COI Requirements for NIH (PHS) Funded Researchers

If you receive funds from NIH or another Public Health Service agency, there are special COI-related considerations and requirements, including additional reporting to the COI office and online training. Read on to learn more about these requirements.

In 2011, the US Department of Health and Human Services (HHS) issued revised regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). Any institution seeking funding through a grant or cooperative agreement from NIH or another PHS agency must comply with these regulations. For more information about these regulations, visit the NIH FCOI FAQs.

Note: These regulations do not apply to Phase I Small Business Innovative Research (SBIR) or Small Business Technology Transfer (STTR) Program proposals or awards, though they do apply to Phase II projects. Phase I SBIR/STTR proposals and awards are treated like any other non-PHS sponsored projects. See COI Considerations for Proposals and Awards for more information.
 

COI Requirements for PHS Awards

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PHS policy requires that investigators declare if they have any outside interests that could present a conflict with each specific award. Therefore, each investigator has to file an award-specific COI report for each PHS award. (As with all award-related COI requirements, “investigator” means Primary Investigator, Co-Investigator, and Key Personnel.) For more information about how to file a COI report, visit the eCOI System webpage.

  • Award-specific reports are recommended* at the point of proposal submission, and required before award acceptance. OSP staff will alert investigators to this requirement.
  • The COI office will review the report to determine whether or not there is a real or apparent conflict between the investigator’s financial interests and the project to be funded by the PHS award.
  • If there appears to be a conflict, the COI staff will work with the investigator to develop a conflict management plan); the plan must be in place before the award may be accepted by Cornell. COI staff must also report the conflict and share the management plan with the funding agency.
  • If there is no conflict between the investigator’s external interests and this award, then COI staff will communicate to OSP that they may release the award.
  • Pre-spending for PHS awards is only allowed if (1) no investigators have a significant financial interest (SFI) related to the award, OR (2) if any investigator does have an SFI, the COI office must complete their review of the individual’s award report, and implement a conflict management plan, if one is needed. If unallowable pre-spending occurs on an award, the funding agency may elect to disallow expenses for the period of time during which the conflict was not managed.  

*NOTE: while award-specific reports are not required at the point of PHS award proposal submission, standard annual COI reports must be submitted before a proposal can be submitted to any funder. See COI Considerations for Proposals and Awards for more details.

COI Requirements for PHS Subawards

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All recipients of PHS funding – including those who receive the funding through a sub-award – are required to comply with PHS regulations pertaining to conflicts of interest.

Outgoing Subawards (Cornell as Prime)

  • Cornell, as primary recipient of a PHS award, is responsible for ensuring that all sub-recipients are in compliance with PHS policy. If a sub-recipient does not have compliant COI policies or procedures, Cornell’s OSP and COI staff will work with the PI to determine an appropriate course of action.
  • If an investigator on a sub-recipient team has a conflict of interest related to the research funded by the PHS award, the sub-recipient institution must inform Cornell about the conflict and how it will be managed. Cornell is responsible for ensuring appropriate and compliant conflict management, which may require changes to the management plan. Once in place, Cornell is responsible for reporting the sub-recipients’ conflicts and management plans to the funding agency.

Incoming Subawards (Cornell as Sub-recipient)

In most cases, if Cornell is the sub-recipient of a PHS award, no additional steps will need to be taken with respect to COI. However, if an investigator on the Cornell team has a real or apparent conflict of interest related to the sub-award, then the Prime award institution will need Cornell to provide relevant information about that award and its management. Cornell’s COI office will work with OSP to navigate this process.

COI Requirements for Reporting Travel

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PHS policy considers any travel reimbursed or paid for by an external entity to be a financial interest subject to COI review. Therefore, each PHS-funded investigator has to disclose any travel related to their Cornell duties that was paid for by an external entity, regardless of whether or not it was related to the PHS award.

Relevant details:

  • Report all travel that is related to university duties, whether the external entity reimbursed you or paid for the travel directly.
  • Reporting retrospectively: report any work-related travel within the 12 months prior to the award start date. This is required prior to acceptance of the award, but recommended at the time of proposal.
  • Reporting throughout the award period: submit a new travel report each time you travel, within 30 days of the travel occurring.
  • Travel reporting can be completed through the same system (eCOI) as all other COI-related reports. For help, visit the eCOI System page.
  • Exclusions: you need not report travel reimbursed or sponsored by the following types of institutions:
    • a federal, state, or local government agency;
    • an institution of higher education as defined at 20 U.S.C. 1001(a);
    • an academic teaching hospital;
    • a medical center; or
    • a research institute that is affiliated with an institution of higher education.

Required Training

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All primary investigators, co-investigators, and key personnel on PHS-funded awards must complete COI training in order for Cornell to remain compliant with PHS regulations. Training details:

  • Cornell uses the online CITI training program to meet this requirement. You can log into CITI using your Cornell NetID and password via this link.
  • Training is required every four years.
  • The COI office maintains an online list of COI course completion records for Cornell personnel.
  • Cornell tracks COI training through CULearn; if you are required to take training, you should receive reminder emails through that system.

Reporting to Sponsor

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Cornell is obligated to submit reports to PHS agencies sponsoring research in cases where conflicts of interest have been identified.

  • Initial Reports: If Cornell finds that an investigator on a PHS-funded award has a significant financial interest that poses a conflict with the research, Cornell must report that conflict to the sponsor prior to spending any sponsored funds.
  • Reports During an Ongoing PHS-funded Research Project: Once a funded project is underway, if a new investigator joins the team, or an existing investigator discloses a new significant financial interest, and Cornell determines that they have a conflict with the sponsored research, Cornell must report that conflict to the funding agency within 60 days of making that determination.
  • Annual COI Reports:  For any COI previously reported by Cornell, Cornell must submit an annual COI report to the funding agency that addresses the status of the financial interest and any changes to the management plan.

Public Disclosures

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Under PHS regulations, members of the public may request from the Cornell COI office information about specific PHS-funded investigators’ conflicts of interest related to their PHS-funded research. We have developed a Request for Information Form for this purpose, which includes additional information about the process for requesting and receiving COI-related information. The Cornell COI office will respond to these request within five business days.

Non-compliance for PHS-Funded Researchers

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For PHS-funded research, violation of Cornell COI policy comes with serious consequences (in addition to the consequences for non-compliance with Cornell COI policy):

  • Cornell must report non-compliance to the sponsor within 30 days of when the University becomes aware of an issue. The report must include specific information, including the name of the individual, the nature of the conflict and the non-compliance, and the steps Cornell has taken or will take to address the problem. The sponsor may respond with additional requirements with which Cornell must comply.
  • 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 you have any other questions about COI considerations and requirements for PHS-funded researchers, please contact the COI office.