View Printer Friendly Version

Conflicts of Interest and Commitment (June 2012)

Operations Manual - Part 9

Conflicts of interest and commitment in research can adversely impact the integrity of research results and the confidence of prospective volunteers in the research enterprise. The University seeks to identify, disclose, and avoid or manage conflicts to avoid these negative repercussions.

[Operations Manual Table of Contents]

I. APPLICABLE POLICIES

The University has a number of bylaws, policies, procedures and practices concerning employees' outside financial or management interests that could form the basis of a conflict. These institutional policies and applicable state law are augmented by school, college, and unit policies on conflict of interest and conflict of commitment. Generally, such 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;
  • Maintenance of appropriate relationships with and fulfillment of obligations to 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 Medical School's COI policy is of particular importance to the HRPP, as most of the greater than minimal risk research that uses human subjects and also presents a financial or management conflict of interest (and almost all human subject research that needs disclosure and conflict management regardless of risk) is done in the Health System. Furthermore this policy explicitly addresses the conditions that must be fulfilled to allow an individual with a significant financial interest to be an investigator.

II. CONFLICTS OF INTEREST OF INVESTIGATORS AND RESEARCH STAFF

A. Identification of Significant Financial or Outside Management Interests in Human Research that Could Form the Basis of a Conflict of Interest

Information on potential conflicts of interest on the part of investigators and research staff relevant to the integrity of human research is identified in a number of ways. These include:

1. Sponsored Projects

Every proposal for externally sponsored research requires an an electronic application in eResearch Proposal Management (eRPM) in which summary information about the proposal is collected. eRPM requires certain certifications and disclosures. It provides an opportunity for faculty investigators to provide certifications that no proposed investigator on the sponsored project, nor his or her immediate family, has a significant financial interest in the proposed research

When a faculty investigator on a proposed research project, or any key personnel, indicate in eRPM that they (or their spouses or domestic partners or dependents) have significant financial or management interests in a sponsored project, formal disclosures are required. Either the Medical School Conflict of Interest Board or the OVPR Conflict of Interest Review Committee reviews disclosures.

Conflict of Interest committees alert IRBs when they receive disclosures associated with human research.

2. Human subject protocol application

The eResearch application includes a process by which each identified investigator personally must either attest to having no significant financial or outside management interest in the research or attest to having disclosed such interests to either the Medical School Conflict of Interest Board or the OVPR Conflict of Interest Review Committee depending on the school of affiliation of the PI.

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

The Medical School has a process of annual faculty and staff disclosures of outside activities. 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 Medical School Conflict of Interest Board. The Board notifies the IRB of situations involving human research.

4. Sponsored project and technology transfer negotiations

To assist in complying with State of Michigan Statute, 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 or management role in the sponsor of the research or in the recipient of the license. Conflict of Interest committees notify the relevant IRBs of situations involving human research.

5. IRB, sponsored project, and technology transfer consultants to Conflict of Interest Committees

Representatives of the IRBs, the sponsored projects office, and the Office of Technology Transfer attend meetings of the Medical School Conflict of Interest Board as consultants. This serves as an additional mechanism for communication and coordination among regulatory functions. Representatives of the sponsored projects office and the Office of Technology Transfer attend meetings of the OVPR Conflict of Interest Review Committee.

The Office of Technology Transfer is the source of information about University equity holdings in proposed sponsors of research or proposed licensees.

B. Conflict Review and Management

As part of the IRB application, PIs, Co-Is and Faculty Advisors, and study team memebrs are required to disclose the following interests:

  • Ownership interest (equity or stock options) of any amount in an outside company or other entity that has activities related to the research when the value cannot be referenced to publicly traded prices or other measure of fair market value;
  • Ownership interest (equity or stock options) of $10,000 or greater in an outside company or other entity that has activities related to the research, when aggregated for the immediate family, when the value can be referenced to publicly traded prices or other measure of fair market value;
  • Ownership interest (equity or stock options) of any amount when the value of the interest would be affected by the outcome of the research;
  • Compensation of $10,000 or greater value when aggregated for the immediate family, or receiving compensation of any amount when the value of the interest would be affected by the outcome of the research;
  • Proprietary interest related to the research of any value including, but not limited to, a patent, trademark, copyright or licensing agreement; and
  • Serving in a leadership position for the agency or company sponsoring the research.

