The Office for Human Research Protections (OHRP), Health and Human Services (HHS) has compiled a summary of the relevant regulatory requirements and guidance issued routinely over the past several years. OHRP has not developed a model written IRB procedures document for institutions to adapt because procedures appropriately can vary significantly among institutions as the result of differences in institution size, the type of research activities, institutional administrative practices, number of IRBs, and local and state laws and regulations. For each required element, the written IRB procedures should provide sufficient step-by-step operational details so that an independent observer can understand how an IRB operates and conducts its major functions.
Pursuant to guidance from OHRP, HHS regulations at 45 CFR 46.103(b)(4) and (5) require that institutions have written IRB procedures for each of the following areas:
This document contains a variety of SOPs covering these requirements as well as others pertinent to the Ball State University IRB.
Questions regarding these SOPs may be made of the Director of Research Integrity at 765-285-5070. For more information on IRB and human subject regulatory requirements, please visit the Office for Human Research Protections at http://www.hhs.gov/ohrp/.
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