Study Personnel Financial Conflicts of Interest and HS IRBs Review Guidance

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.

Financial COIs and human subjects research

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.

What if study team members have a COI management plan?

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:

Is the management plan relevant to the study?
COI management plans apply to a specific study when the managed entity sponsors the study, or when the study uses a technology owned or licensed by the managed entity. If a management plan is relevant to the study, also consider:
Which IRB is the reviewing IRB for the study?
If a UW HS IRB is the reviewing IRB, then UW COI policies apply to all study personnel for whom the UW serves as reviewing IRB. If an external IRB is the reviewing IRB, that IRB determines whether to apply additional COI-related conditions to personnel who have a management plan.
Does the managed person’s participation on the study comply with applicable COI policy?
- Under UW COI policy, if the reviewing IRB finds the study to be minimal risk:
  - The managed person may participate as key study personnel.
  - The managed person may NOT be involved in identifying or recruiting subjects, or in conducting the consent process.
  - If the study meets the definition of a clinical trial, you must designate a non-conflicted co-Investigator or other key personnel on the study with responsibility for acting as an independent reviewer of the data analysis.
  - The COI must be disclosed to study participants unless the reviewing IRB determines this would not be appropriate.
- Under UW COI policy, if the reviewing IRB finds the study to be more than minimal risk:
  - The managed person may NOT serve as key study personnel unless the COI Committee approves an exception to the Human Subjects Research section of the management plan. Even with an approved exception:
- External personnel for whom UW serves as the reviewing IRB must comply with their own institution’s COI policy as well as UW’s. If the external institution does not have a COI policy, contact the HS IRBs Office to discuss how to address this situation.
- UW personnel under an external IRB’s purview may have additional restrictions.

Communicating COI Information to the IRB

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:

In Q13.1.1, enter the name(s) of any study personnel who have management plans for any entities that sponsor the study or own/license a technology used on the study.
In Q13.1.2, upload any applicable management plans.

Q13.1 Outside Activities Report (OAR) and managed entities

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:

Campus policy that requires UW study personnel to submit an OAR annually and whenever new outside activities are undertaken. If you are requesting to cede IRB oversight to an external IRB, all UW study team members must have current OARs before the cede request can be approved.
Campus policy restricting an individual’s participation as key personnel on a human subjects research study if a managed entity sponsors the study OR the study uses a technology owned or licensed by a managed entity.

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 13.1.1.1.
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 13.1.2.1.
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.

COI-related information to provide in other ARROW sections

Study Team pages: Roles for study team members with relevant management plans should not include subject recruitment or consent.
Summary, Research Design pages:
- For any managed COIs that apply to the study, describe how the managed entity or entities are involved in the study and the measures the study will employ to minimize the impact of the COI on human subjects.
- If required by the management plan, identify the non-conflicted co-investigator or other key personnel with responsibility for acting as an independent reviewer of the data analysis.
- For any other financial COIs (i.e. “yes” answers to Q13.2, Q13.3, or Q13.4 on the ARROW COI page), describe the financial interest and the measures that the study will employ to minimize its impact on rights and welfare of human subjects.
Informed consent: Disclose study team member conflicts of interest in consent documents. Model language is available here.
Supplementary Information page: Upload approved management plan exception(s) on this page, along with the exception request memo(s).

Financial COIs and human subjects research

What if study team members have a COI management plan?

Communicating COI Information to the IRB

COI-related information to provide in other ARROW sections

See also