What are the responsibilities of clinical researchers?

One of the presentations at the OHRP hearings of the HHS was by George Annas, a JD who has an MPH (for those outside of north america that means he is a lawyer, but with a masters in public health). He is an influential figure who made the following statement (or something very like it) ‘physicians have a fiduciary obligation to their patients to provide optimal care; researchers have no such obligation.’ He was very emphatic.

He is also wrong.

In neonatology at least, the big majority of trials are performed by physicians who are also researchers. There are a few trials led by epidemiologist/trialists, but even in those trials the local investigators are almost always neonatologists. So what are our ethical responsibilities as clinicians who are also researchers? I think they still include the obligation to provide optimal care, an obligation that has to take into account, as it does in daily clinical practice, the fact that we often do not know what is the optimal treatment. Thus in the NICU, in identical situations, I might choose one treatment one day, and another treatment on the other. That can be consistent with all of my fiduciary obligations, whether I do that because the fellow has made a good argument for one treatment rather than another, and I can’t find any evidence to counter their argument, or because the parents prefer one treatment rather than another, and both are acceptable alternatives, or because it didn’t go well last time, or the phase of the moon has changed…

Professor Annas doesn’t really address that problem in his presentation, but it is addressed in the question session. He doesn’t, however, answer the question when it is posed, he talks about how important people feel it is to be able to choose their own physician. But even if preterm babies chose me as their physician (that really isn’t how it works, by the way) I still often don’t know what is best to do! Annas states that he doesn’t believe that physicians don’t know anything, and that every treatment decision is not a flip of the coin. But nobody said that. Many treatment decisions are evidence based, and many are proven to be better than alternative options. So if a preterm baby with HMD needs to be intubated and still has significant needs for oxygen, we know very well that they should get surfactant. If a full-term baby with hypoxic respiratory failure has an OI that is greater than 25 they should get inhaled NO; whoever they choose to be their doctor, the choice of treatment should be the same. That also has nothing to do with the ethics of uncertainty. Also, in many health care systems you don’t get to choose your doctor, or at least you rarely have an unrestricted choice. In the USA you don’t get an unrestricted choice either, and a baby in an NICU (and his family) really has little or no choice of doctor. That doesn’t change that fiduciary obligation.

Annas talks about the case of the law suit brought in the 80’s by someone who became blind as a result of high O2 levels when he was randomized (with no consent process at all in those days) to the high arm in one of the O2 trials in the 50’s. He describes this atrocious ophthalmologist who repeatedly examined the eyes of the baby every week, watching him going blind and doing nothing about it. He describes this as if it were a case of some ‘Nazi-like’ (my characterization, not his) medical experimentation, and comments that he could only have acted like that if he saw himself as a researcher, and not a physician. But in reality, he could have acted like that while being both, for what was the doctor supposed to do? There was no proof that higher O2 was the cause of RoP, many people doubted it, and there were cases of RoP in both the high oxygen and the low oxygen arms of the trials. Turning down the oxygen would not necessarily have had any effect on the progression of the eye disease (indeed the, much later, STOP-ROP trial showed that it does not). Another baby in the same NICU who was receiving the, then standard, treatment with very high oxygen and also getting repeated eye exams would have been receiving exactly the same care as the baby in the trial, despite being in a ‘fiduciary relationship’ with their physician! And, furthermore, there was no effective treatment; Cryotherapy was not available then, there was nothing anyone could do except watch the retina deteriorating.  Professor Annas has his retrospectoscope on high power, which has created substantial distortion: he seems to think that all the babies in the high oxygen arm of the trial went blind, that switching to low oxygen would have saved the baby’s eyesight, that the doctors knew this and that they were just doing the trial to have a nice publication in order to get famous.

So while I agree that I have a fiduciary obligation to provide optimal treatment, I also have a moral obligation to know what the optimal treatment is, and to know when more than one treatment is equally ‘optimal’, by which I mean equally supported by the current evidence.  I also, simultaneously, have a moral obligation as a researcher to keep trying to find out what the best treatments may be.

I also think that a non-physician investigator, for example Pr Annas, if he decided to do a clinical research project, also has a moral obligation to ensure that the patients in his study are receiving optimal treatment. No-one in a trial is simply a guinea-pig. No-one as a trial subject loses their rights as a person to receive good care. Comparative effectiveness research is a waste of time and money, and is indeed unethical, if we already know that one arm of the trial is optimal therapy and the other is not.

About keithbarrington


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