Contributor(s): Celia B. Fisher, Alexa McKnight
Approximately 28.6 million Americans are current users of illicit drugs, which corresponds to about 1 in 10 Americans overall, with 20.1 million indicating substance abuse dependency (National Survey on Drug Use and Health, 2016). Illicit drug use is characterized by a shifting pattern of cocaine, heroin, morphine, marijuana, methamphetamine, ecstasy, hallucinogens, and prescription pain relievers, tranquilizers, stimulants, or sedatives (National Survey on Drug Use and Health, 2016). The economic burden of substance abuse addiction, the cost of illicit drug use to the U.S. economy is estimated to exceed $1 trillion, taking into account costs associated with criminal justice, social welfare, reduced job productivity or lost earnings, increased health care costs, and the cost of treatment and prevention (National Drug Threat Assessment, 2011., National Institute on Drug Abuse, 2017.)
The intertwining effects of drug abuse and HIV/AIDS presents a significant and ongoing public health burden in our nation, especially in racial and ethnic minority communities, where the poorest and most vulnerable disproportionately suffer social, economic, and health impairments associated with drug abuse (Fisher, 2004). Although PrEP is effective in preventing HIV, adherence is difficult for people who use drugs. This means that the best approach for preventing new infections among these persons and within their communities is the use of comprehensive prevention strategies aimed at drug use and associated behaviors, as injection drug use is one of the main causes of HIV transmission in the U.S. (Abadie, Brown & Fisher, 2018).
However, due to dynamic shifts in drug use patterns, criminalization of drug use, the evolving nature of the HIV pandemic and other HIV risk behaviors, comorbidity, the multiple factors and pathways underlying addiction and treatment resistance, and the chronic relapsing nature of the disorder, few empirically validated treatments have been shown to be broadly effective (Fisher, 2004). The specific vulnerabilities experienced by people who use drugs are shaped by complex, interacting factors that range from comorbid physical and behavioral health conditions to psychosocial and environmental influences. The epidemic nature and lack of empirically validated treatments for drug abuse and related HIV behaviors underscores the critical need to understand the interactions among these factors and how they contribute to the risk for addiction and other related consequences of drug use, and to develop interventions that meet the diverse needs associated with this variability (Fisher, 2004). To this end, community-based studies are seeking to understand the relationship between substance use and HIV risk in socially marginalized and economically disenfranchised populations. This often requires recruitment within public settings and offering of monetary payments for research participation. Both of these intrinsic factors raise ethical issues for the responsible conduct of research.
The principles of beneficence, respect, and justice which form the foundational basis of federal regulations for the protection of research participants (Code of Federal Regulations 46, subpart A) (Department of Health and Human Services [DHHS], 2001) require that investigators maximize research benefits and minimize harms; ensure that consent is informed, rational, and voluntary; and ensure that research benefits and burdens are fairly and equally distributed. However, current federal provisions for the protection of vulnerable populations such as prisoners and children, do not include special protections for individuals with substance use disorder or illegal and health compromising behaviors linked to their drug use (Fisher, 2004). Therefore, special care needs to be taken to account for the factors associated with substance abuse such as poverty, lack of education, related health conditions (e.g., HIV or hepatitis), illegal behaviors to obtain illicit drugs, gender, ethnic minority status, and comorbid psychiatric disorders that present unique ethical challenges (Fisher, 2004).
