Policy on Financial Conflicts of Interest in Research

Effective July 1, 2018

Brandeis University is committed to overseeing the conduct of research in a manner that ensures the integrity of the research process and maintains the public trust and that of sponsors in the integrity and credibility of its faculty, its staff and its research programs.

This commitment requires Brandeis University to ensure that research results are not biased by the external financial interests of persons who are responsible for the design, conduct, reporting or direct administration of sponsored research.

This policy addresses actual, potential and apparent financial conflicts of interest pertaining to sponsored research at the university. It applies to all sponsored projects as well as subawards issued by Brandeis University under the Office of Research Administration.

In accordance with this policy, all externally funded investigators, regardless of funding source, must report their (the sum of their own and their family's) external significant financial interests in a timely manner so that actual, potential and apparent financial conflicts of interest can be identified and responsibly managed.

Note that it is the principal investigator's responsibility to identify all investigators participating in the sponsored research project and ensure that all investigators comply with this policy.

Purpose of This Policy

The purpose of this policy is to identify and address financial conflicts of interest to assure that they do not improperly affect the research activities of the university. The university and its investigators are committed to conducting themselves and university activities in accordance with the highest standards of integrity and ethics, and in compliance with applicable state and federal laws related to financial conflicts of interest and objectivity in research.

The premise of this policy is that each member of the Brandeis research community has an obligation to act in the best interests of the university and must not permit outside financial interests to interfere with that obligation. This policy is intended to increase the awareness of investigators to the potential for financial conflicts of interest, and to establish a process whereby such conflicts, actual, potential or apparent, may be properly managed or avoided.

Applicability

This policy applies to all investigators (as defined below) responsible for sponsored research activities at the university. The university's existing institutional conflict of interest policy remains in effect and applies to all other situations involving the disclosure and resolution of conflicts that are not explicitly covered by this policy.

All investigators engaged in PHS-funded research or research funded by those agencies who have adopted the PHS regulations are also subject to the additional requirements set forth in Appendix A.

All investigators involved in research funded by Health and Human Services contracts must comply with additional requirements as explicated on the CMS Contracts webpage.

Policy Details

This policy is predicated on the expectation that Investigators will conduct their research in a manner that avoids or minimizes conflicts of interest, and will respond appropriately when conflicts of interest arise. To that end, this policy informs investigators about situations that generate financial conflicts of interest related to research and provides mechanisms for investigators and the institution to manage those conflicts that arise. Every investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an investigator should discuss the situation with the institutional official.

Definitions

1. Report and Disclosure of Significant Financial Interests

All investigators are required to disclose their (the sum of their own and their family's) outside significant financial interests to the institution prior to the institution's submission of a sponsored research proposal and on an ad hoc basis, as described below. The institutional official is responsible for the distribution, receipt, processing, review and retention of disclosure forms. Regardless of the disclosure requirements, the investigator, in his or her own best interest, is encouraged to disclose any financial interest that could be reasonably perceived to present a conflict of interest.

  1. Initial Reporting and Disclosures

When submitting an application or proposal package for a sponsored project, investigators are required to disclose whether or not they or their family have outside financial interests that are significant financial interests. In the event a significant financial interest is reported, a significant financial interest disclosure form (pdf) must be submitted to the institutional official for each occurrence of significant financial interest.

In addition, new investigators joining the research team of an ongoing sponsored project must submit to the institutional official a significant financial interest report (pdf), along with any required significant financial interest disclosure forms (pdf), within 30 days of their initial involvement with the project.

  1. Ad hoc Disclosures

All investigators must submit to the institutional official an ad hoc significant financial interest disclosure form (pdf) disclosing any significant financial interest they or their family acquire (e.g., through purchase, marriage or inheritance) within 30 days of discovering or acquiring the significant financial interest.

