Guidance

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

IRBMED

Jul 24, 2007 10:30 am

The probability* and magnitude of harm or discomfort anticipated in the research and 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.

PRINTER FRIENDLY VERSION

Guidelines

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* 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.

*** 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