Medical research plays a key role in modern progress, allowing the development of new methods of treatment, diagnosis and prevention of various diseases. But do not forget about the need to protect the rights and interests of participants in such research.

And so, let’s define what is meant by a clinical trial. According to Armenian law, this is a study involving a human as a subject, conducted in order to identify or confirm the safety and effectiveness of methods for the prevention, diagnosis and treatment of diseases. Permission to conduct clinical trials is issued by the Ministry of Health of the Republic of Armenia based on a positive conclusion of the Clinical Trials Ethics Commission.

According to Article 38 of the Law of the Republic of Armenia “On Medical Assistance and Public Service”, research and tests related to the use of new methods, forms, means and biomedical research can be carried out only with the written consent of the person who will be subjected to it.

What are the rights of a person undergoing a clinical trial?

A person who has decided to undergo a clinical trial has the following rights:

• Right to informed consent – before giving consent, the participant of the medical study must be informed about all aspects of the procedure being carried out, including all goals and stages, risks. In addition, the person must be aware that his participation is voluntary and of what rights he has;
• Right to confidentiality of data – the personal data of the research participant must be kept confidential and the responsibility for their disclosure lies with the organization conducting the study;
• Right to safety – during the examination, the employees of the medical institution are obliged to strictly control all processes in order to prevent possible risks to the health of the participant. All stages should be monitored, regular medical examinations should be carried out, and all undesirable side effects should be immediately identified. In the event of complications, the person must be provided with all the necessary assistance.

All these rights are interrelated and the existence of one without the other threatens the participant of the medical research.

Before participating in a clinical trial, we advise you to seek not only medical, but also legal advice. It is best to do this in the law office of Vardan Khechyan. If your rights have been violated during such a procedure, we will develop the necessary strategy to protect you.

☎+374 33 311 00  

✉vardan@khechyan.com  

🏢 0002 Yerevan, 6 Yekmalyan St., floor 2 

🔗 https://www.armenianlaw.com/ 

Tg: @VardanLaw