Policy and Procedures for Dealing with Financial and Outside Management Conflicts of Interest in Sponsored Projects and Technology Transfer
Policy Statement
The University of Michigan will exercise care in accepting or entering into sponsored agreements and technology transfer agreements in which the Investigators involved (or their Family Members) have Significant Financial Interests or Management Interests that create conflicts. Such agreements will not be accepted if the conflict:
- can be expected with reasonable certainty to compromise the integrity or objectivity of those investigations or undermine the employees' obligations to the University, sponsor, research subjects or students, and
- cannot be satisfactorily managed with appropriate administrative oversight.
The University of Michigan exercises special care in accepting or entering into sponsored research agreements involving human subjects including using drugs, devices or other clinical treatments licensed to third parties.
Background
The overarching University policy on Conflicts of Interest and Conflicts of Commitment (SPG 201.65-1) states:
The University allows and encourages outside activities and relationships that enhance the missions of the University. In addition, University faculty and staff have the right to acquire and retain personal financial interests (including personal income from the transfer of technology) so long as those obligations and commitments do not interfere with their duties or improperly distort the judgments expected of them.
To be eligible to receive grants or cooperative agreements for research from the Public Health Service (including NIH, see PHS policy) or the National Science Foundation (see NSF policy), the University of Michigan is required to have a policy for the disclosure of Significant Financial Interests held by Investigators (or their Family Members) related to proposed research and to have procedures for the institutional review of the relevance of such personal outside interests to the integrity of the research.
The University applies a single policy and procedure for review and approval of all sponsored research and technology transfer agreements, incorporating, to the extent feasible, the federal definitions of "Investigator," and "Significant Financial Interest," and the concept of "relatedness" of a Significant Financial Interest to proposed research.
This Policy, in addition, abides by the State of Michigan Conflict of Interest Law that requires explicit approval of the Board of Regents before entering into a research or technology transfer agreement with University employees or enterprises in which they hold a stipulated interest.
This Policy operates in conjunction with other University policies related to conflict of interest and conflict of commitment, including unit-based policies on conflict of interest and conflict of commitment mandated by SPG 201.65-1.
When the University carries out PHS- or NSF-funded grants or cooperative agreements through subgrantees, contracts, or collaborators, the University standard agreements require that Investigators comply with this Policy or with a policy at their institution that complies with PHS and NSF COI regulations.
Definitions
A Conflict of Interest may take many forms and exists whenever personal, professional, commercial, or financial interests or activities outside of the University have the possibility of (1) compromising a faculty or staff member's judgment; (2) biasing the nature or direction of scholarly research; (3) influencing a faculty or staff member's decision or behavior with respect to teaching and student affairs, appointments and promotions, uses of University resources, interactions with human subjects, or other matters of interest to the University; or (4) resulting in a personal or Family Member's gain or advancement at the expense of the University.
A Conflict of Interest in Sponsored Research exists when the University determines that a Significant Financial Interest or Management Interest in an outside entity could reasonably appear to be affected by the research.
A Conflict of Interest in a Technology Transfer Agreement exists when a University faculty or staff member has an ownership or management interest in a proposed licensee or assignee of University intellectual property.
Disclosure Form means the University's form for disclosure of significant financial or management interests in a sponsored project and/or technology transfer agreement at the University of Michigan. (See http://www.research.umich.edu/policies/um/coi/forms.html)
Family Member includes the Investigator's spouse, domestic partner, and dependents.
An Investigator means the Principal Investigator, Co-Investigators, study team members and any other person at the University or elsewhere who are responsible for the design, conduct, or reporting of a sponsored research project.
Management or Manage means the conditions or restrictions that might be imposed to manage, reduce or eliminate a Conflict of Interest. Examples include, but are not limited to:
- Public disclosure of Significant Financial Interests,
- Monitoring of the research or research management by independent reviewers,
- Assignment of ombudspersons for students,
- Modification of the research plan,
- Disqualification from participation in all or in a portion of the research,
- Divestiture of Significant Financial Interests, or
- Severance of the relationship that creates the Conflict of Interest.
A Management Interest in a Related Entity involved in a technology transfer agreement or to a sponsored project means holding a position of officer, trustee, director, or scientific advisory board member.
A Principal Investigator, for the purposes of this policy, is the person designated on the sponsored project Proposal Approval Form (PAF) as the individual responsible for the administrative and programmatic aspects of the proposed project.
A Related Entity to sponsored research or a technology transfer agreement includes any supplier of equipment, materials, or services, business commercializing a product that the research is intended to evaluate or further develop, or party whose financial interests would reasonably appear to be affected by the research or technology transfer agreement.
A Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g. consulting fees or honoraria); equity interests (e.g., stock, stock options or other ownership interests); and intellectual property rights not held by the University (e.g., patents, copyrights and royalties from such rights). It does not include:
- Salary, royalties or other remuneration received from the University;
- Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
- Income from service on advisory committees or review panels for public or nonprofit entities;
- An equity interest in a publicly traded enterprise that when aggregated for the Investigator and the Investigator's Family Members does not exceed $10,000 in value and does not represent more than 1% ownership interest (42 CFR 50.602 revised for Michigan COI Law); and
- Salary, royalties, or other payments that when aggregated for the Investigator or the Investigator's Family Members over the next twelve months, are not reasonably expected to exceed $10,000.
Although PHS and NSF policies exclude Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Programs from consideration, the University requires Investigators to disclose involvement in these programs.
The Disclosure Process and Referral
The Principal Investigator on a proposed sponsored agreement will determine if a financial Conflict of Interest disclosure is required at the time a Proposal Approval Form (PAF) is first submitted and will make a declaration to that effect on the PAF. The Disclosure Form requests information about Management Interests or Significant Financial Interests in outside Related Entities held by the Investigator and any other individuals (and by their Family Members) who are responsible for the design, conduct, or reporting of the proposed research. A separate Disclosure Form will be submitted upon request to the relevant conflict of interest committee.
