The term “financial conflict of interest in research” refers to situations in which financial considerations may compromise, or have the appearance of compromising, a researcher’s professional judgment in designing, conducting or reporting research. The determination that one has a “conflict of interest” does not imply that the actions or character of an individual investigator are compromised.

Institutional Review Board 

Brown’s Institutional Review Board (IRB) is responsible for reviewing and approving research protocols to ensure that they protect the rights and welfare of human research participants and abide by University policy and applicable federal and state statutes and regulations.

Institutional Review Board (IRB)

Conflict of Interest Review Board

Brown’s Conflict of Interest Review Board is charged with reviewing certain financial disclosures related to Brown research programs, including human subject research. As the outside financial interests of Brown researchers may pose potential or real risks with respect to the rights and welfare of human research participants, Brown has established an integrated process of conflict of interest disclosure and institutional review that aims to accomplish the following:

• Protect the rights and welfare of human research participants
• Preserve objectivity and provide transparency in the design, conduct and reporting of human subject research
• Ensure appropriate disclosure of financial conflicts of interest to human research participants via the consent process, and/or manage, reduce or eliminate conflicts that could interfere with the integrity of the research

Conflict of Interest Review Board

Investigators

When submitting a human subjects research study for IRB review, the investigator is required to indicate whether they have a conflict of interest with the proposed research study. In addition, investigators must also have an up-to-date Conflict of Interest Reporting Form on file with the University. Investigators who have a form on file that is less than 12 months old will be prompted to submit one in Brown’s electronic COI system, InfoEd.

Conflict of Interest in Research

Conflict of interest questions are embedded throughout the protocol submission process, including for the initial submission, requests for amendment and continuing reviews, to facilitate disclosure to the IRB at appropriate points. As indicated in the form, all Brown investigators must make the requested disclosures.

Who Is Considered an Investigator?

An investigator means the project director or principal investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research, which may include postdoctoral fellows, collaborators or consultants. 

A Brown investigator is anyone working on a human subject study protocol that meets the above definition of an investigator and is either appointed by or employed by Brown (and, therefore, must abide by Brown’s Conflict of Interest in Research Policy.

A Brown investigator also means anyone working on a human subject study protocol who meets the above definition of an investigator and doesn’t have a compliant conflict of interest policy at their home institution that they must follow. For example, a collaborator at an affiliated hospital or another domestic research institution will have their own institutional conflict of interest policy and, therefore, they do not need to abide by Brown’s policy. 

However, independent consultants, partners from industry or collaborators from abroad are unlikely to have compliant (per federal regulations) conflict of interest policies, and, therefore, must abide by Brown’s Conflict of Interest in Research Policy. Those individuals must also report any significant financial interests related to the human subject research protocol.

Brown’s Conflict of Interest in Research Policy

Determining Whether an Interest is Related to Your Study

Related financial interests occur when the researcher, their spouse or registered domestic partner or their dependent children have a disclosable financial interest that would reasonably appear to be affected by the research, or when the entity in which the financial interests are held would reasonably appear to be affected by the research.

To assist in evaluating whether a financial interest is related, examples may include:

• Project results could be relevant to the development, manufacturing or improvement of products or services of the entity in which the researcher has a financial interest.
• Project results could validate a treatment approach that is the same or similar or competitive to the approach developed or offered by the entity in which the researcher has a financial interest.
• The researcher has a financial interest in an entity that might manufacture, commercialize or license a drug, device, procedure or any other product used in the project or that will predictably result from the project.
• The researcher has a financial interest in an entity and the project proposes to subcontract a portion of the work, lease property to the entity, make referral of participants to the entity or make purchases from the entity.
• The researcher has a financial interest in an entity that funds or participates in the project.

Requirements if a Conflict of Interest is Identified

The Research Integrity team coordinates conflict of interest review behind the scenes. Potential conflicts of interest are reviewed by the Research Integrity staff together with the Conflict of Interest Review Board. Similarly, if the Conflict of Interest Review Board is prompted to review a human subject investigator’s significant financial interest reported either through the annual conflict of interest process or via a transactional conflict of interest reporting form, the Conflict of Interest Review Board will provide relevant information to the IRB for its consideration.

The IRB will then evaluate whether a disclosure in the informed consent form or other actions are necessary. If disclosure is required and the investigator has not already included recommended disclosure language in the informed consent, then the IRB will specify acceptable language for the informed consent.

IRB-recommended language, including recommending verbiage for different types of situations, is provided in the Additional Consent Language guidance document, a supplement to the consent templates.

• Additional Consent Language
• Consent Forms for Research Participants

Recommendation of Limited Role

When a financial interest may affect the protection of human subjects, disclosure to potential human subjects and/or the public may not be a sufficient method of management of the conflict of interest. In such an instance, the Conflict of Interest Review Board and/or the IRB might recommend or require a limited role of the researcher with the financial interest in recruiting or consenting subjects or in analyzing data.

Disagreement with IRB Assessment

Ultimately, it is the institution’s responsibility to determine whether a significant financial interest is related to your research and, when it involves human subjects, to decide whether it is necessary to disclose such information to research participants. Any appeal to the institution’s determination must be requested in writing and include a detailed rationale as to why the significant financial interest does not create a financial conflict of interest.