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

Area of Science:

• Genomic research ethics
• Informed consent alternatives

Background:

• Genomic research often requires samples and data from consent processes that did not specify secondary uses.
• Alternative consent models are needed for secondary data use.

Purpose of the Study:

• To explore the viability of a waiver of consent with notification and the option to withdraw (WNOW) as an alternative to traditional informed consent for secondary genomic data use.

Main Methods:

• Retrospective case study of a rare-disease protocol with 1,978 participants.
• Implementation of WNOW for genomic data-sharing activities.
• Analysis of institutional review board records, investigator records, and semistructured interviews with staff.

Main Results:

• WNOW was largely successful but decreased genomic data sharing participation by 13.8% due to undeliverable mail and participant confusion.
• A small number of participants responded, some expressing confusion.
• Research in the pediatric arm might have been feasible without a waiver due to existing clinician-family relationships.

Conclusions:

• The practicability of WNOW depends on contextual factors, particularly reliable participant communication.
• WNOW is a potential alternative but requires careful consideration of communication strategies and participant engagement.