Parent perspectives on consent for the linkage of data to evaluate vaccine safety: A randomised trial of opt-in and opt-out consent

Clin Trials: April 8, 2013

Background We examined parents’ consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines.

Methods A single-blind parallel-group randomised controlled trial: 1129 families of babies born at a South Australian hospital in 2009 were sent information at 6 weeks post-partum, 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. At 10 weeks post-partum, 1026 (91%) parents were followed up by telephone interview.  Read more