African Americans and Clinical Research: Evidence Concerning Barriers and Facilitators to Participation and Recruitment Recommendations

Abstract

Purpose of the Study:

The goal of the study was to examine barriers and facilitators to clinical research participation among African Americans, as well as recommendations for overcoming these.

Design and Methods:

Eight focus groups were conducted consisting of 64 individuals. These focus groups targeted 2 groups of individuals: (a) community members, including both individuals involved in research and individuals not involved in research, and (b) community leaders, including clergy, community health care providers and service providers who may influence decisions to participate in research.

Results:

Among participants in both groups, the most common barriers to participation included fear and mistrust of research due to multiple factors, such as a lack of information about research and prevailing knowledge of historical occurrences. Facilitators to research participation included intrinsic factors, such as a desire to help others, and extrinsic factors, such as familiarity with the research recruiter. The focus groups also directly engaged participants in discussions of strategies that might improve recruitment, such as the importance of providing personal stories that enable community members to understand the potential benefits of research.

Implications:

Findings from these focus groups address the mandate from funding agencies that emphasize the importance of including racially diverse populations in clinical research studies, and offer potential solutions for increasing the recruitment and retention of minority participants.

Of an estimated 5.2 million Americans currently affected with Alzheimer’s disease (AD) and other dementias, African Americans have been disproportionately affected by these diseases, and are twice as likely to develop AD and other dementias when compared with whites (Thies & Bleiler, 2013). Older minorities are often diagnosed in later stages of dementia and consequently sustain higher health care costs and levels of chronic morbidity (Zuckerman et al., 2008). It has been hypothesized that lifestyle, environmental and genetic factors contribute to the disproportionate prevalence and risk of dementia among African Americans, but reasons for this disparity are not well understood. The under-representation of older minorities in research related to aging and dementia has limited the generalizability of existing clinical research findings and also perpetuates a degree of uncertainty regarding risks for dementia in minority populations. This underscores the need for increased clinical research participation among African Americans to determine if there are unique differences in risk reduction or treatment response. However, despite the prevalence of higher rates of cognitive impairment and dementia among older African Americans (Thies & Bleiler, 2013), clinical research participation and postmortem examinations in this population continues to remain low (Darnell, McGuire, & Danner, 2011; Schnieders, Danner, McGuire, Reynolds, & Abner, 2013). Furthermore, although federally funded agencies have mandated the inclusion of racially diverse populations in research studies, the recruitment and retention of minority participants remains challenging. For example, according to a recent report, only 5% of clinical trial participants are African American (Coakley et al., 2012). In order to conduct ethnically representative research, investigators must better design recruitment and study strategies that consider barriers and facilitators among minority populations to participation in clinical research. The present study sought to engage community members, as well as community leaders who may influence an individual’s willingness to participate in research, in order to identify barriers and facilitators to research participation among African Americans, and explore recruitment recommendations as a means for effectively increasing African American participation in clinical research studies.

The literature examining barriers and facilitators to clinical research participation has utilized both quantitative and qualitative methodologies. Prior quantitative studies have revealed a number of barriers to clinical research participation, including a lack of awareness about clinical research studies (Brown & Moyer, 2010; George, Duran, & Norris, 2014), mistrust (Byrd et al., 2011; George et al., 2014), fear of experimentation (Corbie-Smith, Thomas, & St George, 2002) and a fear of treatment side-effects (Owens, Jackson, Thomas, Friedman, & Hebert, 2013). Qualitative studies that allow researchers to more descriptively understand the experiences of minority research participants have indicated that distrust appears to be related to historic occurrences involving unethical practices, such as the Tuskegee Syphilis study, the belief that research efforts would not directly benefit minority communities, and concerns that physicians may not be interested in, or willing to, introduce minority participants to research opportunities (Calderon et al., 2006; Corbie-Smith, Thomas, Williams, & Moody-Ayers, 1999; George et al., 2014).

Facilitators for research participation by minority participants identified by prior quantitative studies included altruism (i.e., wanting to help others or their community) (Shavers, Lynch, & Burmeister, 2001), access to health care, compensation, (Byrne, Tannenbaum, Gluck, Hurley, & Antoni, 2014) and minimal risk for participation (Brown & Topcu, 2003). Qualitative studies have added to these findings by revealing some of the specific benefits from research participation perceived by minority individuals, including: finding a cure for diseases, helping others and themselves, free medical care and medications and increased health-related knowledge (Calderon et al., 2006; Schnieders et al., 2013).

