Attitudes and Beliefs of African Americans Toward Participation in Medical Research

Recruiting subjects for participation in medical research has proved to be a challenging task. The problem of recruitment is magnified when considering minorities, particularly African Americans. Recent studies highlight lack of participation in clinical trials among African Americans. ^1-4 Such lack of participation raises concerns about how well findings from clinical trials can be generalized, as well as how beneficial they can be to African Americans. ^5–7 Attempts at increasing participation in clinical studies have been hampered by a paucity of scientific data to guide researchers in design, implementation, and evaluation of recruitment and retention strategies. Patients' attitudes toward research and the researcher, and beliefs about the benefits and risks of involvement in research remain critical factors to be investigated.

Few studies have examined the attitudes of African-American patients regarding perceived barriers to research participation. The available research underscores the importance of patients' attitudes ^8–10 and their perception of research ¹¹ in determining participation in clinical trials. However, these studies have been limited by small sample sizes or interviewing only oncology patients.

We undertook this qualitative study as a first step in exploring the reasons for low participation in clinical trials among African Americans. Our primary aims were to identify and contexualize barriers and facilitators to participation in research. We also examined participants' attitudes and beliefs about the informed consent process, specific knowledge about the Tuskegee Syphilis Study and other real or perceived examples of medical abuse, and the perceived benefits and risks of participation in medical research. Finally, we sought recommendations for improving recruitment of African Americans into clinical trials.

Sixty-three patients completed the screening instrument and 55 were invited for interviews (8 patients were excluded because they met at least one of the following exclusion criteria: not fluent in English, not African American, prisoner, or intoxicated at time of screening). Thirty-three patients participated in the focus groups. Seventy percent of the participants were women. The participants ranged in age from 20 to 78 years. Specific group and participant information is provided in Table 2. The most common reasons given for not being able to participate were schedule conflicts and illness from chemotherapy. We did not find any substantive difference in the comments of oncology patients versus general medicine patients.

Six participants responded “yes” to the question, “Have you ever participated in medical research?” Examples of the previous research included drug studies (nonsteroidal anti-inflammatory drugs, drug therapy for asthma and diabetes, and antidepressant therapy), an oncology clinical trial, and testing a home blood pressure monitor. Two participants stated they were asked to participate in a clinical research study but refused.

Participants expressed a mixed set of positive and negative responses to the question, “What comes to mind when you hear the term medical research?”(Table 3). Although there were more negative terms than positive terms, older participants described the balance of benefits and risks associated with medical research more than younger adults, who primarily perceived risk.

Historically, nonparticipation of African Americans in research has been linked to the history of racism in medical research. ^4,17–22 The most powerful example of this is the Tuskegee Syphilis Study. “For many blacks, the Tuskegee study became a symbol of their mistreatment by the medical establishment, a metaphor for deceit, conspiracy, malpractice, and neglect, if not outright racial genocide.”²³ In the wake of the Nazi experiments and later the Tuskegee Syphilis Study, biomedical research emphasized the protection of the individual patient. ¹ This concern for the protection of human subjects was formally codified in the Nuremberg Code in 1949, ²⁴ which was the beginning of a cascade of regulations emphasizing the protection of human subjects. Some of the most prominent events include the following: The Declaration of Helsinki in 1964, ²⁵ the establishment and strengthening of the institutional review board, exclusion of women of childbearing potential from early phases of drug trials, ²⁶ and the publication of the Belmont Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. ²⁷ As a consequence of many of these regulations designed to protect vulnerable populations from potential abuse, minorities were sometimes seen as a vulnerable population and excluded from participating in clinical trials.

More recently, however, the scientific community began questioning exclusion of certain groups. First, the bioethical principle of justice requires that the burdens and benefits associated with participating in research be distributed within a society. In addition, generalizing and applying research findings from a homogeneous study sample to racially and ethnically diverse populations may not be appropriate. These and other concerns led to the creation of the National Institutes of Health (NIH) Office of Research on Women's Health in 1990 ²⁸ and culminated in the passage of the NIH Revitalization Act by Congress in 1993. ²⁹

The NIH Revitalization Act of 1993, which mandates inclusion of women and minorities as subjects in clinical research, makes it incumbent on investigators to understand and respond to the attitudes and beliefs of potential research participants. Results from this study identify important issues to consider before attempting to recruit African Americans into research studies. While previous studies addressing the concerns of minority populations involved participants from cancer trials ^8,11 and cancer prevention studies, ^9,30 this study also sampled patients presenting for health care not usually associated with research. These participants' comments echo the lack of trust in the medical community ⁹ and concerns about ethical misconduct ^11,30 found in previous studies.

Concerns about participating in research dominated discussions. Participants believed medical research was most beneficial to investigators and gave clear examples of how they might personally suffer from involvement in clinical research. They also expressed concern that African Americans would be least likely to benefit from research findings because of racism or inability to pay for services. In addition, the analogy of being used as a guinea pig was extended not only to research participation but also to medical care at teaching hospitals. Because academic medical centers are often an important location for recruiting study participants, the guinea pig analogy must be taken seriously and addressed by members of the research team.

