University of Connecticut

POLICY ON INDIVIDUAL CONFLICTS OF INTEREST

IN RESEARCH

September 25, 2007

1.  BACKGROUND

The investigators and staff of the University of Connecticut understand that their primary responsibility is to the University and to its mission. Integral to that mission is the pursuit of research excellence and the dissemination of knowledge that emerges from that research. Participation in activities of professional associations; industry collaborations; and other public and private entities can assist in meeting these expectations, while also serving the academic interests of the University. In addition, such participation brings enhanced national and international status to the University and the State. Nevertheless, serious consideration needs to be given to the amount of time and effort that can appropriately be devoted to such pursuits while fulfilling all commitments to the University.

Over the past decade, the opportunity for University faculty and staff to engage in external professional and entrepreneurial activities has increased markedly, and is encouraged by the state and federal governments because of the resulting economic development benefits. The State of Connecticut has determined that the commercialization of University research and technology transfer are critical to Connecticut's long-term economic growth. To support these objectives, the Governor and General Assembly last year appropriated $4M to the University to increase entrepreneurial activities and attract eminent research faculty. In addition, the Legislature appropriated funds to support stem cell research at state higher education institutions with expectation of economic development benefits for the State.  At the same time, scrutiny of such activities has grown, including state and federal regulations dealing with avoiding and managing potential and existing conflicts of interest.  In order for the University of Connecticut to maintain public trust and support in carrying out its mission, including all external activities, the University must demonstrate that it subjects itself to the highest standards of ethical behavior.

2.  PURPOSE

This Policy on Conflicts of Interest in Research (hereinafter, the "Policy") provides guidelines for relationships between the University and its investigators with private industry, federal and state government, and the nonprofit sector that will help to assure the primacy of academic integrity.  The University encourages investigators to engage in appropriate outside relationships, and members of the University community are expected to avoid conflicts of interest that have the potential to directly and significantly affect the University's interests, compromise objectivity in carrying out University responsibilities, or otherwise compromise performance of University responsibilities, unless such conflicts are disclosed, reviewed, and managed in accordance with this Policy.  The fact that an individual has a conflict does not imply that the conflict is unethical or impermissible; it means that the relation of the conflict to the individual's University responsibilities must be carefully examined because conflicts - real or perceived - may impair performance of the University's missions of teaching, research, and public service, as well as jeopardize public trust and support.

3.  APPLICABLE FEDERAL REGULATIONS

 At present, there are three sets of federal regulations (DHHS/PHS/NIH, NSF, and FDA) which serve as the basis for this policy. Copies of these regulations are available at the following web sites.

 Federal Regulations:

The U. S. Public Health Service (PHS) Objectivity in Research

The National Institutes of Health (NIH) Office of Extramural Research:

Conflict of Interest http://grants.nih.gov/grants/policy/coi/index.htm

The National Science Foundation (NSF) Investigator Financial Disclosure Policy http://www.nsf.gov/pubs/stis1996/iin117/iin117.txt

 The Food and Drug Administration (FDA) Guidance for Clinical Investigators on COI Disclosure

http://www.fda.gov/oc/advisory/conflictofinterest/guidance.html

In summary, all three federal policies and regulations stipulate:

a.       Annual financial disclosures on the part of ALL research investigators;

b.      Institutional certification that all proposed and ongoing NIH/NSF/FDA sponsored research is either free of COI, or that such conflicts are adequately managed;

c.       The implementation of an institutional mechanism for managing conflicts of interest in research;

d.      Keeping NIH/NSF/FDA informed if the University is unable to satisfactorily manage actual or potential conflicts of interest;

e.       Sanctions where appropriate; and,

f.        Maintenance of records relating to this policy for at least three years following the termination of a given project.

The definition of "Significant Financial Interest" differs amongst NIH, NSF and FDA.  The differences are primarily with the amount of money (equity, payments, etc.) that is considered a COI.  The University follows the guidelines of NIH for determination of a financial COI, with additional guidance from the FDA and NSF.

 For example, regardless of the source of funding, a COI exists when:

"        The investigator (or family member) has a financial interest in a sponsor (e.g. pharmaceutical company; see Definitions) that exceeds the limits defined below, and

"        The investigator is performing studies that are related to the interests of this sponsor.

4.  DEFINITIONS

Business means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.

Clinical Investigation (DHHS) means any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment here is any use of a drug, except for the use of a marketed drug in the course of medical practice.

Clinical investigation (FDA) means any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding non-clinical laboratory studies.

Conflict of Interest means a situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly.

