Waiving Consent for Comparative Effectiveness Research: What Three Legal Cases Tell Us
Thursday, October 12, 2023
4:00 PM – 5:15 PM ET
Location: Essex C (Fourth Floor)
Waivers of informed consent for studies that compare accepted medical treatments are being proposed by investigators and determined by Institutional Review Boards (IRBs) to be ethical and consistent with the Common Rule or FDA regulations. While not prevalent, comparative effectiveness trials without consent are not rare either. To date, little legal analysis outside of federal regulatory compliance has asked whether waivers of informed consent in this context are acceptable.
We consider the common law claims a patient may reasonably pursue upon learning that their medical treatment was chosen by a process of randomization for research purposes Although the caselaw on research injury claims is limited, our legal analysis finds existing precedent to support a successful lawsuit in battery, lack of informed consent, and breach of fiduciary duty. The presenters will share their legal analysis of a hypothetical research study in which the requirement of prospective consent is waived and examine three compelling precedent legal cases—one for each of the primary claims that might be reasonably asserted.
It is a matter of time before present-day medical research without consent is subjected to judicial scrutiny under common law principles. When this happens, substantial upheaval of emerging research practices may ensue. Anticipating common law concerns can forge alignment between regulatory, legal, and ethical principles, charting a path forward that may permit some modifications to strict regulatory consent, while allowing health care providers to meet their duties to respect patient bodily integrity and autonomy as well as their duties of loyalty, discretion, and care.
Jordan Taylor, B.A. – Research Project Coordinator, The Dartmouth Institute for Health Policy and Clinical Practice, The Dartmouth Institute; Donna Chen, M.D. M.P.H. – Professor, Center for Health Humanities and Ethics, University of Virginia