17. Информация Минздравсоцразвития РФ от 06.12.2011 «Стандартная операционная процедура N 2 «Процедура проведения этической экспертизы информационного листка пациента». // СПС КонсультантПлюс.
18. Информация Минздравсоцразвития РФ от 29.02.2012 «Стандартная операционная процедура N 3 «Клинические исследования с участием детей. Требования к информированию ребенка, а также родителей/усыновителей». // СПС КонсультантПлюс.
19. Федеральный закон от 22.06.1998 N 86-ФЗ (ред. от 30.12.2008) «О лекарственных средствах». // СПС КонсультантПлюс.
20. ICH harmonized tripartite guideline general considerations for clinical trials E8 Current Step 4 version dated 17 July 1997. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. P. 3.1.3.
21. He N. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population //European Journal of Health Law. - 2008. - Т. 15. - С. 223-250. P. 5.8.
22. Guideline guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceutical M3(R2). ICH harmonized tripartite. Current Step 4 version dated 11 June 2009.
23. ICH E11 Note for Guidance on the Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). P. 2.1. Available at: http://www.emea.europa.eu/pdfs/human/ich/271199EN.pdf.
24. Regulation (EC) No 1901/2006 of the European Parliament and of the council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 N L 378, 27.12.2006. P. 8.
25. Regulation (EU) No 536/2014 of the European Parliament and of the council of 16 April 2014
on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. L 158/32 EN Official Journal of the European Union 27.5.2014.
26. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement. Ethical Conduct for Research involving Humans, 1998, Ottawa: Public Works and Government Services Canada (including updates in2000 and 2002, Interagency Advisory Panel on Research Ethics. [Electronic resource.]. - Available at: http://www.southlakeregional.org/doc.aspx?id=876 (Accessed: 15.03.2018).
27. U.S. Dept. of Health & Human Services, Title 45: Public Welfare, Code of Federal Regulations, Part 46: Protection of Human Subjects. [Electronic resource.]. - Available at: https://www.ncbi.nlm.nih.gov/books/NBK19891/ (Accessed: 15.03.2018).
28. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). Guidance for Industry U.S. Department of Health and Human. Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). March 2018. Procedural OMB Control No. 0910-0843 Expiration Date 09/30/2020. P. 1.6, p. 1.29.
29. Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies. U.S. Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research (CDER) January 2006.
30. Code of Federal Regulations. Title 45. Public welfare
department of health and human services. Part 46. Protection of human subjects. Revised January 15, 2009 Effective July 14, 2009. [Electronic resource.]. - Available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (Accessed: 15.03.2018).
Русскоязычные монографии и научные статьи
1. Планирование и проведение клинических исследований лекарственных средств / под ред. Ю. Б. Белоусова. -- М.: Издательство Общества клинических исследователей, 2000. -- 579 c.;
2. Климковская Н.В., Фирсов И.С. Клинические исследования на практике. // Качественная клиническая практика 3/2002.
3. Малышева Е.А., Незнанов Н.Г., Никитин Е.Н., Мирошенков П.В. Биомедицинские исследования в педиатрии. // Качественная клиническая практика, 2002 г., №2, стр. 40-48.
4. Мелихов О.Г. Клинические исследования 2-е изд., испр. и доп. - М.: Издательский дом «Атмосфера», 2007. С. 26; Statistical Principles for Clinical Trials. ICH Harmonized Tripartite Guideline. Recommended for Adoption at Step 4 of the ICH Process on 5 February 1998 by the ICH Steering Committee. P. 2.2.1.
5. Намазова-Баранова Л.С. Можем ли мы сегодня спокойно использовать лекарства у наших детей? 2017. [Электронный ресурс] - Режим доступа: http://www.kdcenter.ru/kd/content/mozhem-li-my-segodnya-spokoino-ispolzovat-lekarstva-u-nashikh-detei (Дата обращения: 18.03.2018).
6. Незнанов Н. Г., Никитин Е. Н., Мирошенков П. В. Биомедицинские исследования в педиатрии // Качественная клиническая практика. -- 2002. С. 2.
7. Низамиева О.Н. Семейное право на рубеже XX - XXI веков: обзор выступлений на Международной научно-практической конференции // Семейное и жилищное право. 2011. N 4. С. 2 - 7.
8. Тополянская С.В. Общие методологические проблемы проведения клинических исследований у детей // ПФ. 2010. №5. С. 9.
9. Тополянская С.В. Этические аспекты проведения клинических исследований у детей // ПФ. 2010. №3. - C. 6-11.
10. Фирсов И.С., Мохов О.И. Мониторинг клинического исследования. // Качественная клиническая практика 2/2002.
Иностранные монографии и научные статьи
1. Agre P., Rapkin B. Improving informed consent: a comparison of four consent tools //IRB: Ethics & Human Research. - 2003. - P. 1-7.
2. Barfield R. C., Church C. Informed consent in pediatric clinical trials //Current opinion in pediatrics. - 2005. - Т. 17. - №. 1. - P. 20-24.
3. Bridge J. A. et al. Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder //American Journal of Psychiatry. - 2009. - Т. 166. - №. 1. - P. 42-49.
4. Broome M. E. et al. Children in research: new perspectives and practices for informed consent //IRB: Ethics & Human Research. - 2003. - Т. 25. - №. 5. - P. S20-S25.
5. Buck M. The placebo response in pediatric clinical trials //Pediatr Pharmacol. - 2012. - Т. 18. - №. 3.
6. Chan T. E. The search for minimal risk in international paediatric clinical trials //Santa Clara J. Int'l L. - 2007. - Т. 5. - P. i.
