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 (MSH) site must be submitted for review to either the MSHREC Office and/or Metro South Research Governance Office (MSRGO).

• 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 MSHREC 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

SSA amendments

• All Site Specific Assessment (SSA) 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 MSRGO review and approval. 

• Upon submission of an amendment, the MSRGO 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

• Site Specific Assessment Procedure

• Research Contracts Approval and Study Execution Form (PDF, 161.57 KB)

Externally approved research projects (not MSHREC)

• 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 MSRGO.

• 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 MSHREC 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 ieMR Record Research Support Module (PowerTrials) Procedure for more information regarding managing amendments and enrolment of patients.

Study commencement

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

Annual progress reporting

Annual progress reports are now due on 30 April each year as per below:

• annual progress reports are not required for studies that were approved as exempt
• where the MSHREC is the approving HREC, there is no requirement to submit an annual progress report to the MSRGO (ie there is no need to establish an SSA or submit an annual progress report under the SSA), however if the approving HREC is not the MSHREC then the report will need to be submitted to those RGOs as per their procedures. 
• a Quick Guide has been developed to assist in submitting an annual progress report

Safety reporting

• The MSHREC no longer requires reports of safety and adverse events.  

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

• MSHREC will review:

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

  • Research protocol violations (not deviations).

  • The Executive Summary of safety information produced for international regulators, such as a Development Safety Update Report (DSUR), may serve as the annual safety report sent to HRECs (a full DSUR is not required). Otherwise a DSUR does not need to be submitted for review if there has been no change to the risk-benefit ratio and thus no ethical implications to the conduct of the study at sites under MSHREC clearance. Please see the NHMRC Guideance: Safety monitoring and reporting in clinical trials involving threapeutic goods for more information. 

Suspension

• From time-to-time a research project may be suspended with approval from the MSHREC.

• To enable a suspension the principal investigator must formally write to the MSHREC 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 MSHREC Office for more information.

Final report/study closure

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

• Final reports are not required for studies that were approved as exempt.

• Where the MSHREC is the approving HREC, there is no requirement to submit a final report to the MSRGO (ie there is no need to establish an SSA or submit a final report under the SSA), however if the approving HREC is not the MSHREC then the report will need to be submitted to those RGOs as per their procedures.

Research Support Scheme (RSS)

• Recipients of MSH RSS research grants are required to provide an annual progress report to the MSHREC via ERM by 30 April each year.

• RSS Conditions of Award state funding may be withdrawn in circumstances where unsatisfactory progress is determined by the MSH Research Committee.

• Final reports are due by 30 April in the year following the funding end date and will be requested via a notification from the MSH SmartyGrants account. The final report will be completed online by the grant recipient through SmartyGrants.

• Recipients of RSS grants prior to 2019 will be provided a Final Report template to complete and submit by email.

External research grants

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

• Reporting requirements will be scheduled in the relevant Funding Agreement. It is recommended the grant recipient diarises reporting deadlines.

• 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.

Post-award management of research grants 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.

• Appropriate oversite of a research grant budget will facilitate timely and accurate financial reporting to the funding body.