Recruitment and Retention of Minority Participants

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Recruitment and Retention of Minority
Participants

• Terry L. Mills, Ph.D.Associate Professor
  andAssistant Dean of the Graduate
  SchoolDirector of the R.E. McNair Scholars
  ProgramOffice of Graduate Minority
  ProgramsUniversity of Florida 115 Grinter
  HallGainesville, FL 32611-5500(352)392-6444(352
  )392-3773 - FAXInternet www.clas.ufl.edu/users/t
  lmills

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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.

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Overview of todays 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.

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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 Womens Health Research).
  www.womancando.org

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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.

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Why we need women and minorities in research
studies

• However, as obvious as the need to include women
  may seem . . .

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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).

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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.)

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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.

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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.

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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.

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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).

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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 Alzheimers study were African
  American

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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.

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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).

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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).

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African American attitudes about research
Recommended strategies 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 . . .

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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).

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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)

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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?

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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.

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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 . . . .

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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?