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:

  • Register4 Members’ contact details; and
  • Data collected from baseline and follow-up questionnaires generated by Register4.

1.2    This policy should 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 cancer research.

2.2    All clinical trials must have submitted their trial to an appropriate Clinical Trials Registry (e.g. ANZCTR, Clinicaltrials.gov).

2.3    All projects must have ethics approval from a properly constituted Human Research Ethics Committee (HREC) that is registered with the NHMRC.

2.4    The privacy of Register4 Members will be protected by approved researchers’ adherence to Australian State and Federal legislative requirements.

2.5    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.

2.6    Research institutions must use best endeavours to make the findings and relevant data from all research conducted through access to Register4 Members publicly available in language the community can understand within a reasonable timeframe, taking into account the project length and publication timeframes.

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 request a letter of Support in Principle from

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

3.2    Researchers with funding can complete an application including copies of the funding application and any feedback and HREC approval. If the AC requires additional information the researchers will be notified.

3.3    The AC will forward the recommendations to approve or not, to Register4. Applicants will be informed of the outcome and those successful will 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    An amendment to the protocol may be necessary for the use of Register4 resource for recruitment of participants including the expression of interest process and requirement for feedback of participation numbers. Register4 will provide the researcher with text that should be added to the research protocol and consent form if it is required. Evidence of approval of this amendment will be required before the project can be launched to the Register4 membership.

4.3    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 may submit an application for amendment to an existing approved project to the AC if the researcher wishes: (a) to vary the original study protocol in any way, including changes to procedures or instruments; or (b) to use the study/data samples in a way that departs the purpose/s stated in the original Application form. Register4 and/or the Access Committee reserve the right to request the submission of a Full Application if it considers that would be more appropriate.

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    Any Register4 Member personal information provided or collected in relation to an approved research project must be used by the research institution in accordance with the Register4 Condition of Use agreement and any protocols approved by Register4..

8.2    Personal information of Register4 Members may only be kept by a research institution as long as it is needed for an approved research project or until the end of the research project as specified in the Register4 application form or as permitted under the Privacy Act 1988 (Cth) (whichever period of time is shorter), unless Register4 agrees otherwise. In particular, no confidential information (including names and addresses) may be transferred outside Australia or passed on to any third party outside the research team without prior written approval from Register4 and the relevant Register4 Member(s). Names and addresses 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 Australian 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 of any circumstances that lead you to believe that the security may have been compromised.

9.  Study Feedback to Register4

9.1    Researchers will provide to Register4 full details of all of the members who were contacted in relation to the Project, including information such as updated contact details, whether the Register4 Member participated in their project, and notifications of any deceased members. It is the researchers’ responsibility to arrange for and ensure the transfer of 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 Register 4 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 using Register4 information must be sent to the Register4.