I. Purpose and Scope
This policy is designed to promote objectivity in research, to assist in the identification of individual and organizational potential and actual financial conflicts of interest related to the design, conduct or reporting of research and sponsored programs, and to support compliance with government regulations applicable to financial or beneficial conflicts of interest.
The policy implements the requirements of certain federal regulations, as defined herein, and applies to all projects funded directly or indirectly, through a subaward from another organization, by the Public Health Service of the U.S. Department of Health and Human Services (PHS), including all PHS agencies, other than Phase One SBIR or STTR awards (collectively the “PHS Regulations”).
It also applies to research funded by other federal funding agencies (e.g. NASA) or other non-federal funding agencies (e.g., American Cancer Society) that follow PHS regulations as well as other federal funding agencies, including but not limited NSF, DOD, DOE, NIJ, or non-federal agencies that include Financial Conflict of Interest terms as a condition of award. This policy does not apply to awards where the funding agency has specifically exempted the award from financial conflicts of interest requirements.
This policy is complementary to Northeastern University’s Policy on Conflict of Commitment and Interest, the Policy on Faculty Outside Professional Activities in the Faculty Handbook, and the Policy on External International Engagements. This policy applies to all faculty and staff members responsible for the design, conduct or reporting of extramurally funded research at Northeastern University.
A. Aggregate: The total of all remuneration, sponsored travel, any equity interests and all other monies from a single source in a 12-month period.
B. Conflict of Commitment: A situation in which an employee engages in an outside professional activity, paid or unpaid, that involves a commitment of time that may interfere, or appear to interfere, with fulfillment of the employee’s obligations to the university, even if the outside activity is valuable to the university or contributes to the employee’s professional development and competence. Conflicts of Commitment may also arise when an external entity attempts to impose an obligation to improperly share information with or withhold information from the university.
C. Designated Official: The Senior Vice Provost for Research or their designee who is ultimately responsible for the review of disclosures of Significant Financial Interests, the design of a management plan related to any relevant Financial Conflicts of Interest and reporting of the interest in accordance with applicable federal agency requirements. The Designated Official may seek guidance from the Research Integrity Committee, as necessary in formulating management plans and will work with appropriate college leadership in the design and execution of the management plan.
D. DOE Regulations: Generally refers to the Department of Energy’s (DOE) regulation entitled Department of Energy Conflict of Interest Policy Requirements for Financial Assistance (FAL 2-22-02), as updated or revised. DOE may require disclosure and review of individual and organizational conflicts of interest.
E. DOD Regulations: Generally refers to to the Department of Defense (DOD) Grant and Agreement Regulations, Part 21, Sec. 32.42, as updated or revised. DOD may require disclosure and review of individual and organizational conflicts of interest.
F. Equity Interests: Refer to stock, stock options, warrants, and other existing or contingent ownership interests.
G. Family: Means an Investigator’s spouse or domestic partner, and dependent children.
H. Financial Conflict of Interest: A Significant Financial Interest, as defined below, that Northeastern University reasonably determines could directly and significantly affect the design, conduct, or reporting of research.
I. Institutional Responsibilities: The Investigator’s responsibilities associated with his or her Northeastern University appointment or position, such as teaching, scholarship, research, creative activity, service, etc. as defined in the Faculty Handbook.
J. Investigator: Includes, but is not limited to, the project director (PD), principal investigator (PI), any co-PI, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or proposed for such funding, which may include, for example, collaborators or consultants.
K. NIJ Regulation: Refers to the National Institutes of Justice (NIJ) requirements for Conflict of Interest and Commitment for individuals as outlined in the NIJ Research Integrity & Validity Policy, as updated or revised. NIJ may require disclosure and review of individual and organizational conflicts of interest.
L. NSF Regulation: Refers to the National Science Foundation (NSF) requirements for Conflict of Interest as outlined in the Proposal & Award Policies & Procedures Guide (PAPPG), as updated or revised. NSF conflict of interest policies applies to research and educational activities.
