Recruitment and Retention of Minority Participants

Recruitment and Retention of Minority Participants Terry L. Mills, Ph.D. IoA Professional Development Series October 9, 2001

Recruitment and Retention of Minority Participants • The purpose of this presentation is to stimulate imaginative thinking about approaches to building trustful relationships with underrepresented populations . . . • that result in long-term collaborative research partnerships with minority participants, thus enhancing grant applications, proposals, and study outcomes.

Overview of today’s presentation • Why we need women and minorities in research studies. • African American attitudes towards research (a focus group study). • NIH requirement to include minorities and women. • A Theoretical Framework to explain recruitment.

Why we need women and minorities in research studies • For many years, researchers did not include women in medical research studies because they believed it would make the studies too complicated. • Medical researchers assumed that if it worked for men, then it would work the same way for women (Society for Women’s Health Research). www.womancando.org

Why we need minorities and women in research studies • Of course, we now know that women and men can react differently to the same treatment. • Some treatments that work for men may not work for women. • Women and men may have different side effects from a drug, or need different doses of a drug than men.

Why we need women and minorities in research studies • However, as obvious as the need to include women may seem . . .

Why we need women and minorities in research studies • A review of the New England Journal of Medicine, Journal of the American Medical Association, Journal of the National Cancer Institute, and Circulation for the years 1993, 1995, 1997, and 1998 showed that among NIH-funded, non-sex specific studies, approximately one fifth of the studies published each year failed to include women as research subjects (Vidaver, LaFleur, Tong, Bradshaw, & Marts, 2000).

Why we need women and minorities in research studies • Moreover, only one quarter to one third of the studies that included women analyzed data by sex of the subjects. • “These data clearly show the need for increased awareness and monitoring of recruitment and retention of women in clinical research and for the analysis of data by sex of the subjects to be carried out consistently” (Vidaver et al.)

African American attitudes about research • Attitudes and beliefs of African Americans toward participation in medical research (Corbie-Smith, Thomas, Williams, & Moody-Ayers,1997): • Mistrust of doctors, scientists, and the government was consistently reported by focus group participants. • Many described concerns about the ethical conduct of clinicians and investigators.

African American attitudes about research • Corbie-Smith et al (continued): • Many focus group participants cited exploitation as supporting evidence for their mistrust of the medical establishment. • Few participants understood the concept of Informed Consent. • Participants saw signing the document as relinquishing their autonomy and as a legal protection for the investigator.

African American attitudes about research • The Tuskegee Syphilis Study continues to cast its long shadow on the contemporary relationship between African Americans and the biomedical community. • Several recent articles have argued that the Tuskegee Syphilis Study has predisposed many African Americans to distrust medical and public health authorities; • and is a significant factor in the low participation of African Americans in clinical trials and in the reluctance of many black people in seeking routine preventive care.

African American attitudes about research • As one AIDS educator put it, "so many African-American people that I work with do not trust hospitals or any of the other community health care service providers because of that Tuskegee experiment. It is like ... if they did it then they will do it again” (Report of the Tuskegee Syphilis Study Legacy Committee - Final Report -- May 20, 1996).

African American attitudes about research • Prior studies also suggest that African Americans are especially difficult to recruit into research. For example: • Arean et al. (1993) reported only one percent of those responding to local newpaper and radio ads were minority. • Ballard, Nash, Raiford, & Harrell (1993) reported that as of 1989 only roughly 10% of participants (60 of 607) in Alzheimer’s study were African American

African American attitudes about research • Eastman (1996) reported that African Americans comprised only 5% of participants in cancer clinical trials. • Reynolds (1996) reported only 6% African American participation in prostate, lung, colorectal, and ovarian cancer screening trial.

African American attitudes about research • A number of researchers have cited barriers to recruitment and retention of African Americans: • researcher and physician bias due to belief that, “there is greater difficulty in obataining African American compliance with a study protocol and that they have higher attrition rates” (Shavers-Hornaday et al, 1997).

African American attitudes about research • Swanson and Ward (1995) suggest that bias is evidenced when researchers exclude minorities on the claim that, “they are hard to reach.” • Another barrier is the small number of minority researchers (Swanson and Ward).

