General information, not legal or insurance advice. Confirm with the scientific ethics committee (CEC), CONIS and a broker licensed in Costa Rica.
Costa Rica has one of the most detailed clinical trial insurance regimes in Latin America. Its rules spell out who must be insured, for how long, where the policy must be enforceable, and how fast the insurer must pay.
Key takeaways
- A civil liability policy is mandatory for clinical research (Ley 9234, art. 31).
- It must be valid and enforceable in Costa Rica, and the insurer must have branches or service centers in the country (Reglamento 39061-S, art. 14(f)).
- Term: from the start of the research until at least two years after it ends, and for each participant from consent signature until three years after their participation ends.
- The sponsor must also cover the investigator and team, and the PI must hold their own policy.
- Every participant receives proof or a copy of the policy with the consent form.
- Insurers must pay within 30 days of receiving complete documentation.
What the law says
Ley 9234, the Biomedical Research Law:
– Art. 31: clinical research must be covered by a civil liability policy protecting participants from damage arising from the research, for the duration of the research and for at least two years after the participant’s participation ends. Policies must follow the principle of proportionality and the dignity of human life, and must be enforceable in the country. The CEC evaluates the policy and sets its term starting from that minimum.
– Art. 32: with the consent form, each participant receives proof or a copy of the policy showing its number, issuer, term of protection, conditions and claim procedure.
– Art. 11(f): the consent form for clinical research must address the insurance policy.
What the regulation adds (Decreto 39061-S)
Art. 14 sets out the policy requirements:
– (a) The sponsor’s policy runs from the start of the research until at least two years after the research ends. The research is treated as ended when the final report is delivered to the CEC.
– (b) Each participant is covered from their consent signature until three years after their participation ends.
– (c) The CEC checks that the policy’s legal coverage period is at least two years.
– (d) The sponsor must provide legal coverage and a civil liability policy for the investigator and team for claims attributable to the research, except negligence, malpractice or protocol violations.
– (e) The PI must hold their own civil liability policy for the cases excluded in (d).
– (f) Every policy must be valid and enforceable in Costa Rica. Sponsors, PIs and CRO-type organizations must make sure their insurers have branches or service centers in the country, so that participants can actually exercise their rights.
Art. 15 covers claims:
– the PI explains to the CEC how participants will understand and use their rights
– the consent form explains how to access benefits under the insurer’s procedures
– insurers deliver funds within 30 days of complete documentation, and may make advances for immediate expenses
– CONIS reports non-compliance to SUGESE, the insurance regulator, for sanctions
Art. 16 says disputes over insurance benefits follow Ley 8956 on insurance contracts.
Note that Ley 9234 art. 31 counts the two years from the end of each participant’s participation, while Reglamento art. 14(a) counts them from the end of the study. Plan for the longer period, and confirm with the CEC.
Planning implications for foreign sponsors
- A worldwide certificate alone is unlikely to work. The test is enforceability in Costa Rica through an insurer with a local service presence. Ask your broker for a Costa Rica solution early.
- Budget for the tail. The policy period extends years beyond last-patient-last-visit.
- Three policies may be involved: the sponsor’s trial policy, the sponsor-provided cover for the investigator and team, and the PI’s own policy.
- Prepare the participant copy. Each participant needs the policy proof, so build it into the consent form packet.
- The protocol comes first. The CEC evaluates the policy against the specific study.
Related guides
- Clinical trial liability insurance in Latin America: requirements by country (our hub guide)
- What insurers need before they’ll quote a clinical trial policy
- Mexico: the COFEPRIS 15-business-day insurance rule
How bioaccess® helps
Costa Rica is a core market for us. We line up the protocol, consent form and CEC requirements with your broker so the policy package passes review the first time. We don’t sell insurance.
FAQ
Is there a minimum coverage amount in Costa Rica?
Neither Ley 9234 nor Decreto 39061-S sets a monetary minimum. The CEC evaluates the policy and its term.
Does the policy have to come from a Costa Rican insurer?
The rule is that it must be valid and enforceable in Costa Rica, with the insurer having branches or service centers in the country. Confirm the structure with a broker licensed in Costa Rica.
Does the rule apply to device trials?
Ley 9234 covers biomedical research with humans, and its regulation (Decreto 39061-S) defines medical devices among the products studied. Confirm device-specific scope with the CEC and CONIS. (Device scope not fully verified.)
Last verified: 28 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.