Summary of New and Revised NIH Requirements for Conflict of Interest (COI) on PHS Awards1, 2

Requirements for PHS Investigators3 / Frequency / Required for Proposal submission / Required forAward acceptance
Annual Report of external interests
*revised* threshold lowered from 10K to 5K
*new* must report all relationships potentially related to university duties
*revised* fewer external entities are excluded from reporting / Annually
Within 30 days of being appointed to a position that requires reporting
ORIA sends out annual notification / Yes
-ORIA tracks compliance
-OSP cannot send proposal unless all investigatorshave completed the annual report / Yes
Review must be complete
Management plan must be in place if necessary
*new* fCOI training
Available online at( / Once every four years
ORIA will track and send reminder / No but recommended so awards are not delayed / Yes
*new* Travel report
-All travel that is related to university duties, whether external entity reimburses investigator or pays for directly.
-Online report available at(
-Exclusions apply- see report form / -Retrospective: Travel within prior 12 months of award date
-Ongoing:Within 30 days of travel during PHS award period
-Investigator must track and report / No but recommended so awards are not delayed / Yes
*new* Proposal/Award specific report of financial interests
-update relationships since annual report and identification of relationship(s), if any, to proposed project
-If fCOI related to the specific project is identified, management plan if needed PRIOR TO accepting award
-Online report available at( / -At the time of proposal submission (recommended) and before award acceptance (required)
-Investigators must report and agree to terms of the management plan (if needed) /
  • No but recommended so awards are not delayed
  • Required before pre-award spending request is reviewed.
/ Yes
Award cannot be accepted until full review of report is complete, and if needed, a management plan is implemented and reported to the NIH.
*new* Resolution of any fCOI, implementation of management plan and reporting to NIH before expenditure of funds
-Pre-spending is allowed if (1) no investigators on the award have a SFI related to the award, or (2) if any investigator has an SFI, a review is completed and if needed, management plan implemented. / -Prior to award acceptance
-If pre-spending occurs on an award, funding agency may elect to disallow expenses for the period of time during which afCOI is not managed. / No / Yes
Award cannot be accepted until full review of report is complete, and if needed, a management plan is implemented and reported to the NIH.
*new* Availability of public information about identified fCOI related to a PHS award
- if an fCOI related to a PHS project is identified and reported to NIH, Cornell must respond within 5 days to a public request for information on the fCOI / -When a valid request received by the COI office, from a member of the public.
-Public request form available at / No / No
*new” Subrecipient compliance requirements:
- a written agreement must be in place with the subrecipient that they are in compliance with the new NIH rules
- prime must report to NIH, all COIs identified by sub recipient on the award, and is responsible for ensuring compliance / -When subrecipient is requested- new Commitment form must be signed.
-If subrecipient does not have own policy, Cornell must decide if it will assume responsibility for compliance for the sub
-Revised contractual terms
-OSP and ORIA must track reporting / No but recommended so that Cornell can determine ifsubrecipient is eligible from a COI perspective, and guide subrecipient to get compliant if needed. / Yes
*new* Increased reporting requirement to PHS agency
If an fCOI related to a PHS award is identified, reporting now includes nature and dollar range of SFI, description of conflict, key terms of the management plan / -Within 60 days after afCOI related to a PHS award is identified. ORIA will complete reporting as needed / No / Yes
*new* requirement for mitigation plan and retrospective reporting
If Cornell determines that work was conducted on a PHS award during a timeframe when COI was not identified or managed, or if the investigator was non compliant with the management plan, it must conduct a retrospective review, implement a mitigation plan to ensure that research was not biased during that period and report to the PHS agency. / -If there is unmanaged COI, or non-compliance with management plan / No / No

1 For details of each of these requirements, please go to

2. PHS Agencies are:

(1) the Agency for Healthcare Research and Quality (AHRQ),

(2) the Agency for Toxic Substances and Disease Registry (ATSDR),

(3) the Centers for Disease Control and Prevention (CDC)

(4) the Food and Drug Administration (FDA),

(5) the Health Resources and Services Administration (HRSA),

(6) the Indian Health Service (IHS),

(7) the National Institutes of Health (NIH), and

(8) the Substance Abuse and Mental Health Services Administration (SAMHSA).

3. PI, Co-PI and any personnel named on the proposal/award. Excluded: Students mentioned by name on proposals but not in the role of PI, Co-PI or key personnel need not report.

1 | Page