2.7 Continuing Review of Research

Last Revised 1/12/2024

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for continuing review of approved research


2.0 Policy

It is the policy of the Organization that:


3.0 Continuing Review Frequency


4.0 Criteria for Review


5.0 Investigator Responsibilities


6.0 ORA/IRB Responsibilities


DOCUMENT HISTORY:

 Written: 2/6/2018 (Approved: 2/6/2018) - original author not recorded

 Revised: 9/7/2018 - revision not documented

 Revised: 1/29/2021 - Clarified “procedures that subjects would undergo as part of clinical care” per (45 CFR 46.109(f)(iii)(B)) (section 3.2.3); clarified which IRBs can perform continuing review (sections 5.2 thru 5.5); various minor clarifications and corrections.

 Revised: 1/30/2023 – Revised to stress distinction between FDA regulated and non-regulated research; clarified process for submission of demographic information for research that is exempt, or for which continuing review is no longer required (section 6.1.4); deleted requirement that convened IRB be notified of Request to Continue Treatment for Enrolled Subjects on Approval Expired Studies; changed “20 working days” to “30 calendar days”; reformatted; various minor clarifications and corrections.

 Revised: 5/17/2023 - Corrected 6.14 to reflect accurate form name, corrected typo of 30 days to 20 days in 6.14.1.

 Revised: 1/12/2024 - Revised section 4.0 to clarify responsibilities of expedited reviewer; added section 6.1.3 to clarify research approved by expedited review prior to January 2019 may undergo expedited continuing review; revised section 6.7 to clarify materials available to, and expected to be reviewed by, the convened IRB or expedited reviewer; other minor stylistic changes.


Revision #14
Created 24 October 2019 21:27:49 by Autumn M Eberly
Updated 17 April 2025 15:47:50 by Robert A Lewis