Clinical Trial Liability Insurance
Liability coverage for a trial sponsor when a research subject is hurt by how a study was run — plus an optional no-fault medical benefit.
This is an estimate, not a bound policy — a licensed VAB producer confirms final terms before coverage starts. Sgt. Savings can answer questions but can't quote, bind, or guarantee coverage.
A sponsor or organization running a human-subject study carries real liability if a subject is injured by a wrongful act in how the trial was conducted, including a failure in the informed-consent process. Clinical Trial Liability Insurance covers that liability for each study listed on your policy, and lets you add an optional no-fault medical expense benefit that pays a subject's study-related medical costs without waiting on a finding of fault. Coverage follows the specific studies you schedule, not your organization's research activity in general.
Who This Is Really For
The ideal buyer.
The ideal buyer is a sponsor, CRO, or research institution that is already committed to running a specific study — the protocol is written, the IRB is engaged, and enrollment is close — and has discovered that general commercial liability coverage doesn't address the specific exposure of a research subject claiming injury from how the trial itself was conducted. The trigger is often procedural rather than a near-miss: an IRB or trial site requiring proof of clinical trial liability coverage before the first subject can be enrolled, or a sponsor scaling from a single-site pilot into a multi-site Phase II study that needs coverage formally scheduled per study rather than assumed under a general policy. This buyer has usually already priced or carries a standard products-liability or professional-liability policy and needs someone to explain why neither one actually reaches informed-consent or trial-conduct claims. What makes this line the right fit — rather than stretching an existing policy to cover it — is that coverage here tracks the specific study on the schedule, which is exactly the granularity an IRB or institutional review process expects to see documented.
- A pharmaceutical, biotech, or device sponsor running human-subject trials
- A contract research organization managing a study on a sponsor's behalf
- An academic or research institution running an investigator-initiated study that needs sponsor-side liability coverage
- An organization an IRB or trial site requires to show clinical trial liability coverage before enrollment starts
- A sponsor running a radiopharmaceutical or investigational-product study that needs coverage carved back for administration exposure
What It Covers
Coverage, broken down.
Liability for Wrongful Conduct in the Trial
Pays for a subject's bodily injury claim tied to how the study itself was run — including informed-consent failures — for each study listed on your policy's schedule.
Optional No-Fault Medical Expense Benefit
Pays a subject's study-related medical costs without requiring a finding of fault, so subjects get care paid for while a liability question is still being sorted out.
Radiopharmaceutical & Investigational-Product Carve-Backs
Available add-backs that restore coverage for administering a radiopharmaceutical or an investigational product where that exposure would otherwise be excluded.
Illustrative Scenario — How This Coverage Responds
Illustrative scenario — an informed-consent dispute
A subject enrolled in a Phase II trial later claims she wasn't properly informed of a known side-effect risk before consenting, and develops a complication tied to the study drug. Whether or not the claim ultimately holds up, defending it takes real legal work while it plays out. Because the study is listed on the sponsor's schedule and the optional no-fault medical benefit was elected, the subject's study-related medical costs can be paid without waiting on that fault question to be resolved, while the liability defense proceeds separately.
Illustrative example for education only — not a claim outcome or a promise of payment. Every claim depends on the actual policy issued and its terms.
More Than One Way In
More scenarios.
Real coverage doesn't fit one story. Here's who else this shows up for.
The CRO managing a multi-site study
A contract research organization is engaged to run a sponsor's trial across a dozen sites nationwide. Before any site opens enrollment, the study is added to the schedule so both the CRO's operational role and the sponsor's liability exposure are addressed under one coordinated policy.
The academic institution running an investigator-initiated study
A university research center designs its own investigator-initiated trial rather than running a sponsor's protocol, and its IRB requires proof of sponsor-side liability coverage before it will approve enrollment. The institution schedules the study on its own policy to satisfy that requirement and protect against an informed-consent claim down the line.
The sponsor adding a gene therapy arm mid-program
A biotech sponsor with an existing trial schedule decides to add a gene therapy arm to its pipeline, a category that carries distinct risk from its earlier studies. Before that arm enrolls its first subject, the sponsor works with VAB to have it specifically named on the schedule rather than assuming existing coverage automatically extends to it.
Know The Gaps
What this doesn't cover.
Every policy has limits. Knowing them before you buy is how you avoid a denied claim later.
Any clinical trial not listed on your policy's schedule of studies
Coverage only follows the specific studies you've scheduled with VAB — add a new trial to the schedule before it enrolls its first subject.
An approved, commercialized product's ordinary product exposure
Once a product clears trials and reaches the market, that risk moves to a standard products-liability policy, not this one.
