The patients have a story to tell: Informed consent for people who use illicit opiates

Introduction

It is an ethical and legal requirement for healthcare professionals to obtain informed consent from patients and research participants. The concept of informed consent is rooted in the value of autonomy, and in the context of standard medical research, obtaining informed consent is a quintessential and obligatory practice. In order for informed consent to be considered valid, voluntariness and comprehension are required. When it comes to people who use opiates however, the issue of informed consent becomes fraught for some research ethics boards (REB) in Canada. Because there is a potential for prospective participants to be intoxicated or experiencing acute withdrawal, ethical issues have been raised. This paper discusses the ethical issues that were raised in the conduct of a study that examined the experiences, opinions and perspectives of staff at the Crosstown Clinic. The Crosstown Clinic provides injectable opiate assisted treatment to people with long standing opioid dependence who have tried and failed with standard treatments such as methadone and buprenorphine. The clinic provides thrice daily injectable diacetylmorphine (medical grade heroin) and hydromorphone to people with an illicit opiate addiction. It is a full service clinic that provides wrap around care for the patients it serves including social service supports and general medical care.

Ethical issues in substance use research

A research participant is considered competent to consent when they can understand the material information, judge the information based on their values, understand both the expected and potentially adverse outcomes, and are able to communicate their views to researchers. The primary elements of informed consent are the participant’s ability to understand what is being asked of them and that their decision about participation in the study is made voluntarily. ¹ Voluntarism has been defined as embodying respect for the person as a human being, as a person with their own history and values and as a moral agent with rights and privileges. ² Voluntariness depends on a person’s beliefs about their options and their motivation for action. ³ In the case of people who use heroin, their choice is constrained by the wider social and psychological circumstances of their addiction.

A number of ethicists have raised concerns about the ability of people who use heroin to provide informed consent. Levy ⁴ states that addiction adversely affects the autonomy of users. The ability of individuals who use opioids to make decisions has been called into question due to the impact of intoxication and withdrawal and the potential long-term consequences of drug use. ⁵ Steel et al. ⁶ stated that researchers should assume that opioid-dependent people are incompetent to provide informed consent unless proven otherwise.

People who use opioids are vulnerable as a result of their marginalization, their social positioning, their criminalization and their addiction. ⁷ In fact, there is research that indicates that early life stress causes addiction ⁸ and there is some literature that indicates that people who use substances are particularly vulnerable. ^9,10 Smith ¹ contends that the capacity of people who use opioids to exercise autonomy and protect their own interests is impaired by their vulnerability. Vulnerable participants have challenges that need to be addressed as part of the research process. ¹¹

There is concern that coercive factors, whether that be the provision of medical grade heroin or cash honorariums, influences decision making by people who use opioids. ¹² In addition, there is a potential for people who use illicit opiates to be cognitively impaired or in withdrawal, which can also impact their ability to make an informed decision.

Although a number of researchers contend that people who use heroin are unable to provide informed consent, there is no consensus. Allbridge and Charles, ¹³ Carter and Hall, ¹⁴ and Uusitalo and Broers ¹⁵ argue that it is not as simple as intoxication or a desire for opiates. The issues that make consent difficult can be addressed in their view by assessing for intoxication before the consent is signed, paying attention to voluntariness, and by ensuring that the research protocol allows for autonomy and decision making capacity. It is apparent that the issue of consent for people who use opiates is fraught and difficult to navigate.

The psychosocial positioning of people who use heroin

People who use opiates are subject to a significant degree of stigmatization, both by the general population and health care providers. ^{16 –18} People who use substances experience multiple layers of stigma. They are stigmatized because of their drug use but also because of issues of poverty, unemployment and homelessness. In addition, because they are more likely to be infected with hepatitis C and HIV, they are subjected to the shame that is associated with these conditions. People who are marginalized and discriminated against are overrepresented in the population of people with addiction to opioids. ¹⁹ The issue of stigma underlies the decision making around consent. It is stigma that leads healthcare providers to believe that people who use opiates are incapable of making sound decisions. It is stigma that underlies the vulnerability that people who use opiates experience.

