1.25 Financial Conflicts of Interest

1.0 Purpose

The purpose of this policy is to describe the Organization’s procedures for identification, management, and minimization or elimination of financial conflict of interest (COI) of responsible personnel, senior administrators, and the Organization itself that could influence the conduct of research or the integrity of the HRPP.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Procedures for Disclosure of Potential COI


5.0 COI Management Plan


6.0 Review of COI Management Plans


7.0 Management of COI in Research Conducted by Subgrantees, Contractors, and Collaborators


8.0 Documentation of COI Management


9.0 Management of Organizational Financial COI


DOCUMENT HISTORY:

 Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded (previous policy #3.12)

 Revised: 6/13/2018 - revision not documented

 Revised 12/8/2022 - Clarified that the ORA is only responsible for assuring the organization has adequate policies and procedures to ensure responsible personnel are appropriately trained (as opposed to the actual training); revised definition of covered persons to match that in HRPP 1.7; clarified definition of Organizational COI; delete specific FDA requirements under 21 CFR 54.4; clarified that, for multi-institution research where the UNMC IRB is the reviewing IRB, the COI Management plan may be generated by the relying institution; clarified that management plan may (but not “must”) include disclosure; clarified process for management plans associated with non-significant FCOI; deleted list of possible management options by COIC; clarified process for expedited review as opposed to convened IRB review; clarified process for review of management plans when organization relies on an external IRB; added requirement that initial review of non-exempt human subject research for which an organizational COI has been identified will be performed by the convened IRB; added “senior organizational officials” to definition of Organizational COI.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board voted and approved: 12/27/2022, 1/13/2023, 1/19/2023, 2/2/2023

 Revised: 6/1/2023 – added examples of possible management options by COIC (section 5.2) as per AAHRPP {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised:8/31/2023 - updated CHMC COI policy name from #ADM100 to ID 13201440. {Robert Lewis - IRB Assoc}

 Revised 1/22/2024 – clarified that an interest “related to the research” is one the COI Officer, COI committee, or the IRB reasonably determines could directly and significantly affect the design, conduct or reporting of research (section 3.4). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #11
Created 21 October 2019 21:52:25 by Autumn M Eberly
Updated 25 January 2024 15:45:25 by Robert A Lewis