Human Research Projects and Clinical Trials
The ÐÓ°ÉÖ±²¥ has a number of policies to protect research participants and ÐÓ°ÉÖ±²¥ staff, students, and titleholders who are leading or participating in approved human research projects.
Pre-conditions to cover:
- Human research must be either approved by the ÐÓ°ÉÖ±²¥'s Human Research Ethics Committee (HREC) or an HREC approved by the ÐÓ°ÉÖ±²¥
- Human research ethics approvals granted by other institutional HRECs must be notified to the ÐÓ°ÉÖ±²¥ using the notification process set out on the Office of Research Ethics, Compliance and Integrity website.
ÐÓ°ÉÖ±²¥ staff, students and titleholders who are involved in approved human research projects are indemnified under the ÐÓ°ÉÖ±²¥â€™s Professional Indemnity and Public Liability insurance policies.
Where the Chief Investigator of a project is representing and working on behalf of The ÐÓ°ÉÖ±²¥ of Adelaide, the project is also indemnified under the ÐÓ°ÉÖ±²¥â€™s Clinical Trials insurance policy.
For more information about insurance cover for human research, please refer to the Human Research Projects Insurance Guide.
Certificates of insurance
Certificates of insurance for human research projects and clinical trials may be downloaded by ÐÓ°ÉÖ±²¥ personnel from Insurance Guides and Certificates.
Adverse events and claims
It is a condition of the ÐÓ°ÉÖ±²¥'s insurance policies that the ÐÓ°ÉÖ±²¥ report to its insurer any adverse event or claim arising during a human research project. Notification ensures that staff, titleholders, students and research participants are indemnified by the ÐÓ°ÉÖ±²¥'s insurance policies.
Researchers must immediately report the details of any adverse event arising during a human research project to both the ÐÓ°ÉÖ±²¥'s HREC Secretariat and the Insurance Office using the adverse event or claim report form.
Third party agreements
Contracts or agreements issued by third parties for the ÐÓ°ÉÖ±²¥ to undertake clinical trials or human research projects often contain clauses that compromise the ÐÓ°ÉÖ±²¥'s insurance. All such agreements must be legally reviewed and approved prior to commencement of the study.