Recontacting Participants for Expanded Uses of Existing Samples and Data: A Case Study

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 1978 participants that implemented WNOW for genomic data-sharing activities. We analyzed Institutional Review Board and investigator records and conducted in-depth semi-structured interviews with key staff members. RESULTS: WNNOW was largely successful at achieving its goals in this case, although the re-contact 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.