The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research (...) sites in the Western Cape and Gauteng, South Africa. (shrink)

The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is thus unsurprising (...) then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks. (shrink)

The empirical literature on the ethical, legal, and social implications of biobanking has almost entirely relied on the perspectives of those outside of biobanks, such as the general public, researchers, and specimen contributors. Little attention has been paid to the perspectives and practices of those who operate biobanks. We conducted a study of U.S. biobanks consisting of six in-depth case studies and a large online survey, which was developed from the case study results. The case studies included qualitative interviews with (...) a total of 24 personnel. Both interview and survey questions focused on how biobanks operate, and what policies and practices govern their relationships with specimen contributors and the researchers who use the specimens. Analysis revealed unexpected ethical dilemmas embedded in those policies and practices that highlight a need for practical planning. In this paper, we review three issues seldom explored in the ELSI literature: 1. the discrepancy between biobankers’ hope that the bank will exist “permanently” and the fact that funding is limited; 2. the lack of planning for what will happen to the specimens if the bank closes; and 3. the concern that once collected, specimens may be underutilized. These dilemmas are missing from current public representations of biobanks, which instead focus on the intrinsic value in storing specimens as essential to the advancement of translational research. We argue that attention to these issues is important for biobanking, and that greater transparency of these policies and practices will contribute to promoting public trust in biobanks. (shrink)

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in (...) the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework. (shrink)

Biobanking is a relatively new concept in Egypt. Building a good relationship with different stakeholders is essential for the social sustainability of biobanks. To establish this relationship, it is necessary to assess the attitude of different groups towards this concept. The objective of this work is to assess the knowledge, attitude, and opinions of Egyptian patients towards biobanking issues. We designed a structured survey to be administered to patients coming to the outpatient clinics in 3 university hospitals in Egypt. The (...) survey included questions estimating the level of knowledge about the term “Biobank”, together with questions about the attitudes and opinions about related issues. Two hundred and fifty-nine patients participated in the survey. Eighty-one percent of participants reported that they never heard about the term before. About 85% expressed that they would be willing to donate their samples for research and about 87% thought that sample donation did not contradict their religious beliefs. Fifty eight percent were willing to participate in a genetic research project, 27.8% supported sharing their sample with pharmaceutical companies, and 32.4% agreed to share their samples with institutions abroad. Although there is limited knowledge about biobanking among Egyptian patients, many had a positive attitude towards sample donation and didn’t show religious concerns against it. However, they showed concerns regarding participation in genetic research and with sharing their samples across borders or with pharmaceutical companies. Public education about biobanking is possible, taking into consideration the specific cultural and legal framework in Egypt. (shrink)