ÐÓ°ÉÖ±²¥

Guidelines for insurance coverage: Human research projects, including psychology studies, and clinical trials.Ìý

Overview

Staff, titleholders, students, and research participants involved in ÐÓ°ÉÖ±²¥-approved human research studies and clinical trials are covered under the ÐÓ°ÉÖ±²¥â€™s insurance policies, subject to specific terms and conditions of each policy.

A research study should only proceed if it has received formal ethical and ÐÓ°ÉÖ±²¥ approval. Refer to the detailed guide here, or contact the Human Research Ethics team for support.

Additional review and approval may be required for:

• Third-party contracts, especially those including indemnity or insurance clauses that may affect ÐÓ°ÉÖ±²¥â€™s insurance may need to be reviewed by Legal.
• Any deviation from standard contract terms also requires delegated authority approval.

Special insurance considerations apply for:

• Studies conducted outside ÐÓ°ÉÖ±²¥, especially in the United States and Canada
• Global collaborations with mutual recognition protocols
• Contracts requiring locally admitted paper
• Research involving controlled substances (e.g., cannabis)

Contact the Insurance Office for guidance before proceeding with such projects.

Key insurance policies

• Clinical Trials
• Medical Malpractice (if medical procedures are involved)
• Professional Indemnity
• Public Liability

Key conditions and exclusions

The ÐÓ°ÉÖ±²¥â€™s insurance coverage is subject to strict terms and conditions. Key conditions and general exclusions include:

• Formal approval requirement:ÌýInsurance coverage applies only to research that has received formal ethical and ÐÓ°ÉÖ±²¥ approval. Any activities conducted before this approval are not covered.
• Qualified supervision and care (if applicable):ÌýWhere clinical or medical procedures are involved
  • Treatment must be delivered by registered and appropriately qualified practitioners.
  • Student participants must be supervised by suitably experienced personnel.
• Adherence to approved protocol:ÌýInsurance may be voided if there is a material breach of the approved study protocol, including unapproved amendments or deviations.
• Informed consent (if applicable):ÌýParticipants must be given clear, accurate, and comprehensive information, and informed consent must be obtained in accordance with ethics approvals. Claims arising from failure to follow proper consent procedures may not be covered.
• Wilful misconduct and breaches:
  • Wilful misconduct, criminal acts, or deliberate breaches of privacy or confidentiality are not covered.
  • Coverage excludes losses arising from fraudulent or intentional acts.
• Negligence of third parties:ÌýThe ÐÓ°ÉÖ±²¥â€™s insurance does not extend to third parties (e.g., external sponsors, collaborators, or contractors). These parties remain responsible for their own negligence and must carry adequate insurance.
• Excluded research activities:ÌýThe following may be excluded or require additional review and approval
  • Research involving high-risk substances or procedures, such as gene therapy, radiation exposure, or novel surgical techniques
  • Studies conducted overseas, particularly in the United States and Canada, due to complex jurisdictional and liability issues
  • Projects requiring locally admitted insurance policies or jurisdiction-specific regulatory coverage
  • Research involving cannabis or other controlled substances

Important study documents

Both these documents are essential for ensuring compliance with ethical and insurance requirements.Ìý

Study Protocol

Must include objectives, methodology, ethics, data handling, monitoring, and conflict of interest disclosures.

Participant Information Sheet and Consent Form (PISCF)

Used to ensure voluntary and informed participation, including the suggested indemnification statement for research participants:

“This study has been indemnified by the ÐÓ°ÉÖ±²¥ of Adelaide. This indemnity is enforceable by you as a participant, and is in addition to your right to pursue compensation through legal proceedings under common law.â€�

Reporting notifiable events

A notifiable event is any incident that may give rise to a claim or expose the ÐÓ°ÉÖ±²¥ to liability. This includes, but is not limited to:

• Patient injury or adverse clinical event
• Allegations or evidence of fraud
• Threats of legal action
• Property damage

All notifiable events, including updates or changes to previously reported events, must be promptly reported to the Insurance Office. Use the Notifiable Event Reporting Form to submit your report.

Further enquiries

ForÌýethical and ÐÓ°ÉÖ±²¥ approval,Ìýcontact the Human Research Ethics team.

For insurance review or coverage clarification, contact the Insurance Office:
CallÌý+61 8 8313 4539
EmailÌýinsurance@adelaide.edu.auÌýÌý