How do I apply to use CUPL?
Lodge a 45 and Up Study Expression of Interest
Prepare a CUPL Research Application for Scientific Review
Supply documents to the Sax Institute for Ethics Review
Fees and charges for accessing CUPL can be obtained by emailing 45andUp.firstname.lastname@example.org. The Sax is a not-for-profit organisation and the charges are calculated on a cost-recovery basis to cover the fees associated with procuring the datasets, regular updates, cleaning and curating the data, and providing the Secure Unified Research Environment (SURE) platform and computing capabilities.
Occasionally the Sax Institute, in collaboration with its partners, is able to offer in-kind funding to meet part or all of the costs of accessing CUPL. Such opportunities will be circulated through the Sax Institute networks.
A Scientific Review ensures all CUPL researchers meet the conditions associated with the use of the data; the project is compliant with the Five Safes Framework; and it is consistent with the aims of CUPL. Guidelines for preparing a CUPL Research Application can be found here.
You need to include two peer reviews from independent experts when you submit your CUPL Research Application (the peer review template can be found here). The reviewers should include at least one content expert: for example, if your study is about cancer, then a professor specialising in cancer research might be one of your reviewers. If your study is using new or complex methodology you may also include a review from a methodological expert. Your institution may be able to suggest reviewers. The Sax Institute can also provide names if you require.
Incorporate the independent reviewers’ feedback into your application before submitting it to the Sax Institute and obtain an updated review of your final proposal. The Sax Institute’s Scientific Review Panel will then review your applications along with the independent reviewers feedback. The panel may contact your reviewers.
Your CUPL Research Application will also include a list of datasets and data variables sought, and justification for each. This information will be submitted via the CUPL Dataset and Variable Selection List. Our Scientific Review will include consideration of whether the datasets and variables requested are appropriate and necessary to answer the research questions. It will also consider whether the research expertise of your team is sufficient in terms of statistical, epidemiological and, if appropriate, clinical expertise.
You will be given feedback from the Sax Scientific Review and an opportunity to revise your protocol in accordance with the advice, if necessary.
This step may take up to four weeks. Some proposals will need to go to data custodians in addition to Scientific Review. You will be advised if this is the case at the time of submission, but in general all research which seeks to use NCIMS-COVID-19 data will be subject to data custodian review, as will all projects seeking to compare health services. Data custodians must be notified of research using COD-URF and CHAMB data, but a data custodian review will not usually be required.
The datasets and variables requested will be reviewed by the 45 and Up Data team who will advise you if there are any changes required.
New CUPL projects (Sub-Studies) are submitted by the Sax Institute as amendments. Project submissions under CUPL are reviewed by the NSW Population Health Services Research Ethics Committee (PHSREC). The Sax Institute cannot guarantee a timeframe for Ethics Review. It is common for ethics committees including PHSREC to seek further information or suggest amendments to a research protocol prior to approval. However, as the CUPL is an umbrella data linkage protocol, it is expected that the timeframe for Ethics Review will be much shorter than would otherwise occur with a new project proposal. To ensure the most timely passage through PHSREC, the Sax Institute can work with you to ensure a high quality proposal is submitted. If amendments are required, we can provide guidance on these so you can update your proposal as quickly as possible. Sometimes amendments have to go back to a full PHSREC meeting review, but often they will be reviewed by the Chair and Secretariat outside the meeting schedule. It is in your interest to ensure that your research protocol is as complete as possible and well-written to facilitate its timely approval.
An amendment needs to be submitted to PHSREC by 5pm on a Monday (see PHSREC submission dates here). You will need to get your final documentation to the 45 and Up Research team at least three business days prior (COB Wednesday) for your proposal to be signed off and uploaded into the Regis system by the Sax Institute.
PHSREC will not grant Ethics approval to any research which requires review and approval from the Aboriginal Health and Medical Research Council of NSW (AH&MRC) without that approval first being granted. Researchers can find information about Indigenous research requiring AH&MRC approval here.
Feedback and approval is sent from PHSREC to the Sax Institute. We will notify you by email of PHSREC feedback or approval, and outline the next steps.
Once PHSREC approval has been received, the 45 and Up Coordinating Centre will send you and your institution the legal agreements. These agreements include: the CUPL Researcher Deed Poll which sets out their individual obligations and must be signed by all reserchers on the project; and the Institutional Agreement, which all data users’ employing or affiliated institutions must sign.
The invoice for the costs of accessing CUPL and using SURE will be sent to the Lead Researcher.
Before accessing the data, all legal agreements – with your organisation and all members of the research team – must be signed, invoices paid and the online CUPL and SURE training modules completed. You will be sent a link to the training interface once PHSREC approval has been received.
The SURE team will create a Project Folder for your research project within SURE and will also upload the datasets and data variables into your SURE Project Folder workspace once all approvals are received. The datasets and variables made available to you will be the ones approved by PHSREC.
