What constitutes an amendment?

• Amendments to a research project which may affect the ongoing ethical and scientific acceptability of the research project or the suitability of the research at the Metro South Health site must be submitted for review to either the Metro South Health HREC Office and/or Metro South Research Governance Office.

• Amendments include but are not limited to:

  • change to the research protocol

  • change to the PICF

  • site specific changes

  • contracts changes

  • change to principal investigator

  • changes to staffing levels or number of sites

  • changes that affect finance or costing

  • inclusion of external institution investigator or team member belongs to a non-Queensland Health Institution, University etc.

Ethics amendments

• Amendments for the Metro South Health HREC must be submitted through ERM Applications as a sub-form to the HREA and include:

  • a brief description of the changes

  • the rationale for the changes

  • any ethical and scientific implications for the ongoing conduct of the research project

  • Amended study documents with updated version control (tracked changes and clean versions).

• Ethical and Scientific Review of Human Research Procedure

Research governance amendments

• All site specific amendments are created in ERM Applications as a sub-form to the SSA.

• Amendments for research governance authorisation require completion of Part B of the Research Contracts Approval and Study Execution Form (RCASE Form). 

• The principal investigator must sign for contractual and Public Health Act changes, and the coordinator is able to sign on behalf the principal investigator for all other amendments.

• HREC approval must always be provided where there are amendments that require Metro South Research Governance Office review and approval. 

• Upon submission of an amendment, the Metro South Research Governance Office will perform a formal review of requirements and relay, via the SSA in ERM, of any outstanding requirements.

• Where there is an impact on the department involved, signatures must be obtained from the Head of Department and/or business/finance manager.

• Signatures can be provided by electronically signing the SSA, uploading an email supporting the study or via wet ink signature PDF on the RCASE Form

• Research Governance (site Specific Assessment) Procedure

• Research Contracts Approval and Study Execution Form (PDF, 157.97 KB)

Externally approved research projects (not MSH HREC)

• For research projects that are externally HREC approved, please submit the HREC approval of the amendment along with any updated site specific changes on the RCASE Form to the Metro South Research Governance Office.

• Research Contracts Approval and Study Execution Form

What is an administrative amendment?

• An administrative amendment is defined as changes to the details of research that have no significant implications for participants or for the conduct, management or scientific value of the research project for example:

  • correction of typographical errors in the protocol or other research project documentation

  • amended contact details for the sponsor or research project staff

  • appointment of new or change of support staff contact.

Amendment fees

• All non-administrative amendments to previously approved Sponsored research protocols that are submitted to the Metro South Health HREC for review attract a fee of $650+GST.

• Research Fees Procedure

PowerTrials

• It is mandatory to maintain the PowerTrials record in the ieMR for studies that involve patient consent.
• Please see PowerTrials - Electronic Medical Record Research Support Module Procedure for more information regarding managing amendments and enrolment of patients.

Study commencement

• Details of when the study commenced must be submitted through ERM.

Progress reporting

From 1 February 2020, for reports due in a given year, the principal investigator will be required to report to the Metro South Health HREC annually by 30 April in that year through Ethics Review Manager (ERM).

Submission dates for annual reports will therefore be as follows:

We recognise that for those who have submitted a report before the introduction of the new reporting timeframe this will initially seem unnecessary, however is required in order to standardise all dates for submission.

Complete details of research activity are provided using the HREC/RGO Annual Progress Report/Final Report MSH/BDHP uploading as a supporting document in ERM.

Multi-centre/single site:

• Multi-centre projects:
  • Metro South Health HREC is approving HREC, include all approved sites activities
  • Metro South Health HREC is NOT approving HREC, submit Progress Report acknowledged by approving HREC to research governance office ONLY (sub form off SSA)
• Single site projects:
  • Progress Report only requires submission to Metro South Health HREC (sub-form off HREA)

Meeting annual reporting requirements will permit ongoing ethical clearance until such a time as a Final Report is submitted - amendment requests for extensions of ethical clearance are no longer required. 

Safety reporting

• The Metro South Health HREC no longer requires reports of safety and adverse events.  

• Metro South Health conforms to the National Health and Medical Research Council (NHMRC) Position Statement: Monitoring and Reporting of Safety for Clinical Trials.

• Metro South Health HREC will review:

  • Safety reports if appropriate and necessity is provided by the researcher.

  • Research protocol violations (not deviations).

Suspension

• From time-to-time a research project may be suspended with approval from the Metro South Health HREC.

• To enable a suspension the principal investigator must formally write to the Metro South Health HREC Chair regarding the circumstances surrounding the suspension.

• The formal letter should also include an indication of when the research project is likely to continue again.

• If you have any questions regarding the suspension process please contact the Metro South HREC Office for more information.

Final report/study closure

• Final Reports are to be submitted via ERM Applications following the same requirements as Progress Reports specifically noting the study is closed and when it was closed.

Research Support Scheme (RSS)

• Recipients of Metro South Health RSS research grants are required to provide an annual progress report to the Metro South Research Support Coordinator.
• Continuation of funding is conditional on the provision of an acceptable report.
• Successful applicants will be advised of any Metro South Health RSS requirements as part of their Approval Letter.

• Final reports are due by 30 November of the year after which the funding has ceased. 
• Researchers must submit one signed paper copy (in PDF format) AND one unsigned electronic copy (Word format only) of the progress/final to the Metro South Health Research Support Coordinator.

• It is recommend submitting for clinicians and researchers to send progress and final reports to the Metro South Research Support Coordinator at least two weeks prior to the submission deadline.

External research grants

• Progress, final and financial reports are required by most funding bodies as part of the conditions of the research grant/award.

• Continued funding of the research project and the eligibility to compete for future funding is often reliant on their completion.

• Clinicians and researchers are encouraged to contact the coordinating body for the research grant for more information about reporting requirements.

Research budgets and Internal Order Numbers (ION)

• Principal investigators and/or research project contacts must meet with their respective business/finance manager at least quarterly to monitor their research cost centre expenditure.

• It is advisable to meet in May of each year applicable to allow effective planning for the new financial year if appropriate.