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 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.

When is it impractical to ask informed consent? A systematic review

“…A first initial search was confined to the use of the meaning of impractical in electronic health record research because we expected the use of this term to be of particular relevance for data intensive research. However, we were able to identify only one ethical analysis by Chen et al 13 who provide insights on possible meanings of impracticable, and four manuscripts on impractical in electronic health record research written by Angela Ballantyne's research group. [14][15][16][17] Due to this limited selection of articles in the field of electronic health record research, and to enrich our findings with broader insights, we decided to look for impractical and its synonyms within other research fields.…”

“…26,28 In biobank research, the same interpretation of impractical was provided as follows: conventional informed consent becomes impractical when participants have moved or passed away, because they are incapacitated, or because the researcher has no current contact information. 13,23,[29][30][31] In addition, impractical in pragmatic trials might also mean that researchers have to spend too many resources on obtaining informed consent if the conventional procedure is followed. 32 Next, asking conventional informed consent from clusters of participants was described in several instances as impractical because of the large sample size of the study.…”

“…36 In biobank research, one article also stated that in order for the informed consent procedure to be impractical, the missing data of the participants who could not be recontacted had to reduce the potential value of the data set. 13 Obtaining informed consent harms the participant…”