Variations, Monitoring & Expiries

Approvals

The HREC will notify the primary investigator, and where applicable, supervisors, once approval has been granted. Where there are outstanding matters the HREC will include this in the approval notification. These outstanding matters need to be addressed and provided to the Ethics Office as soon as possible.

Request for Variations

As Research Projects evolve variations to the original protocol can occur. Please notify the Committee of any changes to your protocol in the course of your research, this can be done by submitting a variation request from the Variation tab of your protocol in ARIES.

Please note: Any variation requests to human ethics protocols, received from students at The Australian National University, must have support from the supervisor for the changes.

Monitoring

Under the NHMRC ethical guidelines, the National Statement on Ethical Conduct in Human Research (2007), research projects that have received ethical clearance from The Australian National University HREC will need to provide a brief report on any ethical issues which may have arisen during the research and whether it proceeded according to the plan outlined in the above protocol. To minimise disruption to ongoing research activities, the Ethics Office will send a reminder email at regular intervals to submit the report using ARIES. The report consists of short questions that update the Ethics Office on the status of your study. Please consult the ARIES Monitoring Guide if you have any issues submitting your latest monitoring report.

Completed protocols

When the data collection phase of the research project is completed you need to advise the Research Ethics team. You can advise the team of your completed data collection under the Monitoring tab in ARIES. It is possible to re-open a completed protocol if further data collection is needed. Please contact the Ethics Office in this instance.

Protocol expiry

The validity of approval for a protocol is five years' maximum from the date of approval. For longer projects you are required to seek advice on whether the protocol can be extended or a new submission is required.Researchers will be informed by the Ethics Office when their protocol is two months from expiry.