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COI Requirements for NIH (PHS) Funded Researchers

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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 Subawards

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.

Required Training

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.

Public Disclosures

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. 

Non-Compliance for PHS-Funded Researchers

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.

Contact

If you have any other questions about COI considerations and requirements for PHS-funded researchers, please contact the COI office.