Researchers can adhere to GCP requirements (4.5.4) and the National Statement (5.5.6) in relation to their approved research projects and implement any required deviation or amendment to the approved protocol to manage an immediate safety risk to participants (or staff).
A qualified physician in consultation with the sponsor should make this decision in regards to the safety of participants (GCP 4.3.1).
Consideration should also be given to the safety of research personnel. Where the decision is made that home visits would be beneficial to the research participant they must not unnecessarily increase risks to the research personnel. Consideration should be given to ensuring there is appropriate sponsor approval in place for this change.
Where CAHS is the sponsor of the research, responsibility regarding urgent safety considerations is delegated to the on-site Principal Investigator and once notification is received will be reviewed by the Scientific Advisory and Safety Committee on behalf of CAHS.
Some examples may be:
- Inability for participants to attend for onsite visits at the hospital
- Requirement to substitute telehealth or phone contacts for remote safety monitoring of participants
- Change in procedures for participants to contact the study team
- Management of adequate amounts of trial medication
- Temporary halt to recruitment
Process for deviations or minor amendments
Deviations or minor amendments made in this category can be notified via e-mail to CAHS.Ethics@health.wa.gov.au and CAHS.RGO@health.wa.gov.au.
All notifications will be provided to the appropriately delegated committee members and governance officers for notice and review. Review will be conducted on behalf of the SASC (that advises the institution as sponsor) as well as the HREC.
An acknowledgment of the receipt of information from the researcher will be provided. If the reviewers consider additional information is required (for example a protocol amendment) you will be notified. If you are advised an amendment is required it will have an expedited review process.
Process for major amendments or safety reports
Any major amendments or safety reports related to COVID-19 and its impact on research must be submitted via RGS but will be processed via expedited review structures. Please contact the shared mailbox above to request an expedited review.
The CAHS Ethics/Governance administrative team will focus on review and approval for currently ongoing projects that are making required changes due to the current situation. The Research support team can assist you with preparation of documentation in relation to these required changes as well as providing support for any new pandemic related research.
Process for standard project amendments and monitoring
Standard project amendments and monitoring should continue to be submitted via RGS according to the usual process. There may be a requirement to limit review / approval / support / monitoring for other projects that are considered non-urgent at this time.
Please e-mail the above shared mailboxes if you need assistance or advice. These mailboxes will continue to be remotely monitored during any period of 'core business only' activity.