If the Peter Mac Ethics Committee provided the ethical review for a project, substantial amendments to approved project documents must be reviewed by a committee or review panel.
Upcoming submission due dates are provided at Submission and Meeting Dates. Other amendments can be reviewed and approved by the Ethics Committee Secretariat and can be submitted at any time. Examples include: addition of sites; addition or change of study personnel; update to contact or sponsor details; correction of minor errors; increase in accrual.
If the reviewing Human Research Ethics Committee (reviewing HREC) is an external Ethics Committee the approved amendment must be submitted for governance review. These amendments can be submitted to the Ethics Secretariat at any time.
Amendments for ethical review
The requirements for submitting Amendments to the Peter Mac Ethics Committee are described in SOP004 Monitoring Ongoing Research
Substantial Amendments
If the Peter Mac Ethics Committee provided the ethical review for a project then all subsequent amendments to the project documents must be submitted to the Peter Mac Ethics Committee for review.
Additional Sites
May be added to a project that received ethical approval from the Peter Mac Ethics Committee depending on the type of research, date of ethical approval and the location of the site.
Urgent Amendments
Implicating patient safety or requests to vary the protocol for the benefit of a specific research participant may be eligible for Interim Approval.
Administrative Amendments
Can be reviewed by the Ethics Secretariat and can be submitted at any time.
Amendments for governance review
Multisite ethical review projects must submit amendments to the reviewing Human Research Ethics Committee (reviewing HREC) for that project. Once an amendment ethical approval has been issued by the reviewing HREC, a Governance Amendment application can be submitted for the Peter Mac site.
The requirements for submitting Amendments to the Peter Mac Research Governance Officer, Ethics Committee Secretariat are described in Guideline001 Governance Review.
Amendment review pathway summary
For more information follow these links:
