[Federal Register Volume 60, Number 179 (Friday, September 15, 1995)]
[Notices]
[Pages 47947-47951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22950]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Agency for Toxic Substances and Disease Registry
Policy on the Inclusion of Women and Racial and Ethnic Minorities
in Externally Awarded Research
AGENCY: Centers for Disease Control and Prevention (CDC) and Agency for
Toxic Substances and Disease Registry
[[Page 47948]]
(ATSDR), Public Health Service (PHS), Department of Health and Human
Services (DHHS).
ACTION: Notice.
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SUMMARY: This notice announces the CDC 1 policy on the inclusion
of women and racial and ethnic minorities in externally awarded
research. On April 10, 1995, CDC published a notice for comments (60 FR
18130) on the Policy on the Inclusion of Women and Minorities in
Externally Awarded Research. During the 60 day public comment period
that ended June 9, 1995, CDC received only a few minor comments.
Therefore, after some small revisions, the notice is being re-published
and will become policy as of October 1, 1995. This policy is intended
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC-supported studies involving human
subjects, whenever feasible and appropriate. Furthermore, it is CDC
policy to identify significant gaps in knowledge about health problems
that affect women and racial and ethnic minority populations and to
encourage studies which address these problems. (Note: This policy is
consistent with requirements for CDC intra-agency research.)
\1\ References to CDC also apply to the Agency for Toxic
Substances and Disease Registry (ATSDR).
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EFFECTIVE DATE: Applicable for all CDC externally awarded research
projects submitted in response to CDC Program Announcements (Requests
for Assistance) and solicitations (Requests for Proposals) announced on
or after October 1, 1995.
FOR FURTHER INFORMATION CONTACT: Dixie E. Snider, Jr., M.D., M.P.H.,
telephone (404) 639-3701 or Barbara W. Kilbourne, R.N., M.P.H.,
telephone (404) 639-1242.
SUPPLEMENTARY INFORMATION:
CDC and ATSDR Policy on the Inclusion of Women and Racial and Ethnic
Minorities in Externally Awarded Research
Table of Contents
I. Introduction
II. Definitions
A. Human Subjects
B. Research
C. Racial and Ethnic Categories
1. Minority Groups
2. Majority Group
III. Policy
Research Involving Human Subjects
IV. Guidance for Applicant Institution Investigators and Decision
Makers in Complying with this Policy
A. General
B. Studies of Public Health Interventions
V. Implementation
A. Date of Implementation
B. Roles and Responsibilities
1. Applicant Institution Investigators
2. CDC Technical/Peer Review Groups
3. CDC Center/Institute/Office Directors
4. CDC Institutional Review Boards (IRBs)
C. External Award Consideration
D. Recruitment Outreach by Externally Awarded Investigators
E. Dissemination of Research Results
VI. Evaluation
CDC Inclusion Review Committee Responsibility and Members
I. Introduction
The Centers for Disease Control and Prevention (CDC) is committed
to protecting the health of all people regardless of their sex, race,
ethnicity, national origin, religion, sexual orientation, socioeconomic
status, or other characteristics. To the extent that participation in
research offers direct benefits to the participants,
underrepresentation of certain population subgroups denies them the
opportunity to benefit. Moreover, for purposes of generalizing study
results, investigators must include the widest possible range of
population groups.
A growing body of evidence indicates that the health conditions and
needs of women are different from those of men. Some health conditions
are unique to women and others are more prevalent in women. For some
illnesses, there are marked distinctions, not only in onset and
progression of disease, but also in the preventive, treatment and
educational approaches necessary to combat them in women. Furthermore,
initial entry into the health care system may be different for some
subgroups of women, such as low-income and uninsured women. Lesbians
may also enter the health care system differently because they may be
less likely to access prevention services, like cancer screening,
because they may not utilize family planning services. The Public
Health Service Task Force on Women's Health Issues published a report
in 1987 stating that it is becoming more important to note the
environmental, economic, social, and demographic characteristics that
influence a woman's health status. The Task Force focused on the direct
and indirect effects these factors could have on the status of a
woman's health and noted that when a woman is ``outside the normal
range of societal expectations,'' that is, she is of a racial, ethnic
or cultural minority or if she is physically or mentally disabled, her
health status is potentially at greater risk. These basic observations
are not always recognized or reflected in study protocols and
proposals.
