Currents in Contemporary Ethics Ethical and Practical Concerns in Developing Payment Policies for Research Involving Children and Adolescents

Institute of Medicine (IOM), The Ethical Conduct of Clinical Research Involving Children, Washington, D.C., 2004, at Recommendation 6.1.

Iltis A. S. DeVader S. R. Matsuo H. , “Payments to Children and Adolescents Enrolled in Research: A Pilot,” Pediatrics 118, no. 4 (2006): 1546–1552.

Id., at 1547.

Id, at 1549.

Id., at 1550.

Menikoff J. , “Just Compensation: Paying Research Subjects Relative to the Risks They Bear,” American Journal of Bioethics 1, no. 2 (2001): 56–58; Grady C. , “Money for Research Participation: Does It Jeopardize Informed Consent?” American Journal of Bioethics 1, no. 2 (2001): 40–44.

Dickert N. Grady C. , “What's the Price of a Research Subject?” New England Journal of Medicine 341, no. 3 (1999): 198–202.

Kirkpatrick M. A. F. , “Factors that Motivate Healthy Adults to Participate in Phase I Drug Trials,” Drug Information Journal 25, no. 1 (1991): 103–115; Bagley S. J. Reynolds W. W. Nelson R. M. , “Is a ‘Wage-Payment’ Model for Research Participation Appropriate for Children?” Pediatrics 119, no. 1 (2007): 46–51; Tishler C. L. Bartholomae S. , “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; Bentley J. P. Thacker P. G. , “The Influence of Risk and Monetary Payment on the Research Participation Decision Making Process,” Journal of Medical Ethics 30, no. 3 (2004): 293–298; Rothmier J. D. Lasley M. V. Shapiro G. G. , “Factors Influencing Parental Consent in Pediatric Clinical Research,” Pediatrics 111, no. 5 (2003): 1037–1041; Hayman R. M. Taylor B. J. Pearl N. G. Galland B. C. Sayers R. M. , “Participation in Research: Informed Consent, Motivation, and Influence,” Journal of Paediatrics and Child Health 37, no. 1 (2001): 51–54; McCarthy A. M. , “Psychological Screening of Children for Participation in Nontherapeutic Invasive Research,” Archives of Pediatrics and Adolescent Medicine 155, no. 11 (2001): 1197.

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; 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 Eckstein S. , ed., Manual for Research Ethics Committees (Cambridge, U.K.: Cambridge University Press, 2003): At 184–195; 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): 286–294; National Council on Bioethics in Human Research (NCBHR), Report on Research Involving Children , Ottawa, Ontario, 1993; British Paediatric Association, Ethics Advisory Committee, Guidelines for the Ethical Conduct of Medical Research Involving Children , London, 1992; see IOM, supra note 1.

Iltis A. S. , “Costs to Subjects for Research Participation and the Informed Consent Process: Regulatory and Ethical Considerations,” IRB: Ethics and Human Research 26, no. 6 (2004): 9–13.

See American Academy of Pediatrics, supra note 10, at 293.

See, e.g., Fernhoff P. M. , “Paying for Children to Participate in Research: A Slippery Slope or an Enlightened Stairway?” Journal of Pediatrics 141, no. 2 (2002): 153–154.

See Dickert Grady , supra note 8.

Emanuel E. Wendler D. Grady C. , “What Makes Clinical Research Ethical?” JAMA 283, no. 11 (2001): 2701–2711.

Ramsey B. W. , “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.

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); 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,” NIH National Institutes of Health Office of Human Subjects Research, available at <http://ohsr.od.nih.gov/info/sheet20.html> (last visited March 12, 2008).

See Dickert Grady , supra note 8.

See Iltis , supra note 11.

See Iltis DeVader Matsuo , supra note 2.