Who is required to submit a disclosure?
Investigators are defined as any university faculty or staff member responsible for the design, conduct, or reporting of Sponsored Programs or university research. This includes the project director or principal investigator, and any other senior/key personnel identified in a grant application, progress report, or any other report related to university research 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.
Are grad students or post-docs required to submit disclosures?
ORSP collects disclosures from all Investigators 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, or reporting 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 make a disclosure in LIRA?
See the LIRA Disclosure Process and Resources webpage.
What should I consider when determining what to disclose?
You must report your and your Immediate Family's relationships with organizations outside of Lehigh, including but not limited to relationships with private or public companies, foundations, non-profit organizations, industry or trade groups, and international educational or research institutions with which you have a financial relationship, if these relationships are related to your Lehigh University research and the relationships meet the definition of a Significant Financial Interest.
Note that for purposes of this policy, Immediate Family refers to your spouse, domestic partner, dependent child(ren), and any other persons residing in your household.
Significant Financial Interests (SFIs) include things such as sources of income from outside the university, ownership interests in publicly traded and private companies, income from intellectual property other than through the university, positions of responsibility in entities outside the university, and certain travel reimbursements. The policy and the COI glossary provide full definitions of SFIs, including dollar thresholds, as well as specific items that do not require disclosure.
The determination of when an fCOI exists is ultimately made by the university. However, the process of identifying, and then managing, financial conflicts of interest begins with your disclosure of any Significant Financial Interests that pose a risk, or would reasonably appear to pose a risk, of impact on any programs and projects for which you carry responsibilities.
You are expected to make a reasonable, good faith determination about whether you have a related SFI that requires disclosure. It is critical to consider whether your Lehigh research or sponsored programs could affect the value of your external SFI, or if your Lehigh research or sponsored programs could have a financial impact on the external entity. The following questions may also be helpful in making the determination:
- Would a reasonable person, informed as to the subject matter and nature of the work, the nature of the financial interests, and the goals or priorities of the outside entities with which the outside interests lie, but not with technical knowledge in my field or understanding of the details of my projects, be concerned that the outside interests could affect my judgment?
- Would students or university colleagues be similarly concerned?
- Would colleagues in my field with understanding of the nature of the financial interests, and the goals or priorities of the outside entities with which the outside interests lie, and detailed understanding of my projects, be concerned that the outside interests could affect my judgment?
In very general terms, an fCOI exists when
- You have a Significant Financial Interest (SFI), and
- Based on your own good faith determination, plus confirmation by the university after you disclose it, that SFI is Related to your research or sponsored program.
What should I do at the time of annual disclosure?
At the time of annual disclosure, you should consider
- all of your external Significant Financial Interests, and;
- the entirety of your Lehigh research portfolio and all sponsored programs for which you carry responsibilities for design, conduct, reporting, or direct administration
and make a good faith determination regarding whether these are related such that your judgment in carrying out those responsibilities could be affected, or could appear to be affected. Disclosure of each Significant Financial Interest for which that is the case is required. If you indicate that you have anything to disclose, the process of collecting relevant information will occur through follow up with the Office of Research Integrity. This provides an opportunity to further discuss your circumstances, in addition to making a formal disclosure.
Note that the annual disclosure is required regardless of whether you have recently made a disclosure for a proposal or project.
Where can I get help determining if my SFI is related to my research and requires disclosure?
Additional guidance on determining if an SFI is related to research and is required to be disclosed is available here.
When you are unable to decide independently, your Department Chair or direct supervisor is in a good position to assist in determining if an external SFI is related to your research and must be disclosed. Others who can assist include your associate dean for research or faculty affairs, and your dean. In conferring with your department chair, supervisor, or dean, it is not necessary to share detailed financial information. Financial information is only collected, and only on an as-needed basis, when a formal disclosure is made through ORSP, VPR, or the Office of Research Integrity.
What are examples of circumstances in which an SFI in an External Entity would be reasonably considered Related to an Investigator's University Research or Sponsored Programs?
An SFI in an External Entity would be reasonably considered Related to an Investigator's university research or Sponsored Programs in circumstances such as the following:
- The External Entity is a collaborator on or provider of materials, products, data or trainee support for the research or is a licensee with improvement rights to technology likely to arise out of the research.
- The Investigator or the External Entity has financial interests that could reasonably be considered to have a potential influence on the design, conduct or reporting of the research.
- The External Entity has a reasonable possibility of being financially affected by the research.
- The External Entity sponsors research at Lehigh University in which the Investigator is directly involved.
- The External Entity makes gifts to Lehigh University that benefit Investigator's research/scholarship (including equipment gifts or loans).
- The External Entity sponsors or makes a product that is under study in research in which Investigator is involved.
- The External Entity sponsors or makes a product that is under study in human subjects in which Investigator is directly or indirectly involved.
- The External Entity licenses Lehigh University intellectual property in which Investigator has a financial interest.
- The External Entity owns intellectual property, materials, or data that may be used in research at Lehigh University.
- The External Entity has a Materials Transfer Agreement, Human Tissue Agreement (MTA/HTA), or Data Transfer and Use Agreement (DTUA) to provide materials or data used in Investigator's research or for materials provided by Investigator to the company/organization.
- The External Entity is the sole-source provider of materials or services or of procurements required for the Investigator to carry out research.
- The External Entity provides financial support for the faculty member's trainees (including graduate students and postdoctoral fellows).
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.
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 at incoi@lehigh.edu
How do I report a change in circumstances since my last disclosure?
Investigators 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 update your Disclosure Profile in LIRA and contact the office of Research Integrity at incoi@lehigh.edu. See LIRA Disclosure Process and Resources.
Do I have to disclose reimbursed or sponsored travel?
Lehigh only requires disclosure of reimbursed or sponsored travel for Investigators on PHS agency sponsored awards.
If you are an Investigator 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.
Investigators on any Sponsored Program or university research, regardless of sponsor, must disclose any and all travel or travel by their Immediate Family that is sponsored or reimbursed by a talent recruitment or development program based outside of the U.S.
Are Investigators 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.
Investigators on any Sponsored Program or University Research, regardless of sponsor, must disclose any and all travel or travel by their Immediate 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 Investigators 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.
What are the Public Health Service (PHS) agencies?
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of Global Affairs (OG)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Planning and Evaluation
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Office of Public Health and Science
- Substance Abuse and Mental Health Services Administration (SAMHSA)
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.