Since the Tuskegee Syphilis Study is seen as a metaphor for research subject abuses, we felt it important to explore the perception in this community. Other authors have described knowledge of the Tuskegee Syphilis Study to be an important deterrent to participation in health promotion and research. ^18,31–36 In this study, the majority of participants were misinformed about many of the historical facts of the Tuskegee Syphilis Study. When the moderator presented facts about the study, participants challenged her, exhibiting a global suspicion of information from any source they could not personally check for authenticity. We suggest that historical accuracy may be less salient than strength of belief. And as indicated in the discussions about what really happened at Tuskegee, it is clear that any attempt to simply present “the facts” as though unquestionable and self-evident may be challenged. It is important to note that all focus group interviews were completed before national media attention focused on the February release of the Home Box Office special “Miss Evers' Boys” and the Presidential apology for the Tuskegee Syphilis Study on May 16, 1997. Current interviews may reveal a higher level of awareness of the Tuskegee Syphilis Study, but misinformation may persist.

Of note, the participants in this study didn't limit their justification of mistrust to the Tuskegee Syphilis Study. In their opinion, “creation” of HIV and military experiments with Agent Orange were among the more recent examples of experimentation. Regardless of whether the instances participants provided as explanations are historically accurate, every instance is perceived as “real” in their minds. The fact that participants drew on historical evidence of exploitation of African Americans in medical research to validate their fear of ethical misconduct is important regardless of historical accuracy. In fact, as Dula ³⁷ and Gamble ^17,38 suggest, mistrust of the medical community can be justified by a long history of exploitation in the name of research that dates back to slavery and continues to the present day. From experimentation during slavery to public health efforts gone awry in sickle cell screening and involuntary sterilization, the authors argue that conspiracy theories cannot be simply written off as paranoia or hypersensitivity.

One of the most significant findings of this study was the interpretation of the consent process. Participants in the study described the consent document as legal protection for researchers and funding institutions rather than describing its use as a method of increasing their understanding during the consent process. As these participants so eloquently point out, achieving a balance between the legal rationale and moral justification of informed consent may not be recognized as a goal by the patient or physician. More often, physicians consider the informed consent process as a legal requirement, rather than an opportunity for facilitating patient autonomy, ^39,40 and view the consent process as having a negative impact on patient care. ⁴¹ The extent to which attitudes of potential participants in research have been shaped by the attitudes of physician-researchers clearly requires further investigation.

Making sure that participants entering a clinical trial are fully informed before they agree to participate in clinical research has been and continues to be a tremendous challenge. The difficulty of informed consent is magnified when cultural differences exist between the study team and the participant. ⁴² The method currently used to inform the patient may be a major hindrance to obtaining fully informed consent. ^43,44 In patients from varying ethnic backgrounds, with different levels of English fluency or limited formal education, written documents often outstrip their comprehension of the intended content. ⁴⁵ In addition to literacy, cultural and linguistic barriers may complicate comprehension of written materials. ⁴⁶ Novel methods of transmitting information such as an instructional video alone, or in combination with the written form, have been shown to be preferred by patients, ⁴⁷ and may increase understanding of the information to be delivered. ⁴⁸ The results of this study support the available literature on patient preferences in the use of other media instead of or in addition to standard written consent. ^49–51 However, more systematic research is needed to address the problems of obtaining consent in populations of varied socioeconomic status and cultural backgrounds.

Most recently, the question has been raised of waiving consent for some areas of clinical investigation. ^52–54 We advocate extreme caution in populations such as the African-American community that are particularly sensitive to the implications of being involved in research without their consent. Although the authors advocating these changes in informed consent have described explicit and ethically sound guidelines for waiver of informed consent for specific protocols, we would strongly suggest that institutional review boards reviewing these protocols not only take into consideration the scientific integrity of the proposed research but also put particular emphasis on the history of medical experimentation of the intended research subjects.

Despite the general negative attitude toward participation in medical research, participants did identify benefits of research. All participants expressed a greater willingness to volunteer for research if there were clear benefits to themselves or their families. Although all participants could discuss the theoretical benefits of medical research, they were less likely to perceive a direct link between these benefits and their own lives. Other investigators have shown that participants expect to obtain personal benefit while contributing knowledge to medical science for the good of society. ^8,55,56 In other studies of perceived benefits of trial participation, medical monitoring and treatment, ^57–61 altruism, ^59,60 and financial compensation ^59,62 were described by participants as important. In the few studies that have looked at reasons for nonparticipation, however, patients described treatment-related concerns. ⁶³ Unfortunately, few of these studies reported the race of the respondents, and none stratified responses according to race or ethnicity.