The majority of studies that have examined barriers and facilitators to clinical research participation have primarily explored this phenomenon from the perspective of the research participant. However, it is not uncommon for patients and families to turn to networks of support within their community for guidance with health-related decisions, as these decisions are often influenced by external factors, such as an individual’s social network (e.g., family, friends, and clergy) and health care network (e.g., physicians and health service providers; Corbie-Smith et al., 2010; Odulana et al., 2014).

A small number of studies have focused specifically on barriers and facilitators among African Americans to participation in clinical research related to aging and dementia (Bonner & Miles, 1997; Connell, Avey, & Holmes, 1994; Darnell et al., 2011; Lambe, Cantwell, Islam, Horvath, & Jefferson, 2011; Williams et al., 2010). Of the studies that have qualitatively examined these issues through the use of focus groups, none, to our knowledge, have specifically included community leaders, such as clergy, community service providers and health care providers in these discussions. Thus, researchers know very little about the perspectives toward clinical research held by these community leaders, individuals who may maintain a measure of influence on the decision to participate in research studies, and who may be an acceptable bridge to knowledge about clinical research for members of the minority community. Additionally, few studies have explicitly asked participants to provide recommendations for how to increase African American participation in research. If future minority participant recruitment efforts are to be successful, recruitment recommendations must come from both the potential participants themselves and individuals that exert a measure of influence on the dissemination and acceptance of knowledge about clinical research within minority communities.

The present study was designed to address these gaps through a series of focus groups that included two types of participants: (a) Community members—both those currently involved in clinical research and those not previously involved in clinical research, all of whom were African American and (b) Community leaders, including clergy and church leaders, as well as community service and health care providers that serve individuals from diverse populations, the majority of whom were African American. The aims of the focus group discussions were to explore: (a) perceptions of barriers to clinical research participation among African Americans, (b) perceptions of facilitators for participation in clinical research, and (c) recommendations regarding potential ways to effectively increase African American participation in clinical research studies related to aging and dementia.

Design and Methods

Participants

A total of 64 individuals participated in one of eight focus groups, comprised of 6–11 participants each. Focus group sessions were held over the course of 1 year from July 2012 to August 2013. Purposive sampling techniques, described subsequently, were utilized to recruit participants within the two participant categories: community members and community leaders (Teddlie & Yu, 2007). All research activities were approved by the Johns Hopkins Institutional Review Boards and participants provided written informed consent prior to the initiation of the research study.

Group 1—Community Members

Community Members Involved in Research

Two focus groups included African American participants enrolled in the Johns Hopkins Alzheimer’s Disease Research Center (JHADRC). A total of 15 individuals participated in these two groups (Group 1 n = 8, Group 2 n = 7). Study participants were identified from the JHADRC database, which includes information about race and diagnostic status. The study was introduced to potential participants via mail or in person by research center personnel. Participants were then contacted by the study personnel, who described the research and determined their interest in participating. Only JHADRC participants who identified themselves as African American or black and did not have a diagnosis of dementia were asked to participate.

Community Members Not Involved in Clinical Research

Two focus groups included African American community members who were not currently participating in clinical research. A total of 19 individuals participated in these groups (Group 1 n = 10, Group 2 n = 9). They were recruited through word of mouth and from African American organizations and listservs (e.g., churches, senior centers, area chapter sororities and fraternities). Participants who were aged 55 or older, and self-identified as African American or black, were enrolled.

Group 2—Community Leaders

Church Leaders and Clergy

Two focus groups included African American church leaders and clergy from the greater Baltimore area. They were invited to participate via written invitation and/or word of mouth. A total of 17 ministers and church leaders participated in these groups (Group 1 n = 11, Group 2 n = 6). Participants who were ordained ministers (i.e., had met the legal requirements to become a licensed minister) or church appointed leaders (i.e., deacon, deaconess, pastor’s wife, or missionary), and self-identified themselves as African American or black were enrolled.

Community Health Care and Service Providers

Two focus groups included community service and health care providers (9 African Americans and 3 Caucasians) who served minority populations. A total of 12 individuals participated in these groups (Group 1 n = 6, Group 2 n = 6). These participants were members of a Memory and Aging Community Advisory Board sponsored by the JHADRC. They were recruited through email and regular mail. The goal was to include current community service and health care providers (e.g., Alzheimer’s Association staff, health outreach worker, community activist, geriatric mental health professional), regardless of ethnic membership, in a dialogue regarding their perceptions of why African Americans choose to, or not to, participate in clinical research studies and what, in their opinion, could be done to increase clinical research awareness and enrollment among African Americans.

