
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (CC BY).
REVIEW
The role of an ethical review in pediatric clinical trials
1 Pirogov Russian National Research Medical University, Moscow, Russia
2 Russian Children’s Clinical Hospital, Moscow, Russia
Correspondence should be addressed to: Natalia V. Teplova
ul. Ostrovityanova, 1, Moscow, 117997, Россия; ur.xednay@vn.avolpet
Author contributions: Teplova NV — concept and design development, editing, approval of the final version of the article for publication, proper presentation of the issues associated with data validity, integrity of all parts. Gratsianskaya AN — collection, analysis, interpretation of data, writing, language- specific text presentation, correspondence to scientific terms. Kostyleva MN — creating a reference list by the order in which the references are cited.
- Jenner E. An Inquiry Into the Causes and Effects of the Variolæ Vaccinæ, Or Cow-P ox. 1798. The Harvard Classics, 1909–1914. http://www.bartleby.com/38/4/1.html
- Nyurnbergskiye protsessy 1945–49. Savenkov AN., Nikolay Kuzanskiy — Okean. M.: Bol’shaya rossiyskaya entsiklopediya, 2013; 451–452 s. (Bol’shaya rossiyskaya entsiklopediya: [v 35 t.] gl. red. YU. S. Osipov; 2004–2017; t. 23). ISBN 978–5–85270–360–6. Russian.
- Weindling P. The Origins of Informed Consent: The International Scientific Commission on Medical War Crimes, and the Nuremberg Code Bulletin of the History of Medicine 75.1. 2001; 37–71 p.
- Khel’sinkskaya deklaratsiya Vsemirnoy meditsinskoy assotsiatsii, http://acto-russia.org/index.php?option=com_ content&task=view&id=2 Russian.
- Opyt “off-label” naznacheniy v pediatricheskom statsionare. Gratsianskaya AN, Kostyleva MN, Postnikov SS, Belousov YUB. Lechebnoye delo. 2014; 2: 4–7. Russian.
- ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population. https://www.ema.europa. eu/en/documents/scientific- guideline/ich-e11r1-guideline-c linicalinvestigation- medicinal-products- pediatric-population- revision-1_ en.pdf
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use https://ec.europa.eu/health//sites/health/files/files/ eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
- Regulation (EC) No 1902/2006, an amending regulation in which changes to the original text were introduced relating to decision procedures for the European Commission https://ec.europa. eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1902/ reg_2006_1902_en.pdf
- Pediatric Research Equity Act (PREA) https://webarchive.library. unt.edu/eot2008/20090117024519/http://www.fda.gov/cder/ pediatric/S-650-PREA.pdf
- Best Pharmaceuticals for Children Act (BPCA) https://webarchive. library.unt.edu/eot2008/20090117024111/http://www.fda.gov/ cder/pediatric/PL107–109.pdf
- Title V of FDA Safety and Innovation Act (FDASIA) https:// www.govinfo.gov/content/pkg/PLAW-112publ144/pdf/ PLAW-112publ144.pdf
- Best Pharmaceuticals for Children Act and Pediatric Research Equity Act July 2016 Status Report to Congress https://www.fda. gov/media/99184/download.
- State of Paediatric Medicines in the EU 10 years of the EU Paediatric Regulation https://ec.europa.eu/health/sites/health/ files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf
- Federal’nyy zakon ot 12.04.2010 № 61-FZ “Ob obrashchenii lekarstvennykh sredstv”. Russian.
- Abdel- Rahman SM, Reed MD, Wells T.G & Kearns GL. (2007). Considerations in the Rational Design and Conduct of Phase I/II Pediatric Clinical Trials: Avoiding the Problems and Pitfalls. Clinical Pharmacology & Therapeutics. 81(4), 483–494. doi:10.1038/ sj.clpt.6100134.
- Pica N. & Bourgeois F. Discontinuation and nonpublication of randomized clinical trials conducted in children. Pediatrics. 138. e20160223 (2016).
