Research ethics approval: comprehensive mechanisms are essential but not available

Abstract

It is now widely accepted that any research involving humans or identifiable human information should be undertaken according to a pre-specified protocol that is submitted for consideration, comment, guidance, and where appropriate, approval by a properly constituted ethical review committee. Similarly, recent legislation such as the Data Protection Act, Human Tissue Act and Mental Capacity Act emphasize the importance of ethical scrutiny of research on human participants, however, in the UK there is no single, national ethics committee that undertakes research appraisal. The process of ethical review for research involving National Health Service (NHS) patients or staff was formalized only fairly recently (in the history of research in UK). The NHS Research Ethics Service is administered by the National Research Ethics Service (NRES, previously COREC), but is only responsible for providing ethical review for research occurring within the NHS (i.e. involving NHS patients, their relatives or carers or NHS staff). The scrutiny of nonNHS research remains the responsibility of the funding organization or the host institution. Currently, there is no equivalent oversight body to NRES for non-NHS research ethics approval. Most universities have now initiated formal processes for ethical review of nonNHS research, prompted in part by the Economic and Social Research Council requirement for ethical approval for all projects it funds. It has been traditional for some disciplines, noticeably academic psychology and sociology, to insist on ethical approval for all research projects carried out by staff and students, but this practice had neither previously been adopted by all university departments nor been standard policy for all UK Universities or other institutions (e.g. charities). The same ethical imperatives used to establish the process of ethical review in the NHS are applicable to any research involving human participants, or their tissue or information. Although NHS patients may be considered vulnerable, non-NHS patients may be no less vulnerable, and non-patients and workers in other organizations may be as prone to exploitation or harm during research as NHS staff and patients. Respect for the rights of individuals, including the need to protect personal information, should be accorded to all research participants, not only those involved in research within the NHS. It makes sense, then, to generalize the process of ethical review from the NHS to the wider community so why has a central ethical review committee not been introduced? There are probably many reasons, but primary among these is probably the simple fact that it is not always obvious whose responsibility it is to instigate the process of formal review. The NHS has a duty of care to all its patients and staff and the Government Social Research Unit’s framework for ethical assurance of all social research conducted by or for the government is an attempt to produce an umbrella ethical framework for all social research conducted by government departments. But no one seemed to be prepared to assume a duty of care for the rest of the general public. Moreover, setting in place formal procedures costs money, as does ensuring their continuation and, until it seemed as though revenue might be lost though lack of procedure, there was little financial incentive for academic institutions, for example, to set up processes that their researchers probably felt simply impeded research anyway. Of course all journals, not just medical ones, could have insisted many years ago on some proof of ethical approval before publishing research on humans or using personal data. This might have led to less research that did not have appropriate research ethics committee approval being published, although it may not necessarily have avoided the research being undertaken. The decision about what counts as evidence of ethical approval is not, however, straightforward. Where local committees have been instigated it can be difficult for journals to be certain that the committees giving approval are properly constituted and experienced. Medical journals face this problem with regard to research that does not originate from ‘developed’ [we have taken the term from the Committee on Publication Ethics (COPE)] countries (see for instance, case 03/12