Your rights
- Voluntariness. Participation is voluntary, and you may withdraw from it at any stage of the study (Article 43, Parts 1 and 4 of the Law “On the Circulation of Medicines”). The GCP Rules add: without any penalty or loss of benefits (clause 4.8.10).
- Information. You are told in advance and in writing about the medicine and the essence of the study, its safety, expected efficacy and degree of risk to you, the terms of participation, the purpose and duration, what to do if something unexpected happens, the terms of insurance and the guarantees of confidentiality (Article 43, Part 2). If no medical benefit to you is expected, you must be told so (clause 4.8.10).
- Plain language. The ethics review assesses whether the information is sufficient for understanding and accessible (Ministry of Health Order No. 586n, Annex 1, item 19). If something is unclear, ask for it to be explained again.
- Safety first. Under the GCP Rules the rights, safety and well-being of participants outweigh the interests of science and society (clause 2.3).
Who protects your interests
- The Ethics Council of the Ministry of Health reviews the study documents before the permit is issued: the protocol, the investigator’s brochure, the patient information sheet, information on the investigators’ experience and the insurance contract (Article 39.1; Order No. 586n).
- The ethics committee. The protocol and the informed consent form are approved by an independent ethics committee; participants may not be enrolled without its written approval (EAEU GCP Rules, clauses 3.3.6 and 4.4.1).
- The investigator physician is responsible for medical decisions and for your care for adverse events related to the study, during and after participation (clauses 4.3.1–4.3.2). The law requires the investigator to have at least three years of experience in clinical trial programmes (Article 40, Part 1).
- The state supervises compliance: where violations affect the completeness and reliability of a study, it is suspended and the medical organisation is issued with an order (Article 40, Part 8.1).
Insurance
Participation in a clinical study is impossible without a compulsory life and health insurance contract for the participant (Article 44, Part 14). The policyholder is the organisation that obtained the permit to organise the study. The terms of insurance are stated in the informed consent of the particular study.
Your data
Records by which you can be recognised are kept confidential and disclosed only to the extent the law permits (EAEU GCP Rules, clause 4.8.10). At the same time, representatives of the sponsor, auditors, the ethics committee and the authorised bodies are entitled to check the original medical records to make sure the data are correct. That is why “complete anonymity” cannot be promised: you are entitled to learn who uses your data and how, and to get the answer in the informed consent. Personal data on this website are processed under the privacy policy.
If something is unclear or worries you. Ask the investigator physician, the clinic administrator or a representative of the ethics committee: the contacts are stated in the informed consent. You can ask questions at any time, and the document should be signed only when everything is clear.
Sources
- Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines”: Articles 39.1, 40, 43, 44 — text on ConsultantPlus.
- EAEU Good Clinical Practice Rules — Council Decision No. 79 as restated by Decision No. 63: clauses 2.3, 3.3.6, 4.3.1–4.3.2, 4.4.1, 4.8.10.
- Ministry of Health Order No. 586n of 31 October 2024.
Questions and answers
Can I leave a study after it has started?
Yes. Participation is voluntary at any stage (Article 43 of Law No. 61-FZ), and under the GCP Rules you may withdraw at any time without penalty or loss of benefits. You do not have to give reasons. Tell the investigator physician: he or she will explain how to end participation properly.
What should I do if I feel unwell 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 for questions are stated in the informed consent.
Who sees my data?
Records that identify you are kept confidential and disclosed only to the extent the law permits. Access to the original medical records is held, among others, by representatives of the sponsor, auditors, the ethics committee and the authorised bodies — you are told this in the informed consent.
This material is general information and does not replace a physician’s advice. The decision to enrol a person in a study is made by the investigator physician.
See also
Informed consent: what to know before you sign
Informed consent is a document you sign after a doctor has explained the study in detail: its aims, procedures, risks, benefits and your rights. Sign it only when everything is clear.
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How taking part in a clinical study works, step by step
Taking part starts with a call and a conversation with a physician, followed by informed consent, an examination and a check against the protocol criteria. If you are suitable, you are given the schedule of visits or admission; at every step you can ask questions and withdraw.
Learn more
Regulatory framework: the rules for clinical trials and bioequivalence studies in Russia and the EAEU
Clinical trials in Russia are governed by Federal Law No. 61-FZ “On the Circulation of Medicines”, the Good Clinical Practice Rules and the Bioequivalence Rules of the Eurasian Economic Union (EAEU), and orders of the Ministry of Health. This page shows what each document contains and which open registers let you check a clinic.
Learn more