Weighing the risks and benefits of pediatric research: A risky business

Archives of Pediatrics and Adolescent Medicine

Volumn 164, Issue 6, 2010, Pages 579-581

  Tait, Alan R ^a  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROPOFOL;

AIRWAY OBSTRUCTION; ANESTHESIA; CHILD SAFETY; CHILD WELFARE; EDITORIAL; MEDICAL AUDIT; NUCLEAR MAGNETIC RESONANCE IMAGING; PATIENT PARTICIPATION; PEDIATRICS; PHYSICAL EXAMINATION; PRIORITY JOURNAL; QUALITY CONTROL; RESPIRATION DEPRESSION; RISK BENEFIT ANALYSIS; SEDATION;

BIOMEDICAL RESEARCH; CHILD; ETHICS COMMITTEES, RESEARCH; ETHICS, CLINICAL; HUMANS; INFORMED CONSENT; PARENTS; RISK ASSESSMENT;

EID: 77953304468     PISSN: 10724710     EISSN: 15383628     Source Type: Journal    
DOI: 10.1001/archpediatrics.2010.58     Document Type: Editorial

References (17)

1. 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. Washington, DC: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; 1979.
2. Additional protections for children involved as subjects in research, subpart D. Fed Regist. 1983;43(46):9814-9820. To be codified at 45 CFR 46.
3. Department of Health and Human Services. Protection of human subjects. 45 CFR 46. Revised June 18, 1991.
4. Wendler D, Belsky L, Thompson KM, Emanuel EJ. Quantifying the federal minimal risk standard: implications for pediatric research without prospect of direct benefit. JAMA. 2005;294(7):826-832. (Pubitemid 41178967)
5. Wendler D, Emanuel E. What is "minor" increase over minimal risk? J Pediatr. 2005;147(5):575-578.
6. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291(4):476-482. (Pubitemid 38129752)
7. Kiringoda R, Thurm AE, Hirschtritt ME, et al. Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center. Arch Pediatr Adolesc Med. 2010;164(6):554-560.
8. Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009; 108(3):795-804.
9. Tait AR, Voepel-Lewis T, Malviya S. Do they understand? (part I): parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology. 2003;98(3):603-608. (Pubitemid 36262584)
10. van Stuijvenberg M, Suur MH, de Vos S, et al. Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Arch Dis Child. 1998;79(2):120-125.
11. Tait AR, Voepel-Lewis T, Malviya S. Factors that influence parents' assessments of the risks and benefits of research involving their children. Pediatrics. 2004; 113(4):727-732. (Pubitemid 38437375)
12. Waters EA, Weinstein ND, Colditz GA, Emmons K. Formats for improving risk communication in medical tradeoff decisions. J Health Commun. 2006;11(2): 167-182. (Pubitemid 43393240)
13. Zikmund-Fisher BJ, Fagerlin A, Roberts TR, Derry HA, Ubel PA. Alternate methods of framing information about medication side effects: incremental risk vs total risk of occurrence. J Health Commun. 2008;13(2):107-124. (Pubitemid 351304461)
14. Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic M, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns. 2008;73(3):448-455.
15. Murgatroyd RJ, Cooper RM. Readability of informed consent forms. Am J Hosp Pharm. 1991;48(12):2651-2652.
16. Kirsch I, Jungelblut A, Jenkins L, Kalstad A. Adult Literacy in America: A First Look at the Results of the Adult National Adult Literacy Survey. Washington, DC: National Center for Education Statistics; 1993.
17. Schwartz LM, Woloshin S, Black WC, Welch HG. The role of numeracy in understanding the benefit of screening mammography. Ann Intern Med. 1997; 127(11):966-972.