The Australian Code for the Responsible Conduct of Research requires that institutions conducting research must have good institutional governance, ethical review, and management practices in place to encourage and monitor responsible conduct of research and promote research integrity.
The responsibilities of institutions for monitoring the conduct of approved research are also described in Chapters 3 and 5 of the National Statement, which states that;
"The granting and continuation of ethical approval of clinical research must be on the condition that, for any trial site under the HREC's responsibility, the researcher:
- conducts the trial in compliance with the approved protocol
- provides reports of the progress of the research, at least annually
- informs the BH HREC, and seeks its approval, of amendments to the protocol, including amendments that:
- are proposed or undertaken in order to eliminate immediate risks to participants;
- may increase the risks to participants; or
- significantly affect the conduct of the research
- notifies, in the manner and form specified by the HREC, any serious adverse events at any of those trial sites."
Accordingly, the BH HREC requires that all amendments to research are submitted to the REGI Unit as follows:
- Minor amendments involving administrative corrections, minor document changes, and insurance certificates, will be reviewed out of session by the REGI Unit; and
- Major amendments, such as significant changes to the protocol or PICF, which may impact the site or affect participants, will be assessed on a case-by-case basis and reviewed by the REGI Unit and HREC specialist reviewers as required.
How to submit an amendment for review
Amendments can be submitted to the REGI Unit for review at any time, and are ratified by the BH HREC.
- Please submit all amendments via email to [email protected] using the HREC Amendment Form
- For funded projects, invoicing details should accompany the amendment - please see our Fees webpage
- Ensure amendment forms are signed by the PI, and where appropriate, the trial coordinator - the REGI Unit accepts scanned signatures
- To facilitate timely approval, please submit clean and tracked versions of all amended documents (including protocol changes, amended PICFs, etc.) along with the HREC Amendment Form
- If a project document is new (i.e. has not previoulsy been submitted to the BH HREC) this should be stated on the HREC Amendment Form
- To ensure that approval emails are correct, please carefully list the documents submitted on the HREC Amendment Form
- Please ensure that all documents part of the amendment are appropriately named - please see our Document Naming Guidelines.
Last Modified: Friday, 26 April 2019