Material and Data Transfer Agreements

Any Sydney Local Health District (SLHD) data that will be used for research purposes and transferred to a non-NSW Health public health site or private organisation must have an executed Data Transfer Agreement (DTA) completed and submitted to the Research Governance Officer prior to the transfer. The Governance Officer will review and arrange for the Chief Executive of the SLHD to sign-off on the agreement.

Similarly, this applies for tissue and specimens. A Materials Transfer Agreement (MTA) must be completed and submitted to the Research Governance Officer prior to any transfer. If transferring both tissues and associated patient data, then an MTA will cover both tissue and data transfer.

Please contact the Research Governance Officer for a copy of the DTA or MTA template. The SLHD institution details on the agreements should be as follows:

Name of Institution: Sydney Local Health District

Address:  Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

ABN: 17 520 269 052

Definitions

Data: Data are measurements or observations that are collected as a source of information and refer to bits of information in their raw form. Data can be classified as personal data, health data or non-personal data. 

Information: Information generally refers to data that have been interpreted, analysed or contextualised.

Material/tissue: Organ, or any part of a human body or any substance extracted from a human body.

Flowchart

Please refer to the flowcharts here for determining whether a DTA or MTA is required for your project. For situations that are not covered in the flowchart, please contact the Research Governance Officer on SLHD-ConcordEthics@health.nsw.gov.au for further advice.

Exclusions for DTA: 

A DTA is not required for the following:

• Clinical trials where there is an existing Clinical Trial Research Agreement (CTRA) in place as the CTRA covers data/sample transfer.
• Studies where there is another agreement in place (e.g. collaborative research agreement) which covers the transfer of data/samples. Legal review of the agreement is required if not using the SLHD DTA template. 
• Studies where SLHD is receiving data from another organisation/institution. However, please check with the transferring organisation/institution whether it requires a DTA. If so:

          - Provide a copy of SLHD DTA agreement for use to the transferring organisation/institution (as this process is quicker) 

          - If the transferring organisation/institute requires their DTA agreement be used, then the DTA will require legal review  and should be submitted to the Research Governance Officer.

• Studies where SLHD is not part of the data collection process, i.e. data is being collected directly from the patient and the patient has consented to this e.g. qualitative survey/questionnaire data.

Exclusions for MTA

An MTA is not required for the following:

• Clinical trials where there is an existing Clinical Trial Research Agreement (CTRA) in place as the CTRA covers data/sample transfer.
• Studies where there is another agreement in place (e.g. collaborative research agreement) which covers the transfer of data/samples. Legal review of the agreement is required if not using the SLHD MTA template. 

NSW Health Pathology

If patient samples are being held with NSW Health Pathology, please contact the Research Governance Office about which agreements are required.

Human Tissue Act 

Any research proposals that are using human tissue/specimens must ensure that its use is in line with the Human Tissue Act (1983). Research using human tissue/specimens must be reviewed by the full Ethics Committee. 

NSW Health has developed a guidance document on the Requirements of the Human Tissue Act (1983) in relation to research & use of tissue. The guidance takes into account amendments made to the Human Tissue Act (1983) in 2003, detailing the legal consent requirements in relation to tissue removed prior to and after 1 November 2003. 

This guidance document is available here.

References

• National Health and Medical Research Council (NHMRC) 2018, ‘National Statement on Ethical Conduct in Human Research 2007 (Updated 2018)’, Commonwealth of Australia
• Office of the Australian Information Commissioner (OAIC) 2022, ‘What is personal information?’ - https://www.oaic.gov.au/privacy/your-privacy-rights/your-personal-information/what-is-personal-information 
• Australian New South Wales Health Government Jan 2018, ‘PD2018_001: Disclosure of unit record data by Local Health Districts for research or contractor services’, NSW Health Government