Research Administration

Home >> Research Integrity and Regulatory Compliance >> Conflicts of Interest & Commitment

• About COIC
• Disclosure Form (DEPA)
• Policy

Conflicts of Interest & Commitment

Overview of Process of Disclosure and Review
University of Colorado, Boulder Campus

A. Purpose

The university encourages scholarship and research that leads to commercial and consulting activities; however, such activities have the potential to lead to conflicts of interest, which may have adverse effects for employees and the university. Therefore, disclosure and management of potential conflicts of interest and commitment is required by:

• the Administrative Policy Statement (APS) on Conflict of Interest (http://www.cu.edu/policies/Academic/coninterest.html)
• the campus policy on conflict of commitment http://www.colorado.edu/facultyaffairs/atoz/one-sixth-rule.pdf.
• Section 510 of the National Science Foundation Grant Policy Manual (http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpm#), and
• the policies and regulations of the National Institute of Health (http://grants.nih.gov/grants/policy/emprograms/overview/ep-coi.htm)

To comply with these requirements, CU Boulder has established a disclosure and review process to deal with potential conflicts of interest and commitment.

B. What is a conflict of interest or commitment?

The APS defines potential conflicts of interest as existing “when an employee’s financial or personal considerations may compromise, or have the appearance of compromising, an employee’s personal judgment in administration, management, instruction, research, and other professional and academic activities.” Potential conflicts of interest are a concern because they may appear to compromise objectivity in research, fulfillment of university duties, and/or proper fiscal management.

In order to determine if a conflict of interest exists, the University has developed a disclosure process. The disclosure process is designed to determine if 1) a discloser has is a significant financial interest in an outside commercial entity that is related to the discloser’s University activities, and 2) if this interest could compromise (or appear to compromise) the discloser’s judgment in his/her university duties, research, or decision making.

Completing the disclosure and review process does not mean one has a conflict of interest. In fact, most disclosures will reveal no potential for conflict. Furthermore, most conflicts of interest will be manageable. Finally, completing the disclosure process will protect employees as well as the university from accusations of misconduct.

According to the APS, the “term ‘conflict of commitment’ relates to an individual University employee’s distribution of effort between employment obligations to the University and ’outside’ professional activities that are generally encouraged, such as consulting, textbook authorship, involvement with professional societies, and participation on review panels, etc..

Such activities are expected insofar as they promote professional development of faculty members and enrich their contributions to the institution, to their profession and to the community.” However, “a conflict of commitment arises when professional service or research contracted outside the University, consultations, or other outside activities (e.g., outside teaching or business) interfere with the paramount obligations to students, colleagues, and the primary missions of the University. Conflicts of commitment primarily involve questions of obligation and effort, but are often tied to financial remuneration or other inducements, and in such cases may also constitute conflicts of interest.”

“Traditionally, the University has allowed full-time faculty to be employed in remunerative consultative or research capacities when such employment did not involve more than one-sixth of their time and energy.” That translates into 39 days during the appointment year of the faculty member on a nine month appointment.

C. Examples of activities/situations that present a potential for conflicts of interest and/or commitment
The APS provides the following three categories of “activities and situations that could present, [or appear to present,] conflicts of interest or commitment”.

1. Activities that are clearly permissible include (but are not limited to):

1. Participation in scientific or professional association activities, editorial responsibilities, or service on scientific review boards and panels;
2. Acceptance of honoraria for commissioned papers and occasional lectures;
3. Performance of professionally related activities such as consulting, textbook authorship, involvement with professional societies, participation on review panels, etc.;
4. Service as a consultant to outside organizations, provided the arrangement does not unreasonably restrict publication of research results obtained within the University;
5. Service on boards and committees of organizations, public or private, that does not distract unduly from University obligations.

2. Activities that present, or may appear to present, potential conflicts of interest include (but are not limited to);

1. University responsibilities that provide an employee with the opportunity to direct university business to a business entity in which he or she has a significant financial or other interest;
2. Conduct of university research the results of which could affect the finances of a business entity in which the employee has a significant financial interest;
3. University receipt of funding for an employee’s university research from a business entity in which the employee has a significant financial interest;
4. Assignment of students or graduate assistants to duties that benefit a business entity in which the person in charge of assignment of those duties has a significant financial interest;
5. Use of university facilities and personnel for the business of a business entity in which the employee has a significant financial interest;
6. Exclusive access to university research is given to a business entity in which the employee has a significant financial interest, unless the business entity is the sponsor of the research.

3. Activities that clearly present such serious problems as to be incompatible with University policies include (but are not limited to):

Assumption of responsibilities for an outside organization that divert a University employee from his or her attention from University duties, or create other conflicts of loyalty.

