Learning health systems (LHS) seek to embed research in clinical care. Some have argued, such as Morain et al. (2026) in the current issue of the American Journal of Bioethics, that patients may ethically be enrolled with a modified (shortened) informed consent. For instance, a study randomizing patients to two equally supported medications for high blood pressure might use an opt-out approach to consent: Rather than asking patients if they agree to enter the study (opt in), as is standardly done, they are informed that they will be enrolled and randomized unless they ask not to be.
IUCB director, Peter Schwartz, MD, PhD, wrote a commentary on Morrain et al.’s recent article, supporting the idea that consent can be ethically modified or even waived in studies like this. Dr. Schwartz points out, however, that studies have shown that patients generally prefer traditional written, opt-in consent. Many will agree to opt-out consent, if that can speed the research, and they often oppose waiver of consent. With this range of opinions among ethicists and patients, Dr. Schwartz argues that a valuable next step would be to conduct a public deliberation to allow patients to decide when it would be acceptable for researchers to deviate from traditional opt-in consent. Researchers at the IU Center of Bioethics have led multiple public deliberations, most recently on biobank research in collaboration with the Indiana CTSI.
You can read Dr. Schwartz's full response here.