Research governance framework
Research governance is a framework for institutions to use to ensure research is conducted responsibly and safely and is scientifically and ethically sound. Research governance considers the legal compliance, financial management, accountability and risk management associated with at a participating site. Research governance is administered by the process of site specific assessment (SSA). Research governance/SSA is essential in the system for streamlined ethical review of multi-site research projects, and it is also used for single-site research projects.
Research governance/SSA is separate from ethics review. Research governance/SSA must occur at all organisations conducting health and medical research. Both ethics approval and research governance/SSA authorisation are required before a research project can commence at a site.
Research governance/site specific assessment - process and practice booklet
This booklet is a practical guide for investigators/trial coordinators, research governance officers and sponsors/contract research organisations. Information in this publication focuses on clinical trials at multiple sites but can be applied equally to other research projects, although some requirements will not apply. The booklet can be downloaded and the appendices are available in a usable format.
Research Governance and Site Specific Assessment Process and Practice
Appendices - Research Governance and Site Specific Assessment Process and Practice
Principal investigators should start their research governance/SSA application as soon as possible. Sign-off is required from departments or authorities involved in the research project, for example:
nursing, health information, pathology, other local requirements, interpreting services, pharmacy, tissue bank(s), radiology/medical imaging, budget approval.
Research governance cover letter and checklist
The research governance cover letter and checklist provides guidance to assist principal investigators to meet the requirements of research governance/SSA.
A copy of the research governance cover letter and checklist should be a supporting document for every research governance/SSA application.
Making a site specific assessment application
Site specific assessment requires the principal investigator (PI) to complete and submit the SSA using the ERM website. All PIs, including the coordinating principal investigator (CPI), must submit a SSA form for their site.
The SSA form addresses the resources, budget details, site specific policies, and declarations from departments, etc. The organisation conducting the research, following HREC approval, must authorise the SSA before a research project can commence at that site.
See Applicant user guide to ERM for detailed instructions on how to create and complete a SSA form.
1. Accessing an SSA form
The coordinating principal investigator (CPI) is responsible for creating the SSA forms for all principal investigators (PIs) at sites and transferring the SSA form using the Roles+ button in ERM to each PI. A notification email ‘Applicant Role Share’ is sent to each PI indicating that a SSA form is in their ERM account for completion.
Each PI requires the Human Research Ethics Application form (HREA) or Victorian low and negligible risk application form (LNR VIC) and supporting documents (same as submitted to the reviewing HREC). All documents uploaded to the ERM ethics application (by the CPI) are automatically available when the Coordinating Principal Investigator has shared the SSA with a Principal Investigator at sites using Roles+ in ERM. All site specific supporting documents should be uploaded to the ERM SSA (by the PI).
When completing the SSA form some fields relating to declarations and authorisation are blocked as these are not to be completed by the PI.
2. Submitting the SSA form to the site research governance officer
The SSA form can be submitted after the associated ethics application has been submitted by the reviewing HREC’s organisation.
Submission of the SSA form and supporting documents is through electronic submission from the ERM website. Use the application’s 'Submit' button tab to submit to the site’s research governance officer (RGO).
The documents will be received by the RGO for administration of the site assessment process. If the SSA form is correctly completed, the RGO will validate the submission. If the SSA is not validated the RGO will notify the PI via a notification email and request that the SSA application is completed and supporting documents correct. The application form can be updated and/or new/modified supporting documents uploaded on the ERM website before the application is re-submitted by the PI.
See the ERM Signatures and Submission Quick Reference Guide document for more information.
3. Ongoing communication with the research governance officer
The site’s research governance officer (RGO) will assess the SSA form and ensure all the required documents are completed including unique site documents. The RGO may request further information from the PI – the application form can be updated and/or new/modified supporting documents uploaded on the ERM website before re-submitting the application. The RGO will make a recommendation regarding site specific assessment.
4. Authorisation of SSA
Evidence of HREC approval must be provided before the CEO/delegate can authorise or not authorise the SSA. Without CEO/delegate authorisation the project cannot begin at the site. The project can begin at a site when HREC approval and research governance/SSA authorisation is complete.
Participating Organisation and Research Governance Officer Contact Details
The following table contains the research governance contact details for organisations participating in the streamlined system. If you have any queries please contact the Coordinating Office Information line on (61 3) 9096 7398.