Clinical trials that involve access to participants, their tissue or data through your Public Health Organisation require Human Research Ethics Committee approval and site authorisation. In addition, an access request review is required if your clinical trial involves one or more of the following:

• Participant recruitment through posters, leaflets, handouts, and letter of invitation but not recruitment through direct contact with potential participants or enrolment;
• Distribution of surveys and questionnaires through staff of the Public Health Organisation but not collation and analysis of responses at that Public Health Organisation; and
• Access to data or tissue held at the Public Health Organisation but not processing or analysis at that Public Health Organisation.
  
  

Access request review is a mechanism used by Public Health Organisations to ensure that the proposed research project complies with minimum governance requirements, and to consider whether to support the provision of access to participants, their tissue or data through the Public Health Organisation as requested by the project. Access requests are managed external to REGIS and the Principal Investigator is responsible for obtaining written agreement from relevant heads of the facilities, locations and services (custodians) that will provide the access required for each clinical trial.

A written request (e.g. letter, public health organisation form or NSW Health form) must be submitted requesting access to participants, tissue and/or data. In the request, the applicant should provide the following information, at a minimum:

• Project title and short title
• Relevant project identifiers
• Coordinating Principal Investigator name and contact information
• Name of study sponsor, if applicable
• Name of Human Research Ethics Committee reviewing the research project
• The resources/services being requested
• The proposed process for accessing those resources/services
• Attached letters or emails confirming the support of each facility, location or service (written evidence of support)

• Attach any documents that will be used at the site (flyers, posters etc)
  
  

Disclosure of unit record data by Local Health Districts for research or contractor services (PD2018_001)

This Policy Directive refers to disclosure of identified or de-identified unit record data relating to the health of an individual or individuals, which are held in Local Health District (LHD) data collections, for the purpose of research or contractor services. The compliance with this policy is mandatory within all LHDs.

The authority to disclose data outside of the organisation is vested in the LHD Chief Executive or delegate in defined circumstances; refer to NSW Health Policy Directive: PD2018_001. Applications for release of data should be made to the data custodian. Data custodians will consider the following:

• if there is a legal basis for the disclosure
• if there is adequate security for the data to be stored and transferred
• the person requesting the data has sufficient experience to reasonably be able to analyse and interpret the results.

The confidentiality undertaking of the data with the external organisation requires a responsible person to authorise to ensure strict confidentiality of data, and understand that the disclosure of any information may constitute an offence under section 22 of the Health Administration Act. All staff at the external organisation with access to the data will also be required to sign a confidentiality undertaking and to complete the NSW Health Code of Conduct.

Who Can Help

• Calvary Mater Newcastle Research Office
• Central Coast Local Health District Research Office
• Hunter New England Local Health District Research Office
• Mid North Coast Research and Knowledge Translation Unit