Published on February 21, 2014 at 8:44 AM
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.
source: Johns Hopkins Berman Institute of Bioethics