Key Changes

Other updates to TSRI’s Policy and procedures as of August 24, 2012 include:

Lower monetary threshold for significant financial interests:  The minimum threshold for reporting a SFI related to institutional responsibilities is any cash, equity, and/or royalty compensation from an outside business, or income from investments other than mutual funds and retirement accounts.  Although PHS regulations have differing thresholds for specific categories of SFI, TSRI has required the same minimum threshold of greater than zero value for any SFI to ensure compliance and consistency of disclosure.

Disclosure of externally funded reimbursed or sponsored travel: TSRI has developed on-line reporting for covered travel available at https://travel.scripps.edu.  This disclosure requirement does not apply to funding provided to the investigator via TSRI (for example, as part of sponsored research projects, paid from departmental discretionary or gift funds), or from an institution of higher education, a federal/state/local government, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

Mandatory FCOI training:  TSRI has developed an on-line FCOI tutorial for PHS-funded investigators available at http://coitraining.scripps.edu on the revised regulations and TSRI Policy.  All PHS-funded investigators must complete online FCOI training prior to the expenditure of funds on any newly funded projects, including noncompeting continuation awards.  Training must be completed at least every four years.  Although PHS Notice of Awards received prior to August 24, 2012, are not subject to these new requirements until the noncompeting continuation award, TSRI is requiring that on-line training be completed before the next award.  More importantly, because research staff may cycle on and off awards at varying times, TSRI is requiring that ALL research staff take the on-line FCOI tutorial to ensure compliance and consistency.

FCOI information made accessible to the public:  The new regulations require public transparency of investigators’ FCOI management plans either by a publicly accessible website or by a written response within five business days to a request for an institution’s financial conflict of interest policy.  This includes providing certain information regarding any key personnel whose significant financial interests are related to PHS-funded research.  Given the short turnaround time allowed for responding to these requests, TSRI will opt to publicly post the required reporting elements of an investigator’s FCOI management plan via this FCOI website after August 24, 2012.

As indicated above, TSRI has developed and implemented the electronic interactive reporting systems to reduce the administrative burden for faculty, research staff, and support staff, for disclosing FCOI, including travel, related to institutional responsibilities, for FCOI training.