Financial Conflict of Interest in Research (INTERIM)

Policy Statement

Sponsored funding is an important part of supporting faculty research and creative scholarship. Faculty and staff of the College have an obligation to scrupulously maintain the objectivity of their research and scholarship, and avoid any conflicts of interest. In addition, faculty and staff whose work is supported by public funds incur a special obligation to preserve the public trust. The Federal Government requires assurance that faculty members are aware of potential conflicts of interest arising from interrelationships with Federal agencies and commercial entities, and of their obligation to notify appropriate College officials of all outside activities that may have conflict of interest implications.

Accordingly, it is incumbent on faculty and staff to report all significant financial interests held by themselves, their spouses, and their dependent children related to their institutional responsibilities, so as to ensure that the design, conduct, management and reporting of federally funded research will not be biased by any related significant financial interest.

This policy applies to any employee of Emerson College who is responsible for the design, conduct, or reporting of research and scholarly activities funded, or proposed for funding, by federal agencies. Additional requirements are applicable to research that is funded by the Public Health Service, as outlined in the policy.

Reason for Policy

Emerson College has developed this policy to protect the integrity of sponsored research and scholarship, promote objectivity in research, and to comply with federal regulations.¹ These regulations require that any faculty and staff member in a position to influence the outcome of a federally funded project take one of the following actions:

• Assert that he or she has no financial conflict of interest with regard to the project, or
• Report any conflict that does exist with regard to the project, or any financial concerns that could potentially be perceived as a conflict of interest

It is the intent and policy of Emerson, as an institution of higher education in receipt of federal research support, to comply with present and future regulations. Specifically, the intent of this policy is to identify and eliminate, or manage, any possible threat to research objectivity at Emerson.

Definitions

Conflict Management Plan (CMP): A plan, submitted by the Investigator, that proposes steps that could be taken to manage, reduce, or eliminate a Financial Conflict of Interest. The submission of a CMP proposal follows a determination by the College that a significant financial conflict of interest exists for the Investigator.

Designated Institutional Official (DIO): the institutional official tasked with reviewing disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the federally-funded research. The Designated Institutional Official (DIO) for Emerson College is the Assistant Provost.

Disclosure of Significant Financial Interests: An Investigator's disclosure of significant financial interests to Emerson College. An Investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest.

Disclosure Review Committee (DRC): The ad-hoc Emerson committee charged with protecting the integrity of Emerson’s externally-funded research enterprise by reviewing and resolving financial conflicts of interest. The Faculty Development and Research Council (FDRC) serves as Emerson’s DRC.

Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of externally funded research.

FCOI Report: Emerson’s report of a financial conflict of interest to a sponsor. Investigator: the Project Director or Principal Investigator, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of externally funded work, which may include, for example, collaborators or consultants.

Investigator: The Project Director or Principal Investigator, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of externally funded work, which may include, for example, collaborators or consultants.

Public Health Service (PHS): The Public Health Service of the U.S. Department of Health and Human Services (DHHS), and any components of the PHS, including the National Institutes of Health (NIH).

Significant Financial Interest (SFI): a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).

The term “significant financial interest” does not include the following types of financial interests:

1. Salary, royalties, or other remuneration paid by the College to the Investigator if the Investigator is currently employed or otherwise appointed by the College;
2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; '
3. Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, or an institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, or an Institution of higher education.

Statements of Elaboration of Policy

I. Responsibilities of Emerson College Regarding Investigator Financial Conflicts of Interest

1. Emerson shall maintain up-to-date, written, enforced policy on financial conflicts of interest that complies with “Subpart F—Promoting Objectivity in Research” from Title 42 of the Code of Federal Regulations, and with Subpart B, §200.112, ‘Conflict of Interest,” from CFR Title 2.² The policy must be made available via a publicly accessible web site. If the policy does not have any current presence on a publicly accessible web site, Emerson shall make its written policy available to any requestor within five business days of a request.
2. Emerson shall designate an institutional official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research. The Designated Institutional Official (DIO) for Emerson College is the Assistant Vice President for Faculty Affairs.
3. Emerson shall inform each Investigator of the Institution's policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of these regulations,
4. Emerson shall takes steps to ensure that any subrecipients that are supported by federally-funded research will comply with these requirements, either by incorporating terms to this effect into a written agreement with the subrecipient institution, or by obtaining written certification from the subrecipient that its own policy is consistent with these federal regulations.
5. Emerson shall require that each Investigator who is participating in federally-funded research submit a completed Disclosure of Financial Conflict of Interest Form prior to engaging in a federally-funded project.
6. Emerson shall require that each Investigator who is participating in federally-funded research submit an updated Disclosure of Financial Conflict of Interest Form at least annually during the period of the award.
7. Emerson shall require that each Investigator who is participating in federally-funded research to submit an updated Disclosure of Financial Conflict of Interest Form within thirty (30) days of the Investigator acquiring or receiving new Significant Financial Interests.

