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 AfricanAmerican 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” (ShaversHornaday 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 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 . . .

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
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

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?
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