Table 1 Analyzed national regulations and professional guidelines
From: Normative framework of informed consent in clinical research in Germany, Poland, and Russia
Country | Name of the legal document | Sections | Date of introduction |
|---|---|---|---|
Germany | Basic Law for the Federal Republic of Germany [11] | Art. 1 | May 23, 1949 |
(Model) Professional Code for Physicians in Germany [12] | Art. 15 | December 14, 1998 | |
Medical Devices Act [13] | Art. 20-22 | August 7, 2002 | |
Regulation on the Application of Good Clinical Practice in Conducting Clinical Trials with Medicinal Products for Use in Humans [14] | Art. 3 | August 9, 2004 | |
Medicinal Products Act [15] | Art. 40-42 | December 12, 2005 | |
Regulation on Clinical Investigations with Medical Devices [16] | Art. 3 | May 10, 2010 | |
Radiation Protection Act [17] | Art. 36 | June 27, 2017 | |
Radiation Protection Regulation [18] | Art. 133-138 | November 29, 2018 | |
Poland | Medical Code of Ethics [19] | Art. 43-44 | May 3, 1992 |
Act on Professions of Doctor and Dentist [20] | Art. 25 | December 5, 1996 | |
Constitution of the Republic of Poland [21] | Art. 39 | April 2, 1997 | |
Pharmaceutical law [22] | Art. 37a-37ia | September 6, 2001 | |
Medical Devices Act [23] | Art. 40-41 | Mai 20, 2010 | |
Regulation on Good Clinical Practice [24] | Art. 7 | Mai 2, 2012 | |
Russia | Constitution of the Russian Federation [25] | Art. 21.2 | December 12, 1993 |
Ethical Code of Russian Physician [26] | Art. 18 | November 1, 1994 | |
Law on Circulation of Drugs [27] | Art. 43 | April 12, 2010 | |
Law on Basics of Health Protection of the Citizens in the Russian Federation [28] | Art. 36.1 | November 21, 2011 | |
GOST R ISO 14155-2014 Clinical Investigations. Good Clinical Practice [29] | Art. 4.7 | June 1, 2015 | |
Regulation on the Procedure for Giving Informed Voluntary Consent to Medical Care in the Framework of Clinical Testing [30] | Art. 2-5 | July 21, 2015 | |
Regulation on the Approval of the Rules of Good Clinical Practice [31] | Art. 52-56 | April 1, 2016 |