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

2. 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

3. 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)

4. 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 with the online registration is sent to
Research Support Services, who will maintain a list of QI projects
registered with Monash Health

5. 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)