Background and Context: Clinically annotated biobanks provide essential infrastructure for translational cancer research. Obtaining patient consent to access biological samples and health data for research can be laborious and inefficient. The Biobanking Stakeholder Network (BSN) Consent Project is a collaborative initiative involving seven hospitals at four NSW sites.
Aim: To develop a universal consent model for biobanking embedded within routine clinical pathways, applicable to any NSW hospital. The model should provide all cancer patients with an opportunity to consent to the use of their biospecimens linked to clinical and health services data to enable translational cancer research.
Strategy/Tactics: Two patient consent formats were deployed – a Local Health District (LHD) approved form (three sites), and a consent sticker embedded within a ‘Request/Consent for Medical Procedure’ form (one site). Multidisciplinary stakeholders were engaged across hospital departments and endorsement sought from high-level LHD executives. Tumour streams were strategically selected to pilot feasibility of surgical staff obtaining consent. Numbers of relevant operations, consents, and final diagnoses were collected.
Programme/Policy Process: Consent forms and educational materials were reviewed by consumer groups and approved by relevant LHD committees. Access to Medicare/Pharmaceutical Benefits Scheme data was sought at three sites and granted at one site to date. A program of staff engagement and education was implemented at all sites, encouraging a gradual shift towards integration of biobanking processes into routine clinical pathways.
Outcomes/What was learned:Pilots have been completed at two sites (breast, upper/lower gastrointestinal, urological and gynaecological cancers), consenting 24/54 (44%, site 1) and 80/110 (60%, site 2) of suitable patients. The main reasons for patients not being offered consent included doctors not remembering, lack of access to forms and time constraints. While early results show a willingness to enhance research capacity for improved cancer outcomes, further work is needed to improve integration of consenting processes.