In addition to Bellberry’s submission guidance, each application should include a NSW HREC Fee Form and address the following;
- Planned numbers of participants to be recruitment at each site included in an application
- A response to the following 2-part question: Please advise the committee of your plans for commencing and conducting this trial given the current public health considerations relating to the COVID-19 pandemic. Please also provide information regarding whether the potential enrolment of individuals will be impacted by their COVID-19 vaccination status (vaccinated or not), or whether participation in the study could impact subsequent COVID-19 vaccination.
New applications on behalf of NSW PHOs, which have not previously undergone a Bellberry review, must be submitted via REGIS.