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Recontacting participants for expanded uses of existing samples and data: a case study.

ABSTRACT: PURPOSE:Facilitating genomic research may require the use of samples and data collected via consent processes that did not include specific descriptions of secondary uses. We explore whether a waiver of consent with notification and the option to withdraw (WNOW) is a viable alternative to written informed consent for secondary uses of samples and data. METHODS:We developed a retrospective case study of a rare-disease protocol involving 1,978 participants that implemented WNOW for genomic data-sharing activities. We analyzed institutional review board and investigator records and conducted in-depth semistructured interviews with key staff members. RESULTS:WNOW was largely successful at achieving its goals in this case, although the recontact effort, relative to proceeding with a waiver, decreased participation in genomic data sharing by 13.8% (n = 253), primarily because 224 letters were returned as undeliverable. A small number of participants responded (n = 89), and some of them expressed confusion and frustration. In the pediatric arm of the study, the research may have been practicable without a waiver, given the relationship between the pediatric clinicians and families. CONCLUSION:The practicability of conducting research on existing specimens without a waiver of informed consent, and whether WNOW is a viable alternative, depend on contextual factors, including a reliable way to communicate with participants.Genet Med advance online publication 26 January 2017.

SUBMITTER: Chen SC

PROVIDER: S-EPMC6097706 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Recontacting participants for expanded uses of existing samples and data: a case study.

Chen Stephanie C SC Berkman Benjamin E BE Hull Sara Chandros SC

Genetics in medicine : official journal of the American College of Medical Genetics 20170126 8

<h4>Purpose</h4>Facilitating genomic research may require the use of samples and data collected via consent processes that did not include specific descriptions of secondary uses. We explore whether a waiver of consent with notification and the option to withdraw (WNOW) is a viable alternative to written informed consent for secondary uses of samples and data.<h4>Methods</h4>We developed a retrospective case study of a rare-disease protocol involving 1,978 participants that implemented WNOW for ...[more]

PMID: 28125076

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Recontacting participants for expanded uses of existing samples and data: a case study.

Publications

Recontacting participants for expanded uses of existing samples and data: a case study.

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