Palliative care research protocols: a special case for ethical review?

Abstract

Between October 2001 and May 2002 the Chairperson and Vice-Chairperson of each Multicentre Research Ethics Committee (MREC) in England, Wales and Scotland took part in a semi-structured interview to ascertain the attitudes of MRECs to palliative care research. Interviews were transcribed and analysed using a grounded theory approach. Most respondents said each protocol was reviewed on its own merits, according to broad ethical principles, but were equivocal as to whether palliative care protocols posed particular or different challenges compared to those from other specialties. Respondents said they reviewed only a small number of palliative care protocols, and that they were less experienced with some of the study methods utilized, particularly qualitative designs. Four main themes emerged from the analysis. Respondents expressed concerns about the protocol itself – in regard to safeguarding the principles of autonomy and justice. There were concerns about how the research would be carried out, especially the protection of patients and the influence and input of the researcher in the process. The third theme concerned the impact of the research on the participant, particularly intrusion, potential distress and the existence of support mechanisms. Fourthly, respondents identified patient groups receiving palliative care (children, the elderly, bereaved families, patients in intensive therapy units, and those from ethnic groupings), who they considered might be particularly vulnerable.