HSA Biobank series: New Consent Form Inspires Collaborative Approach to Biobanking

27 February 2014
HSA Biobank Series: Consent Form

Embedding consent processes into routine patient care pathways has led to dramatic changes in the way that hospital staff, researchers and patients are contributing to the development of the HSA Biobank.

The Translational Cancer Research Network (TCRN) team at UNSW led the development of a biobank consent form, which has now been approved by the forms committee within the South Eastern Sydney Local Health District (SESLHD). This consent form, currently in use at Sydney’s Prince of Wales Hospital, Royal Hospital for Women, Prince of Wales Private Hospital and St George Hospital, is a formal hospital document that can be filed in a patient’s permanent record.

“Normally, research consent forms are lengthy and remain separate to formal hospital documentation, and therefore cannot be placed in a patient file,” says Robyn Ward, Director of Cancer Services at Prince of Wales Hospital.

“What we’ve done is created a consent form that is actually a standard hospital document. This allows hospital staff to recognise the patient’s wishes when it comes to biobank consent, and to facilitate the necessary clinical pathways that lead to a patient successfully contributing tissue to the bank.”

The new consent form is generated in carbon copy, allowing the original to be stored at the HSA Biobank, and a second copy to be kept in the patient’s hospital file. It is supplemented by a patient brochure that captures key information about the biobank’s purpose, the processes involved in patient participation in the biobank, and how patient tissue samples and privacy will be stored and protected, in line with the research ethics requirements that underpin the project.

In another unprecedented change, this time with the approval of the Commonwealth Department of Human Services (DHS), a question about collection of Medicare and Pharmaceutical Benefits Scheme data is now included on the biobank consent form, rather than being captured in a separate DHS form. The HSA Biobank is the first cancer biobank in Australia to have DHS approval for collection of this data using a standard hospital document.

“The DHS and the SESLHD Hospital Forms Committee have both been extremely responsive to requests from the HSA Biobank project, and to the needs of our patients when it comes to participating in hospital-based research,” says Ward.

“With multiple stakeholders involved, it can be a complex process to ensure that all the boxes are ticked when it comes to capturing information in a specific format to meet ethical and legislative requirements.”

The document was also reviewed by members of the TCRN’s Consumer Advisory Committee (CAC), who provided valuable input into how best to structure the form in order to meet patient needs.

“Earlier versions of the consent form were placed at the end of a long, unwieldy document that also contained information about the biobank and the process of collecting, storing and using tissue samples there,” says Gillian Begbie, an inaugural CAC member.

“What resulted from CAC discussions and the work of TCRN staff was the separation of the biobank information into a plain English tri-fold brochure and the development of a simple one page consent form to accompany it. We hope that this will make it easier for as many cancer patients as possible to give permission for their samples to be used for research purposes.”

The HSA Biobank is funded by UNSW with support from NSW Health Pathology and the Cancer Institute NSW. Since its launch in April 2012, patients have now contributed over 1300 tissue samples to the biobank, which will support new discoveries in translational cancer research across Australia.

Read more about the HSA Biobank