[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:
    <bullet> 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?
    <bullet> 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?
    <bullet> 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?
    <bullet> 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?
    <bullet> Could such underrepresentation cause an adverse impact on 
the generalizability and application of results?
    <bullet> Is the underrepresentation correctable?
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:*
    <bullet> 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.
    <bullet> 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.
    <bullet> Determine whether the design of the study is adequate to 
measure differences when warranted.
    <bullet> 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.
    <bullet> 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