TY - JOUR AU - Smilan, Lisa E. AB - American Journal of Law & Medicine, 46 (2020): 413-444 © 2020 American Society of Law, Medicine & Ethics Boston University School of Law DOI: 10.1177/0098858820975532 The Revised Common Rule and Mental Illness: Enduring Gaps in Protections Lisa E. Smilan I. INTRODUCTION II. THE COMMON RULE THEN AND NOW: CHANGES PROVIDE LITTLE CLARITY A. EFFORTS TO SOLIDIFY PROTECTIONS B. ABSENCE OF “MENTAL ILLNESS” IN ORIGINAL AND REVISED COMMON RULE C. IMPAIRED DECISION-MAKING CAPACITY: AN EXCLUSIVE LENS FOR VIEWING MENTAL ILLNESS? D. WHY IMPAIRED DECISION-MAKING CAPACITY IS TOO LIMITED III. WHAT IS VULNERABILITY TO COERCION OR UNDUE INFLUENCE, AND WHO IS VULNERABLE IN THIS CONTEXT? A. COMMON DEFINITIONS 1. Coercion and Undue Influence in Relation to Mental Illness 2. Vulnerability in Relation to Mental Illness B. A CLOSER LOOK AT THE ORIGINS OF VULNERABILITY C. VOLUNTARISM MUST BE CONSIDERED IN ASSESSING MENTALLY ILL PARTICIPANTS’ VULNERABILITIES TO “COERCION OR UNDUE INFLUENCE” IV. CONSULTING THE EXPERTS A. THE EXPERIENCED RESEARCH PARTICIPANT B. REPRESENTATION THROUGH EMPIRICAL RESEARCH C. EXPERTISE ON INSTITUTIONAL REVIEW BOARDS V. POSSIBLE SOLUTIONS A. WHAT HHS COULD/SHOULD DO B. PEOPLE WITH MENTAL-ILLNESS EXPERIENCE ARE INTEGRAL TO RESEARCH REVIEW PROCESS VI. CONCLUSION Lisa E. Smilan, Visiting Scholar, Institute of Law, Psychiatry, and TI - The Revised Common Rule and Mental Illness: Enduring Gaps in Protections JF - American Journal of Law & Medicine DO - 10.1177/0098858820975532 DA - 2020-11-01 UR - https://www.deepdyve.com/lp/cambridge-university-press/the-revised-common-rule-and-mental-illness-enduring-gaps-in-LEZrRtEX1U SP - 413 EP - 444 VL - 46 IS - 4 DP - DeepDyve ER -