Modifications, Changes to Personnel, Safety Reporting, Annual/Final Reports

Modifying approved human research projects

If you intend to modify your project you will be required to submit a modification request form. This can include, but is not limited to, changes to the following:

  • Recruitment, methodology and/or funding
  • Participant information statement and consent form/s (PISCF)
  • Advertisements
  • Approval period i.e. if your ethics approval is due to expire and you require an extension. 

How do I submit a modification request?

  1. Complete a Modification Request
  2. Attach tracked and clean copy of all updated documents 
  3. Submit the modification request via email to the HREC or HREA Panel that provided approval for your project
  4. Submit email by 5pm on a Thursday and the submission will be considered on the following Tuesday.

How do I make changes to the personnel listed on an approved project?

To add or remove an investigator, co-investigator or student from your project you will be required to submit a personnel modification request. This can be done by following the below steps:

  1. Complete a Personnel Modification
  2. Attach your completed Personnel Modification to an email
  3. In the cc section of the email, copy in any named investigators listed on the modification form.
  4. Submit email by 5pm on a Friday and the submission will be considered on the following Tuesday.

 

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Reporting Adverse Events for Drug/Device Clinical Trials

What are the definitions of adverse events for drug/device clinical trials?

  1. Serious Adverse Event (SAE): A SAE is defined at any untoward medical occurrence, whether it is considered to be related to the project or not, that:
    • results in death
    • is life-threatening
    • requires in-patient hospitalisation (≥24 hours) or prolongation of existing hospitalisation
    • results in persistent or significant disability/incapacity
    • results in a congenital abnormality or birth defect
  2. Suspected Unexpected Serious Adverse Reactions (SUSARs): A SUSAR is defined as a SAE which is both suspected as being related to the drug/device and where the nature and severity is not consistent with known information about the drug/device in questions i.e. reasonable suspected causal relationship and unexpected.
     
  3. Adverse Event (AE): Any expected event as defined in the protocol. This event should be managed by the research team using their risk and safety procedures. The events should be recorded in the case report forms, but there is no reporting requirement to the Human Research Ethics Committee (HREC)

Reporting requirements for SAEs and SUSARS:

Reporting requirements Timeframe for reporting Who to submit a report to    
When UNSW is the lead HREC within 72 hours of becoming aware of the event. UNSW HREC, Sponsor & TGA.
When UNSW is not the lead HREC

Six monthly line listings & Data Safety Monitoring Board (DSMB) report.

* If the associated event results in death, it must be notified to UNSW within 72 hours of becoming aware of the event.

UNSW HREC
When UNSW is not the lead HREC, 
but the event happened at UNSW
within 72 hours of becoming aware of the event. Lead HREC, UNSW HREC* (using lead HREC template), Sponsor & TGA
When UNSW is not the lead HREC, but UNSW is the sponsor/provides 
indemnification

within 72 hours of becoming aware of the event.

* The UNSW HREC will forward the SAE/SUSAR report to the UNSW insurance department.

Lead HREC, UNSW HREC* (using lead HREC template), Sponsor & TGA.
 
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Reporting Adverse Incidents for Research not Classified as a Drug/Device Clinical trials

What are the definitions of adverse incident?

Adverse Incidents (AIs): An unexpected event that infringes on participant or researcher safety, health and/or wellbeing.
 

Reporting requirements for AIs:

Reporting requirements Timeframe for reporting Who to submit a report to
When UNSW is the lead HREC within 72 hours of becoming aware of the event. UNSW HREC & Sponsor (if applicable).
When UNSW is not the lead HREC Six monthly line listings & Data Safety Monitoring Board (DSMB) report (if applicable).

 * If the associated event results in death, it must be notified to UNSW within 72 hours of becoming aware of the event.

UNSW HREC
When UNSW is not the lead HREC, but the event happened at UNSW within 72 hours of becoming aware of the event. Lead HREC, UNSW HREC (using lead HREC template), & Sponsor (if applicable).
When UNSW is not the lead HREC, but UNSW is the sponsor/provides indemnification

within 72 hours of becoming aware of the event.

* The UNSW HREC will forward the SAE/SUSAR report to the UNSW insurance department.

Lead HREC, UNSW HREC* (using lead HREC template), & Sponsor (if applicable).
 
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Reporting Protocol Violations & Deviations

What are the definitions of protocol violations and deviations?

  1. Protocol Violation: Failure to comply with study protocol which affects:
    • participant rights
    • participant safety or wellbeing
    • research data integrity
  2. Protocol Deviation: A non-compliance with study protocol has not impact upon participant rights, safety, and wellbeing or data integrity. The events should be recorded in the case report forms/data collection sheets/experiment book, but there is no reporting requirement to the Human Research Ethics Committee (HREC).

Reporting of Protocol Violations & Deviations:

Reporting requirements Timeframe for reporting Who to submit a report to
When UNSW is the lead HREC within 72 hours of becoming aware of the event. UNSW HREC & Sponsor (if applicable).
When UNSW is not the lead HREC No reporting requirements N/A
When UNSW is not the lead HREC, but the event happened at UNSW within 72 hours of becoming aware of the event. Lead HREC, UNSW HREC (using lead HREC template), & Sponsor (if applicable).
When UNSW is not the lead HREC, but UNSW is the sponsor/provides indemnification

within 72 hours of becoming aware of the event.

 Lead HREC (no reporting requirements to UNSW HREC).
 
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Annual and Final Reporting Requirements

Annual Reporting Requirements:

As a condition of ethical approval, all researchers are required to complete and submit an annual report to the UNSW HREC or HREAP. At the beginning of each calendar year, the Human Ethics team will prompt you by email to submit annual report for your active project(s).

Final (completion) Reporting Requirements:

When your project expires or is discontinued you are required to submit a Completion Report.

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