When negotiating a Clinical Trial Agreement (CTA) and aligning with clinical trial insurance coverage, sponsors must carefully balance ethical obligations with the need to manage financial and legal risk. While participant safety is always paramount, overly broad “subject injury” language can unintentionally make the sponsor responsible for injuries unrelated to the investigational product or the protocol. As a direct consequence, drafting may leave gaps between what the sponsor agrees to cover in the CTA and what the insurance policy actually pays.
Sponsors should work closely with their insurance broker, legal and contract management team to ensure alignment between the CTA and the clinical trial insurance policy. Here are the key considerations:
1. Define “Subject Injury” Narrowly and Causally
Sponsors should avoid open-ended definitions of “subject injury” that extend to any harm occurring during a trial. Insurance policies typically only respond to claims where injury is caused by the investigational product or protocol-mandated procedures.
2. Align Coverage Language with the Insurance Policy
A major risk for sponsors is a mismatch between the CTA and the insurance policy. If the CTA promises broader coverage than the policy provides, the sponsor may have to fund subject injury costs out-of-pocket. Problematic CTA phrases include:
- “any injury or illness arising during the trial”
- “injuries as determined by Sponsor” (which could be seen as biased)
- “emergency or necessary care regardless of cause”
These phrases may obligate sponsors beyond their insurance. Instead, tie obligations explicitly to study causation and ensure language mirrors policy wording.
3. Clarify Sponsor Exclusions
Sponsors are entitled to exclude liability for injuries that are not caused by the study. Reasonable exclusions include:
- Pre-existing conditions or underlying disease (unless worsened by the study)
- Negligence or misconduct by the site or investigator
- Non-compliance by participants (e.g., taking contraindicated medications against instructions)
- Injuries unrelated to the study drug or required procedures
4. Avoid Indefinite or Open-Ended Obligations
Sponsors should be cautious of language that:
- Extends liability indefinitely after the trial ends
- Covers all costs “not paid by the participant’s insurance” (which may make Sponsor the insurer of last resort)
- Requires compensation for “pain and suffering” outside the scope of clinical trial insurance
Instead, obligations should be limited to reasonable and necessary medical expenses for injuries directly caused by the study.
5. Separate Subject Injury Coverage from Indemnification
Indemnification clauses are about legal claims and subject injury provisions are about direct participant care. Sponsors should ensure subject injury obligations do not function as blanket indemnity.
Best practice: State that the sponsor will cover direct medical costs for study-related injuries, but that legal claims are handled separately under indemnification provisions and subject to standard limitations.
Key Takeaways for Sponsors
- Insurance Alignment: Never commit in the CTA to cover injuries more broadly than your policy does.
- Causal Language: Limit responsibility to injuries directly caused by the investigational product or protocol-mandated procedures.
- Exclusions Matter: Clearly carve out site negligence, participant non-compliance, and unrelated conditions.
- Survival Limits: Ensure obligations survive appropriately but are not open-ended in time or scope.
Final Word
For sponsors, the risk lies in promising too much. Broadly drafted subject injury language may appear participant-friendly, but it can expose sponsors to uninsured liability. By aligning CTA provisions with insurance coverage and using precise, causation-based language, sponsors can meet their ethical obligations while avoiding unintended financial exposure.
ICE Global Consulting has a team of experienced negotiators and legal counsel, and we have years of experience reviewing thousands of CTAs. Contact us here or at [email protected] to find out how we can help you with your CTAs.