Inclusion of Women and Racial and Ethnic Minorities in Research

CATEGORIES: Science Administration, General Administration
CDC-GA-1996-01 (Formerly CDC-80)
DATE OF ISSUE: 2/16/96 UPDATED: 11/18/2010¹
PROPONENTS: CDC Associate Director for Science
MATERIAL SUPERSEDED: Inclusion of Women and Racial and Ethnic Minorities in Research, 2/16/96; Federal Register Notice Vol. 60,Number 179, pp. 47947-47951, 9/15/1995

SECTIONS:

1. PURPOSE AND SCOPE
2. BACKGROUND
3. POLICY
4. RESPONSIBILITIES
5. REFERENCES
6. ACRONYMS
7. DEFINITIONS

ATTACHMENT

1. PROCEDURES

1. PURPOSE AND SCOPE

It is the intent of the Centers for Disease Control and Prevention (CDC)²; to ensure that research conducted with CDC funds addresses health problems that affect women and minority populations to the extent practicable and relevant to the proposed research. This policy updates the guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects which is supported or conducted by CDC. The guidelines are to ensure that men and women, and members of racial and ethnic minority groups be included in CDC studies involving human subjects whenever feasible and appropriate.

This policy applies to (a) all extramural research projects submitted after the effective date of this policy (includes initial applications and proposals) when the extramural research involves human subjects, and (b) all intramural research projects that involve human subjects. It supersedes the previous version of CDC-GA-1996-01 (Inclusion of Women and Racial and Ethnic Minorities in Research) and Federal Register Notice: Vol. 60, No. 179, 9/15/95 (CDC/ATSDR Policy on the Inclusion of Women and Racial and Ethnic Minorities in Externally Awarded Research).

This policy is consistent with CDC-SA-2010-01³; (Human Research Protections) and CDC-SA-2010-02⁴ (Distinguishing Public Health Research and Public Health Nonresearch).

2. BACKGROUND

This policy addresses CDC’s commitment to protecting the health of all people regardless of their age, sex, race, ethnicity, national origin, religion, sexual orientation, socioeconomic status, or other characteristics. It also addresses Healthy People 2020, the nation’s health agenda, and its overarching goals which are: (1) to help individuals of all ages increase life expectancy and improve their quality of life, and (2) to eliminate health disparities among different segments of the population.⁵

A. Women's Health

It is widely recognized that the health conditions and health care needs of women differ from those of men in a variety of ways. Some health conditions are unique to women and others are more prevalent in women. These differences are largely related to biological and environmental factors. For some illnesses, there are marked distinctions, not only in onset and progression of disease, but also in the approaches necessary to combat them in women.⁶

While some differences are well documented, much is still unknown, and continued research is needed to effectively address women’s health needs. For example, more research is needed to understand how behavioral and sociocultural factors interact with biological factors to affect the health of women over their life stages. Additional examples include the need for research on workplace hazards that affect women’s health, the special health concerns of minority women and all women across the life course, and diseases that affect women differently from men.^7,8,9

CDC’s requirement to include women in research when appropriate and feasible addresses these concerns and facilitates collection of data that can be used to improve the health of women.

B. Racial and Ethnic Minority Health

Health disparities between the white majority and some racial and ethnic minority groups are also well documented. However, whites do not always have better outcomes when compared to other racial minorities. It is commonly accepted that increased participation of minorities in health research will yield additional data which can be used to better understand and improve the health status of minorities. ¹⁰ For the purpose of this policy, minority populations include African American, Hispanic, Asian/Hawaiian/Pacific Islander, American Indians and Alaska Natives.

