Restoring Balance: A Consensus Statement on the Protection of Vulnerable Research Participants

Abstract

A diverse panel convened in June 2011 to explore a dilemma in human research: some traits may make individuals or communities particularly vulnerable to a variety of harms in research; however, well-intended efforts to protect these vulnerable individuals and communities from harm may actually generate a series of new harms. We have presented a consensus statement forged by the panel through discussion during a 2-day meeting and the article-writing process. We have identified practical problems that sometimes arise in connection with providing additional safeguards for groups labeled as vulnerable and offered recommendations on how we might better balance concerns for protection with concerns for justice and participant autonomy.

The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines

“…First, concerns have been raised that the manner in which vulnerability is defined and operationalised in research ethics governance stereotypes and reinforces stigma about whole categories of individuals [9, 12, 31]. Our results reinforce these concerns, as the reliance on listing groups of vulnerable persons is rampant.…”

“…This labelling [6] or sub-population [30] approach does little to bring attention to the importance of context and of assessing the characteristics of individual research participants beyond their membership in a group [5, 6, 9]. It is important to note that research protocols create groups through sampling “ regardless of whether the sample is drawn from a naturally occurring community ” ([9], p. 2221). Understanding this point underscores the fact that group membership in this context may not well capture the various relevant aspects (and potential vulnerabilities) in an individual participant’s situation.…”

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

“…First, it is stigmatizing to screen for decisional capacity when screening is done only with groups deemed likely to lack decisional capacity (DuBois et al, 2012). Second, those who score low on an assessment of decisional capacity are often capable of demonstrating adequate understanding if researchers would take the time to pursue options other than exclusion (Flory & Emanuel, 2004; Nishimura et al, 2013).…”

Protecting and respecting the vulnerable: existing regulations or further protections?

“…If a potential participant's cognitive vulnerability is severe (adaptations cannot improve it sufficiently), permanent (waiting until an appropriate time is futile) and necessary (no medical, psychological, or educational recourse can alleviate it) then the informed consent process cannot function properly. This may be the case in situations of brain injury, coma, persistent dementia, and/or mental illness, but the burden of proof is on the researcher to show that this is the case [23]. Thus, when (and only when) this vulnerability is severe, permanent, and necessary should it be a prime candidate for additional protections, since existing requirements for a proper informed consent process cannot be fulfilled with this population.…”