When reviewing disclosed situations, the committees are aware of the extent to which key investigators and study team members have significant financial or management interests in the research, the extent to which human subjects are involved in the proposed research, the extent to which the university itself has a financial interest in the research, and whether individuals in the administrative hierarchies of the key investigators have financial interests in the research. Committees identify and weigh the significance of risks to human subjects, just as they identify and weigh the significance of conflict risks to other University values. The conflict of interest committees may allow individuals with significant financial or management interests in a research project to participate in that project only with special justification and a committee determination of compelling circumstances. Conflict of interest management plans include the minimal acceptable management to protect human subjects.

Conflict of interest review committees forward any conflict of interest management plans involving human subjects to the relevant IRB. IRBs include conflict of interest 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 an SOP for identifying and avoiding conflicts of interest in reviewing and approving research and in managing office functions.

A member will not be assigned to review an application if the member or a member of his or her immediate family [or spouse, domestic partner, or dependent] (1) is an investigator or a team member of the study; (2) has a significant financial interest in the research, or (3) has other conflicts that the member, the IRB, the Conflict of Interest Review Committee, or OVPR believes might hamper the member's ability to perform an impartial review, including:

  • Ownership interest (equity or stock options) of any amount in an outside company or other entity that has activities related to the research when the value cannot be referenced to publicly traded prices or other measure of fair market value;
  • Ownership interest (equity or stock options) of $10,000 or greater in an outside company or other entity that has activities related to the research, when aggregated for the immediate family, when the value can be referenced to publicly traded prices or other measure of fair market value;
  • Ownership interest (equity or stock options) of any amount when the value of the interest would be affected by the outcome of the research;
  • Compensation of $10,000 or greater value when aggregated for the immediate family, or receiving compensation of any amount when the value of the interest would be affected by the outcome of the research;
  • Proprietary interest related to the research of any value including, but not limited to, a patent, trademark, copyright or licensing agreement; and
  • Serving in a leadership position for the agency or company sponsoring the research.

Any conflicted IRB member or consultant may not be present for, nor count for quorum, nor participate in the deliberations or vote on the disposition of an application in which the member has a conflict as described above. The member may, however, be invited by the IRB to provide information relevant to the Board's consideration of the application.

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

  • Review by expedited procedure;
  • Review of unanticipated problems involving risks to subjects or others; and
  • Review of non-compliance with the regulations or the requirements of the IRB.

The standard operating procedures for each IRB will describe a process for ensuring that if any IRB member is assigned to a review in which he or she has a conflict of interest the research review will be assigned to a non-conflicted member.

Each IRB, when using a consultant for input on a particular proposal, will assure that he or she does not have a conflict of interest, as described above, in the research under review.

IRB and other University staff are subject to University-wide policy (Standard Practice Guide 201.65-1), which requires that University employees not use their official University position of influence to further personal gain, nor the gain of their families or business associates.

IV. INSTITUTIONAL CONFLICTS OF INTEREST

In support of the public interest, the University, acting as an organization, may from time to time form relationships or enter into affiliations or agreements with, or investments 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 also may place the University in situations of institutional conflict of interest ("ICOI") when accepting grants or entering into or engaging in investments or 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 Institutional Conflict of Interest can arise when any interest of the University (such as success of a licensing or technology transfer agreement, income from 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, or any other financial interest) or the personal financial interests of key University leaders (such as personal investments, IP rights, consulting or other income) 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.

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. 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.

Principles:

  • 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 conflicts of interest 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 conflict of interest 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, not the Vice President for Research, 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.