This manual introduces basic ethical concepts useful for the ethics review of research protocols involving human participants. It intends to help research ethics committees in low-income and middle-income countries to design training programmes for ethics committee members, researchers, national regulatory authorities, medical school faculty and other interested stakeholders from health care and research.
The manual contains six introductory chapters on general topics: the role of research ethics committees, ethical analysis, training programmes, evaluation of risks and benefits, confidentiality, and informed consent, with annexes covering financial conflicts of interest in medical research and international guidelines and regulations.
These materials are presented as a starting-point for a basic research ethics training programme. They are designed to draw attention to critical issues, without necessarily resolving them. They are not intended to be an exhaustive summary of all issues in research ethics. Moreover, they should not be viewed as “guidelines” that committees must follow in reviewing research protocols.