Under the NHMRC Funding Agreement, NHMRC no longer requires Administering Institutions (AI) to complete and submit ‘Research Ethics Committee and Regulatory Approvals Clearance Notification’ forms to NHMRC.
It is a requirement that all Institutional approvals be obtained and lodged with the AIs Research Administration Officer (RAO) by the time it is necessary to perform the relevant part(s) of the research activity and all institutional approvals are to be maintained as required for the duration of the grant.
Under the new arrangements, the following applies:
Grants awarded from 1 October 2015
- As part of accepting the offer of funding, AIs accept the requirement stated on the schedule (refer part C) and the Funding Agreement (refer clause 4.2).
- NHMRC will no longer impose application based specific conditions (e.g. for institutional approvals related to Human Ethics clearance, Animal Ethics clearance, Genetic Manipulation clearance and Biosafety) that stop grant payments.
- In certain circumstances it may be possible for some research activity to occur prior to institutional approvals being required (e.g. staff recruitment, planning). In these circumstances, a request to defer the commencement date is not required and NHMRC may begin making payments from the scheduled commencement date.
- Where institutional approvals are needed before any part of the research activity can start, and the Approvals are not expected to be obtained by the scheduled commencement date then the Chief Investigator A should request to defer the commencement date (see Grantee ariations). This will stop payments being made before the necessary institutional approvals are in place and will reduce the need for NHMRC to recover funds.
Grants awarded before 1 October 2015
In order to meet existing unmet application based condition(s) on a grant, AIs will need to provide NHMRC with the following certification:
- Approval of the research activity by relevant institutional committees and approval bodies, particularly in relation to ethics and biosafety will be sought and obtained prior to the commencement of the research, or the parts of the research that require such approvals.
- This certification is to be emailed by the RAO (copy Responsible Officer) to email@example.com.
Institutional approvals not obtained, withdrawn or not renewed
Where an institutional approval necessary for the performance of a part of a research activity has not been obtained by the time it is needed, or is withdrawn or not renewed during the funding period for that research activity the AIs must advise NHMRC immediately either via a grantee variation request in Sapphire (e.g. defer commencement date, defer in-progress grant) or, where this is not possible, in writing to firstname.lastname@example.org.
At any time NHMRC may request further information in relation to decisions made in response to an application for ethics committee or biosafety committee approval, including copies of relevant approvals.
General queries in relation to institutional approvals are to be directed to RAOs in the first instance. If further assistance is required then RAOs may contact email@example.com.