Governing Genetic Databases: Challenges Facing Research Regulation and Practice

Gibbons, Susan; Kaye, Jane; Smart, Andrew; Heeney, Catherine; Parker, Michael

doi:10.1111/j.1467-6478.2007.00387.x

Cited by 39 publications

(28 citation statements)

References 21 publications

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“…These issues all pertain to the relationship between donors and researchers. The existing guidelines and legal frameworks are marked by significant variations in the rules researches are supposed to follow [1,2,3,4,5], and the resulting difficulties for researchers engaged in international collaboration have prompted several attempts of harmonization [6,7,8,9]. From the perspective of the legislator, the easy way to go forward seems to be to establish international standards with common criteria for informed consent, re-contact and feedback of research results.…”

Section: Introductionmentioning

confidence: 99%

Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?

Hoeyer

2009

Public Health Genomics

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Background: Many studies have explored public perspectives on when and how to provide informed consent to biobank research and when to get feedback on research results. Little has been done to explore overarching trends in these studies. Methods: The article is based on a critical reading of the literature found through Medline searches and the PRIVILEGED project compilation of empirical studies. Results: I suggest that tissue type, procurement situation including who is asked to provide consent, and the biobank’s geographical, social and historical context influence how various potential donors view the issues of consent, re-consent, and feedback of research results. In light of this, universal ethical standards for informed consent to and feedback of research results from biobank research seem to run contrary to the diversity of perceptions and expectations among different donors. Conclusion: To respect donor interests, it is necessary to pay more attention to diversity with regard to biobank types and different contexts for donation. We should avoid assuming that words like ‘biobank’ and ‘donor’ can be used in a generic sense – always referring to the same – if we wish to respect and care for the diverse group of individuals who comprise the donating public.

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Section: Introductionmentioning

confidence: 99%

Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?

Hoeyer

2009

Public Health Genomics

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“…Our review of the CIOMS checklist selects only those topics that may raise additional issues specific to this type of study. We did not compare generic topics that are relevant to all genetic medical studies 10,12,41 (eg, information on the funding of the research, the ethical review process, disclosure of data in society and genetic discrimination). 7,10,41 Second, most topics that were not addressed in the information leaflets may have been communicated in other ways by the studies, for example, in information meetings and brochures and in face-to-face discussions between individual participants and research staff.…”

Section: Discussionmentioning

confidence: 99%

“…In practical terms, anonymised data or shared data 16 may be difficult or impossible to destroy, and data that have already been analysed are not completely destroyable, especially if linked in a characterised genealogical tree. 12,33 If, for these reasons, complete withdrawal from the study is not possible, this should be made explicit at the outset. Finally, the right to withdraw consent can only be meaningful if participants are kept up-to-date about any changes in the purpose or direction of the study.…”

Section: Withdrawal Of Consentmentioning

confidence: 99%

“…As this approach is not as widely used at present as large population-based studies, discussion of the ethical issues inherent in genetic epidemiological research has largely focused on genomics and biobanks [3][4][5][6][7][8] and specifically on the tension between the promise of important advances in biomedical research 6,9 and the requirement for robust ethical standards. 7,[10][11][12] New research techniques raise important ethical issues relating to consent [13][14][15][16] ownership, governance, access to information, benefit sharing and community participation. These issues apply partly to every kind of genetic study, but although these issues are also applicable to family-based studies performed in genetically isolated communities, the special characteristics of such communities provide additional challenges to ethical approaches designed for large population-based biobanks.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of participant information and informed consent forms of five European studies in genetic isolated populations

et al. 2009

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on behalf of the EUROSPAN consortiumFamily-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants' information needs in such populations. Using the ethical-legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study.

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“…Biobanks have some defining features, but there is no consensus on what is a "biobank" (Gibbons et al 2007;National Health and Medical Research Council [NHMRC] 2010). Our working definition of a biobank includes large-scale or smaller scale population collections of samples, and disease-specific collections.…”

Section: What Is a Biobank?mentioning

confidence: 99%

Clarifying ethical responsibilities in pediatric biobanking

Spriggs

Fry

2015

AJOB Empirical Bioethics

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Background: The creation of biobanks for storage of human specimens and use in health and medical research is expanding globally. Biobanks hold significant potential to facilitate such research. However, important ethical questions arise, particularly in the pediatric setting, in relation to consent, future use, and the balance of benefits against potential harms. To date, these ethical issues have been undertheorized and underresearched in the biobanks domain. The aim of this study was to examine stakeholder attitudes regarding the ethical responsibilities of researchers, biobank custodians, Human Research Ethics Committees (HRECs), research institutions, and parents. Methods: A qualitative study using semistructured interviews with a purposive sample of key informants (n D 14) with relevant expertise was conducted. Participants were interviewed about their pediatric biobank experiences, the main ethical issues observed as an HREC member, researcher, or custodian, and future needs. Results: Participants expressed concerns about consent processes in the biobanking context, including issues regarding the provision of information, level of understanding, voluntariness, and the point at which children have a role or can consent for themselves. Other major issues raised were biobank quality management, the return of results, and the idea of human tissue as a scarce precious resource. Key informants also highlighted uncertainties about the custodianship of biobank samples and reasonable limits on the custodian's role. Conclusions: Pediatric biobanks are a valuable resource, presenting unique opportunities to advance children's health and well-being. Properly run pediatric biobanks entail responsibilities for institutes, custodians, researchers, and research ethics committees. We discuss ethical implications for pediatric biobank policy and practices, as well as future information needs in light of the study findings.

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Governing Genetic Databases: Challenges Facing Research Regulation and Practice

Cited by 39 publications

References 21 publications

Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?

Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?

Comparison of participant information and informed consent forms of five European studies in genetic isolated populations

Clarifying ethical responsibilities in pediatric biobanking

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