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:
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:
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: