, child care, or cash). Problemsolving mechanisms instituted following the pilot study can include regularly 

scheduled reviews to identify barriers that are interfering with compliance or 

continued participation.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 68 and Minority Subjects in Clinical Research
Periodic retesting and refining of recruitment and retention strategies can also 

be important, for the following reasons:

• Resources can vary during the course of the study, so it may be prudent to 

identify alternative mechanisms in advance. Should problems arise, local 

agencies or organizations may serve as back-ups. By the same token, members 

of the research team may need to take over some of the recruitment functions 

if they prove too time-consuming for hospital or clinic staff.

• Community leaders and hospital or clinic staff can assist in determining the 

most appropriate distribution of resources – for example, instances where 

volunteers may be used in lieu of paid staff and the availability of bilingual 

and sign interpreters.

E Element 5: Establish and Maintain Communication

Establish mechanisms for keeping all those involved in the study (research staff, 

health care providers, participants and their families and communities) apprised of 

progress and, ultimately, study findings. This will not only increase understanding 

and awareness of the project, but will recognize the participants and their health 

care setting or community as valuable partners in the scientific process. 

1 WHY IS THIS IMPORTANT?

Effective communication of study results is another important element in building 

trust in the community. Researchers must remember, however, that their professional

priorities may conflict with the priorities of study participants. Specifically, publication of research results in scientific journals has little value to participants and could 

be perceived as exploitive unless the same results are also conveyed to the participants,

and their communities, in a sensitive manner (Shumaker et al., 1992). Providing the

community and the hospital or clinic staff with a detailed report on the progress of

research is often the first step in developing a long-term relationship of trust and 

cooperation. Future relationships with these populations could depend on whether 

they perceive their role as that of partners in the research or merely “guinea pigs.”

Communication of study results should therefore be among the ethical considerations 

of any research project (see below). Dissemination of research findings can also promote awareness of social, medical and educational resources that have been made 

available as a result of the project.

2 HOW DO I APPROACH IT?

Educated consumers of research may be more likely to participate in research. Research

institutions must do more to educate those who will be targeted as potential research

participants. The following avenues of communication can be used not only for

Recruitment and Retention of Women and Minorities in Clinical Research 69
announcing the study and recruiting participants, but also for disseminating study 

results (Rand et al., 1992). The important point is that participants, their health 

care providers, and their communities understand the outcome of the study and 

that their inestimable contribution is noted and appreciated.

a Use Formal Communication

Formal methods of communication involve the media, including radio (e.g., talk

shows, ethnic language stations, and public service announcements), print (such 

as flyers, posters, hospital newsletters, and newspaper articles in language appropriate to the proposed study group), and television (e.g., talk shows, news shows, 

cable access channels, and ethnic language stations).

b Use Informal Communication

Informal methods of communication can include personal contact (e.g., telephone,

door-to-door, neighborhood events, schools, staff meetings) and multiple sites 

of contact (e.g., health clinics, social service agencies, hospitals and clinics, 

places of worship, union halls, senior citizen centers, shelters, grocery stores, 

beauty salons, day care centers, and support groups).

c Establish Feedback Mechanism

Feedback mechanisms can and should be utilized in the participants’ language to

ensure ongoing success and retention of participants and that follow-up questionnaires reach participants. Study results should also be provided at the completion 

of the study, along with the appreciation of the principal investigator and staff.

d Hire an Outreach Coordinator

Consider employing an outreach coordinator, whose responsibilities might include:

• Setting up monthly meetings with health care or community-based organizations and developing linkages to enhance research participation and to 

“trouble-shoot” problems;

• Developing and preparing health care or community-oriented educational 

materials;

• Attending health care or participant meetings, community health fairs or 

block parties to periodically disseminate study information;

• Providing requested information about the research study to individuals 

and health care and/or community groups through educational presentations 

and workshops;

• Providing in-service training and guidance to all investigative staff, to ensure 

that they are sensitive to the needs, attitudes, and concerns of study participants;

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 70 and Minority Subjects in Clinical Research
• Providing education and training to health care and/or community leaders 

to ensure that they understand the benefits and demands of research and the 

role participants and their health care setting and/or communities play in 

such collaboration; 

• Convening periodic meetings of scientific staff and health care and/or community

leaders (or advisory board) to assess retention and to devise strategies for 

countering drop out and bolstering retention and protocol adherence; and/or

• Addressing participants’ questions of, “What is in it for me?” The coordinator

might emphasize health services and benefits accorded subjects in clinical 

research such as routine physical examinations, comprehensive medical 

screening, free and/or reduced cost medications and laboratory services.

e Announce Study Results

At the conclusion of the study, the research team may wish to host a special 

presentation for participants, hospital or clinic staff, and community groups to 

discuss the outcome of the study and its subsequent application to health.

V SUCCESSFUL STRATEGIES 

Numerous reports suggest that, despite Federal policies and guidelines, the customary 

research subject is still a white male. Many investigators still fail to routinely include 

women and minorities in their study populations. In some cases, stereotyped as “difficult to reach,” “noncompliant,” “unreliable,” and “unwilling,” women and minorities 

have not been routinely included in trials, or trialists have systematically excluded 

them. At the same time, historical, educational, cultural, linguistic, economic, geographic, and social barriers have caused many would-be participants to be fearful, 

unwilling, and/or unable to participate in clinical research studies (Millon Underwood, 

2000; Corbie-Smith, 1999; Hayunga and Pinn, 1996; Millon Underwood et al., 1993). 

The following success stories are derived from efforts by NIH to be inclusive. Tips and 

tools for successful recruitment and retention strategies are presented.

A Study of Women’s Health Across the Nation (SWAN)

Funded initially in September 1994, SWAN is supported by the National Institute 

on Aging, the National Institute of Nursing Research, the National Heart, Lung 

and Blood Institute, Office of Research on Women’s Health, the National Institute 

of Mental Health, and the National Center for Complementary and Alternative 

Medicine. A variety of methods were used to recruit a sample of multi-ethnic women 

(Sowers et al., 2000). A total of 202,985 households or telephone numbers were 

Recruitment and Retention of Women and Minorities in Clinical Research 71
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 72 and Minority Subjects in Clinical Research

Table 2. STRATEGIES FOR RECRUITING AND RETAINING WOMEN 

AND MINORITIES IN CLINICAL RESEARCH1

INVOLVE THE COMMUNITY

ï Develop community networks including a community advisory group to facilitate community entry. 

ï Minority-based Greek organizations may be helpful in gaining entry and trust of the community. Principal investigators

may wish to contact the local chapter of the: Alpha Kappa Alpha sorority, Delta Sigma Theta sorority, Alpha Phi Alpha

fraternity, Omega Psi Pi fraternity, and others.

ï Solicit the support, participation and if appropriate collaboration of women and minority community physicians who 

provide care for the desired population groups.

ï Solicit the support and participation of ministers and ministerial alliance groups in recruiting and retaining study participants.

ï Develop promotional and educational materials designed to increase awareness in the community. 

ï Solicit the support of health care decision makers, community leaders, businesses, social service agencies, and organizations.

ï Identify communication channels that are culturally sensitive and language appropriate.

INVOLVE THE PARTICIPANTS

ï Include women and minority participants in designing the research and preparing study materials to be sure they meet

their needs and expectations and are culturally and linguistically sensitive.

ï Messages of altruism that convey the benefits of the research for future generations (e.g., ìfor your daughterís sakeî) or

staying healthy in order to be there for the family (e.g., ìfamilies need their fathersî) received positive responses from

women and minorities. 

ï Create a participant advisory board to give feedback on forms used, recruitment activities, study procedures, etc.

ï Recruit participants to plan social events and coordinate daily tasks associated with running a clinical research investigation.

STAFF YOUR TEAM RIGHT

ï Women and minority investigators and educators can often foster greater trust among female and minority participants.

ï Include women and members of minority groups on your research staff, particularly women and minorities with the same

ethnic or racial background as the target population. This strategy may not provide immunity to problems of distrust and 

fear but should lessen the severity of the problem.

ï All staff should be instructed to ask how the participant would like to be addressed (Mr., Mrs. first name or nickname). The

participantís response should be noted in the research record. Staff turnover may mandate that this step be repeated. 

Address older adults more formally than younger participants. 

ï Provide pictures of staff in the research setting and include staff pictures in newsletters to facilitate identity and relationships among staff and participants.

ADDRESS LOGISTICAL AND FINANCIAL NEEDS

ï Maintain extended and flexible clinic hours. Weekend work may be required.

ï Provide at-home or work site follow-up for participants.

ï Attempt to combine protocol visits with existing medical appointments.

ï Offer childcare and transportation ñ or reimburse patients for these services.

