Conflicts of interest in research may occur when financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher. Rush University and the Office of Research Compliance
strive to ensure a transparent research process by requiring a disclosure of financial interests.
The new regulations maintain the general framework of the 1995 regulations, but make some significant changes. In particular, the new regulations:
- Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
- Lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000. Also, a $0 threshold for disclosure of equity in a non-publicly traded company.
- Disclosure of externally-funded travel reimbursements.
- Require institutions to report to the PHS Awarding Component additional information on identified financial conflicts of interest and how they are being managed.
- Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.
- Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.
Disclosure of Financial Interests
Disclosure of financial interest in research can be made by accessing the Rush Research Portal (RRP). Investigators can make their disclosures at anytime and must update within 30 days of a change in their financial interest. Annually, Corporate and Research Compliance administer the annual COI Survey based on the fiscal year. For Institutional Review Board (IRB) human subject research, a Protocol Specific Disclosure must be completed. In either instance, the individual with the actual or potential COI remains responsible for updating his/her information on a timely basis, should new information arise.
Disclosure of Funded Travel
PHS-supported investigators, co-investigators, and key research personnel will be required to disclose the occurrence of any reimbursed travel or sponsored travel related to his/her institutional responsibilities. The only reimbursed travel that is excluded from disclosure is that which is sponsored by a federal, state or local government agency or by a U.S. institution of higher education (an accredited college or university). This disclosure must be filed within 30 days of the travel, and includes:
- the purpose of the trip,
- the sponsor/organizer,
- the destination and
- the duration of the travel.
Mandatory Training Requirements
All PHS-funded “investigators” must complete FCOI training prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every 4 (four) years. Current PHS awards are not subject to these new requirements until the noncompeting continuation award. However, we encourage investigators to take the training now to fulfill this mandatory requirement.
The definition of an “investigator” includes the Principal Investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research.
To be compliant with the federal requirements, researchers must complete mandatory training in two ways:
- Online training is available for Rush researchers from the NIH and PHS Investigators can access the online tutorial at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the tutorial, each Investigator will generate a Certificate of Completion and
a. send a copy of the Certificate to Diane Bird
in the Office of Research Compliance (ORC)
2. The Office of Research Compliance will provide training on a case by
case basis. To set up an appointment please contact:
Investigators who have not completed training and are the recipient of a new or renewed award after August 24, 2012 will not be able to participate in PHS funded research until the training has been completed.
FCOI Public Disclosures
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, Rush has opted to publicly post the required reporting elements of an investigator’s FCOI management plan via this FCOI website after August 24, 2012.
Managed Financial Conflicts of Interest (FCOI) with Research Funded by the Public Health Service (PHS) can be viewed here.