Tuesday, March 18, 2014

Is the Nuremberg Code Obsolete?

Long ago and far away, at the conclusion of a worldwide armed conflict, the winning side was shaken to its moral core by the discovery that massive and cruel medical experimentation has been routinely conducted on human beings.  The perpetrators were brought to trial and the verdict included not just punishment for the guilty, but also a message for posterity intended to prevent future atrocities. It was a code of ethics, very brief and written in plain language, and it was named after the city where the trials were held. The Nuremberg Code eventually became the basis for U.S. federal laws governing research on human subjects and known today as the Common Rule. The first article of the Nuremberg Code is about consent:
“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.
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.”
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.

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.


  1. Hmmmm. What I don't quite get is why there is any need to "assign" patients to anything. Docs flip their coins and do what they're gonna do. Health Care Operations make note of whether the patient got heads or tails, and the outcome. Knowledge is refined, papers are published, debate ensues, cookbooks are decried. Some of the Natural Experiments lead to Designed Experiments with consent, randomization, controls and so-forth. Knowledge is refined, papers are published, debate ensues, cookbooks are decried.

    And it all makes much, much less difference than getting an expectant woman at least once before she gives birth to a AP nurse or a doc who simply does what s/he was taught in med school.

    I have become about convinced "we" should halt all medical research for about 50 years and concentrate the resources simply on doing all the f*ing time what we already know works pretty well.


  2. Well done, I agree with you. We need a debate. Currently we are the proverbial "frog in the pot." Our group just presented a paper on ethics and technology, IEEE ACM ITPC Conference, http://princetonacm.acm.org/tcfpro/presentations/Introduction_of_ethics.pdf. I believe you would find the material very interesting.

  3. If ONC spent $24 Billion on EHR and we have not addressed ethics then something is very wrong. Without ethical principles we are relegated to ones and zeros, we no longer have any room for human dignity and informed consent is pure hyperbole.

  4. Did you see Dr. Blumenthal's interview in Forbes, March 19?

    "Now that we have a growing electronic infrastructure for health information, there is a surge of traditional capitalist interest in turning that information into valuable knowledge, and selling it back to patients and doctors. That will happen. But it could never have happened until we got the data into digital form."

    1. Thanks for the reference. I just read it in the Atlantic. Traditional capitalist interest is the main force behind all of this, so I guess I am not surprised (but I am surprised that Dr. B said it in plain language).
      Just in case you missed it, in the now doomed, but sure to be revived, SGR bill (H.R. 4015), scroll down to Section 8, where Congress is regulating how public data should be provided at cost to such private entities, which can turn around and sell it back to physicians and other "stakeholders" who may not disclose it publicly (I guess to protect the "intellectual" property of the sellers). Truly amazing stuff....

  5. So here's a question for any medical ethicists & docs who may be reading this:

    I just heard a story on the radio (NPR; generally reliable about things I know something about so I suppose trustworthy about things I don't know about).

    "We were finding that if people seemed to replace saturated fat — the kind of fat found in cheese, eggs, meat, butter — with carbohydrate, there was no reduction in heart disease."

    So, have we all been "victims" of a great, big clinical trial without informed consent &c wherein we learned that replacing fats with carbs doesn't help?

    What's the difference between this and the SUPPORT oxygen study? Should The Guild consider popular diet books sold by docs and breathless appearances on Oprah unethical? If not, then what's the problem with so-called Learning Activities? If so, what's The Guild going to do about it?


    1. Howdy Tom, I am not part of the "guild" as you very well know, but there is a huge difference in my book between randomizing people into various medical treatments, and observing "naturally" occurring phenomena.
      I don't consider diet books, or anything else, sold by people on Oprah to be medical treatments, even when sold by people with MD after their names.
      I think it's the active and willful randomization process which is the problem here, because at that point both patient and treating physician choice and judgement are nullified.

    2. I'd say that the headlong rush to substitute carbs for fats wasn't "natural" at all -- Guild members caused it claiming expertise proper to The Guild (and profited by it). And it certainly had medical consequences.

      So as long as "Learning Activities" only observe what docs do and what the outcomes are that's permissible "research" with no consent necessary?

    3. I think you are talking about two different things. When you heed the advice of a TV doctor, you certainly don't consider yourself to be his or her patient, and vice versa. You are also not "assigned" to one regimen or another without your consent, and without the benefit of your physician's advice, should you choose to seek such advice.
      Observing the effects of TV advertising, whether by MDs or "personal" trainers or Budweiser, on health does not qualify as a clinical trial, IMHO.

      The ethical questions raised by MDs selling stuff on TV are, I think, an altogether different issue.

  6. Yes Maraglit, I get that. Must I obtain specific consent to make note of your condition, what your doc did, and how it worked? That's the question.

    If I do enough of this, it seems to me it could at least approach the power of a designed clinical trial if the "flip a coin" analogy is mostly right. If you don't want to call it a clinical trial, fine, but in a sense we're all in clinical trials all the time -- we're in a clinic and we try something. I'm having trouble understanding why we should not be EXPECTED to try to learn something from it.

    1. Two things:
      1) Yes, you have to obtain consent to access my medical records, simply because they are MY medical records and I have a "right to be let alone". I am all for proper research and chances are I will allow you to use the data, but it's my call, and my call only.

      2) Being in a clinic and trying something, something that YOUR doctor who is acting in YOUR best interest is recommending, is not the same as being in a clinical trial where you are assigned to a particular course of action which may or may not be in YOUR best interest, regardless of YOUR doctor's opinion. The point here is that they DO NOT flip coins. That was an awfully derogatory remark by that one committee member. Just because medicine is not 100% exact, doesn't mean that it's purely random either...

      And here is my question to you: Is it going to kill them to obtain informed consent? And frankly, I don't care if it does....

  7. Kudos to you for your well written and insightful exposition of where the current push for the collective over the individual seems to be going. The Hastings Center report is worse than chilling and the position of IOM just as alarming.(By the way what David Hume quotes do you mean?)

    1. Thank you. The Hastings Center report is getting philosophical right from the start :-):
      "All our obligations to do good to society seem to imply something reciprocal. I receive the benefits of society, and therefore ought to promote its interest".
      Too bad these quotes seem to always exclude those who quote them....

  8. "Your" medical records belong to the creator of the records. You have a moral and legal expectation of privacy. The owner of the records should be able to do research using those records as long as your privacy is not violated.

    On the other hand, I totally agree that if there is any aspect of your treatment that is chosen for a reason other than your best interest, then you should be informed and give (or not give) your consent.