Questions and Answers on Inclusion
of Minorities and Women in Study Populations
National Heart, Lung, and Blood
National Institutes of Health
Revised: March 2011
The National Heart, Lung, and Blood Institute (NHLBI)
has a continuing commitment to health problems related to minorities and women.
Research (grants, cooperative agreements, and contracts) to be supported by the
Institute must comply with the NIH Inclusion of Minorities and Women policy
that was mandated by law. Women and members of minority groups must be included
in all clinical research studies unless the nature of the research makes it
inappropriate to do so.
Guidelines On The Inclusion Of Women And Minorities As Subjects In Clinical
Phase III clinical trials are held to a higher
- When designing and developing a phase III trial,
the investigator must evaluate all relevant data to assess whether or not the
trial should include adequate numbers of subgroups of participants to allow for
separate and adequately powered analyses.
- Even if no such evidence is available, the trial
must include sufficient numbers of women and minorities to conduct valid
analyses (that is, unbiased assessment) of subgroup effects.
- During the peer review of the trial, this aspect
will be considered in the evaluation.
- Before any phase III trial is funded, this aspect
will be considered by NHLBI staff.
- During the conduct of the trial, and indeed any
clinical study, success in enrolling appropriate numbers of women and
minorities will be monitored by NHLBI staff.
- Finally, it is expected that the investigators will
perform the necessary analyses and include the results in submitted
The following series of questions and answers are
intended to assist you in preparation of research applications in accordance
with the NIH Guidelines. If you have any questions about this policy, please
contact the appropriate NHLBI Division representative listed at the end of this
Question: What is the
definition of clinical research?
Answer: The NIH definition of clinical research
includes all NIH supported biomedical and behavioral research involving human
subjects. Applications for support of clinical research studies should address
the policy by providing a description and justification of the study
Research is a continuum of studies from basic
laboratory to observational to clinical. Assessment of differential effects of
an intervention or therapy on women, men, or members of minority groups and
their subpopulations requires fundamental information on such groups.
Therefore, at the earliest stages of research, investigators are expected to
include individuals (or tissues) of both genders and diverse racial and ethnic
groups in order to generate information necessary for the rational design of
appropriate Phase III clinical trials. Investigators are expected to report
results on all participating gender and minority groups, as appropriate.
(See Section VB. and VI A. in the NIH Guidelines)
Question: What is the
definition of a clinical trial?
Answer: For the purposes of the NIH policy, it is a
broadly based prospective Phase III clinical trial that is designed to evaluate
an experimental intervention in comparison with a standard or control
intervention or to compare two or more existing treatments. Often the aim of
such investigations is to provide evidence leading to a scientific basis for
consideration of a change in health policy or standard of care. The definition
includes pharmacological, nonpharmacological, and behavioral interventions
given for disease prevention, prophylaxis, diagnosis, or therapy. Community
trials and other population-based intervention trials are also included.
(See Section V.A. in the NIH Guidelines)
Question: What is
sufficient and appropriate representation of women and
Answer: Ideally, women and minorities in the study
population are in the same proportions as in the U.S. population having the
disease entity being studied. If prevalence is unknown, the NHLBI standard for
evaluation of the proposed study population is the composition of the
population of the United States which, according to the 2010 census, is 51%
women and 30% minorities. However, there are acceptable justifications for a
study population that does not meet these criteria. (See answers to questions
4-6 below and Section II [subsection on exclusions] in the NIH Guidelines).
Question: Does the policy
permit a study population that contains only one gender or minority group or
Answer: If a study of only one gender or minority
group or subpopulation is proposed, there must be a scientific justification
for limiting the diversity of the study population, such as high prevalence of
the condition, unique disease characteristics, or gaps in knowledge in the
select population. The review committee will include the adequacy and
scientific appropriateness of a justification in its determination of the
priority score. Women of childbearing potential should not be routinely
excluded from participation in clinical research.
