What is true and what is not
| Myth | Fact |
|---|---|
| “Participants are guinea pigs, and nobody protects them” | The rights, safety and well-being of participants outweigh the interests of science (EAEU GCP Rules, clause 2.3). The study documents undergo ethics review, and participation is impossible without a life and health insurance contract (Articles 39.1 and 44 of Law No. 61-FZ). |
| “Once you have signed consent, you cannot leave” | You may withdraw at any stage, without penalty or loss of benefits, and you do not have to give reasons (Article 43, Part 4; GCP Rules, clauses 4.3.4 and 4.8.10). |
| “Consent is a formality that people sign without reading” | It is a process: the physician explains the aim, the procedures, the risks and the benefit, and you ask questions. You can take the document home and sign only when everything is clear. The ethics review separately assesses whether the information in it is understandable. |
| “If you are healthy, you will certainly be accepted” | No: the physician decides by the criteria of the protocol, and they differ between studies. Not being accepted does not mean something is wrong with your health. |
| “Participants’ data are available to anyone” | Records that identify you are kept confidential and disclosed only to the extent the law permits. A limited circle of people and organisations has access to the original medical records: for example, auditors, the ethics committee and the authorised bodies. That is why the words “complete anonymity” would be inaccurate. |
| “Studies are run without checks or permits” | A clinical study is conducted on the basis of a Ministry of Health permit, issued after an expert review of the documents and an ethics review (Article 38, Part 4; Article 39, Part 1). Participants may be enrolled only after the ethics committee’s written approval (GCP Rules, clause 3.3.6). |
| “You can take part as often and as you like” | No: the protocol sets the conditions and the physician decides. The law bars some groups from taking part (pregnant and breastfeeding women and others, Article 43, Part 6). |
| “I will not understand the medical terms” | The information must be sufficient and understandable: the ethics review assesses that, among other things (Ministry of Health Order No. 586n, Annex 1, item 19). If something is unclear, ask for it to be explained again. |
Want to check for yourself? The rules we refer to are collected on the page “Regulatory framework”. How to approach signing consent and which questions to ask the physician is in “Informed consent”.
If you still have questions
Read the page “Safety and rights of participants”, look at the answers to common questions or call +7 (499) 346-21-15.
Questions and answers
Is it true that participants in clinical studies are treated as guinea pigs?
No. Under the GCP Rules the rights, safety and well-being of participants outweigh the interests of science; a study undergoes ethics review, and participation is impossible without consent and insurance. More on the page about participants’ rights.
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
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
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.
Learn more
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