The story of a study

The Crosstown study was initially envisioned and federally funded as a qualitative study where the first author would interview both patients and staff about their experiences, opinions and perspectives about the clinic and its program. The study design was interpretive descriptive and utilized a convenience sample to interview 22 participants, including 18 nurses, 2 social workers and 2 clinic assistants. The participants were interviewed in private. Interview questions were open ended in an effort to obtain comprehensive findings. The interviews were 45–60 min in length. This study is unique. There is nothing similar that exists in the literature.

It became quickly apparent as the proposal proceeded through the review process that the local REB had reservations about including patients in the study and ultimately they made their opinion plain, stating that “there are ethical concerns with the consenting and interviewing of individuals under the influence as they cannot give proper informed consent.” Ultimately, the study was approved but only to interview the staff.

As part of the interview process, the staff were asked what they thought of the REB’s position and they were unanimous in stating that they were in disagreement. Melanie stated, “Point blank, that’s bullshit. [They are] fully capable…they are smart. Just because they use heroin they’re not stupid, they’re smart.” Many of the staff members felt that the REB decision was stigmatizing. Joan commented that it was “incredibly judgmental.” Peter stated “that’s bias and backward thinking.” Kathy said “I think there is a bit of discrimination in that.”

A number of the staff made the point that the patients were not impaired. Natalie pointed out that “they might be on heroin but a lot of them are fully functional. The amount that we give them isn’t supposed to get them high it’s just supposed to help maintain.” Mike noted that

it seems weird to say but they kind of seem like a little bit more themselves after their dose versus before their dose. When they come in especially like with their first one—I mean people are sick, ⁱ they’ve been gone for like eight to whatever, however many hours they’ve been gone. And, you know, so when you’re sick, you’re a little edgy, you’re a little moody, you’re a little grumpy. But afterwards like after hanging out with them in that twenty minute post time they’re laughing, they’re talking, they’re telling jokes.

Some of the staff also noted that the patients often talk to the media about the clinic. Judith talked about how “lots of our patients have given extremely well put together interviews for media.” David mentioned that they needed consent for media interviews. “A lot of the individuals who are part of this clinic they do that media [interview] and that [] is consent based.”

The staff also observed that the REB did not have a problem with approving the two quantitative studies associated with the clinic. The first of these studies, the North American Opiate Maintenance Initiative (NAOMI) compared injectable heroin to methadone. The second study, called the Study to Assess Long Term Opioid Maintenance Effectiveness (SALOME) directly compared injectable heroin to hydromorphone and ultimately the efficacy of oral hydromorphone. In both of these studies, the participants were provided with either injectable heroin or hydromorphone. ¹ Dierdre noted that “they had to sign a consent for the NAOMI (North American Opiate Maintenance Initiative) study. I don’t see how that was safer than this [study].”

Possibly the most important finding that came out of the staff interviews in relation to this question was the idea that the patients should have a voice in the research that is conducted for their program. Shelley stated that many of the patients “would just love to participate in this study.” Alison said “the patients have a story to tell.” It was clear from the interviews that the staff had a good relationship with their patients and were determined to support them. They clearly felt that their patients were autonomous and capable of making decisions about their own health. All of the staff had long-term experience in working with the population. Their attitudes toward people who use illicit drugs were clearly different from that of the general population.

Discussion

Excluding vulnerable people from research over concerns about their ability to provide informed consent may have the unintended consequence of being discriminatory and also denies them the opportunity to contribute to society through research. Excluding vulnerable people can be shaped by a sense of paternalism and overprotection and leads to excluded people being unable to gain the applicable knowledge and benefits that research can potentially offer. ²⁰ This is in itself unethical. The absolute dictum to disallow vulnerable people from giving informed consent excludes people in disadvantaged groups who do not have the power to exercise this right equally. ¹ There is the potential for the needs of vulnerable people to be neglected and thus, the principles of justice and beneficence would be violated. ²¹ The end result of this positioning is that research activity is diluted, with limits in the assumed benefits of research to specific social groups and society. ¹

A number of researchers have taken exception to the generally held position that people who use heroin are incompetent. Levy ⁴ noted that people with an opioid dependence do not just react, they act. Their movements are flexible and intelligent responses to the situations they find themselves in. Levy ⁴ also noted that people with drug dependence issues are not in autonomy limiting states (craving, withdrawal, intoxication) most of the time. It is never right to assume that individuals cannot provide informed consent just by virtue of using illicit opioids. ⁵ Even for substance–dependent individuals, choices are not predetermined or illogical. Rather, they are dependent on the “constellation of rewards and negative consequences in any specific situation.” ²² In consideration of this, their choices are not incompatible with informed consent.

