Slaves to consent?

Nature reports that in response to analysis done by bioethicist Robert Streiffer (and published in the Hastings Center Report), Stanford University may withdraw the use for research of several of its publicly funded stem cell lines because of concerns about consent. In 2001 President Bush decreed that only lines already in existence would be eligible for federal funding – 21 lines were subsequently approved by the NIH.

Streiffer’s article examines the consent forms used in the original obtaining of the embryos from which the lines were generated. He finds that the consent is deficient in two important respects: “they omit information that is important for informed consent and they set restrictions that obstruct key areas of research.” Streiffer concludes that there are grave ethical concerns about the continued use of these lines.

Clearly, obtaining informed consent is important but the question that is not raised by Streiffer is the extent to which it is overridingly important. There are many easy examples of ethics committee decisions that we take to be justified in which consent is not the primary concern. We think for example that there are some risks of harm that are too great for anyone to consent to. If proposed research involved such risks people would not be given the chance to consent. Similarly there is some research that, in virtue of methodological constraints, cannot be performed if consent is required – some observational research is fits into this category. Finally there is good evidence that prospective participants systematically misunderstand the point and context of certain kinds of research. Very few would be inclined, in the face of this evidence, to withdraw all research in which misunderstanding of the research was shown to be possible or even likely for a non-trivial percentage of participants. Given participants’ misunderstanding of randomisation and equipoise the RCT would almost be an historical artefact.

In making decisions about ethically acceptable research we are required to balance considerations – including, in some cases, the extent and quality of the informed consent that is obtained. In some cases, requiring only some imperfect consent may be justified by the nature of the harms involved and the importance of the research. We might think for example that certain kinds of misunderstanding which clearly could compromise fully informed consent were too difficult and costly to manage in the context of particularly pressing and under-funded research.

In the case at hand, it certainly seems to be the true that the consent process involved in procuring the embryos on which the stem cell lines are based was far from ideal. However the NIH decision – that is, the decision about whether it was ethically permissible to use these lines in research given the Bush stipulation about only using established lines – when understood in the broader context in which consent is one of a number of considerations seems a sensible one. There was consent, albeit flawed, but there were only limited stem cell lines that would qualify under the Bush stipulation and the research certainly holds the promise of great benefit.

Comments

[Robert Streiffer]

I appreciate your thoughtful comments on my Hastings Center Report article, “Informed Consent and Federal Funding for Stem Cell Research,” and would like to make a few points in response.

First, it is worth noting that the NIH was not and is not authorized to make the kind of balancing judgment that you are recommending for them, which would allow funding a cell line derived without informed consent from the embryo donors on the grounds of other values. Lines eligible for federal funding have to meet all the criteria set out in Bush’s policy, and one of those was informed consent from the embryo donors. Given the standards for what information is necessary for consent to embryo donation to be informed (also summarized in the article), that standard was clearly not met in a variety of ways, as detailed in the article.

Second, my argument did not start with the premise that informed consent is always morally required for human subjects research. Rather, it started with the narrower claim that permissible hESC research is limited to lines derived with informed consent from the embryo donors. Although you are correct that there are lots of examples of human subjects research that are permissible without informed consent, “Informed Consent” makes the case that this has never been accepted in the context of hESC research or other research involving the donation of human embryos. (There are important philosophical and social/cultural questions as to _why_ embryo donation is different, but it is clear _that_ it is.) Since research involving embryo donation is what is at issue here, your examples from other contexts are not probative.

Third, even if it were true that a lack of informed consent for embryo donation for research is not always required, it would still be true that research with hESC lines derived with informed consent is, other things equal, morally preferable to research with lines derived without informed consent. The main argument in “Informed Consent” is that we now have a significantly better understanding of how to do informed consent in the context of embryo donation for hESC research, and, therefore, (yet) another reason for overturning Bush’s policy is that it doesn’t allow us to use federal funds to capitalize on that knowledge. So far as I can see, your claim that informed consent is not always required would, even if true, leave that argument intact.

[Mark Sheehan]

Dear Robert

Thanks for your comments. A few remarks on your points. I don’t know the details of the specific, legal authorization of the NIH in this regard. If it turns out that they weren’t authorised then perhaps my argument means that they should have been.

My point about balancing is as much about the judgement of what counts as informed consent as balancing consent against other things. Exactly when the consent is appropriately informed is dependent on other issues. The balancing on my view enters at the stage of what counts as informed consent as well as rather than, as you seem to suggest, after the nature of the consent has been determined. At the limit of course almost no consent is fully informed because we cannot be sure of what will happen. I suspect that at bottom I am sceptical of the standards that you refer to as laying down what counts as informed consent.

In terms of your second point, I guess that I’m not convinced that hESC research is that different in principle from other kinds of research. But that, as you point out is a different issue. Of course my examples fail to be probative on the assumption that hESC research is relevantly different.

I certainly agree with the conclusion of this argument but I’m not entirely convinced that the argument by itself will get us there. As I understand it, the argument here is that Bush’s policy should be overturned because there are ethical reasons (consent related) for thinking that the federally funded lines are problematic. But presumably the Bush line is that stem cell research is (by and large) wrong but we must make a concession to the scientists so they can only have funding for the existing hESC lines. Now perhaps this gets the politics wrong but the underlying point is the same, namely, that the predisposition of the Bush position is against hESC research. Pointing out that the currently available lines are ethically problematic will only tell against the Bush position if that position is committed to funding for hESC research and that seems unclear.