Inclusion of Women and Minorities in Clinical Research conducted by Kent State University Investigators
In accordance with its dedication to the highest levels of research integrity, all research at Kent State University is conducted in compliance with the principles of the Belmont Report, the Nuremberg Code, the Declaration of Helsinki and the U.S. Department of Health and Human Services Code of Federal Regulations 45 CFR 46. Kent State has made a commitment to conduct all research, regardless of sponsorship under these principles and all relevant local, state, federal and international regulations in order to provide the same high level of protection for all human subjects participating in research.
Sections of the Code of Federal Regulations (45 CFR 46.111), the U.S. Food and Drug Administration (FDA) and the National Institutes for Health (NIH) address the inclusion of women and minorities in research.
The inclusion of the groups is meant to ensure that they receive an appropriate share of the benefits of research and that they do not bear a disproportionate burden. To the extent that participation in research offers direct benefits to the participants, under-representation of men, women, or minorities denies them the opportunity to receive this benefit. Moreover, for the purpose of generalizing research results, investigators must include the widest possible range of population groups.
The responsibilities of the Kent State University Institutional Review board (IRB) include examining the ethical issues involved in research conducted by KSU Investigators and determining if the selection of subjects is equitable in accordance with the regulations for protection of human subjects (45 CFR 46.111(a)(3)).
The “Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research” were published as a result of the 1993 Revitalization Act. The guidance aims to ensure the inclusion of women and minority groups in NIH- supported clinical research unless there is a clear and compelling rationale and justification establishing that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.
The NIH guidance mandates that:
- NIH ensure women and minorities and their sub populations are included in clinical research;
- for clinical trials, women and minorities and their sub populations are included as subjects. In Phase III clinical trials, they must be included in numbers adequate to allow for valid analyses of differences in intervention effect;
- NIH establish guidelines for circumstances under which such inclusion is inappropriate;
- cost is not allowed as an acceptable reason for excluding these groups; and,
- NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their sub populations as participants in clinical studies.
NIH will not fund any grant, cooperative agreement or contract or support any intramural project which does not comply with this policy. Additionally, research awards covered by this policy require the grantee /contractor to report annually on cumulative enrollment of women and men, and on the race and ethnicity of research participants.
This NIH guidance has helped to strengthen institutions’ policies on including women and minorities in research, and as a result the United States has made some progress in reducing the disparity in health outcomes between the majority and some racial and ethnic minority groups. Health disparities are differences in health outcomes between groups that reflect social inequalities. The 2011 Centers for Disease Control and Prevention (CDC) report entitled “Health Disparities and Inequalities in the United States”, shows that there are ongoing racial/ethnic, economic and other social disparities in health that still need to be addressed. Some key findings of the report include:
- · Lower income residents report fewer average healthy days. Residents of states with larger inequalities in reported number of healthy days also report fewer healthy days on average. The correlation between poor health and health inequality at the state level holds at all levels of income.
- · Large disparities in infant mortality rates persist. Infants born to black women are 1.5 to 3 times more likely to die than infants born to women of other races/ethnicities.
- · Racial/ethnic minorities, with the exception of Asians/Pacific Islanders, experience disproportionately higher rates of new human immunodeficiency virus diagnoses than whites, as do men who have sex with men (MSM). Disparities continue to widen as rates increase among black and American Indian/Alaska Native males, as well as MSM, even as rates hold steady or are decreasing in other groups.
- · Rates of adolescent pregnancy and childbirth have been falling or holding steady for all racial/ethnic minorities in all age groups. However, disparities persist as birth rates for Hispanics and non-Hispanic blacks are 3 and 2.5 times those of whites, respectively.
In your clinical research study design for a research grant or proposal in response to a contract solicitation, the appropriate numbers of men, women, and members of racial/ethnic groups should be based on the scientific question under study (research grants and cooperative agreements) or on requirements set forth in the solicitation statement of work (contract). While diversity and broad representation are strongly encouraged, it is not expected that both sexes and members of every racial/ethnic group and sub population will be included in every study. Consider how the following questions apply to your study before deciding the composition of your target population:
- Is the scientific question/solicitation statement of work applicable equally to both men and women and to all racial/ethnic groups and their sub populations?
- Is the condition under study or defined in the statement of work more prevalent or severe in one particular group?
- For research grants and cooperative agreements, have enough studies already been performed in one or more groups, leaving gaps that can be filled by focusing the research on certain population groups?
After answering these questions, determine the target population you need and your study design by considering the answers to the following:
- In order to obtain the appropriate diversity must I have access to participants from additional clinics or facilities? Will over-sampling of certain groups be possible?
- If a single clinic or facility is not adequate, can the needed participants be enrolled by going to hospitals or other clinical facilities in the nearby geographic region?
- If demographic limitations prevent answering scientific questions locally for the appropriate sex and minority groups, is it feasible or necessary to expand the geographic area or to establish satellite centers?
It is important to note that the NIH policy on inclusion of women in research conducted outside the U.S. is the same as that for research conducted in the U.S. However, for the population of the foreign country the definition of the minority groups may be different than in the U.S. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences.
(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies,
(2) Epidemiologic and behavioral studies,
(3) Outcomes research and health services research.
A. Minority Groups
A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.
The Office of Management and Budget (OMB) Directive No. 15 http://www.whitehouse.gov/omb/fedreg/ombdir15.html defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all Federal reporting. NIH is required to use these definitions to allow comparisons to other federal databases, especially the census and national health databases. The categories in this classification are social-political constructs and should not be interpreted as anthropological in nature.
When an investigator is planning data collection on race and ethnicity, these categories shall be used. The collection of greater detail is encouraged. However, more detailed items should be designed in a way that they can be aggregated into these required categories. Using respondent self-report or self-identification to collect an individual’s data on ethnicity and race, investigators should use two separate questions with ethnicity information collected first followed by the option to select more than one racial designation. Respondents shall be offered the opportunity to select more than one racial designation. When data are collected separately, provision shall be made to report the number of respondents in each racial category who are Hispanic or Latino.
The following definitions apply for ethnic categories.
Hispanic or Latino - a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino."
Not Hispanic or Latino
The following definitions apply for racial categories.
American Indian or Alaska Native - a person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment.
Asian - a person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)
Black or African American - a person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American."
Native Hawaiian or Other Pacific Islander - a person having origins in any of the
original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White - a person having origins in any of the original peoples of Europe, the Middle East, or North Africa.
NIH recognizes the diversity of the U.S. population and that changing demographics are reflected in the changing racial and ethnic composition of the population. The terms “minority groups” and “minority sub populations” are meant to be inclusive, rather than exclusive, of differing racial and ethnic categories.