The 130th Annual Meeting of APHA

Abstract #42936

Elizabeth B. Cooper, JD, School of Law, Fordham University, 33 W. 60th Street, Third Floor, New York, NY 10023, 212-636-7067, ecooper@law.fordham.edu

The legal doctrine of informed consent ("IC") has been criticized for insufficiently protecting patients' rights to understand the risks they may face by agreeing to undergo a procedure or to participate in a clinical trial. Some commentators find fault with the doctrine because it requires that a patient prove not only that she would not have consented to treatment had she been informed of the risks, but also that she was injured by the treatment. Focusing on the principle of autonomy, these critics state that patients should be permitted to pursue informed consent claims, regardless of whether physical harm has resulted. However, this approach raises concerns regarding the difficulty of proving claims and fears that courts will be overrun with complaints, which also may be hard to value. Building from principles of autonomy and justice, non-litigation vehicles may better serve to repair harm to a patient's dignity and educate health care providers ("HCPs") more about patients' needs. For example: 1) borrowing from the "restorative justice" movement, HCPs would meet in a non-adversarial context with patients to understand what happened, to attempt to make them whole, and to guard against similar future behavior; 2) learning from "alternative dispute resolution" models such as mediation or arbitration, health care institutions would create a structure to facilitate risk/benefit discussions between HCPs and patients - either before or after the procedure/trial in question. Although these solutions may not be ideal, they provide an important vehicle for discussion to help strengthen the IC doctrine and empower patients.

Learning Objectives: This session should enable participants to

• articulate the legal and ethical principles underlying informed consent doctrine;
• recognize the numerous ways in which existing doctrine does not satisfy patient need;
• identify new mechanisms to facilitate patient dignity and informed decision-making or to provide recourse in their absence.

Keywords: Bioethics, Decision-Making

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: N/A
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.