African American attitudes about researchRecommendedstrategies for increasing African American participation in research: • Raising awareness through outreach programs. • Publicity campaigns targeted to African Americans. • Increasing awareness of research agendas among physicians . . .

African American attitudes about research • Use of incentives such as financial compensation, therapeutic interventions, provision of health services, and provision of transportation services to facilitate participation. • Better understanding of the underlying distrust and cultural context in which African Americans consider research (Shavers-Hornaday et al. 1997).

NIH Guidelines on inclusion of women and minorities • The National Institutes of Health (NIH) has established guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects, including clinical trials, supported by the NIH, as required in the NIH Revitalization Act of 1993.

NIH Guidelines on inclusion of women and minorities • Because the primary aim of biomedical and behavioral research is to provide scientific evidence resulting in a change in health policy or a standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently. • The guidelines are intended to ensure that all NIH-supported biomedical and behavioral research involving human subjects is carried out in a manner sufficient to elicit information about individuals of both genders and the diverse racial and ethnic groups. • Increased attention, therefore, must be given to gender, race, and ethnicity.

NIH Guidelines on inclusion of women and minorities • NIH funding components will not award any grant, cooperative agreement, or contract or support any intramural project that does not comply with this policy. For research awards that are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of research participants.

Theoretical Framework to Explain the Recruitment Process • The Matching Model (Levkoff, Levy & Weitzman): • Multi-dimensional model that explains various enablers and barriers. • Macro-level enablers and barriers • Mediator-level enablers and barriers • Micro-level enablers and barriers

Theoretical Framework to Explain the Recruitment Process • At the macro-level of analysis, burdens of service demands may restrict community agency personnel from participating in research. • Barriers also exist at the macro-level when the academic institution is perceived as not being “connected” to the community; or when multiple institutions compete for the same sampling pool.

Theoretical Framework to Explain the Recruitment Process • Yet, macro-level factors also can enable recruitment and retention through collaboration with community agencies or offers of technical assistance by academic institutions.

Theoretical Framework to Explain the Recruitment Process • Mediator-level barriers are constructed when: • Gatekeepers attempt to protect participants from real or perceived harm. • When cultural interpretations of health and illness result in denial of the existence of a health condition.

Theoretical Framework to Explain the Recruitment Process • Still, at the mediator-level, gatekeepers also can enable recruitment and retention when they believe the research is important to the community.

Theoretical Framework to Explain the Recruitment Process • At the micro-level, barriers are erected when: • participants and their caregivers distrust research. • participants have fears of family stigma, loss of services, or lack of confidentiality.

Theoretical Framework to Explain the Recruitment Process • On the other hand, the micro-level of recruitment and retention may function to enable the research effort when: • they are disposed to want to tell their stories. • Improve the lives of others • value the research

Theoretical Framework to Explain the Recruitment Process • It is important to note that researchers themselves can take on the role of gatekeepers when: • they do not value the research • the research is opposing their own activist agenda. • interdisciplinary differences among research team members make collaboration difficult.

Possible Focus Group Questions for Community participants (Freimuth et al. 2001) • “What comes to mind when I say research?” • “What is informed consent?” • “What is a clinical trial?” • “Who has ever participated in a research study?” • “Why do you think we are conducting this study?” (our motivation)

Possible Focus Group Questions for Community participants (Freimuth et al. 2001) • “Who benefits from this research?” • “What is your motivation for participation in this study?” • “What concerns do you have about participating in this study?”

Summary • Although the NIH requires inclusion of women and minorities, there still is a need to conduct appropriate gender and race/ethnicity data analyses. • Recruitment of minorities involves an investment in both time and dollars. • We must be willing and interested in cultivating an atmosphere of trust, and taking a longer-term view of data collection.

IoA efforts in the community • Robert Wood Johnson core partnerships. • Coalition for Minority Health. • 8th annual Senior Health Forum. • IoA Senior games sponsorship. • Development of participant pool • Others . . . .

Questions for Group Discussion • What challenges have you faced in recruiting minority participants? • What approaches might we take in building a stronger relationship with the local minority community? • Do you need to be a minority, or a women to successfully recruit and retain minority participation in your research?

Recruitment and Retention of Minority Participants