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Operations Manual - Conflicts of Interest and Commitment

Operations Manual - Part 9

[Operations Manual Table of Contents]

I. APPLICABLE POLICIES

The University follows a number of institutional, state, and federal bylaws, policies, procedures, and practices concerning employees' outside financial or management interests that could form the basis of a conflict. These include, but are not be limited to:

School, college, and unit policies on conflict of interest (COI) and commitment augment these policies and may address the conditions that allow an individual with a significant financial interest to be an investigator. The Medical School’s COI policy is of particular importance to the Human Research Protection Program (HRPP), as the investigators in the U-M Health System conduct the majority of human subjects research with greater than minimal risk that also presents a financial or management conflict of interest (and also conduct the majority of human subjects research that needs disclosure and COI management regardless of risk level).

Generally, policies regulating outside interests seek to promote the following values:

  • Objectivity and integrity in research;
  • Open publication of research results;
  • Appropriate use of sponsor or University funds;
  • Maintenance of appropriate relationships with and fulfillment of obligations to colleagues, students, and other trainees;
  • Fulfillment of administrative duties;
  • Integrity of academic decision-making;
  • Avoidance of "pipelining" University intellectual property to an outside entity outside of an appropriate research agreement; and
  • Protection of and appropriate informed consent with human subjects.

The HRPP requires outside interest disclosure for study personnel when submitting or amending an IRB application for human subjects research. Study personnel listed on the IRB application are required to answer COI questions when they accept their role on the project.

II. CONFLICTS OF INTEREST OF INVESTIGATORS AND RESEARCH STAFF

There are three main steps to the COI review process for human subjects research:

  1. Identification and disclosure of outside interests by investigators and research staff.
  2. Review of outside interest disclosures by a U-M COI review committee to determine if a conflict of interest exists.
  3. Risk/benefit analysis by an Institutional Review Board (IRB).

A. Identification and Disclosure of Outside Interests Related to Human Research

Outside interests or potential conflicts of interest on the part of investigators and research staff (and their spouses, domestic partners, or dependents) relevant to the integrity of human research include, but are not limited to, the following (see the list of outside interest disclosure criteria for more information):

  • Ownership (e.g., equity, shares or stock options) in an outside company or other entity that has activity related to the research;
  • Compensation, other payments or items of value from an outside entity (e.g., consulting fees)
  • Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement; and
  • Paid or unpaid activities and relationships (e.g., serving in a leadership position for the agency or company sponsoring the research, volunteer activities, consulting or serving on a sceintific advisory board).

Information relevant outside interests is identified from a number of transactions that include:

1. Sponsored Project Proposals

Every proposal for externally sponsored research requires submission of a completed eResearch Proposal Approval Form (PAF). This electronic form summarizes information about the proposal and is used for U-M administrative review and approval. The PAF requires the Principal Investigator (PI) to attest to whether or not any proposed investigator on the sponsored project (and/or their spouse, domestic partner or dependents) has a significant financial interest related to the proposed research. If a significant financial or management interest is indicated, formal disclosures are required in M-Inform, the University's outside interest disclosure system.

2. IRB Application

As part of the eResearch IRB application, investigators and study team members indicate if they (and/or their spouses, domestic partners, or dependents) have an outside interest with a non-UM entity associated with the research in one of the following ways:

  • The entity sponsors the research;
  • The entity's products are used in the research;
  • The entity licensed an invention (e.g., device, compound, drug, software, evaluation instrument, etc.) developed by a study investigator or team member, which is being used in the research;
  • Part of the research project will be subcontracted to the entity;
  • Other type of relationship not listed above.

If an outside interest is indicated, formal disclosure from the individual is required in M-Inform.

3. Disclosures first received by schools and colleges pursuant to COI/COC policies

U-M schools and colleges have disclosure processes for reporting outside activities that are outlined in their respetive unit unit Conflict of Interest/Conflict of Commitment (COI/COC) policies. These disclosures are reviewed for identification of potential conflicts of interest not captured by other mechanisms. Potential conflicts of interest related to research or technology transfer are referred to the applicable COI review committee.

