In short
- Taking part in a clinical study is not allowed without a compulsory insurance contract (Article 44, Part 14 of Federal Law No. 61-FZ). The law calls a participant a “patient”; under the Standard Insurance Rules this is anyone who has given voluntary informed consent to take part in a study, including a healthy volunteer (Government Decree No. 714, clauses 2 and 11).
- The contract is concluded by the organisation that obtained the permit for the study, and it pays for it at its own expense. The participant does not pay for the insurance (Part 1).
- You are told the terms of insurance in writing before you take part: they are part of the patient information sheet (the informed consent). The policyholder must acquaint you with the terms of the contract and arrange for a policy to be issued to you (Article 43, Part 2; Standard Rules, clause 20, item “д”).
- Insurance protects you if the study harms your life or health. It does not replace payment for taking part.
What counts as an insured event
An insured event is the death of a patient or a deterioration of the patient’s health, including one leading to disability, where there is a causal link with taking part in the clinical study (Article 44, Part 3). The link, like the payment procedure, is established under the rules of the contract and the law; the terms of your contract are stated in the informed consent.
The payment amounts set by law
Article 44 (Part 5) names the insurance payments for each participant. As of the date of this page they are as follows:
| What happened | Insurance payment |
|---|---|
| Death of the participant | 2,000,000 roubles |
| Deterioration of health with Group I disability | 1,500,000 roubles |
| Deterioration of health with Group II disability | 1,000,000 roubles |
| Deterioration of health with Group III disability | 500,000 roubles |
| Deterioration of health without disability | up to 300,000 roubles, based on the standard rates and the costs actually incurred |
These are the amounts set by law. The terms of a specific contract, including how to claim a payment, are stated in the informed consent and in the contract itself: read them before you sign. The standard insurance rules are approved by Government Decree No. 714 of 13 September 2010 (Article 44, Part 8).
What to ask before you sign
- Who the policyholder is and which insurance company.
- The number and validity period of the contract: it must cover your whole participation.
- What to do and whom to contact if you feel worse.
- Where in the informed consent the insurance terms are stated.
If nobody can answer, that is a reason to stop: without an insurance contract taking part in a study is not allowed. Other warning signs are on the page “How to check that a study is genuine”.
Insurance and payments for taking part are different things
- Insurance payment — protection if the study harms your life or health.
- Payment for taking part — terms reviewed by the ethics committee and stated in the informed consent; see “Payments and compensation”.
Sources
- Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines”: Article 39 (Part 2, item 9), Article 43 (Part 2), Article 44 (Parts 1, 3, 5, 8, 14, 15) — text on ConsultantPlus.
- Standard rules of compulsory life and health insurance of a patient taking part in clinical studies of a medicine — Government Decree No. 714 of 13 September 2010: clauses 2, 11, 20.
- EAEU Good Clinical Practice Rules — Council Decision No. 79 as restated by Decision No. 63 of 1 August 2025 (in force from 10 March 2026): clauses 4.3.1–4.3.2.
Questions and answers
Do I need to arrange insurance myself?
No. The compulsory insurance contract is concluded and paid for by the organisation that obtained the permit for the study (Article 44, Part 1 of Federal Law No. 61-FZ). You only need to learn the terms from the informed consent.
Is the insurance payment part of the payment for taking part?
No. Insurance protects you if the study harms your life or health; it is not payment for taking part and not a refund of costs. The terms of payments for taking part, if any, are stated separately in the informed consent.
What should I do if I feel worse after taking the medicine?
Tell the physician or the medical staff at once: the investigator is responsible for medical decisions and provides the necessary care for adverse events related to the study, during and after participation (EAEU GCP Rules, clauses 4.3.1–4.3.2). Contacts are stated in the informed consent.
Who checks that insurance has been arranged?
Control over the insurance obligation is exercised by the Ministry of Health, which issued the permit for the study (Article 44, Part 15). The Ministry receives a copy of the insurance contract with the application for the permit (Article 39, Part 2, item 9).
This material is for information only and is not legal advice. The rules are cited as of the date of the last update; check the current versions of the documents before making decisions.
See also
Safety and rights of clinical study participants
Taking part in a clinical study is voluntary: you may withdraw at any stage. The study undergoes ethics review, participation is impossible without an insurance contract, and under the GCP Rules the rights, safety and well-being of participants outweigh the interests of science.
Learn more
Payments and compensation to study participants: how it works
The terms of payments to participants are approved by the ethics committee and stated in the informed consent of the particular study: the methods, the amount and the procedure. The amount is set in proportion to participation and does not depend solely on whether the protocol is completed.
Learn more
How to check that a clinical study is genuine
A study of a medicine is conducted only under a permit from the Ministry of Health, taking part is not allowed without an insurance contract, and the terms are explained to you in writing beforehand. You can check all of this yourself: in the permit register, in the licence register and in the informed consent.
Learn more