Developing a practical, accessible resource to support Research Ethics Committees reviewing gene therapy trials.
Authors: Rosie Munday, Hugh Davies and Stephanie Jones with the Oxford “A” Health Research Authority Research Ethics Committee.
Following much public criticism of the oversight of medical research in the 1960s (Pappworth, Beecher, Beecher 2), for the last 50 years it’s been a requirement that clinical research involving human participants undergoes independent scrutiny. Research Ethics Committees (RECs) are one part of this regulation and operate under authority that derives from international guidance such as the World Medical Association’s Declaration of Helsinki, the International Commission on Harmonization (ICH)’s Good clinical practice (GCP) and International and National law.
In the UK, these RECs are overseen by the UK Health Research Authority, which , recognising the need for specialist competence has flagged four UK Research Ethics Committees to review gene therapy proposals.
Oxford “A” NHS REC is one such and, 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” (Mary Warnock 1998 An Intelligent person’s guide to ethics), we’ve worked with experts within and outside our committee to record, discuss and hopefully improve our approach.
Our principles in designing our website with these resources have been:
It must demonstrably support review and address the needs of both the new and experienced reviewer.
It should help REC members see how gene therapy fits into current clinical practice.
It should provide an overview. We are not qualified to give a detailed understanding of the science.
The (universal) principles underpinning good research apply to this as it does to all other research typologies.
As a rapidly changing area, ongoing discussion and sharing of experience with ALL is vital.
In our website http://www.reviewingresearch.com/gene-therapy-research/ you can currently find ten pages/sections to support RECs reviewing gene therapy trials:
1. Common terms and their meaning
The jargon in this area can be daunting, so we provide a list of the common technical words and terms.
2. The science and its clinical value
An introduction to the underpinning science, gene therapies and gene editing, with some clinical applications. This is provided as background. A full understanding is not necessary for all on a REC.
3. A Gene Therapy Timeline
A short history of gene therapy - we’ll try to keep this up to date!
4. Gene therapy: particular KEY issues
The differences between gene therapy and “traditional” research (while recognising there are many similarities) and the particular challenging issues RECs may meet.
5. Starting ethical review
Ethical review can start with seven steps. The first four are captured by the well-known acronym “P.I.C.O.” (Population, Intervention, Comparator, Outcome), but we tentatively add three more “Cs” – Consent, Confidentiality and Compensation to make “P.I.C.O.C.C.C.”
6. An Ethical Review Template
A structure based on the UK Health Research Authority’s ethical review template to help review.
7. Principles of good research
A framework of principles/questions that underpin good or “ethical” research with considerations of the issues that arise in gene therapy research.
8. Seeking consent
General issues on seeking consent and then particular, key issues for gene therapy research.
9. Discussion forum
Case studies to discuss and to which we hope to add so we can capture current topical concerns.
10. References and resources
Some gene therapy related resources.
We present this as a “work in progress” to seek broader input. It is by no means a finished product and given the changing face of gene therapy, it probably never will be!
It’s important for us to recognise that the ethics of these studies is not our monopoly; indeed we firmly promote broader involvement of patients and public alike (PPI). 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 and that’s our reason to present this as a blog for BSGCT, to seek feedback from experts in the field.
We hope you will be able to help us by sending your feedback on any comments on our work directly to us via the form on our website.