A Conflict of Interest does not necessarily arise in connection with the following activities, and this Policy does not automatically prohibit activities such as:

• equity participation in a corporation;
• service as an officer in a corporation;
• service on a governing board;
• service on a scientific advisory board;
• receipt of funding from an external entity in which an employee has an interest;
• acceptance of publication royalties, royalties under the terms of the University Royalty Distribution Policy, or honoraria for papers and lectures; or
• service to outside educational, professional, scientific, artistic, cultural, civic, business, or other organizations, which service enhances the value of the employee to the University, and does not adversely affect the employee's primary commitment to the University.

An Apparent Conflict of Interest arises when an employee is involved in a particular matter, and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the impartiality of the employee in the matter.

Human Subject (DHHS regulations "Protection of Human Subjects" 45 CFR Part 46, as administered by OHRP) means a living individual about whom an investigator conducting research obtains:

1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

Human Subject (FDA regulations 21 CFR 50) means an individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Immediate Family means the investigator's spouse, minor children, and any other persons living in the same household.

Intellectual Property means a product of the intellect that has commercial value, including copyrighted property such as literature or artistic works, and ideational property such as patents, appellations of origin, business methods, and industrial processes.

Investigator means the principal investigator and any other person at the University who is responsible for the design, conduct or reporting of research, and the investigator's immediate family. This shall include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists, and medical or dental students engaged in research conducted in the department).

Participate means to be part of the described activity in any capacity, including but not limited to serving as the principal investigator, co-investigator, research collaborator or provider of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with nodirect access to the data (e.g., control over its collection or analysis) or, in the case of clinical research, to the trial participants, unless they are in a position to influence the study's results or have privileged information as to the outcome.

Research (HHS regulation 45 CFR 46.102(d)) means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Significant Financial Interest (NIH/FDA/NSF) means anything of monetary value, including, but not limited to:

1. An equity interest that when aggregated for the investigator and the investigator's spouse and dependent children exceeded $10,000 over the last 12 months, and/or is expected to exceed $10,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or
2. An equity interest that represents equal to or more than 5% ownership interest in any single entity; or
3. Salary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the investigator and the investigator's spouse and dependent children over the last 12 months exceeded $10,000 or are expected to exceed $10,000 over the next 12 months; or
4. Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.  This requirement applies to all covered studies/research projects, whether ongoing or completed as of February 2, 1999; or
5. Intellectual property rights (e.g., patents, copyrights and royalties from such rights); or
6. A proprietary interest in the tested product, including, but not limited to, a patent, trademark, copyright or licensing agreement; or
7. Significant payments of any sort made by the sponsor of a covered study/research project to the investigator or the investigators' institution to support activities of the investigator exclusive of the costs of conducting the study or other studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment).  This includes payments over the last 12 months, and an estimate of the next 12 months.

 The term does not include:

1.      Salary, royalties, or other remuneration from the University; or

2.      Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities, (Refer to Sec. 14.2); or

3.      Income from service on advisory committees or review panels for public or non-profit entities, (Refer to Sec. 14.2); or

4.      Examples of specific federal exemptions from COI, such as the NIH exemption for Phase I SBIR and STTR grants.

Sponsor means an individual company, or any which takes responsibility for the initiation, management, and/or financing of a clinical trial, or any research project, but who does not actually conduct the investigation.

Technology means memorialized knowledge, experience, information, instructions, and data including, without limitation, formulae and formulations, devices, compounds, drugs, processes, techniques, methods, materials, discoveries, ideas, developments, procedures, results, reports, unpatented inventions, and patent applications.

Technology Transfer means the movement of a new technology from its creator or researcher to a user, especially as products or publications.

5.  KEY ELEMENTS OF POLICY IMPLEMENTATION

The University Conflicts of Interest Policy is designed to identify actual or potential sources of conflicts of interest in research, and to either eliminate, reduce or manage such conflicts. As such, the following sub-sections outline the procedures which will be followed to assure compliance with this policy, and all applicable state and federal regulations related to conflicts of interest.

Due to differences in the reporting structures, the implementation procedures in Section 6 are specific to the UCHC; those in Section 7 are specific to the Storrs campus, all regional campuses, the School of Law, and the School of Social Work.

6.  IMPLEMENTATION AT THE HEALTH CENTER

6.1 Notification of Investigators

A copy of this policy is given to all persons upon hire and, subsequently, upon request by contacting the UCHC Corporate Compliance Office. The policy also resides on the UCHC website under "UCHC Policies". The UCHC Corporate Compliance Office, in cooperation with the Human Resources Department, assures proper distribution to all affected persons. Material changes to the policy will be accessible on the UCHC website.

