[Federal Register: Volume 59, No.
59/Monday, March 28, 1994/Notices]
Department of Health and Human Services
National Institutes of Health
NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research; Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
Editorial Note: This document was originally published at 59 FR 11146, March 9, 1994, and is being reprinted in its entirety because of typesetting errors.
AGENCY: National Institutes of Health, PHS, DHHS.
SUMMARY: The National Institutes of Health (NIH) is establishing guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects, including clinical trials, supported by the NIH, as required in the NIH Revitalization Act of 1993.
EFFECTIVE DATE: March 9, 1994.
ADDRESSES: Although these guidelines are effective on the date of publication, written comments can be sent to either the Office of Research on Women's Health, National Institutes of Health, Building 1,room 203, Bethesda, MD 20892, or to the Office of Research on Minority Health, National Institutes of Health, Building 1, room 255, Bethesda,MD 20892. During the first year of implementation, NIH will review the comments and experience with the guidelines in order to determine whether modifications to the guidelines are warranted.
FOR FURTHER INFORMATION CONTACT: Programmatic inquiries should be directed to senior extramural staff of the relevant NIH Institute or Center named at the end of this notice.
SUPPLEMENTARY INFORMATION: NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.
This document sets forth guidelines on the inclusion of women and members of minority groups and their subpopulations in clinical research, including clinical trials, supported by the National Institutes of Health (NIH). For the purposes of this document, clinical research is defined as NIH-supported biomedical and behavioral research involving human subjects. These guidelines, implemented in accordance with section 492B of the Public Health Service Act, added by the NIH Revitalization Act of 1993, Public Law. (Pub.L.) 103-43, supersede and strengthen the previous policies, NIH/ADAMHA Policy Concerning the Inclusion of Women in Study Populations, and ADAMHA/NIH Policy Concerning the Inclusion of Minorities in Study Populations, published in the NIH GUIDE FOR GRANTS AND CONTRACTS, 1990.
The 1993 guidelines continue the 1990
guidelines with three major additions. The new policy requires
that, in addition to the continuing inclusion of women and members
of minority groups in all NIH-supported biomedical and behavioral
research involving human subjects, the NIH must:
Since a primary aim of research is
to provide scientific evidence leading to a change in health policy
or a 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.
To this end, the guidelines published here are intended to ensure
that all future NIH-supported biomedical and behavioral research
involving human subjects will be carried out in a manner sufficient
to elicit information about individuals of both genders and the
diverse racial and ethnic groups and, in the case of clinical
trials, to examine differential effects on such groups. Increased
attention, therefore, must be given to gender, race, and ethnicity
in earlier stages of research to allow for informed decisions
at the Phase III clinical trial stage.
These guidelines reaffirm NIH's commitment
to the fundamental principles of inclusion of women and racial
and ethnic minority groups and their subpopulations in research.
This policy should result in a variety of new research opportunities
to address significant gaps in knowledge about health problems
that affect women and racial/ethnic minorities and their subpopulations.
The NIH recognizes that issues will
arise with the implementation of these guidelines and thus welcomes
comments. During the first year of implementation, NIH will review
the comments, and consider modifications, within the scope of
the statute, to the guidelines.
The NIH Revitalization Act of 1993, PL 103-43, signed by President Clinton on June 10, 1993, directs the NIH to establish guidelines for inclusion of women and minorities in clinical research. This guidance shall include guidelines regarding--
(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 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 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 * * * defines 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 of Women's Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in the projects of clinical research. 492B(a)(2)
The statute includes a specific provision pertaining to the cost of clinical research and, in particular clinical trials.