There is growing consensus that research involving impoverished and marginalized groups disproportionately burdened by illicit drug use and related HIV risk requires contextually sensitive interpretations of the broad federal regulations to account for the vulnerabilities of these populations(Oransky et al., 2009; Fisher, 2004). While these decisions regarding appropriate protections often rely on the moral compass of researchers and interpretations of regulations by IRBs, the participants experiencing the psychological, medical, social, and economic vulnerabilities tied to drug abuse and related HIV risk behaviors may not concur with these interpretations. The perspectives of illicit drug users can help investigators identify research practices that cause participant distress, violate participant privacy, or threaten participant autonomy not readily discerned through professional logic or scientific inference (Fisher, 2004). As there is no consensus on what constitutes ethical compensation for drug addiction research, the views expressed by a diverse sample of disadvantaged illicit drug users provides an opportunity to begin to understand the subcultural and situational lens through which participants view the efficacy and ethics of recruitment and monetary compensation for nonintervention studies involving HIV testing (Oransky et al., 2009). Participant perspectives can also help investigators and their IRBs to avoid overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from participation in research (Fisher, 2004). In the absence of empirical data to guide their deliberations, IRBs must often rely on their subjective judgments of minimal risk, when in fact prospective participants may view the research as posing little risk and evaluate the benefits as clearly outweighing such risks (Fisher, 2004).
In this module you will see a video that illustrates the ethical challenges for studies in which community recruiters solicit people who appear to have illegal drug use dependence to participate in a non-intervention study involving HIV testing. This video was also shown to a focus group of ethnically diverse and economically disadvantaged urban drug users in an effort to elucidate barriers to recruitment for non-intervention research involving HIV testing through the perspective of this population (Oranksy et al., 2009). While you are watching the video think about the following questions intended to help you organize your thoughts on these topics; Is offering monetary compensation to vulnerable populations due or undue influence? What are the ethical issues raised by offering monetary compensation? What are the privacy and confidentiality concerns that need to be considered in community recruitment? Is providing HIV testing in a non-intervention study a benefit or risk for this population? How would individuals who actually use drugs in this socially disenfranchised population view these ethical questions similarly or differently from you?
This research was supported by a National Institute on Drug Abuse (NIDA) grant (R01 DA015649-01A2) to Fordham University, Principal Investigators, Celia B. Fisher, Ph.D. and Merrill Singer, Ph.D.
Reference: Oransky, M., Fisher, C. B., Mahadevan, M., & Singer, M. (2009). Barriers and opportunities for recruitment for non-intervention studies on HIV risk: Perspectives of street drug users. Substance Use & Misuse, 44, 1642–1659. PMID: 9938935.
What are the perceived personal and social risks that Sarah may face due to the public nature of recruitment for drug-use research that includes HIV testing?
What the literature says: Certain areas of research, including substance abuse research are particularly plagued with difficulties in recruitment because of national law enforcement strategies that use criminal sanctions and stigma to further marginalize drug using populations and create a “hidden population” that is difficult to reach with both non-intervention and treatment services (Fisher, 2004; Oransky et al., 2009; Abadie, Brown & Fisher, 2018). Injection drug users have obvious reasons to conceal their behaviors and to avoid researchers who may be looking for them, including distrust, fear of criminal repercussions, and stigma (Fisher, 2004). Barriers to the recruitment of people who use drugs disrupt essential efforts to develop evidence-based substance use disorder treatment and HIV transmission among this population. Therefore, trust in researchers and appraisal of confidentiality plays a significant role in the recruitment and retention of these vulnerable populations (Oransky et al., 2009; Fisher, 2004; Abadie et al., 2018).
While confidentiality between researcher and research subject is regarded as an obligation for the researcher, in population-based socially sensitive research the position of potential participants within their community must be considered (Abadie et al., 2018; Reed et al., 2014; Slomka et al., 2007). Particularly in research involving public recruitment of participants, there may be situations for which routine procedures for ensuring confidentiality do not provide sufficient protections. For instance, even if the researcher protects the confidentiality of the participant, if recruitment is in a public setting, researchers can’t ensure confidentiality in participants daily life. Through the research recruitment process or participation, itself, individuals may be linked to or identified with the community or a subgroup within the community, and may experience stereotyping, discrimination, or stigmatization due to this exposure. For example, many people with dependence on and addictions to illicit substances are involved in criminal activities to acquire or obtain money to purchase drugs (e.g. sex work), making them vulnerable to arrest and stigma if confidentiality is not adequately protected (Oransky et al., 2009; Fisher, 2004). Additionally, research on drug abuse and related HIV/AIDS risk behaviors elicit sensitive information about HIV status, mental, and physical health that if disclosed could expose drug users to employment discrimination or social rejection. For this reason, researchers need to be sensitive to how fears of dignitary harms due to breaches of confidentiality and exposure to community members may vary in certain communities and contexts (Fisher, 2004).