1. Use for personal profit of unpublished information emanating from University research or other confidential University sources, or assisting an outside organization by giving it unreasonably exclusive access to such information (this section does not supersede Regental policy on classified research); or consulting under arrangements that impose obligations that conflict with University patent policy or with the University's obligations to research sponsors.
2. Conduct of research (that could and ordinarily would be carried on within the University) elsewhere to the disadvantage of the University and its legitimate interests.

D. Review Process

This section focuses on the procedures to be followed to identify and resolve potential conflict of interest or commitment.

Step 1. Disclosure: Faculty member

All faculty, including research faculty, and any other employees with responsibility for the design, conduct or reporting of research, must disclose any significant financial interests and external professional activities that could compromise university decision making or duties. The disclosure must be made annually through a web-based form (Disclosure of External Professional Activities [DEPA]) and must be revised whenever there is a significant change in outside interests or activities. Disclosures will go automatically to the Conflict of Interest Compliance Director. This disclosure also can be used to satisfy the conflict of interest reporting requirements of the Office of Contracts and Grants, the Human Research Committee (HRC or IRB), and the Technology Transfer Office (TTO).

Step 2. Initial Review and Analysis: Compliance Director

The Compliance Director will review the disclosure and make a determination whether or not the activities disclosed are clearly permissible or not. If the disclosed activities are clearly permissible, the Compliance Officer will so notify the faculty member and all relevant University offices. If the activities are not clearly permissible, the Compliance Director, in consultation with the faculty member and unit head, will write a report that includes a description of the facts and an analysis of issues to be considered in a management plan. The Compliance Officer will also develop possible management plans to address the identified conflicts. On difficult issues, the Compliance Director may want to consult with an Advisory Committee (see section E).

Other than in exceptional circumstances, the report shall be given to the unit head within 30 days of receiving complete disclosure information. Any justification for delay should be provided in writing to the Vice Chancellor for Research. However, external deadlines may sometimes require a particularly quick review and analysis.

If the faculty member is the unit head, the disclosure and report should be submitted to the Dean.

Step 3: Evaluation and Development of Management Plan, as Necessary: Unit Head

In cases where the Compliance Director has not already determined that the disclosed activities are clearly permissible, the unit head will use the disclosure statement and report from the Compliance Director to determine whether the potential conflict of interest is 1) permissible, 2) permissible with modification and management, or 3) not manageable and incompatible with university policies.

If determined to be permissible, the unit head will, in consultation with the Compliance Director, put the justification in writing.

If determined to be permissible with management, the unit head will, in consultation with the faculty member and the Compliance Director, devise a written management plan .

If determined not to be permissible, the unit head, in consultation with the Compliance Director, will write a statement listing the reasons for not allowing the activities.

Throughout the process, the unit head may want to rely on the expertise and views of others in the department but should also be aware of the need to keep disclosure information confidential.

The unit head will submit the decision and supporting materials to the college Dean (if the Dean is reviewing a disclosure from the unit head, he or she should submit materials to the Provost). The recommendation should, unless there are special circumstances, be made to the Dean within 30 days of receiving the report from the Compliance Director; faculty may request a review by the Dean if the unit head does not respond within this time span.

Step 4. Approval, Negotiation, or Appeal: Dean

The Dean will review the disclosure report, support materials, the unit head’s decision and, if applicable, the management plan.

• If the Dean concurs with (a) the unit head’s recommendation that the activity is permissible, or (b) the proposed management plan, he or she shall do so in writing and forward the materials to the Compliance Director and the faculty member.
• If the faculty member is in agreement with the Dean’s concurrence, he or she will notify the Dean in writing of his/her acceptance of the decision. Then the matter will be considered to be ‘in compliance’
• If the faculty member does not agree with the Dean’s concurrence, then the matter is referred back to the unit for one final time for reconsideration and/or revision.
• A final unit level recommendation is then made to the Dean for a second and final reconsideration as soon as is reasonably possible. If the faculty member is in agreement with the Dean’s concurrence, he or she will notify the Dean in writing of his/her acceptance of the decision. Then the matter will be considered to be ‘in compliance’.
• If the faculty member does not agree with the Dean’s concurrence, then the matter is automatically referred to the CoI Committee who will consider the matter and make a recommendation for action or management to the Provost. The Provost will then make a final ruling on the matter (see Step 5).
• If the Dean concurs with the recommendation that the activity is not permissible, or if the Dean does not concur with (a) the Chair’s recommendation that the activity is permissible, or (b) the proposed management plan, he or she shall inform the unit head and faculty member.
• the matter is referred back to the unit for one final time for reconsideration and/or revision.
• A final unit level recommendation is then made to the Dean for a second and final reconsideration as soon as is reasonably possible.
• If the Dean now concurs with the management plan, or that the activity is permissible, he/she will notify the faculty member in writing of his/her decision. If the faculty member is in agreement with the Dean’s concurrence, he/she will so notify the Dean in writing. Then the matter will be considered to be ‘in compliance’.
• If the Dean concurs with the Chair’s recommendation that the activity is not permissible, or if the Dean does not concur with (a) the Chair’s recommendation that the activity is permissible, or (b) the proposed management plan, then the matter is automatically referred to the CoI Committee who will consider the matter and make a recommendation for action or management to the Provost. The Provost will then make a final ruling on the matter (see Step 5).

