Guidelines For Using Magnitude Of Harm In Categorizing Risk Level
* IRBs consider both magnitude and probability of harm.
**SACHRP research involving children subcommittee. Kornetsky, S.Z., Fisher, C.B. (October 4-5, 2004) Office for Human Research Protections (OHRP) Subcommittee on Research Involving Children Report/Issues 4th Report for SACHRP Consideration Clarifying 45 CFR Subpart D Definitions, Slide 14.
*** The assessment of risk to a subject is not made at the same time that benefit assessment is made except under the conditions of 45 CFR 46 sections 404-407.
This guidance is not meant to replace individual judgment of risk in any particular study but rather to foster consistency to the extent possible.
Version: Approved by IRB Council 7/24/2007