[Federal Register Volume 60, Number 68 (Monday, April 10, 1995)]
[Notices]
[Pages 18130-18134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8718]
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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 Minorities in Externally Awarded Research
AGENCY: Centers for Disease Control and Prevention (CDC) and Agency for
Toxic Substances and Disease Registry (ATSDR), Public Health Service
(PHS), Department of Health and Human Services (DHHS).
ACTION: Notice and request for comments.
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SUMMARY: This notice is a request for comments on the CDC\1\ policy on
the inclusion of women and minorities in externally awarded research.
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 proactively 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 intraagency research.)
\1\References to CDC also apply to the Agency for Toxic
Substances and Disease Registry (ATSDR).
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DATES: Written comments on the policy must be received on or before
June 9, 1995. This policy, when finalized, will be applicable for all
CDC externally awarded projects submitted on and after October 1, 1995.
ADDRESSES: Written comments can be sent to the Centers for Disease
Control and Prevention, Attention: Office of the Associate Director for
Science, Mailstop D-39, 1600 Clifton Road, NE., Atlanta, GA 30333.
FOR FURTHER INFORMATION CONTACT: Inquiries should be directed to 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 Policy on the Inclusion of Women and
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
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) and the Agency
for Toxic Substances and Disease Registry (ATSDR) are 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 poor and uninsured women. Lesbians may also
enter the health care system differently because they may be less
likely to seek or receive prevention services, like cancer screening,
because they may not seek or receive 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 in 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 an ethnic or
cultural minority or if she is physically or mentally disabled, her
health status is 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's
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 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 follow-up to outbreak investigations).
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 changes that may occur as it is reviewed
and revised. OMB Directive No. 15 defines the minimum standard of basic
racial and ethnic categories, which are used below. Despite their
limitations (as [[Page 18132]] 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 to 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: African
American and Caribbean (Haitian, Jamaican, West Indian, Trinidadian).
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, etc.) 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 the CDC that inclusion
is inappropriate or clearly not feasible. This policy does not apply to
studies when the investigator cannot control the race, ethnicity, and
sex of subjects; however, women and racial and ethnic minority
populations must not be routinely and/or arbitrarily excluded from such
investigations. Women of childbearing potential should also not be
routinely and/or arbitrarily excluded from participation; however,
there are ethical/risk issues to consider for exclusion. Information on
differences in outcome or risk profiles should be further 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 in research 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 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) There is substantial scientific evidence that there is no
significant difference between the effects that the variables to be
studied have on women and/or racial and ethnic minority groups;
(4) There are already substantial scientific data on the effects
that variables have on the excluded population;
(5) Inclusion is inappropriate under other circumstances determined
acceptable by the CDC.
In each protocol or proposal, the composition of the proposed study
[[Page 18133]] population must be described in terms of sex and racial
and ethnic group together with a rationale for its choices. Sex and
racial and ethnic 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 the
proposed outreach programs, if necessary, for recruiting women and
racial and ethnic minorities as participants. Investigators must
safeguard the consent process by promoting open and free communication
with the study participants. Investigators must seek to understand
cultural differences and variety of languages inherent in the
population to be enrolled. The possibility of non-proficiency of
speaking and/or reading English by a potential study participant must
be considered and assurances given that adequate provision has been
made for appropriate translation of the consent document or the
availability of translators to ensure an adequate understanding of the
research.
B. Studies of Public Health Interventions
Investigators must consider the following when planning an
intervention 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 this. 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 entry of men and women 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 a reason to suspect that there may be adverse events in
pregnant women, pregnancy status may need to be determined prior to
enrollment for some intervention trials.
V. Implementation
A. Date of Implementation
This policy applies to all CDC externally awarded projects
submitted on and 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 and 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 in studies, and any required justifications for exceptions
to the policy.
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, should include
women and racial and ethnic minorities and will do the following:*
Evaluate the proposed plan for the inclusion of both sexes
and racial and ethnic minority populations for appropriate
representation or evaluate the proposed justification when
representation is limited or absent.
Evaluate the proposed exclusion of a certain racial and
ethnic minority population and males or females on the basis that a
requirement for inclusion is inappropriate.
*C/I/O Directors may waive this requirement if it is clearly
inappropriate or clearly not feasible.
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 meet 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 responsible for ensuring that CDC investigators have
adequately addressed the inclusion of women and racial and ethnic
minorities in research protocols that require CDC 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
nor support any externally funded project to be conducted or funded in
fiscal year 1996 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(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 [[Page 18134]] 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 populations to which they
pertain, especially racial and ethnic minority populations which 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: March 30, 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. 95-8718 Filed 4-7-95; 8:45 am]
BILLING CODE 4163-18-P