ï Offer parents small gifts for their children. This may serve as an additional incentive and acknowledges parentsí 

sacrifices and absence from childcare responsibilities.

ï Reimburse patients for their time. Financial incentives may range from $5.00 up to as much as $25.00 per visit. Gift certificates

and large cash lotteries may be popular with some groups. Obviously, cultural and religious norms should be observed.

ï Explore potential of insurance coverage for ancillary care and other expenses associated with participation.

ï For each research participant, maintain a list of alternate contacts to improve your options for staying in touch since 

some women and minority groups may be highly mobile. 

IMPROVE COMMUNICATION

ï Provide additional time and assistance to those participants with special needs, e.g., parents with young children, older

adults, persons with hearing and sight limitations, those with low literacy levels and participants for whom English is a 

second language, since they may require extra efforts to understand what is required of them.

ï Allow extra time to review the studyís benefits and limits with options for 1:1 exchange of information. Videotaped 

messages may be helpful in low literacy groups. Remember, some minority groups regard research as guinea pig 

experimentation so the extra time will allow for questions and answers. Some women may be momentarily distracted 

by other competing demands such as children, ìto doî lists, or other physical needs. Extra time under these circumstances may allow for refocusing.

ï Study materials should be tailored with consideration of cultural and demographic characteristics of women or 

minority group(s).

ï Pictorial representation or use of videotape media might be used to explain the research.

ï Inform participants of tangible benefits such as free or reduced cost services associated with participation in clinical research.

ï Inform the participantís own health care provider about study progress, results and outcomes.

ï Inform participants about the study protocol, treatment, and implications through meetings, research teas, newsletters,

health fairs or other regular updates.

ï Acknowledge the contributions of patients in ways that are meaningful to them such as certificates of appreciation,

cards on birthdays or other special occasions, invitation to join ìlayî speakers bureau or other public recognition.

ï Use focus groups to identify and understand potential barriers to participation 

of women and minority group members.

Source: Adapted from the NIDA Clinical Trials Network brochure ìSuccessfully Including Women in Clinical Trials.î
screened for women eligible for participation in the SWAN Cross-Sectional Study, 

and 16,065 women were eligible and completed the interview. Of these, 6,521 women 

were cohort-eligible and asked to participate in the SWAN Longitudinal Study; a total 

of 3,306 women entered the Longitudinal Study. 

Each of seven sites surveyed one of four minority populations and a Caucasian population. Each site employed community development and outreach strategies to engage 

community gatekeepers. These gatekeepers included ministerial alliance groups who 

were apprised of the planned study and were requested to give support to the study by

informing their congregations. Some of the sites used flyers and doorknob literature 

packets as a way of preparing the communities. The investigators also used newsletters,

with staff pictures, to keep the community and participants informed of study progress. 

Recruitment incentives included diagnostic testing (with results sent to the women’s

health providers), a small freezer (used to retain samples) that became the women’s 

property to keep at the conclusion of the study, and community health fairs. Note 

cards, birthday cards and other printed forms of communication were employed in 

the study to acknowledge the value of participants to the study.

B Mental Health Services for Women in Public Medical Care

Investigators conducted a research project focused on women seen in county-run 

healthcare settings serving poor young women (primarily WIC Clinics and Family

Planning Clinics) in Prince George’s and Montgomery counties, MD, and Arlington

County, VA. Previous studies have documented that untreated mental disorders in primary care settings represent a serious public health problem. However, these studies 

did not include young poor women (a group at high risk for these mental disorders, 

yet low mental health users), who rarely are seen in primary health care settings.

Prior to beginning the National Institute of Mental Health-funded project, researchers

spent one year courting providers in county clinics, including the WIC program, family

planning clinics and pediatrics, in order to gain access to the population of interest.

Researchers worked to establish relationships and trust with the clinics by providing 

services and consultation and by working at integrating themselves into the clinic 

team (e.g., attending regular clinic meetings and providing services that went beyond 

mental health services such as child care, and translation services). 

Significant resources were invested in pursuing subjects. These included repeated 

phone outreach and face-to-face contacts at home or work or during regular primary 

care clinic appointments. Investigators were careful not to become intrusive: the 

decision to pursue subjects was based on reports from the women that the repeated

attempts to reach them signaled caring on the part of the researcher. The significance 

Recruitment and Retention of Women and Minorities in Clinical Research 73
of racial and ethnic match between provider and subject was unclear, but outreach and

trust issues were significant issues. Often women were not immediately responsive, but

would later agree to enter care. Through outreach efforts, they realized they could trust 

the study staff and would turn to them when crises in their lives occurred.

Data collection for this study ends in 2003. The researchers are pilot testing communitybased interventions, such as partnering with an ongoing “Promotoras de Salud” program 

(a lay health worker program funded by the Daughters of Charity), to examine the 

feasibility of such organizations providing outreach and support services to supplement 

traditional mental health care services for disadvantaged minorities with mental health

care needs.

C African American Hereditary Prostate Cancer (AAHPC) Study

This multicenter genetic linkage study was organized by Howard University and the

National Human Genome Research Institute, with support from the National Center 

on Minority Health and Health Disparities and the National Cancer Institute. Six

Collaborative Recruitment Centers were responsible for the identification and enrollment of 100 African American families; recruitment strategies included mass media 

campaigns, physician referrals, community health fairs/prostate cancer screenings, support groups, tumor registries, as well as visits to churches, barber shops, and universities.

Investigators utilized various incentives depending on the site, including a copy of the 

subject’s family tree, plaques with inscriptions related to the study, free medical screening, and reimbursement for travel and other related expenses. The study was publicized 

through presentations at professional meetings and other physician organizations 

and groups. Some strategies did not work as well as anticipated, including flyers and 

presentations at churches and racial/ethnic specific groups, health fairs and cancer 

screening events (Royal, 2000). By far, the most productive recruitment mechanisms 

were physician referrals and tumor registries.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 74 and Minority Subjects in Clinical Research
VI CONCLUSION

Data on successful recruitment and retention strategies for women and minorities in 

clinical research suggests that strategies tailored to the inclusion, recruitment and retention of a specific study, with deliberate consideration for the target population, is critical 

to its success. Recurring barriers in clinical research (fear and distrust, lack of knowledge, 

lack of transportation, interference with work and family, intense subject burden, and 

financial costs) are modifiable. Further, the flexibility and readiness of staff to modify 

or add elements of outreach may be helpful in improving accrual of women and minorities in clinical studies. 

Recruitment and Retention of Women and Minorities in Clinical Research 75

Section 5

Human Subjects Protections 

and Inclusion Issues

HUMAN SUBJECTS PROTECTIONS

AND INCLUSION ISSUES

Ethical issues involved in the conduct of biomedical research are a topic of considerable 

debate. Clinical trials in particular will remain a focal point, given the nature and scope 

of the expanding need for clinical research and existing global public health concerns 

such as AIDS, cancer, gene therapy, diseases related to aging, resistant bacteria, and 

biological warfare. Well-publicized failures in the conduct of clinical research have left 

some groups suspicious of the motives and methods of medical research. As informed and 

knowledgeable research practitioners, we can begin by making sure that medical research 

practices are sound and ethical. 

As indicated above, concerns about clinical researchers and the research environment 

have led to debates about the best way to promote high standards in research and the 

ethical conduct of research. A greater transparency of the process, in concert with open 

communication is essential to restore the public’s faith in clinical research. Researchers 

have an obligation to participants and to the research endeavor to ensure that the design 

and conduct of studies are both sound and ethical. Elements of the ethics of research on 

human subjects are provided below.

I WHAT ARE THE ETHICAL PRINCIPALS THAT GOVERN RESEARCH 

INVOLVING HUMAN SUBJECTS

The Public Health Service Act requires that each entity which applies for a grant, 

contract or cooperative agreement for any project or program which involves the 

conduct of biomedical or behavioral research involving human subjects provide evidence 

that the research plan protects the rights and welfare of human subjects by minimizing 

risks, selecting subjects equitably, obtaining informed consent, and ensuring privacy 

and confidentiality and has established an Institutional Review Board (IRB) to review 

the research project.

The Code of Federal Regulations, Title 45, Part 46 Protection of Human Subjects 

(45 CFR 46), Subpart A is the federal policy for the protection of human subjects, 

and is referred to as “The Common Rule.” The Common Rule implements the sections 

of the Public Health Service Act relevant to the Protection of Human Research Subjects.

(The analogous FDA regulations, 21 CFR 50 and 56 have similar requirements.)

The regulations are implemented by the IRB.

79
The Belmont Report (a report of the National Commission for the Protection of Human

Subjects) attempts to summarize the basic ethical principles for the conduct of biomedical 

and behavioral research involving human subjects. Three basic principles encompassed 

in the Belmont Report are:

1 Respect for Persons – treating individuals as autonomous agents and ensuring protection 

of persons with diminished autonomy.