In its 2005 National Health Disparity Report, the Agency for Healthcare Quality and Research states that disparities related to race, ethnicity, and socioeconomic status are observed in almost all aspects of health and health care.¹¹ Health disparities between majority and minority populations account for dramatically shorter life expectancy, higher morbidity rates, and inadequate access to quality health care. A notable problem is that these disparities persist over time, despite significant advances in the prevention, treatment, and diagnosis of disease over the past 50 years, and in many cases the gap has grown.^12,13,14

There is a continued need for greater representation and participation of racial and ethnic minorities in research in order to: (a) better understand and address health problems for their subpopulations; (b) inform policies, practices, and research aimed at improving health outcomes; and (c) track and evaluate progress toward the goal of eliminating health disparities. Especially lacking is practical knowledge on determinants of health that influence multiple risk factors and multiple disease outcomes, and community level knowledge that is “locally relevant and culturally appropriate."^15,16,17

CDC’s policy to ensure the inclusion of racial and ethnic minorities in research is but one way to address the need for new knowledge to reduce health disparities. The challenges associated with collecting meaningful data will vary according to the research focus, the sample size, and study design. The guidelines in this policy are intended to help researchers make decisions that ensure appropriate levels of inclusion.

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3. POLICY

It is the policy of CDC that women and racial and ethnic minorities must be sufficiently represented in human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons that justify under-representation. Given the volunteer nature of subject participation in research, direct efforts should be made to actively recruit and enroll women and minorities in all funded research. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) of Title 45, Code of Federal Regulations (C.F.R.) Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including women and minorities as participants. If women and minorities will not be adequately represented in the research, the application or proposal must present an acceptable justification for the under-representation.^18,19

It is the policy of CDC that women of childbearing potential should not be routinely or arbitrarily excluded from participation. However, ethical issues must be considered for inclusion and exclusion. HHS regulations at 45 C.F.R. Part 46 Subpart B extend additional protections for pregnant women, human fetuses and neonates involved in research. These regulations must be considered when research may involve pregnant women. ²⁰ Information conveying adverse differences in outcome or risk profiles for pregnant women and fetuses is a valid reason for exclusion.

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 the investigation of outbreaks that do not involve women or racial/ethnic minorities).

This policy will be reviewed by the Office of the Associate Director for Science with the goal of improving procedures, clarifying responsibilities and optimizing the intent and impact of the policy. This review will occur, at a minimum, every three (3) years.

4. RESPONSIBILITIES

This policy applies to (a) all extramural research projects submitted for receipt dates after the effective date of this policy (includes initial applications and proposals), and (b) all intramural research projects, when the extramural or intramural research involves human subjects. Certain individuals and groups have special roles and responsibilities with regard to the adoption and implementation of these guidelines.

A. Investigators

Investigators shall assess the theoretical and empirical linkages between sex/gender, race, ethnicity and health in their topic of study. Following this assessment, the principal investigator will address the policy in each application or protocol, providing the required information on inclusion of women and minorities and any required justifications for studying a sample of participants in which women and racial/ethnic minorities are under-represented for good reasons. Investigators are also responsible for monitoring implementation of this policy during the conduct of the study.

• Recruitment Outreach

Investigators and their staff(s) shall 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 derived 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, non-proficiency 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, e.g., minimizing the possibility of coercion or undue influence in the incentives or rewards offered in recruiting into or retaining participants in scientific studies.

• Dissemination of Research Results

Investigators and program managers are strongly urged to make special efforts to disseminate relevant research results to the communities who participated in the studies and to the affected populations, especially minority populations that may have cultural, language, and socioeconomic barriers to the easy receipt of such information. Dissemination and translation strategies include, but go beyond, scientific publications and presentations. In order to adequately reach communities and key stakeholders, dissemination efforts will need to apply innovative and relevant approaches such as social media, community networks or changes in policy.

B. Centers, Institutes and Offices (CIOs)

CIOs are responsible for ensuring that CDC-conducted and CDC-supported studies involving human subjects meet the requirements of these guidelines. CIO Directors will inform investigators and other appropriate staff concerning this policy and monitor its implementation during the development, review, award, and conduct of research.

C. CDC Project Officers and Program Officials

CDC Project Officers and Program Officials shall design their Funding Opportunity Announcements (FOAs) in compliance with this policy. CIO Directors shall ensure this policy is fully considered and implemented prior to the release of the FOA 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 which does not comply with this policy beginning with the date of its implementation.