Recall or withdrawal costs for the investigational product
Pulling a product from a trial is a business decision with its own cost — budget for it separately, since this policy doesn't fund it.
A willful failure to obtain informed consent
This covers a mistake in the informed-consent process, not a deliberate decision to skip it.
Off-protocol or unauthorized use of the investigational product
Coverage tracks the approved study protocol — using the product outside it steps outside the policy too.
Gene or cell therapy trials not specifically scheduled
These carry distinct risk and need to be named on the schedule, or carved back by endorsement, before the trial enrolls.
Behind The Quote
What goes into the decision.
What actually moves your price and your approval — no black box.
Therapeutic area and product type
A gene therapy, cell therapy, or radiopharmaceutical study carries distinct risk from a conventional small-molecule trial, so underwriting needs the specific product type disclosed — and often carved back by endorsement — before that study can be added to the schedule.
Trial phase and subject population size
A larger, later-phase study with more subjects represents more potential claims exposure than a small early-phase pilot, which factors into how the study is scheduled and priced.
Whether the no-fault medical expense benefit is elected
Adding this optional benefit changes both the coverage's cost and its function — it lets subjects get study-related medical costs paid without waiting on a fault determination, which matters most for higher-risk protocols.
Trial sites outside the U.S.
A study with a site outside the U.S. needs local trial insurance in place as well, since this policy generally applies on top of that requirement rather than replacing it — disclose international sites so the schedule reflects the full trial footprint.
Discipline in updating the study schedule
Because coverage only follows what's actually listed, keeping the schedule current — new studies added before enrollment, new arms or therapeutic categories flagged — is what keeps a real gap from opening up between what the sponsor is running and what's actually covered.
Getting Covered
How it actually works.
- List every study you want covered on the policy's schedule before it enrolls its first subject.
- Choose whether to add the optional no-fault medical expense benefit for subjects.
- If a subject is injured, the claim is evaluated against the wrongful-conduct standard, and the no-fault benefit — if elected — pays medical costs without waiting on a fault finding.
- Add a new study to the schedule any time your trial program expands.
Let's get you covered.
Tell us what you need on Clinical Trial Liability Insurance — a licensed VAB advisor follows up personally. No bots, no runaround.
Looking for a session that's already scheduled? Browse upcoming webinars.
Availability
Available nationwide as primary coverage for studies run in the U.S. and its territories or Puerto Rico. For a trial site outside the U.S., this policy applies on top of the trial insurance required locally rather than replacing it.
Questions, answered straight
No jargon on clinical trial liability insurance — just what you're actually asking.
The claim has to be first made against you while the policy is active and reported to VAB, and it has to tie back to conduct during a covered study — it isn't about when the underlying trial activity happened.
No. This covers liability tied to how the trial itself was conducted, including informed consent. Once a product is approved and on the market, ordinary product exposure moves to a separate products-liability policy.
Coverage follows the specific study on your schedule, not a site-by-site listing — but the study itself needs to be added before enrollment starts, and site details help VAB scope the risk correctly.
For a study run outside the U.S., this policy generally applies on top of the trial insurance required locally, rather than replacing it.
It pays a subject's study-related medical costs without needing to prove the sponsor was at fault, so a subject's care isn't held up while a separate liability question gets sorted out.
Beyond This Coverage
What people in your situation also need.
Business Banking
A sponsor or CRO running trial operations still needs day-to-day operating accounts sized for how research funding and grant disbursements actually move.
ExploreBusiness Services
Research organizations juggling IRB, sponsor, and site relationships often need the same back-office support any growing business does.
ExploreRelated Coverage
Coverage people pair with this.
Miscellaneous Professional Liability Insurance
Base-form errors & omissions coverage for a professional service business, built around the specific services you actually provide.
Learn morePsychedelic Therapeutics Liability
Liability coverage built for state-licensed psychedelic therapy providers.
Learn moreManaged Care Errors & Omissions
Liability coverage built for how health plans actually get sued — over decisions, not treatment.
Learn moreReady to talk it through?
Get a quote in minutes, or ask Sgt. Savings a straight question first — no pressure, no runaround.
Insurance products described on this page are marketed by The Veteran Alliance, a licensed insurance producer, and underwritten by one or more separately licensed insurance companies, which may include Corgi Insurance Company and its affiliates. The insurer that actually underwrites your policy, its licensing status in your state, and any state-required notices will be identified in your quote and policy documents. Coverage, limits, eligibility, and pricing are determined by the underwriting insurer, may vary by state, and may change. Nothing on this page is a quote, an offer of insurance, a binder, or a guarantee of coverage — coverage takes effect only when a policy is issued.