The Tulane HRPO assists IRB Board Members in the review process of human subject studies.  As part of that effort, this portion of the site contains resources for the Board Members.

The HRPO will provide annual evaluations of IRB Members (IRB Chair, Vice-Chair, and IRB Members) regarding their IRB performance and duties.  All members will be allowed to provide feedback and/or comments/suggestions on an on-going basis.  

IRB Board Member Conflict of Interest Letter 

General

IRB Board Member Orientation Packet

IRB Board Member Module

IRB Membership Functions

How to use IRBNet as a Board Member (Powerpoint) 

Biomedical IRB

Biomedical Reviewer Sheet for Initial Submissions (Convened IRB)

Biomedical Board Member IRBNet Instructions

Social/Behavioral IRB

Social/Behavioral Reviewer Sheet for Initial Submission (Convened IRB)

Social/Behavorial Board Member IRBNet Instructions

Training Sessions

August 30, 2011 - Social/Behavioral IRB Board Member Training on Expedited Reviews

March 21, 2011 - Regulatory Information and Reviewing as a Board Member

July 2010 - Scientific Review, Research Approval Criteria, Vulnerable Pop., IRB Actions, Unanticipated Problems, and ICH-GCP

July 22, 2010 - Conflict of Interest Policies Training presented by the COI Committee

May 6, 2010 - AAHRPP Training - Required Findings and Determinations presented by Jeffrey Cohen, HRP Associates, Inc.

June 26, 2009 - Tulane HRPO IRB Board Member Training Presentation

January 16, 2009 - An Overview of Basic IRB Regulations

Regulations

The Belmont Report

Regulations to follow when reviewing research:

For all Research (The Common Rule):

OHRP - CFR 45 Part 46 - Protection of Human Subjects
Subpart A - Basic DHHS Policy
Subpart B - Pregnant Women, Fetus, and Neonates
Subpart C - Prisoners
Subpart D - Children

For FDA Regulated Research:

FDA - CFR 21 Part 50 - Protection of Human Subjects
FDA - CFR 21 Part 56 - Institutional Review Boards

For Clinical Trials:

ICH Good Clinical Practice