The Mental Capacity Act 2005 placed for the first time research concerning adults lacking mental capacity upon a statutory footing. However, while the legislation which regulates the inclusion of such adults in ‘intrusive research’ safeguards researchers and research participants alike some controversy remains as to its implementation. This paper focuses upon two specific issues raised by the legislation. First, what constitutes ‘intrusive’ research and whether all issues concerning research involving adults lacking mental capacity should be referred to NHS research ethics (...) committees. Secondly, the role of one of the statutory safeguards–the ‘consultee’. These are individuals who are to be consulted regarding the inclusion of adults lacking mental capacity in research. It contrasts the ‘personal’ and ‘nominated’ consultees and considers whether there is a risk that the legislation may result in a new ‘quasi profession’ of consultees in the future. (shrink)

This study aims to provide an overview of RECs (research ethics committees) in Chinese universities, encompassing both medical and non-medical studies. The primary objective is to identify major challenges faced by RECs in Chinese universities and draw meaningful implications from the findings. The investigation focuses on 42 comprehensive Chinese universities, and the results reveal that while all universities have implemented RECs in various forms, only 28.6% explicitly stipulate ethical review requirements for non-medical disciplines. Furthermore, RECs in Chinese universities encounter various (...) challenges, including insufficient attention to research ethics review, inadequate ethics review systems and regulations, a lack of education and training, and lacking ethics review for non-medical research. This paper proposes recommendations for establishing robust RECs in Chinese universities, seeking to enhance ethical governance in research. By addressing the challenges identified, these recommendations aim to strengthen ethical oversight, foster a culture of responsible research, and uphold the highest ethical standards across diverse academic disciplines. (shrink)

There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation (...) it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion. (shrink)

While ethical norms for conducting academic research in the United Kingdom are relatively clear, there is little empirical understanding of how university research ethics committees (RECs) themselves operate and whether they are seen to operate well. In this article, we offer insights from a project focused on the Scottish university context. We deployed a three-sided qualitative approach: (i) document analysis; (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings. We found that RECs have diverse (...) operation and vary in terms of what members understand to be the remit of their REC and what should constitute the content of ethics review. Overall, though, most participants perceive university RECs as operating well. When asked what they consider to be areas for further improvement, most commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities; more accurate reflection of the REC role as part of the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment, and, for the members themselves, their career advancement. Based on our findings and subsequent discussions during an end-of-project roundtable with stakeholders, we propose a model of collaboration that can address some of the identified areas that could benefit from further improvement. This model would facilitate a heightened awareness of the importance of supporting REC members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible. (shrink)