Biobanks are an international phenomenon today and promise solutions to hitherto unanswered questions in biomedical research. However, though India may benefit from biobanking activities and output, the regulatory landscape for biobanks remains woefully inadequate. The Guidelines of the Indian Council of Medical Research, which prescribe the conditions for the operation of biobanks, do not adequately address the concerns that emerge in view of the socio-politico-economic backdrop peculiar to the Indian situation. The lack of awareness and understanding of the implications of (...) bioethical issues and requirements on the part of research participants, and inadequate engagement with these issues and requirements on the part of interested personnel could exacerbate growing concerns over effective scientific and ethical management of biobanks, especially commercial ones that have emerged. The role of the State is to be highlighted here as facilitator of such research, mindful of the developmental and health-related needs of the Indian people, regulator of such research, ensuring ethical and regulatory requirements are met, and enabler of access to the productive outcomes of such research, keeping in mind the principles of egalitarian distribution of common resources for the good of all. (shrink)

Background Interest in biobanking for collection of specimens for non-communicable diseases research has grown in recent times. This paper explores the perspectives of Nigerians on donation of specimen for the biobanking research. Methods We conducted 16 Focus Group Discussions (FGD) with individuals from different ethnic, age and socio-economic groups in Kano (North), Enugu (Southeast), Oyo States (Southwest) and Abuja, the Federal Capital Territory (Central) of Nigeria. We used topic guides and prompt statements to explore the knowledge and understanding of interviewees (...) to general issues about biobanking of biospecimens, their use and specifically about role of biobanking in non-communicable diseases research. Results A total of 123 individuals participated in 16 focus group discussions in 2011. Our participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it and saw it as a worthwhile venture. Half of our study participants supported use of broad consent, a quarter supported restricted consent while the remaining quarter were in favour of tiered consent. Most discussants support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. The majority preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the course of the research instead of financial compensation. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs. Conclusions Our study demonstrates that our participants accepted biobanking once they understand it but there were different attitudes to elements of biobanking such as type of consent. Our study highlights the need to carefully document population attitudes to elements of modern scientific research and the consenting process. (shrink)

Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical concerns actually (...) addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system. (shrink)

Mainstream academic debate on the ethics of human gene editing is currently not as inclusive as it should be. For example, it currently does not give due consideration to Indigenous groups and cultures, such as those living in rural and remote areas of Canada. Once such people are given due consideration, then several important points emerge, which have so far gone unnoticed or under‐emphasized in the debate. This article focuses on two of those points: (a) Some vulnerable people who are (...) currently being ignored in the debate may not desire to use gene editing, even if it is safe, effective and affordable, and they will have compelling reasons for making this decision; and (b) even if such people do decide to use the technology, the gene editing enterprise itself is unlikely to do much good for them (and may even be harmful to them), as it alarmingly misses the point regarding the underlying contributing causes of the most pressing problems that those people are facing. Therefore, the promise of the gene editing enterprise is a hollow one for some groups of vulnerable people. These considerations should be used more prominently to guide debate on the ethics of human gene editing. (shrink)

In July 2020, the H3Africa Ethics and Community Engagement (E&CE) Working Group organised a webinar with ethics committee members and biomedical researchers from various African institutions throughout the Continent to discuss the issue of whether and how biological samples for scientific research may be accessed by commercial entities when broad consents obtained for the samples are silent. 128 people including Research Ethics Committee members (10), H3Africa researchers (46) including members of the E&CE working group, biomedical researchers not associated with H3Africa (...) (27), representatives from the National Institutes of Health (16) and 10 other participants attended the webinar and shared their views. Several major themes emerged during the webinar, with the topics of broad versus explicit informed consent, defining commercial use, legacy samples and benefit sharing prevailing in the discussion. This report describes the consensus concerns and recommendations raised during the meeting and will be informative for future research on ethical considerations for genomic research in the African research context. (shrink)

Biobanks are designed with particular purposes in mind. These purposes are reflected in the governance frameworks that define the conditions for participation and access by researchers. In this paper, I analyse two different models: the commercially aligned deCODE biobank and the ‘public good’ framework of UK Biobank. These diametric models have both featured ‘the public interest’ as pivotal to their achievements. However, if properly understood, the public interest rhetoric of deCODE actually conflicts with any professed community interest. The reasons why (...) are explained, and the effects this has on conditions for participation are critiqued, before reflecting on how each model might have an impact on reproductive health research. (shrink)