Creating a New Ethical Climate for Drug Research in Children and Pregnant Women
详细信息 查看全文
- 作者：Doreen Matsui (1)
Gideon Koren (2)
1. Departments of Paediatrics and Medicine ; Children鈥檚 Hospital ; London Health Sciences Centre ; Child Health Research Institute ; University of Western Ontario ; 800 Commissioners Road East ; London ; ON ; N6A 5W9 ; Canada
2. Division of Clinical Pharmacology and Toxicology at the Hospital for Sick Children ; University of Toronto ; 555 University Ave ; Toronto ; ON ; M5G 1X8 ; Canada - 刊名：Pediatric Drugs
- 出版年：2015
- 出版时间：February 2015
- 年：2015
- 卷：17
- 期：1
- 页码：1-3
- 全文大小：161 KB
- 参考文献：1. Koren G. A practical approach to risk-benefit estimation in pediatric drug research. Pediatr Drugs. 2015;17(1):13鈥?.
2. Leibson T, Koren G. Informed consent in pediatric research. Pediatr Drugs. 2015;17(1):5鈥?1.
3. Chau K, Koren G. The principle of equipoise in pediatric drug trials. Pediatr Drugs. 2015;17(1):17鈥?1.
4. Matsui D. Ethics of studies of drugs in pregnancy. Pediatr Drugs. 2015;17(1)31鈥?.
5. Ward RM, Sherwin CMT. Ethics of drug studies in the newborn. Pediatr Drugs. 2015;17(1):37鈥?2.
6. Welisch E, Altamirano-Diaz LA. Ethics of pharmacological research involving adolescents. Pediatr Drugs. 2015;17(1)55鈥?.
7. Rumney P, Anderson JA, Ryan SE. Ethics in pharmacologic research in the child with a disability. Pediatr Drugs. 2015;17(1):61鈥?.
8. Schechter T, Grant R. The complexity of consenting to clinical research in phase I pediatric cancer studies. Pediatr Drugs. 2015;17(1):77鈥?1.
9. Kleiber N, Tromp K, Mooij MG, van de Vathorst S, Tibboel D, de Wildt SN. Ethics of drug research in the pediatric intensive care unit. Pediatr Drugs. 2015;17(1):43鈥?3.
10. Neuman G, Shavit I, Matsui D, Koren G. Ethics of research in pediatric emergency medicine. Pediatr Drugs. 2015;17(1):69鈥?6.
11. Macleod S, Knoppert DC, Stanton-Jean M, Avard D. Pediatric clinical drug trials in low-income countries: key ethical issues. Pediatr Drugs. 2015;17(1):83鈥?0.
12. Canadian Institutes of Health Research, 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. 2010.
13. Cummings L. Get on board with the research ethics review process. Can Nurse. 2012;108:28鈥?3.
14. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report鈥擡thical Principles and Guidelines for the Protection of Human Subjects of Research. 1979. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. Accessed 31 July 2014.
15. Westra AE, Wit JM, Sukhai RN, de Beaufort ID. How best to define the concept of minimal risk. J Pediatr. 2011;159:496鈥?00. CrossRef
16. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291:476鈥?2. CrossRef
17. Needham AC, Kapadia MZ, Offringa M. Ethics review of pediatric multi-center drug trials. Pediatr Drugs. 2015;17(1):23鈥?0.
18. Madadi P. Ethical perspectives on translational pharmacogenetic research involving children and pregnant women. Pediatr Drugs. 2015;17(1):91鈥?.
19. Guillemin M, Gillam L, Rosenthal D, Bolitho A. Human research ethics committees: examining their roles and practices. J Empir Res Hum Res Ethics. 2012;7:38鈥?9. CrossRef
20. Greaney AM, Sheehy A, Heffernan C, Murphy J, Mhaolr煤naigh SN, Heffernan E, Brown G. Research ethics application: a guide for the novice researcher. Br J Nurs. 2012;21(1):38鈥?3. CrossRef
21. Dawson AJ, Yentis SM. Contesting the science/ethics distinction in the review of clinical research. J Med Ethics. 2007;33:165鈥?. CrossRef - 刊物主题：Pediatrics; Pharmacotherapy; Internal Medicine;
- 出版者：Springer International Publishing
- ISSN：1179-2019
文摘