The Minimal Risk Standard Revealed.ppt

The Minimal Risk Standard Revealed Leah Belsky Ezekiel J. Emanuel Kimberly Thompson David Wendler The Imperative for Pediatric Research Less than 1/3 of drugs prescribed to children have been tested in children. Pediatricians are regularly prescribing drugs that have not been proven safe and effective in children. To improve pediatric medicine, more pediatric research is needed. Protecting Pediatric Subjects The importance of conducting pediatric research must be balanced with protection of individual research subjects. Ensuring protection is especially important in non-beneficial research. Smallpox Vaccine Development of a vaccine for smallpox offered important possible benefits to children. Toxicity studies were needed before efficacy studies could be conducted. Toxicity studies posed risks to subjects without any potential medical benefit. How Much Risk is Acceptable? It is widely agreed that non-beneficial research is acceptable when risks are sufficiently low. What constitutes “sufficiently low”? How much risk is acceptable in this context? The US Federal Regulations IRBs may approve studies that do not offer pediatric subjects a prospect of direct benefit when the risks are ‘minimal’ or a ‘minor increase’ over minimal. What is Minimal Risk? The federal regulations define minimal risk as the: “Probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” 45CFR 46.102(i) Are These Procedures Minimal Risk? An MRI without sedation in healthy 11 year-olds. Allergy skin testing in healthy 11 year-olds. 3 blood draws in healthy 7 year-olds. One dose of Ritalin. What do U.S. IRB Chairs say? MRI w/out sedation in healthy 11 year-olds What do US IRB Chairs Say? Allergy skin testing in healthy 11 year olds Unjustified Variability? The variability in IRB