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, or proposed for such funding, which may include, collaborators or consultants.

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

All MSU employees included as PD/PI's or Co-PD/PI's in the proposal.

Yes. 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.

All other named individuals in the proposal who weren't included in the Senior Key Personnel section of the Proposal Development document. This includes individuals who are named in the proposal, but are not requesting payment from PHS/NSF.

Currently the Proposal Development document can only capture information for MSU employees.

PHS and NSF 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. Only PHS/NSF proposals are required to include all named individuals in the proposal on the Proposal Development document.

No. Only those listed in the Senior Key Personnel section on the Proposal Development document will be included in the route to approve the proposal.

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

In the Project Participants section of the Proposal Development document there is a drop down list where a Participant Type must be selected. Individuals with a Participant Type that starts with "Investigator" will be considered a PHS/NSF Investigator.

For PHS/NSF proposals only, anyone listed in the Senior Key Personnel section of the Proposal Development document and those listed in the Project Participants section with an "Investigator" Participant Type must complete an Annual Disclosure prior to proposal submission.

The Annual Reports box next to their name will be checked.

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

If an individual was listed on the Senior/Key Personal Profile form in the proposal or as Senior Personnel on the proposal budget, OSP will add this person to the Project Participants section of the Proposal Development document with an Investigator Participant Type. Anyone that is added will be required to complete an annual disclosure prior to proposal submission.

If the individual was listed as Other Project Personnel in the budget or budget justification, OSP will add this person to the Project Participants section of the Proposal Development document with a non-Investigator Participant Type.

This is likely incorrect. Either they need to change their Participant Type on the Proposal Development document to an Investigator Type, or they need to change their role on the Senior/Key Person Profile form to Other Significant Contributor.

We would encourage PHS and NSF Investigators to complete FCOI training prior to proposal submission, but OSP will not, at this time, withhold submission of a proposal if an Investigator has not completed the training.

However, if an award is made OSP will not authorize an account to be setup prior to all PHS investigators completing 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 and/or NSF regulations. This form should be received prior to submission.

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 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 NIH's 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, www.coi.msu.edu, which will include MSU's compliant policy. You can also direct them to the FDP Institutional Clearinghouse, http://sites.nationalacademies.org/PGA/fdp/PGA_070596, 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 proposals, who do not have their own PHS compliant FCOI policy, must complete FCOI training through MSU. Please contact the COI office, www.coi.msu.edu/, for guidance on how this training requirement is completed.

There is a report you can run in the Reports and Statistics section of the SPA website called "FCOI Disclosure and Training Status." This report lists the faculty for the unit selected, along with their certification and training dates.