Focus Groups Procedures and Questionnaire

Meetings with participants were conducted at locations that were deemed most convenient for them. Prior to the start of each focus group discussion, participants were asked to complete a brief questionnaire. The questionnaire gathered basic demographic information from participants, their current level of knowledge regarding clinical research studies and information about the types of studies in which they were most likely to participate. Because some of the questions were sensitive in nature (e.g., income) and the goal was to have the questionnaire completed in its entirety, participants were not asked to provide identifying information.

The moderator was the same individual for each of the focus groups and was an African American (TH). During focus group discussions, participants were asked to convey their individual perceptions of clinical research and why they felt that many African Americans demonstrated support or trepidation toward research study participation. The discussions were guided by a semistructured interview, which contained predetermined open-ended questions and prompts (see Supplementary Appendix). The group sessions were 1–2hr in duration. Each session was recorded in its entirety, using a digital-audio recording device; permission was specifically obtained from group participants to do so. Focus group participants were given an honorarium ($10 gift card) for their time, provided with a light meal, and reimbursed for travel expenses.

Data Analysis

The questionnaire was completed by all of the participants. Responses to the questionnaires were summarized, and the percentage of participants endorsing each item was quantified and reported in aggregate.

Focus group sessions were transcribed verbatim from the audio files and responses were coded, using Atlas.ti (2013) software for qualitative data analysis. Line-by-line coding and microanalysis of data was performed to generate a coding scheme. Open, axial and selective coding analysis techniques were used. Open coding is an analytic process by which the researcher identifies concepts (codes) and uncovers various properties and dimensions that emerge from the data (Strauss & Corbin, 1998). Line-by-line coding or microanalysis allows the researcher to generate a coding scheme. Axial coding techniques were then employed to organize the data and identify categories and subcategories. The coded responses were then organized into mutually exclusive categories and subcategories (Strauss & Corbin, 1998). Lastly, selective coding was employed once no new properties, dimensions or relationships emerged from the data (Krefting & Krefting, 1991). Grounded theory was utilized to generate themes, to identify concepts, and to facilitate interpretation of the data (Strauss & Corbin, 1998).

The reliability of the codes was examined in order to establish data credibility and to ensure methodological rigor (Krefting & Krefting, 1991). The following quality control steps were implemented. Quotes coded by the primary coder (TH) were reviewed for accuracy of code assignment by two of the co-authors (VV, CP); where necessary, revisions were suggested (e.g., code additions or removals). To ensure consistency of code use, an additional coder (either VV or CP) reviewed these suggestions and disagreements were resolved through consensus discussion. During this process, suggestions were also made for merging or removing extraneous codes (e.g., duplicate codes, nonspecific codes), or adding more specific descriptive codes in order to more clearly represent emergent themes. These latter suggestions were then reviewed by the primary coder (TH) and agreed upon by consensus.

In order to better understand the emerging themes, we reported the frequency of themes mentioned by focus groups (e.g., 50% indicates that a theme was mentioned in four out of eight focus groups). This quantification schema was used to distill the large amount of information generated by the focus groups.

Results

Participant Demographics

Table 1 presents descriptive statistics of the study participants. There were a total of 64 participants, with a mean age of 66. Participants were predominantly African American (96.9%) and women (71.9%), with 66% reporting 13 or more years of education. Approximately half of participants had a yearly income of $30,000 or more (53.1%), with the remainder having an annual income below that level. The majority of participants had heard about clinical research (75%).

Table 1.

General Characteristics of Participants

Demographics (N = 64)	Descriptive statistics, number (%)
Age in years, mean (SD)	66.27 (11.06)
Gender
Female	46 (71.9)
Male	18 (28.1)
Race
African American	62 (96.9)
Caucasian	3 (3.1)
Income
<15,000	12 (18.8)
15,000–30,000	15 (23.4)
30,000–45,000	10 (15.6)
45,000–65,000	7 (10.9)
65,000 or more	17 (26.6)
Education (years)
Less than 12	7 (11.0)
12 (completed high school)	15 (23.4)
13 or more	42 (65.7)
Employment status
Retired	44 (68.8)
Full-time	11 (17.2)
Part-time	6 (9.4)

Responses to Questionnaire About Clinical Research

Table 2 presents responses to the portion of the questionnaire that examined perceptions regarding clinical research among the focus group participants. When participants were asked whether they believed that research was done for a good cause, 82.8% answered most or all of the time (89.2% of women and 66.7% of men). When asked whether they believed there was a danger that clinical research study findings could be misused, 9.4% answered never, whereas 68.8% answered sometimes. Analyses revealed that a higher percentage of women (76.1%) compared with men (50.0%) felt that findings from clinical research studies could sometimes be misused.

