Concord Hospital Concord Hospital
The Concord Research Office

What's New

Updated May, 2021

 

REGIS Tasmania and Northern Territory now part of National Mutual Acceptance (NMA) Scheme 

The NMA scheme has recently been bolstered to include all Australian states and territories. NSW NMA certified HRECs, in their capacity as a lead HREC, can approve the addition of sites in the Northern Territory and Tasmania.

To conduct research in the Northern Territory applications will need an additional review by a specialist ethics committee formed by Menzies School of Medical Research. If there are further questions about conducting research in Tasmania and Northern Territory please do not hesitate to contact the Tasmanian Research Governance Office or Menzies HREC. Guidance on the Northern Territory site specific assessment (SSA) process and forms are available from the NT Health research website, contact nthealth.rgo@nt.gov.au

 

Governance post-authorisation submissions in REGIS

From Monday, 1 February 2021 researchers must use REGIS to submit   governance post-authorisations amendments (including progress reports, safety reports, CTRA amendments, insurance certificates, changes to local study personnel, First Patient In etc.)

NB: Where Ethics is being managed by REGIS the Annual Progress Reports should filter down to the NSW sites listed in REGIS. For sites outside NSW please submit through the relevant system in that jurisdiction.

NB: Where Ethics is outside of REGIS and is being managed in another jurisdiction, the HREC approved annual progress reports must be submitted to the sites under ‘Progress Report – External HREC milestone’

NB: If your milestone is not showing in your dashboard, please contact the approving Governance Officer and request for one to be created for the relevant milestone. 

Walk through videos for each of the above processes can be accessed on the REGIS QRG page https://regis.health.nsw.gov.au/how-to/ 

 

Expressions of Interest - HREC Membership

The Concord Repatriation General Hospital Human Research Ethics Committee is currently seeking expressions of interest for vacancies in the following category:

  • Community Representatives, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work

If you wish to express interest in joining the Committee in the above capacity, please contact:

HREC Executive Officer - Ms Kate Flinders Kate.Flinders@health.nsw.gov.au or 02 9767 5622

HREC Chair - Professor David Le Couteur David.LeCouteur@sydney.edu.au
 

 REGIS

Please see the REGIS section of our website for more information.

Researchers are encouraged to set-up an account in REGIS https://regis.health.nsw.gov.au/  and should refer to the REGIS Quick Reference Guides (QRGs) https://regis.health.nsw.gov.au/how-to/ for instructions on how to create an application in the system.
If you experience technical issues, you are advised to contact the REGIS Helpdesk on 1300 073 447 or email support@f1solutions.com.au. The help desk is open Monday to Friday from 7 am to 7 pm (excluding public holidays).

 

NHMRC Safety Reporting

 The Safety Monitoring and Reporting section of our website is now live. Please check this section for more information.

In November 2016, NHMRC released new guidance on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (the Guidance). The Guidance replaces the 2009 Australian Health Ethics Committee (AHEC) Position Statement on safety reporting. The NSW Office for Health and Medical Research (OHMR) fully supports implementation of the Guidance, which will streamline clinical trial safety reporting and monitoring for Australia. Researchers and Sponsors are asked to adopt the new safety reporting guidelines from 3 October 2017.

KEY CHANGES
HRECs will no longer receive: Single case Adverse Events (AEs), Serious Adverse Events (SAEs)/Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)* or device/non-therapeutic good trial equivalents or six monthly line listings.

HRECs will receive: All significant safety issues, annual safety reports and investigator’s brochure updates. These will be submitted to the HREC by the Sponsor (or their delegate).

Research Governance Officers (RGO) will no longer receive: Any IB updates, any single case AEs, SAE/SARs, external SUSARs or device/non-therapeutic good equivalents, and six monthly line listings.

Research Governance Officers (RGO) will receive: All significant safety issues (SSIs), any local SUSARs/ Unanticipated Serious Adverse Device Effects (USADEs)/ Unexpected and Related Serious Adverse Event (URSAEs) arising from the site and any research-related events that meet the definition of an incident. These will be submitted by the investigator to the local RGO.

