NAPNAP Position Statement on Protection of Children Involved in Research Studies

References 

1. Albert Einstein College of Medicine. (2003). Enrollment of minors in research: Principles and guidelines. New York, NY: Retrieved from http://www.aecom.yu.edu/cci/page.aspx?id=9952
2. American Academy of Pediatrics. Informed consent, parental permission, and assent in pediatric practice (RE 9510). Pediatrics. 1995;95:314–317
   • MEDLINE
3. American Academy of Pediatrics. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 1995;95:286–294
   • MEDLINE
4. Department of Health and Human Services & National Institutes of Health Office for Protections from Research Risks. (2005). Code of federal regulations, DHHS regulation, 45 C.F.R. § 46.D (2005) and FDA regulation, 21 C.F.R § 50.D (2005). Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
5. Institute of Medicine. Ethical conduct of clinical research involving children. Washington, DC: National Academies of Practice; 2004;
6. Iltis AS, Wall A, Lesandrini J, Rangel EK, Chibnall JT. Federal interpretation and enforcement of protections for vulnerable participants. Journal of Empirical Research on Human Research Ethics. 2009;4(1):37–41
7. Koelch M, Singer H, Prestel A, Burkert J, Schulze U, Fegert JM. “…because I am something special” or “I think I will be something like a guinea pig”: Information and assent of legal minors in clinical trials—assessment of understanding, appreciation and reasoning. Child and Adolescent Psychiatry and Mental Health. 2009;3(1):2
8. Kon AA. Assent in pediatric research. Pediatrics. 2006;117:1806–1810
   • CrossRef
9. Lindeke LL, Hauck MR, Tanner M. Practical issues in obtaining child assent for research. Journal of Pediatric Nursing. 2000;15:99–104
   • Abstract
   • Full-Text PDF (492 KB)
   • CrossRef
10. U.S. Department of Health, Education, and Welfare. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research and The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Retrieved from http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm