New conflict-of-interest rules take effect Aug. 24

Mandated federal conflict-of-interest rules will tighten considerably on Aug. 24, affecting thousands of faculty, staff and some students on campus.

“We are getting the word out across campus that investigators – anybody who is responsible for the design, conduct or reporting of research – needs to know and follow these new regulations,” says Matt Richter, a conflict-of-interest program specialist in the Office of Research Policy at the Graduate School.

The new rules apply to anyone with federal grants, and also to others who perform human-subjects research, Richter says.

 “We are talking about almost anybody listed on a grant application. About 10,000 people on campus already file an outside activity report (OAR), and at least that many will be filing under the new, enhanced requirements,” he says.

As before, the OAR is the starting place for all reporting.

One key change concerns timing: Within 30 days of starting a new financial relationship, like a stock purchase, consulting agreement, or the formation of a legal entity such as a partnership or corporation, investigators must report that financial interest via the electronic OAR process.

While anyone with a UW–Madison appointment or federal funding, or on a human-subjects protocol, must file an OAR, the threshold for conflict-of-interest review by the Graduate School has been reduced from $10,000 to $5,000 corresponding to the changes in federal regulations.

Grantees who are deemed to have a conflict will receive “management” concerning data security and possible restrictions on grant-funded activities. 

Special requirements apply to recipients of funding from the Public Health Service, which includes the National Institutes of Health:

• Mandatory reporting of any travel if expenses are reimbursed by an outside entity that is not a university, government agency, medical research center, teaching hospital or research institute; and
• Financial conflicts of interests managed by the UW (but not the entire OAR report) will be publicly available according to new federal regulations.

Training on federal conflict-of-interest regulations is required before engaging in research, and at least every four years thereafter, for all federally funded and human subjects investigators.

“We want to make these federally mandated changes as painless as possible for the campus,” says Richter.

“All UW faculty and most academic staff will still have to file an annual OAR, but there are significant changes in what you must disclose, and particularly when things must be disclosed. Keep in mind the 30-day deadline for reporting a new or changed financial relationship,” he says.

More information on the new rules can be found here.