Table 2.

Participant Responses to Questionnaire About Clinical Research

Questionnaire items (N = 64)	Number (%)
1. Do you believe that clinical research is done for a good cause?
Never	1 (1.6)
Sometimes	4 (6.3)
Often	3 (4.7)
Most of the time	27 (42.2)
All of the time	26 (40.6)
2. Would you consider participating in a clinical research study?
Yes	41 (64.1)
No	8 (12.5)
Not sure, need more information	14 (21.9)
3. Would you consider participating in the following clinical studies? (% yes)
Memory study	57 (89.1)
Invasive study	49 (76.6)
Clinical drug trial	17 (26.6)
Brain donation study	28 (43.8)
Imaging study	47 (73.4)
4. Do you believe that there is a danger that findings from clinical research studies could be misused?
Never	6 (9.4)
Sometimes	44 (68.8)
Often	4 (6.3)
Most of the time	3 (4.7)
All the time	0 (0.0)
5. How likely is it that your family would allow you to participate in a clinical research study?
Never	3 (4.7)
Unlikely	6 (9.4)
Possibly	14 (21.9)
Likely	32 (50.0)

The majority of participants were willing to participate in cognitive studies (89.1% of the total sample, 95.7% of women, 72.2% of men), studies involving the collection of blood (76.6% of the total sample, 84.8% of women, 55.6% of men) and imaging studies (73.4% of the total sample, 76.1% of women, 66.7% of men). However, participants were less inclined to participate in blinded clinical drug trials; more specifically, participants were less likely to agree to engage in medical studies in which they did not know if they would be receiving an experimental treatment or a placebo (73.4% of the total sample said no), with women (80.4%) being more inclined to say no than men (55.6%). The majority of participants were also less inclined to participate in brain donation studies; of the 56.3% that said no, men (77.8%) were more resistant to participation than women (47.8%); 43.8% of the participants indicated a willingness to agree to brain donation. No significant differences were observed in the distribution of responses from one set of focus groups to another.

Emerging Themes From Focus Groups

The coded responses from the focus groups revealed several central themes related to attitudes toward clinical research studies. Themes expressed by at least 50% of focus groups are listed in Table 3, which includes 38 independent codes. The frequency of themes does not necessarily indicate the importance of one theme over another.

Table 3.

Frequency (%) of Emerging Themes From Focus Groups

Codes	All groups	Community members	Community leaders
Barriers
Fear of research or healthcare system	100	100	100
Historical occurrences and past unethical research practices (e.g., Tuskegee, Henrietta Lacks Hopkins initiatives)	100	100	100
Lack of information about research (e.g., about the research process, to make an informed decision, preconceived notions, etc.)	100	100	100
Distrust (general)	87.5	100	75
Unknown medication (drug vs. placebo), side effects, or study manipulations	87.5	100	75
Cultural beliefs influenced by community’s shared beliefs/opinions (e.g., religion)	75	50	100
Urban legends	75	100	50
Selectivity in participation—willingness to participate in some research studies but not others	62.5	75	50
Mistrust due to past negative experiences with research or healthcare	62.5	100	25
Unfamiliarity with presenter or research recruiter	62.5	25	100
Unwilling to take too many or any more tests/medications	50	50	50
Facilitators—intrinsic factors
Altruism—giving back and helping others (e.g., future generations)	100	100	100
Benefits of research (e.g., knowledge or resources gained)	100	100	100
Research needed/necessary/important	100	100	100
Past positive experience with research and/or healthcare	87.5	75	100
Personal experience with dementia (including Alzheimer’s disease) or cognitive change	75	75	75
Cultural beliefs influenced by community’s shared beliefs/opinions	62.5	25	100
Facilitators—external factors
Familiarity or comfort with the person discussing research	87.5	75	100
Compensation for participation	75	100	50
Physician suggests research participation	62.5	75	50
Recruitment recommendations
Convey how university research programs have benefited individuals, groups and the community	100	100	100
Need for presenter to tell a story about his/her experience with research (making it more personal)	100	100	100
Need to educate audience about what research is, opportunities for participation and different types of research studies	100	100	100
Individual (recruiter or organization) that audience can identify with, feels comfortable with or feels they can trust	87.5	75	100
Targeting younger generations to assist with recruitment	75	75	75
Address past negative events (e.g., past unethical practices, urban myths, etc.)	62.5	50	75
Compensation for participation	62.5	75	50
Differences in approach when introducing the idea of research (e.g., dependent on person, age, relationship, etc.)	50	0	100
Need for multiple recruitment approaches	50	50	50
Recommended recruitment mediums or venues
Clergy and churches	100	100
Radio	62.5	75	50
Social media	62.5	50	75
Television or film	62.5	75	50
Brochures, pamphlets and flyers	50	25	75
Fraternities and sororities	50	50	50
Newspapers or magazines	50	50	50
Organized meetings, conventions and seminars	50	25	75
Places where people congregate (e.g., to sit, talk, listen, wait)	50	25	75

