1.     Purpose and application

The purpose of this policy is to describe the conditions of access to the Register4 resource.

1.1    The Register4 resource encompasses any one, or a combination of, the following:

  • Data from baseline and follow-up questionnaires;
  • Data collected from completed research which Register4 members participated in;
  • Register4 members.

1.2    This policy should also be read in conjunction with the Register4 Conditions of Use Agreement, which specifies the conditions that must be satisfied by approved users of the Register4.

2.    This policy is based on the following principles:

2.1    Research projects relevant to breast cancer will be prioritized over other research.

2.2    All clinical trials must have submitted their trial to a Clinical Trials Registry.

2.3    All projects must have ethics approval from a formally constituted Human Research Ethics     Committee (HREC).

2.4    All projects must be peer reviewed by a Tier 1 Peer Review Committee before the application for access can proceed to the Access Committee for assessment. The following are classified as Tier 1 Peer Review Committees: National Breast Cancer Foundation, National Health and Medical Research Council, Cancer Australia, Australian Research Council, Cancer Councils, Cancer Institute NSW, State Government, universities, Australian Cancer Research Foundation, and Victorian Breast Cancer Research Consortium.

2.5    The privacy of Register4 members will be protected by approved researchers’ adherence to Australian state and Federal legislative requirements. 

2.6    Register4 members who consent to participate in approved research projects are not to be subjected to any undue burden as a result of their participation. 

2.7    The findings from all research conducted through access to Register4 members and their data will be made publicly available in language the community can understand within a timeframe as specified by Register4

3.    Requirements for Applications for Access to Register4 members

3.1     Researchers who are in the process of submitting grants and are interested in utilising Register4 as part of their research protocol may register as a Register4 member to request a letter of Support in Principle.

If funding is approved a full application must be submitted to Register4 and subjected to formal review by the AC detailed in 3.2. 

3.2    Researchers with funding can complete an application including evidence of peer review and HREC approval for review by the AC. If the AC requires additional information the researchers will be notified.

3.3    Research projects with funding but without peer review (pilot studies for example) will be assigned to the National Breast Cancer Foundation’s Research Advisory Committee (RAC) who will provide a peer review for the AC by considering the scientific validity, feasibility and capacity of the applicant(s) to undertake the work and the potential public benefit of the project.  

3.4     Once the AC has approved an application, the successful applicant will be informed and be required to formally agree to the Conditions of Use Agreement.

4        Ethical approval

4.1    All AC approvals will be subject to the applicant obtaining ethical oversight. Evidence of this     approval must be provided before the project is formally approved.

4.2     For some applications, approval of a specialised Aboriginal and Torres Strait Islander Health Research Ethics Committee is also required. See Point 7 for more information. 

5        Amendments to a protocol

5.1    Applicants utilising Register4 are encouraged to submit an application for amendments to an existing approved project to the AC. The AC will consider amendments requesting access to additional members or data. Where an amendment request requires different kinds of data from the original request, the AC reserves the right to request a separate full application.

6        Data access

6.1    All approvals will be subject to the applicant having the requisite funding to conduct the project.     

7        Access to Indigenous status data and/or Indigenous Study cohort members

7.1    Applications for access to Indigenous status data and/or Indigenous Study cohort members will be required to obtain ethical approval from an Aboriginal and Torres Strait Islander Health Research Ethics Committee in the following circumstances: 

  • An application should be made for research for which any one of the following applies:
  • The experience of Aboriginal people is an explicit focus of all or part of the research; or
  • Data collection is explicitly directed at Aboriginal peoples; or
  • Aboriginal peoples, as a group, are to be examined in the results; or
  • The information has an impact on one or more Aboriginal communities; or
  • Aboriginal health funds are a source of funding.

However, an application for research concerning the general population need only be made to the Committee if any one of the following applies:

  • Any of the five factors listed above are present; or
  • Aboriginal people are known, or are likely, to be significantly over-represented in the group being studied (e.g. compared to the 2.1% of the total NSW population as shown in the 2006 Census); or
  • The Aboriginal experience of the medical condition being studied is known, or is likely, to be different from the overall population; or
  • There are Aboriginal people who use the services being studied in distinctive ways, or who have distinctive barriers that limit their access to the services; or
  • It is proposed to separately identify data relating to Aboriginal people in the results.

If there is doubt as to whether or not approval of this Committee is required, please contact the relevant Aboriginal and Torres Strait Islander Health Research Ethics Committee.

8        Member Privacy and Confidentiality

8.1    If names and addresses of Register4 members are released in confidence and with formal consent to a researcher, he or she must guarantee that the information will be used only in accordance with the protocol approved by the Register4.

8.2         Names and addresses of Register4 members who are actively participating in the research project may only be kept for the length of the research project as specified in the Register4 application form. In particular, no confidential information (including names and addresses) may be passed on to any third party without written approval from the Register4. Names     and address of Register4 members who were screened out of the research project, refused to participate in the research project, or withdrew from the research project, must not be retained once it has been confirmed they will not, or are no longer an active participant in the research project.

8.3    The researcher/s must agree to comply with the Privacy Act 1988 (Cth) and relevant     Australia State and Territory laws, including the National Privacy Principles, and in line with national and international best practice.

8.4    Register4 must be notified of any security breach that involves Register4 data, or in any circumstances that lead you to believe that the security may have been compromised.

9        Study Feedback to Register4

9.1    Researchers will forward to Register4 the total number of members who participated in their study. It is the researchers’ responsibility to secure their HREC to transfer this information to Register4.  

10    Subsequent or Follow Up Studies

10.1    If researchers wish to approach Register4 members for a subsequent or follow-up study outside the scope of their original application, or otherwise vary the procedures in the initial protocol, standard Register4 application procedures (outlined above) will need to be followed. Researchers are not permitted to re-contact members who participated in their original study for any future or follow-up studies without permission from Register4.

11    Acknowledgement

11.1    It is mandatory for researchers utilising Register4 to acknowledge the resource in any     presentation and or published work that results from using the resource, using the standard acknowledgement clause supplied by Register4.

11.2    A reprint of all publications that result from a study must be sent to the Register4.

12.    Dispute Resolution

12.1    If a researcher believes at any time that they disagree or are in dispute with the Register4 about the approval, processing or coordination of their project, the researcher is able to access the Dispute Resolution Process to facilitate resolution of the issue/s whereby the issue is put before the Sub-Committee for resolution.