- Changes to Personnel
- Extension or Re-activation of Approval
- Changes to PICF
- Changes to Recruitment Methods/Advertising
- Other
- Submission Requirements
During the course of a research project either a researcher or an external sponsor may require amendments to be made to a research project. These amendments most commonly involve the following:
- Change to the personnel on the research team
- Extension of the approval or re-activation of the approval granted by the Human Research Ethics Committee (HREC)
- Change to the Participant Information and Consent Form(s)
- Change to recruitment methods/advertising
- Changes to other documents such a protocol, Investigator’s Brochure, surveys or questionnaires
Notification of amendments to research projects must be submitted to the Peninsula Health HREC via the Research Program using the HREC Amendment Form. This form is to be signed by the Principal Investigator.
Additional documentation may be required depending on the nature of the amendment submitted (detailed below).
Please note that multi-site clinical trials reviewed under the Streamlined Ethical Review Process should refer to the Consultative Council for Human Research Ethics (CCHRE) website for the requirements regarding reporting and monitoring of approved research projects.
Change to personnel on the research team
Researchers are to notify the HREC of any researcher joining or leaving the research project. This will require the completion of the HREC Amendment Form accompanied by the Change to Research Personnel Form. Researchers should contact the Research Program if they are unsure whether a new member of the research team should be listed on the project.
Extension of the approval or re-activation of the approval granted by HREC
Researchers are to complete the HREC Amendment Form and provide the original expected completion date, the new expected completion date and the reason for the extension or re-activation of the project. They must also provide justification for this change and any ethical issues that may result.
Change to the Participant Information and Consent Form(s)(PICF)
Changes to the Participant Information and Consent Forms (PICF) may be required for a number of reasons including change to Principal Investigator or other research personnel named in the document, inclusion of updated safety information or changes to the protocol. The researcher is required to submit the HREC Amendment Form accompanied by the revised PICF(s).
Researchers must specify if existing patients are to be re-consented using the revised PICF and are to provide justification for changes and identify ethical issues that may arise as a result of these changes.
The revised PICF is to have all changes marked using tracked changes, or additions and changes to the text underlined and deleted original text marked with strikethrough. Please note coloured text to indicate changes will not be accepted.
NB: A new version number and date is required in the footer of each page of the revised PICF (even when changes are administrative).
Changes to Recruitment Methods/Advertising
The Human Research Ethics Committee is required to review and approve any changes to the participant recruitment methods/advertising.
A copy of the revised material must be submitted to the HREC along with the HREC Amendment Form. If recruitment involves telephone conversation, a script should be provided wherever possible.
It is imperative that the Principal Investigator provides a brief, clear and simple explanation as to what the changes are, what they mean, why they have occurred and any ethical issues that may occur as a result of these changes.
Changes to other documents such a surveys or questionnaires
The Human Research Ethics Committee is required to review and approve any changes to documentation relating to a research project. This includes changes to protocols, Investigator’s Brochures, surveys, questionnaires, advertising material etc. It is recommended that all revised documentation is marked with a version number and date.
A copy of the revised material must be submitted to the HREC along with the HREC Amendment Form.
It is imperative that the Principal Investigator provides a brief, clear and simple explanation as to what the changes are, what they mean, why they have occurred and any ethical issues that may occur as a result of these changes.
Submission Requirements
Requests for amendment approval are to be submitted electronically and in hard-copy and must be printed single-sided and free from staples. Please only submit one copy of each document unless otherwise specified.
Amendment Fee
Please note that protocol amendments initiated by a commercial sponsor will incur a fee of $660 incl GST. Please refer to the fee schedule for further information.