2 Beneficence – securing the well being of persons by doing no harm and maximizing 

possible benefits and minimizing possible harms.

3 Justice – fairness in the distribution of benefits and burdens among research subjects.

Implementation of Belmont Principles

The key feature of ethical research is consent to participation. Consent safeguards 

a subject’s autonomy. An individual maintains control over their life by deciding 

either to consent or not to consent. Additionally, consent protects human dignity. 

The individual is recognized as having inherent worth, and may not be used as mere 

means to an end. Furthermore, consent provides assurance, to the public, that researchers

are not manipulating or deceiving human subjects. Finally, consent elevates subjects of

research to be participants in research, and to realize that their participation is essential 

to the research process.

The fair selection of research subjects is critical to the ethical conduct of research. Fair

selection ensures that no single population is approached too often for participation or 

is placed at increased risk because circumstance makes them unable to refuse to participate in research. Conversely, fair selection means that no single population is selected 

to receive only the benefits of research while never having been asked to assume any

potential harms associated with participating in research.

A Informed Consent

Human subjects in research must participate willingly. Voluntary participation also 

means that subjects have enough information to give informed consent (consent of 

participation provided by the participant with full knowledge of the risks and benefits).

The signed informed consent document must include information on the purpose 

and benefit of the research, all foreseeable risks or discomforts, study duration, 

research contact person, right to withdraw, and whether the research is classified. 

The informed consent documents should be clear, concise, informative, and explained 

in a manner that is understood by the research participant. Informed consent, whether 

oral or written, may not include language that appears to waive the subject’s legal rights 

or that appears to release the investigator or anyone else from liability for negligence.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 80 and Minority Subjects in Clinical Research
Investigator(s) and staff(s) should take precautionary measures to ensure that ethical 

concerns are clearly noted in the informed consent document, to minimize the possibility of coercion or undue influence in the incentives or rewards offered in recruiting 

into or retaining participants in studies. 

For example, some minority groups may fear lack of sensitivity and objectivity by the

research team about their needs, values and beliefs, or if they will receive the same level 

of care as other groups in the study. For this reason, the informed consent process should

include one or more information sessions about the goals of the research and the reasons

for differences in participation between groups, if they exist. 

Developing an informed consent document that meets the needs of diverse groups 

may require an understanding of health problems and conditions of different racial 

and ethnic subpopulations, as well as attention to socioeconomic differences involving

occupation, income, education, religious beliefs, and cultural values. 

B Conflict of Interest 

Although conflicts of interest are not restricted to clinical research, unmanaged 

conflicts of interest in the context of clinical research have had the appearance of 

leading to bad consequences and have led to lingering mistrust of clinical researchers.

IRB Review of Protocols and Approval of Consent Documents

(http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finguid.htm)

All IRBs (Institutionally based and non-Institutionally based) should be cognizant 

of the source of funding and funding arrangement for each protocol they review, and 

the source and arrangement for the funding the IRB’s review of each protocol.

When an institutional official or conflict of interest committee or its equivalent 

determines that a potential Institutional conflict is problematic, the IRB should review 

the Institution’s financial relationship to the sponsor of a specific trial and determine

whether the trial should be permitted to be carried out at the Institution. If so, the IRB

should consider how this should best be managed, including what modifications might

need to be made to the protocol or to the Consent form. 

When the institutional official or conflict of interest committee or equivalent 

determines that a clinical investigator has potential conflict of interest that cannot 

be eliminated, and must be reduced or managed in some way, IRBs should consider 

not only what modifications might need to be made to the protocol or Consent, but 

also other approaches as appropriate. 

Human Subjects Protections and Inclusion Issues 81
IRBs should carefully consider the specific mechanisms proposed to minimize the 

potential adverse consequences of the conflict in an effort to optimally protect the 

interests of the research subjects. In general, if there are any financial conflict of 

interest issues on the part of the clinical investigator, he or she should not be directly

engaged in aspects of the trial that could be influenced inappropriately by that conflict.

These could include: the design of the trial, monitoring the trial, obtaining the 

informed consent, adverse event reporting, or analyzing the data. 

II DATA AND SAFETY MONITORING PLAN AND DSMBS

NIH policy requires that investigators submit a general description of the data and safety 

monitoring plan for clinical trials (biomedical and behavioral intervention studies) as 

part of the research application. In developing your Data and Safety Monitoring Plan, 

you should refer to the NIH Policy for Data and Safety Monitoring (http://grants.nih.gov/

grants/guide/noticefiles/NOT-OD-00-038.html. See also (http://grants.nih.gov/grants/guide/

notice-files/not98-084.html).

NIH specifically requires the establishment of Data and Safety Monitoring Boards 

(DSMBs) for multi-site clinical trials involving interventions that entail potential 

risk to the participants. 

A DSMB is an independent research monitoring board. Generally, experts in all scientific 

disciplines needed to interpret the data and ensure patient safety should conduct the 

monitoring activities. Ideally, participants in monitoring a trial are in no way associated 

with the trial. Committee membership can include clinical trial experts, biostatisticians,

bioethicists, or other clinicians. 

The objectives of the DSMB are to ensure (1) risks associated with participation are 

minimized to the extent practical, (2) integrity of the data, and (2) ethics of the clinical 

trial. Additionally the DSMB has the responsibility to stop a trial if safety concerns arise 

or if the objectives of the trial are met.

All clinical trials, including physiologic, toxicity, and dose-finding studies (Phase I); 

efficacy studies (Phase II); and efficacy, effectiveness and comparative trials (Phase III) 

will require monitoring if the studies have multiple clinical sites, are blinded 

(masked), or if they include high-risk interventions or vulnerable populations. 

(See http://grants.nih.gov/grants/guide/notice-files/not98.084.html).

The method and degree of monitoring needed is related to the degree of risk involved 

to the participants as well as size, complexity, and scope of the research effort. The 

monitoring effort can range from monitoring by the principal investigator or the NIH 

program staff in a small Phase I study to the establishment of an independent DSMB

for a large trial. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 82 and Minority Subjects in Clinical Research
III INSTITUTIONAL REVIEW BOARD (IRB)

As IRBs implement current guidelines for the inclusion of women and minorities 

and their subpopulations, they must also implement the regulations for the protection 

of human subjects as described in 45 CFR 46, “Protection of Human Subjects.” They 

should also take into account the Food and Drug Administration’s (FDA’s) “Guidelines 

for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” 

Vol. 58 Federal Register 39406.

A What Is the Role of the IRB?

An IRB is a group that has been formally designated to review and monitor biomedical 

and behavioral research involving human subjects in accordance with DHHS and/or 

FDA regulations. An IRB has the authority to approve, require modification in, or 

disapprove research to ensure protection for human’s subjects.

IRBs that approve studies of products regulated by the FDA must be in compliance 

with 21 CFR 50 & 56. Federal funds support does not need to be involved for the 

FDA regulations to apply. However, when research studies involving products 

regulated by FDA are funded and supported by DHHS, the research institution must 

comply with both the DHHS (45 CFR 46) and FDA (21 CFR 50&56) regulations.

The IRB must prospectively review and approve any changes that occur in your 

human subject research procedures. If unanticipated problems occur, or if human 

subjects are harmed, including physical injury, or there is improper disclosure of private

information, economic loss or other harmful occurrences, the IRB must be notified. 

IRBs are also responsible for determining whether informed consent is required 

from the subjects involved and secure whether privacy and confidentiality protections are adequate.

When appropriate, the IRB should also determine that the research plan makes 

adequate provision for monitoring the data collected to ensure the safety of subjects, 

to protect the privacy of subjects, and to maintain the confidentiality of the data.

Institutions engaged in human subject research must ensure that the composition 

of the IRB membership and its position within the institution’s administrative 

structure provides the IRB with the freedom to make decisions and conduct its 

oversight activities in an autonomous manner.

Broad participation by members outside the institution, who have no interest in the 

outcome of the research and the business interests of the institution, is encouraged 

as a way of protecting the integrity of the IRB process.

Human Subjects Protections and Inclusion Issues 83
B What Are the Criteria for IRB Approval of Research?

The essential criteria for IRB approval of research are based on the ethical principals 

that govern your research as outlined in the Belmont Report. The following requirements must be met in order to have your research reviewed and approved by the IRB:

• Risks to subjects must be minimized;

• Risks to subjects must be reasonable in relation to anticipated benefits;

• Selection of subjects must be equitable;

• Informed consent must be sought from each prospective subject or the subjects legally

authorized representative; and

• The research plan must be appropriately monitored to ensure the privacy of subject 

data, the safety of subjects, and protection of their rights and welfare, particularly 

for vulnerable populations.

