Saturday, July 14, 2007

Human Tissue Act: Tissue Banks with ongoing ethical approval 1

This post continues continuing the series on the implications of the Human Tissue Act for research ethics committees (RECs) within the UK. In the last post in the series: Tissue Banks I noted that at the moment seeking ethical approval for a tissue bank is voluntary. However I also pointed out that you can get approval for a tissue bank, such that researcher don't need to seek further ethical approval to carry out research on its tissue.

The advantage to researchers of doing this is clear, it saves them time and hassle both in terms of filling out forms and in terms of waiting for research ethics committee approval. Particularly for long ongoing multi-part studies this could be a real boon.

However it places RECs in a bit of a tricky position, because while they are interested in facilitating research they also want to ensure that appropriate scrutiny is given to each project. So the question really is what sort of tissue banks should be approved of to no longer need ethical approval?

I should note before I begin this discussion that these are just my preliminary thoughts, and I will no doubt revise my position after further reflection and discussion.

To start off with, I should note this is a somewhat odd addition to the powers of a REC, as far as I can tell, it is not something that anybody associated with REC or in the wider bioethics literature has argued for. Which in some ways makes deciding what to approve more difficult, because there has been very little discussion of it.

There are roughly three options for RECs faced with these sorts of decisions.

1. approve none of these applications
2. approve some
3. approve all

While I think the third option is clearly out, the first bears at least some consideration before we move on to consider the second option.

There are two reasons a REC might feel that it could never approve these sorts of applications. The first reason is that it may be felt that this is never ethically acceptable, that all medical research requires review by an independent REC. This seems to be the position put forward in the Declaration of Helsinki:

"The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol
should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects."

So REC members could reject all of these applications on the grounds that they are never ethically acceptable.

The second ground on which REC members could reject these applications is that they may not feel that they are in a position to make the kinds of decisions required to allow these banks to go ahead. This is because this is a significant change in the role of a REC. Typically REC's are deciding on a case by case basis. But this is instead more of a structural decision, not something RECs are typically expert in. In other words REC's are used to looking at the issues involving one research project where these are relatively spelt out for them, not deciding how an ongoing series of research projects should be governed and administered to ensure they are ethical. It is an entirely different kettle of fish. As such it may be appropriate to refuse to make these decisions and simply maintain the old system of deciding on a case by case basis.

I think both these arguments have at least something going for them, and so we should be very cautious about which tissue banks get approved to not need further ethical approval. However I also think there are some limited circumstances in which these banks may be approved. I will discuss those circumstances in the next post in this series.

1. World Medical Association, Ethical Principles for Medical Research Involving
Human Subjects (Declaration of Helsinki), last updated Tokyo, 2004.

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