- Federal’nyy zakon ot 21.11.2011 № 323-FZ (red. ot 31.07.2020) “Ob osnovakh okhrany zdorov’ya grazhdan v Rossiyskoy Federatsii” (s izm. i dop., vstup. v silu s 01.09.2020). Stat’ya 20. Informirovannoye dobrovol’noye soglasiye na meditsinskoye vmeshatel’stvo i na otkaz ot meditsinskogo vmeshatel’stva. Russian.
- Kodeks Rossiyskoy Federatsii ob administrativnykh pravonarusheniyakh ot 30.12.2001 № 195-FZ (red. ot 15.10.2020, s izm. ot 16.10.2020). Stat’ya 25.3. Zakonnyye predstaviteli fizicheskogo litsa. Russian.
- Grazhdanskiy kodeks Rossiyskoy Federatsii (chast’ pervaya) ot 30.11.1994 № 51-FZ (red. ot 31.07.2020), GK RF Stat’ya 6. Primeneniye grazhdanskogo zakonodatel’stva po analogii. Russian.
- Grazhdanskiy kodeks Rossiyskoy Federatsii (chast’ pervaya) ot 30.11.1994 № 51-FZ (red. ot 31.07.2020). Stat’ya 6. Primeneniye grazhdanskogo zakonodatel’stva po analogii. Russian.
- Federal’nyy zakon ot 21.11.2011 № 323-FZ (red. ot 31.07.2020) “Ob osnovakh okhrany zdorov’ya grazhdan v Rossiyskoy Federatsii” (s izm. i dop., vstup. v silu s 01.09.2020). Stat’ya 20. Informirovannoye dobrovol’noye soglasiye na meditsinskoye vmeshatel’stvo i na otkaz ot meditsinskogo vmeshatel’stva. Russian.
- How to Conduct Clinical Trials in Children: A Tutorial. Shakhnovich et al. Clin Transl Sci. 2019. 12: 218–230. doi:10.1111/cts.12615.
- Klinicheskiye issledovaniya v detskoy bol’nitse: rol’ komiteta po etike. Opyt rossiyskoy detskoy klinicheskoy bol’nitsy. Vaganov NN, Gratsianskaya AN, Kostyleva MN. Zamestitel’ glavnogo vracha. 2013; 8 (87): 12–22. Russian.
- Federal’nyy zakon ot 12.04.2010 № 61-FZ «Ob obrashchenii lekarstvennykh sredstv». Glava 7, stat’ya 38, pp. 1–3.
- Federal’nyy zakon ot 21.11.2011 № 323-FZ «Ob osnovakh okhrany zdorov’ya grazhdan v Rossiyskoy Federatsii». Russian.
- Postanovleniye Pravitel’stva RF ot 29.09.2010 № 771 «O poryadke vvoza lekarstvennykh sredstv dlya meditsinskogo primeneniya na territoriyu RF». Russian.
- Prikaz Minzdrava RF ot 02.08.2012 № 58n «Ob utverzhdenii administrativnogo reglamenta Ministerstva zdravookhraneniya RF po predostavleniyu gosudarstvennoy uslugi po vydache razresheniy na vvoz na territoriyu RF zaregistrirovannykh i (ili) nezaregistrirovannykh lekarstvennykh preparatov…». Russian.
- Prikaz Minzdravsotsrazvitiya RF ot 09.08.2005 № 494 «Ob obespechenii bol’nykh lekarstvennymi sredstvami dlya individual’nogo primeneniya po zhiznennym pokazaniyam». Russian.
- Prikaz Minzdrava RF ot 20.12.2012 № 1175n «Ob utverzhdenii poryadka naznacheniya i vypisyvaniya lekarstvennykh preparatov, a takzhe form retsepturnykh blankov na lekarstvennyye preparaty, poryadka oformleniya ukazannykh blankov, ikh ucheta i khraneniya. Russian.
- Gratsianskaya AN. Klinicheskiye ispytaniya s uchastiyem detey. Kachestvennaya klinicheskaya praktika. 2005; (2): 15–18. Russian.
- Belousov YuB, Gratsianskaya AN. Klinicheskiye issledovaniya v pediatricheskoy praktike. Kachestvennaya klinicheskaya praktika. 2008; (2): 22–23. Russian.