Note: Frequency indicates the percentage of focus groups that mentioned the particular theme (e.g., 50% within all groups indicates that 4/8 focus groups mentioned the theme; 50% within community members or community leaders indicates that 2/4 focus groups mentioned the theme).

Overall frequencies of the codes are shown, as well as the frequencies for the two participant subgroups mentioned earlier: (a) community members and (b) community leaders. These central themes are discussed subsequently in three broad categories, along with quotes that are representative of the codes reported. The three categories include: (a) perceived barriers to research participation, (b) potential facilitators for research participation, and (c) recommendations for recruitment efforts to increase minority enrollment in clinical research studies (including recommended mediums and venues for dissemination). Additionally, for the facilitators of research participation, we included two subcategories, related to intrinsic and extrinsic motivation factors, guided by the theory of cognitive evaluation (Ryan & Deci, 2000).

Barriers to Participation

Participants described many reasons why they, or others they knew, might be hesitant to participate in clinical research studies. The most frequently expressed included: (a) a lack of information about research, (b) fear of research or the health care system, (c) mistrust resulting from historical occurrences involving unethical practices toward minorities, (d) a general distrust of research and health care, and (e) discomfort with unknown study procedures, such as unknown medications or side effects.

Lack of Information Regarding Research

Participants identified knowledge gaps in a number of areas, including a lack of understanding about the research process, research methods, and types of clinical research; lack of information to make an informed decision; and preconceived notions about research.

You know there is a lack of awareness or lack of information or lack of education, so they don’t know the questions to ask because the only thing that they know is what they’ve heard.

And I think there’s this….lack of understanding about what’s going on and a lot of people have preconceived notions about what clinical trials are about or what happens as a result of clinical trials….and I think we have to go back and do a lot of education.

Fear of Research

Participants stated that there was fear of the unknown and, related to this lack of knowledge, was the fear of being used as “guinea pigs”.

But I think that most times, people are frightened; they’re worried about what’s going to happen to them.

You know black folks have a fear of being you know used again…as a guinea pig or experimented on.

Historical Occurrences of Past Unethical Research Practices and Urban Legends

Participants expressed a fear of research practices and potential inhumane experimentation, primarily based on past historical occurrences involving poor and vulnerable populations and ‘urban legends’ (e.g., stories passed down through generations as truth, often with ambiguous origins and little evidence, if any, to support their validity) in the minority community. Collective beliefs and disparities regarding past medical treatment appear to have been passed down from generation to generation and to perpetuate deeply rooted feelings of mistrust towards formal health care institutions and research.

You know they avoid it at all costs… I think it’s anything when you get unfortunately a lot of people in the room who have a white coat and they’ve had that stigma and they think about Tuskegee, they think about Henrietta Lacks, they think about any type of research that’s been done on an African American and has not gone well.

I think one reason is if you’ve been around as long as I have. You have been aware of some of the studies and some of the studies and some of the programs that they’ve had that was not done properly and that…Tuskegee…I’m from Alabama. And I was at Tuskegee at the time that this study was going on; I knew some of the physicians and nurses but I had no idea. That it was being done the way that it was done….So naturally, later when you find this out, you’re a little scared of maybe getting into something that you’re going to be hurt rather than healed from.

