RT Journal Article
SR Electronic
T1 A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 619
OP 625
DO 10.1136/medethics-2011-100145
VO 38
IS 10
A1 Jesia G Berry
A1 Philip Ryan
A1 Michael S Gold
A1 Annette J Braunack-Mayer
A1 Katherine M Duszynski
A1 for the Vaccine Assessment Using Linked Data (VALiD) Working Group
YR 2012
UL http://jme.bmj.com/content/38/10/619.abstract
AB Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. Results The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. Conclusions The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000332022.