The Ad Hoc Advisory Group's proposals for research ethics committees: a mixture of the timid, the revolutionary, and the bizarre.

T he Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees (AHAG) is a curious document. The remit of the review was focused on the workings and effectiveness of NHS research ethics committees (both the local committees (LRECs) and the multicentre committees (MRECs)). The Group was primarily set up in response to a series of complaints from medical researchers about the new research governance regime in the UK as a result of the Clinical Trials Directive and the Governance Arrangements for NHS Research Ethics Committees. The opportunity was also taken to consider the role of research ethics committees in a wider context, and take account of recent developments in relation to the ethics review of social care research, student projects, as well as recent legislation such as the Human Tissue Act, and the Mental Capacity Act. However, the resulting report is a strange mixture of the timid, the revolutionary, and the bizarre. A good example of the report’s timidity is its reluctance to propose fundamental change to the process of review or seriously limit the type of research that requires REC review. To its credit AHAG does suggest that some research ‘especially surveys and many studies on NHS staff, could normally be conducted safely without a requirement for REC review’ (section 3.1). This is, of course, to be welcomed. However, the report ultimately seems dismissive of the general complaint from researchers that the current process is inappropriately uniform. For example, in section 3.2, it is argued that the ‘common perception that the NHS REC system is dominated by the review of clinical trials’ is a mistake. This claim is supported by the statistic that only 15% of applications are for such trials. However, this misses the point. The objection is to the fact that the system and the application form are designed with clinical trials in mind. Even if this system is appropriate for clinical trials, and this might be doubted, it is not clear that the same system is appropriate for all types of research. In essence, AHAG fails to acknowledge the diversity of research that comes before NHS committees. Given this diversity, it is not clear that one form, one process, and one committee structure is appropriate. Rather, the review of research ought to be proportionate to the possibility of harm resulting from the research and should seek to balance any possible harm against other considerations. Whilst it must be acknowledged that research may cause harm, the current system does not seem to recognise that such risks differ to a significant degree depending upon the nature of the study and the methodology employed. Currently, the degree of ethics review and scrutiny is not correlated with the degree of risk to participants. Research must go to an NHS REC if the research falls into particular categories—for example, if it involves NHS patients, NHS staff, or is carried out on NHS property—whatever the risk of harm. As a result some research with a serious potential risk of harm does not need NHS review even when it has potential clinical application—for example, a piece of physiology research into the affects of reduced oxygen intake conducted in a university—whereas some health care research with a very low risk of harm does need to be reviewed—for example, a nurse talking to her colleagues about their attitudes to a series of ethical issues. Presumably this reluctance to consider more wide-ranging reform for the review process is a result of AHAG’s acceptance that the current system is the best way to prevent harm to research participants. What is strange about this is the apparent unwillingness to judge potential benefits from research along with those possible harms. Surely, any such review of research should begin with an acknowledgement of the benefits that much clinical research brings? If you look for this in the AHAG Report you will be disappointed. While the report notes the importance of promoting ‘research of real value’ (section 2.6) it never mentions the benefits that might come from clinical research, such as the reduction in mortality as a result of research into childhood cancer. AHAG seem to miss the idea that whilst research ethics committees should take the risk of harm seriously, they should balance it against other considerations. Sometimes these other considerations should take priority. This same attitude was also visible in the earlier Doyal Report recommending the adoption of Student Project Ethics Committees (SPECs). That report fails to take seriously the benefits to us all from having suitably trained health care researchers, and the need for them to be involved in clinical research at an early stage in their careers. Instead, Doyal’s central claim is that student projects are not primarily about the production of research but the training and/or education of the student-researchers. They suggest that this means that such ‘research’ potentially breached the Declaration of Helsinki as the benefits of the research to the participants do not clearly outweigh any risk of harm. However, an alternative conclusion would be that it is inappropriate to use Helsinki to judge student projects, as they are not medical research and do not, generally, pose the dangers to patients that may result from, say, drug trials. A second year medical student project asking ten people with diabetes about their quality of life does not need to be dealt with in a similar way to a randomised controlled trial funded by a large pharmaceutical company. It is vital that governance arrangements are proportionate to the risk of harm likely to result from the proposed intervention. Unfortunately, AHAG seem to support the move towards the creation of SPECs, although their exact intentions (in point 13, appendix 3) are rather opaque. What is clear is their support for separate new committees to review phase 1 trials and social care research. No clear justification is given for this multiplication of committees, and it is striking that they will all to be based around different categories of research, rather than related to any potential degree of risk related to the research. EDITORIAL 435