The following outline the insurance limits required for Sponsored Clinical Trials and Non-regulated clinical research being conducted at the Nova Scotia Health Authority.
- Phase 1 and 2 Clinical Trials, a minimum of $10M CAD per occurrence/claim and in the aggregate for both General and Product Liability insurance.
- Phase 3a/b Clinical Trials, a minimum of $5M CAD per occurrence/claim and in the aggregate for both General and Product Liability insurance.
- Phase 4/observational study a minimum of $2M CAD per occurrence/claim and in the aggregate of General and Product Liability insurance.
- For non-regulated clinical research, a minimum of $2M CAD per occurrence/claim and in the aggregate of General Liability insurance.
- CROs (if applicable) should provide General Liability insurance of at least $5M CAD per occurrence/claim and in the aggregate.
Proof of global insurance must be made available upon request (if the policy is held by a non-Canadian Sponsor). It is the expectation that the insurance policy be provided by a properly licensed insurer recognized in Canada. If a Sponsor’s insurance policy is limited to a specific clinical trial and is on an annual/within a defined time basis, proof of annual renewal must be provided to ensure continuity of coverage for the duration of the clinical trial and to cover claims after the completion of the study as outlined in the terms and conditions of the signed Clinical Trial/Research Agreement/Contract.
Nova Scotia Health holds Worker’s Compensation insurance within statutory limits, Employer’s liability insurance not less than $10M CAD per occurrence, Commercial General Liability insurance not less than $10M CAD per occurrence and Professional Liability insurance not less than $10M CAD per claim.
The Principal Investigator (if a physician) shall rely on and maintain membership in good standing with CMPA (Canadian Medical Protective Association) for the duration of the Study and while maintaining medical practice privileges and appointments at NSHA. Note: as this is a defense fund rather than insurance, it does not have specific minimum coverage amounts.
Indemnity and Study Participant Reimbursement
Nova Scotia Health is a body corporate under the Health Authorities Act (Nova Scotia) and a Nova Scotia Government Reporting Entity. Pursuant to the Finance Act (Nova Scotia), there are restrictions on the ability of Nova Scotia Health Authority (NSHA) to enter a contract that includes an indemnity. As a “Government Reporting Entity” as defined in the Act. Section 77, Nova Scotia Health is precluded by law from entering “net debt obligations” and an indemnity is listed within the definition of a net debt obligation within the category of contingent liabilities. Nova Scotia Health and the PI will be responsible and accept liable provided that the failure causes the claim, Its/his/her negligence or gross negligence or intentional wrongdoing - Failure to comply with applicable law/rules and regulations and Failure to follow the protocol (except for deviations due to medical necessity)
It is the expectation that the Sponsor of a research study indemnify and hold harmless the PI and Nova Scotia Health its/her/his trustees, directors, officers, affiliates, employees, agents, appointees (including Investigator and sub-investigators), students (if applicable), sub-contractors (if applicable), each being a separate indemnitee. To the extent the claims arise out of or are caused by conduct of study (anything required by the protocol, including without limitation injury to study subjects arising from administration of study drug/device/placebos/comparators or study procedures), sponsor’s negligence or intentional wrongdoing; including without limitation failure to conduct study in accordance with applicable laws, and sponsor’s use of results
Indemnification is expected to be provided directly by Sponsor either in the clinical trial agreement or in a separate indemnification/insurance/warranty agreement made with Nova Scotia Health and PI. If the clinical trial agreement is between sponsor’s agent contract research organization (CRO) Nova Scotia Health and PI, Sponsor must at minimum provide written confirmation/representation to Nova Scotia Health and PI that CRO has authority to bind Sponsor to the agreement as a principal.
Study subject reimbursement (medical care of study subjects): Sponsor will reimburse institution/investigator/subject as applicable for costs of reasonable medical expenses required due to injury arising from study drug/device/materials, from protocol procedures. Reimbursement may be denied by sponsor to the extent that: government sponsored insurance pays for treatment, the injury is caused by Institution/Investigator negligence. Subjects should not be excluded due to own negligence.
Governing law
Nova Scotia Health can only agree to the Governing law/jurisdiction of a Canadian province, preferably Nova Scotia and the federal laws/courts appliable therein. Nova Scotia Health is unable to agree to the governing law and jurisdiction of the Province of Quebec and countries outside of Canada. Should the parties not be able to agree on governing laws and jurisdiction, silence may be accepted.
Force Majeure
Due to the highly unionized environment at NSHealth and the recent pandemic, a force majeure clause is requested to be inserted near the end of the contract. This provides each party with the opportunity to be released from its contractual obligations should it be unable to perform as agreed upon resulting from a labour dispute, pandemic, or an incident outside of its control.
Counterparts
A counterpart clause in included in every contract to clarify that separate copies of the agreement may be executed by different parties and each copy will be considered to be an original. This also provides the opportunity to have contracts signed by all parties in tandem.
Form 1572
As an ICH/GCP compliant foreign site, Nova Scotia Health is not required to be listed on the IND as this is not required by the FDA, see 21 CFR 312.120 and 2010 FDA guidance, “Frequently Asked Questions – Statement of Investigator (Form FDA 1572)” – sections 9 – 15 re: foreign sites http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf and thus are not required to complete a Form 1572. Please do not include Nova Scotia Health or the Nova Scotia Health PI on this Form. If either are included, an REB waiver to participate is required to be requested and provided by the Sponsor.
Importer of record
Should a Study require the importing of materials, drugs, or devices outside of Canada, Nova Scotia Health requests that it nor any PI be listed as the “Importer of Record.” In the event a Sponsor or third party does NOT have a Canadian supplier, then Nova Scotia Health may be able to clear the goods and be listed as the importer of record. If there are associated brokerage fees that are assumed by Nova Scotia Health, it is the expectation that these fees be invoiced to and covered by the Sponsor or associated third party.
