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OHRP Guidance - Written IRB Procedures

NOTE: THIS GUIDANCE REPLACES OHRP’S JULY 11, 2002 GUIDANCE ENTITLED “GUIDANCE ON WRITTEN IRB PROCEDURES.” THIS GUIDANCE HAS BEEN UPDATED TO INCLUDE THE FOLLOWING CHANGES:
(1) CONTENT REGARDING CONTINUING REVIEW HAS BEEN REVISED TO BE CONSISTENT WITH THE CONTENT OF OHRP’S JANUARY 15, 2007 “GUIDANCE ON REVIEWING AND REPORTING UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS AND ADVERSE EVENTS;”

(2) PARAGRAPH A.(4) UNDER “ADDITIONAL OHRP GUIDANCE RELEVANT TO WRITTEN IRB PROCEDURES” HAS BEEN REVISED TO BE CONSISTENT WITH OHRP’S POSITION REGARDING WHEN IRB’S MUST DEFER APPROVAL OF RESEARCH; AND

(3) FORMATTING CHANGES.
Office for Human Research Protections (OHRP)

Department of Health and Human Services

This guidance represents OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

Guidance on Written IRB Procedures

Date: January 15, 2007

Scope:
This document outlines the required elements of written Institutional Review Board (IRB) procedures under Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR Part 46) and provides an overview of relevant OHRP guidance regarding each required element.
Target Audience:
This document primarily is intended to assist IRB administrators, IRB chairpersons, and other relevant institutional officials who may be responsible for preparing and maintaining written IRB procedures.

BACKGROUND

OHRP frequently receives requests for guidance and clarification regarding the content of written IRB procedures. In order to assist institutions in developing adequate written IRB procedures, OHRP has compiled the following summary of the relevant regulatory requirements and guidance issued routinely by OHRP over the past several years.


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