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Respecting Autonomy Over Time: Policy and Empirical Evidence on Re-consent in Longitudinal Biomedical Research

Wallace, SE   Gourna, EG   Laurie, G   Shoush, O   Wright, J

Bioethics   30 (3) 210–217

DOI: 10.1111/bioe.12165

March 2016   (First published online May 2015)

http://onlinelibrary.wiley.com/doi/10.1111/bioe.12165/abstract;jsessionid=A9047BED07347A0C71268D2FC16C8ED6.f01t03

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.