Last Updated 27th September 2017
1. NHMRC Safety Reporting
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 18th September 2017.
• 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 (via the coordinator).
• 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.
2. Western Australia Health joining National Mutual Acceptance (NMA)
As of 31 August 2017, Western Australia will be joining 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:
As of 31 August 2017, 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.
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, Western Australian Specific Module (WASM) must be completed in addition to the NEAF. 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 found in the updated documents on the NMA page.
3. TRANSITION FROM THE NATIONAL ETHICS APPLICATION FORM (NEAF) TO THE HUMAN RESEARCH ETHICS APPLICATION (HREA)
On 31 August 2017*, the National Health and Medical Research Council’s (NHMRC’s) Human Research Ethics Application (HREA) will replace the National Ethics Application Form (NEAF) in Online Forms.
From the 31 August 2017*, all new ethics applications regardless of study risk level should be generated on a HREA inside of Online Forms. (Please do not access the HREA from the NHMRC site). This change applies to all NMA jurisdictions, so that all multi-jurisdictional projects regardless of study risk level may be submitted on a HREA under NMA.
NEAF, SSA, NSW LNR and NSW LNRSSA applications that have already been created/in progress in online forms prior to 31 August will not be affected, and can still be submitted until further notice.
• The HREA is an online ethics application form developed for all human research.
• The HREA is designed to guide applicants through the ethical principles of the National Statement on Ethical Conduct in Human Research (2007) and will enable the HREC to complete a more comprehensive ethical review of your research. In addition, many of the questions are hyperlinked to the relevant sections of the National Statement to enable you to ensure that all relevant issues are addressed in your response.
• HREA has been designed to cover all types of research, it can be used for applications for ethics approval of research that requires full HREC review or Low and Negligible Risk research applications that are processed under expedited review. This is because HREA is a logic driven form so that as you complete each section only the relevant sections for your research are generated. Note: that the level of review required will be determined by the Manager of Research Ethics and Governance on receipt of this application.
• A project description or protocol must accompany the HREA. Please see https://hrea.gov.au/OmniNet/Pages/ProjectDescription for guidance only. Remember HREA must completed within Online Forms.
• The SSA process remains the same, the only difference being there will only be one type of SSA for all research.
• More information on HREA and FAQs can be accessed here.
*The 31 August launch date is dependent on NHMRC issuing a final notification of the HREA licence to Infonetica, the provider of Online Forms.
4. Research Ethics and Governance Information System (REGIS)
The Research Ethics and Governance Information System (REGIS) is a new online portal that is being introduced by the Office of Health and Medical Research (OHMR) to manage ethics and site governance of health and medical research projects in NSW and ACT public health organisations (PHOs). It will replace AU-RED and the Online Forms website as one system, and will be accessible by PHOs and researchers. It will facilitate the creation, processing and storage of ethics and site-governance applications as well as post-approval/authorisation, progress reports, safety notifications and amendments.
REGIS will incorporate the National Health and Medical Research Council’s new ethics application form, the Human Research Ethics Application (HREA), which will replace the National Ethics Application form (NEAF) (see above). There will also be a number of key changes to the existing ethics and research governance processes which will allow for a more streamlined process.
Royal Prince Alfred Hospital Human Research Ethics Committee (HREC) has been chosen as a soft launch site for REGIS, meaning that it will be one of the first sites to be using REGIS (as well as Concord Hospital HREC and Hunter New England HREC). The estimated timeline dates for REGIS implementation at RPA Hospital is 1 November 2017 for the commencement of researcher submission of applications into REGIS. However, this date may be subject to change. Please this date in mind if you are intending to submit an application in the upcoming months.
We will update SLHD researchers and our website as we receive more information on when REGIS will be implemented for our site. Please check our website in the “What’s New” section in the upcoming months for updates on this transition and available training for researchers.
For more information about REGIS and to receive updates from their website directly, please register your email at the REGIS website: https://regis.health.nsw.gov.au/
5. Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (the Guidance)
NHMRC recently 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. OHMR is currently integrating the revised safety reporting procedures into NSW Health policy which will be available early- to mid-2017. In the interim, researchers and sponsors are asked to continue to follow current safety reporting practices until further notice.
6. 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.
7. 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.