THE CLEAR STUDY DATA AND BIOSPECIMEN ACCESS POLICY
Purpose of Study
The purpose of Cancer Council NSW’s Cancer Lifestyle And Evaluation of Risk Study (the CLEAR Study) is to establish a large scale epidemiological cancer dataset and bio-bank for all types of adult cancers, and make these accessible to the research community. This is in order to better understand, prevent and manage cancer through providing a high quality collaborative research resource.
The purpose of this Data and Biospecimen Access Policy is to set out the conditions for gaining approval to conduct a research project using data or bio-specimens from the CLEAR Study.
The CLEAR Study is a collaborative resource. Subject to meeting the access principles set out in this Data and Biospecimen Access Policy, all applications will be considered, whether they are from charitable, academic, government or commercial entities, from Australia or overseas except where that organisation fails to meet the requirements for forming a partnership with Cancer Council NSW according to the Cancer Council NSW Commercialisations and Partnership Policy.
This policy should be read in conjunction with:
- the CLEAR Study Cost Recovery Charges document which outlines fees and charges for access to, and use of, the CLEAR Study data and biospecimens; and
- The CLEAR Study Data and Biospecimen Application and Assessment Procedure.
- The project purpose must be related to cancer prevention, control or treatment
Data and bio-specimens from the CLEAR Study are to be used for the purposes of furthering advances in cancer prevention, cancer control and/or cancer treatment. Proposed projects must demonstrate how they will contribute to one or more of these objectives.
Priority may be given to projects that meet Cancer Council NSW organisational objectives in cancer research.
- The project must be scientifically and methodologically sound
The project proposal must have been assessed as being scientifically and methodologically sound by an independent peer review process or by the members of the CLEAR Study Expert Advisory Committee.
The project methods must provide for the use of any bio-specimens within a 12 month period after access is granted. After the expiry of this 12-month period, the bio-specimens will revert to the general collection and a new application for access will need to be made.
- Researchers must have relevant experience
Each investigator will be assessed for their credibility to undertake the proposed research task, which will be based on their experience in undertaking epidemiological research. Investigators with no/minimal experience in this field will be required to carry out the proposed project in collaboration with the CLEAR study team (or other epidemiological research teams).
- Projects seeking access to biospecimens must demonstrate a likely public benefit that justifies access to limited and depletable resources
Access to the biospecimens that are limited and depletable will be carefully controlled and coordinated. The quantity of sample that is required will be judged against the potential benefits of the research project, with advice from appropriate experts as required.
- The project must have ethical approval
All approvals will be subject to the applicant obtaining ethical approval, where this is required under the National Statement on Ethical Conduct in Human Research. Evidence of this approval must be provided before data and/or biospecimens are released to researchers. A letter from the relevant Ethics Committee confirming that ethics approval is not needed will be required from applicants seeking data without an ethics clearance.
Applicants requesting access to CLEAR Study data and other linked datasets such as those available from the Master Linkage Key maintained by the Centre for Health Record Linkage (CHeReL) must obtain additional ethics approval from the NSW Population and Health Services Research Ethics Committee or the Ethics Committee appropriate for that data set.
- The privacy and confidentiality of CLEAR Study participants must be protected
- In general, researchers will have access to de-identified participant data only. Projects may use the same or overlapping data as other approved projects
There will be no restrictions on the number of researchers who can access the same or overlapping questionnaire data that are already contained within the CLEAR Study,however, applicants will be advised of a potential duplication of efforts with another research group.
- Researchers must be willing to pay for access to data and bio-specimens on a cost-recovery basis
Researchers must pay for access to the CLEAR Study on a cost-recovery basis for their proposed research, with fixed charges for initiating the application review process and for data and a variable charge dependent on the number of samples, and/or tests or preparation for record linkage which may be required for the research project. CLEAR Study data will not be released to applicants until fees have been paid. These charges apply to all investigators, including CLEAR Study investigators and Cancer Council NSW employees.
Refer to the CLEAR Study Cost Recovery Charges for more information.
- Researchers must be willing to execute a Data Use and Material Transfer Agreement and comply with its terms
The CLEAR Study Data Use and Material Transfer Agreement is in a standard format which can be provided on request. It covers matters including:
A requirement that successful applicants submit their findings within a mutually agreed time period and return their results to the CLEAR Study so that they are available for other researchers to use for cancer-related research that is in the public interest;
A requirement that successful applicants make a reasonable effort to publish their research findings in an appropriate peer-reviewed journal, unless Cancer Council NSW has provided written approval for not doing so; and
Researchers who provide funding to derive individual data results from the CLEAR Study (e.g. from a SNP analysis) will be allowed to use those individual data results for a limited period of time, after which the individual results will be made available for other researchers to use.