Reporting to Institutional Officials and Regulatory Agencies- POL024   

 

 

Abstract: 
This policy describes the IRB's obligation to report certain determinations to UAB officials, regulatory and other federal regulatory agencies, and sponsors.

Effective Date: 3/30/2007

 

Review/Revised Date: 7/5/2013

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 
   
 
 

POLICY STATEMENT

It is UAB policy that UAB officials and regulatory agencies (including sponsors) will receive reports of the following IRB determinations:
  • Non-compliance determined to be serious or continuing non-compliance;
  • Problems determined to be unanticipated problems involving risks to subjects or others in accordance with POL006 and PRO106; and
  • Suspensions or terminations of IRB approvals.
The IRB Chair (or designee) and the OIRB Director (or designee) will report all of the above determinations in writing to UAB’s Institutional Official within 10 working days of the decision.

The report will contain the following information:
  • The name of the institution conducting the research if other than UAB;
  • Title of the research project and/or grant proposal;
  • The name of the sponsor and sponsor’s contact information for the protocol if the sponsor is other than UAB;
  • Name of the principal investigator on the protocol;
  • Number of the research project assigned by the IRB and the ID number of any applicable federal award(s) (grant, contract number, or cooperative agreement) or sponsor protocol(s);
  • A detailed description of the problem and the reasons for the determination;
  • Corrective actions taken or planned to address the problem; and
  • Any supplementary materials having relevance to the decision.
The IRB will send a copy of the letter notifying the Investigator of any of the above determinations to the principal investigator’s departmental chair or other institutional official, as appropriate.

When the IRB makes a determination of suspension or termination of IRB approval, the IRB Chair (or designee) will notify the Institutional Official immediately.

Following receipt of a report of one of the above determinations, the UAB Institutional Official within 10 working days will notify, in accordance with OHRP guidance on reporting incidents (http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html), the following entities or individuals:
  • OHRP, if applicable
  • FDA, if applicable;
  • DoD funding agency component, if applicable;
  • DOE Project Officer, if applicable;
  • Protocol sponsor, if applicable; and
Other appropriate UAB personnel.