D. Technical/Peer Review Groups

If applicable, in conducting technical/peer review of protocols, technical/peer review groups, to the extent possible, will include women and minorities with relevant professional backgrounds and experience and will do the following:

• Evaluate the proposed protocol for appropriate inclusion of both sexes and minority populations
• Evaluate the appropriateness of the proposed justification when women and racial/ethnic minorities are under-represented or absent from the study population
• Determine whether the design of the study is adequate to measure differences between women and men and racial/ethnic minorities and non-minorities when warranted
• Evaluate the plans for recruitment and outreach for study participants. Include these criteria as part of the technical assessment

Requirements pertaining to Federal Advisory Committee Act (FACA) panel composition are administered by the CDC Management Analysis and Services Office (MASO); Federal Advisory Committee Management Branch.²¹

E. Institutional Review Boards (IRBs)

CDC IRBs are expected to consider whether investigators have appropriately addressed the inclusion of women and minorities in research protocols that require CDC IRB review.

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5. REFERENCES

Agency for Healthcare Quality and Research. National Health Disparities Report, AHQR 2005. Available at: http://www.ahrq.gov/qual/nhdr05/nhdr05.pdf. Accessed November 5, 2010.

Beech B, and Goodman M. (eds.) Race and Research: Perspectives on Minority Participation in Health Studies. Washington, DC: APHA; 2004.

CDC-SA-2010-01 (Human Research Protections)
http://www.cdc.gov/od/science/integrity/docs/cdc-policy-human-research-protections.pdf

CDC-SA-2010-02 (Distinguishing Public Health Research and Public Health Nonresearch)
http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

Centers for Disease Control and Prevention, Office of the Associate Director for Science Internet site. Retrieved from: http://www.cdc.gov/od/science/index.htm. Accessed November 4, 2010.

Centers for Disease Control and Prevention, Office of Minority Health Internet site. Retrieved from:
http://www.cdc.gov/omhd/Topic/MinorityHealth.html. Accessed September 23, 2010.

Centers for Disease Control and Prevention. Office of Women’s Health Internet site; Retrieved from: http://www.cdc.gov/women/. Accessed September 23, 2010.

Federal Advisory Committee Act (FACA); General Services Administration. Available at: http://gsa.gov/portal/category/21242

Griffith D, Moy E, Reischl T, and Dayton E. National data for monitoring and evaluating racial and ethnic health inequities: Where do we go from here? J Health Education and Behavior. 2006:470-487.

Healthy People 2020. Retrieved from: http://www.healthypeople.gov/hp2020. Accessed September 23, 2010.

Monitoring Adherence to the NIH Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. Comprehensive Report: Tracking of Human Subjects Research as Reported in FY07 and FY08. Available at:
http://orwh.od.nih.gov/inclusion/2009AnnualTrackingInclusionComprehensiveRpt.pdf

National Institutes of Health. Inclusion of Women and Minorities as Participants in Research Involving Human Subjects: Policy Implementation Page, 2001. Retrieved from: http://grants.nih.gov/grants/funding/women_min/women_min.htm. Accessed September 23, 2010.

National Institutes of Health. Office of Research on Women’s Health Internet site; Retrieved from: http://orwh.od.nih.gov/. Accessed September 23, 2010.

National Institutes of Health. Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. Department of Human Services, National Institutes of Health, Amended, October 2001. Available at: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Accessed on September 23, 2010.

Office of Management and Budget. Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity. Executive Office of the President, Office of Management and Budget, Office of Information and Regulatory Affairs. Federal Register Notice, October 30, 1997. Available at: http://www.whitehouse.gov/omb/fedreg/ombdir15.html. Accessed September 23, 2006.

Public Welfare; Protection of Human Subjects. 45 C.F.R. pt 46 Subpart B (through 6/23/05). Available at: http://ecfr.gpoaccess.gov.

Report of the Secretary’s Task Force on Black & Minority Health. U.S. Department of Health and Human Services. August 1985. Available at: http://www.omhrc.gov/assets/pdf/checked/ANDERSON.pdf. Accessed September 23, 2010.

