Guidelines for Evaluating Potential Conflicts of Interest
Approved April 21, 2006

Review criteria
Review criteria include: a) the research activities of an individual making an outside activities report, b) whether an activity is on-going or has ended, c) whether the activity is reportable on the Outside Activities Report, and d) the level of the financial interest associated with an activity. The following are the review criteria for these areas.

Research activities
For the COI Committee to review and manage outside activities, the individual must be a principal investigator, co-investigator, or key personnel on federally funded research or human subjects research subject to oversight by the UW-Madison. Specifically, one of the two following criteria must be true:

1. the individual’s position at the UW-Madison would allow him or her to affect the design, conduct, or reporting of federally-funded research, or
2. the individual is a principal investigator (PIs), co-investigator (Co-PIs), or other key personnel on human subjects protocols reviewed by UW-Madison IRBs and is (a) a UW-Madison employee, (b) a UW-Madison student, or (c) other project personnel, regardless of his or her relationship with UW-Madison, who has a personal financial interest in one or more business entities and whose situation is not reviewed and managed by another institution with respect to potential financial conflicts of interest related to the protocol in question.

The COI Committee may also review the outside activities of any investigator at the request of his or her Dean’s Office or a UW-Madison IRB and provide advice on managing the situation.

Time period
The COI Committee evaluates outside activities active at the time of committee review. However, UWS8 requires individuals to report all activities from the previous year on the Outside Activities Report. The COI Committee staff should classify activities that ended before the individual filed the Outside Activities Report as “no review.” Committee members should recommend that any activities completed at the time of review be classified “no review.”

Nonreportable activities
The COI Committee only reviews activities that are reportable on the annual Outside Activities Report. A detailed description of reportable and nonreportable activities is available on the Outside Activities Reporting Web site.

Level of financial interest
The COI Committee reviews activities that meet or exceed the following financial thresholds:

1. Compensation of $10,000 or more in a calendar year
2. An ownership interest in a publicly-traded company valued at $10,000 or more or equal to 5% or more of the equity in the company
3. Any ownership interest in a privately-held company
4. Any leadership position

The COI Committee staff assign outside activities that do not meet the criteria for review to “no review” status.

No management financial interests
Some outside activities meet the criteria for review, but the COI Committee may determine that these activities do not require management and assign them to “no management” status. Either the staff or committee members may assign activities to “no management” status. Such activities include:

1. Compensation from or ownership in a company that does not sell products or services (or is not working towards selling products or services) AND does not fund research (e.g. hospitals, law firms, insurance companies, etc.)
2. Compensation from or ownership in an agricultural business that markets only generic commodities (i.e. commodities that the industry generally markets) AND is not using proprietary techniques from UW research. Generic commodities include corn, potatoes, milk (BST, BST-free, or organic), hogs, organic strawberries, food-grade soybeans, goat milk, etc. The following are not generic commodities: genetically engineered milk for protein X, breeding stock with Y trait, or nursery plants with Z mutation.
3. Compensation for other employment (self or spouse) as long as there are no connections between UW research and the other position
4. Compensation for consulting or other activities from a government agency or another university
5. Compensation from a professional society
6. Compensation to a spouse for speaking or consulting, even if the spouse is employed in the same field
7. Royalties managed by other universities
8. Ownership interests in a press
9. Ownership in consulting businesses reviewed under COI Committee guidance on review of this interest
10. Leadership positions when the individual and his or her immediate family: a) do not receive compensation, b) do not hold an ownership interest, and c) have no other participation with the business entity (e.g. consulting, serving on a scientific advisory board, receiving funds for research)
    

Financial thresholds
The COI Committee tracks outside activities meeting the criteria for review and not falling into one of the “no management” types to a management level based on financial thresholds.

For individuals whose outside activity includes a combination of compensation, ownership, and leadership, the management level is determined for each type of financial interest and the highest level is given to the relationship. For example, a researcher receiving over $20,000 for consulting and holding stock valued at $15,000 with one publicly-traded company would receive a full management plan for the relationship with that company.

Staff may assign “limited management” status to activities meeting the indicated criteria. Committee members make the initial recommendation that the committee assign an activity to “full management” status.

	No review	No management	Limited management	Full management
Compensation	<$10,000/year	See “No management financial interests.”	$10,000- <$20,000	>=$20,000
Ownership interest in a publicly-traded company	<$10,000 AND <5% equity	See “No management financial interests.”	$10,000 - <$20,000 AND <5% equity	>=$20,000 OR >=5% equity
Ownership interest in a privately-held company	No ownership interest	See “No management financial interests.”		Most ownership interests
Leadership position**	No leadership position	Leadership positions without financial interests or other participation		All other leadership positions

**Leadership positions are defined as positions with fiduciary responsibility, including senior managers (presidents, vice presidents, etc.) and members of boards of directors. Scientific advisory board membership is not a leadership position.

Determining nexus
While assessing the need for management, the COI committee considers whether an outside activity or financial interest has a “nexus” with the individual’s research activities at the UW-Madison.

An outside activity has a nexus with an individual’s research activities if the outside activity arises from or relies upon the academic expertise that qualifies that individual to participate in federally funded research or human subjects research. The potential for conflict with an outside activity or financial interest is strengthened by other relationships between the individual or his or her immediate family and the business entity associated with the financial interest or outside activity.

Management condition summary
The COI Committee uses standardized management plans. The following is a summary of the management provisions at the different levels. Standard management plans are posted on the COI Committee’s Web site.

Management provisions	No review	No management	Limited management	Full management
Publications and Presentations	NA**	NA	Yes	Yes
Interaction with Students and Staff	NA	NA	Yes	Yes
Reporting of Outside Activities	NA	NA	Yes	Yes
Outside Activities Agreement	NA	NA	Yes	Yes
Research Support from the Entity or Entities	NA	NA	No	Yes
Use of University Facilities and Services	NA	NA	No	Yes
Purchases	NA	NA	No	Yes
Annual Review	NA	NA	No	Yes
Human Subjects Research***	NA	Policy notice	Yes, Disclosure of financial interests to research participants	Yes, Restrictions on research roles in particular circumstances

**Not applicable.

***Included for human subjects researchers only.

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