To maintain the integrity of Drexel University, its personnel, and the public’s interest as it relates to conflicts of interest and conflicts of commitment in research.

The policy applies to regular-rank tenure and non-tenure track faculty members. These faculty members will hold one of the following titles: unmodified professor, associate professor and assistant professor; unique named titles associated with named chairs; and approved non-tenure track titles including professor of the practice, clinical professor, research professor, lecturer and medical instructor (and associate/assistant professors of the same categories). 

Furthermore, the policy also applies to: 1) individuals granted Principal Investigator status and 2) those individuals employed by the University and providing material benefits to externally funded research projects. This will be indicated by being named a key personnel or receiving salary from effort on a U.S. federal, state or local government funded project that had financial activity within the preceding twelve months.

“Significant Financial Interest” is defined by federal and state statutes as: 1) anything of monetary value, including but not limited to, salary or other payments for services (e.g. consulting fees or honoraria) that exceed $5,000, 2) equity interest (e.g. stock options, stocks, or other ownership interests) of > 5%, and 3) intellectual property rights, (patents, copyrights, etc.).

• Using University resources in activities that may lead to financial gain for the faculty member (or their immediate family).tra 
• Using University resources to benefit an external entity 
• Using the name of the University in promoting activities that may lead to financial gain for the faculty member (or their immediate family). 
• Interacting with students in external as well as internal roles. e.g., seeing students as clients or patients, employing students for non-University work. 
• Engaging in research in which a faculty member (or their immediate family) has a financial interest, including interests in a start-up company and/or interests related to licensed intellectual property. 
• Having a relationship or affiliation between the faculty and the source of information or materials. 
• Competing with the University for clients, contracts, etc. 
• Financial involvement of a faculty member (or their immediate family) with an outside organization, or holding a position in an outside organization. 
• Having an external interest that could be implicated in internal University decisions. e.g., contracts, hiring, research, or in giving advice. 
• Payments from outside entities or stock interests greater than $5,000. 
• Receiving royalties or other licensing proceeds from intellectual property you invented and are evaluating or further developing 
• Negotiating on behalf of the University for the purchase of materials from a company in which you have a financial interest 
• Assigning as the required text for a course a book for which you receive royalties 
• Using students to perform services for a company in which you have a financial interest

You can find the COI training here.

New Users: During CITI registration, be sure to use your Drexel abc123 username and email. Next, you will be prompted to add courses. Select the courses required for your research. The next screen will prompt you to select Basic or Refresher. Choose ‘Basic’ if this is your first time taking a course under Drexel. Choose Refresher if you have already been certified in a basic course under Drexel. On the next page, select the group that most closely reflects the main emphasis of your work (Medical or Social Behavioral). 

If you have an existing CITI account, ensure that your profile is affiliated with Drexel University. Doing so will allow the IRB to access the courses you have completed. Please take the steps outlined in the ORI CITI Update Email SOP [PDF] to update your preferred address to your Drexel email.

Yes. You will be asked to disclose the outside interests of your spouse or domestic partner and your dependent children that relate to your institutional responsibilities at the University.

Annually ORI’s COI team will solicit disclosures via email.  Disclosure requests will be emailed to any individual listed as key personnel on research (proposals/protocols). A completed form is required at least annually, and the COI/COC policy requires that a disclosure form be updated within 30 days of a change to an Outside Interest. COI/COC forms are collected and managed by Drexel ORI-COI.

Likewise, outside interests (e.g., intellectual property), even if not generating revenue, could also present conflict concerns. Outside Activities and Interests related to key personnel’s Institutional Responsibilities, even when not compensated or non-monetary, require disclosure to Drexel University.

Intellectual Property Rights and Interests (IP). Intellectual property rights and interests relating to patents or copyrights upon receipt of income related to such rights and interests. Also included (and required to be disclosed) are intellectual property rights and interests relating to patents or copyrights — regardless of whether income has been received — in any case where the technology underlying the patent or copyright is the subject of key personnel’s research at Drexel.

Payments for services (consulting, lectures, advisory board payments, or honoraria); 

Equity interests, i.e. stocks, stock options, and other ownership interests; ** 

Intellectual property rights (e.g., licenses and royalties); 

Donations (monetary, unrestricted funds, in-kind designated for research) 

Relationships and activities with foreign institutions and funding agencies 

All external professional activities. 

Federally funded Individuals are also required to disclose items such as sponsored or reimbursed travel and/or gifts and gratuities. These disclosures should be made using appropriate mechanisms and in accordance with relevant university policies.  

**Some publicly traded stock must be disclosed, but only in specific circumstances. – Do you own now, or expect to own in the next 12 months, more than $5,000 in stock, in a PUBLICLY HELD ORGANIZATION that provides funds to Drexel in support of your Institutional Responsibilities (e.g. teaching, research, committee, or other administrative responsibilities)? Do not include investments where you do not directly influence investment decisions, such as mutual funds and retirement accounts. Do include stock/options, warrants and other existing ownership interests.