(A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is (sic) not a permissible consideration in determining whether such inclusion is inappropriate. 492B(d)(2)
(ii) In the case of other projects
of clinical research, the guidelines shall provide that the costs
of such inclusion in the project is (sic) not a permissible consideration
in determining whether such inclusion is inappropriate unless
the data regarding women or members of minority groups, respectively,
that would be obtained in such project (in the event that such
inclusion were required) have been or are being obtained through
other means that provide data of comparable quality. 492B(d)(2)
Exclusions 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 between--
(i) The effects that the variables
to be studied in the trial have on women or members of minority
groups, respectively; and
(ii) The effects that 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)
A. Research Involving Human Subjects
It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale 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 a 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. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages.
The inclusion of women and members
of minority groups and their subpopulations must be addressed
in developing a research design appropriate to the scientific
objectives of the study. The research plan should describe the
composition of the proposed study population in terms of gender
and racial/ethnic group, and provide a rationale for selection
of such subjects. Such a plan should contain a description of
the proposed outreach programs for recruiting women and minorities
B. Clinical Trials
Under the statute, when a Phase III
clinical trial (see Definitions, Section V-A) is proposed, evidence
must be reviewed to show whether or not clinically important gender
or 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
As such, investigators must consider
the following when planning a Phase III clinical trial for NIH
Cost is not an acceptable reason for
exclusion of women and minorities from clinical trials.
NIH funding components will not award any grant, cooperative agreement or contract or support any intramural project to be conducted or funded in Fiscal Year 1995 and thereafter which does not comply with this policy. For research awards that are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of research participants.
A. Date of Implementation
This policy applies to all applications/proposals and intramural projects to be submitted on and after June 1, 1994 (the date of full implementation) seeking Fiscal Year 1995 support. Projects funded prior to June 10, 1993, must still comply with the 1990 policy and report annually on enrollment of subjects using gender and racial/ethnic categories as required in the Application for Continuation of a Public Health Service Grant (PHS Form 2590), in contracts and in intramural projects.
B. Transition Policy
NIH-supported biomedical and behavioral research projects involving human subjects, with the exception of Phase III clinical trial projects as discussed below, that are awarded between June 10, 1993, the date of enactment, and September 30, 1994, the end of Fiscal Year 1994, shall
be subject to the requirements of the 1990 policy and the annual reporting requirements on enrollment using gender and racial/ethnic categories.
For all Phase III clinical trial projects
proposed between June 10, 1993 and June 1, 1994, and those awarded
between June 10, 1993 and September 30, 1994, Institute/Center
staff will examine the applications/proposals, pending awards,
awards and intramural projects to determine if the study was developed
in a manner consistent with the new guidelines. If it is deemed
inconsistent, NIH staff will contact investigators to discuss
approaches to accommodate the new policy.
Administrative actions may be needed
to accommodate or revise the pending trials. Institutes/Centers
may need to consider initiating a complementary activity to address
any gender or minority representation concerns.
The NIH Director will determine whether
the Phase III clinical trial being considered during this transition
is in compliance with this policy, whether acceptable modifications
have been made, or whether the Institute/Center will initiate
a complementary activity that addresses the gender or minority
representation concerns. Pending awards will not be funded without
Solicitations issued by the NIH planned
for release after the date of publication of the guidelines in
the Federal Register will include the new requirements.
C. Roles and Responsibilities
While this policy applies to all applicants
for NIH-supported biomedical and behavioral research involving
human subjects, certain individuals and groups have special roles
and responsibilities with regard to the adoption and implementation
of these guidelines.The NIH staff will provide educational opportunities
for the extramural and intramural community concerning this policy;
monitor its implementation during the development, review, award
and conduct of research; and manage the NIH research portfolio
to address the policy.
1. Principal Investigators
Principal investigators should assess
the theoretical and/or scientific linkages between gender, race/ethnicity,
and their topic of study. Following this assessment, the principal
investigator and the applicant institution will address the policy
in each application and proposal, providing the required information
on inclusion of women and minorities and their subpopulations
in research projects, and any required justifications for exceptions
to the policy. Depending on the purpose of the study, NIH recognizes
that a single study may not include all minority groups.
2. Institutional Review Boards (IRBs)
As the IRBs implement the guidelines,
described herein, 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 title 45
CFR part 46, ``Protection of Human Subjects.'' 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.
