Researchers must obtain JH&FMHN Human Research Ethics Committee (HREC) approval and site authorisation before implementing amendments to research studies.
Examples of amendments include the addition of new sites; changes to research personnel; and changes to, or addition of documents.
Corrections to typographical errors or amendments to details which do not affect the version number or date of documents need not be submitted.
Researchers are asked to complete an amendment form and submit clean and tracked copies of any amended study documents with revised version control.
Consultation with relevant JH&FMHN stakeholders, and support by Executive Directors and/or Service Directors should be documented in the relevant section of the amendment form.
Submissions will also be reviewed by the Research Governance and Ethics Officer, and referred for further governance review as appropriate.
For more information, go to Resources and contact the Research Governance and Ethics Officer.