Standardised consent/ethics
Current issues identified in relation to consent and ethics approval for the collection and storage of tissue samples as part of cancer clinical trials included the need for:
- increased awareness and application of national guidelines for consent and ethics developed by the Australian Health Ethics Committee (AHEC) and issued by the NHMRC,3 as well as the Harmonisation of Multi-centre Ethical Review (HoMER) project.4
- public engagement about the benefits of tissue collection and the importance of information collected from specimens held in biobanks.
It was suggested that the ultimate goal in Australia should be to obtain consent for the collection and storage of tissue samples for the purposes of research from all patients at the point of diagnosis. One possibility would be an opt-out rather than an opt-in policy and would ideally include storage of samples for germ line sampling and assessment of somatic mutations. However, there are major health consumer concerns with such an approach and much would need to be done to gain wide acceptability. The need for a streamlined, efficient process that could be applied beyond cancer was identified.
In developing a standardised approach to consent, questions to be considered included the timing of obtaining consent (at diagnosis versus on entry to the clinical trial), as well as who should obtain consent. Other questions included:
- Process for informing the patient or family members about the implications of the information obtained from sample analysis.
- Implications of use of tissue after death.
- Sampling considerations (for example, collection of normal tissue, blood samples and relapse tissue).
A number of possible roles for COSA in facilitating a standardised approach to consent and ethics were identified. This included lobbying for legislation around the process of consent for tissue banking although there was some debate about whether such an approach is appropriate. Other possible roles include liaison with the Royal College of Pathologists of Australasia (RCPA), and undertaking a review of international and national consent procedures. It was also suggested that COSA could be involved in the development of common guidelines, templates and procedures, as well as in public engagement about the altruistic benefits of tissue collection and storage.
Collection and storage of samples
A number of obstacles to the collection and storage of tissue samples by CCTGs were identified, including the lack of pathology contact before trial initiation and lack of standardised approaches to sampling and storage. The absence of financial incentives for pathologists to be involved in the collection, storage and release to third parties of tissue for research purposes was also seen as a barrier. Other identified issues related to the range and complexity of approaches to tissue collection and storage. For example, difficulties associated with certain techniques, such as obtaining frozen samples and limitations of paraffin-embedded samples, can influence the quality of samples. However, despite these issues, there was a view that funders and policy makers are currently unaware of the complexities of tissue collection and storage.
A number of possible solutions to encourage a consistent approach to the storage of tissue samples were identified. Several solutions focused on the need for greater involvement of pathology from the trial outset, including:
- inclusion of a pathologist on trial management committees and, where possible, at each participating site
- scientific acknowledgement of pathology input
- consideration of reimbursement options for pathologists involved in tissue sampling, with the option of a Medicare item number for collection and preparation of tissue by pathologists for the purposes of research.
It was also suggested that pre-definition of a biological or translational research question with a clinical trial that has a clear clinical objective was important to promote clinician engagement and to encourage the collection of a sufficient quantity of tissue of appropriate quality for testing. Other solutions included creation of a virtual network to allow samples to be collected and stored locally, but accessed nationally and a future goal of collecting a second block of tissue to be stored locally for future studies as standard.
Possible roles identified for COSA included collaborating with the RCPA to centralise coordination of pathology input, as well as with appropriate partners to lobby government for a Medicare number to reimburse pathologists for collection of tissue for research purposes. It was also suggested that COSA could be involved in tendering for activities to support localised collection and storage of tissue samples.
Distribution of samples
The heterogeneity of existing tissue banks was identified as a key issue in limiting the distribution of tissue samples for the purposes of clinical research. It was suggested that additional tissue samples collected in relation to a specific clinical trial should be quarantined from translational research samples. Such clinical trial samples should remain under the governance of the Trial Management Committee. In contrast, access to ‘open collection’ samples for biomarker discovery, pre-clinical studies and translational research should be managed by the respective tissue bank.
The sustainability of tissue banks was considered to be dependent on: international best practice and standard operating procedures;5 database management and clinical linkages; long-term funding through a range of avenues, including federal and state government, grants and philanthropic groups; and the amalgamation of consortiums to maximise efforts.
The potential role of COSA in advocating for funding was discussed.
Opportunities for funding
A range of potential sources of funding were identified to support the collection, storage and distribution of tissue for oncology clinical trials and translational research in Australia (table 2).