Answers
| 1. | A financial interest is anything of economic value, including a fiduciary relationship with an outside company. Examples include positions such as board of director, officer, partner, scientific advisory board or technical advisory board membership; non-JHU salaries; consulting income; stock or stock options (vested or not vested). |
| 2. | A financial interest in a sponsor is a relationship between the PI or Key Personnel and the sponsor (either directly, or through a spouse, registered domestic partner or dependent child). Some examples are equity holdings in the sponsor, a directorship with the sponsor, income received from the sponsor, or employment in the sponsor by a spouse. A related interest is one where an individual's financial interest in an entity other than the sponsor might appear to be affected by the design, conduct, or reporting of the sponsored research. Examples of related financial interests:
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| 3. | A financial conflict of interest in research is a situation in which people might perceive that your financial relationships may compromise your professional judgment in conducting, analyzing, or reporting research. Therefore, JHU SOM reviews and manages these arrangements to protect the integrity of the research, institution, and individual. Example: An investigator may have a financial conflict of interest if he or she is a consultant to the company sponsoring research in his or her laboratory. Example: A faculty member owns significant equity in a company whose product he or she wants to test. |
| 4. | No. A financial interest related to research does NOT automatically mean that you cannot participate in the research. The Committee on Outside Interests and the Vice Dean for Research have determined that many conflicts of interest can be reduced, eliminated or managed in order to allow participation in research projects. |
| 5. | Under Federal Regulations. Principal Investigators and Key Personnel* must disclose financial interests in non-governmental entities (e.g., for-profit entities) that are supporting research. Research support can be in the form of grants, contracts, subcontracts or subgrants, gifts, and donated equipment or supplies. Additionally, disclosures of financial interests related to research and research training are required when the research is supported by certain federal agencies, including NIH and NSF, or by sponsors who require review under federal guidelines, such as the American Cancer Society. Under JHU SOM Policy. Faculty members, staff, trainees, post-doctoral fellows, students, administrators, and researchers must disclose financial interests in entities supporting research. * Key Personnel are defined as other members of the research team who will be responsible for the design, conduct or reporting of the research or other activities of the proposed project. |
| 6. | When the grant application, human subjects protocol, consulting agreement, or a proposed license agreement is submitted, you should answer affirmatively that a potential conflict of interest exists. In addition, you should disclose your relationship with the company/entity on eOPC at https://e-opc.jhmi.edu. |
| 7. | The Office of Policy Coordination reviews disclosures to determine whether the interest constitutes a conflict of interest that must be eliminated, reduced or managed per the JHU SOM policy. If the Office determines that a conflict exists, the Committee on Outside Interests reviews the case and determines an appropriate strategy for management. |
| 8. | The Committee generally meets once per month. In most cases, unless the Committee needs additional information to make a decision, management plans are issued within ten to fifteen business days after the Committee meeting. |
| 9. | The decision of the Committee on Outside Interests may be shared with University officials as deemed necessary. In cases relating to projects involving human subjects, the recommendation will be shared with the IRB. It may also be shared with the research sponsor if requested. Other than mandated disclosures or limited internal disclosures, the information is treated as confidential. |
| 10. | The following examples are intended as general examples only. It is important to remember that cases are individually reviewed, and each outcome is based on the details of that particular case. |
Case #1: Investigator's financial interest is relatively modest for a one time engagement. If the financial interest in the sponsoring entity is a small amount of income or a travel reimbursement or honoraria for one-time consulting, the Office of Policy Coordination will recommend acceptance of the compensation with no stipulations. | |
Case #2: Investigator has an ongoing consulting relationship with the sponsor and/or entity providing a product for the study. The investigator is compensated in cash. If the investigator anticipates an ongoing consulting relationship with the research sponsor and/or has equity holding in the research sponsor, then the Committee would recommend that the investigator disclose these interests in presentations and publications. In addition, if the research involves human subjects, the Committee would recommend: limiting compensation to $25,000 per year, disclosure, and listing a disinterested individual in the consent form. | |
Case #3: The owner of a small company is in an officer role, and the company is sponsoring human subjects research. The Principal Investigator is the owner of a small company and is acting as an officer in the role of Vice President. The company now wants to sponsor research on campus, which involves the testing and improvement of its proprietary equipment, and graduate students will be involved with the project. This is conflicted because the PI is an officer in the sponsoring company and has significant ownership. The conflict is even more significant because graduate students are involved in the work and its human subject work. The conflict is not easily manageable because the PI and the company management are the same person. The Committee concluded that this significant conflict was not manageable and did not approve the project. |
