The first of two commentaries on "Respecting Donors to Biobank Research," from the January-February 2013 issue. © 2013 by The Hasti.

This paper discusses the discourse of ‘participation’ in the context of genetic databases. Focusing on UK Biobank, it suggests that this discourse can be seen as a reflexive institutional response to public ambivalence towards science and expertise. Drawing on empirical evidence from focus groups, I explore how people from various backgrounds constructed and contested two different kinds of participation in UK Biobank. The first relates to people providing research materials to genetic databases and the second to people becoming ‘co-decision makers’ (...) in these projects. My analysis highlights how focus groups positioned themselves and others in relation to UK Biobank and drew on a variety of ‘discursive repertoires’, such as altruism, public ignorance, expertise, and lay empowerment. I conclude that discourses of participation reflect the way people position themselves and others - as experts, publics, patients, or research subjects - in relation to the opportunities and uncertainties of new biomedical research. (shrink)

So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of (...) recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 37-38, January 2012.

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)

ABSTRACT There is growing concern about the reuse and exportation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing (...) country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re‐use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels. (shrink)

ABSTRACT With the controversial ethical issues on the creation of human embryos through cloning for therapeutic research, which holds more promise for medical breakthroughs that the world could ever imagine and the acknowledgement by many scientists that this biotechnology may not lead in the near future to therapies; this country report discusses the approach Singapore takes on human stem cell research, interjected with the authors’ own arguments and suggestions especially on research compensation injuries, an often neglected important issue. International comparative (...) viewpoints taken by the major countries in the world are also included in the appendix. (shrink)

It is unclear whether the regulatory distinction between non-identifiable and identifiable information—information used to determine informed consent practices for the use of clinically derived samples for genetic research—is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know (...) about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario. Curiosity-based reasons were the most common among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples. (shrink)

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research (...) on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right. (shrink)