Version
6.4
Date Updated
Friday, April 27, 2012
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 131
AAHRPP Elements: I.1.B., I.5.D., III.2.D


POLICY


For reports involving changes to the protocol made without IRB approval to eliminate apparent immediate harm to subjects of changes, the IRB also decides whether the change was necessary to eliminate apparent immediate hazards to the subject, and whether there was insufficient time for IRB review.  If these conditions are both false, the incident represents a protocol violation.

  1. Federal regulations [45 CFR 46 .103(b) (5); 21 CFR 56.108(b), and 38 CFR 16.103(b) (5)] require each institution to have "…written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) ... any serious or continuing non-compliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval.”  This document describes UIC's policy and procedures for addressing complaints and allegations of potential non-compliance with Federal and State regulations, with University policies regarding research, and with the requirements of the HSPP.
  2. It is UIC policy that investigators, research team members, faculty and staff must report any allegations or observations of apparent serious or continuing non-compliance in human subject research.  Complaints or allegations of Non-compliance may be directed to the OPRS, IRB, OVCR Associate Director for Research Compliance, HPA or IO.  Research subjects and individuals not directly involved with conducting or overseeing the research are also encouraged to report suspected non-compliance. 
  3. This policy is applicable to all human subject research activities of UIC faculty, staff, students, or others within the jurisdiction of the UIC HSPP.  The policy extends to adjunct and/or volunteer faculty when their appointment is listed among the investigator's credentials in study documents.