This section of the ARROW COI page pulls data from the UW COI database and updates automatically throughout the life of a study.  

The OAR section lists study team members who have not submitted a UW OAR in the current calendar year. This information is advisory for the study team. It does not affect IRB review and requires no comment from IRB staff.  

The managed entities section lists study team members who have COI management plans for any outside entity. Only managed entities related to the research require IRB consideration.

Entities are related to the research if the study team answers “yes” to Q1 (a managed entity sponsors the study) and/or to Q2 (a managed entity owns or licenses a technology used on the study). Per HRP-001 Definitions SOP, a financial interest is also related to the research if an entity is a competitor of a study sponsor or the product or service being tested. 

Q3 allows a study team to explain why an apparent conflict does not relate to the study, or, if there are multiple management plans listed, to specify which ones do not relate to the research. If Q1 and Q2 are both “no,” Q3 may be left blank. 

Note: If no study team members have managed entities, the questions above do not appear, and Q1 is “Intellectual Property.” See section 4 below. 

ARROW applications approved prior to 2017 do not pull data from the COI database. Study teams must identify management plans relevant to the study. 

If UW is the reviewing IRB, external personnel with a related COI must provide a management plan. If UW is a relying institution, study teams are responsible for reporting any relevant managed COI to the reviewing IRB. See HRP-055. 

Exceptions (if applicable) need to be uploaded on the ARROW Supplemental Information page. All UW management plans use the same template, and therefore do not need to be uploaded to the application.

Minimal risk studies 

Review study materials to confirm that conditions in UW COI management plan section VI.C are met: 

1. Consent documents disclose the COI, unless the IRB does not require such disclosure. The consent template includes model language. 
2. Managed individual(s) do not participate in identification and recruitment of subjects or obtaining informed consent. 
3. If the study meets the management plan’s definition of a clinical trial, the study team designates a non-conflicted co-investigator or other key personnel on the study with responsibility for acting as an independent reviewer of the data analysis. 

If reviewing a COI for external personnel, confirm that requirements in the relying institution’s management plan are met. If requirements imposed by the relying institution appear less stringent than the UW’s, request comment from the IRB (or an IRB Director [IRBD] for non-committee items) regarding the need for additional limitations consistent with UW COI policy. 

Refer to HRP-055 for additional IRB review considerations.  

Identify the financial COI, whether the managed individual(s)’ activities on the study comply with the management plan, and any questions or recommended modifications in the Pre-review Checklist (HRP-401) or Non-Committee Checklist (HRP-402). 

Document in the minutes that the managed study team member(s) are in compliance with COI management plan requirements for minimal risk studies, or specify the IRB-requested modifications needed for compliance with the management plan. Use example minutes language from the relevant minutes guidance document. 

More than minimal risk studies 

Individuals with relevant conflicts of interest cannot serve as PI, co-I, or key personnel on more than minimal risk studies absent an exception. If the COI Committee has approved an exception to the management plan, review the exception request memorandum, exception approval notice, and study materials to confirm: 

1. The managed individual’s role as described in application and/or protocol is consistent with the conditions specified in the exception request memorandum. 
2. The application and/or protocol describe measures for minimizing bias consistent with those specified in the exception request. 
3. Consent documents disclose the COI, unless the IRB does not require such disclosure. The consent template includes model language.
4. Refer to HRP-055 for additional IRB review considerations.  

If the COI Committee has not yet approved an exception to the management plan, advise the study team during pre-review that the IRB cannot approve the managed individual’s participation on the study team without an approved exception. The study team may postpone IRB review until after the COI Committee has made a determination about the exception request, or the study team may remove the managed individual from the study team pending COI Committee approval of an exception. Direct the study team to consult COI webpages and COI staff for information about exception requests. 

If UW is the reviewing IRB for external personnel with a related COI, review their management plan per HRP-055 and request IRB comment about the acceptability of including the managed individual(s) on the study team.  

Identify the financial COI, whether the managed individual(s)’ activities on the study comply with the management plan, and any questions or recommended modifications in the Pre-review Checklist (HRP-401) or Non-Committee Checklist (HRP-402). 

Document in the minutes that the managed study team member(s) are in compliance with COI management plan requirements for minimal risk studies, or specify the IRB-requested modifications needed for compliance with the management plan. Use example minutes language from the relevant minutes guidance document. 

The ARROW COI page asks about ownership of intellectual property (IP) used in the study and about fiduciary or financial relationship with entities that will be involved in this study or that may be significantly affected by it. If the study team responds “yes” to either question, a prompt for additional information will pop up in the application. 

1. Ensure that the response clearly describes the nature of the IP or entity relationship and how the study may affect it.  
   Note that royalty income from intellectual property assigned to the Wisconsin Alumni Research Foundation (WARF) is not considered a significant financial interest under campus COI policy. 
2. Consult with COI staff to determine what, if any, COI management requirements apply in this situation. 
3. In HRP-401 Notes or -402 Additional Information, describe the potential conflict and any added protections or disclosures recommended to safeguard subjects’ rights or welfare. Request IRB determination about measures to mitigate potential conflict, such as disclosure in the consent form. 
4. In the COI section of the minutes or in HRP-402, document the IRB’s determination. 

The ARROW COI page asks if study team members receive any financial incentives for recruiting subjects or for any other purpose directly related to the study. If the study team answers “yes,” a prompt for additional information will pop up in the application. 

1. Payment to professionals in exchange for referring potential participants (“finder’s fees”) and payment tied to the rate or timing of enrollment (“bonus payments”) is prohibited. See Investigator Manual General Recruitment Guidelines.  
2. See campus Conflicts of Interest policy Payments from Business Entities section for details on permissible payments for subject enrollment or referral.  
3. In HRP-401, describe the payments and whether they are allowable under campus policy. For allowable payments, request IRB determination about the need for any added protections or disclosures to safeguard subjects’ rights or welfare.  
4. In the COI section of the minutes, document the IRB’s determination.