In order to disseminate knowledge and expertise in research and teaching outside the institution, Johns Hopkins University faculty members engage in a variety of outside activities and the institution supports and encourages these activities. It is important to recognize, however, that the financial interests and time commitment that may be associated with providing advisory services, and engaging in entrepreneurship, inventorship, and related activity have the potential to conflict with one’s primary obligations to Johns Hopkins and to impact academic integrity and objectivity. Permitted outside activities will vary depending on the individual’s employment or appointment status, relationship to research, and other factors. All disclosures of outside activities must be submitted through JHU eDisclose.
A conflict of interest may arise when a financial interest is related to one’s research and may affect or appear to affect the objectivity of the research, the safety and welfare of human research subjects, or the interests of students and trainees. A conflict of interest also may arise if a financial interest has the potential to affect one’s responsibilities other than research, such as teaching or administrative duties.
A disclosed financial interest is considered related to one’s research if the research could impact the value of the company in which the financial interest is held (or from which it derives) or the value of its products or those of its competitors. If the financial interest is related to one’s research and it has the potential to impact the objectivity of the research, the safety of human research subjects, or the rights and interests of students or trainees,there is a conflict of interest.
Review for conflict of interest with research follows the JHU Policy on Financial Interests and Financial Conflicts of Interest with Research, which complies with PHS regulations on objectivity in research. The goal of each review is to determine whether a disclosed financial interest relates to an individual’s research, regardless of research sponsor, and, if so, whether it creates a conflict of interest with the research.
Disclosures are reviewed for:
The questions posed below, when answered “yes”, are examples of potential conflicts of interest:
This list is not exhaustive. There may be other instances when an external activity could pose a potential conflict and would need to be reported. Contact our office for guidance if you are unsure if an activity needs to be reported.
Familial relationships may also give rise to potential conflicts of interest. A familial conflict can occur when a faculty member hires a spouse, domestic partner, child, or other relative to work on his or her projects. A familial conflict can also occur when the faculty member’s spouse, domestic partner, child, or other relative has a financial interest related to the faculty member’s research or institutional responsibilities. Such arrangements must be reported. Faculty members are prohibited from supervising relatives or determining salary or remuneration for relatives.
The Conflict of Interest Committee reviews all reports of outside activities to determine whether a potential conflict of interest exists. If the Committee finds a potential conflict exists, the Committee informs the faculty member in writing of required conditions to manage the conflict. Common management conditions required by the Committee could include:
If the Committee finds that the conflict cannot be managed, the Committee can prohibit the proposed external activity.
Changes in previously disclosed relationships with outside entities may require that the Conflict of Interest Committee re‐review both the disclosure and any conditions in place to manage the conflict. For example, a consulting relationship with a company disclosed in eDisclose could pose a conflict if the faculty member subsequently receives a grant from the company to do research. In these situations, faculty should provide information about this additional relationship to the company in eDisclose.
The primary duty of full‐time faculty members is to the University. Faculty members engage with industry, government, and professional associations to further their knowledge, research, and other professional activity. At the same time, faculty must not let outside commitments interfere with their obligations to fulfill their University responsibilities. Faculty members are expected to act in the best interests of the University and in furtherance of the University’s mission at all times. A Conflict of Commitment may occur when faculty members’ time and attention devoted to external activities interferes with their ability to fulfill their obligations to the School. The existence of a potential conflict does not indicate that the activity is prohibited; most conflicts of commitment can be managed. Disclosures on outside commitments are reviewed for compliance with institutional policies and standards, including:
Faculty members who receive their full‐time salary are allowed to consult or engage in entrepreneurial activity one day (ten hours) per week. Faculty members who receive less than full‐time salaries are allowed to consult beyond the one‐day per week limit when classes are notin session. The total number of days per year that faculty on part‐time appointments may consult may be determined by the formula [52 x F] + [(1‐F) x 6 x 52], where F is the fraction of full‐time equivalent salary that the Academic Staff member receives. Faculty who wish to pursue outside activities that exceed these limits must receive approval from the Dean of the appropriate School.
