ABSTRACT Objective: To describe how local research ethics committees (LRECs) consider and apply research ethics in the evaluation of biomedical research proposals. Design: A qualitative study was conducted using purposeful sampling, focus groups and a grounded theory approach to generate data and to analyse the work of the LRECs. Setting and participants: 11 LRECs of the Mexican Institute of Social Security (IMSS). Results: LRECs considered ethics to be implicit in all types of research, but that ethics reviews were only necessary (...) for projects that included the direct participation of human beings. The LRECs appeared to understand the importance of consent, as in the completion of a consent form, but did not emphasise the importance of the process of acquiring ‘informed’ consent. The committees considered their main roles or functions to be: (a) to improve the methodological quality of research and to verify – if applicable – the ethical aspects; (b) to encourage personnel to undergo research training; (c) to follow‐up research to oversee the adherence to norms and compliance with a specified research timetable. Conclusions: This study provides a valuable insight into how these LRECs understand the ethical review process. The emphasis of the committees was on rules, regulations, improving research methodology and research training, rather than a focus on efforts to protect the rights and well being of research subjects. The results encourage further normative and descriptive lines of investigation concerning education and the development of LRECs. (shrink)

It is hypothesised and argued that “the four principles of medical ethics” can explain and justify, alone or in combination, all the substantive and universalisable claims of medical ethics and probably of ethics more generally. A request is renewed for falsification of this hypothesis showing reason to reject any one of the principles or to require any additional principle(s) that can’t be explained by one or some combination of the four principles. This approach is argued to be compatible with a (...) wide variety of moral theories that are often themselves mutually incompatible. It affords a way forward in the context of intercultural ethics, that treads the delicate path between moral relativism and moral imperialism. Reasons are given for regarding the principle of respect for autonomy as “first among equals”, not least because it is a necessary component of aspects of the other three. A plea is made for bioethicists to celebrate the approach as a basis for global moral ecumenism rather than mistakenly perceiving and denigrating it as an attempt at global moral imperialism. (shrink)