Version date: 3/7/2019
This document describes the information University of Wisconsin Madison (UW) study teams should provide to their reviewing IRB regarding financial conflicts of interest (COIs) and how financial COIs affect IRB review of human subjects research applications.
Federal regulations and UW-Madison / UW System policies govern outside activities reporting and conflict of interest determinations. The UW-Madison COI Committee uses these regulations and policies to determine whether UW personnel have significant financial COIs that require management. Among other requirements, COI management plans restrict the managed person’s participation in human subjects research related to the managed entity.
IRBs have the responsibility and authority to evaluate how financial COIs affect specific human subjects research projects. An IRB cannot overturn any conditions a COI Committee or other entity designated to assess and manage COIs places on investigators. An IRB may, however, impose conditions stricter than those imposed by the COI Committee (or equivalent entity) if the IRB determines that additional measures are needed to protect the rights and welfare of research participants due to an actual or potential financial COI.
When a UW Health Sciences IRB (HS IRB) is the reviewing IRB for a study, the HS IRB considers financial COIs for all study team members under its purview (UW personnel and any external personnel for whom the UW is serving as reviewing IRB). When the reviewing IRB is external (e.g. an independent IRB, the NCI CIRB, or another institution’s IRB), the UW must provide current information about study personnel COIs to the reviewing IRB.
Before submitting a new human subjects research application for IRB review, and for all ongoing human subjects research studies, study teams should consider the following if any personnel are assigned a COI management plan:
Study teams use the ARROW application’s COI section to provide information about study team member COIs. Study teams must provide accurate COI information at initial review and report any changes in study team members’ COI status while the study is ongoing.
The following sections provide guidance for each COI-related question in ARROW and additional information the IRB will need for adequate review.
Note for ARROW applications approved by an HS IRB prior to mid-2017: For these applications, study teams need to enter COI information manually:
ARROW applications created after mid-2017 automatically display certain information from the UW-Madison COI database and hide or show additional questions depending on study team responses. Q13.1 on the COI page lists any study team members who have not completed an OAR for the current calendar year. Q13.1 also identifies any study team members who have COI management plans and all their managed entities.
Use the pre-populated information in Q13.1 to ensure that all study personnel are in compliance with:
This table below is intended to assist study teams in completing the Conflict of Interest (COI) page in ARROW:
|13.1.1 Do any of the managed entities sponsor the study?||Select “yes” for this question if any of the managed entities listed in 13.1 provides funding for the research study.
Select the relevant entity or entities in 126.96.36.199.
|13.1.2 Do any of the managed entities own or license a technology being used in the study (including any agent, device, or software)?||Select “yes” for this question if the study uses any technology owned or licensed by any of the managed entities listed in 13.1.
Select the relevant entity or entities in 188.8.131.52.
|13.1.3 If any of the management plans identified in 13.1 are not relevant to the study, please explain why.||No response is required if both 13.1.1 and 13.1.2 are "no."
If there are multiple managed entities, some of which are relevant to the study and others which are not, please use this box to explain why only some management plans apply and not others.
|13.2 Do any study team members involved in the design or conduct of the research (including their spouses and dependent children) own intellectual property that will be used in the study or project?||Select "yes" if any study team members involved in the design or conduct of the research (including their spouses and dependent children) own intellectual property that will be used in the study or project.
Then list the relevant people and the companies or business entities in 13.2.1.
|13.3 Besides the sponsor(s) of this project or entities listed above, do any study team members have a fiduciary or financial relationship with entities that will be involved in this study or that may be significantly affected by it?||Select "yes" if any study team members have a fiduciary or financial relationship with entities other than the study sponsor or entities listed in 13.1 that will be involved in the study or may be significantly affected by it.
Then name the entity and describe its involvement on the study.
|13.4 Do any of the study team receive any incentives for recruiting human subjects or any other purpose directly related to the study or project?||Select "yes" if any study team members receive incentives for recruiting human subjects or for any other purpose directly related to the study or project. See Recruitment of Research Participants guidance for prohibited incentives. Then describe the nature of the incentive in 13.4.1.|
OVCRGE resources, including:
Frequently Asked Questions about Conflict of Interest Conflict of Interest Policy Outside Activities Reporting