Participants also provided a wide range of strategies for improving recruitment of African Americans into clinical studies. Many participants tended to filter all information through their personal networks and to engage in a communal process of decision making. This appears to apply not only to possible research participation but also to medical treatment options and recommendations. The majority of participants requested broader education about the importance of and opportunities for participation in medical research. The suggestion to increase awareness of research may be taken as a call for a more open and frank dialogue about medical research with the African-American community. Addressing the myths and acknowledging the abuses surrounding medical research held by many in the African-American community could create an opportunity for dialogue to heal the breached trust represented by Tuskegee but personalized by these participants in other events.

The issue of trust was a recurrent theme throughout the entire discussion of participation in research. Although participants expressed concerns about the ethical conduct of researchers in general, they also noted that a trusting relationship was important for them to feel comfortable as participants in clinical studies. Other authors have suggested that trust developed between a primary care provider and a patient is the only way fear of exploitation in research can be overcome ⁶⁴ and that lack of trust in the researcher is the primary barrier to African-American participation in clinical trials. ³⁰ The possibility remains, however, that interpersonal trust, when it exists, may override a truly informed and carefully deliberate decision. More research is needed to examine the duality of trust within the doctor-patient relationship and its impact on medical decision making, with emphasis on the influence of managed care on the time needed to establish and maintain interpersonal trust within the physician-patient relationship. As fewer patients are able to use their social network to choose a provider, and as time constraints increasingly limit the clinical interaction, a trusting relationship may take longer to develop if it develops at all. In fact, other authors have documented that physicians practicing in a managed care environment were concerned about their ability to respect patient autonomy. ⁶⁵ The implications for clinical decision making and enrollment into clinical trials have yet to be delineated.

As in all studies, there are limitations. First, although the focus group interview is an important tool to explore participants' experiences, attitudes, and beliefs, this qualitative research methodology is used primarily to generate, rather than test, hypotheses. The results presented here should be validated through quantitative research. Cross-sectional studies of a nationally representative sample would help describe the impact of socioeconomic status and other demographic variables on willingness to participate in research. Second, participants were interviewed at only one site with a fairly homogeneous socioeconomic profile. The attitudes and beliefs expressed in this cohort may not be representative of African Americans in other geographic areas or from other socioeconomic strata. In particular, Atlanta, Ga, may represent a special geographic area in its proximity to Tuskegee, Ala, location of the Centers for Disease Control and Prevention, the last administrative home of the Tuskegee Syphilis Study, and staged productions of “Miss Evers' Boys” in the early 1990s. For these and other reasons, participants in this geographic region may be more acutely aware of the Tuskegee Syphilis Study. In addition, caution should be exercised in extending these results to other racial and ethnic minorities. Interviews with other populations would be important to describe the extent that these opinions are held by other sociodemographic groups.

Despite these limitations, this qualitative study gives voice to African-American mistrust of the medical community in general and medical research in particular. The absence of trust has emerged as a stumbling block in efforts to include African Americans in clinical research. Although the Tuskegee Syphilis Study has come to symbolize exploitation of minorities, participants also believed HIV infection, Agent Orange exposure, and Central Intelligence Agency distribution of crack cocaine in black communities were contemporary evidence that the legacy of abuse continues in this population.

In addition, the informed consent process seems to hinge on the presence or absence of interpersonal trust, rather than the intended careful deliberation of benefits and risks. Further research is necessary to understand the factors that contribute to the development of interpersonal trust between investigator and participants and the impact of trust on decision making around research participation.

Recently, the AIDS epidemic and clinical trial participation have created a new dilemma in research participation. African Americans are disproportionately affected by HIV/AIDS, yet they continue to be underrepresented in clinical trials. ^35,64,66,67 This may be partly due to distrust of the medical establishment among African Americans. ^18,35,68 Conversely, the AIDS epidemic has also changed people's perceptions of biomedical research such that certain populations are demanding access to clinical trials and experimental drugs rather than protection. ⁶⁹ AIDS research may involve a unique subgroup of clinical trials. The range of attitudes and beliefs of participants in AIDS research and how they may differ from participants in other clinical trials deserves further inquiry.

Investigators would do well to solicit and incorporate the suggestions of African-American community members and potential participants in designing research protocols and recruitment strategies. The model of community consent and a collaborative relationship with the population under investigation is not new, and its use has been described in the United States ^70–73 as well as international communities. ⁷⁴ However, finding ways to effectively implement community consent, as a complement to individual consent, may be particularly important in African-American and other ethnic minority populations in which the collective community can be valued as highly as the individual. Not only might this inclusive approach lead to fewer failed efforts, it could help forge strong community partnerships thereby transcending the devastating effects of societal mistrust. Finally, in our opinion, the Presidential apology on May 16, 1997, for the Tuskegee Syphilis Study may represent the greatest opportunity for a new era of respect, partnership, and trust between African Americans and the biomedical research community.

The authors thank Anna Dixon, Michele Revels, and Eric Zook, PhD, of Macro International for their expertise in organizing and executing the focus group interviews. They also thank Dr. William T. Branch for his unwavering support and encouragement throughout this project. This research was supported by an intramural grant from The Emory Medical Care Foundation.