If the Principal Investigator discloses a Conflict of Interest in Sponsored Research, or if the project representative from the Division of Research Development and Administration (DRDA) is aware of a Management Interest or Significant Financial Interest, the DRDA representative will refer the proposed project to either the University Conflict of Interest Review Committee or the Medical School Conflict of Interest Board.
The Office of Technology Transfer (OTT) will refer proposed agreements involving a Conflict of Interest in a Technology Transfer Agreement to either the University Conflict of Interest Review Committee or the Medical School Conflict of Interest Board.
If the outside interests of an Investigator or employee change so as to introduce a new, heretofore undisclosed Significant Financial Interest or Management Interest in a sponsored research project or technology transfer agreement, the individual is honor-bound to initiate a disclosure or to revise a disclosure already submitted.
Committee Review
The Vice President for Research is the designated Institutional Official responsible for Conflict of Interest policy for sponsored projects and technology transfer agreements. The Office of the Vice President for Research (OVPR) has established a conflict of interest committee to receive disclosures referred from DRDA or OTT and review and Manage the risks associated with the disclosed situation. The committee has eight members representing the diverse interests of the Colleges and Schools. Committee members are named by the Vice President for overlapping 3-year terms.
The Vice President for Research has delegated to the Medical School Conflict of Interest Board the authority and responsibility to review and Manage the risks associated with sponsored projects in which a conflicted Principal Investigator has a primary appointment in the Medical School, when the principal conflicted individual related to a proposed technology transfer agreement has an appointment in the Medical School, or when otherwise agreed to by the two committees.
Other situations or categories of situations may be delegated in whole or in part by the University Conflict of Interest Committee to the Medical School Conflict of Interest Board. The University Conflict of Interest Committee will not impose requirements on individuals with primary appointments in the Medical School, and the Medical School Conflict of Interest Board will not impose requirements on individuals with primary appointments outside the Medical School without consultation with the other committee.
The delegation from OVPR to the Medical School Conflict of Interest Board is conditioned upon the Board having at least one member unaffiliated with the Medical School and on the establishment, maintenance, and communication to OVPR and DRDA of sponsored project specific Management.
With regard to a disclosed situation, the conflict of interest committees will identify Conflict of Interest risks and evaluate their magnitude. The committee may:
- Recommend that the proposal or agreement go forward without modification, or
- Require some specific type of administrative oversight or Management, or
- Recommend the withdrawal of the proposal or suspension of the technology transfer arrangement.
DRDA or OTT will make an initial determination whether any situation recommended to go forward triggers the State Conflict of Interest law, thereby requiring approval by the Board of Regents. Those situations, along with information on the proposed Management, will be forwarded to the Vice President for Research for approval, and, if approved, sent to the Board of Regents.
Each review committee will have the assistance of administrative staff in handling the flow of paperwork, correspondence, record keeping, and the oversight and implementation of Management decisions made by the committee.
Each committee will review sponsored projects under conflict of interest Management at least annually.
Reporting Conflicts of Interest to the Public Health Service
To the extent a Significant Financial Interest or Management Interest involves sponsored research covered by Public Health Service (PHS) regulation, the University will report, prior to the expenditure of any funds, the existence of a Conflict of Interest (but not the nature of the interest or other details) and assure that the Conflict of Interest has been Managed in accordance with this Policy. For Significant Financial Interests or Management Interests identified subsequent to the initial PHS award, the University will notify the PHS of the Conflict of Interest and assure that the Conflict of Interest has been Managed in accordance with this Policy within sixty days of identification. Upon request, the University will make information available to the U.S. Department of Health and Human Services (HHS) regarding identified Conflicts of Interest and how those interests have been Managed to protect the research from bias.
Appeal
A decision by the University Conflict of Interest Review Committee not to approve the acceptance of a sponsored project, to suspend negotiations on a technology transfer agreement, or to require administrative Management objectionable to an interested party may be appealed to the Vice President for Research within 30 days of the date the committee notifies the individual of the committee's decision.
Within 14 days of receipt of a written appeal, the Vice President for Research will decide either to endorse the committee's decision or to reverse the decision. The Vice President may impose conditions on the arrangement before approval. (If the Vice President for Research has a financial Conflict of Interest himself or herself the decision will be made by the Provost or another Executive Officer without such a conflict.)
The Vice President will respond in writing to an appeal and notify the relevant committee of his/her decision and the reasons for it.
Record Retention
Significant Financial Interest and Management Interest disclosures and all actions taken by the University with respect to these interests will be maintained for at least three years from the date of submission of the final expenditures report unless other state or federal law requires a longer retention period.
Noncompliance
The University Conflict of Interest Review Committee, the Medical School Conflict of Interest Board, and the OVPR will work cooperatively with Investigators and others to resolve any minor noncompliance.
Flagrant or repeated noncompliance with policy, procedures, or Management requirements after notice is handled through University disciplinary procedures and/or in accordance with the Policy on Integrity in Scholarship.
Failure by an Investigator to comply with this Policy as determined by the University that has biased the design, conduct or reporting of PHS funded research will be promptly reported by the University to the PHS including the corrective action taken or to be taken.
In any case in which the HHS determines that PHS-funded clinical research that evaluates the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator who did not disclose, or have under management, a conflicted interest, the University will require the Investigator(s) to disclose the Conflict of Interest in each public presentation of the results.
Contact Information
Questions about this Policy may be directed to the contact listed on the following web site: http://www.research.umich.edu/policies/um/coi/contact.html.