Sex and Gender. Online Course. National Institutes of Health. Available at: http://sexandgendercourse.od.nih.gov/. Accessed September 23, 2010.

Standards for the Classification of Federal Data on Race and Ethnicity. Office of Management and Budget. Available at: http://www.whitehouse.gov/omb/fedreg/ombdir15.html

Stanley S and Dhindsa MS. Ethical and racial disparities research: Issues and problems. J Health Education and Behavior. 2006:459-469.

Wizemann M and Pardue ML (eds). Exploring the Biological Contributions to Human Health: Does Sex Matter? Institute of Medicine, Committee on Understanding the Biology of Sex and Gender Differences; 2001. Washington, DC; National Academy Press.

Women’s Health. Report of the Public Health Service Task Force on Women’s Health Issues. Public Health Rep. 1985 Jan-Feb;100(1):73-106. Retrieved from: http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1424718&blobtype=pdf . Accessed September 23, 2010

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6. ACRONYMS

APHA	American Public Health Association
CDC	Centers for Disease Control and Prevention
CFR	Code of Federal Regulations
CIO	Center, Institute, Office
FACA	Federal Advisory Committee Act
FOA	Funding Opportunity Announcement
HHS	Department of Health and Human Services
IRB	Institutional Review Board
OMB	Office of Management and Budget

7. DEFINITIONS

Minority Populations
For the purpose of this policy, the term “racial and ethnic minority,” refers to American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander populations as defined in the revision to Office of Management and Budget (OMB) Directive No. 15, “Standards for the Classification of Federal Data on Race and Ethnicity.” Data collection and reporting activities pertinent to this policy should be in compliance with this OMB Notice of Decision, which defines the minimum categories for data on race and ethnicity for Federal statistics, program administrative reporting, and civil rights compliance reporting. Retrieved from:
http://www.whitehouse.gov/sites/default/files/omb/assets/information_and_regulatory_affairs/
re_guidance2000update.pdf.

Research

The definition “research,” which applies to this policy is in Title 45 CFR 46.102(d), the Department of Health and Human Services regulations for the protection of human subjects: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” (See also policy CDC-SA-2010-02, Distinguishing Public Health Research and Public Health Nonresearch.)

Human Subjects

The definition of “human subjects” which applies to this policy is drawn from Title 45 of the U.S. Code of Federal Regulations, Part 46, 102(f): “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (See also policy CDC-SA-2010-01, Human Research Protections.)

Intramural Research

Research conducted by CDC staff (employees, contractors, visiting scientists, fellows, agents, and students) in its own facilities or its components (research programs and research studies) and scientific investigations and developmental efforts supported by CDC through contracts and performed by other organizations. Research programs are typically the mission related research agenda or portfolio for the CIO. Research studies include projects undertaken by CDC scientists that involve research findings intended for dissemination and that are not funded through assistance (grant or cooperative agreement) or acquisition (contract).

Extramural Research

Research activities funded through a grant or cooperative agreement instrument (assistance relationship).

