Hostname: page-component-cd9895bd7-hc48f Total loading time: 0 Render date: 2024-12-26T22:57:15.240Z Has data issue: false hasContentIssue false
  • English
  • Français

Currents in Contemporary Ethics

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

Published online by Cambridge University Press:  01 January 2021

Ana S. Iltis ,
Hisako Matsuo  and
Shannon R. DeVader
Get access Rights & Permissions [Opens in a new window]

Extract

An Institute of Medicine (IOM) panel charged with reviewing the system for overseeing research involving children concluded in 2004 that Institutional Review Boards (IRBs), institutions engaged in research, and study sponsors should “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children’s] research participation.” We previously reported data on practices and policies in the U.S. regarding payments to children who participate in research and their parents. Here, we report additional results from our study and identify some of the decisions that must be made in developing payment plans and on which payment policies will be expected to offer guidance. We conclude that further conceptual analysis and empirical research are necessary before IRBs, institutions, and sponsors can develop specific rules on numerous aspects of payment. Nevertheless, payment policies that promote the ethical treatment of children in research and their parents can be developed. We propose a structure for such policies.

Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 413 - 418
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Institute of Medicine (IOM), The Ethical Conduct of Clinical Research Involving Children, Washington, D.C., 2004, at Recommendation 6.1.Google Scholar
Iltis, A. S., DeVader, S. R., and Matsuo, H., “Payments to Children and Adolescents Enrolled in Research: A Pilot,” Pediatrics 118, no. 4 (2006): 1546–1552.CrossRefGoogle Scholar
Id., at 1547.Google Scholar
Id, at 1549.Google Scholar
Id.Google Scholar
Id., at 1550.Google Scholar
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.CrossRefGoogle Scholar
Dickert, N. and Grady, C., “What's the Price of a Research Subject?” New England Journal of Medicine 341, no. 3 (1999): 198–202.CrossRefGoogle Scholar
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., and Nelson, R. M., “Is a ‘Wage-Payment’ Model for Research Participation Appropriate for Children?” Pediatrics 119, no. 1 (2007): 46–51; Tishler, C. L. and 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. and 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., and 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., and 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. et al., “Psychological Screening of Children for Participation in Nontherapeutic Invasive Research,” Archives of Pediatrics and Adolescent Medicine 155, no. 11 (2001): 1197.CrossRefGoogle Scholar
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.Google Scholar
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.CrossRefGoogle Scholar
See American Academy of Pediatrics, supra note 10, at 293.Google Scholar
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.CrossRefGoogle Scholar
See Dickert, and Grady, , supra note 8.Google Scholar
Emanuel, E., Wendler, D., and Grady, C., “What Makes Clinical Research Ethical?” JAMA 283, no. 11 (2001): 2701–2711.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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).+(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++(last+visited+March+12,+2008).>Google Scholar
See Dickert, and Grady, , supra note 8.Google Scholar
See Iltis, , supra note 11.Google Scholar
See Iltis, , DeVader, , and Matsuo, , supra note 2.Google Scholar