Lay REC members: patient or public?

Abstract

In practice, the role of lay members of research ethics committees (RECs) often involves checking the accessibility of written materials, checking that the practical needs of participants have been considered and ensuring that a lay summary of the research will be produced. In this brief report, I argue that all these tasks would be more effectively carried out through a process of patient involvement (PI) in research projects prior to ethical review. Involving patients with direct experience of the topic under investigation brings added value beyond the contributions typically made by lay REC members, who are often not patients themselves. This is because PI tailors the design and conduct of research to the specific interests and concerns of the people who will actually take part in a project and make use of its findings. If a project has PI in its early stages, then a similar input from lay REC members could at best result in duplication of effort and at worst create the potential for conflict. The rationale for lay REC membership will therefore need to change from 'contributing a patient perspective' to 'ensuring transparency and public accountability in REC decisions'. This has implications for addressing more strategic questions about lay REC membership, including who is best recruited to the role and how they should be expected to contribute in practice.

Public involvement could usefully inform ethical review, but rarely does: what are the implications?

“…Public involvement in the design stage of research, prior to ethical review, has the potential to increase the ethical acceptability of the research, and to facilitate the decision-making process for RECs [ 3 , 4 , 21 ]. This review of the researchers’ reports of involvement in the IRAS application forms, suggests that many researchers may still be unclear about this particular added-value of involvement.…”

“…Involving the public 1 in research prior to REC review helps to design studies that are ethically acceptable to the people who will be taking part [ 2 – 6 ]. Public involvement addresses the issues of main concern to REC decision-making [ 7 ], by helping to ensure that: the research genuinely reflects the interests of the people who will potentially benefit the study design is ethically acceptable to participants and their practical and support needs will be met the process of obtaining consent genuinely informs potential participants the findings will be communicated to participants and the wider public [ 3 , 4 ] …”

Integrating Scientific Review, Ethical Assessment and the Patient Perspective in Clinical Studies - Two Cases

“…For patients, we developed membership criteria including higher education, interest in research, and ability to communicate in English with lay persons and scientists. This is in line with the proposed function and review role as described for professionals [6] and patients [14,15]. These boards reviewed and advised on study protocols, patient information sheets and informed consent forms (PIS-ICFs), and monitor all ethical, scientific conduct or safety issues arising during the study.…”

“…Commitment should however not be compromised by providing incentives for members apart from reimbursement of expenses. We emphasise that the single integration of the different perspectives, the obligation to have patients as members of the ethics committee [7,14], and the collaborative development of appropriate tools to engage all members of a legal ethics committee or competent authority need to be established for research ethics assessments in current medical research.…”

Science review in research ethics committees: Double jeopardy?

“…Thus, student research is subject to academic critique by the supervisory team in the university (Humphreys, 2008), any statistical arrangements required in the research need to be verified by an independent statistician before submission of the protocol can be made to the REC (Williamson et al, 2000), and use of radiation has to be approved by a medical physicist. Staley (2012) has also pointed out that where there is evidence of adequate prior patient involvement in the planning of research, the RECs might also accept this evidence as demonstrative of patients being broadly content with the research proposed. RECs receive confirmation that such scrutiny has taken place.…”