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EMU Research

Policies and Procedures

INTRODUCTION

As the sponsored research environment becomes more complex and greater emphasis in placed on collaboration between both public and private entities, the potential for conflicts of interest increases. Eastern Michigan University, in its commitment to academic freedom, transparency, and the dissemination of research findings, as well as to upholding the public’s trust in science, has developed this conflict of interest policy so that financial conflicts can be identified, reviewed, and mitigated, creating an environment in which individual interests do not affect the objectivity necessary for research pursuits. 

This policy governing financial conflict of interest applies to all externally-sponsored Investigators of Eastern Michigan University. The Provost and Vice President of Academic Affairs is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institutional Official is implemented.  Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to Institutional policy.

DEFINITIONS

Sponsored Research means research at EMU supported at least in part through money and/or donated equipment by any organization or entity not directly affiliated with EMU

Conflict of Interest Subcommittee (COI Committee) means the subcommittee of the Academic Integrity Committee that is designated to monitor implementation of this policy.

ORC means the Office of Research Compliance of EMU.

Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.

Financial Interest means anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.

Financial Interest does NOT include: 

  • salary, royalties, or other remuneration from EMU
  • income from the authorship of academic or scholarly works
  • income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
  • equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities.  This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available.  It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers, unless that entity is itself the subject of research by the Investigator.

Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:

  • if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or 
  • if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or
  • if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or
  • is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Institution, or
  • is reimbursed or sponsored travel related to their institutional responsibilities, subject to the exclusions outlined above.

 Financial Conflict of Interest means a Significant Financial Interest that the COI Committee reasonably determines could directly and significantly affect the design, conduct or reporting of externally sponsored research.

Institutional Official means the individual within the Institution that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities.  For the purposes of this policy, the Institutional Official is designated as the Associate Provost and Associate Vice President of Graduate Studies and Research.

Institutional responsibilities means the Investigator’s professional responsibilities associated with his or her Institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.  

Investigator means any individual who is responsible for the design, conduct, or reporting of sponsored research, or proposals for such externally-sponsored funding.  This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or students.  The definition may also include collaborators or consultants as appropriate.

Research means a systematic investigation, study, or experiment designed to contribute to generalizable knowledge.  The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a device or material).

Recipient means the entity that receives an award, including grants, contracts and cooperative agreements for Sponsored Research.

Subrecipient means an entity that receives a subaward, including subawards under grants, contracts and cooperative agreements to carry out part of a Sponsored Research project.

CONFLICT OF INTEREST :

This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. To that end, this policy informs Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and the Institution to manage those conflicts of interest that arise, and describes situations that are prohibited.  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 university Research Compliance Officer or Institutional Official.  

DISCLOSURE OF FINANCIAL INTERESTS

All Investigators involved in sponsored research are required to disclose their significant financial interests as defined above to the Institution on an annual and on an ad hoc basis, as described below. The Office of Research Compliance is responsible for the distribution, receipt, processing, review and retention of disclosure forms.  

  • Annual Disclosures-  All Investigators involved in sponsored research must disclose their Significant Financial Interests that are related to the investigator’s institutional responsibilities to the Institution, through the ORC, on an annual basis.  All forms should be submitted to the Research Compliance Officer by March 1 for the previous calendar year.
  • Ad hoc Disclosures-  In addition to annual disclosure, certain situations require ad hoc disclosure.  All Investigators involved in sponsored research must disclose their Significant Financial Interests to the Institution Official, through the Office of Research Compliance, within 30 days of their initial appointment or employment.  All investigators involved in human subject or animal research must submit an ad hoc disclosure prior to obtaining approval from the University Human Subjects Review Committee (UHSRC) or Institutional Animal Care and Use Committee (IACUC), as appropriate. UHSRC or IACUC approval will not be granted until the declared Conflict of Interest has been reviewed. Failure to submit an ad hoc disclosure prior to UHSRC or IACUC approval will be considered non-compliance.

