Appropriate compensation of pediatric research participants: Thoughts from an Institute of Medicine committee report

Journal of Pediatrics

Volumn 149, Issue 1 SUPPL., 2006, Pages

  Ramsey, Bonnie W ^a  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DATA ANALYSIS; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; MEDICAL LITERATURE; MEDICAL RESEARCH; METHODOLOGY; ORGANIZATION; PEDIATRICS; PRIORITY JOURNAL; PROSPECTIVE PAYMENT; REIMBURSEMENT; UNITED STATES;

CHILD; COMPENSATION AND REDRESS; HUMANS; INSTITUTE OF MEDICINE (U.S.); PATIENT SELECTION; RESEARCH SUBJECTS; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES;

EID: 33745597050     PISSN: 00223476     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpeds.2006.04.045     Document Type: Article

References (24)

1. Roberts L. Polio. health workers scramble to contain African epidemic. Science 305 (2004) 24-25
2. Simone J.V. Childhood leukemia. successes and challenges for survivors. N Engl J Med 141 (2005) 166-171
3. Steinbrook R. Testing medications in children. N Engl J Med 347 (2002) 1462-1470
4. US Food and Drug Administration. Modernization Act of 1997 (FDAMA-1997), section 505A. Available online at: http://www.fda.gov/oc/fdama/default.htm.
5. US Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Final rule (1998). http://www.fda.gov/ohrms/dockets/98fr/120298c.pdf (21 CFR Parts 201, 312, 314, and 601). December 2. Available online at: http://www.fda.gov/ohrms/dockets/98fr/120298c.pdf.
6. th Cong. (January 4, 2002).
7. Institute of Medicine. Ethical Conduct of Clinical Research Involving Children (2004), The National Academies Press, Washington, DC
8. Department of Health and Human Services. Protection of human subjects(45 CFR 46) (2001). http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html October 1. Available online at: http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html
9. US Food and Drug Administration. Protection of human subjects. (21 CFR 50) (2002). http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr50_02.html April 1. Available online at: http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr50_02.html.
10. Food and Drug Administration, HHS. International Conference on Harmonisation. guidance on E11 clinical investigation of medicinal products in pediatric populations. Fed Regist 65 242 (2000) 78493-78494 Dec 15
11. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002). http://www.cioms.ch/frame_guidelines_nov_2002.htm November. Available online at: http://www.cioms.ch/frame_guidelines_nov_2002.htm.
12. US Food and Drug Administration. Guidance for institutional review boards and clinical investigators. 1998 Update. cooperative research (1998), US Food and Drug Administration, Rockville, MD. http://www.fda.gov/ohrt/irbs/research.html Available online at: http://www.fda.gov/ohrt/irbs/research.html.
13. Weise K.L., Smith M.L., Maschke K.J., and Copeland H.L. National practices regarding payment to research subjects for participating in pediatric research. Pediatrics 110 (2002) 577-582
14. Dickert N., Emanuel E., and Grady C. Paying research subjects. an analysis of current policies. Ann Intern Med 136 (2002) 368-373
15. American Academy of Pediatrics. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 95 (1995) 286-294
16. CenterWatch clinical trials listing services (2000), CenterWatch, Boston. http://www.centerwatch.com Available online at: http://www.centerwatch.com.
17. Wendler D., Rackoff J.E., Emanuel E.J., and Grady C. The ethics of paying for children's participation in research. J Pediatr 141 (2002) 166-171
18. Institute of Medicine. Responsible Research. A Systems Approach to Protecting Research Participants (2003), The National Academies Press, Washington, DC
19. De Angelis C., Drazen J.M., Frizelle F.A., Haug C., Hoey J., Horton R., et al. International Committee of Medical Journal Editors. Clinical trial registration. a statement from the International Committee of Medical Journal Editors. N Engl J Med 351 12 (2004) 1250-1251
20. Borzekowski D.L., Rickert V.I., Ipp L., and Fortenberry J.D. At what price? The current state of subject payment in adolescent. J Adolesc Health 33 (2003) 378-384
21. Broome M.E., Richards D.J., and Hall J.M. Children in research. the experience of ill children and adolescents. J Fam Nurs 7 (2001) 32-49
22. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), US Government Printing Office, Washington, DC
23. Dickert N., and Grady C. Paying research subjects. an analysis of current policies. N Engl J Med 341 (1999) 198-203
24. US Food and Drug Administration. Orphan drug regulations. (Part 316 Subpart C Section 316.3). Available online at: http://www.fda.gov/Orphan/21cfr316.html.