Offer of Indemnity to SLHD
(Insert Date)
Research Governance Officer
Research Development Office, Royal Prince Alfred Hospital
Sydney Local Health District
Dear Research Governance Officer,
Name of HREC reviewing the research project: SLHD Ethics Review Committee (RPAH Zone)
Protocol Short Title and Number: XXXXXXXXXX (“Study”)
SLHD HREC RPAH Zone Identification Number: (Insert Prot No X______)
Name of Principal Investigator: (Insert PI name)
Facilities/locations/services included in this application: Chris O`Brien Lifehouse
Name and ABN of Local Sponsor:XXXX
The Local Sponsor has been informed that there is an existing arrangement between Sydney Local Health District (“SLHD”) and Chris O’Brien Lifehouse (“Lifehouse”) for the treatment of public patients at Lifehouse. It is proposed that those patients may be assessed for their suitability for participation in the above Study.
Further, Lifehouse may have been requested SLHD to provide contracted clinical services, such as radiology and pathology services, to participants in the above Study. The details of anycontracted services are included within the Site Specific Assessment (SSA) documents provided to SLHD.
The Local Sponsor acknowledges the above arrangement and acknowledges thatSLHD/Royal Prince Alfred Hospital is not a site involved in the Study.
In consideration for the participation of the public patients in the Study, the Local Sponsor has offered a standard Medicines Australia form of Indemnity to SLHD on the basis of the above.
Ifyou have any questions in relation to the project, please contact the Project Clinical Research Associateby telephone on (insert phone number). The address for correspondence is:
______
______
______
Yours sincerely,
SIGNED by a duly authorised representative of the Sponsor who certifies that they have authority to sign on behalf of the Sponsor
Name: ______
Signature: ______
Date: : ______
Agreement and approval by Public Health Organisation
Recommended by SLHD Research Governance Officer
Name: ______
Signature: ______
Date: ______
Approved by Chief Executive SLHD
Name: ______
Signature: ______
Date: ______