 6.2 Financial Disclosure Procedures

The Office of Research Compliance annually distributes the COI Financial Disclosure Form (attached as Appendix 1) to UCHC Department Administrators in the Schools of Medicine and Dental Medicine for distribution to all investigators engaged in research conducted in the department. Annual distribution of disclosure forms occurs in May/June for the previous July 1 - June 30 calendar year.

Department Administrators are responsible for assuring that completed forms are forwarded to the Office of Research Compliance. From the COI Financial Disclosure Forms, the Director of the Office of Research Compliance determines whether a COI exists.

If a COI exists, the Director of the Office of Research Compliance requires the investigator to complete a Supplemental Information Form (attached as Appendix 2). The Office of Research Compliance presents the case to the COI Management Committee to either manage or eliminate the conflict, as noted in Section 6.3.

Investigators are responsible for ensuring that an updated UCHC COI Financial Disclosure Form shall be completed and filed at any time during the year when their significant financial interests may change.

Whenever an investigator submits a proposal for funding of a new or continuing project, the investigator signs a UCHC Statement of Commitments and Proposal Approval form thereby acknowledging that financial disclosure forms have been submitted and that either no COI exists or any COI has been disclosed and managed per the UCHC policy. If a COI is noted as being present or pending review, the Associate Vice President for Research Administration and Finance will notify the Office of Research Compliance. The Office of Research Compliance determines whether a COI management plan is in place. If not, a COI Disclosure Form is completed by the investigator and sent to the Office of Research Compliance for review. Once a proposal is funded, expenditures on that account cannot be accessed until the COI is managed or eliminated.

When research involves human subjects, the investigator must disclose COI(s) to the IRB with every submission of protocols. If an investigator has a COI, but a management plan is not on file with the IRB, then the IRB will refer this information to the COI Management Committee, and hold approval of the protocol until the COI Management Committee makes a determination.

In the event that UCHC is unable to resolve an identified COI, the Director of Research Compliance will notify, in writing, the Associate Vice President for Research Administration and Finance of this, and the facts surrounding the case. In the event that notification of research sponsors is required, the Director of the Office of Research Compliance will ensure that this notification occurs.

6.3 Resolution and/or Management of COI

The COI Management Committee is appointed annually by the Executive Vice President for Health Affairs, upon recommendation of the Deans of the Schools of Medicine and Dental Medicine.

The COI Management Committee is composed of five (5) senior faculty, one of whom will be appointed as chair, and one community member. Responsible efforts are made to have representation on this committee of faculty who have experience in industrially sponsored research, as well as basic and clinical research. The Director of the Office of Research Compliance serves as an ex-officio member of the Committee.

The COI Management Committee determines whether the financial interest identified by the investigator could affect decisions related to either the design, conduct, or reporting of research. The Committee then determines what conditions or restrictions, if any, should be imposed by the UCHC to manage such conflicts; or it may decide that the probability that the financial interest would affect the participation of the individual is too remote to warrant any specific conditions or restrictions. The Committee will be authorized to request any other information that it deems necessary to assist it in this determination.

 Examples of conditions or restrictions that might be imposed to manage or eliminate actual or potential COI include:

1.         Public disclosure of significant financial interests;

2.         Monitoring of the individual and/or their work by independent reviewers;

3.         Modification of the research;

4.         Disqualification from participation in all or a portion of the activities that are the subject of the COI;

5.         Divestiture of the financial interests; or,

6.         Severance of relationships that create actual or potential conflicts.

If a COI is identified as a result of the procedures outlined in Section 6.2, the COI Management Committee is responsible for:

• Notification of the researcher of the management plan designed by the Committee for his/her COI;
• Notification of the Office of Research and Sponsored Programs to assure that no spending of funds from involved grants occurs without prior approval of the COI Management Committee;
• Notification of funding sponsors as required;
• Notification of the Human Subjects Protection Office of COI management plans when the research involves human subjects.

The Office of Research Compliance will notify the above individuals, offices, and sponsors.

 Reasonable efforts will be made to maintain the privacy of information gathered in the Committee's deliberations, within the limits imposed by applicable laws and regulations.

6.4 Maintenance of Records

All records related to the implementation of this policy, e.g., COI Financial Disclosure Forms, Supplemental Information Forms, minutes of the meetings of the UCHC COI Management Committee, notifications to funding agencies, etc., shall be maintained in the Office of Research Compliance. These records shall be securely maintained. Research COI records must be maintained for a period of at least three years following the termination of the project. COI records shall be subject to periodic review for compliance with this policy by the UCHC Compliance Office, or by any agency, per the regulations cited in Section 4 above.