Informed consent assumes that a potential participant has autonomy. Autonomy however, is not an all or nothing concept. Even though addiction has an adverse impact on autonomy, there is no reason to think that many people who use opiates “are not autonomous enough” to give their consent. ⁴ While their autonomy can be impaired, they retain some degree of control over their drug use and some degree of autonomy. ¹⁴

Responsible advocacy has been suggested as a way of protecting vulnerable people to ensure that they are able to participate in research that has the potential to benefit them, their families and communities. Responsible advocacy is about protecting vulnerable individuals from harm, and protecting their welfare by maximizing their capacity for self-determination. ^1,23,24 Responsible advocacy seeks to combine a researcher’s ethical identity as both advocate and social conscience. ²⁵ There are three principles that underlie responsible advocacy:

Advocacy is a moral obligation for health care staff and it requires them to have a level of understanding about their clients to help them understand the situation they are confronted with and to make good decisions. ¹ If researchers adopt the position of responsible advocacy, they might be more able to determine if their patients have the capacity to provide informed consent and help them to understand the proposed research. ²⁶ Responsible advocacy asks practitioners and researchers to not only look at the obvious issues that affect participants but to understand the underlying issues that contribute to social inequality. Research is both objective, using defined, rigorous and replicable methods, and partisan, meaning that it reflects underlying values and assumptions that determine conceptualization, choice and analysis of research problems. ²⁷ It is important to understand how the conduct of the research impacts on participants, and specifically, how our beliefs about informed consent can impact enrollment.

It is important for REBs to understand how researchers can protect their patients from harm and ensure that they are capable of signing an informed consent. Albridge and Charles ¹³ recommend assessing potential participants for intoxication. They suggest building extra time into the research protocol to ensure that understanding has occurred, utilizing a teaching then testing method to ensure that the information provided about the study is understood, and training fieldwork staff to be sensitive to signs of intoxication.

Well-designed research can filter out people who lack capacity and recruit those whose capacity to consent is not in doubt. ⁴ Risks need to be minimized and communicated clearly during the consent process so that the participant’s decision making is supported. ⁵ It is important to understand how coercive factors can affect the voluntarism of participants so that assessments can be developed that detect impairments in self-determination. ²² Informed consent should be seen as an ongoing process that is repeated several times during the research process, whether that involves interviews or biomedical interventions. ¹¹

It is important to understand vulnerability as not just a person, but a situation. People are vulnerable as a result of socioeconomic forces that impact their life. The person needs to be viewed in context. If vulnerability as a context-related and situational concept is combined with existing approaches to informed consent, ethical principles can be balanced and preserved at every step of the research process. ²⁰ Researchers and ethicists often make assumptions about people and their vulnerability and competence based on their lifestyle and socioeconomic status. These assumptions are not always valid. A homeless patient with mental illness may be managing his daily affairs. His diagnosis and membership in a disadvantaged group may suggest impaired research decision making capacity where none exists. ²⁸ Potential participants should be treated as moral agents and be given a voice by involving them in the process of determining whether they participate in research or not. The Tri-council Policy Statement in regards to ethics in Canada does not preclude vulnerable people from participating in research. The guiding statement is that vulnerable people should be provided with special procedures to protect their interests. ²⁹

Conclusion

There is a careful balance between protecting vulnerable participants and making paternalistic decisions that are supposedly in their best interest. It is ironic that the people most in need of attention in order to improve their condition are the people who are most frequently left out of qualitative research. ¹¹ If there is one theme that is prevalent in the copious literature arguing against inclusion of people who use heroin in research, it is that protectionist concerns about recruitment incentives and consent comprehension, may be overstated. ²² Such concerns do not promote the interests of research participants. It is clear that more work needs to be done to establish the rights of people who use heroin to provide voluntary informed consent. Arendt ³⁰ talked about the right to have rights and that these rights should be guaranteed by humanity. Qualitative research gives voice to people who are most often silenced and marginalized. ¹¹ People who use heroin need to be given an opportunity to share their voice and tell their story.