All research using CUPL must be conducted through the secure SURE environment. SURE enables researchers to access the datasets and variables approved for their research project from any desktop using a virtual computer interface. Each researcher is granted a unique set of user credentials which enables them to log in to SURE and access their Project Folder Workspace. These credentials must not be shared.
No unit record files are permitted to be taken out of SURE and all files uploaded into and out of SURE are audited by the Sax Institute to ensure compliance with the obligations for data custodians.
All researchers must complete training in the use of SURE and CUPL prior to being given access to any datasets and data variables.
Researchers are expected to familiarise themselves with the conditions associated with using CUPL which are outlined in the Researcher Deed Poll. Researchers are also expected to notify the Sax Institute immediately if they become aware of any problem or breach in data security and use. This includes loss of credentials or becoming aware of credentials being shared.
The Sax Institute has implemented a strong governance framework for CUPL which ensures the highest levels of data governance and security.
There is no limit to the number of researchers on an investigator team, nor on the number of participating research institutions. However, the number of researchers who will access unit record data through SURE should be kept to the absolute minimum to meet ethical principles for using public data, and as outlined in the Five Safes Framework requirements. In most instances, it would be expected that only the Lead Researcher and one to two others (including expert statisticians and epidemiologists) would need to access unit record data. Sometimes the Lead Researcher will not access data as specialist data analysis skills are required to achieve the research aims, but the Lead Researcher remains responsible for ensuring the conduct of the project abides by all conditions.
All researchers must sign the Researcher Deed Poll and undertake a CUPL training module. Data users’ affiliated institution must sign the Institutional Agreement which governs the use of data under CUPL. This can take some time if there are multiple data users who belong to a number of different institutions, so it is important to ensure that you have factored this into your project timeline.
All researchers named on the proposal must comply with the requirements set out in the Researcher Deed Poll.
Yes. However, all amendments will need to be reviewed by the 45 and Up Research team, and may also require submission of an amendment for PHSREC review. Researchers should be aware that such amendments may incur additional costs, and that the approval process may also take some time.
If you think you need to amend your research protocol, it is important to contact the 45 and Up Research team as early as possible at 45andUp.Research@saxinstitute.org.au.
The timeframe for access is determined by the scope of the research project and time required to achieve the research aims. The timeframe is nominated by the researcher and specified in the legal agreements. The time period will commence once all requirements for access are satisfied and the data has been uploaded into the individual research SURE Project Folder. Researchers may request an extension, and pay costs associated with such extensions. Please provide at least two months’ notice.
All files and data that are in the SURE Project Folder will be archived for a minimum of seven years. Researchers can pay a fee to access their archived files during this time period if required. There is also the option to suspend a SURE workspace and project folder which may be more appropriate if a researcher expects they may need to re-access their data during the process of peer review.
Researchers are responsible for ensuring that all permissions associated with the datasets, data variables and other files in the SURE Project Folder have been made to enable the Sax Institute to archive the data. This includes third party permissions relating to software, coding and datasets.
All researchers using CUPL are required to provide at least an annual progress report using a standard form. The specific reporting requirements for each research project will vary in accordance with the research objectives, funding source and other factors.
Research using some datasets, for example COD-URF, will require more frequent reporting. Researchers will be advised of this at the time of receipt of their approval to conduct research using CUPL, and the frequency and format of reporting will be detailed in the Institutional Agreement.
The research outputs expected from each project will also be specified in Schedule 1 of the Institutional Agreement. Researchers are required to notify the Sax Institute as soon as possible if there is any variance to these expected outputs, either in timing or scope.
All research manuscripts undertaken through CUPL, including papers, reports, conference presentations and abstracts must be submitted to the Sax Institute for Technical Review at least 30 business days prior to intended submission for publication. Please ensure your manuscript meets the guidelines for Technical Review, which are available here. If required, additional time needs to be allowed for review by the MBS and PBS data custodians (Services Australia).
Manuscripts must not include small cell sizes in tables, or text, or other statistical metrics that could lead to calculation of groups with less than six people, or any other combinations of rare variables that might lead to a privacy breach.
Manuscripts must appropriately acknowledge data custodians, and if appropriate, include caveats on datasets and data variables, such as changes in variable definition or time periods of collection, using the preferred words provided by each data custodian.
Technical Review does not include rewriting or editing manuscripts for grammar or writing style. Nor is it used as a means of censoring research publication. It is focused on ensuring that the technical requirements of using the 45 and Up Study are met and the obligations of data custodians are fulfilled. Ensuring your manuscript meets the guidelines may expedite approvals.
When the manuscript has been accepted for publication, and at least 15 business days prior to its intended publication, researchers need to submit the manuscript to the Sax Institute to allow time for data custodians to be briefed.