Faculty members may not hold a substantive appointment at another academic institution without approval of the Dean ofthe appropriate School. Significant management roles (e.g., officer in company or positions that involve supervision of the work of others and/or day‐to‐day responsibility for operating decisions) usually are demanding in terms of both time and energy. Accordingly, Faculty members who wish to accept significant managerial responsibilities in a company or another organization must negotiate an appropriate reduction in University responsibilities and compensation with the Dean of the appropriate School.
The following individuals need to disclose:
In addition, all full‐time and salaried part‐time faculty are required to complete an Annual Certification. See the eDisclose reporting instructions for easy-to-follow steps to submit your Annual Certification.
Late disclosure and failure to disclose may have serious consequences. Under federal conflict of interest regulation, if there is a failure to disclose, belated disclosure, or belated review of financial interests that the institution determines create financial conflicts of interest with PHS‐supported research, the
institution must undertake a retrospective review of the completed research for bias. In addition, failure to comply with policies on conflict of interest and commitment may lead to review under professional misconduct procedures.
Individuals must disclose the outside activities and financial interest listed below if they are related to your “institutional responsibilities.” Institutional responsibilities may include, among other things, research, teaching, clinical care/practice, and administrative responsibilities. Disclosure is required so the School can review outside interests and activities for conflict of interest and conflict of commitment.
You must disclose any of the above outside activities or financial interests of your spouse, domestic partner and/or minor dependents if they relate to your institutional responsibilities.
If you are an investigator on PHS‐funded research, you must disclose occurrences of reimbursed or sponsored travel related to your institutional responsibilities when the amount of travel during the 12 months preceding the disclosure reaches or exceeds $5,000 in the aggregate for a particular entity. (Note: This aggregate value includes travel for spouses, domestic partners and dependent children unless the travel occurs in the course of their employment by the entity.) This does not include travel that is reimbursed or sponsored by a U.S. federal,state, or local government agency, teaching hospital, medical center,U.S. institution of higher education, or related research institute. Exceptions also include travel reimbursements to Johns Hopkins, travel payments made by Johns Hopkins, or travel charged to a Johns Hopkins account.
Faculty are responsible for ensuring that private agreements are in compliance with all University policies. All commitments to provide consulting or other services to outside entities must be governed by a written agreement that is established in advance, includes a detailed outline of the services to be provided, and specifies the associated compensation. You may wish to consult your own legal advisor before signing a private agreement or contract with an outside organization.
Conflicts of interest can arise in tech transfer when a faculty member is conducting research involving a product for which the faculty member is a licensed inventor. Faculty should report conflicts arising out of tech transfer activities at the time the research activities are proposed and provide relevant updates
in eDisclose as they arise.
Conflicts of interest in human subjects research deserve special scrutiny because of the potential for such conflicts to affect the rights and welfare of human subjects. Faculty conducting human subjects research must indicate a potential conflict of interest on the IRB application and must report this
through eDisclose. The COI Committee will review the report and make management recommendations to the IRB and the PI. A common management condition includes disclosure of the arrangement in the in the consent form.
The IRB can decide whether to a) accept the Conflict of Interest Committee recommendations, b) accept the recommendations with additional management measures prescribed by the IRB, or c) conclude that the human subjects research cannot proceed.
In accordance with 42 CFR 50 Subpart F, the School must report to NIH those conflicts that are determined to be financial conflicts of interest (FCOI) related to Public Health Service (PHS) funded research. If the COI committee determines that a financial interest could directly and significantly affect the design, conduct or reporting of PHS supported research, the School will report this FCOI to the NIH. However, this does NOT mean that the research cannot be done but, instead, that a management plan for avoiding biased research must be in place. Federal regulations also require that the school respond to requests from any member of the public for information regarding FCOIs reported to NIH that are associated with PHS‐funded research.
Grant and contract submission requires disclosure of potential conflicts related to the research to the Office of Research Administration (ORA) and in eDisclose. The Conflict of Interest Committee considers these disclosures for review and management.