Perceptions of Risk in Research Participation Among Underserved Minority Drug Users

Abstract

Research with underserved minority drug users is essential to quality health care and prevention. Understanding how participants perceive risk in research is necessary to inform research regulators so that research protections are neither lax, exposing participants to harm, nor overly stringent, thereby denying access to beneficial research. Data from 37 semistructured interviews of underserved, African-American crack cocaine users, collected from February to May 2006 in a large, urban setting, were analyzed using content analysis. In three hypothetical studies, participants recognized risks as relative and articulated and evaluated specific risks. Research regulators may enhance the accuracy of risk assessment in research by incorporating the views of participants. Study implications and limitations are noted. Future research on risk perception in research participation is suggested.Keywords risk perception; drug use; HIV/AIDS; research ethics; underserved minorities; research participation; research risk Access to preventive health measures and treatment is essential for drug users with or who are at risk for HIV/AIDS. But simply ensuring access is not enough: Prevention and treatment must be high quality, based on rigorous research evidence. Weighing the risks and benefits of research participation is standard practice in all research, but especially so in research with "vulnerable" participants such as drug users and minority populations. Understanding how participants perceive risk in research is necessary to inform research regulators so that research protections are neither lax, exposing participants to harm, nor overly stringent, thereby denying access to beneficial research (Mastroianni and Kahn, 2001). Although all health research conducted in the United States is assessed for proportional risks and benefits by Institutional Review Boards (IRBs), little is known about whether and/or how underserved minority drug users at risk for HIV perceive risks associated with research participation. The question of risk in research is important because minority populations are underrepresented in research and may have difficulty gaining access to experimental treatments for HIV infection (Gifford et al., 2002). If IRBs and other research regulators require protections based on an assumption of risk disproportional to the actual situation, they may inadvertently work to deny underserved minorities the benefits of access to HIV and substance abuse research.The use of illicit drugs exposes users to a variety of risks related to harm. How such risks are recognized and defined is pertinent to individual, research, and policy efforts to decrease risk. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptEpidemiologists view risk as an objective and quantifiable phenomenon. On the other hand, social scientists have argued that risk cannot be measured as an absolute value. Rather, perceptions of risk are formulated through social processes in which individuals and communities engage. The defin...

Addiction Research Ethics and the Belmont Principles: Do Drug Users Have a Different Moral Voice?

“…Compulsive thoughts and impulsive behaviors associated with addiction have often led to more general claims of drug users’ compromised autonomy. While decisional capacity may be impaired during periods of intoxication or cravings, the emphasis on moral agency and personal responsibility expressed by some of our respondents adds to a growing body of ethics scholarship calling for appreciation and cultivation of autonomy in illicit drug using and other vulnerable research populations (Buchanan, 2008; Foddy & Savulescu, 2006; Slomka et al, 2008). …”

“…However, as drug use investigators have long noted, such research efforts are stymied by how difficult it is to recruit these “hidden populations” (Ompad et al, 2008; Scott, 2008; Vernon, 2007; Watters & Biernacki, 1989). There is a growing consensus that breaking down recruitment barriers requires an understanding of local beliefs about research practices within the context of community norms (Fisher, 2004; Fry, Madden, Brogan, & Loff, 2006; Grady et al, 2006; Oransky et al, 2009; Plumridge & Chetwynd, 1998; Rhodes et al, 2008; Slomka et al, 2008; Velleman et al,1993). This preliminary investigation adds to the growing literature by highlighting the moral lens through which street drug users view ethical dilemmas encountered by addiction researchers and illuminates new areas meriting investigation.…”

“…The few studies available focus on general levels of sociomoral reasoning, community attitudes toward the morality of drug use, the ethics of clinical research, and perceptions of research risk interpreted through the lens of traditional moral development theory or regulations for the protection of human participants (Grady et al, 2006; Rhodes, Zikic, Prodanovic, Kuneski, & Bernays, 2008; Slomka, McCurdy, Ratliff, Timpson, & Williams, 2008; Stevenson, Hall, & Innes, 2004). Applying traditional frameworks to the design of research ethics practices involving drug users and others who may deviate from traditional social norms may be inadequate when they do not reflect the practical ethical challenges confronted by drug use investigators nor inquiry into how these populations view and manage their moral worlds (Klockars and O’Connor, 1979).…”

“…Consequently, research ethics discourse informed by participants’ moral perspectives confers contextual legitimacy to ethics-in-science decisions and gives participants the respect due all persons as moral agents in their own right (Dickert & Sugarman, 2005; Fisher, 1999). Failure to understand the moral principles and values applied by participants can result in an overestimation or underestimation of participant risk and personal agency leading to an overexposure to research harms or overprotective limitations on access to beneficial research (Mastroianni & Kahn, 2001; Slomka et al, 2008). …”

Factors Associated with Past Research Participation Among Low-Income Persons Living with HIV

“…[18][19][20][21] Few investigators have considered the role of study type in examining participation in HIV-related research. Our earlier qualitative research showed that individuals with or at risk for HIV perceived risks and benefits of hypothetical survey, medical, and vaccine studies differently, 22 suggesting that perception of risk-benefit ratio based on type of study could also be a factor in deciding whether to participate in research.…”