Respecting autonomy over time: policy and empirical evidence on re-consent in longitudinal biomedical research
journal contributionposted on 2015-05-07, 10:18 authored by Susan E. Wallace, Elli G. Gourna, G. Laurie, Osama Shoush, Jessica E. Wright
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 reconsent 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.
This article was written as part of the on-going project ‘Re-consent to Research: Views of Participants’, for which the authors are grateful to the Wellcome Trust [WT097093MA] and the UK Medical Research Council for funding.
Author affiliation/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Health Sciences
- VoR (Version of Record)