Summary of Regulatory Changes: Key Changes
Blue indicates change from 1995 regulations

  • Requirement that institution determines if a disclosed financial interest is related to the employee’s institutional responsibilities (change from study responsibilities only)
    • OUHSC PHS Investigator discloses all Significant Financial Interests (SFIs)
  • PHS definition: de minimis threshold for disclosure is lowered (to $5K), includes any equity, and scope of outside compensation subject to disclosure is broadened (now includes non-profit organizations)
  • Disclosure for financial interests in the previous 12 months (new timetable)
  • Travel, reimbursed or covered, must be disclosed to institution regardless of dollar amount (new)
  • Paid authorship, royalties, copyrights, textbooks, must be disclosed to institution (new)
  • Mandatory training requirement every 4 years for investigators (new)
  • Timely disclosure of any changes in significant financial interest must occur within 30 days (new)