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Monitoring and reporting

Amendments to Approved and Authorised Research

Amendments to approved and authorised research protocols should be submitted to the Human Research Ethics Committee (HREC) (who approved the project) and the Research Governance Office so they can be assessed with regard to ethical considerations and any potential impact on the site.

Researchers should consult with the approving HREC regarding submission requirements for amendments to the HREC.

Amendment submissions to the Research Governance Office should include:

  1. HREC approval of the changes
  2. a covering letter containing project details (e.g. HREC / governance reference number), summary of the changes, and an explanation of the likely impact on Sunshine Coast Hospital and Health Service (SCHHS) resources (if relevant)
  3. evidence of support from the Head of Department and Business Services Manager where the amendment will have an impact on resources or funding
  4. any supporting documentation (e.g. updated consent form; variation to Research Agreement, amended Public Health Act 2005 approval letter).

Once the amendments have been reviewed by the Research Governance Officer, an authorisation or acknowledgement letter will be provided.

Common changes that require submission to the HREC and Research Governance Office include changes to:

  • Investigators
  • Eligibility criteria or the participant group
  • Processes for obtaining patient consent
  • Processes for collecting data
  • Facilities/hospitals involved in the research
  • Agreements, indemnity or insurance.

Progress and Final Reports

The monitoring process of approved and authorised research includes the review of Progress Reports and a Final Report (on completion/cessation of the study). Progress reports should be submitted annually to both the HREC and Research Governance Office, beginning 12 months after the original HREC approval date. More regular reporting may be required for complex research or research that holds a high degree of risk. The HREC and Research Governance approval / authorisation letters indicate the frequency of reporting required for each project.

Researchers should contact the approving HREC to determine the required reporting forms for the HREC.

Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions

All Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) must be reported to the HREC and Research Governance Office. For definitions of SAEs and SUSARs, refer to the National Health and Medical Research Council website or the project specific protocol.

Researchers should contact the approving HREC to determine the required reporting forms for the HREC.

Expiry of Ethics Approvals and Research Governance Authorisations

HREC approval periods are determined by the individual HREC but are generally issued for three years from Queensland Health HRECs. It is the Researchers responsibility to check the HREC approval expiry date (which is found in their approval letter). Where a project will extend beyond this date, it is the researcher’s responsibility to apply for and receive an extension to the ethics approval period before approval expires.

Research Governance authorisation will only be given for the term of the HREC approval. It is therefore important that any extensions to the HREC approval date are submitted to the Research Governance Office for acknowledgement to maintain current and valid Research Governance authorisation.

Monitoring and Auditing Approved Research

The SCHHS Research Governance Office is authorised to conduct monitoring activities on approved and authorised research. A monitoring activity may involve a review of the following documents and processes:

  • Amendments
  • Use of approved and authorised documents
  • Process for obtaining informed consent (including visual check of signed consent forms)
  • HREC and Research Governance reporting and correspondence (including SAEs and annual reports)
  • Data collection forms and methods
  • Data storage and security issues
  • Credentialing and CVs of research personnel.

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Last updated: 25 February 2016

Contact:

Research Governance Unit:

Administration: (07) 5202 3005

Governance: SC-Research-Governance@health.qld.gov.au

Grants: SC-Research-Grants@health.qld.gov.au

Clinical trials: SC-Clinicaltrials@health.qld.gov.au

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