Ethics Post Approval Guidelines

Amendments to approved projects must be submitted via REGIS. All revised documents must have the following included in the footer on every page: version number, date and page number (i.e. Version 1 01/01/2022 page 1 of 2).  

To help expedite review, please note the following:

• All sections of the REGIS Amendment Form must be completed in detail, including a summary of the description of/reason for/ethical implications of the amendment – it is not sufficient to simply direct the reviewer to another document
• Incomplete forms or those lacking sufficient detail may be returned to the sender for completion
• The Amendment Form must be approved by the Principal Investigator
• All updated documents must be: 
  • Listed in the amendment form
  • Included with the submission in both tracked changed and clean versions
  • Have updated version number and date in the footer of each document (also please take care to update any other reference to the version/date of the document mentioned anywhere e.g. on the front of the study protocol etc.)

Please note the submission closing dates for the relevant committee meeting when submitting your amendment.

Change of study staff – only a change of PI or CPI needs to be reported to the attention of the HREC.

IB Amendments must be submitted via REGIS using the instructions provided in the Quick Reference Guides.

IB Amendments will be provided to a Scientific Reviewer for approval.

Within the Public Health System

Only sites within NSW can be added to an LNR project. Sites outside NSW (Victoria, Qld and SA only) can be added to clinical trials under the National Mutual Acceptance arrangements. 

Please provide the following for review by the Ethics and Governance Office:

• REGIS Amendment Form – including full name of new site and the name of the nominated PI for that site
• PI details:
  • Brief CV  (2/3 pages) for new PI 
• Master PISCF – if one has not already been reviewed and approved by SESLHD HREC
• Other documents: depending on what documents were required for submission for other study sites then they will also have to be included for the new site such as:
  • CTN (if applicable) – a CTN for the new site will need to be submitted to the TGA
  • HREC Only Indemnity (if applicable) 
  • Radiation Safety Report from relevant site RSO (if applicable to study) 
  • Victorian Specific Module (if Victorian site)

Sites external to the Public Health System

Where a proposed site is outside of the public health system an executed External Entity Agreement (EEA) with SESLHD must be put in place.

Please provide the following information to facilitate drafting of the agreement by the Research Office:

• Business name
• ABN
• Business address

Please contact the SESLHD Research Governance Officers (RGO) via SESLHD-RSO@health.nsw.gov.au to determine whether they will require any additional/amended documentation.

Please provide the following for review by the Ethics and Governance Office:

• REGIS Amendment Form (signed by PI)
• Confirmation (letter or email) from outgoing PI agreeing to the change
• Brief CV (2/3 pages) for new PI 
• Updated PIS&CFs with name of new sponsor/PI
• If commercially sponsored - Updated indemnities, CTN and CTRA as required
• If not commercially sponsored - state on amendment form “Not Commercially sponsored - no other updated documents are required”.

Annual reports must be submitted via REGIS using the Quick Reference Guides.

Closure of a Study Site

Where one site of a multi-site study closes a letter from the Coordinating PI outlining the reasons for the site closure and providing details of the study status at that site, should be provided to the HREC.

NB: The RGO for that site will also have to be notified of the site closure.

Study Closure/Completion

Please submit a completed Annual progress Report Form – signed by the PI.

Please tick section 1C and provide the following information: 

• Date project completed 
• Attach a 1-page report including hypothesis, participant numbers, results, final outcomes and any resulting publications

Extension of approval must be submitted in an Annual Report via REGIS with one separate page to provide a clear rationale for the request and the length of the extension required (1-5 years). 

Most studies receive ethical approval for a period of 5 years.  If the study has not been completed in this time then you may wish to request an extension of up to another 5 years.

Requests for an extension of ethical approval are reviewed and granted at the discretion of the Executive Officer. In certain circumstances researcher may be requested to resubmit their research projects for review by the HREC or one of its subcommittees. 

Please submit your application for an extension at least 3 months prior to expiry of current ethical approval.   

Safety reports must be submitted in accordance with Safety Report Guidelines and on the appropriate form.

The NSW OHMR has formally accepted and endorsed the updated NHMRC Safety Reporting Guidance and in response, has published a new Policy Directive (PD2017_039) titled 'Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations'. This is effective now, applies to new and existing research projects and aligns with national and international standards.

For further details including frequently asked questions, please refer to the OHMR website.

What are the changes to the reporting requirements?

Fewer reports are required, and all safety reporting to the HREC and/or RGO is the responsibility of the Sponsor of the trial.

The OHMR has mandated the use of 2 forms. Please use them from now on:

• Significant Safety Issue (SSI) Notification Form (reporting from the Sponsor to the HREC)
• SUSAR/USADE/URSAE Notification Form (reporting from Local Investigator to the local RGO)

HRECs will no longer receive: Single case AEs, SAE/SARs and SUSARs* or device/non-therapeutic good trial equivalents or six monthly line listings.

HRECs will receive:

• All Significant Safety Issues (SSI); and
• Annual Safety Reports and Investigator's Brochure updates.

Report all SSIs in the Significant Safety Issue Form. Annual Safety reports can be reported in the Annual Progress Report, on the sponsor’s template or in the form of the most recently updated Investigator’s Brochure or DSUR/DSMB report.

RGOs will no longer receive: Single case AEs, SAE/SARs and external SUSARs* or device/non-therapeutic good equivalents or six monthly line listings.

RGOs will receive:

• Local SSIs;
• Local SUSARs/USADEs/URSAEs; and
• Any research-related events that meet the definition of an incident.

Report all local SUSARs/USADEs/URSAEs in the Local SUSAR/USADE/URSAE Notification Form.

Note: If a SAE/SAR/SUSAR meets the definition of an SSI, it will be reported to the HREC/RGO through that reporting mechanism.

In trials where SESLHD is the sponsor?

The sponsor’s reporting responsibility is delegated by the SESLHD CE to the Coordinating Principal Investigator or Principal Investigator. It is the responsibility of the CPI/PI to ensure compliance with NHMRC and OHMR policy and guidance.

Where the sponsor is another entity - for example, a University, you should seek guidance from that institution. It is likely that the delegation will be to the Principal Investigator.

Please also see the following policies and guidelines for further information:

• Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
• Guidance: Safety Monitoring and Reporting for Clinical Trials
• Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
• Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods

Protocol deviations should be submitted via REGIS with a cover letter explaining the issue and the request to HREC.