Developing a practical resource to improve the ethical standing of gene therapy trials

By Rosie Munday, Hugh Davies and Stephanie Jones with Oxford “A” Health Research Authority Research Ethics Committee

Oxford “A” NHS REC is one of the four UK Research Ethics Committees flagged to review gene therapy proposals. Following the philosopher Mary Warnock’s sage advice I do not believe you can make moral judgements unless, as far as possible, you know what you are talking about”

On behalf of the committee, we have worked with experts within and outside our committee to record, discuss and hopefully improve our approach by deepening our understanding of both the science and the ethics. It can be found at this link.

Our principles in designing this have been

  1.    It must explore the ethical dimensions of this work.
  2.    It must put it into clinical  context and help REC members see how gene therapy fits into current clinical practice
  3.    We recognise the (universal) principles underpinning good research apply to this as it does to all other research typologies but also see particular issue that we need to explore.
  4.    As a rapidly changing and challenging area, ongoing discussion and sharing of experience with ALL is vital

We present this “work in progress” to seek broader input. It is by no means a finished product. The ethics of these studies is not our monopoly; indeed we firmly promote broader involvement of patients and public alike (PPI). We seek the broader view that JME can provide and we will try to incorporate ideas from all with a legitimate interest so this resource might be of use to all. We think it might help gene therapy researchers applying to RECs or IRBs. At the least, it may indicate how Research Ethics Committees approach these studies. If we are in error, we hope we will be corrected.

Authors: Rosie Munday, Hugh Davies and Stephanie Jones with Oxford “A” Health Research Authority Research Ethics Committee

Competing interests: None declared.

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