There are a number of legitimate and valuable tools for gaining information and evidence for scientific advance and improving health care. These include research, evaluation, audit, and others. There is a real danger that UK “researchers” using tools other than “research”, duly following guidance in UK research regulation stating a lack of need for ethical review, find that journal editors will not consider their manuscript for publication because editors dispute the definition of what needs or does not need ethical review.
Many of these issues, of course, also apply to animal ethics approval.
The remit of Research Ethics Committees (RECs) is the consideration of research, and the Health Research Authority (HRA) holds firmly to the view that health research should undergo independent ethical review. Audit, service evaluation and public health surveillance, usually of minimal risk, are excluded under official policy (GAfREC 2.3.12 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/213753/dh_133993.pdf). Their scrutiny lies elsewhere. While this is contended by some, it can be robustly defended and is current UK policy. Hence “researchers” need to categorise their work at an early stage to determine appropriate review. With its partners, the National Research Ethics Service (now part of HRA) collected the literature in 2009 and devised categorisation (http://www.hra.nhs.uk/documents/2013/09/defining-research.pdf) to help and set up a queries line to arbitrate in case of difficulty. In these it was recognised that there could be no clear, unambiguous answer. Judgement is needed and has to be given if the work is to proceed. In 2013 this guidance was further refined and a decision tool developed (http://www.hra-decisiontools.org.uk/research/).
By and large the distinction is clear (if it looks like a duck, then it is a duck) but difficulties in categorisation can arise and there is the risk that, in following guidance, “researchers” can then be disadvantaged if regulators, reviewers and editors either don’t recognise due regulations or don’t share common guidance. It is a concern that has been voiced on several occasions through our queries line. In such a case there is the possibility that REC review is deemed unnecessary within UK regulation at the beginning but later publication is jeopardised if a journal editor disagrees.
The HRA approached COPE and together it was agreed to put this discussion paper on the COPE website for discussion at the COPE Forum, to seek views and, if possible, establish a common approach which would not disadvantage “researchers” (and would expedite health care work).
Questions for discussion
1. What current guidance do journal editors use to determine if Research Ethics Committee review is mandatory for publication? 2. Can we develop a shared process (using current decision tools) that doesn’t unfairly disadvantage “researchers” (and hinder research based care)? 3. Recognising that in inevitable grey areas, judgement is needed and will vary, can we develop a process to resolve differences between regulators and editors, that doesn’t burden the researcher to start with? 4. Is this a problem beyond the UK and part of what Greg Koski has defined as the creeping “hyperregulation” of research?
Download the PDF for the full discussion