Community members mentioned some specific barriers more than community leaders, including individual experiential factors, such as distrust of research and health care, urban legends, and mistrust due to past negative experiences with research or health care. Conversely, community leaders placed more emphasis on barriers related to personal familiarity with research, including cultural and shared beliefs about research and knowledge of the person presenting the research program.

Facilitators of Research

Potential facilitators for research participation were broadly classified as intrinsic and external factors, as shown in Table 3. Participants described a number of potential intrinsic facilitators for research participation by minorities, including: (a) the importance of understanding of the potential benefits of research, (b) giving back to the community & helping others, and (c) feeling that research is needed and important. Extrinsic facilitators included: (a) knowledge of past positive experiences with research and (b) familiarity with the presenter and research recruiter.

Potential Benefits of Research (Intrinsic)

Participants expressed a number of potential benefits to research, including both general benefits and also personal access to knowledge or resources.

And they were doing a research study on it so it was a perfect opportunity to find out more about it, get the literature and… Some little guidelines.

Well I participated in a diabetic study….And it was helpful because I am a diabetic. And it was surprising to learn some of the things that I needed to know you know….We preachers, you know we love fried food and all that and our members are blessing us and killing us. But it helped me to understand better what to do and how to handle the situation.

Giving Back and Helping Others (Intrinsic)

Altruism was also a prominent facilitator to research participation, and many participants indicated personal experience with dementia or AD.

You know it was a family decision for us and it was because of how devastating Alzheimer’s disease is… And we made a conscious decision that we wanted to donate her brain…if that would help find a cure.

So we need to really look at research as being a way of finding out how we can help our future because the future is our children and if they have those diseases, what are we going to do.

Research is Needed and Important (Intrinsic)

Participants described the importance of research, emphasizing a feeling that research was necessary because it helps others, in finding a cure, and in gaining an understanding of diseases.

Well I think it is necessary for certain things… When you’re studying about different illnesses… What really caused them and what can we do to help us get, to get from one step to the next step… I think a lot of time, but we, so that’s the only way you’re going to find out a lot of time what’s, what’s going on.

Yes, well I have the same feeling about the research. I think it has helped; that it’s necessary.

Community members placed a greater emphasis than community leaders on compensation. In contrast, community leaders placed a greater emphasis on personal familiarity with research and the individual presenting the research, in addition to the influence of cultural beliefs. Of note, the most common facilitators described by both groups were intrinsic, suggesting that internally motivating factors, as suggested by the theory of cognitive evaluation (Ryan & Deci, 2000), play a strong role in decisions to participate in clinical research.

Recommendations for Recruitment Strategies

Participants recommended a number of recruitment strategies that might increase involvement in research by minorities, including: (a) the need to educate community members about the various aspects of research, (b) the importance of conveying how research programs have benefited individuals, groups and communities, (c) the importance of providing personal stories that enable community members to understand the potential benefits of research, and (d) having research discussed by an individual that the audience can identify with or trust. The latter point, as well as the suggestion to use varying approaches when introducing research (e.g., based on an individual’s age, relationship with presenter, etc.), were particularly emphasized by community leaders.

Need to Educate People About What Research is and Opportunities for Participation

Building on the lack of education as a barrier to participation, participants emphasized the importance of educating potential research participants on various aspects of research, including different types of clinical and behavioral research studies (e.g., memory studies, imaging studies, clinical drug trials, brain donation programs), research benefits, what research studies involve, opportunities for participation, as well as information about research safe guards and protections that ensure studies are conducted in a manner that is ethical and maintains subjects’ rights and wellbeing.

You gotta use all the words; clinical research trials occupational whatever; in the title at least give it to them face front and say, this is what it is and explain to them what that means, what that means they’re going to do.

There was a workshop on dementia and it was given by a family that I know about and they had it… every year and this gentleman got up and said that he suggested everybody get involved in these studies… And he was naming all the things that he had done and how it helped, improved his health as well as you were getting compensation for your time.

Need to Convey Individual, Group and Community Benefits of Research

Participants emphasized the importance of conveying the benefits of research in order to promote an understanding of research importance to the individual and community.

Once you get to really realize what you’re adding to the pieces of helping somebody else, not just you or somebody in your family…you gotta use the family members; it’s something personal. Because if it ain’t personal, it don’t mean nothing to me.

