There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department of (...) Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

A global health archive consisting of podoconiosis tissue slides and blocks, was donated to Brighton & Sussex Medical School in 2014. There is little guidance on the socioethical and legal issues surrounding the retrospective use of archived or ‘abandoned’ tissue samples, which poses a number of questions relating to the ethical standing of the archive. There is a great deal of interpretation in the guidelines that are currently in existence; however, modern ethical principles cannot be applied as it is not (...) feasible to either reconsent or retrospectively seek approval. Our research team believed that it was unethical to leave the archive in storage, as this option favours neither researcher nor subjects. Permission was obtained from the Human Tissue Authority and a local ethics board for the tissues to be utilized in on-going research on podoconiosis aetiology. There is a delicate balance between the benefits gained by society relating to the development and progress of scientific research and the risks to the donor regarding the reuse of their tissues. Clearer guidelines should be made available to ensure that researchers are able to reuse tissue archives in contemporary research. (shrink)

Freely given informed consent to participation is the ethical cornerstone of research in health care. However, in mental health settings, there are many patients who lack the capacity to give such consent to participate in research. There is an abundance of guidance now available on how researchers might think about this issue and the Royal College of Psychiatrists has also recently reviewed its guidance to members about the ethics of research. In this piece, I will discuss some of the issues (...) that were raised during the revision process, and add some reflections of my own. (shrink)