Federal Conflict of Interest Business Procedure FAQs

1. Agency for Healthcare Research and Quality (AHRQ)
2. Agency for Toxic Substances and Disease Registry (ATSDR)
3. Centers for Disease Control and Prevention (CDC)
4. Food and Drug Administration (FDA)
5. Health Resources and Services Administration (HRSA)
6. Indian Health Service (IHS)
7. National Institutes of Health (NIH)
8. Substance Abuse & Mental Health Services Administration (SAMHSA)
9. Office of Global Affairs (OG)
10. Office of the Assistant Secretary for Health (OASH)
11. Office of the Assistant Secretary for Preparedness and Response (ASPR)

1. Alliance for Lupus Research
2. Alpha-1 Foundation
3. American Asthma Foundation
4. American Cancer Society
5. American Heart Association
6. American Lung Association (ALA)
7. Arthritis Foundation
8. CurePSP
9. Juvenile Diabetes Research Foundation (JDRF)
10. Lupus Foundation of America (LFA)
11. Patient-Centered Outcomes Research Institute (PCORI)
12. Susan G. Komen Foundation

The Project Director or Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS/NSF/DOE, or proposed for such funding, which may include, collaborators or consultants. Solicitations, particularly for DOE, may require additional project participants to follow the FCOI regulations.

It is the responsibility of the PD/PI to ensure that all individuals who fall within the definition of a PHS/NSF/DOE Investigator are properly identified as such either on the Proposal Development document or on other proposal documents.

For System-to-System proposals: All individuals (MSU and non-MSU) who should be included on the R&R Senior/Key Person Profile form, should be included.

For Summary proposals: all MSU employees included as Senior/Key in the proposal (e.g., PD/PIs, Co-PD/PIs, Co-Is, Key Persons). Anyone who is receiving F&A (overhead) credit for a proposal should be included in the Senior Key Personnel section of the Proposal Development document. Departments and colleges will continue to be responsible for making the determination of who should be receiving F&A credit.

PHS, NSF, and DOE have stated that the position or title of an individual doesn't determine whether or not they would fall under the definition of an Investigator. The PI will ultimately be responsible for determining who will be responsible for the design, conduct or reporting of the research, which may include post-docs and graduate students.

No. Those with a Key Person role are only included in the route if they have been added to the Credit Allocation. Only MSU employees can be added to the Credit Allocation.

If the individuals are listed in the Key Personnel section of the Proposal Development document you should assume they are considered PHS/NSF/DOE Investigators.

For PHS/NSF/DOE proposals only, anyone listed in the Key Personnel option of the Proposal Development document must complete a Project Based disclosure, and have an up-to-date Annual disclosure, prior to proposal submission.

In December, 2021, the Department of Energy issued an interim COI policy which requires each Investigator who is planning to participate in the DOE award to disclose the Investigator's significant financial interests (and those of the Investigator's spouse and dependent children) no later than the time of proposal for the DOE award. This applies to awards through DOE and the National Nuclear Security Administration (NNSA).

The COI Disclosure Information table displays the date of the last Annual Disclosure. The table is located in the COI Disclosure sub option of the PD, or in Supplemental Information in the IP/Award.

If we were to submit the proposal, MSU would be out of compliance with the COI regulations. If you suspect that an annual disclosure and/or project based disclosure will not be able to be completed prior to the deadline, please let OSP know right away.

If an individual was listed as a Key Person in the proposal or as Senior Personnel on the proposal budget, OSP will send a note to the research administrator requesting this person be added as a Key Person to the PD.

No. We would encourage PHS and DOE Investigators to complete FCOI training prior to proposal submission, but it is not required. For PHS and DOE, FCOI training is required prior to account setup for an award. NSF does not require FCOI training.

The subrecipient organization needs to complete MSU's subrecipient commitment form, which indicates whether or not their organization has a FCOI policy that is compliant with the PHS/NSF/DOE regulations. This form should be received prior to submission. If the entity participates in the FDP Expanded Clearinghouse, you can view their certification for COI compliance here.

If the subrecipient organization does not have a compliant policy, they will fall under MSU's policy and will be required to complete a paper FCOI form. We should have a copy of this completed form prior to submission.

For NIH no-pay consultants listed on the Senior/Key Person Profile form with a Consultant role, we highly suggest the role be changed from Consultant to Other with a description of "Other Significant Contributor." NIH defines an Other Significant Contributor as follows:

Individuals who commit to contribute to the scientific development or execution of the project, but do not commit any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at effort of "zero person months" or "as needed." Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs). Consultants should be included if they meet this definition.

For paid consultants, PI's should make sure the consultant falls under the definition of Senior/Key personnel. If they do, they will be required to follow MSU's FCOI policy and must complete a paper FCOI form prior to submission.

Yes, the subrecipient organization needs to complete MSU's Subrecipient Commitment Form. This form should be received prior to submission.

No. Unless there is a special requirement in a solicitation, the Subrecipient Commitment Form will meet the requirements of receiving a Letter of Intent.

You can direct them to MSU's COI website, which will include MSU's compliant policy. You can also direct them to the FDP Expanded Clearinghouse, where MSU has added itself as an educational institution that is in compliance with the PHS FCOI rules and regulations.

Subrecipient investigators and consultants on PHS and DOE awards, who do not have their own PHS/DOE compliant FCOI policy, must complete FCOI training through MSU. Please contact the COI office for guidance on how this training requirement is completed.