3. 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 will be instructed, as follows:
4. NIH Advisory Councils
In addition to its current 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.
5. Institute/Center Directors
Institute/Center Directors and their
staff shall determine whether:
(a) The research involving human subjects, (b) the Phase III clinical trials, and (c) the exclusions meet the requirements of the statute and these guidelines.
6. 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.
7. Recruitment Outreach by Extramural
and Intramural Investigators
Investigators and their staff(s) are
urged to develop appropriate and culturally sensitive outreach
programs and activities commensurate with the goals of the study.
The objective should be to actively recruit 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) and staff(s) should take precautionary
measures to ensure that ethical concerns are clearly noted, 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. It is also the responsibility of the
IRBs to address these ethical concerns.
Furthermore, while the statute focuses
on recruitment outreach, NIH staff underscore the need to appropriately
retain participants in clinical studies, and thus, the outreach
programs and activities should address both recruitment and retention.
To assist investigators and potential
study participants, NIH staff have prepared a notebook, ``NIH
Outreach Notebook On the Inclusion of Women and Minorities in
Biomedical and Behavioral Research.'' The notebook addresses both
recruitment and retention of women and minorities in clinical
studies, provides relevant references and case studies, and discusses
ethical issues. It is not intended as a definitive text on this
subject, but should assist investigators in their consideration
of an appropriate plan for recruiting and retaining participants
in clinical studies. The notebook is expected to be available
early in 1994.
8. Educational Outreach by NIH to
Inform the Professional Community
NIH staff will present the new guidelines
to investigators, IRB members, peer review groups, and Advisory
Councils in a variety of public educational forums.
9. Applicability to Foreign Research
Involving Human Subjects
For foreign awards, the NIH policy
on inclusion of women in research conducted outside the U.S. is
the same as that for research conducted in the U.S.However, with
regard to the population of the foreign country, the definition
of the minority groups may be different than in the U.S. If there
is scientific rationale for examining subpopulation group differences
within the foreign population, investigators should consider designing
their studies to accommodate these differences.
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 Trial
For the purpose of these guidelines,
a ``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.
B. Research Involving Human Subjects
All NIH-supported biomedical and behavioral
research involving human subjects is defined as clinical research
under this policy. Under this policy, the definition of human
subjects in title 45 CFR part 46, the Department of Health and
Human Services regulations for the protection of human subjects
applies: ``Human subject means a living individual about whom
an investigator (whether professional or student) conducting research
obtains: (1) Data through intervention or interaction with the
individual, or (2) identifiable private information.'' These regulations
specifically address the protection of human subjects from research
risks. It should be noted that there are research areas (Exemptions
1-6) that are exempt from these regulations. However, under these
guidelines, NIH-supported biomedical and behavioral research projects
involving human subjects which are exempt from the human subjects
regulations should still address the inclusion of women and minorities
in their study design. Therefore, all biomedical and behavioral
research projects involving human subjects will be evaluated for
compliance with this policy.
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:
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 which is distinguished by either
racial, ethnic, and/or cultural heritage.
The Office of Management and Budget
(OMB) Directive No. 15 defines the minimum standard of basic racial
and ethnic categories, which are used below. NIH has chosen to
continue the use of these definitions because they allow comparisons
to many national data bases, especially national health data bases.
Therefore, the racial and ethnic categories described below should
be used as basic guidance, cognizant of the distinction based
on cultural heritage.
American Indian or Alaskan Native: A person having origins in any of the original
peoples of North America, and who maintains cultural identification
through tribal affiliation or community recognition.
Asian or Pacific Islander: A person having origins in any of the original
peoples of the Far East, Southeast Asia, the Indian subcontinent,
or the Pacific Islands. This area includes, for example, China,
India, Japan, Korea, the Philippine Islands and Samoa.
Black, not of Hispanic Origin: A person having origins in any of the black racial
groups of Africa.