From time to time, changes are made in the human subjects regulations and in their 

interpretation by IRBs and by the Office of Human Research Protections and the 

Center for Scientific Research. It is important to review and understand thoroughly 

the most current regulations before starting research.

In all cases, good judgment, openness of the recruitment and retention process and 

reliance upon objective, third party oversight can effectively minimize the potential 

for harm to subjects and safeguard the integrity of the research.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 84 and Minority Subjects in Clinical Research
Section 6

Appendices

APPENDIX A

GLOSSARY

Acculturation: Degree to which people from a particular cultural or ethnic group 

display behavior that reflects the influence of pervasive, mainstream norms of behavior.

Assimilation: Extent to which an individual enters a new culture and becomes a part of it.

Includes both the motivation of the individual to enter the mainstream culture and the 

extent to which members of the mainstream culture welcome or discourage the entry and

inclusion of that person in the mainstream culture.

Clinical research: The definition of clinical research for the purposes of the NIH policy 

on the inclusion of women and minorities in clinical studies was amended in 2000 to 

reflect the accepted definition from the 1997 Report of the NIH Director’s Panel on 

Clinical Research which can be found at the following URL: http://www.nih.gov/news/

crp/97report/execsum.htm. The Panel recommended that the NIH use the following definition as its standard for all analyses. Clinical research was defined in three parts as follows:

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 and/or obtains readily

identifiable private information. 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.

Clinical trial (NIH-defined Phase III): NIH has developed a special definition for an NIHdefined Phase III clinical trial to be used regarding this policy when referring to a clinical trial.

This is to distinguish this type of trial from the other types of clinical research which NIH 

supports, and from other definitions, e.g. by the Food and Drug Administration (FDA). 

For the purpose of the NIH policy, 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 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. 

87
In determining whether a study fits the NIH definition of a Phase III clinical trial, an 

essential consideration is trial outcome - whether it would contribute to a change in the 

standard of care or contribute to a change in public health policy, regardless of the number 

of participants in the study. This NIH definition of a Phase III clinical trial is broad and

encompases the wide range of research that NIH sponsors. It differs from the FDA definition of Phase III clinical trials, which focuses primarily on a clinical investigation of drugs,

vaccines, biologics, and devices. Clinical trials of experimental drugs covered in the FDA 

definition proceed through four phases (21 CFR Section 312.21, 4/1/94 edition). For 

additional information regarding the FDA definitions of the different phases of clinical 

trials, check the NIH Clinical Trials Website at: http://clinical trials.gov.

Community-based organizations: Organizations that have their origins or basis within 

the community and which utilize some aspect of the community’s goals, mandate, or 

objectives as part of their efforts.

Communication channels: The means by which a message gets from a source to a receiver.

Mass media channels are more effective in making people aware of a new idea; interpersonal

channels are more effective in persuading people to adopt a new idea.

Cultural competence: A set of academic and interpersonal skills that allows individuals 

to increase their understanding and appreciation of cultural differences and similarities 

within, among, and between groups. This requires a willingness and ability to draw on 

community-based values, traditions, and customs and to work with persons who are 

knowledgeable about and from the community in developing focused interventions, 

communications, and other supports.

Cultural diversity: Differences in race, ethnicity, language, nationality, or religion among 

various groups within a community, organization, or nation. A city is said to be culturally

diverse if its residents include members of different racial and/or ethnic groups.

Cultural sensitivity: Respect for ethnic individuals and for their culture; the recognition 

that such individuals have cultural health beliefs and practices; the integration of those 

beliefs and practices in the overall treatment plan for the patient.

Ethnicity: easily identifiable characteristic that implies a common cultural history with 

others possessing the same characteristic. Based on Federal reporting standards the ethnic 

categories required by NIH are Hispanic/Latino or not Hispanic/Latino. Hispanic/Latino

includes persons of Cuban, Mexican, Puerto Rican, South or Central American, or other

Spanish culture or origin, regardless of race.

Formative evaluation: Collects information about the components of the recruitment and

retention aspects of the research project. Information from this type of evaluation can be used

to test messages, select communications channels, and revise the communication process.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 88 and Minority Subjects in Clinical Research
Health disparities: Diseases, disorders, and conditions that disproportionately afflict 

individuals who are members of racial and ethnic minority groups.

Health literacy: the degree to which individuals have the capacity to obtain, process, 

and understand basic health information and services needed to make appropriate 

health decision.

Health promotion: is the combination of educational and environmental supports for 

actions and conditions of living conducive to health.

Impact evaluation: Focuses on the long-range results of the program and subsequent 

changes in health status. Impact evaluations are rarely possible because they are costly, 

involve extended commitment, and may depend upon other strategies in addition to 

the recruitment and retention component of the research project.

Majority group: Typically used to describe a group of individuals, self-identified as white, 

not of Hispanic Origin, and referring to a person or persons having origins in any of the 

original peoples of Europe, North Africa, or the Middle East.

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 following racial/ethnic

minority groups are those currently identified by the Office of Management and Budget

(OMB) for federal reporting: American Indian/Alaska Native; Asian, Black or African

American, Hispanic/Latino, Native Hawaiian or Other Pacific Islander. The minority 

group (and subpopulation) to which an individual belongs is determined by self-reporting. 

This classification is for administrative purposes and is prevalent in the scientific and other 

literature and databases available for research. The purpose of investigators routinely specify

the racial/ethnic population(s) under investigation is to systematically obtain data on the various minority groups and subpopulations. Related goals are to fill the gaps of health research

information for these populations, and to reduce/eliminate health disparities and to ensure

results are applicable to all citizens. Investigators may report their findings in the research 

literature consistent with the purpose of the research. 

Multicultural: Designed for, or pertaining to, two or more distinctive cultures.

Outcome evaluation: Provides descriptive information on the project and can be used 

to document short-term results. Task-focused results describe the output of the activities 

(i.e., number of participants recruited as a result of a talk show in a local television station).

Short-term results describe the immediate effects of the strategies on the target population

(i.e., percentage of the target group that is participating in one of the research protocols).

Glossary 89
Outreach strategies: These are outreach efforts by investigators and their staff 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 the collaboration.

Process evaluation: Documents the degree of implementation of the recruitment and 

retention activities. It describes how many items, of what materials, are provided to 

whom, by whom, and when and whether they responded. This type of evaluation may 

look at the origin of the research project, the methods used, the target population, 

program personnel/staff, and cost.

Sex/Gender: The term gender refers to the classification of research subjects into either 

or both of two categories: women and men. Sex refers to biological sex, either male or 

female. For inclusion purposes, biological sex should be used, either male or female.

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. 

Site of intervention: A specific location used to establish contact with or gain access 

to subjects within the neighborhood or community in which they reside. Examples 

include schools, work sites, beauty shops, barber shops, ethnic grocery stores, small group 

meetings in people’s homes, community clinics, hospitals, and day-care centers.

Subpopulations: Each racial/ethnic group contains subpopulations which 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. 

Underserved: individuals or groups who lack access to health services or health-related 

information relative to the national average. The underserved population may include 

residents of rural, remote or inner-city areas; members of certain racial and ethnic 

groups; socioeconomically disadvantaged persons; or people with disabilities.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 90 and Minority Subjects in Clinical Research
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 from 

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 gender and racial/ethnic groups.

Glossary 91

APPENDIX B

SELECTED REFERENCES ON OUTREACH FOR RECRUITMENT

AND RETENTION OF WOMEN AND MINORITIES IN

CLINICAL RESEARCH

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Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 94 and Minority Subjects in Clinical Research
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Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 102 and Minority Subjects in Clinical Research
APPENDIX C

NIH POLICY AND GUIDELINES ON THE INCLUSION OF

WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL

RESEARCH, AMENDED OCTOBER 2001

Summary: This notice updates the NIH policy on the inclusion of women and 

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

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

in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/notice-files/

NOT-OD-00-048.html). It incorporates the definition of clinical research as reported in the 

1997 Report of the NIH Director’s Panel on Clinical research. Also, this notice provides 

additional guidance on reporting analyses of sex/gender and racial/ethnic differences in 

intervention effects for NIH-defined 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.

103

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.
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: 

a the circumstances under which the inclusion of women and minorities as subjects 

in projects of clinical research is inappropriate ...; 

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

c the operation of outreach programs ... 492B(d)(1)

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

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

be included as subjects, the Director of NIH shall ensure that the trial is designed and 

carried out in a manner sufficient to provide for valid analysis of whether the variables 

being studied in the trial affect women or members of minority groups, as the case may 

be, differently than other subjects in the trial. 492B(c)

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

The term “minority group” includes subpopulations of minority groups. The Director 

of NIH shall, through the guidelines established...define the terms “minority group” 

and “subpopulation” for the purposes of the preceding sentence. 492B(g)(2)

The statute speaks specifically to outreach and states that:

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

Women's Health and the Director of the Office of Research on Minority Health, shall 

conduct or support outreach programs for the recruitment of women and members of 

minority groups as subjects in the projects of clinical research. 492B(a)(2)

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 104 and Minority Subjects in Clinical Research
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) 

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 betweeni 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)

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 105
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 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 106 and Minority Subjects in Clinical Research
be addressed by the proposed NIH-defined Phase III clinical trial and the design of 

that trial must specifically accommodate this. For example, if men and women are

thought to respond differently to an intervention, 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. 