6.5 Notification of Research Sponsors, Federal Agencies and Private Foundations

The Office of Research Compliance will notify research sponsors, federal agencies and private foundations, as may be required by policies or agreements between UCHC and funding sources, of any actual or potential conflicts of interest; including any measures taken to reduce, manage or eliminate such conflicts.

7.  IMPLEMENTATION AT THE STORRS AND REGIONAL CAMPUSES

7.1 Disclosure of External Interests

Each investigator must disclose all of his/her significant financial interests (including those of the spouse and dependent children) that would reasonably appear to be affected by the instructional, research, or service activities funded or proposed for funding by an external sponsor, agency, or organization, or in entities whose financial interests would reasonably appear to be affected by such activities.  

Disclosures of any conflict of interest shall be made annually, and at the time of submitting any proposal for external funding, or immediately upon request by the University.

Disclosures of any conflict of interest shall be made by completing the Significant Financial Interest Review Form.  A new form must be completed for each proposal to be submitted for external funding, and the Significant Financial Interest Review Form will be made a part of each proposal submitted to the University. A copy of this form may be obtained from the Office for Sponsored Programs or the Office for Sponsored Program's website:  http://www.osp.uconn.edu/.  Additionally, the form may be found on the Research Compliance website:  http://www.compliance.uconn.edu/.

The Significant Financial Interest Review Form must be updated annually during the period of the award, and at any time new reportable significant financial interests are recognized.

When research involves human subjects, the Investigator must disclose COIs to the Institutional Review Board (IRB) with every submission of protocols.  If an Investigator has a COI, but a management plan is not on file with the IRB, then the IRB will refer this information to the COI Committee and hold approval of the protocol until the Committee makes a determination.

7.2 Responsibility for Implementation of This Policy

The Provost is responsible for overseeing the implementation of the Policy.  Possible sanctions for violation of the Policy, including furnishing false, misleading, or incomplete information, can range from administrative intervention to termination of employment, all in accordance with applicable University policies.  The Provost, or his/her designee, will review all breaches of the evaluation and review process, including:

1. failure to comply with the process (by refusal to respond, by responding with incomplete or knowingly inaccurate information, or otherwise) ;
2. failure to remedy conflicts; and
3. failure to comply with a prescribed monitoring plan.

The Provost has delegated the review process to the Office of the Vice Provost for Research and Graduate Education (hereinafter referred to as OVPRGE).  The Assistant Vice Provost for Research/Director of Research Compliance does an initial administrative review, and refers the matter to the Conflicts of Interest Committee (COIC). 

7.3 The Conflict of Interest Committee

The Conflict of Interest Committee (COIC) is appointed by the VPRGE, and serves as the resource with respect to matters involving conflicts of interest, and involving the identification and management, mitigation, or elimination of specific conflicts of interest.  The COIC shall be chaired by the VPRGE or his/her designee.  It shall also include not less than five (5) additional appointed members with broad representation across the University, and one community member who is not a University employee.  Members shall serve three-year staggered terms.

7.4 Conflict Management

If the COIC identifies a conflict, it will resolve the conflict by management, mitigation, or elimination.  Frequently, the mere disclosure of a conflict is sufficient management.  However, certain situations may require the formation of a Management Committee.

7.5 Restrictions

Examples of conditions or restrictions that might be imposed to manage, mitigate, or eliminate conflicts of interest include, but are not limited to:

• public disclosure of significant financial interests, including disclosure on manuscripts submitted for publication, on abstracts and posters submitted for presentation, and on informed consent documents;
• monitoring of instruction, research, or service activities by independent reviewers;
• modification of the instruction, research, or service activity plan;
• disqualification of an individual from participation in the portion of the externally funded activity that would be affected by that individual's significant financial interest;
• divestiture of an individual's significant financial interest;
• relinquishment or reassignment of duties;
• severance of relationships or holdings that create conflicts.

7.6 Records for the COIC

All Project-Specific Evaluation Forms and all records of actions taken to resolve or mitigate conflicts of interest will be maintained by the Assistant Vice Provost for the COIC for a period of at least three (3) years beyond the termination or completion of the sponsored award to which they relate, or until the resolution of any action involving those records, whichever is longer.

7.7 Reporting Conflicts of Interest to Funding Sources

The Office of the Vice Provost for Research and Graduate Education shall be responsible for timely notification of research sponsors as may be required by the sponsors' policies, or agreements between the University and the sponsors, of any actual or potential non-resolved conflicts of interest, including any measures taken to reduce, manage, or eliminate such conflicts.

