Ethical Norms and the International Governance of Genetic Databases and Biobanks: Findings from an International Study

Capron, Alexander Morgan; Mauron, Alex; Elger, Bernice Simone; Boggio, Andrea; Ganguli‐Mitra, Agomoni; Biller‐Andorno, Nikola

doi:10.1353/ken.0.0278

Cited by 44 publications

(14 citation statements)

References 15 publications

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“…Generally, experts were more positive about biobanking because they had greater knowledge of the issue than non-experts and they all shared very positive attitudes (87,141). However, even the experts did not always share their enthusiasm toward all aspects of biobanking (134). Similar findings were noted by ERB members: although they would often disagree on many issues relevant to biobanking, a broad general agreement was nearly always present among them (112,118,142).…”

Section: Resultsmentioning

confidence: 99%

Ethical aspects of human biobanks: a systematic review

et al. 2011

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AimTo systematically assess the existing literature on ethical aspects of human biobanks.MethodWe searched the Web of Science and PubMed databases to find studies addressing ethical problems in biobanks with no limits set (study design, study population, time period, or language of publication). All identified articles published until November 2010 were included. We analyzed the type of published articles, journals publishing them, involvement of countries/institutions, year of publication, and citations received, and qualitatively assessed every article in order to identify ethical issues addressed by the majority of published research on human biobanking.ResultsHundred and fifty four studies satisfied our review criteria. The studies mainly came from highly developed countries and were all published in the last two decades, with over half of them published in 2009 or 2010. They most commonly discussed the informed consent, privacy and identifiability, return of results to participants, importance of public trust, involvement of children, commercialization, the role of ethics boards, international data exchange, ownership of samples, and benefit sharing.ConclusionsThe focus on ethical aspects is strongly present through the whole biobanking research field. Although there is a consensus on the old and most typical ethical issues, with further development of the field and increasingly complex structure of human biobanks, these issues will likely continue to arise and accumulate, hence requiring constant re-appraisal and continuing discussion.

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Section: Resultsmentioning

confidence: 99%

Ethical aspects of human biobanks: a systematic review

et al. 2011

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“…The issue regarding consent in biobanking is raging worldwide and no real consensus has yet emerged on this issue [48]. It is clear that while consent is important and should be an essential feature of the biobanking process, the notion of informed consent being a core ethical principle may need to be re-examined for biobanking.…”

Section: Discussionmentioning

confidence: 99%

Challenges in biobank governance in Sub-Saharan Africa

Staunton

Moodley

2013

BMC Med Ethics

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BackgroundBiological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples.MethodsA literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found.ResultsIt was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples.ConclusionCollaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.

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“…Although they have existed in some form for over 60 years, their recent surge in numbers, size, and prominence [1] has focused attention on the changing nature of biomedical research and relationships among investigators, research participants, and the organizations that fund and manage these entities [2-9]. This surge in numbers coincides with success in sequencing the human genome in 2003, the subsequent explosion of new bioinformatics technologies and developments in next-generation sequencing [10,11], and the vision of improved health through genomic medicine [12].…”

Section: Introductionmentioning

confidence: 99%

Characterizing biobank organizations in the U.S.: results from a national survey

et al. 2013

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BackgroundEffective translational biomedical research hinges on the operation of 'biobanks,' repositories that assemble, store, and manage collections of human specimens and related data. Some are established intentionally to address particular research needs; many, however, have arisen opportunistically, in a variety of settings and with a variety of expectations regarding their functions and longevity. Despite their rising prominence, little is known about how biobanks are organized and function beyond simple classification systems (government, academia, industry).MethodsIn 2012, we conducted the first national survey of biobanks in the U.S., collecting information on their origins, specimen collections, organizational structures, and market contexts and sustainability. From a list of 636 biobanks assembled through a multi-faceted search strategy, representatives from 456 U.S. biobanks were successfully recruited for a 30-minute online survey (72% response rate). Both closed and open-ended responses were analyzed using descriptive statistics.ResultsWhile nearly two-thirds of biobanks were established within the last decade, 17% have been in existence for over 20 years. Fifty-three percent listed research on a particular disease as the most important reason for establishment; 29% listed research generally. Other reasons included response to a grant or gift, and intent to centralize, integrate, or harmonize existing research structures. Biobank collections are extraordinarily diverse in number and types of specimens and in sources (often multiple) from which they are obtained, including from individuals, clinics or hospitals, public health programs, and research studies. Forty-four percent of biobanks store pediatric specimens, and 36% include postmortem specimens. Most biobanks are affiliated in one or multiple ways with other entities: 88% are part of at least one or more larger organizations (67% of these are academic, 23% hospitals, 13% research institutes). The majority of biobanks seem to fill a particular 'niche' within a larger organization or research area; a minority are concerned about competition for services, although many are worried about underutilization of specimens and long-term funding.ConclusionsEffective utilization of biobank collections and effective policies to govern their use will require understanding of the immense diversity found in organizational features, including the very different history and primary goals that many biobanks have.

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Ethical Norms and the International Governance of Genetic Databases and Biobanks: Findings from an International Study

Cited by 44 publications

References 15 publications

Ethical aspects of human biobanks: a systematic review

Ethical aspects of human biobanks: a systematic review

Challenges in biobank governance in Sub-Saharan Africa

Characterizing biobank organizations in the U.S.: results from a national survey

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