The disparity in health outcomes between majority and some racial
and ethnic minority groups is now well documented. Although some
minority populations, e.g., some Asian groups, have better overall
health status than non-Hispanic whites, many racial and ethnic minority
populations have dramatically shorter life expectancy, higher morbidity
rates and inadequate access to quality health care. The Secretary for
the Department of Health and Human Services' Task Force on Black and
Minority Health issued a report in 1985 noting the underrepresentation
of racial and ethnic minorities in research. This underrepresentation
has resulted in significant gaps in knowledge about the health of
racial and ethnic minority populations and their responses to
interventions.
II. Definitions
A. Human Subjects
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 conducting research
obtains (1) data through intervention or interaction with the
individual or (2) identifiable private information.''
B. Research
Under this policy, the definition of research in title 45 CFR part
46, the Department of Health and Human Services regulations for the
protection of human subjects, applies: ``Research means a systematic
investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.'' All
proposed research involving human subjects and conducted using CDC
funding will be evaluated for compliance with this policy, including
those projects that are exempt from Institutional Review Board (IRB)
review (as specified in title 45 CFR part 46). However, nothing in this
policy is intended to require IRB review of protocols which otherwise
would be exempt. This policy applies to all CDC externally awarded
research regardless of the mechanism of financial support (e.g., grant,
cooperative agreement, contract, purchase order, etc.). This policy
does not apply to those projects in which the investigator has no
control over the composition of the study population (e.g., cohort
studies in which the population has been previously selected, or
research to follow-up outbreak investigations.)
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C. Racial and Ethnic Categories
1. Minority Groups
This policy shall comply with the Office of Management and Budget
(OMB) Directive No. 15, and any subsequent revisions to the Directive.
OMB Directive No. 15 defines the minimum standard of basic racial and
ethnic categories. Despite limitations (as outlined in the Public
Health Reports ``Papers from the CDC/ATSDR Workshop on the Use of Race
and Ethnicity in Public Health Surveillance''), these categories are
useful because they allow comparisons among many national data bases,
especially Bureau of the Census and national health data bases.
Therefore, the racial and ethnic categories described below should be
used as basic minimum guidance, cognizant of their limitations.
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 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 of race.
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.
While investigators should focus primary attention on the above
categories, CDC recognizes the diversity of the population. For
example, Blacks describe themselves in several different ways,
including African-American, Caribbean (Haitian, Jamaican, West Indian,
Trinidadian), etc. Native Hawaiians have expressed the desire to be
considered a separate racial/ethnic category exclusive of the current
Asian/Pacific Islander designation. Therefore, investigators are
encouraged to investigate national or geographic origin or other
cultural factors (e.g., customs, beliefs, religious practices) in
studies of race and ethnicity, and their relationship to health
problems. Furthermore, since race, ethnicity, and cultural heritage may
serve as markers for other important characteristics or conditions
associated with a health problem or outcome, investigators should
actively seek to identify these other characteristics or conditions.
III. Policy
Research Involving Human Subjects Applicant institutions must
ensure that women and racial and ethnic minority populations are
appropriately represented in their proposals for research.
Women and members of racial and ethnic minority groups should be
adequately represented in all CDC-supported studies involving human
subjects, unless a clear and compelling rationale and justification
establishes to the satisfaction of CDC that inclusion is inappropriate
or clearly not feasible. Although this policy does not apply to studies
when the investigator cannot control the race, ethnicity, and sex of
subjects, women and racial and ethnic minority populations must not be
routinely and/or arbitrarily excluded from such investigations.
In addition, women of childbearing potential should also not be
routinely and/or arbitrarily excluded from participation even though
there are ethical/risk issues to consider for inclusion and exclusion.
Information on adverse differences in outcome or risk profiles for
pregnant women may be reason for exclusion. Therefore, pregnancy status
may need to be determined prior to enrollment for some studies and, if
necessary, during an intervention to safeguard the participants'
health.
IV. Guidance for Applicant Institution Investigators and Decision
Makers in Complying with this Policy
A. General
In determining whether special efforts should be made to set
specific enrollment goals for women and members of racial and ethnic
minority groups, or whether to design special studies to specifically
address health problems in such populations, principal investigators
should consider the following points:
Is the disease or condition under study unique to, or is
it relatively rare in men, women or one or more racial and/or ethnic
minority populations?
