An investigator has a conflict of interest in a research study when he/she has interests in the outcome of the research that might compromise the integrity of the research.
To ensure the objectivity of the research, an investigator conducting human subjects research, has an ethical responsibility to disclose a possible conflict of interest or the possible appearance of a conflict of interest.
Investigators must, in the above types of research, disclose to COUHES all existing financial interests in the research as part of their initial application, continuing review submissions and at any time the investigators’ interest changes. If a financial interest exists then investigators must submit a Supplement for Disclosure of Financial Interest form for each key personnel associated with the research.
This Supplement will be reviewed as appropriate by the COUHES Chairman, the Director of the Office of Sponsored Programs and the Vice President of Research. This review will be conducted in accordance with MIT’s policy of financial conflicts of interest in research.
In addition, COUHES will evaluate whether a disclosed interest needs to be included in the consent document, or otherwise managed to address the potential for coercion.
A financial interest may be in:
- any item (drug, device, software, technology, method etc) being evaluated, or
- an entity that is a sponsor of the research or is an entity that would reasonably appear to be affected by the research.
Financial interests include, but are not limited to the following:
- A position as director, officer, partner, trustee, consultant or employee of, or any position of management in a related entity
- An investment or ownership interest in a related entity, including stocks, bonds, warrants and options.
- Any income 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.
- A loan from a related entity.
- A gift or gifts 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.
An individual’s interests also include interests held by a spouse, domestic partner or child.