Challenging Vulnerability: Institutional Stigma and Ethical Considerations in Clinical Research
By: Nicole Edgar
In recognition of Mental Illness Awareness Week, which highlights the importance of advocating for those with mental illness, it is crucial to revisit the conversation of how we view individuals will mental illness and their participation in research. Those of us who work in research know the importance of the ethical guidelines that govern our work. These ethical policies serve to guide institutions and investigators on conducting high quality research while protecting the rights of research participants. These policies, such as the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) in Canada, also outline potential special populations requiring additional consideration for including in research. These include individuals who are captive populations (e.g., prisoners); those without the capacity to consent; pregnant women; and, those belonging to racialized communities. Historically, groups requiring special consideration have often faced serious injustices and have been subjected to highly unethical treatment in research. Examples of these ethical atrocities include the Tuskegee Syphilis Study; testing of dioxin (Agent Orange), radioactive isotopes and other chemicals on prisoners in Philadelphia; and, testing female oral contraceptives on poor, uneducated Puerto Rican women without consent.
The argument of “who is vulnerable” in research is long-standing and, yet, there is still no consensus on who should be included [1]. Canadian policy defines vulnerable individuals as those with “a diminished ability to fully safeguard one’s own interests in the context of a specific research project” [2]. The determination of who is “vulnerable” is made by individual ethics boards and ranges from only those populations outlined in TCPS-2 to expanded criteria of 15 or more groups. One group that often makes the “special considerations” list is those with mental health issues. When justifying the inclusion of those with mental health issues, we have faced questions such as “Can people who are suicidal even give consent?”; “Won’t asking people about their depression make them more depressed?”; and, “Are suicide rates actually higher in Indigenous communities?”. Statements like these might seem “dated”, rooted in stigma and misinformation, but these are questions that have been posed by various ethics boards in the last 5 years. As researchers, we should carefully consider how this blanket approach to vulnerability affects our work, creating a culture of exclusion and perpetuating stigma.
It is important to think about why we consider those with mental health issues to be inherently vulnerable. Are we speaking from experience? Do we work with someone with lived-experience who expressed concerns? Is our unconscious bias leading our decisions? Bracken-Roche and colleagues highlighted several misconceptions in their 2016 paper about the perceived vulnerability of psychiatric patients in research and why this view needs to be re-visited [3]. Their findings echo many of our experiences working in mental health research:
Patients with mental health issues are often assumed to have a lack of decisional capacity, regardless of their illness. This is misinformation we encounter time and again during ethical reviews – “but can these patients consent?” Those with mental health issues are not unique when it comes to issues of capacity. As with any population, some individuals will have diminished capacity (think of those with severe psychosis) and those who are no different from any other individual making healthcare decisions. Studies have repeatedly shown that mental health patients do not inherently have a diminished capacity [3]. By assuming that individuals with mental health issues cannot consent, we are depriving them of the choice to consider participation in research.
There is still a lack of understanding about what it is to live with a mental illness. Frequently we are asked “won’t asking about this individual’s suicidal thoughts/self-harm/depression make them worse?”. Evidence has demonstrated that asking participants about suicide, for example, is not only safe, but it may even have a small therapeutic benefit [4]. Not asking those living with mental illness about their symptoms and experiences does not benefit them and only serves to increase feelings of shame and self-stigma. Asking about mental health symptoms is not “one-size-fits-all” situation, some conversations, such as those about trauma, require a different approach to ensure that harm is not being done, both to patients and to research staff.
Lastly, many ethics boards and research committees have limited lived-experience input, especially from those with mental health issues. Those living with mental health issues do not experience healthcare in the same way as those with cancer or heart disease, often due to both self-stigma and institutional stigma. Participants with mental health issues may be less willing to come forward to talk about their issues and may require an active effort to be included in the process. Failing to include their voices at the table means their unique needs are often not considered in the development of research policies and procedures.
Many of these issues result from perpetuating stigma at all levels – public, institutional – and may exacerbate self-stigma. Despite moving towards improved inclusivity, many of our policies are left behind because of outdated views of what it means to live with mental illness. We often don’t think twice that terminal patients with only experimental treatment options aren’t classified as “vulnerable” during ethical reviews, yet an individual living with mental illness is automatically considered to be less capable of safe-guarding their treatment choices. The unconscious bias that results from institutional stigma, or stigmatizing policies, can result in harm to participants, hindering research and perpetuating self-stigma.
Bracken-Roche and colleagues put forward their call for change more than 5 years ago, yet very little has changed. A blanket approach fails to consider the nuance about what may make a participant vulnerable and, ultimately, encourages exclusion and perpetuates stigma and unconscious bias. Protecting those who are vulnerable is crucial, as history has repeatedly demonstrated, but as evidence changes so must our views of what it means to be vulnerable. As researchers, it is time that we challenge the status quo and engage in meaningful discussions with our leadership about how to improve inclusivity and eliminate stigma in clinical research.
References
[1] Bracken-Roche D, Bell E, Macdonald ME, Racine E. (2017). The concept of “vulnerability” in research ethics: an in-depth analysis of policies and guidelines. Health Research Policy and Systems. 15(8): 1-18. DOI: 10.1186/s12961-016-0164-6
[2] Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council. (2018). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Article 4.7, p. 54.
[3] Bracken-Roche D, Bell E, Racine E. (2016). The “Vulnerability” of psychiatric research participants: Why this research ethics concept needs to be revisited. Canadian Journal of Psychiatry. 61(6): 335-339. DOI: 10.1177/0706743716633422