The Havasupai Indian Tribe Case — Lessons for Research Involving Stored Biologic Samples

Mello, Michelle M.; Wolf, Leslie E.

doi:10.1056/nejmp1005203

Cited by 324 publications

(259 citation statements)

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“…And this desire for retaining control is arguably heightened in cases where the research or use of samples and information could be discriminatory or stigmatizing [37][38][39] and when the research goals conflict with cultural or religious beliefs. 40,41 Here, donor support and participation for biobanks might wane for stigmatizing or contentious areas of research and donors would be reluctant to have their samples be freely used and shared with others.…”

Section: (Participant 5)mentioning

confidence: 99%

“…[37][38][39][40][41] Similarly, people may be disinclined to provide samples and information and have their data shared with organizations they deem less trustworthy including private industry, government and law enforcement agencies, employers, biotech companies, and insurance agencies, 17,18,38,39 On the basis of this rationale, a conceptual proposal was developed that some biobanks, mostly smaller disease-specific biobanks, eg, a cancer biobank, may benefit from incorporating exclusion clauses in their informed consent process. 28 Exclusion clauses are written within informed consent forms and can be explained verbally.…”

Section: (Participant 5)mentioning

confidence: 99%

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Scientists’ perspectives on consent in the context of biobanking research

2014

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Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

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Section: (Participant 5)mentioning

confidence: 99%

Section: (Participant 5)mentioning

confidence: 99%

Scientists’ perspectives on consent in the context of biobanking research

2014

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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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“…In April 2010, ASU and the tribe agreed to settle the lawsuit out of court. As part of the settlement, ASU formally apologized to the tribe, returned the samples, and paid the tribe $700,000, which was divided among forty-one participants (Mello and Wolf, 2010). Indian farmers have been using extracts from neem tree seeds (Azadirachta indica) as a pesticide for centuries.…”

Section: Box 2 Data Sharing and Intellectual Propertymentioning

confidence: 99%