Participant perspectives from those who viewed this: The main barriers to recruitment expressed by this group were concerns about recruiters asking eligibility questions related to drug use or HIV status in a public setting where others could overhear (Oransky et al., 2009). They felt that the recruiter’s behavior could risk public awareness of drug use or start rumors that they were HIV positive, which could lead to social stigmatization by both family and community members (Oransky et al., 2009). Another perceived barrier to recruitment were participant fears about getting in trouble with the law for their illegal drug use. Focus group members also believed drug users would avoid recruiters if they suspected them to be undercover law enforcement officers targeting them or that public contact could expose them to greater risk for arrest (Oransky et al., 2009).
Would Sarah have agreed if the study had not offered $40? Is the amount, $40, fair or coercive? How do you set fair compensation for this population?
What the literature says: Federal guidelines permit compensation for effort, time, and inconvenience of research as long as no “undue inducements” are offered to lure people into participating and incentives are not included as a “benefit” in risk-benefit analyses (OHRP, 1993). Although paying research subjects is a common practice, it is described as “one of the more contentious ethical problems” facing institutional review boards (IRBs). The U.S. federal regulations and the leading international codes of research ethics require that consent to participation in research be obtained in a manner that minimizes the possibility of coercion and undue influence (Largent & Lynch, 2017). In 1981, Ruth Macklin was the first to raise the question of due and undue influence in research (Macklin, 1981). To understand concerns about the influence of money on research participation decisions, it is useful to make an important distinction. The Belmont Report defines coercion as what occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance (The Belmont Report, 1978). Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate reward or other overture in order to obtain compliance (Largent & Lynch, 2017; Resnick, 2015). Additionally, whereas undue inducement may compromise the validity of consent by creating a cognitive distortion and impairing comprehension, coercion compromises the voluntariness of consent by the threat of harm (Resnick, 2015).
Emanuel offers four guiding elements to evaluate whether an inducement is undue: “(1) Offered Good—individuals are offered something that is valuable or desirable in order to do something; (2) Excessive Offer—the offered good must be so large or in excess that it is irresistible in the context; (3) Poor Judgment—the offer leads individuals to exercise poor judgment in an important decision; and, (4) Risk of Serious Harm—the individual’s poor judgment leads to sufficiently high probability that he or she will experience a harm that seriously contravenes his or her interests” (Emanuel, 2005). Despite this criteria, great heterogeneity in payment still exists as the various laws, regulations, and ethical guidelines that govern human subjects research offer little guidance about what specific factors render offers of payment ethically acceptable or fair (Brown et al., 2018; Macklin, 1981).
Federal regulations and the Belmont report have offered us definition of coercion and undue influence but there is controversy over the extent to which offering monetary compensation for research participation is or is not ethical. On the one hand, monetary compensation has been associated with potential undue influence and exploitation. The central features of existing literature on the ethical debate regarding the use of monetary incentives as a recruitment technique with research on active injection drug users and related HIV risk have focused on two components (Oransky et al., 2009). The first is whether it is ethical for researchers to provide cash payments when they may be used to support drug use following participation. The second component raises concerns over the capacity of these vulnerable populations and whether or not monetary incentives unduly induce and compromise the ability of members of addicted and impoverished populations to give voluntary and uncoerced consent (Oransky et al., 2009; Fisher, 2004).
