Financial Conflicts of Interest in Research and Sponsored Programs

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Lehigh University is committed to conduct of research and sponsored programs in a manner that

  • is consistent with our academic mission;
  • maintains the trust of our sponsors and the public, and;
  • promotes compliance with applicable federal and state laws, regulations, and policies regarding financial conflicts of interest.

These commitments require the university to identify and manage any real or apparent financial conflicts of interest (fCOIs) related to research and sponsored programs.

The information on this page helps to summarize the requirements in the Lehigh University fCOI Related to Research and Sponsored Programs Policy. Here you will find guidance on

  • to whom the policy applies;
  • what Lehigh activities are covered by the policy;
  • what you should consider when determining what you need to disclose, and;
  • specific circumstances related to conflicts of interest and COI management. 

Email your questions to: incoi@lehigh.edu

 

What is a financial conflict of interest (fCOI)?

In common language, a financial conflict of interest, or an fCOI, exists when there is reasonable concern that an outside financial interest, role, or obligation could, or could appear to, compromise a person's objectivity in carrying out their academic research.

The university policy on Financial Conflicts of Interest Related to Research and Sponsored Programs formally defines an fCOI as follows:

"An fCOI exists when the university reasonably determines that an individual's Significant Financial Interest is Related to University Research or Sponsored Programs and could directly and significantly affect the design, conduct, or reporting of the University Research or Sponsored Program."

Financial conflicts of interest can be real or apparent. Situations occur in which decisions made in designing or conducting a study, or in reporting results, could have a direct and significant effect on the value of a financial interest or on a person’s ability to follow through on obligations they’ve made to an entity outside the university, whereby the person’s judgment in carrying out the academic work could be compromised. Situations can also occur in which such effect is technically unlikely, yet considering the circumstances others - colleagues, students, sponsors, the public - would reasonably be concerned.

Identifying and managing fCOI begins with the individual’s good faith determination of any Significant Financial Interests (SFIs) that may present real or apparent financial conflicts of interest. The policy specifically identifies SFIs that are to be considered. This is followed by collection of information necessary for the university to confirm the existence of an fCOI and, working with the individual, take the steps necessary to maintain confidence in the integrity of university programs. Such steps include management of conflicts of interest that are amenable to management, and avoidance of circumstances that would make management difficult or unreliable.

 

To whom does this policy apply?

The policy applies to any university employee who is, or has been in the past 12 months, responsible for the design, conduct, reporting, or direct administration of research, including

  • research supported only by university resources, including university salaries;
  • research undertaken as an independent scholar as part of the role of a faculty or staff member, and;
  • anyone responsible for the conduct or administration of any sponsored program, whether the program supports research or another activity. While not dependent upon title or position, this includes PI, co-PI, and others identified as key personnel.

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

Direct administration includes 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.

 

What Lehigh activities are covered by the policy?

The policy applies to all research whether supported by a sponsor or supported only by university funds, including university salaries, and to all sponsored programs whether they support research or other activities. Specifically, the policy covers design, conduct, and reporting, and direct administration.

 

When is disclosure required?

You are required to disclose any related SFIs at the following times:

  • With each Sponsored Program proposal submission to ORSP. ORSP will ask for and collect your disclosure as a part of the proposal preparation and submission process.
  • Prior to acceptance of an award from research investment programs run by the OVPR. OVPR will ask for and collect your disclosure prior to distributing your award.
  • Prior to engaging in research supported by university resources, when not already disclosed through a proposal submission or award process. You are responsible for notifying your Department Chair or direct supervisor if you have related SFIs to disclose, and they will notify the Office of Research Integrity to begin the formal disclosure process.
  • Within 30 days of material changes to circumstances that affect existing disclosures.
  • Annually, as a member of the faculty, or as a staff member to whom this policy applies, you must
    • confirm your involvement in a role that is covered by the policy during the prior calendar year;
    • confirm your understanding of your obligations under the policy, and;
    • considering the entirety of your research portfolio and any sponsored programs for which you have responsibilities, indicate whether you have any related SFIs to disclose.

Please see the annual confirmation and disclosure section below for more details about the annual process.


What should I consider when determining what to disclose?
You must report your and your 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, 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 confirmation and disclosure?
Annually, as a member of the faculty, or as a staff member to whom this policy applies, you need to confirm your involvement in a role that is covered by the policy during the prior calendar year, confirm your understanding of your responsibilities under the policy, and considering the entirety of your portfolio indicate whether you have and SFIs to disclose.  An annual email distribution provides the timeline for responding and directs you to the online survey.
 
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.
 
If you remain unsure about whether your external financial interest is related to your research and you are required to disclose it to the university, please contact the Office of Research Integrity by emailing us at incoi@lehigh.edu.
I know that I have related SFIs that require disclosure. What materials should I prepare?
The Office of Research Integrity will provide you with the guidance you need to prepare a complete Financial Conflict of Interest (fCOI) disclosure. This worksheet is designed to help you gather the information that you’ll need. 
 
Note: The worksheet is for your personal use, and is optional. It is not a substitute for a Financial Conflict of Interest (fCOI) disclosure, and it is not to be provided to the Office of Research Integrity.
 
Additional fCOI Resources

Please visit the following page for the fCOI Policy, Disclosure Forms, Glossary and Guidance

Additional fCOI Resources

Naomi Coll, MPH, CPH, CIP
Director of Research Policy and Compliance
Lehigh University
nac314@lehigh.edu
Phone: 610-758-2985