M. Outside Professional Activities: Means compensated and uncompensated activities undertaken outside of an Investigator’s Institutional Responsibilities, relate to the Investigator’s area of professional expertise.
N. PHS Regulations: Refers to the Public Health Agency’s (PHS) regulations entitled “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R. Part 50, Subpart F) and “Responsible Prospective Contractors” (45 C.F.R. Part 94). The National Aeronautics and Space Administration (NASA) has implemented and follows the PHS regulations.
O. Research Integrity Committee: is comprised of faculty responsible for advising on research integrity matters, including conflicts of interest and commitment by offering guidance on feasible management plans, consistent with this policy.
P. Remuneration: Includes salary and payments for services, such as consulting fees, Honoria or paid authorship.
Q. Senior/Key Personnel: Are identified in the grant application, progress report, or any other report submitted to a funding agency, and include, but are not limited to, the PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation.
R. Significant Financial Interest:
1. A financial interest or income received or held by an Investigator, alone or in combination with their Family (and not expressly excluded below) that reasonably appears to be related to the Investigator’s Institutional Responsibilities. Examples of Significant Financial Interests that must be disclosed are:
a. Interest or income in or from a publicly traded entity where:
- The aggregate value of the remuneration and the value of any equity interest as of the date of disclosure exceeds the funding agency’s threshold. For example, the PHS threshold is $5,000. This includes any remuneration received during the 12-month period preceding the disclosure, or expected to be received in the 12 months after the disclosure; or
- The entity is sponsoring any of the Investigator’s research.
- Interest or income in or from a non-publicly traded entity where the aggregate value of remuneration exceeds the funding agency’s threshold. For example, the PHS threshold is $5,000. This includes when any equity interests are held.
b. Interest in the form of income related to intellectual property rights and interests paid by an entity other than Northeastern University.
c. Sponsored Travel related to Institutional responsibilities not reimbursed or sponsored by Northeastern University, as defined below; or
d. As specifically defined by the funding agency.
- Significant financial interest does not include:
a. Remuneration of royalties paid by Northeastern University to the Investigator;
b. Remuneration from authorship of academic or scholarly works;
c. Remuneration and sponsored/reimbursed travel related to seminars, lectures, or teaching engagements sponsored by, or from advisory committees or review panels for:
– Federal, state, or local governmental agencies;
– U.S. institutes of higher education;
– U.S. research institutes affiliated with institutes of higher education; and
– Academic teaching hospitals, and medical centers.
d. Equity interests in or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions for such vehicles; or
e. As specifically defined by the funding agency.
S. Sponsored Travel: Travel expenses paid to or on behalf of an Investigator by a single external entity in a 12-month period; including travel imbursed or paid on behalf of an Investigator’s Family member by a single external entity within a 12-month period if such travel reasonably appears to be related to the Investigator’s Institutional Responsibilities.
A. DISCLOSURE REQUIREMENTS
Full and prompt disclosure is critical to Northeastern University’s ability to identify, manage, and eliminate financial conflicts of interest. There are three types of disclosures:
1. Annual Disclosure. Investigators, as defined above, must disclose their significant financial interests and commitments to Northeastern University on an annual basis. This disclosure is part of the university’s annual conflicts of commitment and interest disclosure.
2. Proposal-related Disclosures. Prior to submitting a proposal for funding, any investigators identified in the proposal and other project personnel, if requested by the Designated Official or designee, must disclose whether any Investigator holds any Significant Financial Interest and if so, how they may be related to the Investigator’s Institutional Responsibilities. If there is a potential relationship, the Investigator must file a full disclosure with additional information regarding the relationship of the project to the Significant Financial Interest prior to the submission of the proposal to the funding agency.
a. A funding agency may, from time to time, require Northeastern to collect disclosures for all faculty, staff, students, and other contributors participating in the purpose, design, conducting, or reporting of the proposed project.
b. In such cases, the university may be required to collect Ad Hoc Disclosures from students or external contributors (as needed) to fulfill this requirement.
