Opportunities and Obligations for Collaborators

Principles of Use of Biological Samples

Principles of Use of the CLEAR Study Data

Publications Arising from CLEAR Study Data and Biological Samples

 

 

Opportunities for and Obligations of the Collaborators:

Opportunities

• Collaborators will receive acknowledgment in publications, as defined in the document Publications Arising from CLEAR Study Data and Publications.
• Cancer Council will provide collaborators access to CLEAR Study data and biological samples on a preferential basis, provided those projects meet the approval of the Expert Advisory Comittee (EAC).
• Cancer Council will provide collaborators with access to statistical resources for approved studies on a preferential basis
• Collaborators will have the opportunity to nominate particular areas of research interest and will be invited to participate in any analyses conducted in these areas
• Cancer Council will provide assistance with the preparation of applications for external grant funding to use CLEAR data in studies approved by the EAC
• Cancer Council will provide an on-site clinical recruitment officer to assist the study recruitment process if patient numbers justify such an investment.

Obligations

An investigator defined as a Collaborator in The CLEAR Study will, for the benefit of the Study:

• Recruit, or otherwise provide access to, a minimum number of study participants eligible for the Study, (whether through provision of completed Study questionnaires and blood samples, or by access to clinic lists, new patient lists, facility to send mail to patients).  This number to be negotiated on a case by case basis, and determined by cancer type and size of hospital site, but should be not less than 100 patients and 100 controls
• Nominate as Site Principal Investigator at an active clinical site which has site specific ethical approval
• Provide introduction to other clinicians at that site, and actively encourage and facilitate their participation in the Study
• Provide invitations to the investigators and members of the CLEAR Study team to attend suitable clinical meetings throughout the life of the Study
• Provide an annual progress report for each recruitment site.  EAC will provide an appropriate format for the report.

 

Principles of Use of Biological Samples

CLEAR Study collects biological samples – blood – to help us understand the relative contribution of environment and genes to cancer risk.

In the future, the Study aims to collect tissue.  This information will also be added to the Study resource when it becomes available.

Any individual or group can use the biological samples held by the CLEAR Study, provided that ethical and scientific quality criteria are met, and provided that the specified project meets the study objectives as defined in the Protocol of the CLEAR Study. At least one CLEAR Study Investigator must be a named investigator for the specified project.

Use of the biological material currently comes under three categories:

1. Sample analysis and reporting using the biological samples through an agreed program of work: Interested individuals or groups can work with the Cancer Council NSW CLEAR Study team to design a program of work with targeted analyses and identified outputs using a set or subset of the biological samples.
2. Baseline questionnaire data: Data from the baseline self-administered questionnaire completed by cohort participants will be available for analyses in conjunction with analyses of the biological specimens. These questionnaire data include information on: health; lifestyle; demographics; and social, economic and other factors that might influence health.
3. Linkage studies: Projects using baseline questionnaire data linked with other Health Data can also be undertaken. The Study has in-principle ethics approval to link to data sets held by Medicare Australia (including MBS and PBS data sets), the Department of Veterans’ Affairs and the NSW cancer registries.
4. Sub-studies: Participants in the Study have given consent to be approached to participate in follow-up studies.

Applications to use the CLEAR Study resource are reviewed by the CLEAR Study Expert Advisory Committee. This Committee has established principles for using the CLEAR Study resource. The aim of these principles is to encourage use of data and biological materials from the CLEAR Study to conduct high quality research that it is in the public interest.

Processes for applying to use the CLEAR Study resource depend on the type of project being undertaken. Charges for use of the Study resource also vary according to the type of project being undertaken. Principles guiding the charging policy for the CLEAR Study as well as principles for undertaking sub-studies and limiting respondent burden are also clearly articulated.

Ethics approval for any project using the CLEAR Study resource must be obtained through the lead committee, St Vincent’s Hospital Human Research Ethics Committee.

It is noted that the CLEAR Study blood samples are a finite resource.  Any part of the samples not used must be returned to the Biobank.

 

Principles of Use of the CLEAR Study Data

Any individual or group can use the data held by the CLEAR Study, provided that ethical and scientific quality criteria are met, and provided that the specified project meets the study objectives as defined in the Protocol of the CLEAR Study.  At least one CLEAR Study Investigator must be a named investigator for the specified project.