What are the characteristics of the population to which
the protocol results will be applied? Does it include both men and
women? Does it include specific racial and ethnic minority populations?
Are there scientific reasons to anticipate significant
differences between men and women and among racial and ethnic minority
populations with regard to the hypothesis under investigation?
Are there study design or recruitment limitations in the
protocol that could result, unnecessarily, in underrepresentation of
one sex or certain racial and ethnic minority populations?
Could such underrepresentation cause an adverse impact on
the generalizability and application of results?
Is the underrepresentation correctable?
Does racial and ethnic characterization of study subjects
serve a bona fide purpose or might it serve only to stigmatize a group?
Inclusion of women and/or racial and ethnic minority groups in
research can be addressed either by including all appropriate groups in
one single study or by conducting multiple studies. In general,
protocols and proposals for support of studies involving human subjects
should employ a design with sex and/or minority representation
appropriate to the scientific objectives. It is not an automatic
requirement that the study design provide sufficient statistical power
to answer the questions posed for men and women and racial and ethnic
groups separately; however, whenever there are scientific reasons to
anticipate differences between men and women and/or racial and ethnic
groups, with regard to the hypothesis under investigation,
investigators should include an evaluation of these sex and minority
group differences in the study proposal. If adequate inclusion of one
sex and/or minority group is impossible or inappropriate with respect
to the purpose of the proposed study, or if in the only study
population available, there is a disproportionate representation of one
sex or minority/majority group, the rationale for the study population
must be well explained and justified. The cost of inclusion of women
and/or racial and ethnic minority groups shall not be a permissible
consideration for exclusion from a given study unless data regarding
women and/or racial and ethnic minority groups have been or will be
obtained through other means that provide data of comparable quality.
Acceptable reasons for exclusion are as follows:
(1) Inclusion is inappropriate with respect to the health of the
subjects;
(2) Inclusion is inappropriate with respect to the purpose of the
study;
(3) Substantial scientific evidence indicates there is no
significant difference between the effects that the
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variables to be studied have on women and/or racial and ethnic minority
groups;
(4) Substantial scientific data already exist on the effects that
variables have on the excluded population;
(5) Inclusion is inappropriate under other circumstances as
determined by CDC.
In each protocol or proposal, the composition and rationale for
inclusion of the proposed study population must be described in terms
of sex and racial and ethnic group. Sex and racial and ethnic
characteristics, conditions, and other relevant issues should be
addressed in developing a study design and sample size appropriate for
the scientific objectives of the investigation. The proposal should
contain a description of proposed outreach programs, if necessary, for
recruiting women and racial and ethnic minorities as participants.
Investigators must facilitate the informed consent process by promoting
open and free communication with the study participants. Investigators
must seek to understand cultural and linguistic variables inherent in
the population to be enrolled, and procedures must be established to
ensure appropriate translation of the consent document whenever
necessary.
B. Studies of Public Health Interventions
Investigators must consider the following when planning an
intervention trial or a clinical trial:
If the data from prior studies strongly indicate the
existence of significant differences of clinical or public health
importance in intervention effect between the sexes or among racial and
ethnic populations, the primary question(s) to be addressed by the
scientific investigation and the design of that study must specifically
accommodate the difference(s). For example, if men, women, and racial
and ethnic minority groups are thought to respond differently to an
intervention, then the study should be designed to answer separate
primary questions that apply to men, women, and/or specific racial and
ethnic groups with adequate sample size for each.
If the data from prior studies strongly support no
significant differences of clinical or public health importance in
intervention effect between subgroups, then sex and race and ethnicity
are not required as subject selection criteria; however, the inclusion
of sex and racial and ethnic subgroups is still strongly encouraged.
If the data from prior studies neither support nor negate
the existence of significant differences of clinical or public health
importance in intervention effect, then the study should include
sufficient and appropriate male and female and racial and ethnic
minority populations so that valid analysis of the intervention effect
in each subgroup can be performed.
If women of childbearing potential are to be included and
if there is reason to suspect that adverse events may occur in pregnant
women, pregnancy status should be determined prior to enrollment.
V. Implementation
A. Date of Implementation
This policy applies for all CDC externally awarded research
projects submitted in response to CDC Program Announcements (Requests
for Assistance) and solicitations (Requests for Proposals) announced on
or after October 1, 1995.
