In 1974, the United States Congress asked a question prompting a national conversation about ethics: which ethical principles should govern research involving human participants? To embark on an answer, Congress passed the National Research Act, and charged this task to the newly established National Commission for the Protection of Human Subjects…

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members' perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members' perspectives on ethical aspects in applications involving children with severe health conditions. The…

Arab researchers encounter formidable obstacles when conducting and publishing their scientific work. We conducted semi-structured interviews with 17 Arab researchers from various Arab Middle East countries to gain a comprehensive understanding of the difficulties they face in research and publication. We analyzed the transcripts using reflexive…

The Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing…

In this paper we reflect on the looming question of what constitutes expertise in ethics. Based on an empirical program that involved qualitative and quantitative as well as participatory research elements we show that expertise in research ethics and integrity is based on experience in the assessment processes. We then connect traditional…

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…

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article,…

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the…

Key historical landmark research malpractice scandals that shocked the international community (Nazi doctors' experiments, Tuskegee study, Jewish chronic disease experiments, Krugman's Willowbrook hepatitis study) were the origin of the institution of ethics review prior to carrying out research involving humans. Nonetheless, it is plausible that…

The research ethics committee (REC) is a key element of university administration and has gained increasing importance as a review mechanism for those institutions that wish to conduct responsible research, along with safeguarding research ethics standards, scientific merit and human rights of participants. Given the critical role of the…

Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee (REC) member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.

Institutional Review Boards (IRBs) and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function -- the management of risk -- using a flawed theoretical and practical approach. At the time…