Any individual who receives and/or is paid on a PHS-funded research grant is required, by federal regulation to disclose all reimbursed or sponsored travel (i.e., that which is paid on behalf of the individual). Travel should be disclosed to Drexel within 30 days of the travel. Travel can be disclosed here.  

Individuals with research sponsored by the U.S. Public Health Service (PHS) of the U.S. Department of Health and Human Services are required to disclose certain information about all sponsored or reimbursed travel if the investigator and the travel both meet certain criteria (listed below): 

• The faculty or staff member is paid for research that is sponsored/funded by the PHS (e.g. any NIH funding greater than 0% effort); 
• The travel is reimbursed or sponsored by some external entity (see exceptions below); and 
• The sponsored travel is related to your institutional responsibilities to Drexel (e.g. as a physician scientist, you’re being sponsored to speak about your science, as opposed to being sponsored to speak on unrelated topic, like a hobby).

You do not have to report travel if it is reimbursed or sponsored by any of the following:

• A U.S. institution of higher education; 
• A U.S. federal, state or local government agency; 
• A U.S. academic teaching hospital; or 
• A U.S. research institute that is affiliated with an institution of higher education. 

Investigators, including Subrecipient Investigators, must disclose all travel information related to foreign Institutions of higher education or the government of another country. Otherwise, travel supported by all other sponsors must be reported, including foundations, professional associations, societies, professional boards, corporations, etc. If the travel qualifies for reporting (i.e. is sponsored and is related to professional responsibilities) using the Drexel Travel web site, you must report: Destination; purpose; sponsor; start date; end date; if international.

Yes. You must report all of your outside activities, even if you did not receive payment for them. Report any activities, relationships or interests that you have that were not coordinated or negotiated by Drexel.

Yes. Even if you did not get paid, all consulting services you provide for non-profit organizations must be disclosed if they relate to your individual responsibilities at the University.

Institutional responsibilities are defined as an investigator’s professional responsibilities on behalf of the institution, as defined by the institution, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships. And service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards

You do not need to report work you perform on grant or other panels evaluating applications for research funding from the United States government (e.g., from NIH, NSF, NASA, etc.). 

You should disclose work that you performed or expect to perform for the US federal government that give, or could be perceived to give, the University an unfair competitive advantage in securing or that could bias judgment on a government contract.  Consider services you performed as an employee, independent contractor, or consultant for the federal government or for any other entity. 

Organizational Conflicts of Interest (OCIs) can result when the nature of the work someone at the University performs for the federal government creates an actual or potential conflict of interest for the University on a future Federal award. OCIs can occur when someone at the University prepares or writes specifications for federal funding opportunities, has access to non-public information that provides a competitive advantage, or when someone is evaluating or assessing any work performed by others at the University.

A conflict of interest may arise when a faculty member’s relationship with an outside entity might appear to bias that individual’s judgment in performing his or her professional responsibilities at the University. A conflict of commitment may arise when a faculty member engages in external activities or assumes external commitments that might appear to compromise their ability to fulfill the responsibilities of their university obligations.

Please check with your Dean or Department Head as it relates to this policy**

No, outside activities may not involve the use of university facilities, materials, services, personnel, or information without prior University approval and a written agreement between all parties.

No, faculty member should not include Drexel as a party for their personal contracts.  Negotiation of the terms of the contract or agreement is the responsibility of the faculty member.  The faculty member should ensure the terms of any such agreement, including confidentiality and intellectual property terms, are consistent with his/her obligations under applicable Drexel policies.  Research in Drexel facilities must not be conducted under such personal contracts or agreements.

Each person’s situation is different. Conflicts are managed on a case-by-case basis to ensure that the unique needs of the individual and the University are met.

Management plans are intended to mitigate the potential bias of an apparent or potential conflict to preserve the integrity of the research.

Disclosing the potential conflict to appropriate sources inside and/or outside the University; 

Modifying or limiting the faculty member’s duties to minimize or eliminate the conflict; 

Reducing the faculty member’s appointment to accommodate the outside interest or activity; 

Securing the faculty member’s agreement to modify or suspend outside activity, use of university resources, or other activities that create the potential conflict; 

Prohibiting certain outside activity as inconsistent with the faculty member’s obligations to the University; 

Initiating an oversight plan to mitigate potential bias; 

Other actions or steps, as appropriate.

University resources includes time, funding, facilities, equipment, intellectual property, personnel, materials, or information/data that would not be available to the general public and that you would not be free to disclose to other members of the larger scientific community by publication or presentation. Any consulting agreement that requires you to use University resources, other than incidental use of phone/email/computer, should be restructured as an agreement with the University for your services as a university employee. View the Conflict of Interest Advisory webpage here.

The advisory memo linked here contains a list of reminders that one should be mindful of when maintaining outside relationships. It is intended to protect faculty/staff members, as well as the University, from even the appearance of a conflict of interest or commitment.

Yes, Faculty members may dispute decisions made in response to the disclosure or non-disclosure of a potential conflict of interest or commitment. The recourse for such a dispute is to make a request in writing to the Conflict of Interest Committee . Once a request is received, the ORI-COI office will issue an email notifying the individual that their case is under review.

