fCOI: Frequently Asked Questions

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Who is required to submit a disclosure?

Project Personnel, which is defined as any university faculty or staff member responsible for the design, conduct, reporting, or direct administration of University Research and/or Sponsored Programs.

“Design, conduct, or reporting” of research means oversight, decision-making, or participation in research that includes creating the structure, roles, and/or the protocol of a research project, participating in the execution of research roles and protocols; participating in the publication, presentation, or discussion of the research results.

“Direct administration” of research means oversight or decision-making impacting research, such as selection of vendors, determining the allocation of funds, negotiating budgets, deliverables, or other terms with sponsors, protocol review and approval, or managing resulting intellectual property.

Project Personnel includes all Senior and Key Personnel, defined as the Project Director/Principal Investigator and any other person identified as Senior or Key Personnel by the institution in a grant application, project report, or any other report submitted to the sponsor, as well as any person identified by the sponsor as specifically stated in award documents. Senior and Key Personnel further include those identified on PHS awards or cooperative agreements issued on or after August 24, 2012 when travel is paid or reimbursed.

Are grad students or post-docs required to submit disclosures?

ORSP collects disclosures from all Project Personnel identified on a Sponsored Program proposal as Senior or Key Personnel. If grad students and/or post-docs are both named on a proposal and are responsible for the design, conduct, reporting, or direct administration of the Sponsored Program, they must also submit a disclosure. Post-docs and grad students who are unsure of their disclosure requirements should contact the Principal Investigator submitting the proposal.

How do I report a change in circumstances since my last disclosure?

Project Personnel are required to submit an updated disclosure within 30 days of any material changes to their circumstances that affect existing disclosures. To submit an update to an existing disclosure, please contact Naomi Coll at nac314@lehigh.edu.

Are disclosures required annually?

Project Personnel must disclose every instance of an SFI in an External Entity that is Related to their role as Project Personnel on University Research and/or Sponsored Programs at least annually.

ORSP and VPR both collect disclosures from all Project Personnel when they are listed on a Sponsored Program proposal administered through their respective offices. Project Personnel who submit a disclosure with a Sponsored Program proposal at least one per year through either the ORSP or VPR meet the annual disclosure requirement.

All faculty and staff who engage in University Research are responsible for understanding their disclosure obligations and for notifying their Department Chair/direct supervisor prior to engaging in University Research if they have a related SFI to disclose. “University Research” includes any research activity supported by university funds, regardless of source. This may include research conducted using department funds, which are not administered through the ORSP or VPR and thus do not include a Sponsored Program proposal-based disclosure process.

What are the Public Health Service (PHS) agencies?

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. Office of Global Affairs (OG)
9. Office of the Assistant Secretary for Health (OASH)
10. Office of the Assistant Secretary for Planning and Evaluation
11. Office of the Assistant Secretary for Preparedness and Response (ASPR)
12. Office of Public Health and Science
13. Substance Abuse and Mental Health Services Administration (SAMHSA)

(Source: http://thefdp.org/default/fcoi-clearinghouse/fcoi-agencies/)

Do I have to disclose reimbursed or sponsored travel?

Lehigh only requires disclosure of reimbursed or sponsored travel for Project Personnel on PHS agency sponsored awards.

If you are Project Personnel on a PHS funded award, you must disclose any reimbursed or sponsored travel (i.e. paid on your behalf), related to your Lehigh University responsibilities for the preceding twelve months. This must be disclosed no later than the time of application for a PHS sponsored program. You must also submit an updated disclosure within 30 days of each occurrence of reimbursed or sponsored travel.

This requirement excludes any travel that is reimbursed or sponsored by Lehigh University; a U.S. federal, state, or local government agency; a U.S. non-profit 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 in the U.S.

This requirement also does not apply to travel that does not meet Lehigh’s definition of an SFI. It does not meet the definition of an SFI if when aggregated over 12 months, travel reimbursed or sponsored by a single External Entity totals less than $5,000. See the next FAQ, “Are Project Personnel on PHS funded awards required to disclose all travel?" below for more information.

Project Personnel on any Sponsored Program or University Research, regardless of sponsor, must disclose any and all travel or travel by their Family that is sponsored or reimbursed by a talent recruitment or development program based outside of the U.S.

