Email this article Legal aspects of conducting clinical trials and military trials with the participation of military personnel
- Authors: Fateev I.V.1, Seleznev A.B.1, Ivchenko E.V.1, Ivanov V.S.2
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Affiliations:
- State Research Testing Institute of Military Medicine
- S.M. Kirov Military Medical Academy
- Issue: Vol 40, No 3 (2021)
- Pages: 51-56
- Section: Reviews
- URL: https://ogarev-online.ru/RMMArep/article/view/77283
- DOI: https://doi.org/10.17816/rmmar77283
- ID: 77283
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Abstract
Currently, the procedure for conducting clinical trials and military trials is regulated by a number of regulatory documents ranging from Federal laws to local orders of medical organizations. The article analyzes the regulatory documents of the Russian Federation in relation to conducting clinical trials and military trials with the participation of military personnel. It is noted that the legal status of a volunteer (military personnel) when conducting research in full-scale conditions is not fixed. In addition, in the case of conducting research with the involvement of military personnel as volunteers, it should be borne in mind that a serviceman has the right to engage in scientific, pedagogical and other creative activities. There is no regulatory document defining payments to volunteers participating in clinical trials. These organizational aspects require legislative permission to exclude legal conflicts in the planning, organization and conduct of research involving military personnel as volunteers (patients) (bibliography: 9 refs).
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##article.viewOnOriginalSite##About the authors
Ivan V. Fateev
State Research Testing Institute of Military Medicine
Author for correspondence.
Email: gniiivm_2@mil.ru
ORCID iD: 0000-0003-4014-3973
SPIN-code: 5781-0083
M.D., D.Sc. (Medicine)
Russian Federation, 4, Lesoparkovaya str., Saint Petersburg, 195043Aleksey B. Seleznev
State Research Testing Institute of Military Medicine
Email: gniiivm_2@mil.ru
M.D., Ph.D. (Medicine), Associate Professor
Russian Federation, 4, Lesoparkovaya str., Saint Petersburg, 195043Evgeniy V. Ivchenko
State Research Testing Institute of Military Medicine
Email: gniiivm_2@mil.ru
ORCID iD: 0000-0001-5582-1111
SPIN-code: 5228-1527
M.D., D.Sc. (Medicine), Associate Professor
Russian Federation, 4, Lesoparkovaya str., Saint Petersburg, 195043Valeriy S. Ivanov
S.M. Kirov Military Medical Academy
Email: Ivanovmed84@mail.ru
ORCID iD: 0000-0002-2643-7767
SPIN-code: 1965-4741
Russian Federation, 4, Lesoparkovaya str., Saint Petersburg, 195043
References
- Lyutov RV, Chepur SV, Fateev IV. et al. Features of the organization and conduct of clinical and military trials with the participation of military personnel. Military Medical Journal. 2019;340(9):10–13. (In Russ.)
- Ivchenko EV, Ivanov VS, Shustov SB. Legal regulation of clinical drug trials for the use in military-medical organisations. Military Medical Journal. 2015;336(6):53–60. (In Russ.)
- Federal Law of 12.04.2010 No. 61-FZ (with amendments and additions) “On the Circulation of Medicines”. Available at: http://www.consultant.ru/document/cons_doc_LAW_99350/ (access 01.06.2021). (In Russ.)
- Order of the Ministry of Health of the Russian Federation of April 1, 2016 No. 200n “On the approval of the rules of good practice”. Available at: http://www.consultant.ru/document/cons_doc_LAW_203764/ (access 01.06.2021). (In Russ.)
- Order of Rostekhregulirovanie dated September 27, 2005 No. 232-st “On approval of the national standard”. Available at: http://www.consultant.ru/document/cons_doc_LAW_258206/ (access 01.06.2021).
- Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 (as revised on November 24, 2020) “On approval of the Rules for state registration of medical devices”. Available at: http://www.consultant.ru/document/cons_doc_LAW_140066/ (access 01.06.2021).
- Federal Law of November 21, 2011 No. 323-FZ (with amendments and additions) “On the basics of protecting the health of citizens in the Russian Federation”. Available at: http://www.consultant.ru/document/cons_doc_LAW_121895/ (access 01.06.2021).
- Federal Law of 11.08.1995 No. 135-FZ (as amended on 08.12.2020) “On charitable activities and volunteering (volunteering)”. Available at: http://www.consultant.ru/document/cons_doc_LAW_7495/ (access 01.06.2021).
- Federal Law of 27.05.1998 No. 76-FZ (with amendments and additions) “On the status of military personnel”. Available at: http://www.consultant.ru/document/cons_doc_LAW_18853/ (access 01.06.2021).
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