And with the statistics and everything and maybe a film or something you know… You gotta show them… So we know what they don’t like about it… But you can also show them; well this is what we are doing for you… The benefits of research. We have done this.

Need for Presenter to Tell Story About His/Her Experience With Research

Focus group participants felt it important for individuals to hear stories about successful experiences with research participation, making the request for participation more personal. Participants suggested these stories should describe topics such as: why the individual chose to get involved, what specific procedures were included in the research study, and the importance of the research study in which the individual participated.

And I would participate quicker by her being involved in it than somebody else who wasn’t just giving me the literature and saying, you know you should because you’re aging or your family history or anything like that… I need somebody who’s been in there, their feet have gotten wet, they’ve gone through it and they’ve come out on the other end.

So to kind of get up and tell their story; it might, that might go a longer way than if I just got up there as a researcher you know and said that you know this is the benefits and this is why it’s needed and this is what we’re doing so…

The focus group participants also suggested a number of venues and mediums they felt would be most productive in educating minority community members about research. The most commonly mentioned venues included: (a) church-sponsored events, (b) radio, (c) social media, and (d) television or film. Additional venues recommended by focus group participants are listed in Table 3.

Discussion

In this study, we used focus groups to explore barriers and facilitators to participation in clinical research among African Americans by engaging both community members and community leaders; this latter group included clergy, church leaders and community health care and service providers (i.e., individuals who community members may rely on to make decisions about research participation). In addition to gaining insight into factors that dissuade and encourage research participation, we included explicit questions about strategies that might facilitate recruitment into research.

Similar to findings from other studies (George et al., 2014), barriers to research included the influence of past historical occurrences in which African Americans were subjected to unethical medical practices, which has perpetuated a far reaching mistrust among community members toward research and limits study participation. Relative to community leaders, community members were more likely to emphasize the multifaceted nature of their mistrust, such as past negative experiences with research or health care providers and urban legends. Although the questionnaire data indicated that the vast majority of participants felt research was generally done for a good cause, barriers related to mistrust and misuse of findings were reported consistently in both the questionnaire results and focus groups.

Both the quantitative and qualitative data in the study also highlighted the specific types of studies involved as directly relevant to the decision to participate. This selectivity in participation was reflected by the fact that participants indicated a willingness to participate in some research studies but not others. The majority of participants stated they were willing to participate in noninvasive memory and imaging studies, and slightly invasive studies that required blood draws; however, they were less willing to consider clinical drug trials or brain donation programs. Focus group discussions indicated that drug trials presented a particular barrier to participation, due to the possibility of the subject receiving an “unknown drug” (e.g., the experimental treatment or the placebo), as well as the fear of side effects. Participants additionally indicated a general unwillingness to take too many medications. The finding with regard to a differential willingness to participate in research, depending on the type of study, emphasized that despite consistent barriers to research participation, minority individuals are willing to participate in certain studies, particularly when those are clearly explained.

Community members and community leaders indicated multiple factors that may facilitate participation, which can be broadly classified as intrinsic and external factors. Intrinsic factors included altruism, belief in the potential benefits and general importance of research, past positive involvement with research, and personal experiences that encouraged research engagement (e.g., a loved one diagnosed with AD). External facilitators included familiarity with the person discussing research, considerate research staff who acknowledged their participation, and compensation (e.g., monetary compensation, gift cards). Interestingly, community members tended to more strongly emphasize the importance of compensation, whereas community leaders emphasized the influence of shared cultural beliefs within the community (e.g., beliefs about the importance of helping others). This distinction that may stem from differences in perspective (i.e., potential research participant vs. the role of the individual as a leader in the community. Regardless, these findings suggest that recruitment efforts should include both intrinsic and extrinsic factors that appeal to targeted segments of the community in order to successfully recruit study participants.

A limited number of prior studies have detailed potential recruitment solutions to overcome barriers to minority recruitment into clinical research studies related to aging and dementia. These have included: hiring African American staff, including community leaders in recruitment, and providing compensation (Branson, Davis, & Butler, 2007; George et al., 2014; Hatchett, Duran, & CuJuan, 2000). Our study sought to explicitly ascertain recommendations from community members and community leaders regarding how researchers could overcome some of these barriers in order to increase African American participation in clinical research programs.

