“Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose

Petrini, Carlo

doi:10.1016/j.socscimed.2009.10.004

Cited by 105 publications

(79 citation statements)

References 16 publications

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“…The lack of public awareness about the BioTrust poses ethical questions about the meaningfulness of the available "opt-out" option for the legacy DBS (Petrini 2010;Shickle 2006). It could also become a liability for the BioTrust if it leads to public mistrust or the kind of backlash that occurred in Texas and Minnesota.…”

Section: Discussionmentioning

confidence: 99%

“…Some experts, for example, suggest a blanket consent approach is an appropriate way to satisfy ethical obligations due to biobank donors under certain conditions (Petrini 2010), while others have argued that informed consent fails to "fit" in biobanking, and that a strict policy of anonymization of samples should be pursued in its place (Caplan 2009). This latter option would come at a cost to the scientific promise of public health biobanks, whose linkability to public health data make them so potentially valuable.…”

Section: Discussionmentioning

confidence: 99%

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Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Thiel

Platt

et al. 2013

J Community Genet

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Biobanks raise challenges for developing ethically sound and practicable consent policies. Biobanks comprised of dried bloodspots (DBS) left over from newborn screening, maintained for long-term storage, and potential secondary research applications are no exception. Michigan has been a leader in transforming its DBS collection, marketing its biobank of de-identified samples for health research use. The Michigan BioTrust for Health includes approximately 4 million unconsented retrospective samples collected as early as 1984 and prospective samples added since the fall of 2010 with blanket parental consent. We engaged Michigan citizens to ascertain public attitudes, knowledge, and beliefs about the BioTrust and informed consent. A convenience sampling of 393 participants from communities around the state of Michigan (oversampling for minority populations) participated in meetings addressing newborn screening, the BioTrust and informed consent, yielding quantitative and qualitative survey and discussion data. Participants affirmed the principle of voluntary informed participation in research and advocated for greater public awareness of the existence of the BioTrust. Most expressed support for the use of DBS for research and a desire for greater involvement in granting permission for research use. Opinions varied as to which specific research uses were acceptable. Participants indicated a desire for greater engagement, public awareness, and more active decision making on the part of biobank participants and parents. Diversity of opinion over which research areas were deemed acceptable problematizes the blanket consent model that currently applies to the BioTrust's prospective DBS collection and that could become the new norm for research using de-identified data under proposed changes to the Common Rule.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Thiel

Platt

et al. 2013

J Community Genet

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“…Various models of consent have been proposed for secondary research use of biospecimens (Hansson et al 2006;Mello and Wolf 2010;Petrini 2010;Stjernschantz Forsberg et al 2011;Wendler 2012). Many biobanks have used a notice model of consent, in which individuals are notified that their biospecimens may be used for secondary research purposes, often as part of a general consent form used at the time of donation.…”

Section: Introductionmentioning

confidence: 99%

Differences in preferences for models of consent for biobanks between Black and White women

et al. 2015

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Biobanks are essential resources, and participation by individuals from diverse groups is needed. Various models of consent have been proposed for secondary research use of biospecimens, differing in level of donor control and information received. Data are needed regarding participant preferences for models of consent, particularly among minorities. We conducted qualitative semi-structured interviews with 60 women to examine their attitudes about different models of consent. Recruitment was stratified by race (Black/White) and prior biobank participation (yes/no). Two coders independently coded interview transcripts. Qualitative thematic analysis was conducted using NVivo 10. The majority of Black and White participants preferred Bbroad^consent (i.e., blanket permission for secondary research use of biospecimens), and the second most preferred model for both groups was Bstudyspecific^consent (i.e., consent for each future research study). The qualitative analysis showed that participants selected their most preferred model for 3 major reasons: having enough information, having control over their sample, and being asked for permission. Least preferred was notice model (i.e., participants notified that biospecimens may be used in future research). Attitudes toward models of consent differed somewhat by race and prior biobank participation. Participants preferred models of consent for secondary research use of biospecimens that provided them with both specific and general information, control over their biospecimens, and asked them to give permission for use. Our findings suggest that it will be important for researchers to provide information about future uses of biospecimens to the extent possible and have an explicit permission step for secondary research use.

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“…9,34,35 On the other hand, it is suggested that obtaining specific consent for every linkage or re-use may be overly burdensome or impossible, because this could result in costly and time-consuming procedures, poor recruitment, consent bias, or unwarranted intrusion into the private lives of individuals. [36][37][38] As a response to the difficulties in obtaining specific consent, adapted models of consent have been put into practice and discussed in the literature. The most common adaptations of consent are models that shift away from specific consent, such as 'broad consent', covering a broad range of future data uses.…”

Section: Adapting Consentmentioning

confidence: 99%

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

et al. 2015

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Medical research is increasingly becoming data-intensive; sensitive data are being re-used, linked and analysed on an unprecedented scale. The current EU data protection law reform has led to an intense debate about its potential effect on this processing of data in medical research. To contribute to this evolving debate, this paper reviews how the dominant 'consent or anonymise approach' is challenged in a data-intensive medical research context, and discusses possible ways forwards within the EU legal framework on data protection. A large part of the debate in literature focuses on the acceptability of adapting consent or anonymisation mechanisms to overcome the challenges within these approaches. We however believe that the search for ways forward within the consent or anonymise paradigm will become increasingly difficult. Therefore, we underline the necessity of an appropriate research exemption from consent for the use of sensitive personal data in medical research to take account of all legitimate interests. The appropriate conditions of such a research exemption are however subject to debate, and we expect that there will be minimal harmonisation of these conditions in the forthcoming EU Data Protection Regulation. Further deliberation is required to determine when a shift away from consent as a legal basis is necessary and proportional in a data-intensive medical research context, and what safeguards should be put in place when such a research exemption from consent is provided.

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“Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose

Cited by 105 publications

References 16 publications

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Differences in preferences for models of consent for biobanks between Black and White women

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

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