8.  APPEALS

In situations where an investigator disputes the decision of a COI Management Committee, the investigator may request to present his case to the COI Management Committee in person. An investigator who disagrees with the COI Committee's findings may appeal in writing to the Designated Official (Executive Vice President for Health Affairs at UCHC/Vice Provost for Research and Graduate Education at the Storrs Campus). An appeal may be made in regard to whether the professional judgment of the investigator is likely to affect his or her conduct of research, but investigators may not contest the terms and conditions of this policy (e.g., they may not contest the prohibitions relating to significant financial interests, nor the remedy for such interests). One copy of the appeal must be sent to the Designated Official and another copy of the appeal must be sent to the COI Committee. The Designated Official may agree with the COI Committee's findings and/or recommendations, or may amend such findings and/or recommendations. The Designated Official shall promptly notify the investigator and the COI Committee in writing of the conclusions of his or her review, including the actions that must be taken by the investigator to comply with this policy. Upon receipt of the Designated Official's written report, the investigator must promptly comply with the actions specified in that report.

9.  PROHIBITED ACTIVITIES

Consistent with the regulations outlined in Section 4, it is the policy of the University that conflicts of interest in research may be allowable, provided that an acceptable plan of management can be developed and implemented in situations where such conflicts arise, as long as such management plans are not in conflict with applicable state and federal regulations.

10.  ASSESSMENT OF RISK

10.1 The Review Process, Including Risk Assessment by the COIC

 Upon referral, the Committee shall review all material related to a potential or apparent conflict of interest, considering the following:

Risk Factors:

1. Risk increases with amount, i.e., the larger the amount of financial interest, the greater the risk;
2. Risk on equity holding is higher than risk associated with cash interests;
3. Personal compensation and research support increases risk;
4. Participation of research trainees and graduate students on projects increases risk;
5. Human subjects involvement increases risk;
6. Financial interest in the outcome may compromise the technical management of the project and the use of facilities;
7. The leaders of the project have the most responsibility.

 Risk Levels:

1. Low level - Consulting interest only:  Solve with public disclosure on publications.
2. Medium level - Consulting and Research:  Disclose interest to participating graduate students and their thesis committees; Reveal interest to IRB committee if clinical study and to patients.
3. High level - Equity holdings:  All the above, plus some limits on trading during the period of the conflict.

11. SANCTIONS

 Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the appropriate responsible Institutional Official in consultation with the Dean of the appropriate School with advice from the Investigator(s) Department Head. Sanctions include, but are not restricted to:

"        Letter of reprimand

"        Notification to professional and/or scientific societies, funding agencies and/or professional journals

"        Reassignment of duties

"        Termination of grant support

"        Adjustment of research space allocation

"        Adjustment of salary

"        Suspension

"        Dismissal

12. EXAMPLES OF ACTIVITIES WHICH ARE NOT A COI

The following synopsis is presented as another educational resource to the University research community. It is simply a set of different scenarios which have been gleaned from various institutional policies and publications about conflicts of interest in research. For purposes of this policy, the definition of conflict of interest is as stated in Section 4 above.

Activities that are not a COI

"        Receiving royalties for copyrights and patents obtained in accordance with University policy and State law;

"        Receiving honoraria for giving seminars or guest lectures, (Refer to Sec. 14.2);

"        Duty to professional organizations, peer review panels, publication boards, and accreditation bodies,      (Refer to Sec. 14.2);

"        Ownership of company where there is no relationship to University responsibilities;

"        Ownership of mutual funds which may invest in companies that support the investigator's research.

13. AUDIT PROCEDURES

In order to ensure that all declarations are being made and conflicts managed, each campus will implement a relevant audit program through the University's Office of Audit, Compliance and Ethics.

14. STATE OF CONNECTICUT

14.1 Ethics for Public Officials

Connecticut General Statutes, Sec. 1-79 through 1-89 stipulates what types of activities are allowable for state employees who may have financial interests in companies which do business with the State of Connecticut. http://www.ethics.state.ct.us/.

There are state regulations that deal with research activities. If investigators are doing research and receive any investment opportunities or payment directly from a company, the investigator needs to make sure that they are in compliance with the State Code of Ethics.

14.2 Differences with Federal Regulations

The federal (NIH/FDA/NSF) definition of significant financial interest (Section 3) exempts "income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities" and "income from service on advisory committees or review panels for public or non-profit entities". 

The University policy acknowledges that income from non-profit entities may create an appearance of conflict of interest even when received for performing seminars, lectures, teaching engagements, or service on an advisory committee/review panel.  Therefore, such income must be reported to, and reviewed by, the University.

Income from U. S. governmental agencies (federal, state or local) for seminars, lectures, teaching engagements, or service on an advisory committee/review panel is exempt from review under the University policy.