Hispanic: A person of Mexican, Puerto Rican, Cuban, Central
or South American or other Spanish culture or origin, regardless
2. Majority Group
White, not of Hispanic Origin: A person having origins in any of the original
peoples of Europe, North Africa, or the Middle East.
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.
Each minority 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 of specific racial and ethnic origin. Attention
to subpopulations also applies to individuals of mixed racial
and/or ethnic parentage. Researchers should be cognizant of the
possibility that these racial/ethnic combinations may have biomedical
and/or cultural implications related to the scientific question
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.
G. Research Portfolio
Each Institute and Center at the NIH has its own research portfolio, i.e., its ``holdings'' in research grants, cooperative agreements, contracts and intramural studies. The Institute or Center evaluates the research awards in its portfolio to identify those areas where there are knowledge gaps or which need special attention to advance the science involved. NIH may consider funding projects to achieve a research portfolio reflecting diverse study populations. With the implementation of this new policy, there will be a need to ensure that sufficient resources are provided within a program to allow for data to be developed for a smooth transition from basic research to Phase III clinical trials that meet the policy requirements.
VI. Discussion--Issues in Scientific Plans and Study Designs
A. Issues in Research Involving Human Subjects
The biomedical and behavioral research
process can be viewed as a stepwise process progressing from discovery
of new knowledge through research in the laboratory, research
involving animals, research involving human subjects, validation
of interventions through clinical trials, and broad application
to improve the health of the public.
All NIH-supported biomedical and behavioral
research involving human subjects is defined broadly in this guidance
as clinical research. This is broader than the definition provided
in the 1990 NIH Guidance and in many program announcements, requests
for applications, and requests for proposals since 1990.
The definition was broadened because
of the need to obtain data about minorities and both genders early
in the research process when hypotheses are being formulated,
baseline data are being collected, and various measurement instruments
and intervention strategies are being developed. Broad inclusion
at these early stages of research provides valuable information
for designing broadly based clinical trials, which are a subset
of studies under the broad category of research studies.
The policy on inclusion of minorities
and both genders applies to all NIH-supported biomedical and behavioral
research involving human subjects so that the maximum information
may be obtained to understand the implications of the research
findings on the gender or minority group.
Investigators should consider the
types of information concerning gender and minority groups which
will be required when designing future Phase III clinical trials,
and try to obtain it in their earlier stages of research involving
human subjects. NIH recognizes that the understanding of health
problems and conditions of different U.S. populations may require
attention to socioeconomic differences involving occupation, education,
and income gradients.
B. Issues in Clinical Trials
The statute requires appropriate representation of subjects of different gender and race/ethnicity in clinical trials so as to provide the opportunity for detecting major qualitative differences (if they exist) among gender and racial/ethnic subgroups and to identify more subtle differences that might, if warranted, be explored in further specifically targeted studies. Other interpretations may not serve as well the health needs of women, minorities, and all other constituencies.
Preparatory to any Phase III clinical trial, certain data are typically obtained. Such data are necessary for the design of an appropriate Phase III trial and include observational clinical study data, basic laboratory (i.e. in vitro and animal) data, and clinical, physiologic, pharmacokinetic, or biochemical data from Phase I and Phase II studies. Genetic studies, behavioral studies, and observational, natural history, and epidemiological studies may also contribute data.
It is essential that data be reviewed from prior studies on a diverse population, that is, in subjects of both genders and from different racial/ethnic groups. These data must be examined to determine if there are significant differences of clinical or public health importance observed between the subgroups.
