title: Respecting Autonomy Over Time: Policy and Empirical Evidence on Re-Consent in Longitudinal Biomedical Research.
abstract: Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort studies, tissue banks and biobanks. Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on 'responsive autonomy,' that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed.
authors.forename: Susan E
authors.identifier: http://orcid.org/0000-0002-2995-1673
authors.initials: SE
authors.lastname: Wallace
authors.forename: Elli G
authors.initials: EG
authors.lastname: Gourna
authors.forename: Graeme
authors.initials: G
authors.lastname: Laurie
authors.forename: Osama
authors.initials: O
authors.lastname: Shoush
authors.forename: Jessica
authors.initials: J
authors.lastname: Wright
mesh_terms: D018070:Biological Specimen Banks; D035843:Biomedical Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards; D026684:Personal Autonomy; D012107:Research Design; D012108:Research Personnel; D014015:Tissue Banks
keywords: autonomy; biobank; consent; policy; re-consent