- Ad Hoc Disclosures. An investigator must disclose, on an ad hoc basis, any newly acquired or discovered Significant Financial Interest or commitment:
a. Within 30 days following the date on which the Significant Financial Interest is acquired or arises;
b. Prior to the Investigator commencing participation in any research project the Investigator is joining; or
c. Within 30 days of being hired by the university.
B. DISCLOSURE REQUIREMENTS
1. In addition to the disclosures required by the Conflict of Interest and Commitment Policy, the PHS Regulations require Investigators to disclose to Northeastern University, any Sponsored Travel undertaken by the Investigator related to his or her Institutional Responsibilities, as defined above. Such Sponsored Travel must be included in the aggregate value when calculating an Investigator’s financial interests, in order to determine whether the Sponsored Travel rises to the level of Significant Financial Interest.
2. Travel disclosures must be made if travel is reimbursed or sponsored by an organization other than:
a. Northeastern University;
b. Federal, state or local governmental agencies;
c. U.S. institutions of higher education;
d. U.S. research institutes affiliated with institutes of higher education; and
e. U.S. academic teaching hospitals and medical centers.
All travel reimbursed or sponsored by a non-U.S. entity must be reported, and may be reported to any relevant federal funding agency as required by their regulatory requirements.
3. Such disclosures must be made by the Investigator within 30 days following reimbursement or within 30 days following the completion of the trip if the organization or entity funds the travel directly.
4. The travel disclosure must include at a minimum, the purpose of the trip, the identity of the organization or entity funding the travel, the destination, and the duration of the trip (usually measured in days).
C. Review and Management of Disclossures
1. The Financial Conflict of Interest regulations in this policy require Northeastern to evaluate all Investigator disclosures against the scope of the award to determine if any interests could influence the design, conduct or reporting of the research (i.e. SFI determinations or other reportable financial or beneficial interests). NU-RES initiates the evaluation by the Designated Official.
2. If a SFI or other reportable conflict is reported by the Designated Official, NU-RES will work with the Designated Official and the Research Integrity Committee to craft a project management plan and report the conflict to the funding agency in accordance with their specific procedures. A project management plan is distinct from Conflict Management and Avoidance Plans (CMAPs) which may be required under the university’s Policy on Conflict of Interest and Commitment. CMAPs are designed to balance outside interests against commitments to the university, while the project management plan is designed to ensure the objectivity of results relative to a specific, externally funded project.
3. As outlined in the Rights in Teaching, Research and Scholarship’s Conflict of Interest and Commitment obligations reinforce that faculty’s “primary energies and professional interests” lie with the university. Thus, unique challenges may be presented with respect to SBIR/STTR Phase II awards, which often require synergy between the faculty and start-up in which they may have an interest. SBIR/STTR programs have specific terms and conditions that vary by funding agency, program, and contract. Thus Financial Conflicts of Interest related to such awards will be assessed based on the specific fact pattern presented.
D. Required Public Disclosures
Funding agency regulations include a requirement for Northeastern University to respond to public requests for information regarding Financial Conflicts of Interests related to awards subject to the funding agency’s regulations. Northeastern University must respond to any public request for information within five (5) business days. a
E. Subawards Issued by Northeastern University Subject to Conflict of Interest Regulations
1. When Northeastern University issues a subaward to another organization to carry out a portion of a funded project that has implemented requirements for evaluating and managing conflicts of interest, Northeastern is required by regulation to include those requirements in all subawards at any tier.
a. When issuing subawards under such awards, Northeastern University will require subrecipient organizations have a financial conflict of interest policy that complies with the relevant regulations or the subrecipient must be willing to comply with the Northeastern policy and procedures as it relates to the specific subaward.
b. This requirement will be set forth in the Northeastern University subaward.
c. Exceptions to this policy must be approved by the Designated Official.
