Abstract
As I noted in the description of the case this was based on current controversies in the US relating to a particular piece of research, and the regulatory response to this research. As such there has been plenty written about it, and rather than rehash all of these discussions, I thought it would be helpful to focus on the central question that I put forward in the case – should the researchers simply describe the risks as “no more than those in ordinary practice” or should they detail these possible risks?
Both paths have risks attached to them – describing them as ordinary practice may underplay the risks involved, however fully detailing them may prevent some parents enrolling their children despite the same risks applying to them outside the study.
This is difficult to settle retrospectively because knowing the results of the trial clouds our judgment – we now know unfortunately that there was a higher morbidity rate associated with a lower level of oxygen supplementation. While some authors have argued that this shows that parents ought to have been informed about these potential risks, the authors of the SUPPORT study and their defenders have argued that they were in a state of equipoise in regards to the risks, and they didn’t know – indeed were hoping to avoid – that those on lower supplementation would have higher morbidity.
For the sake of the discussion I suggest we take this claim at face value – the authors believed they had no reason to think that participating in the research would expose babies to any risk outside of those already existing in normal practice. Given this what should they disclose?
There seems to me to be two reasons to nonetheless favor wider disclosure over a narrower description of the risks. The first reason is that being part of the research may change the risk profile in some way – so for example, in the SUPPORT trial allocating the patients to the two arms and artificially ensuring lesser or greater supplementation by using rigged oximeters though all the participants are subject to “normal risks” the distribution of those risks are different, since given that normal treatment is a range, many physicians may aim for the middle of the range rather than the extremes. The second reason is simply that the risks can be described in the information sheet as those of normal practice, but it can also be acknowledged that the research may impact on the risks present and/or change their allocation. That way parents who enroll their children in the research, if the worst happens, cannot think this occurred because of the research, and they weren’t given the choice to avoid it.
Given this I favor disclosing risks of normal treatment within participant information sheets.