Clinical Trials Research

Contractual requirements: Insurance is usually a required component when contracting with third parties.

Jurisdictional requirements: If your trial involves sites outside of Canada, you may be held to very specific insurance obligations. Many countries have regulations surrounding clinical trial insurance, with mandated specifications regarding coverage, limits and permissible insurers.

Transferring risk: Despite risk management techniques to prevent or mitigate claims, there still remains a degree of inherent risk in clinical trials. Acknowledging the potential for costly litigation in the event of a claim, an insurance policy is a cost-effective method of transferring some of this risk.

The University & the researcher: The University's coverage is extended to the Governors of the University of Alberta, its directors, officers and current employees. This includes physicians who carry out research and related academic activities as employees of the University and excludes activities related to clinical treatment or private medical practice, including research conducted within a private clinic.

Clinical treatment & CMPA: Insurance protection for claims arising from clinical treatment and medical malpractice is covered by the Canadian Medical Protective Association (CMPA). This is an independent program outside of the University of Alberta.

Sub-sites, drug or device companies, third parties: Each entity involved in a clinical trial should be required to maintain insurance for their activities as part of the trial. Whenever the University is obligated to provide insurance for other sub-sites or third parties, a stand-alone insurance policy will be required.

Most clinical trials within Canada can be covered under the University's standard insurance program with CURIE. Insurance & Risk Assessment must be engaged (and an application completed) when:

1. The trial including any sub-site is outside Canada
2. The trial will recruit participants who are not residents of Canada
3. The investigator is not a current employee of the University of Alberta
4. The sponsor of a trial will not indemnify and hold harmless the University or seeks indemnification for risk outside of the University's control. This includes situations where a sponsor will not indemnify the University for use of their protocol, drug, device or equipment used in a trial
5. The University is required to provide insurance coverage for non-University entities
6. Where another party allocates risk to the University for employment practices, fines, penalties, violation of statue, punitive or exemplary damages, human rights, discrimination, intellectual property, product defect or recall as well as workers' compensation
7. Where a risk assessment results in a "high" level risk rating
8. The study will have more than 500 participants
9. Limits of liability required is more than $10 million per occurrence and in the aggregate

The University's standard insurance program with CURIE will apply to trials inside Canada if the following criteria are met:

1. The Principal Investigator (PI) must be a current employee of the University of Alberta and the Governors of the University of Alberta must be the joint or sole sponsor of the research study (please note that "employee" in this situation means that the PI is engaged in research or academic activities on behalf of the Governors of the University of Alberta);
2. Throughout the term of the study, the PI must be a current member in good standing with the CMPA and is responsible for maintaining good standing with the CMPA;
3. Research activities will be limited to Canadian sub-sites with only Canadian residents as study participants;
4. The trial study is limited to a maximum of 500 Canadian participants;
5. Consent is not deferred. Participants shall provide their consent prior to engaging in research;
6. General and/or errors and omissions liability limits as required under any agreement is restricted to $5 million per occurrence;
7. Each party will insure its own obligations under the clinical trial agreement.

Many countries outside of Canada have laws that dictate insurance requirements for a clinical trial. Insurance & Risk Assessment must be engaged (and an application completed) as a stand-alone insurance policy most likely will be required. It is strongly recommended that PIs contact the CMPA directly to confirm clinical medical malpractice will be extended in another country. The following information must be submitted to Insurance & Risk Assessment for review prior to seeking funding.

1. Copy of the most recent clinical trial agreement
2. Copy of the approved protocol
3. Completed application form

Extra costs incurred as a result of this insurance are the responsibility of the Principal Investigator. This will include all premiums as well as local jurisdictional taxes. A speedcode to process payment will be required prior to providing confirmation of insurance.

Please do not sign any agreement that includes or requires the following:

Copies of Insurance Policies: Under no circumstance will the University's insurer(s) agree to provide/disclose copies of any insurance policy unless a standalone policy is effected where all parties are specifically named as an insured.

Disclosure of University Claim Information: At no time will the University disclose claims information.

Excess and/or Contributory Insurance: The University's insurance policies are for the benefit of the Governors of the University of Alberta and will not be considered excess or contributory over any other parties insurance.

Generic Insurance Terms: Language which references industry standard or professional guidelines is not appropriate and should not replace requirements for specific insurance policy types or limits required.