(See Section VI.C. and VI.D. in the NIH
Question: Can study
populations in other related studies (research portfolio) be used to justify a
study population that does not comply with the policy?
Answer: In cases where the proposed study population
is limited in diversity, it may be possible to justify this situation if the
combination of the study population in the application and related past or
ongoing studies provides the diversity required by the policy. Applicants
should use published reports and discussions with NHLBI staff concerning
ongoing research to identify studies that provide the diversity. A list of such
studies, the study population composition, and a discussion of the basis of the
research portfolio justification should be incorporated, as appropriate, into
the application. NHLBI will determine if the research portfolio justification
is adequate to allow support of the project.
(See Section V.G. in the NIH Guidelines)
Question: What should
applicants do if they are in a geographic area that does not offer a study
population with the diversity required by the policy?
Answer: Applicants must address this issue in terms of
the purpose of the research, the relevant characteristics of the disease,
disorder, or condition, and the feasibility of developing a collaboration,
consortium, or other arrangements to include minority groups. A justification
is required if there is limited representation. Peer reviewers and NHLBI staff
will consider the justification in their evaluations of the project.
(See Section VI.D. in the NIH Guidelines)
Question: Is it acceptable
to use existing cohorts that are deficient in women or minority
Answer: Use of an existing cohort that lacks the
diversity required by the policy must be justified. The nature of the
scientific question, a requirement for data provided by the cohort, or research
portfolio balance may provide the basis of a justification.
(See Section IV.C.1., VB., and VI.A. in the NIH
Question: Is increased
cost an acceptable justification for not including women, minorities, and
Answer: No. The policy states that the cost associated
with increasing the diversity of a study population composition to include
women, minorities, and minority subpopulations is not an acceptable
justification for excluding them.
(See Section I., II., III.A., and III.B. in the NIH
Question: What is the
definition of minority groups and minority subpopulations?
Answer: There are four minority racial groups:
American Indian/Alaska Native; Asian; Native Hawaiian/Pacific Islander; and
Black. Individuals of Hispanic origin are an ethnic minority and may be of any
race. Caucasians, not of Hispanic origin, are considered the majority group for
the purpose of this policy.
Each minority group contains subpopulations that may
be defined by geographic origin, national origin, cultural differences, or
mixed racial and/or ethnic parentage. The minority group or subpopulation to
which an individual belongs is determined by self-reporting.
( See Section V.E.1. through V.E.3. in the NIH
Question: Do all minority
groups and subpopulations have to be included in a study
Answer: It is not expected that every minority group
and subpopulation will be included in each study. However, broad representation
and diversity are strongly encouraged, even if multiple clinics and sites are
needed to accomplish it. When determining the composition of the study
population, health of the subjects, scientific issues, e.g., high prevalence of
a condition, different disease characteristics, or gap(s) in knowledge in a
minority subpopulation, should be considered. If the prevalence of the disease,
disorder, or condition is not known or if normal volunteers are used in the
study, the proportion of minority group and subpopulation participants in the
study population should reflect their population in the United States.
(See Section II [subsection on exclusions] and
IV.C.1. in the NIH Guidelines)
Question: What is meant by
outreach efforts to recruit women, minorities, and members of minority
Answer: Outreach efforts are attempts by
investigators and their staff to recruit and retain women and minority
populations. Such efforts could include involvement of organizations and
persons relevant to the populations and communities of interest, e.g.,
religious organizations, community leaders, and public and private
institutions. The research plan should contain a description of the
institutions. The research plan should contain a description of the proposed
outreach programs for recruiting women and minorities as participants. An NIH
Office of Research on Women's Health publication is available (in
PDF ), " Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research, August 1994 " contains information to assist investigators develop outreach programs.
(See Section IV.C.7. and V.F. in the NIH
Representatives for Inclusion of Minorities and Women in Study
Office of Science and Technology
Last Updated September 2011