4. Sponsored project and technology transfer negotiations

To assist in complying with State of Michigan statutes, sponsored project and technology transfer negotiators identify and forward to the conflict of interest review committees proposed research or licensing agreements in which a University employee has a significant financial interest in or management role with the sponsor of the research or is the recipient of the license. The applicable COI committee (COI-UMOR or MEDCOI) reviews these transactions and the associated outside interest disclosures to determine if a conflict of interest exists and requires management. The COI committee alerts the appropriate IRB when they receive disclosures, or are notified of situations, associated with human research.

B. Conflict of Interest Review and Management

When an IRB application includes an indication of a related outside interest, a U-M COI commmittee conducts a risk review to:

  • Ensure appropriate management of the conflict in order to eliminiate or reduce risk to the project, the investigators, and the University.
  • Provide guidance on applicable informed consent language in order to notify and protect the study subjects.

The COI Committee reviews the M-Inform disclosure, the IRB application, and applicable related transactions (e.g., resesarch proposals and license and option agreements) to determine the extent to which:

  • Key investigators and study team members have significant financial or management interests in research;
  • Human subjects are involved in the proposed research;
  • Individuals in the administrative hierarchies of the key investigators have financial interests in the research;
  • The University itself has a financial interest in the research.

Representatives of the IRBs, the Office of Research and Sponsored Projects (ORSP), and the Office of Technology Transfer (OTT) attend COI committee meetings as consultants, as appropriate. They provide source information regarding human subjects research, sponsored projects, contracts and agreements, and University equity holdings in proposed sponsors of research or proposed licensees.

Individuals with significant financial or management interests in a research project may be allowed to participate in that project only with special justification and a COI committee determination of compelling circumstances. Conflict of interest management plans include specific management provisions to protect human subjects.

C. IRB Risk/Benefit Analysis

The IRB has access to COI management plans established for key personnel listed on the IRB application. IRBs include COI risk in their risk/benefit analysis and may place additional restrictions on the conflicted individuals or the research in its entirety, up to and including disapproving participation of a conflicted individual or disapproving the research. IRBs have final authority to determine whether any disclosed interest and its management allows the research to be approved. IRBs typically require disclosure to potential subjects in the informed consent document if a key investigator, study team members, or the institution itself has a financial interest in the research.

III. CONFLICTS OF INTEREST OF IRB MEMBERS, CONSULTANTS AND STAFF

Each IRB has a Standard Operating Procedure (SOP) for identifying and avoiding COI in reviewing and approving research and in managing office functions. The SOP describes the process for re-assigning reviews to a non-conflicted member when an IRB member is assigned to a review in which he or she has a COI in the research

An IRB member or a consultant with the IRB will not be assigned to review an application if he/she (and/or their spouse, domestic partner, or dependents):

  • Is an investigator or a team member of the study;
  • Has a significant financial interest in the research, such as the criteria listed above;
  • Has other conflicts that the member/consultant, the IRB, the COI Committee or the U-M Office of Research (UMOR) believes might hamper that individual's ability to perform an impartial review.

IRB members and consultants are also prohibited from participating in the following activities in which they have a conflict of interest:

  • Board review of the applicable IRB application, including meeting attendance, quorum count, deliberations for, and the vote on the disposition of the application;
  • Review by expedited procedure;
  • Review of unanticipated problems involving risks to subjects or others;
  • Review of non-compliance with the regulations or the requirements of the IRB.

The member or consultant may, however, be invited by the IRB meeting to provide information relevant to the IRB's consideration of the application.

IV. INSTITUTIONAL CONFLICTS OF INTEREST

In support of the public interest, the University, acting as an organization, may form relationships with, enter into affiliations or agreements with, or invest in outside companies or organizations for mutual benefit. Through these relationships, the University can translate the knowledge of its faculty, staff, students and trainees into socially useful applications, enrich education and research with practical experience, purchase goods and services, and secure financial returns to support the University's missions. These relationships may place the University in situations of "Institutional Conflict of Interest" (ICOI) when accepting grants from, making investments in, or engaging in activities with these outside companies or organizations that compromise or appear to compromise the University's fulfillment of its mission in an objective unbiased manner ("Direct Institutional Conflict of Interest" or "Direct ICOI").