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 107
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.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 108 and Minority Subjects in Clinical Research
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 United States. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators 

should consider designing their studies to accommodate these differences.

Investigators and their staff(s) are urged to develop appropriate and culturally sensitive outreach programs and activities commensurate with the goals of the study or

objectives of the contract. The objective should be to actively recruit and retain the

most diverse study population consistent with the purposes of the research project.

Indeed, the purpose should be to establish a relationship between the investigator(s) 

and staff(s) and populations and community(ies) of interest such that mutual benefit 

is derived for participants in the study. Investigator(s) should take precautionary 

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

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

recruiting into or retaining participants in studies.

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

educational materials, including a notebook titled, “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/human subjects/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,

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 109
• to evaluate the proposed exclusion of minorities and women on the basis that a

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

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

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

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

when warranted,

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

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

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

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

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

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

Further information on instructions for contracts may be obtained at the following

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

Or contact:

National Institutes of Health

Division of Acquisition Policy and Evaluation

Office of Acquisition Management and Policy

6100 Executive Boulevard, Room 6C01

Phone: 301-496-6014

Fax: 301-402-1199

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.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 110 and Minority Subjects in Clinical Research
7 NIH DIRECTOR

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

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

include within the requirements of these guidelines on the basis of circumstances 

other than the health of the subjects, the purpose of the research, or costs. 

IV DEFINITIONS

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

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

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

A Clinical Research

Clinical research is defined as:

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

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

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

definition are in vitro studies that utilize human tissues that cannot be linked to a 

living individual. Patient-oriented research includes: (a) mechanisms of human disease, 

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

(2) Epidemiologic and behavioral studies, 

(3) Outcomes research and health 

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

B NIH-defined Clinical Trial

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

prospective Phase III clinical investigation, usually involving several hundred or 

more human subjects, for the purpose of evaluating an experimental intervention 

in comparison with a standard or control intervention or comparing two or more 

existing treatments. Often the aim of such investigation is to provide evidence leading 

to a scientific basis for consideration of a change in health policy or standard of care. 

The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community 

trials and other population-based intervention trials are also included.

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 111
C Valid Analysis

The term “valid analysis” means an unbiased assessment. Such an assessment will, on 

average, yield the correct estimate of the difference in outcomes between two groups of

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

valid analysis does not need to have a high statistical power for detecting a stated effect.

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

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

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

unbiased process such as randomization

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

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

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

D Significant Difference

For purposes of this policy, a “significant difference” is a difference that is of clinical 

or public health importance, based on substantial scientific data. This definition differs

from the commonly used “statistically significant difference,” which refers to the event

that, for a given set of data, the statistical test for a difference between the effects in 

two groups achieves statistical significance. Statistical significance depends upon the

amount of information in the data set. With a very large amount of information, one 

could find a statistically significant, but clinically small difference that is of very little 

clinical importance. Conversely, with less information one could find a large difference 

of potential importance that is not statistically significant.

E Racial and Ethnic Categories

1 MINORITY GROUPS

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

distinguished by racial, ethnic, and/or cultural heritage.

The Office of Management and Budget (OMB) Directive No. 15 http://www.

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

maintaining, collecting and presenting data on race and ethnicity for all Federal 

reporting. NIH is required to use these definitions to allow comparisons to other 

federal databases, especially the census and national health databases. The categories 

in this classification are social-political constructs and should not be interpreted as

anthropological in nature. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 112 and Minority Subjects in Clinical Research
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.

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 113
3 SUBPOPULATIONS

Each racial and ethnic group contains subpopulations that are delimited by 

geographic origins, national origins and/or cultural differences. It is recognized 

that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on selfreporting 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.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 114 and Minority Subjects in Clinical Research
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:

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 115

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. Eleanor Hanna

National Institute on Alcohol Abuse 

and Alcoholism

Willco Building

6000 Executive Boulevard, Suite 514

Rockville, MD 20892

Telephone: 301-594-6231

Email: ehanna1@mail.nih.gov

Dr. John McGowan 

National Institute of Allergy 

and Infectious Diseases

6700 B Rockledge 

6700 Rockledge Drive

Bethesda, MD 20817

Telephone: 301-496-7291

Email: jm80c@nih.gov

Dr. Julia Freeman

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases

Natcher Building 

Building 45, Room 5AS19F

Bethesda, MD 20892

Telephone: 301-594-4543

Email: freemanj@ep.niams.nih.gov

Dr. Susan Streufert 

National Institute of Child Health 

and Human Development

6100 Executive Boulevard

Building 61EB, Room 4A05

Bethesda, MD 20892

Telephone: 301-435-6856

Email: streufes@mail.nih.gov
Dr. Julie Gulya

National Institute on Deafness and 

Other Communication Disorders

Executive Plaza South 

6120 Executive Boulevard, 

Room 400D-7

Rockville, MD 20892

Telephone: 301-435-4085

Email: gulyaj@ms.nidcd.nih.gov

Dr. Norman S. Braveman 

National Institute on Dental and 

Craniofacial Research

Natcher Building

Building 45, Room 4AN24C

Bethesda, MD 20892

Telephone: 301-594-2089

Email: BravemanN@de45.nidr.nih.gov

Dr. Robert Hammond

National Institute of Diabetes and 

Digestive and Kidney Diseases

2 Democracy Boulevard, Room 715

Bethesda, MD 20892

Telephone: 301-594-8834

Email: hammondr@extra.niddk.nih.gov

Dr. Teresa Levitin

National Institute on Drug Abuse

Neuroscience Building

6001 Executive Boulevard, Room 3158

Bethesda, MD 20852

Telephone: 301-443-2755

Email: tlevitin@nida.nih.gov

Dr. Anne P. Sassaman

National Institute of Environmental 

Health Sciences

P.O. Box 12233, MD EC-30

Research Triangle Park, NC 27709

Telephone: 919-541-7723

Email: sassaman@niehs.nih.gov

Dr. Alison Cole

National Institute of General 

Medical Sciences

Natcher Building

Building 45, Room 2AS49K

Bethesda, MD 20892

Telephone: 301-594-1826

Email colea@nigms.nih.gov

Dr. Richard Nakamura

National Institute of Mental Health

Neuroscience Building 

6001 Executive Boulevard, Room 8235

Bethesda, MD 20852 

Telephone: 301-443-3675 

Email: rnakamur@mail.nih.gov

Dr. Meredith Temple

National Institute of Neurological 

Disorders and Stroke

Neuroscience Building 

6001 Executive Boulevard, Room 2227

Bethesda, MD 20892- 9525

Telephone: 301-496-1447 

Email: templem@ninds.nih.gov

Dr. Mark Guyer

National Human Genome 

Research Institute

Building 31

31 Center Drive, Room B2B07

Bethesda, MD 20892

Telephone: 301-496-7531

Email: guyerm@exchange.nih.gov

Dr. Carole Hudgings

National Institute of Nursing Research

Natcher Building

45 Center Drive, Room 3AN-12

Bethesda, MD 20892

Telephone: 301-594-5976 

Email: carole_hudgings@nih.gov

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 116 and Minority Subjects in Clinical Research
Dr. Christine Goertz

National Center for Complementary 

and Alternative Medicine

Building 31

31 Center Drive, Room 5B-58

Telephone: 301-402-1030 

Email: GoertzC@od.nih.gov

Dr. Geoffrey Cheung

National Center for Research Resources

Rockledge Centre I

6705 Rockledge Drive, Room 6118

Bethesda, MD 20817

Telephone: 301-435-0768

Email: cheungg@ncrr.ncrr.nih.gov

Dr. Kenneth Bridbord

Fogarty International Center

Building 31

31 Center Drive, Room B2C39

Bethesda, MD 20892

Telephone: 301-496-2516

Email: bridbordk@ficod.fic.nih.gov

Dr. Joan T. Harmon

National Institute of Biomedical 

Imaging and Bioengineering

6707 Democracy Boulevard, Room 697

Bethesda, MD 20892

Telephone: 301-594-8813

Email: joan_harmon@nih.gov

Dr. Eric Bailey

National Center for Minority Health 

and Health Disparities

2 Democracy Boulevard, Suite 800

Bethesda, MD 20817

Telephone: 301-402-1366

Email: baileye@od.nih.gov

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research 117

APPENDIX D

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. 

