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Submitting an amendment

All proposed changes to a HREC approved project must be submitted to the Human Research Ethics Committee (HREC) and Research Governance Officer (RGO) for review prior to implementation of the amendment. All General Amendments to the NSLHD Research Office require a method of payment form to accompany the submission. Please refer to fees and payments for further guidance.

Ethics

The NSLHD HREC Executive Committee review all amendment requests to approved research projects. Please click here for the meeting submission deadlines and meeting dates.

All amendments are to be submitted via Regis.

Amendment types include;

  • General Amendments – changes that affect the conduct, design or methodology of a study and include changes to:
    • Information previously provided in the HREA and/or protocol
    • Information sheets and consent form/s for participants or to any other supporting documentation for the study.
  • Addition of a new research site
  • Request for an extension of HREC approval

 

Amendments should include:-

  • A brief description of modifications and rationale including any summary of changes provided by the sponsor;
  • Implications for the ongoing conduct of the project; and
  • Any need to amend the protocol, Participant Information Sheet and Consent Form or any other documents.

 

Amendments to documents are required to:-

  • Be provided in two versions: one version showing tracked changes and one with accepted tracked changes, with a cover page summarising the changes for large documents such as Investigator’s Brochures or protocols;
  • Contain revised version numbers; and
  • Include version dates and page numbers on each page.

 

Instructions on how to submit an ethics amendment can be found here;

  • Ethics guidance on submitting an amendment can be found PDF icon here External Link
  • Ethics guidance on responding to an information request can be found PDF icon here External Link

 

Governance

The Principal Investigator at a site is responsible for notifying the Research Governance Officer (RGO) of all HREC approved amendments to a research project. Please note that amendments cannot be reviewed by the RGO without evidence of relevant HREC approval

 

Payment;

A Method of Payment (MOP) form is required for all governance amendments that require authorisation. A method of payment form is not required for governance authorised amendments if the HREC is NSLHD.

Amendments for governance authorisation;

  • Protocol
  • Investigator Brochure
  • Participant Information sheets and consent form/s
  • Other supporting documentation for the study including but not limited to posters, flyers, patient visit cards.

 

Amendments for governance Noting/Acknowledgement;

  • HREC Extension
  • Contract Changes
  • TGA Acknowledgement
  • Study Budget
  • Certificate of currency.


If ethics is in REGIS
A site General Amendment form will need to be submitted to each applicable site after ethics approval.


If ethics is outside of REGIS
Please submit a site amendment form in REGIS within the related site application for notification. Please upload the ethics amendment approval letter, approved ethics document(s) and site specific document(s) into REGIS Please be advised governance do not require copies of tracked versions.

  • Governance guidance on submitting an amendment can be found PDF icon here External Link
  • Governance guidance on responding to an information request can be found PDF icon here External Link