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Commentary on: Alexander S, Pillay R, Smith B. A systematic review of the experiences of vulnerable people participating in research on sensitive topic. Int J Nurs Stud 2018;88:85–96.
Implications for practice and research
Nurses can confidently recommend a research study to patients from vulnerable populations because the overall impact on their well-being is generally modest and most patients with research-induced distress are still glad they participated.
Vulnerable patients value their role as research participants and, even if there is some distress caused by participating, most patients still feel their participation is worth it.
Context
Vulnerable populations (e.g. mentally ill, terminally ill, physical or sexual trauma, children, cognitively impaired, homeless, prisoners, migrants/refugees) are at the risk of distress when asked sensitive questions (eg, past trauma, mental illness, illegal activity, addiction).1 2 This systematic review by Alexander et al summarises the current literature exploring how participants from vulnerable populations feel about their experiences as research subjects, the distress it induces and their feelings about the distress.2
Methods
An extensive literature search was conducted with a systematic process for including or excluding studies. Eleven studies were included and narratively synthesised. Extensive clinical and methodological heterogeneity precluded statistical pooling. These studies were generally rated as moderate or strong using standardised methods.
Findings
This systematic review focused predominantly on patients with trauma, mental illness and terminal illness asked questions about these experiences. A solid majority felt that participation was not distressing or in some cases, even beneficial (ie, cathartic, reduced feelings of loneliness and stigma). However, up to 10% did feel some additional distress and up to 5% felt severe distress in some studies. In general, those with more severe illness or trauma at baseline were more likely to feel distress and greater magnitude of distress. However, even among the distressed participants, many patients still felt they should be empowered to choose whether to participate, not have outside entities restrict access to research that can move the field forward. Experiencing increased distress for many was an altruistic act that some participants were willing to undergo to help others in the future.
Commentary
Ethics boards are charged with protecting research subjects and are supposed to be especially careful when dealing with vulnerable populations. Boards need to understand that many of the patients with trauma, mental illness and terminal illness in research studies do not experience distress. Some receive tangential benefits, but a few do experience increased distress. However, in most cases the increased distress does not lead to regret.
Since the first study included in the review was from the year 2000, these studies were approved by ethics boards who were especially careful about what to approve. In research where the benefits to the participants or to science were poor, those participants might consider the increased distress unnecessary. In addition, this review did not address distress that could be caused by coercing vulnerable people to participate in research. In circumstances where people (ie, children asked to participate by teachers, prisoners asked to participate by guards) who did not feel free to decline participating or to withdraw if they felt untoward distress, the level of distress experienced could be much greater. This systematic review’s results are congruent with a study of 120 patients with a history of suicidal behaviour or ideation enrolled in a 6- month study. Participating in the study led to infrequent changes that were small and tended to reflect a reduced risk of suicidality. While overwhelmingly safe in the overall population, a few people were at greater risk as a result of participating.3
The question becomes, is this systematic review proof that ethics boards have been an unnecessary hindrance and should give greater latitude to researchers in the future or have ethics boards been successful in limiting research to more important studies that are less distressing? Unfortunately, both may be true, and this question cannot be answered by this systematic review. What is clear is that research in vulnerable people is critically important and ethics boards and researchers need to find the appropriate balance between ensuring quality and safety. With fear of litigation and negative press, some institutions may adhere to a ‘first do no harm’ paradigm, but this is likely not an optimal approach.
Footnotes
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.