Patient consent to research not always necessary, leading bioethicists say

Fully informed consent is not ethically required for some types of health research, leading bioethics experts contend in an article published in the latest issue of the New England Journal of Medicine.

The experts—including Ruth Faden, director of the Berman Institute of Bioethics at Johns Hopkins, and Nancy Kass, the Berman Institute's deputy director for public health—advocate for a more nuanced approach to consent, noting that in some cases a time-consuming consent process is unnecessary for patient protection and could actually impede improvements in patient care.

Their position is a considerable break from principles that have guided research ethics and regulation for decades.

The commentary is published in the Feb. 20 issue of the New England Journal of Medicine

"Current consent and oversight practices too often overprotect patients from research that has little impact on what matters to patients," the commentary says, "while in other cases oversight practices underprotect patients from medical errors and inappropriate medical management."

The commentary's authors are thought leaders in the field of bioethics: Faden and Georgetown University philosophy professor Tom L. Beauchamp, co-authored A History and Theory of Informed Consent, and Kass is an innovator in public health ethics and author of the widely referenced "Kass framework" for ethics analysis of public health programs. Beauchamp was also the principal author of The Belmont Report, which established the ethical principles that have formed the foundation of national and professional policy regarding research with human subjects in the decades since its 1978 release.

"The current oversight system, requiring informed consent for most clinical research, grew out of a scandal-ridden period in which people were used in research and exposed to significant risk without their knowledge or consent," they write, referring to the oft-cited Tuskegee Syphilis Study and other lesser-known, unethical research that came to light in the 1960's and '70s. "Our Common Purpose Framework builds on traditional principles of clinical and research ethics, including The Belmont Report, but is designed to provide guidance for activities where research and practice are integrated to enable rapid, systematic learning."