    Prior to commencing sponsored research or applying for external funding, where the Investigator has a Significant Financial Interest, or in cases where an investigator does not have a disclosure on file, the Investigator must affirm the currency of the annual disclosure or submit to the Institutional Official through the Office of Research Compliance an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity.  The Institution will not submit a research proposal unless the Investigator(s) named in the proposal have submitted such ad hoc disclosures.  In addition, all Investigators involved in sponsored research must submit to the Institutional Official through the Office of Research Compliance an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.  
  • Travel- Investigators involved in sponsored research must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest.  Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.  The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.  

REVIEW AND DECISION OF THE INSTITUTIONAL OFFICIAL

When a disclosure form reveals a Significant Financial Interest, it will be reviewed y by the COI Committee for a determination of whether it constitutes a Financial Conflict of Interest.  If a Financial Conflict of Interest exists, the COI Committee will recommend a course of action to the Institutional Official for managing, reducing, or eliminating the conflict of interest as appropriate. 

A Financial Conflict of Interest will exist when the COI Committee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of sponsored research.  If the COI Committee determines that there is a Financial Conflict of Interest that can be managed, then the COI Committee will delineate required components of a written management plan.  The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related sponsored research goes forward.  

The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.  

REPORTING TO SPONSORING AGENCY

The Institutional Official  will report financial conflicts of interest or non-compliance to involved granting agencies in accordance with agency regulations.  If EMU is a Subrecipient and the funding for the Research is made available from a Recipient, such reports shall be made to the Recipient prior to the expenditure of any funds and within 60 days of any subsequently identified financial conflict of interest such that the prime awardee may fulfill their reporting obligations to the sponsoring agency.

INVESTIGATOR NON-COMPLIANCE

  • Disciplinary Action-  The Institutional Official will work closely with Investigators to resolve conflicts of interest if possible.  In the event, however, that an Investigator’s failure to comply with this Policy is flagrant or repeated, the Institutional Official may suspend all relevant activities or take other disciplinary action, including suspension until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented.  
    The Institutional Official’s decision to suspend research activities because an Investigator’s 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, COI Committee and, where applicable, the IRB or IACUC, and will notify the individual of the right to appeal the decision.  The institution will promptly notify the granting agency of the action taken or to be taken as required by agency regulations.  If the funding for the research is made available from a prime PHS awardee, such notification shall be made promptly to the Recipient for reporting to PHS. 
  • Retrospective Review-  In addition, if the Institutional Official determines that 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 failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, the COI Committee will complete a retrospective review of the Investigator’s activities and the externally sponsored research project to determine 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, PI, name of 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 granting 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. This retrospective review will be completed in the manner and within the time frame established in agency regulations. If bias is found, the institution will promptly notify the granting agency and submit a mitigation report in accordance with the agency regulations.  The mitigation report will identify elements documented in the retrospective review, 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.

TRAINING

Each Investigator must complete training on this Policy, the investigator’s responsibilities regarding disclosure and the PHS regulations prior to engaging in research funded by PHS, and at least every four years thereafter.  They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.

RECORD RETENTION

The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a minimum period of three years from the date the final expenditure report is submitted to the granting agency or to the prime awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.

CONFIDENTIALITY

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

PUBLIC ACCESSIBILITY

Prior to the expenditure of funds, the Institution will publish on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:

  • The Significant Financial Interest was disclosed and is still held by the senior and key personnel;
  • A determination has been made that the Significant Financial Interest is related to the externally-sponsored research; and
  • A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.

The information to be made available shall be consistent with the requirements of the PHS regulation.   BTW, IREM maintains a website for the institution where required disclosures are posted.

REGULATORY AUTHORITY

This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.

Further information can be found in "Eastern Michigan University Policy Manual"

Elevating Communities, Inspiring Generations

EMU Research, 200 Boone Phone: 734.487.3090 mail orda_dept@emich.edu