Title: Defining vulnerability in the context of human participant research with TBI survivors Authors: (Z. Boka) Zoltan Boka1 and (C.P. Nauhaus) Carolyn P. Neuhaus23 The Belmont Report and subsequent research ethics scholarship commit researchers, Institutional Review Boards (IRBs), and regulators to protecting vulnerable persons who are heightened risk of being taken advantage of in research. However, the question of who is vulnerable, and why they are vulnerable, remains unsettled in research ethics literature. This presents an ethical problem. Research participants labeled “vulnerable” are often lumped together, stripped of their individuality and right to self-determination (Bracken-Roche, Bell and Racine 2016). The exclusion of vulnerable groups and persons from biomedical research slows, if not prevents, the development of, treatment and cures for the very conditions that render people vulnerable, whether cognitive impairment, traumatic brain injury, or psychiatric illness (Moore 1994). The present paper defends the application of a nuanced, context-dependent definition of vulnerability when it comes to research involving conscious and responsive survivors of traumatic brain injuries (TBI). Hurst (2008) proposed that vulnerability be defined relative to specific harms of the experiment itself to participants. She rejects consent-based, harm-based, and interest-based accounts of vulnerability because they are excessively broad and too focused on enumerating deficiencies rather than understanding the specific harms encountered in research participation. Hurst argues that vulnerability “is not restricted to the likelihood of faulty consent or even to the limited capacity to defend one’s own interests.” Instead, she proposes that vulnerability is “a claim to special protection…understood as an identifiably increased likelihood of incurring additional or greater wrong” than others who would participate in the same experiment. This shifts attention from the participants to aspects of the research study that increase likelihood of harm. 1 IRB and Bioethics Director, Lehman College, CUNY 2 Rudin Post-Doctoral Fellow, Division of Medical Ethics, NYU School of Medicine 3 INES (International Neuroethics Society) Member We agree with this approach to defining vulnerability, and see it as the best way to discern appropriate special protections for TBI survivors in research. Our paper applies the Hurst (2008) framework to a hypothetical IRB submission and asks how the protocol might put TBI survivors at a greater risk of incurring additional or greater wrong than their non TBI-survivor peers. TBI survivors are more dependent and isolated than their non-injured peers (Morton & Wehman 1995) and feel alienated from social norms. Some treatment professionals regard them as being anxious to please (Nella and Butera-Prinzi 2008). Isolation, alienation, and eagerness to please make some members of this population more likely to consent to research participation to curry favor with the PI and their staff and have satisfying social experiences. This is one way in which TBI survivors are made vulnerable: They have an increased likelihood of incurring harm because they are more apt to agree to research participation, and continue in research despite harms. The paper will help IRBs apply special scrutiny to protect TBI survivors in a nuanced, targeted way. References: Bracken-Roche, D., E. Bell, and E. Racine 2016. The “Vulnerability” of psychiatric research Participants: Why this research ethics concept needs to be revisited. The Canadian Journal of Psychiatry 61(6): 335-339. Hurst, S. A. 2008. Vulnerability in research and health care; describing the elephant in the room. Bioethics 22(4), 191-202. Moore, D.L. 1994. An IRB Member’s Perspective on Access to Innovative Therapy. Albany Law Review 57(3): 559-581. Morton, M. V. and P. Wehman 1995. Psychosocial and emotional sequelae of individuals with traumatic brain injury: a literature review and recommendations. Brain injury, 9(1): 81-92. Nella, C. and F. Butera-Prinzi 2008. Acquired brain injury: Reconstructing meaning following traumatic grief. Grief Matters: The Australian Journal of Grief and Bereavement, 11(2): 64-69.