For more information on the safety monitoring and reporting responsibilities of Sponsors, Principal Investigators, the HREC, the Institution, and the Therapeutic Goods Administration, please refer to the Guidance here or email/call the Research and Ethics office for any queries.


Western Australia Health joining National Mutual Acceptance (NMA)

On 31 August 2017, Western Australia joined the National Mutual Acceptance (NMA) scheme of single ethical review for health and medical research conducted in more than one participating jurisdiction’s public health organisations (PHOs). Currently Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are participating in National Mutual Acceptance (NMA).

Seeking Ethics Approval Process for New NMA Studies:
From 31 August 2017, a Human Research Ethics Committee (HREC) in Western Australia may approve a research study submitted under the NMA Scheme, for study sites in ACT, NSW, Queensland, South Australia, and Victoria. Similarly, all NMA certified reviewing HRECs in NSW may approve a study under NMA for Public Health Organisations in Western Australia, for any new studies reviewed as of 31 August 2017.

Adding a Western Australian Site to an Existing Project:
After 31 August 2017, to add a Western Australia site to an existing project approved under NMA, an ethics amendment needs to be submitted to the original reviewing HREC requesting the approval of the additional site.

For studies taking place in Western Australia, the Western Australian Specific Module (WASM) must be completed in addition to the HREA. All other NMA procedures remain the same. Further information on NMA, including a list of human research projects that are excluded from NMA for research conducted in WA, can be here.

Clinical Trial Metrics

Clinical Trial Metrics In July 2016 the NSW Office for Health & Medical Research (OHMR) introduced a requirement for all NSW Local Health Districts (LHDs) to provide data for clinical trial metrics. These metrics will be utilised to measure the success of reform initiatives introduced by OHMR to improve trial approval and enrolment processes, and to improve NSW’s ability to competitively initiate and deliver health and medical research, including clinical trials.
The data collection process is facilitated and managed through the Concord Hospital Research Office. For commercially-sponsored trials only, investigators will be asked to provide data for two metrics:

Metric 5 - Date first participant is enrolled to the clinical trial. If this date is more than 40 days after site authorisation, a reason for lack of enrolment will need to be provided. This data will be collected for all commercially sponsored clinical trials where an SSA authorisation has been issued on or after 01/07/2016.

Metric 6 - Total number of participants enrolled over the life of a clinical trial at Study Closure (ie when study is closed to enrolment/recruitment at the site). If the total number of participants enrolled to the trial is less than the minimum enrolment target for the site (as specified in the CTRA), a reason for not reaching target will need to be provided. This data will be collected for all commercially sponsored clinical trials closed to enrolment at the site on or after 01/07/2016.

The OHMR document, NSW Metrics for Health and Medical Research, including Clinical Trials can be found here.

New Clinical Trial Research Agreement Templates

Medicines Australia has advised that the four original Clinical Trial Research Agreements templates have been recently revised and updated. In addition a new Agreement has been prepared for Phase 4 Clinical Trials with a Contract Research Organisation Acting as the Local Sponsor. The revised templates and the new Phase 4 with a CRO as the Sponsor template, dated March 2017, are now available.
The link can be found here.

Summary of Transition arrangements from MA website
• Companies and other sponsors of clinical trials may start to use the updated CTRA templates from 1 May 2017.
• There is no need to revise the CTRA for any clinical trial which has already been submitted to an HREC for review, or for any clinical trial that has commenced.
• Between 1 May 2017 and 31 July 2017 companies and other sponsors of clinical trials may choose to either use the current (November 2012/March 2013) versions of the CTRA templates or the March 2017 versions for new clinical trial projects. Both are acceptable.
• For all new clinical trials for which submissions to HRECs will be made on or after 1 August 2017, the March 2017 CTRA templates must be used.