These concerns have prompted institutional restrictions by ethics boards around compensation, such as limiting compensation to reimbursement of incidentals or lowering monetary values and have led some proponents to advocate the elimination of financial compensation (Collins et al., 2017; Abadie, Brown & Fisher, 2018). The arguments regarding due and undue inducement has largely dwelled within the framework of benefit and harms. In contrast to this, Fisher, Oransky, and other scholars argue that an equally legitimate question is the issue of justice and the extent to which individuals who use drugs are provided fair payment. Grady and her colleagues offer some insight by distinguishing between monetary compensation and monetary incentives. They espouse that payment for compensation involves participants being fairly compensated for their time and effort, recognizing the contribution subjects make to research (Grady, 2005). Inadequate incentives are also emerging as a topic of research particularly in low income communities where providing monetary compensation may be considered an ethical responsibility. Denying the possibility of payment to autonomous research subjects with limited opportunities for earning money further restricts their options and can reinforce economic inequities between drug abusing and non-abusing populations, rather than protecting them (Brown et al., 2016; Oransky et al., 2009; Grady, 2005).
Participant perspectives from those who viewed this: Consistent with Slomka and fellow researchers’ interview findings, focus- group respondents articulated that factors associated with their structural vulnerability (e.g. poverty, unemployment) meant that monetary incentives were often essential for their research participation (Oransky et al., 2009; Slomka et al., 2007; Collins et al., 2017). Many focus group members viewed research as a transactional process, or legitimized supplementary form of income, allowing participants to assert some power over the research process by compelling researchers to provide what they perceived as their right to fair compensation for a service performed (Collins et al., 2017). In response to concerns about participants using monetary compensation for drugs, respondents rejected paternalistic approaches to limit monetary compensation as efforts to limit their autonomy. Participants viewed themselves as just like anyone else, autonomous and capable of determining for themselves the most appropriate ways to use money obtained as compensation for research participation, even if that happened to be for drugs (Oransky et al., 2009; Slomka et al., 2007). Moreover, participant accounts elucidated that they found it patronizing, offensive, and misguided that researchers would attempt to control drug use by providing participants with noncash coupons, highlighting how gift cards exacerbated their structural vulnerability by creating additional barriers to accessing resources (Oransky et al., 2009; Collins et al., 2017). While focus-group members rejected stereotypical views of monetary incentives leading to increased drug-use behavior, there was agreement in their assessment that the effects of withdrawal placed them in a relatively vulnerable position as prospective research subject when offered cash incentives to enroll in a research study (Oransky et al., 2009; Abadie, Brown & Fisher, 2018).
Is offering HIV testing a due or undue inducement in populations where access to HIV testing may not be externally available? Is testing for HIV a research risk or a benefit? According to federal regulations, incentives are not a research benefit, but is HIV testing?
What the literature says: Unlike participant options regarding research on other diseases, individuals tested for HIV/AIDS must be informed of and cannot be given the option “not to know” the results of testing (OHRP, 1993) except if such knowledge would (a) increase suicidality or (b) preclude persons from whom valuable knowledge is needed from study participation. Participants must also receive risk-reduction counseling that includes (a) safer sex guidelines; (b) information on why drug users should not share needles, breast-feed, or donate or sell blood plasma, organs, or sperm; and (c) the necessity (Fisher, 2004).
Participant perspectives from those who viewed this: Participating in a study that provides HIV testing can be perceived as a barrier to some and to others a benefit or incentive for participation (Fisher, 2004). Focus-group respondents identified HIV testing as a deterrent to potential participants who fear they would be inflicted with the knowledge that they were HIV positive (Oransky, et al., 2009). Discovering that one was HIV positive was perceived to be both emotionally distressing and potentially devastating for one’s familial or romantic relationships. On the other hand, a smaller number of respondents believed that learning one’s HIV status through research not only benefits the individual who learns their status and can adapt accordingly, but also other members of his/her community (Oransky, et al., 2009). Participating in a study that provides HIV testing is also perceived as a benefit by participants who test positive for HIV if participation includes HIV counseling and referrals to affordable treatment centers (Fisher, 2004).
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