Payments from third party companies or contractors should be reported as coming from the parent company.  For example, if "Company A" hires a contractor to run a conference, and the honorarium check comes from a third party, the money should still be attributed to "Company A" and should be included on the COI reporting form.

In general, companies that are owned by larger companies (for example, Janssen and Ortho Biotech are owned by Johnson & Johnson) will be treated as one entity (the overarching company - Johnson & Johnson in this case), unless the COI Office specifically concurs that the subsidiary truly operates independently of the holding company. In the case of subawards, if there are flow down terms please list the primary funder. (for example, if the sponsor is Stockton University and the Prime is Department of the Army, list Department of the Army as the Sponsor).

The first significant venture capital or angel equity investment financing for a startup following a seed round (the traditional definition).

Because it may be difficult to determine fair market value for privately-traded companies, all related equity holdings in privately-traded companies must be reported in the annual COI reporting process.  In most cases, any equity in a non-publicly traded company is treated as if it exceeds all thresholds and is managed accordingly if there is an identified research overlap.

A very broad definition is a privately held company in which a faculty or staff member holds an equity interest.

Yes, you must disclose the relationship and you must follow the policy requirements for consulting agreements with industry.

When an Investigator fails to comply with the Institution’s Financial Conflict of Interest policy or the management plan, the Institution shall within 120 days: 

a) complete a retrospective review of the Investigator’s activities and the NIH-funded research project to determine any bias in the design, conduct or reporting of research; 

b) document the retrospective review consistent with the regulation; and 

c) document the Institution’s determination as to whether any NIH-funded research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with the Institution’s Financial Conflict of Interest policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research.  

If bias is found, the Institution shall notify the NIH promptly and submit a mitigation report to the NIH that shall address the following: 

• impact of the bias on the research project and 
• the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.  

Thereafter, the Institution shall submit FCOI reports annually, in accordance with the regulation. Depending on the nature of the Financial Conflict of Interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator’s participation in the NIH-funded research project between the date that the Financial Conflict of Interest is identified and the completion of the Institution’s independent retrospective review, in accordance with 42 CFR 50.605(a)(3) and 42 CFR 50.605(b)(3).  

In addition, if the NIH determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations. 

Other sponsors or granting agencies determine these sanctions generally on a case-by-case basis. University sanctions can be applied for non-compliance regardless of funding source.

Yes.  In each case when the regulation refers to exclusions of Institutions of higher education as defined in 20 U.S.C. 1001(a) or a federal, state or local government agency, the reference is made to a United States (U.S.) Institution of higher education or a federal, state or local government agency within the U.S.

Any individual who receives and/or is paid on a funded research grant is required by federal regulation to disclose all reimbursed or sponsored travel (i.e., that which is paid on behalf of the individual). Travel should be disclosed to Drexel within 45 days of the travel. Travel can be disclosed here.

Individuals with research sponsored by the U.S. Public Health Service (PHS) of the U.S. Department of Health and Human Services are required to disclose certain information about all sponsored or reimbursed travel if the investigator and the travel both meet certain criteria (listed below): 

• The faculty or staff member is paid for research that is sponsored (e.g. any NIH funding greater than 0% effort); 
• The travel is reimbursed or sponsored by some external entity (see exceptions below); and 
• The sponsored travel is related to your institutional responsibilities to Drexel (e.g. as a physician scientist, you’re being sponsored to speak about your science, as opposed to being sponsored to speak on unrelated topic, like a hobby). 

You do not have to report travel if it is reimbursed or sponsored by any of the following: 

• A U.S. institution of higher education; 
• A U.S. federal, state or local government agency; 
• A U.S. academic teaching hospital; or 
• A U.S. research institute that is affiliated with an institution of higher education. 

Investigators, including Subrecipient Investigators, must disclose all travel information related to foreign Institutions of higher education or the government of another country. Otherwise, travel supported by all other sponsors must be reported, including foundations, professional associations, societies, professional boards, corporations, etc. If the travel qualifies for reporting (i.e. is sponsored and is related to professional responsibilities) using the Drexel Travel web site, you must report: Destination; purpose; sponsor; start date; end date; if international.

COI/COC training is included as part of the annual disclosure process. Everyone that accesses the disclosure form must go through the training slides to get to the disclosure form the first time the form is accessed each year. The training slides are also available as an option for review after the form has been submitted. Per PHS regulation, education is required immediately when: 

•  Financial conflict of interest policies are revised in a manner than changes investigator requirements; 
• An investigator is new to the institution; 
• An investigator is found to be noncompliant with financial conflict of interest policies and procedures. 

You can find the COI disclosure form here. 

If you have additional disclosures, please contact the ORI-COI team at FCOI@drexel.edu.

Because the SBIR/STTR grants create complex relationships, a separate procedure document has been created.  Please see the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Implementation Procedure webpage here when considering an application for either of these grant categories.

Series A Funding does not include funding from federal grants such as STTR/SBIR, funds from “friends and family”, or other Drexel translational funding sources.

For Research related COI: ORI-COI, Email: FCOI@drexel.edu.