Are Project Personnel on PHS funded awards required to disclose *all* travel?

No. PHS regulations allow institutions to set internal thresholds for disclosing travel. Lehigh University has set its threshold to $5,000 to align with the general SFI threshold. Therefore, you only need to disclose travel that meets the following criteria:
• The aggregate value of the travel sponsored or reimbursed by a single entity over a 12 month period is greater than $5,000; and
• The travel is related to your Lehigh University responsibilities and professional expertise.

If an External Entity sponsors or reimburses multiple small trips, each of which is individually valued at less than $5,000, it must be disclosed if the aggregated total over the 12-month period exceeds $5,000.

Project Personnel on any Sponsored Program or University Research, regardless of sponsor, must disclose any and all travel or travel by their Family when the travel is sponsored or reimbursed by a talent recruitment or development program based outside of the U.S.

The $5,000 threshold for disclosure does not prohibit Project Personnel on PHS awards from having sponsored or reimbursed travel of more than $5,000. Rather, it means that travel exceeding the $5,000 threshold must be disclosed.

I have an SFI in an External Entity. How do I know if it is Related to my Lehigh Sponsored Program or University Research?

Project Personnel are required to disclose a Significant Financial Interest (SFI) in an External Entity when the SFI is Related to a Sponsored Program or University Research.

Project Personnel should make a reasonable, good-faith determination as to whether the Sponsored Program or University Research could affect the value of a financial interest, or have a financial impact on the External Entity in which they hold an SFI. For example, Project Personnel are not required to disclose a Family member’s salary with a company that’s business focus is not related to the Project Personnel’s Sponsored Program or University Research.

Keep in mind that the relevant fCOI in Research and Sponsored Programs policy pertains only to Lehigh University Sponsored Programs and University Research.

Sponsored Programs are:
• Programs funded by a sponsor through a grant, contract, or agreement with the university, including, but not limited to research, education, testing, outreach, etc., and;
• Programs funded through Lehigh University’s internal grant programs administered by the office of the Vice President and Associate Provost for Research and Graduate Studies (VPR).

University Research is:
• Any research activity supported by university funds, regardless of source.

I am still not sure if my SFI in an External Entity is Related to my Lehigh Sponsored Program or University Research. Where do I go for help?

When individual faculty members are unable to make the determination independently, their Department Chair is in the best position to assist in determining if an SFI in an External Entity meets the definition of Related pursuant to this policy. Department Chairs should have the understanding of a faculty member’s research sufficient to help the faculty member make this determination.

It is not necessary and not recommended that faculty members share detailed financial information outside of a formal disclosure submission via Research Integrity/ORSP. Department Chairs need only to know that the faculty member has an SFI, but not the details of that SFI, in order to assist in making the relatedness determination.

If after working together to make a determination, an individual faculty member and their Department Chair are still unsure if the faculty member’s SFI in an External Entity is Related to their Lehigh Sponsored Program or University Research, they should contact the office of Research Integrity.

I have an external financial interest, but it does not meet the disclosure thresholds established in this policy. Is there anything else I need to do or know?

The fCOI Related to Research and Sponsored Programs policy pertains only to Lehigh University Sponsored Programs and University Research. External financial interests that do not meet the policy’s disclosure thresholds because they do not meet the definition of Significant Financial Interest (SFI) and/or are not Related do not need to be disclosed pursuant to this policy. However, it is possible that other institutional requirements apply.

Internal Audit administers the separate Lehigh University Conflict of Interest policy, which pertains more broadly to all Lehigh University staff, faculty, trustees, and officers external financial interests that may present conflicts of interests related to non-research university activities. If Project Personnel believe they may have a financial interest that does not fall within the scope of the Financial Conflicts of Interest Related to Research and Sponsored Programs policy, but may instead fall within the broader scope of the Lehigh University Conflict of Interest policy, the individual should contact Internal Audit directly.

Lehigh University Conflict of Interest policy and Internal Audit contact information is available here: https://www1.lehigh.edu/internalaudit

The Rules and Procedures of the Faculty outlines requirements and expectations around faculty engagement in activities of a professional nature for additional compensation, and other activities that could give rise to a real or apparent conflict of interest.

Nepotism-related questions or concerns should be directed to Human Resources.