Dataset Information

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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Publications

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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Project description:ObjectivesTo recontact biobank participants and collect cognitive, behavioural and lifestyle information via a secure online platform.DesignBiobank-based recontacting pilot study.SettingThree Finnish biobanks (Helsinki, Auria, Tampere) recruiting participants from February 2021 to July 2021.ParticipantsAll eligible invitees were enrolled in FinnGen by their biobanks (Helsinki, Auria, Tampere), had available genetic data and were >18 years old. Individuals with severe neuropsychiatric disease or cognitive or physical disabilities were excluded. Lastly, 5995 participants were selected based on their polygenic score for cognitive abilities and invited to the study. Among invitees, 1115 had successfully participated and completed the study questionnaire(s).Outcome measuresThe primary outcome was the participation rate among study invitees. Secondary outcomes included questionnaire completion rate, quality of data collected and comparison of participation rate boosting strategies.ResultsThe overall participation rate was 18.6% among all invitees and 23.1% among individuals aged 18-69. A second reminder letter yielded an additional 9.7% participation rate in those who did not respond to the first invitation. Recontacting participants via an online healthcare portal yielded lower participation than recontacting via physical letter. The completion rate of the questionnaire and cognitive tests was high (92% and 85%, respectively), and measurements were overall reliable among participants. For example, the correlation (r) between self-reported body mass index and that collected by the biobanks was 0.92.ConclusionIn summary, this pilot suggests that recontacting FinnGen participants with the goal to collect a wide range of cognitive, behavioural and lifestyle information without additional engagement results in a low participation rate, but with reliable data. We suggest that such information be collected at enrolment, if possible, rather than via post hoc recontacting.

Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

Similar Datasets

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