USU is implementing a new set of procedures responsive to recently issued regulations from the Department of Health and Human Services (DHHS).
The implementation of the new regulations can be seen as a result of recent incidents like the one in Georgia where a psychologist failed to report more than a million dollars to the federal agency that funds most of his work. USU will be tracking disclosures of outside financial interests by investigators who receive funds from DHHS separately from other disclosures.
“I call it the slippery slope to regulation,” said Russ Price, USU’s federal compliance manager. “The new regulations introduce a significantly higher level of oversight, but apply only to DHHS-sponsored researchers.”
According to Price, the transition to these new requirements has been in the works for over a year. The most important new requirements being implemented include:
- Disclosure of all significant financial interests that exceed $5,000 are now required. In the past the limit has been $10,000, and only financial interests that related to USU duties were reportable.
- Disclosures of the financial interests must be made at the time the proposal is submitted, rather than when charges to the agency are first incurred.
- The institution will make more information available to funding agencies about financial interests that are determined to represent conflicts of interest, including how those conflicts are being managed.
- Certain information about conflicts of interest must be accessible to the public. USU must be able to provide this information to a requester within five days.
- Investigators who receive PHS funding must be trained on a regular basis regarding the regulation and USU’s conflict of interest policies and procedures.
“We are sensitive to the significant time researchers are spending on administrative tasks already,” said Mark McLellan, vice president for research and dean of the School of Graduate Studies. “Until more of the federal complex adopts the approach that DHHS has implemented, we will continue to run our Conflict of Interest disclosures for DHHS-funded and non-DHHS funded investigators on parallel tracks.”
– Russ Price