Identifiable excess surgical tissue is an important resource for medical research but we have become overly restrictive about consent requirements. I suggest we devolve consent to ethics committees for ordinary research projects involving human tissue, retaining the requirement for explicit consent only for those sensitive research situations where there is significant risk of harm to individual interests in privacy.

Can researchers, interested in novel ways to assess HIV seroprevalence among populations which are otherwise hidden, collect condoms that have been discarded on the ground in a public sex environment and test them for HIV? Researchers, who use other types of abandoned samples, such as discarded syringes, hair or saliva samples, or excess biological samples, confront similar issues. This review evaluates whether such abandoned tissues can be studied based on U.S. Code of Federal Regulations and literature on related issues including: (...) research involving banked tissues, blinded seroprevalence studies, and property claims that individuals might make on the samples.It also addresses broader questions of potential for stigma and risk to individuals and communities. The article concludes that the research should be permitted legally because either it does not involve human subjects, or it satisfies the requirements for waiver of consent; and that the research should also be permitted because the ethical principal of avoiding harm to individuals is fully satisfied based on a careful reading of the lessons of the tissue bank, biological property rights, and blinded seroprevalence study debates, as well as a consideration of other potential harms that might be involved. (shrink)

Can researchers, interested in novel ways to assess HIV seroprevalence among populations which are otherwise hidden, collect condoms that have been discarded on the ground in a public sex environment and test them for HIV? Does the Code of Federal Regulations address this question, and if not, what areas of research ethics might provide guidance to an IRB considering such a study? These questions arose as part of a preliminary study to test the feasibility of collecting discarded condoms from a (...) public sex environment in Massachusetts, and testing contained semen for HIV. Although the methodology of this study is somewhat unusual, the questions raised are not. Researchers, who wish to use other types of abandoned samples such as discarded syringes, hair or saliva samples, or even excess biological samples, commonly confront similar issues, and the analysis utilized here could guide design and review of other studies. (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)