Use of the Data currently comes under four categories:

1. Consulting and data analysis on an ad-hoc fee for service basis: Arrangements can be made for the Cancer Council NSW CLEAR Study team to undertake one-off pieces of work using the Data.
2. Baseline questionnaire data: Data from the baseline self-administered questionnaire completed by cohort participants will be available for analyses. These data include information on: health; lifestyle; demographics; and social, economic and other factors that might influence health.  Interested individuals or groups can work with the Cancer Council NSW CLEAR Study team to design a program of work with targeted analyses and identified outputs.
3. Linkage studies: Projects using baseline questionnaire data linked with other Health Data can also be undertaken. The Study has in-principle ethics approval to link to data sets held by Medicare Australia (including MBS and PBS data sets), the Department of Veterans’ Affairs and the NSW cancer registries.
4. Sub-studies: Participants in the Study have given consent to be approached to participate in follow-up studies.  

Applications to use The CLEAR Study resource must first be reviewed by the CLEAR Study Expert Advisory Committee (EAC). This Committee has established principles for using the CLEAR Study resource. The aim of these principles is to encourage use of data from the CLEAR Study to conduct high quality research that it is in the public interest.

Ethics approval for any project using the CLEAR Study resource must be obtained through the lead committee, St Vincent’s Hospital Human Research Ethics Committee.

Processes for applying to use the CLEAR Study resource will be determined by the EAC and will depend on the type of project being undertaken. Charges for use of the Study resource will also vary according to the type of project being undertaken.

Principles guiding the charging policy for the CLEAR Study as well as principles for undertaking sub-studies and limiting respondent burden will be defined by the EAC and clearly articulated.

 

Publications Arising from CLEAR Study Data and Biological Samples

Publications arising from the analysis of the CLEAR Study data or the CLEAR Study biological material will be the joint responsibility of Cancer Council NSW, the CLEAR Study investigators and, on a case by case basis, specified collaborators.

Collaborators will ensure the timely exchange of draft documents and dissemination of research findings. For multi-authored papers, a reasonable review period will be designated, and after that date, if comments are not received, approval will be deemed to be granted

No publications or presentations will be made by any collaborator without the express permission of the Expert Advisory Committee.

In the case where analyses have been led by a collaborator outside the CLEAR Study Investigator team, the following principles will apply:

• A study investigator must have been involved in the analysis
• A draft copy of any publication or report containing or based on data from the Data Set or on data from the biological samples (Publication) must be forwarded to the CLEAR Study Principal Investigator, at least 30 days prior to proposed submission, for technical review by the Expert Advisory Committee
• no publication of a Publication should occur if Expert Advisory Committee, in its discretion, notifies the Recipient that Expert Advisory Committee considers that the Publication uses inappropriate methodology to analyse the Data Set. If the Recipient has not received such notice from the Expert Advisory Committee within 30 days after providing the Publication to the Principal Investigator for review, the Recipient may submit it for publication
• The CLEAR Study is acknowledged in any Publication in the following format or such other format Cancer Council NSW requires:
• The CLEAR Study is an initiative of Cancer Council NSW.  The CLEAR Study investigators are A Professor Freddy Sitas, A Professor Dianne O’Connell, Dr Karen Canfell, Professor Michael Barton, Professor Robyn Ward, A Professor Emily Banks
• All collaborators are to be acknowledged in a required format determined by the EAC
• a copy of any final Publication is forwarded to the CLEAR Study Principal Investigator and the Cancer Council NSW may choose to obtain an irrevocable, transferable, royalty-free licence (including the right to sub-license) from the relevant copyright owners to reproduce and adapt the Publication and communicate it to third parties 

 

Authorship of the publications reporting the results will include the CLEAR Study investigator(s) as relevant, and collaborators and colleagues who make a substantive contribution and those who satisfy the criteria of the Vancouver / BMJ guidelines for the authorship of scientific manuscripts

Authorship order will be decided on a case-by-case basis but, in principle, authorship for papers should be negotiated in advance, particularly with regard to first, second, third, last and corresponding authors, although the order may be revised according to actual contribution as the manuscript is written.