fCOI: Frequently Asked Questions

You are here

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.