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¹Updated to conform to current policy standards and updated CDC/ATSDR guidance.
²References to CDC also apply to the Agency for Toxic Substances and Disease Registry (ATSDR).
³ http://www.cdc.gov/od/science/integrity/docs/cdc-policy-human-research-protections.pdf
⁴http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf
⁵Healthy People 2020. Retrieved from: http://www.healthypeople.gov/hp2020. Accessed September 23, 2010.
⁶Wizemann M and Pardu ML (eds). Exploring the biological contributions to human health: does sex matter? Institute of Medicine, Committee on Understanding the Biology of Sex and Gender Differences; 2001. Washington, DC; National Academy Press.
⁷Beech B, and Goodman M (eds). Race and research: perspectives on minority participation in health studies. Washington, DC: APHA; 2004.
⁸Sex and Gender. Online Course. National Institutes of Health. Retrieved from: http://sexandgendercourse.od.nih.gov. Accessed November 5, 2010.
⁹Wizemann M and Pardu ML (eds). Exploring the biological contributions to human health: does sex matter? Institute of Medicine, Committee on Understanding the Biology of Sex and Gender Differences; 2001. Washington, DC; National Academy Press.
¹⁰Beech and Goodman. (See Note 3.)
¹¹Agency for Healthcare Quality and Research. National Health Disparities Report, AHQR 2005. Available at: http://www.ahrq.gov/qual/nhdr05/fullreport/Index.htm . Accessed September 23, 2010.
¹²Beech and Goodman. See note 3.
¹³CDC; Office of Minority Health. See note 2.
¹⁴Griffith D, Moy E, Reischl T, and Dayton E. National data for monitoring and evaluating racial and ethnic health inequities: where do we go from here? J Health Education and Behavior. 2006:470-487.
¹⁵Beech and Goodman . See note 3.
¹⁶CDC Office of Minority Health. See note 2.
¹⁷Report of the Secretary’s Task Force on Black & Minority Health. U.S. Department of Health and Human Services. August 1985. Retrieved from: http://www.omhrc.gov/assets/pdf/checked/ANDERSON.pdf. Accessed September 23, 2010.
¹⁸NIH. Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. DHHS. Available at: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
¹⁹Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research: As Reported in FY07 and FY08. Available at: http://orwh.od.nih.gov/inclusion/2009AnnualTrackingInclusionComprehensiveRpt.pdf
²⁰Public Welfare; Protection of Human Subjects. 45 CFR pt. 46 Subpart B (through 6/23/05). Retrieved from: http://ecfr.gpoaccess.gov.
²¹Federal Advisory Committee Act (FACA); General Services Administration. Available at: http://gsa.gov/portal/category/21242

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Attachment

A. PROCEDURES

1. General

In determining whether special efforts should be made to set specific enrollment goals for women and members of minority groups, or whether to design special studies to specifically address health problems in such populations, principal investigators must consider the following questions:

• Is the disease or condition under study overrepresented, relatively common, and/or relatively rare in men, women or one or more 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 minority populations?


• Are there scientific reasons to anticipate differences of public health importance between men and women and among minority populations with regard to the hypothesis under investigation? 


• Are there study design or recruitment limitations in the protocol that could result unnecessarily in under-representation of one sex or certain minority populations?  Could such under-representation cause an adverse impact on the generalizability and application of results?


• Does racial and ethnic characterization of study subjects serve a bona fide purpose, or might it serve only to stigmatize a group? When stigma is a concern, what steps or study design considerations are undertaken to minimize or prevent stigma?

Inclusion of women and 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 minority representation appropriate to the scientific objectives. This policy does not require that the study design provide sufficient statistical power to answer the questions posed for men and women and minority groups separately.  However, when there are scientific reasons to anticipate such differences with regard to the hypothesis under investigation, investigators should include an evaluation of these sex and minority group differences along with estimates of statistical significance in the study proposal.

If adequate inclusion of one sex or minority group is impossible or inappropriate with respect to the purpose of the proposed study, the rationale for the study population must be well explained and justified. Similarly, 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 minority groups shall not alone be the permissible justification for non-compliance with the policy in a given study. However, if data of comparable quality regarding women and minority groups have been or will be obtained through other means, then the cost of inclusion of women and minority groups in the study would be persuasive.  Acceptable reasons for exclusion are as follows:

• Inclusion is inappropriate with respect to the health of the subject
• Inclusion is inappropriate with respect to the purpose of the study
• Substantial scientific evidence shows no difference of public health importance between the effects that the variables to be studied have on women and minority groups
• Inclusion is inappropriate under other circumstances as determined by the CDC CIO Associate Director of Science


• 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/gender and racial/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 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 and accommodate 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

2. Studies of Public Health Interventions

Investigators should consider the following when planning an intervention trial or a clinical trial:

• If the data from prior studies strongly indicate the existence of differences that are of clinical or public health importance in intervention effect between the sexes or among minority 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 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 specific minority groups with adequate sample size for each


• If the data from prior studies strongly support no 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  differences of clinical or public health importance in intervention effect, then the study should include sufficient and appropriate male and female and 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 or fetuses, pregnancy status should be determined prior to enrollment

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