II. Required COI and Responsible Conduct of Research Training for Federally-Funded Investigators

1. All researchers funded by any federal agency must have completed the "Responsible Conduct of Research" training³ and received their certification for completion of the training prior to beginning work on a federal grant. This requirement applies to faculty, postdoctoral associates, graduate students, undergraduate students, and staff who are or will be working on a federally-funded project.
2. Each PHS-funded Investigator must complete Conflict of Interest Training⁴ prior to engaging in research related to any PHS-funded grant, and at least every four years thereafter while the grant is active, or at other times when required by the Designated Institutional Official.

III. Avoidance of Financially Conflicting Interests.

1. Faculty members should not permit outside activities and financial interests to compromise their primary commitment to the mission of Emerson College, and their academic activities.
2. Faculty members should refrain from actions that could reasonably discredit the College and their academic and scholarly integrity, and they should avoid circumstances that a reasonable observer would believe create an undue risk that the prospect of personal financial gain could inappropriately influence a faculty member’s judgment or actions in fulfilling their academic and scholarly obligations.

IV. Process for Internal Disclosure of Financial Interests.

1. Each Investigator covered by this policy will annually report whether or not they have Significant Financial Interests (SFI) related to their institutional responsibilities according to the following schedule:
   1. At the time of application for sponsored funding,
   2. At least annually thereafter during the period of research activity, with submittal of the annual disclosure coinciding with the due date of the project’s Progress Report, and
   3. At any time during the research within thirty days of the discovery or acquisition of a new reportable financial interest.
2. An Investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest.
3. All Disclosure Statements and related documents are considered sensitive information. As such, they will be treated as confidential and will not be disclosed to anyone outside the DIO, the Disclosure Review Committee, and its staff without the Investigator's consent except:
   1. In response to a request from a sponsor; or
   2. Pursuant to a judicial order or lawfully issued subpoena.

V. Disclosure Review

1. The Executive Director of the Office of Research and Creative Scholarship will perform the initial review of Disclosure Statements.
2. If a Disclosure Statement does not report any Significant Financial interests, the form will be countersigned by ORCS and securely saved in a password-protected electronic file folder.
3. If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the DIO or designee to determine whether the SFI constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the DIO will determine a course of action to eliminate, reduce, or manage the conflict, as appropriate. The DIO will consult as appropriate with relevant colleagues, including the Provost, ORCS, school deans, department chairs, and Office of the General Counsel to develop and implement a Conflict Management Plan (see Section VI, “Conflict Management Plans”).
4. In instances when the DIO cannot make a determination as to how an FCOI may be managed, a Disclosure Review Committee (DRC) will review the disclosure statement. The FDRC, which consists of faculty representing all of Emerson’s academic departments, serves as Emerson’s DRC.
5. The DRC has 60 days to determine whether the Significant Financial Interests of the Investigator (and immediate family) could reasonably be expected to affect the design, schedule, conduct, or reporting of the activities funded or proposed for funding, and, if so related, whether the Significant Financial Interest represents an FCOI. An Investigator's Significant Financial Interest is related to the research when the DRC reasonably determines that the SFI could be affected by the research; or is in an entity whose financial interest could be affected by the research. The DRC may involve the Investigator in its determination of whether an SFI is related to the research. The DRC may request additional clarifying information from the individual, which will be treated as non-public information to the extent allowed by law.
6. If an FCOI exists, the DRC shall request the Investigator submit a proposed Conflict Management Plan that details steps that could be taken to manage, reduce, or eliminate the FCOI. The DRC shall review the proposed CMP and approve it, or add conditions or restrictions to ensure that any conflict is managed, reduced, or eliminated.
7. The DIO and ORCS will be responsible for monitoring Investigator compliance with a CMP until completion of the project.
8. In all cases, resolution of the FCOI or establishment of an acceptable CMP must be achieved before expenditure of any externally funded award to Emerson.