119
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

• Hispanic or Latino – A person of Cuban, Mexican, Puerto Rican, South or 

Central American, or other Spanish culture or origin, regardless of race. The term

“Spanish origin” can also be used in addition to “Hispanic or Latino.” 

• Not Hispanic or Latino 

Racial Categories 

• American Indian or Alaska Native – A person having origins in any of the original 

peoples of North, Central, or South America, and who maintains tribal affiliations 

or community attachment. 

• Asian: A person having origins in any of the original peoples of the Far East, 

Southeast Asia, or the Indian subcontinent including, for example, Cambodia, 

China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, 

and Vietnam. (Note: Individuals from the Philippine Islands have been recorded 

as Pacific Islanders in previous data collection strategies.) 

• Black or African American – A person having origins in any of the black racial groups 

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

or African American.” 

• Native Hawaiian or Other Pacific Islander – A person having origins in any of the 

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

• White – A person having origins in any of the original peoples of Europe, the 

Middle East, or North Africa. 

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

on ethnicity and race, investigators should use two separate questions with 

ethnicity information collected first followed by the option to select more than 

one racial designation. 

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

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

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

who selected multiple racial categories reported as the “number selecting more than 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 120 and Minority Subjects in Clinical Research
one race”; and, (d) the number of respondents in each racial category who are Hispanic 

or Latino. Investigators may provide the detailed distributions, including all possible 

combinations, of multiple responses to the racial designations as additional information.

However, more detailed items should be designed in a way that they can be aggregated 

into the required categories for reporting purposes. NIH is required to use these definitions

to allow comparisons to other federal databases, especially the census and national health

databases. Federal agencies will not present data on detailed categories if doing so would

compromise data quality or confidentiality standards. 

II GUIDANCE ON REPORTING ETHNICITY/RACE AND SEX/GENDER 

IN CLINICAL RESEARCH 

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

to address the Inclusion of Women and Minorities (see http://grants.nih.gov/grants/

funding/women_min/women_min.htm). NIH defines clinical research as: (1) Patientoriented 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, or (d) development of new technologies. 

(2) Epidemiologic and behavioral studies. (3) Outcomes research and health 

services research. 

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

Proposals, and Intramural Projects 

1 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 

2 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

NIH Policy on Reporting Race and Ethnicity Data 121
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/Inclusion Old_Form.pdf 

3 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. 

4 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/

enrollment report.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.] 

5 IF DATA COLLECTION IS COMPLETE, SUCH THAT NO NEW/ADDITIONAL SUBJECT CONTACT IS PLANNED: 

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

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

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

III FREQUENTLY ASKED QUESTIONS 

1 WHAT CATEGORIES SHOULD I USE IN MY APPLICATION TO ESTIMATE RACE AND ETHNICITY, 

GIVEN THE NEW OMB STANDARDS? 

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

listed in the table “Targeted/Planned Enrollment Table” for New Applications. First, 

the investigator should report the anticipated total number of males and females to 

be enrolled by Ethnicity (Hispanic or Latino, Not Hispanic or Latino). Then, the 

investigator should report the anticipated total number of males and females by 

Racial Categories (American Indian or Alaska Native, Asian, Native Hawaiian or

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

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

of subjects in the Racial Categories section. Investigators do not need to estimate 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 122 and Minority Subjects in Clinical Research
the anticipated number of individuals reporting multiple racial categories (either 

total number reporting multiple categories or number reporting specific combinations) for New Applications. However, the investigator must follow the OMB 

guidelines, which include allowing respondents to select multiple race categories, 

once data collection commences. 

2 WHAT IF MY NEW APPLICATION INVOLVES ANALYZING SECONDARY DATA IN WHICH THE RACE

AND ETHNICITY CATEGORIES DO NOT COMPLY WITH THE NEW OMB GUIDELINES? 

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

OMB guidelines and does not plan to collect any new/additional data from the 

subjects, this should be noted in the New Application. In this circumstance, the 

investigator should complete the “Targeted/Planned Enrollment Table” for a New

Application and the “Inclusion Enrollment Report” for Continuation Applications,

Competing Supplement Applications, and Annual Grant Progress Reports if the 

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

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

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

3 THERE ARE MANY WAYS OF TABULATING THE MULTIPLE RACE AND ETHNICITY RESPONSES, 

PARTICULARLY SINCE THE RACE AND ETHNICITY CATEGORIES ARE NOT MUTUALLY EXCLUSIVE. 

DO THE NUMBERS I REPORT HAVE TO ìADD UPî? 

The numbers in several parts of the two tables must be the same. In both the

“Targeted/Planned Enrollment Table” for a New Application and the “Inclusion

Enrollment Report” for Continuation Applications, Competing Supplement

Applications, and Annual Progress Reports, the sum in “Ethnic Category: Total 

of All Subjects” must equal the sum in “Racial Categories: Total of All Subjects.” 

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

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

number reported in Part A of the “Inclusion Enrollment Report.” Footnotes in 

the tables clearly identify which numbers must be the same. 

4 CAN I USE THE TARGETED/PLANNED ENROLLMENT TABLE OR THE ENROLLMENT INCLUSION

REPORT TO COLLECT DATA FROM INDIVIDUALS? 

Neither the Targeted/Planned Enrollment Tablet nor the Enrollment Inclusion

Report should be used for collecting data from individuals. These tables are only 

to be used for reporting aggregate data. 

To collect data from an individual respondent, investigators should use respondent 

self-report or self-identification and use two separate questions. The first question 

should be about ethnicity, followed by a question that provides the option of selecting

NIH Policy on Reporting Race and Ethnicity Data 123
one or more racial designations. An example of a format for collecting information 

from an individual can be found in the “Ethnic Origin and Race” section of the

Personal Data Form Page in the PHS 398 (rev. 5/01) http://grants.nih.gov/grants/

funding/phs398/personal.pdf 

5 CAN I ASK MORE DETAILED QUESTIONS ABOUT ETHNICITY AND RACE THAN THESE GUIDELINES INDICATE? 

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

researchers are encouraged to explore collecting additional types of information on 

race and ethnicity that will provide additional insights into the relationships between

race and ethnicity and health. For example, after asking the ethnicity and then the 

race questions, researchers may opt to ask study participants who choose multiple 

categories to identify the group that they identify with primarily. Further questions 

identifying membership in subpopulations within the ethnic and racial categories 

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

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

additional information on ethnicity or race. Information on subpopulations may 

be reported by listing the information in an attachment to the required table. 

6 I HAVE ALREADY BEGUN DATA COLLECTION AND MY CATEGORIES DO NOT COMPLY WITH THE

NEW OMB STANDARDS. DO I NEED TO CHANGE MY QUESTIONS ON RACE AND ETHNICITY

IN THE MIDDLE OF THE STUDY? 

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

questions on race and ethnicity prior to the completion of the study. For Annual

Progress Reports, in this circumstance, investigators should note that the research 

project was initiated prior to the implementation of the new reporting guidelines. 

If the data do not accurately correspond with the new categories, the investigator 

may continue to use the format in the 4/98 Version of the Inclusion Table. 

7 I BEGAN DATA COLLECTION PRIOR TO THE NEW STANDARDS, BUT MY RACE AND ETHNICITY

QUESTIONS COMPLY WITH THE NEW STANDARDS. I SUBMITTED MY ORIGINAL ESTIMATES OF THE STUDY

COMPOSITION USING THE OLD STANDARDS. HOW SHOULD I PRESENT THE DATA IN THE PROGRESS REPORT? 

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. 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 124 and Minority Subjects in Clinical Research
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 self-reporting or self-identification to 

collect data on ethnicity and race, investigators should use two separate questions 

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

than one racial designation. 

Additional Information and NIH Contacts Additional information on NIH policy

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

at the website http://grants.nih.gov/grants/funding/women_min/women_min.htm.

