All researchers conducting human subjects research have an ethical responsibility to disclose a real or perceived financial conflict of interest to COUHES in their initial application, continuing review questionnaire, or anytime the researcher’s Financial Interests (FI) change.
A conflict of interest (COI) can be any situation in which financial interests (FI) or other personal considerations have the potential to compromise a researcher’s professional judgment and objectivity in the design, conduct or reporting of research. MIT has a responsibility to ensure that its teaching and research environment fosters the generation of new knowledge and positive learning opportunities for students and preserves the integrity of its research enterprise and the public’s trust. MIT policy, therefore, requires that MIT officers, faculty, and staff and others acting on its behalf avoid or mitigate real or perceived financial conflicts of interest and ensure that their activities and interests do not conflict with their obligations to MIT or its welfare. Each Study Personnel/Investigator must submit a Supplement for Disclosure of Financial Interest if a Financial Interest exists. The Supplement will be reviewed by the COUHES Chairman and the MIT COI Officer, as appropriate, in accordance with MIT’s Financial Conflicts of Interest in research policy. COUHES will evaluate whether a disclosed Financial Interest needs to be included in the consent document or managed to address the potential for coercion. Any questions about a potential COI or the MIT COI policy should be discussed with the department, lab or center head, or MIT’s COI Officer (firstname.lastname@example.org). For all COUHES specific policy, process and forms related questions, please e-mail (email@example.com).
Study Personnel/Investigator: means the individual or individuals who are independently responsible for the design, conduct, or reporting of the research project. This is typically, the principal investigator and any co-principal investigator (i.e. the project leadership), though in some cases the principal investigator may determine that others are independently responsible for the project.
Family: means an Investigator’s spouse or domestic partner and dependent children.
Financial Interest: Study personnel/investigators and their Family are not permitted to have financial interests that could reasonably appear to be related to the research (e.g. evaluation of a drug, device, software, technology, method, etc.). The following activities by the researcher or their Family constitute a financial interest in the research:
- A position as director, officer, partner, trustee, consultant or employee of, or any position of management in a Related Entity
- An investment or Equity interest in a Related Entity
- Any Remuneration from a Related Entity. This includes but is not limited to, salaries and wages, consulting income, honoraria for services performed, per diem, reimbursement for travel or other expenses, rental income, dividends and interest, and proceeds from sales.
- Loan(s) from a Related Entity.
- Gift(s) from a Related Entity.
- An intellectual property interest on a patent, patent application or copyright that is related to the proposed research. This includes intellectual property assigned or licensed to M.I.T.
Financial Conflict of Interest is a FI that MIT reasonably determines could directly and significantly affect the design, conduct, or reporting of research
Related Entity: means any domestic or foreign, public or private, for profit, non-profit or governmental organization in which the Investigator, alone or in combination with his or her Family, holds a Financial Interest.
Remuneration: includes salary and payments for services, such as consulting fees, honoraria or paid authorship, and cash or in kind gifts from entities for which you provide services and, for PHS Investigators, Sponsored Travel.
Sponsored Travel: (applies only to PHS Investigators) means (a) travel expenses paid to an Investigator or travel paid on an Investigator’s behalf, by a single entity in any 12-month period and (b) travel reimbursed to or paid on behalf of Study Personnel/Investigator’s Family by a single entity in any 12-month period ONLY if such travel reasonably appears to be related to the Investigator’s Institutional Responsibilities. See the PHS Addendum for more information.
Institutional Responsibilities: means the Investigator’s responsibilities associated with his or her MIT appointment or position, such as research; teaching; administration; conference attendance, research presentations or lectures at other universities or uncompensated publication review; and service on MIT committees.