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.

The authority to disclose data 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.

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).

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