Should a researcher have a concern regarding the HREC’s consideration of their research project, the matter should be referred, in writing, to the Chief Medical Officer, Corporate Services, Monash Health, Monash Medical Centre, Locked Bag No. 29, Clayton, 3168.
Any complaints regarding the conduct of a research project should be made in writing to the Manager, Human Research Ethics Committee.
Researchers may consider engaging with consumers when developing research proposals involving Monash Health consumers, their carers or families because a consumer/s may be able to offer some valuable insights on the proposed research and this will assist in strengthening the research. Monash Health has a Consumer Participation Register and of the researchers were to contact the Consumer Partnerships Manager Ms Amy Lewis via email firstname.lastname@example.org or telephone 0481 909 859, Amy will be able to advise if there are consumers who may be interested in offering advice on the proposed research.
Monash Health has adopted the NHMRC (2018) guidance Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.
In this guidance, the terms Protocol violation and Protocol deviation are replaced by Serious Breach and Non-serious Breach.
A serious breach is defined as a breach of Good Clinical Practice (GCP) or the Protocol that is likely to affect to a significant degree:
1. The safety or rights of a research participant, or
2. The reliability and robustness of the data generated in the research project.
Although GCP requires all deviations to be reported to the trial sponsor, not all deviations require reporting to the reviewing Human Research Ethics Committee (HREC). HRECs need only be made aware of the small sub-set of deviations that meet the above definition of a serious breach.
It is the responsibility of the Sponsor to determine whether any suspected breach meets the definition of a serious breach. Sponsors must report serious breaches to the HREC within 7 calendar days of confirming a serious breach has occurred.
The Principal Investigator must report all serious breaches occurring at the Monash Health site to the institution (Research Governance Office) within 72 hours of being notified of the serious breach.
Non-Serious Breaches are not required to be submitted to the Research Governance Office.
Third parties (e.g. trial sites) may report a serious breach directly to the HREC in the following situations:
• The investigator/institution has good evidence that a serious breach has occurred but the sponsor disagrees with their assessment and is unwilling to notify the HREC, or
• The investigator/institution has become aware that the sponsor may have committed a serious breach.