While data from prior studies relating
to possible differences among intervention effects in different
subgroups must be reviewed, evidence of this nature is likely
to be less convincing than that deriving from the subgroup analyses
that can be performed in usual-sized Phase III trials. This is
because the evidence from preliminary studies is likely to be
of a more indirect nature (e.g. based on surrogate endpoints),
deriving from uncontrolled studies (e.g. non-randomized Phase
II trials), and based on smaller numbers of subjects than in Phase
III secondary analyses. For this reason, it is likely that data
from preliminary studies will, in the majority of cases, neither
clearly reveal significant differences of clinical or public health
importance between subgroups of patients, nor strongly negate
In these cases, Phase III trials should
still have appropriate gender and racial/ethnic representation,
but they would not need to have the large sample sizes necessary
to provide a high statistical power for detecting differences
in intervention effects among subgroups. Nevertheless, analyses
of subgroup effects must be conducted and comparisons between
the subgroups must be made. Depending on the results of these
analyses, the results of other relevant research, and the results
of meta-analyses of clinical trials, one might initiate subsequent
trials to examine more fully these subgroup differences.
C. Issues Concerning Appropriate Gender Representation
The ``population at risk'' may refer to only one gender where the disease, disorders, or conditions are gender specific. In all other cases, there should be approximately equal numbers of both sexes in studies of populations or sub-populations at risk, unless different proportions are appropriate because of the known prevalance, incidence, morbidity, mortality rates, or expected intervention effect.
D. Issues Concerning Appropriate Representation of Minority Groups and Subpopulations in All Research Involving Human Subjects Including Phase III Clinical Trials
While the inclusion of minority subpopulations in research is a complex and challenging issue, it nonetheless provides the opportunity for researchers to collect data on subpopulations where knowledge gaps exist. Researchers must consider the inclusion of subpopulations in all stages of research design. In meeting this objective, they should be aware of concurrent research that addresses specific subpopulations, and consider potential collaborations which may result in complementary subpopulation data.
At the present time, there are gaps
in baseline and other types of data necessary for research involving
certain minority groups and/or subpopulations of minority groups.
In these areas, it would be appropriate for researchers to obtain
such data, including baseline data, by studying a single minority
It would also be appropriate for researchers
to test survey instruments, recruitment procedures, and other
methodologies used in the majority or other population(s) with
the objective of assessing their feasibility, applicability, and
cultural competence/relevance to a particular minority group or
subpopulation. This testing may provide data on the validity of
the methodologies across groups. Likewise, if an intervention
has been tried in the majority population and not in certain minority
groups, it would be appropriate to assess the intervention effect
on a single minority group and compare the effect to that obtained
in the majority population. These types of studies will advance
scientific research and assist in closing knowledge gaps.
A complex issue arises over how broad
or narrow the division into different subgroups should be, given
the purpose of the research. Division into many racial/ethnic
subgroups is tempting in view of the cultural and biological differences
that exist among these groups and the possibility that some of
these differences may in fact impact in some way upon the scientific
question. Alternatively, from a practical perspective, a limit
has to be placed on the number of such subgroups that can realistically
be studied in detail for each intervention that is researched.
The investigator should clearly address the rationale for inclusion
or exclusion of subgroups in terms of the purpose of the research.
Emphasis should be placed upon inclusion of subpopulations in
which the disease manifests itself or the intervention operates
in an appreciable different way. Investigators should report the
subpopulations included in the study.
An important issue is the appropriate
representation of minority groups in research, especially in geographical
locations which may have limited numbers of racial/ethnic population
groups available for study. The investigator must address this
issue in terms of the purpose of the research, and other factors,
such as the size of the study, relevant characteristics of the
disease, disorder or condition, and the feasibility of making
a collaboration or consortium or other arrangements to include
minority groups. A justification is required if there is limited
representation. Peer reviewers and NIH staff will consider the
justification in their evaluations of the project.
NIH interprets the statute in a manner
that leads to feasible and real improvements in the representativeness
of different racial/ethnic groups in research and places emphasis
on research in those subpopulations that are disproportionately
affected by certain diseases or disorders.
VII. NIH Contacts for More
The following senior extramural staff
from the NIH Institutes and Centers may be contacted for further
information about the policy and relevant Institute/Center programs:
Dr. Marvin Kalt, National Cancer Institute, 6130 Executive Boulevard, Executive Plaza North, room 600A, Bethesda, Maryland 20892, Tel: (301)496-5147.
