Medicine: | Covid - 19 Vaccine Gamaleya Research Institute |
Criteria: | A2. Commits to comply with human rights standards in product development & marketing |
Norm: | Red |
Norm Explanation:The company has published a document in which they state that the Biomedical Ethics Committee is acting in accordance with the following documents (via Google translate):
1. Helsinki Declaration of the World Medical Association
2. Constitution of the Russian Federation (1993 to becomeI 21)
3.Russian Federal Law "Basics of Russian Law Federation on Citizens' Health" (1993)
4. Federal Medicines Act;
5. About the OST 42-511-99 "Rules for conducting quality clinical trials in the Russian Federation"approved by the Ministry of Health in 1998.
6. Russian Federation National Standard "Good Clinical Practice" (GOST P52379-2005). This document complies with GCP rules, and its 3rd section is devoted to the order of ethics committees.
7. Order of June 19. N 266 "On the approval of the rules of clinical practice in the Russian Federation"; 2003 г
8.Order of the Ministry of Health and Social Development of Russia No.774n of August 31, 2010 "On the Ethics Council"
9.Order of the Ministry of Health and Social Development of Russia No.753n "On the approval of the order of organization and conduct of an ethical examination of the possibility of conducting a clinical examination of a drug for medical use and a form of conclusion of the Ethics Council"
10.Order of the Ministry of Health and Social Development of Russia No.775n "On the approval of the procedure for reviewing the report on the need to make changes in the protocol of clinical examination of the drug for medical use"
11. Russian Federal Law No.152-Fz of July 27, 2006 "On Personal Data"
These documents do not include an explicit human rights statement (the Russian Constitution contains human rights, but that does not make this an explicit statement to adhere to HR).
Resource:
https://gamaleya.org/en/about/eticheskiy-komitet/
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