Doing Research with Vulnerable Populations: The Case of Intravenous Drug Users

Blake Murdoch,Timothy Caulfield

doi:10.7202/1044290ar

Abstract

This review article considers ethical concerns when doing research on potentially vulnerable people who inject drugs (PWID) in a Canadian context. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans broadly addresses many of the traditional ethical principles of research on vulnerable persons, but does so at the cost of clarity and precision. Vulnerability is contextual rather than absolute. When doing research with vulnerable persons, informed consent should be obtained from an independent person, and comprehension should be checked using questioning. Participants can be vulnerable due to many factors, including addiction, chronic disease, socioeconomic and racial status, and lack of education. The ability of PWID to give informed consent can be compromised by undue influence or intoxication, but existing research shows that neither the mode nor the magnitude of compensation has a significant effect on new rates of drug use. Compensation can also help dispel the therapeutic misconception. Intoxication rather than undue influence is the main concern when obtaining informed consent from PWID. The stigmatization of PWID as incapable of consent should be avoided. Paternalistic exclusion from research can harm PWID and exacerbate their vulnerability by reducing our knowledge of and ability to specifically treat them. As such, we must collect better data about the effects of research ethics policies. Studies to this effect should focus on experiences, perspectives and needs of potentially vulnerable research participants. Research ethics boards in Canada should adopt an evidence-based approach when applying discretionary power to proposals for clinical research.

Highlights

Responsabilités des évaluateurs externes Les évaluations des examinateurs externes sont prises en considération de façon sérieuse par les éditeurs et les auteurs dans la préparation des manuscrits pour publication
Fisher found that street drug users “share with investigators an appreciation for foundational moral principles guiding research regulation” and that they “have the ability and willingness to grapple with core dimensions of morality” [47]
The likelihood that harm is caused by the exclusion from research of persons who are broadly stereotyped as vulnerable creates an imperative to collect better data as to the effects of relevant research ethics policies

Summary

Introduction

Intravenous drug addiction causes serious vulnerability in society, producing high rates of chronic disease such as HIV, Hepatitis B & C and tuberculosis, as well as social deterioration and psychological harm [1,2,3,4,5,6,7]. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women, prisoners, those with mental health issues and those with diminished capacity for self-determination Ethnocultural minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly and inequitably in research, or have been excluded from research opportunities. In considering the need for an alteration to consent requirements, researchers and REBs should consider whether the prospective participants (as individuals, groups, or populations) are in vulnerable circumstances (see Article 4.7). The most obvious questions regarding recruiting PWID for research revolve around the ability to give informed consent [33] These participants are potentially at risk of experiencing undue influence on decision-making due to intoxication, cognitive deficits from long-term substance abuse, comorbid psychiatric disorders, and other factors [29]. Suggestions for ensuring proper consent when faced with potential intoxication include checking understanding, extending the timeframe for consent and its withdrawal, training staff to check for signs of intoxication, and excluding from the outset those who are obviously intoxicated [45,46]

Findings

Discussion

Conclusions