VI. Conflict Management Plans.

1. Pursuant to Section V, paragraphs F, G, and H, if an FCOI exists, the DIO and/or the DRC shall request the Investigator submit a proposed Conflict Management Plan that details steps that could be taken to manage, reduce, or eliminate the FCOI. The DIO and/or the DRC shall review the proposed CMP and approve it, or add conditions or restrictions to ensure that any conflict is managed, reduced, or eliminated.
2. Such conditions or restrictions may include, but are not limited to, the following:
   1. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
   2. Monitoring of the research by independent reviewers;
   3. Modification of the planned activities (possibly subject to sponsor approval);
   4. Disqualification from participation in all or part of the project;
   5. Divestiture of significant financial interests;
   6. Severance of relationships creating conflict;

VII. Retrospective Review

1. When a previously unreported Significant Financial Interest is retrospectively reported during an ongoing project, the DIO shall:
   1. Review the significant financial interest within sixty (60) days; determine whether it is related to federally-funded research;
   2. Determine whether an FCOI exists;
   3. Follow the steps outlined in Section VI, “Conflict Management Plans.”
2. In addition, whenever an FCOI is not identified or managed in a timely manner and is subsequently determined by the DIO and/or the DRC to constitute a FCOI on a federally-funded project, the DIO, working with ORCS, shall, within 120 business days of determination of noncompliance:
   1. Complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research;
   2. The DIO and ORCS shall document the retrospective review including; reason(s) for the retrospective review; detailed methodology used for the retrospective review; findings of the review; and conclusions of the review;
   3. Based on the results of the retrospective review, the DIO shall update the previously submitted FCOI report. The report shall specify any actions, if needed, that will be taken to manage the FCOI going forward.
   4. If bias is found, the DRC is required to notify the Federal Awarding Component promptly and submit a mitigation report. Thereafter, Emerson must submit FCOI reports annually. Depending on the nature of the financial conflict of interest, the DIO and/or the DRC may determine that additional interim measures are necessary with regard to the Investigator's participation in federally-funded research.

VIII. Appeals.

Appeals of the DRC's decision may be made to the Emerson’s General Counsel, who will consult with the Investigator, the Provost, the DIO, and the DRC. General Counsel will make a final determination, which shall be final and binding upon all parties, except for faculty who are members of the Emerson College Chapter of the American Association of University Professors (ECCAAUP) Collective Bargaining Agreement, who retain the right to grieve the decision via the grievance procedure outlined in Article 10 of the ECCAAUP Collective Bargaining Agreement.

IX. Compliance.

As part of the annual or updated Financial Disclosure Statement, each Investigator must certify that if the DRC determines a conflict exists, the Investigator will adhere to all conditions or restrictions imposed upon the project, and will cooperate fully with the individual(s) assigned to monitor compliance with this policy and all applicable federal guidelines.

X. Enforcement.

1. Failure to properly disclose relevant financial interests or to adhere to conditions or restriction imposed by the DRC will be considered a deviation from accepted standards of conducting research at Emerson. Alleged violations of this policy will be investigated by the DRC, which will make recommendations for action to the Provost. Breaches of policy include:
   1. Failure to file the necessary disclosure statements;
   2. Knowingly filing incomplete, erroneous, or misleading disclosure forms;
2. If a determination has been made that the policy has been violated, the Provost may impose sanctions, including notification to sponsor and termination of award; formal admonition; a letter to the Investigator's personnel file; and suspension of the privilege to apply for external funding and/or seek IRB approval.

XI. Records.

The Office of Research and Creative Scholarship will maintain records of all disclosures and associated activities securely and confidentially. All records will be maintained for three (3) years following the letter of termination or completion of the project or resolution of any government action involving the records. Records will not be routinely provided to PHS sponsors unless required by Federal law, or the agency submits a written request, or Emerson is unable to satisfactorily manage an actual or potential conflict of interest. The Executive Director for the Office of Research and Creative Scholarship will be responsible for communications with sponsors. Disclosure statements and associated information will not be released without notifying the Investigator.

Cross References to Related Policies:

Policy and Procedures for Responding to Allegations of Research Misconduct Ethics and Conflict of Interest Policy

Human Subject Research Principal Investigators of Sponsored Projects Policy

Research Integrity Training Policy

Responsible Officer

Executive Director Office for Research and Creative Scholarship

Key Offices to Contact

The Executive Director Office for Research and Creative Scholarship and Provost/Vice President for Academic Affairs are responsible for the oversight and implementation of this policy

Links to Procedures or Forms

• Emerson Financials Conflict of Interest Disclosure Form
• CITI Program “Responsible Conduct of Research (RCR)” Training
• CITI Program “Conflicts of Interest (COI)” Training

Interim Policy Updated: November 12, 2020

¹/strong>See “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)”: https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=992817854207767214895b1fa023755d&rgn=div5&view=text&node=42:1.0.1.4.23&idno=42#sp42.1.50.f

² “Conflict of Interest (2 CFR Part 200, Subpart B, §200.112)” https://www.ecfr.gov/cgi-bin/text-idx?node=2:1.1.2.2.1&rgn=div5#se2.1.200_1112

³ “CITI Responsible Conduct of Research Training” https://about.citiprogram.org/en/series/responsible-conduct-of-research-rcr/

⁴ “CITI Conflicts of Interest Training” https://www.citiprogram.org/index.cfm?pageID=85