2. Review of Significant Financial Interest Disclosures

All disclosure forms revealing a significant financial Interest will be reviewed promptly by the institutional official or designee for a determination of whether the significant financial interest constitutes a financial conflict of interest. If a financial conflict of interest exists, the institutional official will take action to eliminate, reduce or manage the conflict, as appropriate. The institutional official may, at his or her discretion, convene a committee for guidance in specific cases, or in the application of this policy to particular situations.

A financial conflict of interest will exist when the institutional official or designee determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of sponsored research. If it is determined that there is a financial conflict of interest that can be managed, the institutional official or designee will develop a conflict management plan that specifies the actions that have been, or shall be, taken to manage the financial conflict of interest. The conflict management plan must be approved by the institutional official before any related research goes forward.

To address complex situations, oversight committees may be established by the institutional official to periodically review the ongoing activity, to monitor the conduct of the activity, to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the conflict management plan.

In the event the investigator is dissatisfied with the decision of the institutional official, the investigator may file a petition in writing with the institutional official, who will review the decision in consultation with a committee and the investigator and make the final determination.

3. Reporting to Agency

Should any deemed conflict or noncompliance require reporting to a particular funding agency, the institutional official will report in accordance with applicable agency regulations. If the funding for the research is made available from a prime awardee, such reporting shall be made available to the prime awardee such that they may fulfill their reporting obligations to the agency. For Nastional Science Foundation-funded research, the institutional official will keep the NSF's Office of the General Counsel appropriately informed if it finds the institution is unable to satisfactorily manage a conflict of interest.

4. Investigator Noncompliance

  1. Retrospective Review

In the event the institutional official determines that (1) a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or (2) an Investigator failed to materially comply with a Conflict Management Plan for a Financial Conflict of Interest, a committee appointed by the Institutional Official will complete a retrospective review within 120 days of the Institution’s determination of noncompliance to establish whether the Research conducted during the period of non-compliance was biased in the design, conduct, or reporting of the Research.

Documentation of the retrospective review shall include the project number, project title, name of the Principal Investigator, name of the Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.

The Institutional Official will update any previously submitted report to the funding agency or the prime awardee relating to the Research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the report will include a mitigation report in accordance with the applicable regulations, including a description of the impact of the bias on the Research project and the plan of action to eliminate or mitigate the effect of the bias.

  1. Disciplinary Action

In the event of an investigator’s failure to comply with this policy, the institutional official may suspend all relevant activities or take other disciplinary action until the matter is resolved.

An institutional official's decision to impose sanctions on an investigator because of failure to comply with this policy, or failure to comply with the decision of the institutional official, will be described in a written explanation of the decision to the investigator along with the individual's right to appeal the decision.

5. Subrecipient Requirements

Brandeis must take reasonable steps to confirm that all investigators who are subrecipients participating in externally funded research are subject to conflict of interest rules and procedures that comply with the requirements of the applicable funder.

Each subrecipient must provide assurances to Brandeis that it has policies and procedures that comply with the requirements of the funder or otherwise adopt this policy as their own prior to submission of externally funded research proposals or applications and execution of a written agreement between Brandeis and the subrecipient. Subrecipients will complete the Brandeis significant financial interest report for subrecipients if they do not have their own policy, as well as the significant financial interest disclosure for subrecipients, when applicable.

6. Record Retention

The institutional official will maintain a database of all disclosures of significant financial interests, conflict management plans and related documents for a period of three years from the date the final expenditure report is submitted to the agency or to the prime awardee.

7. Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans and related information will be confidential. However, the institution may make such information available to (1) an agency funding the research of an investigator, (2) to a requestor of information concerning financial conflict of interest related to funding or (3) the primary entity who made the funding available to the institution, if requested or required. If the institution is requested to provide disclosure forms, conflict management plans and related information to an outside entity, the investigator will be informed of this disclosure.

Appendix A

Additional Requirements on Financial Conflicts of Interest Related to Public Health Service Funding

Effective Aug. 24, 2012

Agencies Subject to Appendix A