7. Freedman, B. 1987, 'Equipoise and the ethics of clinical research', N Engl J Med, Vol. 317, No 3. P. 141.
8. Gidding S. S. et al. A policy regarding research in healthy children //The Journal of pediatrics. - 1993. - Т. 123. - №. 6. - P. 852-855.
9. Harris M, Taylor G, Jackson D. Clinical evidence made easy. Hockley, Essex: Scion Publishing Ltd; 2014.;
10. Hubert Otho Ballard, Lori Ann Shook, Joseph Iocono, Philip Bernard, Don Hayes and Jr. Parents' Understanding and Recall of Informed Consent Information for Neonatal Research. // IRB: Ethics & Human Research, Vol. 33, No. 3 (May-June 2011), pp. 12-19.
11. Joseph DP, Caldwell PHY,Craig JC. Registered paediatric clinical trials: a global context. Poster presentation International Congress of Pediatrics 2013 (ICP), The 27th Congress of International Pediatric Association 24-29 August 2013 Melbourne, Australia. 2013.
12. Fortney J. A. Assessing recall and understanding of informed consent in a contraceptive clinical trial //Studies in Family Planning. - 1999. - Т. 30. - №. 4. - P. 339-346.
13. Karlberg, J.P.E. Reviewing Clinical Trials: A Guide for the Ethics Committee. Clinical Trials Centre, The University of Hong Kong Hong Kong SAR, PR China, 2010. P. 32.
14. Kummar S. et al. Phase 0 clinical trials: conceptions and misconceptions //The Cancer Journal. - 2008. - Т. 14. - №. 3. - P. 133-137.
15. Lenz W. et al. Thalidomide and congenital abnormalities //The Lancet. - 1962. - Т. 279. - №. 7219. - P. 45-46.
16. Lewis D. W., Winner P., Wasiewski W. The placebo responder rate in children and adolescents //Headache: The Journal of Head and Face Pain. - 2005. - Т. 45. - №. 3. - P. 232-239.
17. Marshall P. A. et al. Negotiating decisions during informed consent for pediatric Phase I oncology trials //Journal of Empirical Research on Human Research Ethics. - 2012. - Т. 7. - №. 2. - P. 51-59.
18. Massimo L. M., Wiley T. J. Randomization, informed consent and physicians' communication skills in pediatric oncology: a delicate balance //Bulletin du cancer. - 2005. - Т. 92. - №. 12. - P. 10067-10069.
19. McNeill P. Paying people to participate in research: why not? //Bioethics. - 1997. - Т. 11. - №. 5. - P. 390-396.
20. Olechnowicz J. Q. et al. Assent observed: children's involvement in leukemia treatment and research discussions //Pediatrics. - 2002. - Т. 109. - №. 5. - P. 806-814.
21. Ottenbacher KJ, Cooper MM. Drug treatment of hyperactivity in children. Dev Med Child Neurol. - 1983. - T. 2. - P. 358-66.
22. PieterJ .J. Sauer Researcihn children. A repod of the EthicsW orking Groupo f the GES. // Eur J Pediatr. - 2002. - T. 161. - P. l -5.
23. Rothner A. D. et al. Zolmitriptan oral tablet in migraine treatment: high placebo responses in adolescents //Headache: The Journal of Head and Face Pain. - 2006. - Т. 46. - №. 1. - P. 101-109.
24. Scherer D. G. The capacities of minors to exercise voluntariness in medical treatment decisions //Law and human behavior. - 1991. - Т. 15. - №. 4. - P. 431-439.
25. Spilker B. Guide to Clinical Trials. N.Y.:Raven Press, 1992 - 284 p.
26. Steinbrook R. Testing medications in children // N. Eng. J. Med. -- 2002; 347 (18). P.1462-1470.
27. Ward F. R. Chaos, vulnerability and control: parental beliefs about neonatal clinical trials //Journal of Perinatology. - 2009. - Т. 29. - №. 2. - P. 156-162.
28. Wendler D. et al. The ethics of paying for children's participation in research //The Journal of pediatrics. - 2002. - Т. 141. - №. 2. - С. 166-171.
1. University Of Chicago Medical Center. «Placebo-controlled Clinical Trials Put Children With Asthma At Risk.» ScienceDaily. ScienceDaily, 5 January 2004. [Electronic resource.]. - Available at: www.sciencedaily.com/releases/2004/01/040105065202.htm (Accessed: 24.03.2018).
2. Practical and ethical issues in pediatric clinical trials. By Applied Clinical Trials Editors. Applied Clinical Trials. Jul 01, 2002. [Electronic resource.]. - Available at: http://www.appliedclinicaltrialsonline.com/practical-and-ethical-issues-pediatric-clinical-trials-0 (Accessed: 15.03.2018).
3. European Medicines Agency. Science medicines health. Official site http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000265.jsp
4. The World Bank. Population ages 0-14 (% of total). The United Nations population division's world population prospects. 2011. [Electronic resource.]. - Available at: http://data.worldbank.org/indicator/SP.POP.0014.TO.ZS/countries/1W?display=default (Accessed: 30 May 2013).
5. [Electronic resource.]. - Available at: https://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ (Accessed: 02.02.2018).
6. NCI Dictionary of Cancer Terms. National Cancere Institute. [Electronic resource.]. - Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/endpoint (Accessed: 02.02.2018).