B. Roles and Responsibilities
Certain individuals and groups have special roles and
responsibilities with regard to the implementation of these guidelines.
1. Applicant Institution Investigators
Applicant institution investigators should assess the theoretical
and/or scientific linkages between sex, race and ethnicity and their
topic of study. Following this assessment, the applicant institution
investigator will address the policy in each protocol, application and
proposal, providing the required information on inclusion of women and
minorities, and any required justifications for exclusions of any
groups.
2. CDC Technical/Peer Review Groups
In conducting technical/peer review of contract, grant, or
cooperative agreement applications for scientific and technical merit,
CDC Center/Institute/Office (C/I/O) Directors will ensure that CDC
technical/peer review groups, to the extent possible, include women and
racial and ethnic minorities, and will do the following: *
* C/I/O Directors may waive this requirement if it is clearly
inappropriate or clearly not feasible.
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Evaluate the proposed plan for the inclusion of both sexes
and racial and ethnic minority populations for appropriate
representation.
Evaluate the appropriateness of the proposed justification
when representation is limited or absent.
Determine whether the design of the study is adequate to
measure differences when warranted.
Evaluate the plans for recruitment and outreach for study
participants including whether the process of establishing partnerships
with community(ies) and recognition of mutual benefits will be
documented.
Include these criteria as part of the technical assessment
and assign a score.
3. CDC Center/Institute/Office Directors
CDC C/I/O Directors are responsible for ensuring that CDC
externally awarded research involving human subjects meets the
requirements of these guidelines. CDC C/I/O Directors will also inform
externally awarded investigators concerning this policy and monitor its
implementation during the development, review, award, and conduct of
research.
4. CDC Institutional Review Boards (IRBs)
CDC IRBs are expected to consider whether CDC investigators have
adequately addressed the inclusion of women and racial and ethnic
minorities, in research protocols that require CDC IRB approval, as an
additional criterion for IRB approval.
C. External Award Consideration
CDC project officers shall design their Requests for Contracts and
Requests for Assistance in compliance with this policy. CDC C/I/O
Directors shall ensure this policy is fully considered and implemented
prior to the release of the Request for Contract and Request for
Assistance to the CDC Procurement and Grants Office. CDC funding
components will not award any grant, cooperative agreement, or contract
for external research projects announced on or after October 1, 1995,
and thereafter which does not comply with this policy.
D. Recruitment Outreach by Externally Awarded Investigators
Externally awarded investigators and their staff(s) are urged to
develop appropriate and culturally sensitive outreach programs and
activities commensurate with the goals of the research. The purpose
should be to establish a relationship between the investigator(s),
populations, and community(ies) of interest so that mutual benefit is
achieved by all groups participating in the study. Investigators should
document the process for establishing a partnership with the
community(ies) and the mutual benefits of the study and ensure that any
factors (e.g., educational level, nonproficiency in English, low
socioeconomic status) are accounted for and handled appropriately. In
addition, investigator(s) and staff should ensure that ethical concerns
are clearly noted and enforced, such that there is minimal
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possibility of coercion or undue influence in the incentives or rewards
offered in recruiting into or retaining participants in scientific
studies.
E. Dissemination of Research Results
Externally awarded investigators are urged to make special efforts
to disseminate relevant research results to the communities who
participated in the studies and to the affected populations, especially
racial and ethnic minority populations that may have cultural,
language, and socioeconomic barriers to the easy receipt of such
information.
VI. Evaluation
CDC Inclusion Review Committee Responsibility and Members
A CDC Inclusion Review Committee (IRC) with representatives from
the CDC Office of the Associate Director for Science, the CDC Office of
the Associate Director for Minority Health, and the CDC Office of the
Associate Director for Women's Health will review any questions,
issues, or comments pertaining to this policy and recommend necessary
changes or modifications to the Director, CDC. This committee will meet
regularly to review compliance with this policy and evaluate the impact
of this policy on research activities at CDC. The CDC IRC may
periodically conduct random audits of research protocols to assess
compliance with this policy.
Dated: September 8, 1995.
Claire V. Broome,
Deputy Director, Centers for Disease Control and Prevention (CDC) and
Deputy Administrator, Agency for Toxic Substances and Disease Registry
(ATSDR).
[FR Doc. 95-22950 Filed 9-14-95; 8:45 am]
BILLING CODE 4163-18-P
