“The voluntary consent of the human subject is absolutely essential.
This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.Some 67 years later, a generation of medical researchers with no first hand memories of either Nuremberg or what preceded it, are finding the absolute nature of this ethics code to be a hindrance in their morally superior efforts to save the world from health care system inefficiencies. In this day and age of readily and abundantly available electronic data, the antiquated processes of obtaining proper consent from experimental subjects one by one, for simple things like comparative effectiveness research (CER) or quality improvements (QI), are slowing down the computerized trains of progress. After all, we are not talking about hacking people with machetes or purposely infecting them with horrible diseases or any of the nightmarish scenarios that brought about the terror embedded in the Nuremberg Code. We are talking about a clearly beneficent learning system, made possible by health information technology, where every patient is a research subject and every doctor is a research assistant, and we all cheerfully share and cooperate to advance our collective medical knowledge and to make health care better and cheaper. The inconsequential details can be safely left to our betters, who are now, always will be, and in America always have been, on the side of angels.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.”
Following the controversy surrounding the National Institutes of Health (NIH) funded SUPPORT trial, which tested the effects of different oxygen saturation targets for premature infants (within acceptable “standard of care” limits), the Office for Human Research Protections (OHRP) held a public hearing in August 2013 regarding the nature of informed consent for randomized clinical trials. Leaving the SUPPORT controversy aside, two very distinct opinions regarding consent emerge from reading the various testimonies before the committee. The traditional opinion argues that there is a difference between treatment and research and that informed consent is required for both, including study of “standard care” interventions, CER and QI; that randomization always deprives research subjects of the judgment of their physician and that these issues are governed by law (e.g. the Constitution and such). The progressive view, presented by testimony from members of the Institute of Medicine (IOM), its Clinical Effectiveness Research Innovation Collaborative (CERIC), NIH and other research establishments, posits that randomization of “standard care” interventions poses no additional risks to patients, since doctors’ decisions are essentially like flipping a coin anyway, and therefore patients in this new learning system may be subjected to randomized CER and QI experiments without explicit consent and with minimal, if any, information (e.g. “something posted on the door”).
The notion of a Learning Health Care System has been introduced by IOM, and it forms the basis of the Federal Health IT Strategic Plan published and maintained by the Office of the National Coordinator for Health Information Technology (ONC). ONC describes the vision of a learning system to be “an environment where a vast array of health care data can be appropriately aggregated and analyzed, turning data into knowledge that can be put to immediate use”. The immediate concern with this utopian structure is of course privacy of the observed, and the basic individual right to not be observed. However, as the IOM/ONC thought process evolves, and as evident from the OHRP hearing and subsequent articles recently published by IOM and research industry affiliated individuals (here and here), the learning system is not only assuming that patients should be observed without explicit consent, but that they should also be subjected to randomized experimentation without explicit consent, if the designers of experiments classify their activities as CER or QI, all within the boundaries of “standard care”.
Furthermore, a Hastings Center Report, briefly mentioned in the OHRP hearing, introduces the idea that all patients have a “duty” to subject themselves (and their children) to health system “learning activities”, which include randomized experiments, with or without informed consent, depending on the nature of the experiment, the level of difficulty in obtaining consent and the judgment of the health system. The duty of course is to contribute to the common good. The implicit assumption being made here is that “The System” is experimenting on people solely for the common good as well, and that we can trust the beneficence of “The System” in perpetuity, or until we discover otherwise. This line of thought is indeed congruent with the modern trend to manage the health of populations, which is quickly replacing the old fashioned view of medicine as a personal service, where the locus of trust was the individual physician and the overriding interest was the individual patient.
So how do we get from here to there? The old HIPAA law grants permission to health care facilities to use and disclose health care information for the purpose of treatment, payment, and health care operations, and patients must sign HIPAA consent forms prior to obtaining any type of treatment (exclusive of true emergencies where consent is implied). If we “broaden” the meaning of health care operations, which is already broad enough to drive a truck through, to include “learning activities”, and if we define “learning activities” to include randomized clinical research on human subjects that poses only incremental risk to patients, compared to doctors flipping coins, then we have the ability to monitor, collect and analyze any and all data on every single patient. To complete the task, the Secretary of Health and Human Services (HHS) will need to provide additional regulatory “guidance” on how the Common Rule can be ever so slightly relaxed to exclude certain “learning activities”, and hence the OHRP hearings (OHRP is part of HHS).
I do understand that this is a complex subject and opinions may differ, so a vigorous debate is healthy. But this debate cannot take place in obscure OHRP hearing rooms, or on the pages of the New England Journal of Medicine, or even in multi-stakeholder IOM round table meetings. With all due respect to distinguished researchers, bioethicists and political appointees, this subject is above and beyond the pay grade of all currently involved in it. This debate is not about paperwork or IRB management techniques. This debate is about diminishing those humanitarian protections that inconvenience the electronic age of Big Data and little people, and no amount of patient-centered terminology (or David Hume quotes), will change that. This debate should take place on the front page of the New York Times, the Wall Street Journal, CNN, MSNBC, Fox News, and the floors of Congress, and eventually in front of the Supreme Court. This debate is ours to settle. Vox populi, vox Dei.