February 19, 2014

Media contact: Leah Ramsay 202.642.9640, lramsay@jhu.edu

Patient Consent to Research Not Always Necessary, Bioethicists Say

Under the right conditions, full informed consent is not ethically required for some types of health research, according to leading bioethics experts. The experts focus in particular on the comparison of common treatments in the February 20 issue of the New England Journal of Medicine (NEJM), arguing that in some cases a time-consuming consent process is not only unnecessary from the standpoint of protecting patients, but also potentially harmful to patients when it functions as an obstacle to gaining new knowledge that can improve the quality of the care patients receive.

The position is a considerable break from ethics principles that have guided research ethics and regulation for decades. The commentary addresses two concepts generating debate in the healthcare and bioethics fields: the idea of learning healthcare systems, as articulated by the Institute of Medicine (IOM), in which “continuous learning” from clinical practice feeds directly into improving future patient care; and randomized comparative effectiveness research (CER), in which patients are randomly assigned to different, widely used treatments for their condition – all of which are thought to be effective and safe – to determine which treatments work best for which patients.

“In a mature learning healthcare system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all,” the commentary states.

However, the authors note that no such system exists today with fully developed ethical safeguards, including patient engagement, to allow a study impacting patient care to be ethically acceptable.

The commentary’s authors are thought leaders in the field of bioethics: Ruth R. Faden and Tom L. Beauchamp, co-authors of the book A History and Theory of Informed Consent, and Nancy E. Kass, 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 in 1978, which established the ethical principles that have formed the foundation of national and professional policy regarding research with human subjects in the decades since.

“Current consent and oversight practices too often overprotect patients from research that has little impact on what matters to patients, while in other cases oversight practices underprotect patients from medical errors and inappropriate medical management,” the commentary states, echoing concepts put forth in the authors’ previous publication on the topic, a two-article justification and ethical framework for a learning healthcare system, published in the Hastings Center Report in January 2013.

According to the commentary in NEJM, the necessary ethics oversight in the proposed learning healthcare system would require “significant patient engagement,” incorporating patients in significant numbers on ethics committees that approve research for one of three tiers of consent: 1) research that is determined to have no negative effects on clinical or other outcomes or values that matter to patients will proceed without consent but with “public notification” to the patient community in the healthcare system; 2) research determined to have minor but still meaningful effects on patients’ interests, will proceed with specific notification to affected patients, who will have an option to decline participation; and 3) research with potential negative impact will require written, informed consent from individual patients before proceeding.

The authors provide examples of research involving randomization they believe could qualify for the first two categories if a fully “ethically mature” learning healthcare system were in place, including studies comparing the effectiveness of using email or text messages as medication reminders to patients, or comparing two commonly used medications for hypertension, with physicians able to make alterations at any time.

Of the context for the creation of The Belmont Report and the policy it has influenced, Beauchamp, Faden and Kass write: “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,” 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,” a concept more in step with today’s moral priorities of health care access and quality, and with the digital age’s ever-increasing data crunching and rapid sharing capacity.

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