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

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

NIH Policy on Reporting Race and Ethnicity Data 125

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. Eleanor Hanna

National Institute on Alcohol Abuse

and Alcoholism

Willco Building

6000 Executive Boulevard, Suite 514

Rockville, MD 20892

Telephone: 301-594-6231

Email: ehanna1@mail.nih.gov 

Dr. John McGowan 

National Institute of Allergy 

and Infectious Diseases

6700 B Rockledge 

6700 Rockledge Drive

Bethesda, MD 20817

Telephone: 301-496-7291

Email: jm80c@nih.gov 

Dr. Julia Freeman

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases

Natcher Building

Building 45, Room 5AS19F

Bethesda, MD 20892

Telephone: 301-594-4543

Email: freemanj@ep.niams.nih.gov

Dr. Susan Streufert 

National Institute of Child Health 

and Human Development

6100 Executive Boulevard

Building 61EB, Room 4A05

Bethesda, MD 20892

Telephone: 301-435-6856

Email: streufes@mail.nih.gov 

Dr. Julie Gulya

National Institute on Deafness and 

Other Communication Disorders

Executive Plaza South 

6120 Executive Boulevard, Room 400D-7

Rockville, MD 20892

Telephone: 301-435-4085

Email: gulyaj@ms.nidcd.nih.gov 

Dr. Norman S. Braveman 

National Institute on Dental and 

Craniofacial Research

Natcher Building

Building 45, Room 4AN24C

Bethesda, MD 20892

Telephone: 301-594-2089

Email: BravemanN@de45.nidr.nih.gov 

Dr. Robert Hammond

National Institute of Diabetes and

Digestive and Kidney Diseases

2 Democracy Boulevard, Room 715

Bethesda, MD 20892

Telephone: 301-594-8834

Email: hammondr@extra.niddk.nih.gov 

Dr. Teresa Levitin

National Institute on Drug Abuse

Neuroscience Building

6001 Executive Boulevard, Room 3158

Bethesda, MD 20852

Telephone: 301-443-2755

Email: tlevitin@nida.nih.gov 

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 126 and Minority Subjects in Clinical Research
Dr. Anne P. Sassaman

National Institute of Environmental 

Health Sciences

P.O. Box 12233, MD EC-30

Research Triangle Park, NC 27709

Telephone: 919-541-7723

Email: sassaman@niehs.nih.gov 

Dr. Alison Cole

National Institute of General 

Medical Sciences

Natcher Building

Building 45, Room 2AS49K

Bethesda, MD 20892

Telephone: 301-594-1826

Email: colea@nigms.nih.gov 

Dr. Richard Nakamura

National Institute of Mental Health

Neuroscience Building 

6001 Executive Boulevard, Room 8235

Bethesda, MD 20852 

Telephone: 301-443-3675 

Email: rnakamur@mail.nih.gov 

Dr. Mary Ellen Michel

National Institute of Neurological 

Disorders and Stroke

Neuroscience Building 

6001 Executive Boulevard, Room 2227

Bethesda, MD 20892- 9525

Telephone: 301-496-1447 

Email: michelm@ninds.nih.gov 

Dr. Mark Guyer

National Human Genome 

Research Institute

Building 31

31 Center Drive, Room B2B07

Bethesda, MD 20892

Telephone: 301-496-7531

Email: guyerm@exchange.nih.gov 

Dr. Carole Hudgings

National Institute of Nursing Research

Natcher Building

45 Center Drive, Room 3AN-12

Bethesda, MD 20892

Telephone: 301-594-5976 

Email: carole_hudgings@nih.gov 

Dr. Christine Goertz

National Center for Complementary 

and Alternative Medicine

Building 31

31 Center Drive, Room 5B-58

Telephone: 301-402-1030 

Email: GoertzC@od.nih.gov 

NIH Policy on Reporting Race and Ethnicity Data 127

129

APPENDIX E

GRANTS, OLD INCLUSION TABLE, TARGETED/PLANNED

ENROLLMENT TABLE, INCLUSION ENROLLMENT TABLE,

CONTRACTS, INCLUSION ENROLLMENT PROGRAM

ANNUAL TECHNICAL PROGRESS REPORT

Inclusion Table

This report should NOT be used for data collections from study participants.

Principal Investigator/Project Director__________________________________________

(Last, First, Middle)

Grant Number (if known):____________________________________________________

Study Title:________________________________________________________________

American Asian or Black, Not White, Not

Indian or Pacific of Hispanic of Hispanic Other or

Alaskan Native Islander Origin Hispanic Origin Unknown Total

Female

Male

Unknown

Total

Sample Form
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 130 and Minority Subjects in Clinical Research

Targeted/Planned Enrollment: Number of Subjects

Sex/Gender

Ethnic Category Females Males Total

Hispanic or Latino

Not Hispanic or Latino

Ethnic Category Total of All Subjects*

Racial Categories

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Racial Categories: Total of All Subjects*

*The ìEthnic Category Total of All Subjectsî must be equal to the ìRacial Categories Total of All Subjects.î

Targeted/Planned Enrollment Table

This report should NOT be used for data collections from study participants.

Study Title:_______________________________________________________________

Total Planned Enrollment:___________________________________________________
Enrollment Tables 131

PART A: Total Enrollment Report: Number of Subjects Enrolled to Data (Cumulative) by Ethnicity and Race

Sex/Gender

Ethnic Category Females Males Unknown or Not reported Total

Hispanic or Latino **

Not Hispanic or Latino

Unknown (Individuals not reporting ethnicity)

Ethnic Category Total of All Subjects* *

Racial Categories

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or not reported

Racial Categories: Total of All Subjects* *

PART B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

Racial Category Females Males Unknown or Not reported Total

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or not reported

Racial Categories: Total of Hispanics and Latinos **

*These totals must agree

**These totals must agree

Inclusion Enrollment Report Table

This report should NOT be used for data collections from study participants.

Study Title:______________________________________________________________

Total Enrollment:___________________ Protocol Number:_______________________

Contract Number:_________________________________________________________
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 132 and Minority Subjects in Clinical Research

Use when the contract involves human subjects unless it has been determined by the government

that the inclusion of women & minority groups in the study population is not appropriate.

PART A: Total Enrollment Report: Number of Subjects Enrolled to Data (Cumulative) by Ethnicity and Race

Sex/Gender

Ethnic Category Females Males Unknown or Not reported Total

Hispanic or Latino

Not Hispanic or Latino

Unknown (Individuals not reporting ethnicity)

Ethnic Category Total of All Subjects*

Racial Categories

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or not reported

Racial Categories: Total of All Subjects*

PART B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

Racial Category Females Males Unknown or Not reported Total

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or not reported

Racial Categories: Total of Hispanics and Latinos**

*These totals must agree

**These totals must agree

Inclusion Enrollment Report: Contracts

This report should NOT be used for data collections from study participants.

Study Title:______________________________________________________________

Total Enrollment:___________________ Protocol Number:_______________________

Contract Number:_________________________________________________________
Review of the Inclusion Policy 133

Annual Technical Progress Report Format for Each Study: Contracts

Study Title:________________________________________________________________

Date:_____________________________________________________________________

Provide the number of subjects enrolled in the study to date according to the 

following categories:

Subpopulations of the minority groups should also be repoted using a similar format.

Use for follow-on or renewal contracts involving human subjects that began collecting 

data prior to FY02 only if the data being collected does not fit into the 10/2001 standards 

(see Inclusion Enrollment Report) Note: Whenever possible and appropriate, the “Inclusion

Enrollment Report” should be used in lieu of this reporting format.

American Asian or Black, Not White, Not

Indian or Pacific of Hispanic of Hispanic Other or

Alaskan Native Islander Origin Hispanic Origin Unknown Total

Female

Male

Unknown

Total

135

APPENDIX F

RESOURCES AVAILABLE ON THE INTERNET

I OER INCLUSION OF WOMEN AND MINORITIES POLICY IMPLEMENTATION

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

Provides links to:

A October 2001 Amended Policy on Inclusion of Women and Minorities as 

Subjects in Clinical Research

B August 2001 Policy on Reporting Race and Ethnicity Data: Subjects in 

Clinical Research

C Old and New Enrollment Tables for reporting Target and Enrollment Data

II ORWH POLICY ON WOMENíS INCLUSION AS PARTICIPANTS IN RESEARCH

http://www4.od.nih.gov/orwh/inclusion.html

Provides links to:

A NIH-wide aggregate Inclusion data Reports prepared by the NIH Tracking and 

Inclusion Committee;

B Outreach Notebook that includes a Question and Answer section to assist in the 

preparation of research applications and in the development of outreach activities as

they relate to the inclusion of women and minorities as subjects in clinical research. 

III OER PEER REVIEW POLICY AND ISSUES

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

Provides information about Review policies, in particular reviewer instructions for evaluating

inclusion of women and minorities in clinical research and analysis plans for NIH Phase-III

Clinical Trials.

IV NIH FORMS AND APPLICATIONS 

http://grants.nih.gov/grants/forms.htm

Provides links to the PHS 398 and PHS 2590 Instructions and Forms.

http://rcb-intranet.nci.nih.gov/

Provides links to RFP and Contract Workforms.

APPENDIX G

45 CFR 46 

SUBPART B: ADDITIONAL PROTECTIONS FOR

PREGNANT WOMEN, HUMAN FETUSES AND

NEONATES INVOLVED IN RESEARCH

Source: Federal Register, November 13, 2001 (Volume 66, Number 219), Rules and Regulations,

Page 56775-56780, from the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13no01-9]. 

