8.6 Study Hold, Suspension, and Termination

Last Revised: 1/20/2023

1.0 Purpose

The purpose of this policy is to describe the process for study holds, study suspensions, and study termination.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Study Holds by PI, Sponsor, DSMB, FDA or Other Funding Agency


5.0 Suspension of IRB Approval


6.0 Termination of IRB Approval


7.0 Organization Directed Termination of IRB Approval


8.0 Reporting Suspensions and Terminations to OHRP, Department and Agency Heads, and FDA

Suspensions and terminations are reported in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved 4/4/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 1/20/2023 - Simplified Purpose statement; revised section 2.0 to reflect specific authorities granted in the body of the policy; removed reference to appeals panel and substituted option to seek consultation with the IRB or any other persons (section 7.8); stylistic changes.


Revision #8
Created 24 October 2019 21:45:35 by Autumn M Eberly
Updated 17 April 2025 16:12:12 by Robert A Lewis