During this unprecedented time, many researchers are having to consider alternative methods in which to conduct their research. This may include considering clinical trial participants' needs due to self-isolation, travel restrictions or reluctance to attend a Public Health Organisation at this time.
Clinical trial Sponsors, sites and researchers should be guided by the procedures outlined in the Office for Health and Medical Research (OHMR) guidance document on the impact of COVID-19 on the conduct of clinical trials.
Ideally any required changes to the conduct of a research project that deviate from the approved protocol should be managed as a Protocol Amendment however changes can be implemented as an Urgent Safety Measure (USM).
USM's must be submitted using a Significant Safety Issue (SSI) Notification Form to the reviewing HREC as soon as possible and no later than 72 hours of the sponsor becoming aware of the USM.
All significant safety issues, urgent safety measures and serious breaches impacting on patient safety must be submitted using a Significant Safety Issue (SSI) Notification Form to the reviewing HREC as soon as possible and no later than 72 hours of the sponsor becoming aware of the USM.
Please be reminded of the need to obtain informed consent from participants should any immediate changes to the conduct of the research directly impact their participation.
The NSLHD Human Research Ethics Committee (HREC), the NSLHD Animal Ethics Committee (AEC) and the (RNSH) Institutional Biosafety Committee (IBC) will continue to operate as per the dates and deadlines on the NSLHD Research Office website, observing current requirements for social distancing.
In this constantly changing environment please continue to check the [email protected] auto email reply for the most up to date information from the Research Office including Committee meeting updates.