Dr. Richard Mowery, National Eye Institute, 6120 Executive Boulevard,Executive Plaza South, room 350, Rockville, Maryland 20892, Tel: (301)496-5301.
Dr. Lawrence Friedman, National Heart, Lung and Blood Institute, 7550 Wisconsin Avenue, Federal Building, room 212, Bethesda, Maryland 20892,Tel: (301) 496-2533.
Dr. Miriam Kelty, National Institute on Aging, 7201 Wisconsin Avenue, Gateway Building, room 2C218, Bethesda, Maryland 20892, Tel: (301) 496-9322.
Dr. Cherry Lowman, National Institute on Alcohol Abuse and Alcoholism, 6000 Executive Boulevard, Rockville, Maryland 20892, Tel: (301) 443-0796.
Dr. George Counts, National Institute of Allergy and Infectious Diseases, 6003 Executive Boulevard, Solar Building, room 207P,Bethesda, Maryland 20892, Tel: (301) 496-8214.
Dr. Michael Lockshin, National Institute of Arthritis and Musculoskeletal and Skin Diseases, 9000 Rockville Pike, Building 31, room 4C32, Bethesda, Maryland 20892, Tel: (301) 496-0802.
Ms. Hildegard Topper, Bethesda, National Institute of Child Health and Human Development, 9000 Rockville Pike, Building 31, room 2A-03, Bethesda, Maryland 20892, Tel: (301) 496-0104.
Dr. Earleen Elkins, National Institute of Deafness and Other Communication Disorders, 6120 Executive Boulevard, Executive Plaza South, room 400, Rockville, Maryland 20892, Tel: (301) 496-8683.
Dr. Norman S. Braveman, National Institute on Dental Research, 5333 Westbard Avenue, Westwood Building, room 509, Bethesda, Maryland 20892, Tel: (301) 594-7648.
Dr. Walter Stolz, National Institute of Diabetes and Digestive and Kidney Diseases, 5333 Westbard Avenue, Westwood Building, room 657, Bethesda, Maryland 20892, Tel: (301) 594-7527.
Ms. Eleanor Friedenberg, National Institute on Drug Abuse, 5600 Fishers Lane, Parklawn Building, room 10-42, Rockville, Maryland 20857, Tel: (301) 434-2755.
Dr. Gwen Collman, National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, North Carolina 27709, Tel: (919) 541-4980.
Dr. Lee Van Lenten, National Institute of General Medical Sciences, 5333 Westbard Avenue, Westwood Building, room 905, Bethesda, Maryland 20892, Tel: (301) 594-7744.
Dr. Dolores Parron, National Institute of Mental Health, 5600 Fishers Lane, Parklawn Building, room 17C-14, Rockville, Maryland 20857, Tel: (301) 443-2847.
Dr. Constance Atwell, National Institute of Neurological Disorders and Stroke, 7550 Wisconsin Ave., Federal Building, room 1016, Bethesda, Maryland 20892, Tel: (301) 496-9248.
Dr. Mark Guyer, National Center for Human Genome Research, 9000 Rockville Pike, Building 38A, room 605, Bethesda, Maryland 20892, Tel: (301) 496-0844.
Dr. Teresa Radebaugh, National Center for Nursing Research, 5333 Westbard Avenue, Westwood Building, room 754, Bethesda, Maryland 20892, Tel: (301) 594-7590.
Dr. Harriet Gordon, National Center for Research Resources, 5333 Westbard Avenue, Westwood Building, room 10A03, Bethesda, Maryland 20892, Tel: (301) 594-7945.
Dr. David Wolff, Fogarty International Center, 9000 Rockville Pike, Building 31, room B2C39, Bethesda, Maryland 20892, Tel: (301) 496-1653.
Dated: March 3, 1994.
[FR Doc. 94-5435 Filed 3-8-94; 8:45 am]
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