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 proceed

SUBMITTER: Chen SC 

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

REPOSITORIES: biostudies-literature