In all cases, the Dean should respond within 30 days of having received the materials from the unit head.

The Dean may rely on the advice of the Compliance Director to the extent thought necessary for a measured and informed decision.

Step 5 Appeal: Conflict of Interest Committee

The Committee will consider appeals by reviewing the written materials; consulting with the Compliance Director, faculty member, and unit head as needed; and making a recommendation to the Provost for a final determination. The committee shall have 60 days from the date it receives an appeal to forward its recommendation and supporting materials to the Provost. Should it take longer than 60 days, the committee shall provide an explanation of the delay to the faculty member and Provost.

E. Conflict of Interest Personnel

Compliance Director

Under the supervision of the Vice Chancellor for Research and with guidance from the Advisory Committee, the Compliance Director will, as described above, take a key role in the review process. In addition, the Compliance Director will (again under supervision of the Vice Chancellor for Research and with guidance from the Advisory Committee) have other responsibilities:

1. Maintain records of disclosures and reviews across campus and complete a yearly report of campus conflict of interest issues for the Provost, Chancellor, and President.

2. Coordinate procedures with the Office of Contracts and Grants to help meet conflict of interest requirements for external funding; with the Technology Transfer Office to make sure commercial applications of university IP meet conflict of interest requirements; and with the Human Research Committee to meet conflict of interest requirements in human subjects research.

3. Inform faculty of the conflict of interest policies and the importance of compliance, offer training sessions and resources to faculty and chairs on conflict of interest procedures, and develop a set of management plan templates that can help researchers know what to expect when they have a potential conflict of interest.

4. Monitor compliance with conflict of interest policies across campus and report problems to the Vice Chancellor for Research and bring policy concerns to the Conflict of Interest Committee

Advisory Committee

This informal committee (consisting of the Associate Vice Chancellor for Research, University Counsel, Director of OCG, Director of Research Integrity, and Vice President for Technology Transfer) will give guidance to the Compliance Director, provide an additional resource for faculty, chairs, and deans, and help deal with special problems and disputes that arise over conflict of interest issues. It will meet informally as needed.

Conflict of Interest Committee

The committee will consist of at least eight faculty members – appointed by the Vice Chancellor for Research and recommended by the associate deans for natural sciences, social sciences, humanities, and engineering, and the Deans of other colleges on campus – and one member from outside the university. The committee members will elect one of the faculty members as the chair. The Associate Vice Chancellor for Research, Legal Counsel, Director of OCG, Director of Research Integrity, Associate Vice President for Technology Transfer, and Compliance Director will serve as non-voting members of the committee. The committee will meet at least once per semester to discuss policy issues and to conduct necessary business as needed.

Key duties of the Conflict of Interest Committee will include

1. the handling of appeals regarding conflict of interest management rulings
2. the provision of advisory input to appropriate appointing authorities (e.g. Chairs, Deans, etc.) on matters of alleged conflict of interest or commitment violations; and
3. initiation of changes to this policy.

A committee member shall be recused from discussion and voting on a particular matter if:

1. The committee member has a compelling personal interest in the matter (such as research or academic collaboration with the faculty member under consideration); or
2. The committee member has a financial interest in the matter under;consideration.

F. Confidentiality
All records and information provided by an employee for the purpose of
disclosure and management and all official records of disclosure and management
shall be considered confidential. Any information disclosed by an employee as required by this policy shall be used solely for the purpose of administering this policy and may not be used for any other purpose unless required by law. Unauthorized disclosure of any such information by an employee shall be deemed to be unethical behavior and shall be punishable under the Faculty Booklet, Part IV. REVIEW OF FACULTY CONDUCT AND SANCTIONS FOR UNPROFESSIONAL CONDUCT BY A FACULTY MEMBER

G. Violations and sanctions

1. Conflict of interest/commitment violations may include, but are not limited to,
a. failure to disclose conflicts of interest or commitment;
b. false or inadequate disclosure of conflicts;
c. failure to adhere to a prescribed conflict of interest/commitment management plan.
2. Alleged conflict of interest violations should first be brought to the attention of the appropriate unit head (Chair or Director) and the Compliance Director. The Compliance Director, in consultation with the unit head (or appropriate designees), should make an initial determination on the veracity and seriousness of the alleged conflict of interest violation(s). If it is determined that an allegation should be dismissed, the basis for dismissal should be documented and reported to the Associate Vice Chancellor for Research. Furthermore, if the dismissed allegation is determined to be malicious in intent, that shall be reported to the immediate administrative supervisor of the person making the unfounded allegation as per Part IV. Section B. 1. of the Faculty Booklet. If alleged violations are found to have a factual basis, the unit head and Compliance Director will consult with the subject of the allegation to attempt to address the conflict through the development of management plans or other administrative actions. If the conflict can be so resolved, that should also be documented and reported to the Associate Vice Chancellor for Research.

