How to check that a clinical study is genuine

Five checks in ten minutes

None of them requires special knowledge, and you can do each before you sign anything or give your details.

1. The permit to conduct the study

A clinical study of a medicine is conducted under a permit from the Ministry of Health of Russia. The Ministry keeps a register of the permits issued and publishes it on its website together with the list of medical organisations that conduct such studies (Federal Law No. 61-FZ, Article 38, Parts 4 and 8).

The register is on the website of the State Register of Medicines: grls.minzdrav.gov.ru (in Russian), the section “Клинические исследования” (Clinical studies) → “Реестр РКИ” (Register of permits), the page “Register of permits for clinical studies”. You can search it by the protocol title, the medicine name, the permit number (“Номер РКИ / ЗКИ”) and the organisation conducting the study.

Please note: in a register entry this is the study’s organiser (the medicine developer or a company it engaged), not the clinic. An entry does not name the clinics, only how many there are. So it is best to ask the coordinator for the protocol title and the medicine name, and better still for the permit number and date. If a study is conducted under a permit, it should be entered there (the law allows some details not to be published). If you cannot find it, ask the coordinator for the name of the study and the medicine and the permit number: you may be searching under the wrong name.

2. The clinic’s licence

An organisation that conducts a study carries out medical activity, so it must hold a licence (Federal Law No. 99-FZ, Article 12). Roszdravnadzor publishes licence data in the Unified Licence Register: find the organisation by name, tax number (INN) or registration number (OGRN) (you have to tick “I am not a robot”), open the licence entry and compare the addresses where the activity is carried out with the address you are invited to. The results list shows the licensee’s location: this is the organisation’s legal address, and it may differ from the address where participants are received.

Where to check the documents of Bessalar Clinic is described on the page “Licences and permits”.

3. Participant insurance

Taking part in a clinical study is not allowed without a compulsory life and health insurance contract for the participant (Article 44, Part 14). 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 policyholder is the organisation that obtained the permit to organise the study, and it pays for the insurance at its own expense (Part 1). The terms of insurance are communicated to you in writing in the patient information sheet (the informed consent): Article 43, Part 2.

What to ask before you sign: who the policyholder is, which insurance company, the number and validity period of the contract, and what to do if you feel worse. The policyholder must acquaint you with the terms of the contract and arrange for a policy to be issued to you (Standard Rules, clause 20, item “д”). More on the page “Insurance for clinical study participants”.

4. Informed consent

Before you take part you must be told in writing about the medicine and the essence of the study, its safety, expected effectiveness and degree of risk, 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). You must be given enough time to read the document and ask questions, and your questions must be answered (EAEU GCP Rules, clause 4.8.7); you can ask to take the document home and discuss it with your family. Sign it only when everything is clear. The study documents, including the consent form, undergo ethics review before the study starts (Article 39.1; EAEU GCP Rules, clause 3.3.6).

If you are not allowed to read the document, are rushed to sign or your questions are not answered, that is a reason to stop. More: “Informed consent”.

5. Requests that should not be made

These are not rules of law but practical warning signs. Stop and ask questions if:

• you are asked for money for taking part, a “fee”, “paperwork” or an advance payment;
• before a personal talk with a doctor you are asked to send your passport, photos of documents, diagnoses or test results by messenger or through a website form;
• you are rushed (“places are running out, decide today”) or not allowed to take the consent home;
• you are promised “100% safety” or treatment for a healthy person: every medicine carries risks, and if no benefit to your health is expected, you must be told so (EAEU GCP Rules, clause 4.8.10, item “з”);
• nobody can name the study, the organisation that conducts it and the policyholder.

How we do it

• On the Bessalar Clinic website we ask only for your name and phone number. We do not collect a health questionnaire on the website: you discuss health information with the doctor in person.
• The coordinator tells you which studies are currently enrolling and books you a talk with the doctor. The doctor explains the terms of taking part before you sign the consent.
• Clinic address: 44 Karamyshevskaya Embankment, entrance 1, 5th floor, Moscow; phone +7 (499) 346-21-15. You can compare the address with the licence in the register mentioned above.

Questions and answers

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

Insurance for clinical study participants: what the law provides

Taking part in a clinical study of a medicine is not allowed without a compulsory life and health insurance contract for the participant. The organisation that obtained the permit for the study is the policyholder and insures at its own expense; the terms of insurance are stated in the informed consent.

Learn more

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

Clinic licences and permits

The clinic conducts clinical studies under a licence for medical activities and in line with the principles of Good Clinical Practice (GCP) and its own standard operating procedures.

Learn more