Public trust is essential to the scientific endeavor. It is therefore paramount that research conducted at NIU be unbiased and of the highest integrity. Toward this end, and in line with changes to NIH regulations related to financial conflict of interest, the NIU Office of Research Integrity (ORI) has revised its Research Conflict of Interest Policy. The purpose of the policy is to better ensure that financial conflicts of interest to do affect the conduct of research performed at NIU.
The new policy has specific provisions that pertain to research funded by the Public Health Service (PHS) and the National Institutes of Health (NIH). Key changes are briefly described below. However, all investigators are encouraged to review the regulations, the new NIU Research Conflict of Interest Policy, and to complete the Financial Conflict of Interest Disclosure Form.
Responsibilities for PIs: PIs will be ultimately responsible for ensuring that all personnel supported by or working on a PHS or NIH grant are aware of, and comply with these new requirements. This includes faculty, staff, post-docs, and students. The revised language of the policy defines investigators (those covered by the regulations as: the principal investigator (PI), co-investigator (Co-I) and any other person(s) (e.g., post-doctoral fellows, senior scientists, graduate students) responsible for the administration, design, conduct, or reporting of sponsored research.
This definition is not limited to individuals titled or budgeted as “investigator”. Any individual/relevant personnel may be considered investigators (and therefore responsible for completing NIU Financial Relationship Disclosure Forms) if the PI or relevant supervisor determines that the individual/personnel should be considered an investigator.
For disclosure purposes, investigator(s) completing the form also includes immediate family members: his/her spouse, domestic partner, and dependent children.
Different Monetary FCOI Threshold: A significant change in the regulation for PHS-supported personnel is a reduction in the monetary amount considered to be a “significant” financial interest for PHS-supported researchers. The current $10,000 threshold will be reduced to $5,000 received from a given entity within a twelve month period. Under the new regulations, receipt of $5,000 or more from a research sponsor in consulting income, honoraria, stock or equity ownership, or personal payment of travel expenses by a sponsor will now be considered “Significant,” and will require formal disclosure of the supported person’s interest to NIU and HHS, and require the development of a FCOI management plan.
Expanded Financial Interests Sources and Disclosure Requirements: The new regulation for PHS-supported personnel now covers financial interests received from any source (with the exception of federal and state agencies, U.S. colleges and universities, and academic medical centers), which may relate to all professional activities of an investigator – not just his/her research-related activities. The new regulation also requires that PIs, co-investigators and key research personnel update their annual COI disclosures within thirty days of acquiring a new significant financial interest.
New Travel Disclosures: PHS and NIH-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 – not just research. 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. Disclosures should be made in the form of an email to David Stone, Associate Vice President for Research (email@example.com).
New FCOI Training Requirements: The new PHS/NIH regulations include new FCOI training requirements. All personnel currently supported by PHS or NIH funds - investigators, co-investigators and key research personnel – are required to complete formal FCOI training. The Office of Research Integrity is currently in the process of scheduling these trainings. PHS and NIH-funded investigators will then be expected to repeat the training at least once every four years. For these purposes, ORI will offer regularly scheduled training sessions (Once dates have been determined they will be posted on this page). New personnel must take COI training within 30 days of PHS or NIH support.
New Public Accessibility Requirements for FCOI Information: For PHS and NIH-supported activities, the revised regulations have a significant public accessibility requirement. When appropriate, NIU will make certain information concerning identified FCOI publically available. The information required will include: the name of the faculty member (or key research personnel), his/her position with respect to the research, the nature of the significant financial interest, and the range of the financial interest.
Timeline: The new regulations take effect on the 24th of August 2012. All personnel supported by PHS and NIH funds will be required to:
We have sent individual email notification to all personnel our records indicate are PHS/NIH supported. If you think these regulations currently apply to you and have not been contacted, or if you have any further questions, please contact David Stone, Associate Vice President for Research (firstname.lastname@example.org or 753-9282).
(Sources: http://grants.nih.gov/grants/policy/coi/ and Kansas State University).