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A guide to the general conditions for healthy volunteers (the EAEU Bioequivalence Rules and Federal Law No. 61-FZ). Your answers are not sent anywhere: the check runs in your browser.
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This is a guide, not a medical opinion or a questionnaire: you discuss diagnoses with the doctor in person. The final decision is made by the doctor under the protocol of a specific study.
The protocol sets the conditions
There is no single list by which everyone is selected. Each study has a protocol with inclusion and non-inclusion criteria, and they are the same for all candidates. The protocol must set them out clearly (EAEU Bioequivalence Rules, clause 28). The decision on enrolment is taken by the investigator physician on the basis of these criteria, not by a request on the website.
What is usually considered when selecting healthy volunteers
For bioequivalence studies the EAEU Rules name these conditions:
- Age — at least 18 (clause 28).
- Body mass index — where possible 18.5–30 kg/m² (clause 28).
- Health. Eligibility is confirmed by laboratory tests, a medical history and an examination by a physician (clause 29).
- Smoking. Participants are, where possible, selected from non-smokers (clause 29).
- Alcoholism and drug addiction, including in the past, are grounds for not enrolling a person (clause 29).
- Sex does not matter, but the physician considers the risk to women of childbearing potential (clause 29).
Other studies may set other conditions: for example, on medicines taken, lifestyle or test results. They are explained in the conversation before informed consent is signed.
Who is barred by law
The Law “On the Circulation of Medicines” prohibits clinical trials involving:
- orphans and children left without parental care;
- pregnant and breastfeeding women;
- military personnel;
- law-enforcement officers;
- persons serving a prison sentence and persons held in pre-trial detention.
For some groups there are provisos. For example, a trial of a medicine intended specifically for pregnant and breastfeeding women is allowed if the necessary information can be obtained only in that way and measures are taken to rule out any risk to the woman, the foetus and the child; for military personnel, the proviso covers medicines specially developed for use in combat conditions, emergencies and the treatment of injuries caused by chemical, biological and radiation factors (Article 43, Part 6).
Not being accepted does not mean something is wrong with your health. A protocol needs a particular set of conditions, and a person may fail to fit for reasons unrelated to well-being: for example, because of medicines taken or the visit schedule. More in “How volunteer selection works”.
How to find out whether you are suitable
Call +7 (499) 346-21-15 or send a request. The administrator will tell you which studies are currently recruiting and book you in for a conversation with a physician. We do not collect a health questionnaire on the website: you discuss diagnoses and history with the physician in person.
Sources
- EAEU Bioequivalence Rules — EEC Council Decision No. 85: clauses 27–29.
- Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines”, Article 43 (Part 6) — text on ConsultantPlus.
Questions and answers
Can I take part if I smoke?
The protocol decides. In bioequivalence studies the EAEU Rules prefer non-smokers “where possible” (clause 29), so some studies do not recruit smokers. Ask the administrator about the conditions when you book.
Can women take part?
Yes, sex in itself does not matter (EAEU Rules, clause 29), but the risk to women of childbearing potential is considered in selection. The law prohibits pregnant and breastfeeding women from taking part in clinical trials, the exception is a trial of a medicine intended specifically for them, where the necessary information can be obtained only in that way and measures are taken to rule out any risk to the woman, the foetus and the child (Article 43, Part 6 of Law No. 61-FZ).
From what age can I take part?
In bioequivalence studies, from 18 (EAEU Rules, clause 28). The law allows children to take part only in the cases it names directly, and with the consent of their parents or adoptive parents in the patient information sheet (Article 43, Part 5). Otherwise the conditions are set by the protocol.
If I have a chronic illness, will I be accepted?
For studies in healthy volunteers, as a rule not: the selection criteria require the absence of significant disease. But it depends on the protocol; a physician will discuss it in person, and we do not collect health questionnaires on the website.
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
How a volunteer is selected for a clinical study
Selection begins with a talk and informed consent. Then the doctor carries out an examination and checks whether you meet the protocol criteria. The decision is made by the study doctor on the basis of those criteria.
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
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