When the Subject Is a Person, the Liability Is Different.
Protecting the sponsors, sites, and research organizations that run human studies
Clinical trials carry an exposure that no ordinary business policy was built to handle: bodily injury to the human beings who volunteer as research participants. The moment a study moves from the lab into people, the liability changes character — it is governed by informed consent, institutional review board (IRB) oversight, strict protocols, and, in most of the world, by law. A participant can be harmed by the investigational drug, device, or biologic, by a procedure required by the protocol, or by an error in how the trial is designed or conducted, and the resulting claims reach well beyond what a standard products or general liability policy will answer. For sponsors, research sites, and the contract research organizations that run studies on their behalf, clinical-trial liability is the coverage the whole program is built around.
Properly structured, it protects the participants, the study, and every party with a stake in the trial.
The Clinical Trial's Signature Exposure
The defining exposure is injury to a research participant — a reaction to the investigational product, a complication from a protocol-required procedure, or harm traced to the conduct of the study. These claims are high-severity, often involve vulnerable subjects, and are shaped by informed-consent and IRB requirements that do not, by themselves, eliminate liability. Compounding it is a compliance exposure most sponsors underestimate: many countries legally require a local, admitted clinical-trial policy and no-fault participant compensation before a single subject can be enrolled, with statutory minimum limits that vary by jurisdiction. A trial injury and a missing local policy are the two exposures that define this class.
Key Risks in Clinical Trial Operations
Clinical trial sponsors, sites, and research organizations face exposure related to:
Bodily injury to a participant from the investigational drug, device, or biologic
Injury from a procedure or intervention required by the study protocol
Claims that informed consent was inadequate or that the IRB process failed
No-fault compensation obligations owed to injured participants regardless of negligence
Errors in protocol design, trial conduct, data management, or safety reporting
Foreign trials run without the locally mandated, admitted trial insurance
Breach of participant health data and trial records
The injury claim and the country-by-country insurance mandate are what define the exposure.
Core Coverages for Clinical Trials
A properly built clinical-trial program typically includes:
Clinical Trial Liability — Covers bodily injury to human participants arising from the investigational product, the protocol, or the conduct of the study.
No-Fault Participant Compensation — Provides the compensation many countries require for a trial injury without the participant having to prove fault.
Investigational Product Liability — Responds to injury caused by the trial drug, device, or biologic itself during the study.
Protocol & Professional Liability — Covers errors in protocol design, trial conduct, safety reporting, and data management.
Foreign & Locally Admitted Trial Policies — Provides the country-compliant, locally issued insurance and certificates required to run studies abroad.
General Liability — Protects against third-party injury and property damage at trial sites and facilities.
Cyber & Privacy — Protects participant health information, consent records, and trial data from breach.
Property & Cargo — Insures the investigational product and temperature-sensitive shipments between sites.
What's Commonly Overlooked
Clinical-trial programs are most often weakened by:
Assuming a U.S. products or general liability policy covers human-subject injury — it usually excludes it
Running a foreign trial without the locally admitted policy and compensation the country requires
No-fault compensation obligations treated as a formality rather than funded coverage
Limits set below a jurisdiction's statutory minimum, stalling site activation
Trusting informed consent and IRB approval to eliminate liability rather than reduce it
The gap that hurts most is enrolling participants abroad without the compliant local trial insurance the law demands.
Real-World Claim Examples
A participant suffers a serious adverse reaction to an investigational drug and brings a claim
A protocol-required procedure injures a subject during the study
A regulator halts a foreign site because the required local trial policy was never issued
A participant alleges the consent process failed to disclose a known risk
A data breach exposes the health records and identities of enrolled subjects
A single participant-injury claim, or a non-compliant foreign trial, can stall an entire development program.
Regulatory & Compliance Context
Human clinical research is governed by Good Clinical Practice (ICH-GCP), the FDA's regulations for investigational drugs and devices (IND and IDE), the Common Rule for the protection of human subjects, and IRB oversight, with informed consent required throughout. Internationally the picture is stricter on insurance: the EU Clinical Trials Regulation and many national laws — across Europe, the UK, India, and elsewhere — mandate specific trial insurance and no-fault compensation schemes with set minimum limits, and proof of a compliant local policy is a condition of starting a site. Underwriters expect this framework documented, and a trial's design, phase, geography, and participant population drive both the terms and the limits.
Why Proper Placement Matters
Trial phase, geography, and the investigational product drive everything. A first-in-human Phase I study, a large multinational Phase III, and a device trial present different severities and different legal insurance requirements, and the program has to be mapped country by country so every site is compliant before it activates. Underwriters weigh the protocol, the participant population, the indication and product class, the countries involved, and the sponsor's and CRO's track record. Most clinical-trial risk is written in specialty markets that can issue locally admitted policies through a global network and carve the human-subject terms a study requires. Presenting a disciplined protocol, a clear country map, and documented GCP compliance is what secures both the coverage and timely site activation.
Our Approach
At Cory Washington & Co., we build clinical-trial coverage around the study itself — mapping every country to its local insurance and compensation requirements, placing admitted policies where the law demands them, and sizing limits to the protocol and participant population so no site is held up at activation. We coordinate the trial program with the sponsor's or CRO's broader liability, and with the multinational structure foreign studies require. We also insure the companies behind the science, including biotech R&D firms, the broader life sciences company, and diagnostics and genomics labs.
When the subject is a person, coverage can't be an afterthought — we build the trial program so protection and compliance are in place before the first participant enrolls.
All insurance descriptions on this website are provided by Cory Washington & Co. LLC strictly for general informational purposes. They are not intended to be, and should not be relied upon as, legal, financial, or insurance advice. The information presented is general in nature and does not guarantee the availability, terms, conditions, or scope of any insurance coverage. Actual coverage is determined solely by the specific policy language issued by the insurer and remains subject to underwriting approval. Nothing on this website creates or implies an agent-client relationship, binds coverage, or alters any existing policy. Cory Washington & Co. LLC expressly disclaims any liability for actions taken, or not taken, based on the content provided here. For advice regarding your particular situation, please consult directly with a licensed insurance professional at Cory Washington & Co. LLC or another qualified insurance professional, and always review your policy documents in full.
See the coverages a clinical trials business may carry — core, prevalent, and situational — plus the gap most often missed, in the Clinical Trials Coverage Checklist.
Complete the Clinical Trials Supplemental online in a few guided steps, download the fillable PDF, or browse all applications.
Frequently Asked Questions
How do I get clinical trials insurance through Cory Washington & Co.?
Request a quote or contact our team. We start with a short conversation about your operations, analyze your exposures, then negotiate clinical trials insurance across multiple carriers that compete for your account and present options with the trade-offs explained. Cory Washington & Co. LLC is licensed in all 50 states.
How much does clinical trials insurance cost?
There is no flat rate. The cost of clinical trials insurance reflects your industry, your size (payroll and revenue), your claims history, and the limits and deductibles you choose. We market your account to multiple carriers, compare the real quotes side by side, and explain what is driving each number so you can weigh coverage against price with confidence.
Who needs clinical trials insurance?
Whether clinical trials insurance is strictly required depends on your state, your contracts, and your lenders or clients. Even where it is not mandatory, going without it can leave serious financial gaps. We assess your exposure and any contractual requirements, then structure coverage that meets both.
What if another agency has already declined or non-renewed my coverage?
Difficult, specialty, and previously-declined placements are a core part of our work. We access excess & surplus (E&S) and specialty markets that many generalist agencies cannot, and we explain the trade-offs clearly so you can decide with confidence.
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