An ICOI can arise when any interest of the University or the personal financial interests of key University leaders has the possibility of compromising the judgment or behavior of faculty or staff or leaders themselves with respect to teaching and student affairs, appointments or promotions, uses of University resources, interactions with subjects or patients, objectivity or research, or other activity of the University. These interests include, but are not limited to:

  • Licensing or technology transfer agreements;
  • Income from University investments;
  • Potential increase in the value of equity held by the University in a faculty start-up;
  • The prospect or receipt of gifts to the University;
  • Personal investments, intellectual property rights, or income from consulting or other activity of key University leaders;
  • Other financial interests of the University.

Outside relationships or financial interests of the University's leadership with outside companies or organizations may raise issues related to ICOI by virtue of the leaders' ability to influence decisions about the University's relationships, or processes, policies or functions of the University. These outside relationships or financial interests may appear to interfere or actually interfere with the obligation for University leadership to act in the University's best interests. The Standard Practice Guide 201.65-1 applies to all employees of the University. Key University leaders are required to report to their superiors (department chairs to deans, deans to the provost, executive officers to the President, and the President to the Regents) any outside activity and financial or other interest that could affect the performance of any of their leadership obligations. Interests are eliminated or managed as deemed appropriate by the office receiving the disclosure.

The following Institutional Conflict of Interest Principles have been endorsed to guide the development and refinement of strategies to assure the highest level of integrity to maintain the public trust. In all relationships and activities, the University and its leadership are expected to abide by the highest standards of conduct in education, research and public service. The Principles are intended to operate in conjunction with other University policies related to conflict of interest and commitment, including unit-based policies on conflict of interest and commitment mandated by Standard Practice Guide 201.65-1.

  • The University and its leadership are responsible for furthering and collectively protecting the University's missions of education, research and public service;
  • Commercial collaborations and the transfer of technology between the University and industry are encouraged and play a critical role in furthering the University's missions by generating new discoveries and facilitating the use of those discoveries for the public benefit;
  • Direct and Indirect ICOIs that are not disclosed and remain unmanaged may appear to interfere or actually interfere with the obligations of the University and its leadership to further and protect the missions of the University;
  • No outside relationship or financial interest of the University or its leadership should interfere with or compromise the missions of the University;
  • The ICOI management process will ensure that the activities of the University and its leadership remain principled, capable of withstanding intense public scrutiny and protective of the University's missions;
  • The ICOI management process will be rational, well publicized, transparent and consistently applied.

Failure to abide by ICOI policies may subject offenders to potential sanctions ranging from verbal warning to termination of employment. (See: Regent Bylaw 5.08 & 5.09 and Standard Practice Guide 201.12)

Conflicts of interest resulting from interests of the institution itself are addressed by various institutional policies and practices.

The University of Michigan is addressing institutional COI in research and in human subject research, specifically, in a step-wise fashion designing policies and implementing procedures first in high-risk circumstances.

When conducting reviews of research projects, the COI committees have access to information on any University equity in an outside organization associated with the research as well as information on any significant financial or management interest in start-up companies by University administrators. The COI committee may also inquire about gifts to the University. From time to time the two COI committees may seek consultative advice from each other or refer a situation in its entirety to the other committee to manage a potential COI situation associated with significant outside interests.

The University's equity in start-up companies is managed as part of the University's broader investment portfolio and therefore no different from other institutional investments. This helps avoid bias or favoritism. The Chief Financial Officer (CFO), not the Vice President for Research (VPR), coordinates University investments utilizing outside managers to assist with investment strategy. A determination to liquidate the University's investment in a holding is never a research decision. The University has established a special policy and procedures for institutional conflict of interest in clinical trials of drugs, devices, or biologics supported by university start-up companies. (See: Policy on Institutional Conflict of Interest in Clinical Trials of Drugs, Devices, or Biologics Supported by University Start-up Companies). This policy establishes principles and procedures designed to ensure that clinical trials conducted at the University of Michigan involving a drug, device, or biologic are conducted without untoward influence resulting from the university's equity holdings or from significant financial interests of senior management personnel. The policy establishes an ICOI Committee appointed by the President and housed in the Office of the President. The committee membership includes at least one individual unaffiliated with the University.