Research Agreements and Indemnity
Research agreements set forth the conditions of the collaboration or service provided by the Sunshine Coast Hospital and Health Service (SCHHS) and the requirements of all parties in meeting their obligations in relation to the research project. An agreement will be required if:
- The research involves an external third party such as a pharmaceutical company, Clinical Research Organisation, private research institute or facility, or external health organisation
- The Investigators are a university employee or the research is conducted by a student
Research agreements are made between the external organisation(s) and “Sunshine Coast Hospital and Health Service” ABN: 21 667 257 934. The SCHHS Chief Executive (or delegate) signs all agreements on behalf of the SCHHS. Principal Investigators cannot be a party to the Agreement but may sign to acknowledge the Agreement.
The SCHHS accepts and encourages the use of the Medicines Australia Clinical Trial Research Agreements for use in clinical trials and clinical research; and the Medical Technology Association of Australia Clinical Investigation Research Agreement for use in device trials.
Non-standard agreements can also be negotiated for other types of research. Contact the Research Governance Office for advice on how to proceed with developing a non-standard research agreement.
Confidentiality Disclosure Agreement
Where a sponsor or collaborative group requires the SCHHS to enter into a Confidentiality Disclosure Agreement, these documents should first be forwarded to the Principal Investigator for review and confirmation of the terms of the agreement. Confidentiality Disclosure Agreements are made between the external organisation and either the Principal Investigator or the “Sunshine Coast Hospital and Health Service” ABN: 21 667 257 934. In circumstances where the agreement is between the external organsisation and the SCHHS, SCHHS Chief Executive (or delegate) will sign the agreement on behalf of the SCHHS.
Indemnity is a contractual arrangement between parties to protect them from specified actions, losses or claims. All commercially sponsored research must include the Medicines Australia Standard Form of Indemnity for Clinical Trials available at the Medicines Australia Website.
Research that is not commercially sponsored and involves collaboration with an external organisation must also provide assurances of indemnity. Where appropriate, this may be included within the Research Agreement.
All commercially sponsored research must provide evidence of appropriate insurance before Research Governance authorisation can be given. Other external collaborators may also be required to provide evidence of current insurance appropriate to the type of research.
Research Governance Office
Questions regarding research agreements, indemnity and insurance requirements can be directed to the Research Governance Officer:
Phone: (07) 5202 2991
Sunshine Coast Hospital and Health Service,
PO Box 5340, Sunshine Coast MC Qld 4560
Level 1, Lakeside Building, Sunshine Coast University Hospital,
6 Doherty Street, Birtinya Qld 4575