Editorial

Move to SAGE Publications

It is with great pleasure that we publish the first issue of Research Ethics with a new publishing house, SAGE. For those institutions across the globe which subscribe to the standard package of academic journals published by SAGE, articles are now available to download conveniently online along with past issues of the journal, formerly known as Research Ethics Review, which may otherwise have been overlooked or neglected by many interested readers and researchers in the field. There is more good news. As well as a new and comprehensive guide for contributors (found at http://www.uk.sagepub.com/msg/rea.htm), we welcome the introduction of an efficient and impressive online submission system called SAGE Track, which allows authors, reviewers and we editors to keep track of and comment on manuscripts at the click of a button. To register an account as an author or reviewer, you need simply to sign in to Manuscript Central (found at http://mc.manuscriptcentral.com/rea). Away you go.

Call for papers: special issue 2012

Following the highly successful special issue on systems of governance published in 2011, we are now inviting authors to submit articles for our special issue this year to be published in December. The new topic is the ethics and governance of mechanistic or ‘proof of concept’ studies which involve human subjects yet which precede phase I clinical trials and often evade the regulation and oversight associated with formal research and clinical trials. We strongly encourage submissions on this neglected topic and we look forward to reviewing this work which, we hope, will serve to better inform both sponsors and regulators of research on the ethics of these important studies. To submit your article, please use our on-line submission procedure (http://mc.manuscriptcentral.com/rea). The deadline for submissions to be considered for this issue is 1^st September 2012.

New rules for research ethics committees

It would be neglectful for me as Editor not to pick up and discuss the recent changes to policy governing the practice of research ethics committees across the National Health Service in the UK. After a long gestation period, the new edition of the Governance Arrangements for Research Ethics Committee (GAfREC II) came into force across the UK on 1 September 2011 (Department of Health, 2011). Some of the changes to the 2001 edition are bold and controversial, while others are subtle and have been introduced almost without comment, yet are important for those interested in why we have such committees at all and how well they solve the moral difficulties they set out to solve. For institutional review boards and ethics committees outside the UK, this will serve as an interesting, if seemingly remote, experiment which they might do well to watch carefully before making any such changes of their own.

Moves toward introducing ‘proportionate’ review by executive subcommittees, while equally controversial, have been proposed and piloted for a long time, and the new edition merely endorses these now accepted practices (Edwards and Omar, 2008; Hunter, 2007). Perhaps the most controversial change to the remit of ethics committees is to exclude research involving health or social care staff unless it falls under other provisions such as those requiring review of clinical trials. Relaxing the requirement to review research involving health staff seems to need justification if only because it changes the status quo. The new edition helpfully states that the interests and rights of employees are already protected under employment law and the employer already owes them a duty of care. Rather unhelpfully, however, the same document merely states that this duty of care is different from the ‘duty of care that care providers owe to users of their services’ (GAfREC II, 2.3.13). While this is undoubtedly factually true, it is less clear whether they are morally disanalogous. Physician-investigators have potentially conflicting interests whomsoever their subjects. The rules concerning employment do indeed offer some protection for employees, as do professional rules and common law offer some protection for patients and other service users. But, it seems to me that these legal rules do little to mitigate against the investigator’s potentially conflicting interests in either case. We might even think that service staff require more protection as they are vulnerable to manipulation or coercion by virtue of their employment. Service staff may now present both a captive and convenient sample population.

A less obvious but perhaps more welcome change gives ethics committees a higher public profile. This may sound morally redundant or even blatantly political, but has an important basis in their very rationale. If we accept that trust in a social role is the core idea in managing conflicting interests (Erde, 1996), and we accept that ethics committees are necessary to prevent an investigator’s potential conflict of interests becoming morally problematic (Edwards, 2009), it follows that it would not be sufficient for ethics committees simply to review their protocols but that they should also make their work transparent to help justify public trust in the institution of clinical research. Much of the work of ethics committees is still not, however, in the public domain (Ashcroft, 2004), yet GAfREC II puts new emphasis on the need for transparency and public accountability. In particular, members of ethics committees should now be seen to be independent and impartial (amongst other things) as well as being actually free from certain potentially conflicting interests (GAfREC II, 3.2.6). And this clause concerning conflicting interests seems to go further than the previous requirement simply that members must not represent any ‘special interest’ groups. There would indeed seem little point in trying to solve a problem by introducing another in its place. There remains little empirical work, however, on how the public view the work of ethics committees. Despite growing concern to involve the patients and the public in research as commentators or as collaborators, we cannot (yet) be sure that the appearance of ethics committees has the effect on public trust we might expect and intend. Without further study, we do not know whether ethics committees are counter-productive in this regard by diminishing rather than augmenting levels of public trust in research. Their very existence does imply that researchers are not fully trustworthy after all. If this result were to turn out to be true, policy-makers might need to reconsider their simple strategy of involving the public whenever and however they can, and think about engaging the public more fully in informed and interested debate when it really counts and when policy-makers’ trust is truly at stake.