If the allegations cannot be resolved or addressed at the unit level, the matter will be referred to Conflict of Interest Committee (CoIC), and both the AVCR and Legal Counsel notified. The CoIC will consider the violation allegations. The CoIC may use the Advisory Committee as a resource, but the CoIC will be ultimately responsible for providing the AVCR, the Compliance Director, and the appropriate appointing authorities with a written report of the committee’s findings, and any recommendations for corrective or disciplinary action.

3. Sanctions and Discipline

For violations of this policy, the Committee may recommend one or more of the
following disciplinary and/or administrative actions:

1. Disciplinary actions (including but not restricted to):

(1) emphasizing, orally or in writing, to the faculty member his or her professional responsibilities;
(2) oral or written admonition of the faculty member;
(3) confidential reprimand of the faculty member;
(4) public reprimand of the faculty member;
(5) reassignment, temporarily or permanently, of the faculty member’s office or other working space (with the appropriate consent of any academic unit affected);
(6). reassignment, temporarily or permanently, of the faculty member’s courses or other duties;
(7) reassignment, temporarily or permanently, of the employee to another academic unit (with the appropriate consent of any academic unit affected);
(8). withholding raises or privileges for the employee for a specified period or until the employee demonstrates, under the terms of the sanction, that he or she has terminated the unprofessional conduct;
(9) temporary or continuing reduction in salary or privileges of the employee;
(10) suspension of the employee for a period stated or until stated conditions are met; or
(11) termination of employment or dismissal of the employee
2. Freezing of research funds, other research restrictions, etc
3. Withholding payment owed under a purchasing contract relating to the conflict;
   
4. Recission of University contracts entered into in violation of this Conflict of Interest Policy or of state law;
5. Recovery of the amount of financial benefit received by an employee as a result of his or her violation of this policy;
6. Other similar and appropriate actions.

H. Definitions

Business entity means a sole proprietorship, partnership, association, joint
venture, corporation, firm, trust, foundation, or other organization or entity
used in carrying on a trade or business, including parent organizations of such
entities or any other arrangement in which an entity operates through a
subsidiary.

Compensation means anything of economic value, however designated, which is
paid, loaned, granted, given, donated, or transferred to any person or business
entity for or in consideration of personal services, materials, property, or the
like.

Disclosure of External Professional Activities (DEPA) is the annual form used to disclose individual potential conflicts of interest.

Employee means any person who is employed by the University, whether full or
part time, and includes but is not limited to staff, faculty, postdoctoral
appointees, residents and students. It also includes investigators as defined by
the referenced federal policies and individuals who are not paid on a project
(i.e., volunteers).

Family means, for the purposes of this policy, spouse/same gender domestic partner and/or dependent children.

Intellectual property means any ideas, inventions, technology, creative
expression and embodiments thereof, in which a proprietary interest may be
claimed, including but not limited to patents, copyrights, trademarks, know-how,
and biological materials.

Investigator includes the principal investigator co-principal investigators, and any other person at the University who is responsible for the design, conduct, or reporting of research or educational activities.

Research means a systematic investigation designed to develop or contribute to
generalizeable knowledge. The term encompasses basic and applied research and
product development.

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 interest (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).
The term does not include:

• salary, royalties or other remuneration from the University of Colorado;
• income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
• income from service on advisory committees or review panels for public or nonprofit entities;
• an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed the amount indicated by funding agencies for value and percentage of ownership (currently $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and a 5% ownership interest) in any single entity; or
• salary, royalties or other payments from a single entity, that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed the amount indicated by funding agencies (currently $10,000) during a twelve month period;
• income from/ownership in mutual funds and/or pension funds;

• any ownership interests in a business entity by an  investigator on a Phase I SBIR grant or application with that business entity.

Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of certain Federal agencies under Pub. L. 97-219, the Small Business Innovation Development Act, as amended. For the purposes of this policy, the term SBIR includes the Small Business Technology Transfer (STTR) Program, which was established by Pub. L. 102-564.

Definition adapted from section 510 of the National Science Foundation’s Grant Policy Manual