- If a subrecipient Investigator has a Financial Conflict of Interest, Northeastern University is responsible for reporting the Financial Conflict of Interest to the funding agency on behalf of the subrecipient.
a. Subrecipients must report Financial Conflicts of Interest to Northeastern University within 45 days of discovering the Financial Conflict of Interest so that Northeastern University may report it to the funding agency in a timely manner.
b. Northeastern University may be required by the relevant regulations to make information regarding subrecipient Financial Conflict of Interest available to the public in the same manner that Northeastern University uses to with respect to its own Financial Conflict of Interest disclosures, see the section above on Required Public Disclosures.
c. Northeastern University will notify the subrecipient of any requests for information.
d. Questions regarding the specifics of a subrecipient’s Financial Conflict of Interest will be directed to the subrecipient.
F. Subawards Issued to Northeastern University Subject to Conflict of Interest Regulations
When Northeastern University makes a proposal for or receives a subaward from a Pass-Through Entity (PTE) to carry out a portion of a project subject to conflict of interest regulations, Northeastern University must comply with the relevant regulations regarding Financial Conflicts of Interest.
1. This Policy, which covers the obligations set forth under such regulations applies to these proposals and awards rather than the policies of the Pass-Through Entity.
2. In the event a Financial Conflict of Interest is identified under a subaward, Northeastern University will provide the Pass-Through Entity with the project management plan described above.
3. Reports are provided in the same form and format as Northeastern University uses in connection with its direct awards.
4. The Pass-Through Entity is also responsible for any public accessibility reporting as required by any applicable regulation, see the section above on Required Public Disclosures.
5. The Pass-Through Entity may also be subject to state-specific disclosure requirements.
G. Retrospective Review
1. Retrospective reviews will be conducted in cases where a Financial Conflict of Interest is not identified or managed in a timely manner due to any of the following:
a. Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
b. Failure by Northeastern University to review or manage such a Financial Conflict of Interest; or
c. Failure by the Investigator to comply with a Financial Conflict of Interest management plan.
2. Northeastern University must, within 60 days of its determination of non-compliance, complete a retrospective review of the Investigator’s activities and the funded research to determine whether the design, conduct, or reporting of the funded research, or any portion thereof, conducted during the period of non-compliance, was biased.
3. Retrospective reviews will be conducted by NU-RES in consultation with the respective College Dean’s Office, the Designated Official, the Research Integrity Committee, the Office of General Counsel, and the University Compliance Department.
Northeastern University must provide training regarding this policy and the PHS, NASA and DOE Regulations to Investigators.
1. Investigators must complete the training prior to engaging in research related to any project subject to the PHS, NASA and DOE Regulations, and
2. At least every four (4) years thereafter. Investigators must also complete training immediately when:
a. The Financial Conflict of Interest Policy is substantively amended in a manner that affects the requirements of Investigators;
b. Northeastern University determines that the Investigator has not complied with this Policy or with a management plan related to his or her research; or
c. An Investigator is new to Northeastern University.
3. Training is provided through the Collaborative Institutional Training Initiative (CITI). More information can be found at Northeastern University’s Research Training webpage.
I. Record Retention
As it pertains to the requirements of this policy, on behalf of the Designated Official, NU-RES will retain all disclosures, conflict management plans, and related documents for a period of at least seven (7) years following submission of the final expenditure report for the applicable project to the funding agency or Pass Through Entity, unless any litigation, claim or negotiation, audit, or other action involving the records is commenced before expiration of the seven-year period, in which case, records will be retained until completion of the action and resolution of all issues.
IV. Additional Information
Please visit the NU-RES Financial Conflict of Interest webpage (https://research.northeastern.edu/nu-res/compliance/compliance-committees-programs/financial-conflict-of-interest/) for additional information.
Principal Investigator; Financial Conflict of Interest; Conflict of Commitment; Significant Financial Interest; Public Health Service; Department of Health and Human Services; Objectivity in Research
Last Revision Date: May 31, 2023
Issued: August 24, 2012