Currents in contemporary ethics: Ethical and practical concerns in developing payment policies for research involving children and adolescents

Journal of Law, Medicine and Ethics

Volumn 36, Issue 2, 2008, Pages 413-418

  Iltis, Ana S ^a   Matsuo, Hisako ^a   DeVader, Shannon R ^b,c  

^a SAINT LOUIS UNIVERSITY   (United States)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c Maine Department of Health and Human Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; CHILD; ECONOMICS; ETHICS; HUMAN; INFANT; INFORMED CONSENT; MEDICAL RESEARCH; PEDIATRICS; PRESCHOOL CHILD; PROFESSIONAL STANDARD; PSYCHOLOGICAL ASPECT; RESEARCH SUBJECT;

ADOLESCENT; BIOMEDICAL RESEARCH; CHILD; CHILD, PRESCHOOL; ETHICS COMMITTEES, RESEARCH; HUMANS; INFANT; INFORMED CONSENT; PEDIATRICS; RESEARCH SUBJECTS;

EID: 44949214965     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.00285.x     Document Type: Article

References (33)

1. Institute of Medicine (IOM), The Ethical Conduct of Clinical Research. Involving Children, Washington, D.C., 2004, at Recommendation 6.1.
2. A. S. Iltis, S. R. DeVader, and H. Matsuo, "Payments to Children and Adolescents Enrolled in Research: A Pilot," Pediatrics 118, no. 4 (2006): 1546-1552.
3. Id., at 1547.
4. Id., at 1549.
5. Id.
6. Id., at 1550.
7. J. Menikoff, "Just Compensation: Paying Research Subjects Relative to the Risks They Bear," American Journal ofBioethics 1, no. 2 (2001): 56-58;
8. C. Grady, "Money for Research Participation: Does It Jeopardize Informed Consent?" American Journal of Bioethics 1, no. 2 (2001): 40-44.
9. N. Dickert and C. Grady, "What's the Price of a Research Subject?" New England Journal of Medicine 341, no. 3 (1999): 198-202.
10. M. A. F. Kirkpatrick, "Factors that Motivate Healthy Adults to Participate in Phase I Drug Trials," Drug Information Journal 25, no. 1 (1991): 103-115;
11. S. J. Bagley, W W Reynolds and R. M. Nelson, "Is a Wage-Payment' Model for Research Participation Appropriate for Children?" Pediatrics 119, no. 1 (2007): 46-51;
12. C. L. Tishler and S. Bartholomae, "The Recruitment of Normal Healthy Volunteers: A Review of the Literature on the Use of Financial Incentives," Journal of Clinical Pharmacology 42, no. 4 (2002): 365-375;
13. J. P. Bentley and P. G. Thacker, "The Influence of Risk and Monetary Payment on Üie Research Participation Decision Making Process," Journal of Medical Ethics 30, no. 3 (2004): 293-298;
14. J. D. Rothmier, M. V. Lasley, and G. G. Shapiro, "Factors Influencing Parental Consent in Pediatric Clinical Research," Pediatrics 111, no. 5 (2003): 1037-1041;
15. R. M. Hayman, B. J. Taylor, N. G. Pearl, B. C. Galland, and R. M. Sayers, "Participation in Research: Informed Consent, Motivation, and Influence," Journal of Paediatrics and Child Health 37, no. 1 (2001): 51-54;
16. A. M. McCarthy et al., "Psychological Screening of Children for Participation in Nontherapeutic Invasive Research," Archives of Pediatrics and Adolescent Medicine 155, no. 11 (2001): 1197.
17. Royal College of Physicians, "Research on Healthy Volunteers, a Report of the Royal College of Physicians," Journal of the Royal College of Physicians of London 20, no. 4 (1986): 243-257;
18. EU Clinical Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, "On the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use," in S. Eckstein, ed., Manual for Research Ethics Committees (Cambridge, U.K.: Cambridge University Press, 2003): at 184-195;
19. American Academy of Pediatrics, Committee on Drugs, "Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations," Pediatrics 95, no. 2 (1995): 286294;
20. National Council on Bioethics in Human Research (NCBHR), Report on Research Involving Children, Ottawa, Ontario, 1993;
21. British Paediatric Association, Ethics Advisory Committee, Guidelines for the Ethical Conduct of Medical Research Involving Children, London, 1992;
22. see IOM, supra note 1.
23. A. S. Iltis, "Costs to Subjects for Research Participation and Üie Informed Consent Process: Regulatory and Ethical Considerations," IRB: Ethics and Human Research 26, no. 6 (2004): 9-13.
24. See American Academy of Pediatrics, supra note 10, at 293.
25. See, e.g., P. M. Fernhoff, "Paying for Children to Participate in Research: A Slippery Slope or an Enlightened Stairway?" Journal of Pediatrics 141, no. 2 (2002): 153-154.
26. See Dickert and Grady, supra note 8.
27. E. Emanuel, D. Wendler, and C. Grady, "What Makes Clinical Research Ethical?" JAMA 283, no. 11 (2001): 2701-2711.
28. B.W. Ramsey, "Appropriate Compensation of Pediatric Research Participants: Thoughts from an Institute of Medicine Committee Report," Journal of Pediatrics 149, no. 1, Supplement 1 (2006): S15-S19.
29. Food and Drug Administration (FDA), "Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update," at Payment to Research Subjects, available at 〈http://www.fda.gov/ oc/ohrt/irbs/toc4.html〉 (last visited March 12, 2008);
30. Clinical Bioethics Department, Warren Grant Magnuson Clinical Center, "Sheet 20: Guidelines for Remuneration of Research Subjects in the Intramural Research Program and Registration in the Clinical Research Volunteer Program Database," NIII National Institutes of Health Office of Human Subjects Research, available at 〈http://ohsr.od.nih.gov/info/ sheet20. html〉 (last visited March 12, 2008).
31. See Dickert and Grady, supra note 8.
32. See Iltis, supra, note 11.
33. See Iltis, DeVader, and Matsuo, supra note 2.