Human Research Projects and Clinical Trials

The University has a number of policies to protect research participants and University staff, students, and titleholders who are leading or participating in approved human research projects.

To obtain cover for your Human Research Project, you must:

  • Ensure the project has been through the appropriate level of ethical review, and that ethics approval has been granted, before it can commence. All human research must be either approved by the University's HREC or an HREC approved by the University.
  • If ethics has been granted by an institution other than the University of Adelaide, you must notify the Human Research Project to the University's HREC via the online notification form. Please contact the Office of Research Ethics, Compliance and Integrity for assistance with online notifications or refer to the support materials and guides.

Insurance is only available if persons providing medical treatment are qualified to perform the treatment, and in the case of students participating, there is appropriate supervision.

Insurance does not extend to indemnify third parties or Sponsors, and won't cover any wilful misconduct or deliberate breaches of confidentiality.

Certificates of insurance

Certificates of insurance for human research projects are issued via the ethics approval notification form. If you require a certificate of insurance for your project, please ensure you indicate this on the 'indemnification details' section when completing the online notification form. The Legal and Risk Branch will review the form and on approval email a certificate of insurance to the investigators involved in the project.

Adverse events and claims

It is a condition of the University's insurance policies that the University 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 University's insurance policies.

Researchers must immediately report the details of any adverse event arising during a human research project to both the University's HREC Secretariat and the Legal and Risk Branch using the adverse event or claim report form.

Third party agreements

Contracts or agreements issued by third parties for the University to undertake clinical trials or human studies often contain clauses that compromise the University's insurance. All such agreements must be legally reviewed and approved prior to commencement of the study.

 

Human Research Projects Insurance Guide

Adverse Event Report Form