Recruitment recommendations tended to be closely related to the most significant barriers to participation. For example, (a) all focus group participants emphasized that recruiters should tell their story about their experience with the research process. Consistent with this point, participants also stressed the need for community members to identify with the individual(s) responsible for educating or recruiting for research studies. For example, they conveyed the importance of having someone that they could relate to, who could convey their personal experiences with the research process, answer their questions and/or alleviate their concerns. They suggested that this approach would be more compelling than abstract presentations of a research protocol and help to dispel prevailing myths.

Focus group participants also underscored the importance of (b) study recruitment methods clearly emphasizing how past programs at the institution conducting the research have benefited the community, explicitly addressing feelings of fear and mistrust by discussing past unethical practices and including a detailed explanation of research safeguards. Participants suggested that proactively addressing this issue may improve recruitment, because both true aspects of the history of medical mistreatment and “urban legends” are passed down from generation to generation in the African American community.

With respect to the general lack of information about clinical research in the community, focus group participants recommended (c) a need to educate audiences about the differing types of clinical research (e.g., memory studies, imaging studies, clinical drug trials, and brain donation programs) and the variety of opportunities for participation. Variability in willingness to participate by type of clinical study indicated that a clear and thorough presentation about the specific types of research being proposed, and what participants would be asked to do, may result in more successful recruitment. Other recommendations included (d) the importance of compensation (e.g., honoraria, gift cards), which was particularly emphasized by community members as a facilitator of research participation, as a confirmation that researchers recognized the value of the participants and the value of their time, consistent with prior studies (Hatchett et al., 2000).

Participants suggested (e) targeting younger generations as a potential recruitment strategy, given that these are individuals to whom older individuals may listen. Respondents felt that aiming recruitment efforts at the entire family (a “family approach”), instead of primarily targeting the older adult or primary caregiver, would aid in overcoming community resistance and fear towards research participation. This would include, for example, a need to educate younger generations about both memory loss and aging and the importance of AD research. Participants felt that younger generations could influence the perspectives about research held by older adults and their willingness to participate in studies. Relative to community members, community leaders more strongly indicated the importance of using different approaches when introducing the idea of research based on various audience characteristics (e.g., one’s relationship with potential participants; age; and the person being addressed). Additionally, respondents felt that (f) creative approaches incorporating the use of social media (e.g., Facebook and Twitter) and internet websites could be used to effectively increase awareness about dementia, dispel the stigma associated with AD and highlight the positive aspects of research. The varied recruitment recommendations provided in the present study are in line with a recent suggestion that multiple recruitment strategies should be implemented for recruiting older adults into clinical trials (McHenry et al., 2012). Taken together, these results have implications for national efforts to increase the participation of older adults and under-represented populations in research studies, including the National Institute on Aging’s “Recruiting Older Adults into Research” (ROAR) project (http://www.nia.nih.gov/health/publication/roar-toolkit).

This study included some limitations that serve as important directions for future research. By studying these issues through focus groups, we were unable to include the perspectives of those individuals with a strong aversion to all research studies. These individuals, if included, could shed more light on barriers to research participation. Additionally, the questionnaire was completed immediately before the focus groups were conducted, and it is possible that this may have biased the comments of some participants during the focus group. Moreover, questionnaire data was collected anonymously, in an effort to encourage participants to answer questions that may have been sensitive in nature (e.g., income). This prevented comparisons of subgroups of participants, based on their response to the questionnaire. For example, future research could compare groups of individuals based on age, education, income, or degree of expressed skepticism about research, based on a questionnaire. Moreover, this report does not include a comparison of individuals who had versus those who had not participated in clinical research studies, because only two of the focus groups were selected on the basis of prior research participation, reducing the power to conduct such an analysis.

The strengths of this study are that focus groups specifically involved both community members and community leaders in order to gain a broader perspective on barriers and facilitators to clinical research participation. Thus, they included both the viewpoints of potential research participants as well as the community leaders who may influence their decisions. The study also directly engaged participants in the process of suggesting strategies that might improve recruitment of African American participants. The overarching conclusions from this study are: (a) although significant barriers exist for African Americans when considering whether to participate in research, there are many specific recruitment approaches that can be used to overcome feelings of fear, mistrust, and a lack of information and, (b) there is a willingness among many African Americans to participate in research, given the right approach and information to overcome knowledge deficits and long-standing fears.

Supplementary Material

Supplementary material can be found at: http://gerontologist.oxfordjournals.org.

Funding

This work was supported in part by grants from the National Institute on Aging (P50 AG005146 and T32 AG027668).