[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.) 

[[Page 47949]]


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