Research Support Services Process Maps for Ethics Review & Site Authorisation October 2016

HREC Operating Procedures for the Review of Low and Moderate to High Risk Projects Submission of Research Proposal to Research Support Services for HREC Review HREC Secretariat identifies if the application is Low or Moderate to High Risk Low Risk Applications include: a. Questionnaire studies that do not involve: - Personally intrusive questions - A major time commitment from staff and/or patients - Plans to publish information that could potentially identify specific individuals b. Most student projects involving data collection (by questionnaires or from records) from small numbers of patients c. Some quality assurance projects – particularly those involving minor privacy concerns d. Clinical research projects involving only patient record review Moderate to High Risk Applications include: a. Clinical trials involving new therapies or established therapies used for new indications b. Major surveys or epidemiological studies involving extensive data collection from patients c. Studies involving the extraction of personally sensitive information from records d. Research involving invasive procedures Application is reviewed by Low Risk Review Virtual Panel (within 7 days of submission) HREC meets and determines if the project is to be approved or not approved, together with approval conditions (within 14 days of submission) HREC Deputy Chair advises HREC Secretariat of review outcome (within 8 days of submission) HREC Secretariat notifies the researcher of outcome (within 3 days of meeting) HREC Secretariat notifies the researcher of outcome (within 9 days of submission) HREC Secretariat together with the Medical Administrator review the responses from the researcher and determine if the project is to be granted final approval or not (within 3 days of receipt of responses) HREC Secretariat together with the Medical Administrator review the responses from the researcher and determines if the project is to be granted final approval or not (within 3 days of receipt of responses) Upon meeting Conditions of Approval – HREC Review letter of approval issued(within 3 days of receipt of responses) Upon meeting Conditions of Approval – HREC Review letter of approval issued(within 3 days of receipt of responses) Approval of application ratified at next HREC meeting

Human Research Ethics Committee (HREC) Operating Procedures for Incorporating Therapeutic Committee Review of Clinical Trials Human Research Ethics Committee (HREC) Operating Procedures for Incorporating Therapeutic Committee Review of Clinical Trials Submission of Proposal to Research Support Services for HREC Review Prepare HREC Agenda Papers & Circulate to HREC 1 copy of proposal forwarded to Director of Pharmacy to enable 1 Therapeutics Committee representative to review the proposal Therapeutics representative provides a written report on pharmacology and toxicology issues in respect of any clinical trial to the HREC secretariat by 12noon on the HREC meeting date. If the Therapeutics representative would like to attend the HREC meeting, they are to inform the HREC secretariat by 12noon on the meeting day. HREC meets and determines if the project is to be approved or not approved, together with approval conditions HREC Secretariat notifies the researcher of outcome, incorporating the Therapeutics Review requirements. A copy of the letter sent to the Therapeutics Committee (within 3 days of meeting) HREC Secretariat together with the Medical Administrator reviews responses. If the Therapeutics representative requests to review the responses or if there is a disagreement between what the Therapeutics representative have requested and the response from the researcher, then the Therapeutics representative will review the response (within 3 days of receipt of responses) Upon meeting Conditions of Approval – HREC Review letter of approval issued (within 3 days of receipt of responses)

Quality Improvement/Assurance Registration Staff Member undertaking a QI activity follows an online decision guide, to assess whether the activity would meet QI criteria at Monash Health or whether the activity would be deemed to be a research activity requiring ethical review If the answer is YES or N/A to all of the questions in the decision guide, the activity would meet the criteria of being a Quality Improvement Activity at Monash Health If the answer is No to any of the questions in the decision guide, the activity would need to follow a HREC review pathway Staff member completes the online registration on the decision tree and commences activity An automated email with the online registration is sent to Research Support Services, who will maintain a list of QI projects registered with Monash Health

Operating Procedures for Site SpecificAuthorisation Submission of Application to Research Support Services for Governance Review Application reviewed by Site Specific Authorisation Coordinator and a Medical Administrator to the HREC. (within 3 days of receipt of application) Application requires some further information prior to authorisation being granted Eg. Approval from supporting department, Clinical Trial Research Agreement Application is complete and no further information is required prior to authorisation being granted. Site Specific Authorisation Coordinator advises researcher on any outstanding issues required prior to authorisation being granted (within 3 days of receipt of application) Upon meeting requirements for Authorisation – Site Specific Authorisation letter of issued (within 3 days of receipt of application) Site Specific Authorisation Coordinator reviews responses from researcher (within 3 days of receipt of responses) Upon meeting requirements for Authorisation – Site Specific Authorisation letter of issued (within 3 days of receipt of responses)