ß46.201 TO WHAT DO THESE REGULATIONS APPLY?

a Except as provided in paragraph (b) of this section, this subpart applies to all research

involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable

neonates conducted or supported by the Department of Health and Human Services

(DHHS). This includes all research conducted in DHHS facilities by any person and 

all research conducted in any facility by DHHS employees.

b The exemptions at Sec. 46.101(b)(1) through (6) are applicable to this subpart.

c The provisions of Sec. 46.101(c) through (i) are applicable to this subpart. Reference 

to State or local laws in this subpart and in Sec. 46.101(f) is intended to include the 

laws of federally recognized American Indian and Alaska Native Tribal Governments.

d The requirements of this subpart are in addition to those imposed under the other subparts

of this part.

ß46.202 DEFINITIONS

The definitions in Sec. 46.102 shall be applicable to this subpart as well. In addition, as used 

in this subpart:

a Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity,

spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

b Delivery means complete separation of the fetus from the woman by expulsion or extraction

or any other means.

c Fetus means the product of conception from implantation until delivery.

137
d Neonate means a newborn.

e Nonviable neonate means a neonate after delivery that, although living, is not viable.

f Pregnancy encompasses the period of time from implantation until delivery. A woman 

shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs 

of pregnancy, such as missed menses, until the results of a pregnancy test are negative 

or until delivery.

g Secretary means the Secretary of Health and Human Services and any other officer 

or employee of the Department of Health and Human Services to whom authority 

has been delegated.

h Viable, as it pertains to the neonate, means being able, after delivery, to survive (given 

the benefit of available medical therapy) to the point of independently maintaining 

heartbeat and respiration. The Secretary may from time to time, taking into account 

medical advances, publish in the Federal Register guidelines to assist in determining

whether a neonate is viable for purposes of this subpart. If a neonate is viable then it 

may be included in research only to the extent permitted and in accordance with the

requirements of subparts A and D of this part.

ß46.203 DUTIES OF IRBS IN CONNECTION WITH RESEARCH INVOLVING 

PREGNANT WOMEN, FETUSES, AND NEONATES.

In addition to other responsibilities assigned to IRBs under this part, each IRB shall 

review research covered by this subpart and approve only research which satisfies the 

conditions of all applicable sections of this subpart and the other subparts of this part.

ß46.204 RESEARCH INVOLVING PREGNANT WOMEN OR FETUSES.

Pregnant women or fetuses may be involved in research if all of the following conditions 

are met:

a Where scientifically appropriate, preclinical studies, including studies on pregnant 

animals, and clinical studies, including studies on nonpregnant women, have been 

conducted and provide data for assessing potential risks to pregnant women and fetuses;

b The risk to the fetus is caused solely by interventions or procedures that hold out the

prospect of direct benefit for the woman or the fetus; or, if there is no such prospect 

of benefit, the risk to the fetus is not greater than minimal and the purpose of the 

research is the development of important biomedical knowledge which cannot be 

obtained by any other means;

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 138 and Minority Subjects in Clinical Research
c Any risk is the least possible for achieving the objectives of the research;

d If the research holds out the prospect of direct benefit to the pregnant woman, the 

prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect 

of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal

and the purpose of the research is the development of important biomedical knowledge 

that cannot be obtained by any other means, her consent is obtained in accord with 

the informed consent provisions of subpart A of this part;

e If the research holds out the prospect of direct benefit solely to the fetus then the 

consent of the pregnant woman and the father is obtained in accord with the informed 

consent provisions of subpart A of this part, except that the father's consent need not 

be obtained if he is unable to consent because of unavailability, incompetence, or 

temporary incapacity or the pregnancy resulted from rape or incest.

f Each individual providing consent under paragraph (d) or (e) of this section is fully

informed regarding the reasonably foreseeable impact of the research on the fetus 

or neonate;

g For children as defined in Sec. 46.402(a) who are pregnant, assent and permission 

are obtained in accord with the provisions of subpart D of this part;

h No inducements, monetary or otherwise, will be offered to terminate a pregnancy;

i Individuals engaged in the research will have no part in any decisions as to the timing,

method, or procedures used to terminate a pregnancy; and

j Individuals engaged in the research will have no part in determining the viability 

of a neonate

ß46.205 RESEARCH INVOLVING NEONATES.

a Neonates of uncertain viability and nonviable neonates may be involved in research 

if all of the following conditions are met:

1 Where scientifically appropriate, preclinical and clinical studies have been 

conducted and provide data for assessing potential risks to neonates.

2 Each individual providing consent under paragraph (b)(2) or (c)(5) of this section 

is fully informed regarding the reasonably foreseeable impact of the research on 

the neonate.

3 Individuals engaged in the research will have no part in determining the viability 

of a neonate.

4 The requirements of paragraph (b) or (c) of this section have been met as applicable.

45 CFR 46 139
b Neonates of uncertain viability. Until it has been ascertained whether or not a neonate 

is viable, a neonate may not be involved in research covered by this subpart unless the 

following additional conditions have been met:

1 The IRB determines that:

i The research holds out the prospect of enhancing the probability of survival of 

the neonate to the point of viability, and any risk is the least possible for achieving

that objective, or

ii The purpose of the research is the development of important biomedical knowledge

which cannot be obtained by other means and there will be no added risk to the

neonate resulting from the research; and

2 The legally effective informed consent of either parent of the neonate or, if neither 

parent is able to consent because of unavailability, incompetence, or temporary 

incapacity, the legally effective informed consent of either parent's legally authorized

representative is obtained in accord with subpart A of this part, except that the 

consent of the father or his legally authorized representative need not be obtained 

if the pregnancy resulted from rape or incest.

c Nonviable neonates. After delivery nonviable neonate may not be involved in research 

covered by this subpart unless all of the following additional conditions are met:

1 Vital functions of the neonate will not be artificially maintained;

2 The research will not terminate the heartbeat or respiration of the neonate;

3 There will be no added risk to the neonate resulting from the research;

4 The purpose of the research is the development of important biomedical knowledge 

that cannot be obtained by other means; and

5 The legally effective informed consent of both parents of the neonate is obtained in

accord with subpart A of this part, except that the waiver and alteration provisions 

of Sec. 46.116(c) and (d) do not apply. However, if either parent is unable to consent

because of unavailability, incompetence, or temporary incapacity, the informed consent

of one parent of a nonviable neonate will suffice to meet the requirements of this 

paragraph (c)(5), except that the consent of the father need not be obtained if the 

pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet

the requirements of this paragraph (c)(5).

d Viable neonates. A neonate, after delivery, that has been determined to be viable may 

be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.

Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 140 and Minority Subjects in Clinical Research
ß46.206 RESEARCH INVOLVING, AFTER DELIVERY, THE PLACENTA, 

THE DEAD FETUS OR FETAL MATERIAL.

a Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; 

or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with

any applicable Federal, State, or local laws and regulations regarding such activities.

b If information associated with material described in paragraph (a) of this section is 

recorded for research purposes in a manner that living individuals can be identified, 

directly or through identifiers linked to those individuals, those individuals are research 

subjects and all pertinent subparts of this part are applicable.

ß46.207 RESEARCH NOT OTHERWISE APPROVABLE WHICH PRESENTS 

AN OPPORTUNITY TO UNDERSTAND, PREVENT, OR ALLEVIATE A SERIOUS

PROBLEM AFFECTING THE HEALTH OR WELFARE OF PREGNANT WOMEN,

FETUSES, OR NEONATES.

The Secretary will conduct or fund research that the IRB does not believe meets the 

requirements of Sec. 46.204 or Sec. 46.205 only if:

a The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare 

of pregnant women, fetuses or neonates; and

b The Secretary, after consultation with a panel of experts in pertinent disciplines (for 

example: science, medicine, ethics, law) and following opportunity for public review 

and comment, including a public meeting announced in the Federal Register, has 

determined either:

1 That the research in fact satisfies the conditions of Sec. 46.204, as applicable; or

2 The following:

i The research presents a reasonable opportunity to further the understanding, 

prevention, or alleviation of a serious problem affecting the health or welfare 

of pregnant women, fetuses or neonates;

ii The research will be conducted in accord with sound ethical principles; and

iii Informed consent will be obtained in accord with the informed consent 

provisions of subpart A and other applicable subparts of this part.

45 CFR 46 141

143

APPENDIX H

POWERPOINT SLIDE SHOW

SEX/GENDER AND MINORITY INCLUSION IN NIH CLINICAL

RESEARCH: WHAT INVESTIGATORS NEED TO KNOW
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 144 and Minority Subjects in Clinical Research
Powerpoint Slide Show 145
Outreach Notebook for the Inclusion, Recruitment, and Retention of Women 146 and Minority Subjects in Clinical Research
Powerpoint Slide Show 147

NIH PUBLICATION NO. 03-7036