title: Recontacting participants for expanded uses of existing samples and data: a case study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Stephanie C
authors.initials: SC
authors.lastname: Chen
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.|National Human Genome Research Institute, Bethesda, Maryland, USA.
authors.forename: Benjamin E
authors.identifier: 0000-0002-9098-0799
authors.initials: BE
authors.lastname: Berkman
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.|National Human Genome Research Institute, Bethesda, Maryland, USA.
authors.forename: Sara Chandros
authors.identifier: 0000-0001-8742-4997
authors.initials: SC
authors.lastname: Hull
mesh_terms: D000328:Adult; D002648:Child; D033002:Duty to Recontact; D005240:Feasibility Studies; D036281:Genetic Research; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D010358:Patient Participation; D035583:Rare Diseases; D012189:Retrospective Studies