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:
[1]
"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.
http://www.wma.net/e/policy/b3.htm
Saturday, July 14, 2007
Human Tissue Act: Tissue Banks with ongoing ethical approval 1
Saturday, July 07, 2007
Human Tissue Act: Tissue Banks
This post continues the series of posts on the Human Tissue Act. Thus far I have examined when individual applications to use human tissue without consent should and shouldn't be approved. In this post I am going to look at a different issue, the issue around granting approval to a human tissue bank.
A human tissue bank is a store of human tissue that will be used for further, perhaps at this point unknown, research purposes. Classically these were common resources that many universities and hospitals in the UK gathered and human tissue was routinely retained for research purposes, often without explicit consent. To a large degree this and the outcry following the Alder Hey's scandal was what prompted the Human Tissue Act in the UK. However, the government didn't want to simply ban tissue banks since they rightly recognised that this would prevent worthwhile research. So instead the act regulates these tissue banks, ensuring that they meet good practice standards, in particular in regards to storage conditions and consent. This is primarily done by requiring a license from the Human Tissue Authority. However a tissue bank can also voluntarily seek approval of their practices from a National Health Service Research Ethics Committee. While this not a legal requirement, it could be seen as part of good practice. There may also be a bonus for research groups in that it is possible to request ethical approval such that research projects associated with the bank do not need to seek further ethical approval if they are only using tissue from that bank. This can only be granted by a limited number of RECs and in a later post in this series I will explore when RECs ought to approve these applications.
Wednesday, June 27, 2007
The Human Tissue Act: When should applications to not require consent be approved?
This is a continuation of a series of posts on the Human Tissue Act in the UK. It is primarily aimed at trying to work out what the practical implications of the HTA are for members of National Health Service Research Ethics Committees (RECs) and especially highlight the responsibilities it places upon them.
In this post: Human Tissue Act: Intro I noted that the HTA had placed RECs in the potentially difficult position of having to decide when research on human tissue can take place without consent. In this post: HTA Reject I discussed which applications to use human tissue should be rejected. In this post I am going to discuss what sorts of research should be approved to not need consent for the use of human tissue. I should note though that there is definitely still a grey area here, and often whether a project is genuinely justifiable will rely in part on the good it might do.
Some reasonably clear cases:
1. Where there was prior consent to use this tissue for generic research purposes.
While this is arguably a form of consent, given the lack of information the consenter had, it is hard to see how this is informed consent. Nonetheless presuming the research is of worth, this seems straightforwardly the sort of project that could be approved under these provisions.
2. Where consent cannot now be obtained.
This may be because the tissue is a left over diagnostic sample from a person who is now dead. Or it could be that the tissue is old and contacting the person is nearly impossible. Or finally the tissue may have been anonymised so there is no link to the original owner of the tissue. In these cases again presuming the research is of some merit, it seems the REC should give consent.
Some grey areas:
1. Where contacting the donor would be possible but costly or tricky.
This is a grey area because it will depend on how much funding the project has, the merits of the project and how costly or difficult it will be to contact donors.
2. Distressed Proxy consent
These are case where the originator of the tissue cannot now consent for themselves, but another can who may be very distressed by the request. Take for example the parent of a child who has been admitted with acute septicaemia. While you could ask them for consent for their child’s left over blood samples to be used in a research project the quality of this consent would be likely to be poor given the stress they are under. Likewise the very request might cause great distress. It could be argued that this distress should be taken to outweigh the need for consent.
None of this should be taken as definitive, it is instead explorative.
I will explore these issues further in later posts in this series.
Wednesday, June 13, 2007
Human Tissue Act: When shouldn't a request to not require consent be granted
In this post: The Human Tissue Act An open question for Research Ethics Committees Part 1 I introduced a series of posts that I intend to make regarding the Human Tissue Act (In the UK) and it's implications for Research Ethics Committees. I noted that the Human Tissue Act gave RECs the responsibility of deciding when human tissue may be used without seeking consent from the research subject. In this post I'm going to explore some of the cases where I think a request to not require consent shouldn't be granted.
The first and most obvious case would be one where the gathering of consent is easy. Take for example a piece of prospective research intending to use the left over waste blood samples taken from diabetics who have come in for a routine clinic as soon as these samples are gathered. It really adds minimal cost or hassle to get properly informed consent in this scenario, so an application to waive the need for informed consent ought not be approved.
Harder cases are when there is some hassle or cost involved in getting informed consent, where for example the patient is not competent, or the sample is older and the patient needs to be contacted via mail. Nonetheless I am inclined to think that in many of these cases if the collection of the sample is routine rather than urgent, or if the patient is contactable then RECs should be reluctant to not require informed consent.
Do you have any other cases to suggest?
In the next part of this series I will discuss when these applications should be approved.
Saturday, May 26, 2007
The Human Tissue Act An open question for Research Ethics Committees Part 1
The Human Tissue Act, aside from the existence of Research Ethics Committees themselves is perhaps the most complained about thing currently in the UK research environment. It is easy to see why, it is an extremely complicated act, covering many different areas, not just research. In this series of posts I want to explore some of the implications of the HTA for research and for National Health Service Research Ethics Committees (RECS).
In this particular post I want to explore something that the Human Tissue Act explicitly thrusts onto RECS. This is deciding when researchers do not need to get consent to use human tissue for research purposes. The act makes it lawful to use (note not collect, this is governed by common law) human tissue for research purposes if it is properly anonymised, and if it is approved of by a recognised research ethics committee. This like many items in the act is presumably intended to play a balancing role between the need to foster good quality research on one hand and on the other to respect people's rights to control their body and material derived from their body.
However this leaves a REC in the uncomfortable position of deciding when they ought to allow research to proceed, and when they ought to require explicit consent. It could be the case that RECs should simply allow all such research since it would be lawful, but this misses the point of requiring REC approval, if it was just a rubber stamp then why require it legislatively?
Surprisingly there has been no guidance issued by the National Research Ethics Service and there is little in the literature specifically about this. (Although there is much which indirectly bears on it.)
The next entry in this series will speculate on some cases when a REC should permit this, and some cases when it should reject this.
