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, management and education regarding potential conflicts of interest and commitment is required by/related to:
To comply with these requirements, CU Boulder has established an education, disclosure and review process to deal with potential Conflicts of Interest and Commitment.
Background: What is a conflict of interest or Commitment (COIC)?
According to University Administrative Policy (APS), conflicts of interest exists "when an employee's financial or personal considerations may compromise, or have the appearance of compromising, an employee's personal judgement in exercising any university responsibility in instructions, research, administration, management, and other professional activities." Ethical behavior toward students and scientific integrity in the conduct and reporting of research are of paramount concern. Potential conflicts of interest are important 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;
Completing the disclosure and review process does not mean one has a conflict of interest. In fact, most disclosures will reveal no conflicts. 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, the authorship of educational materials, involvement with professional societies, and participation on review panels, etc.. Such activities are expected insofar as they promote professional development of disclosers 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. Other affiliations that present more obvious concern are ‘outside’ positions of administrative authority (e.g., directorship), and ownership of a business entity.
Traditionally, the University has allowed employees 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 19.5 days per each semester. In addition, regular and periodic consulting, remunerated scholarship and service activities require department approval.
While the processes outlined in this policy speak to the oversight activities by Office of Conflicts of Interest under the direction of the Vice Chancellor Of Research, they do not preclude the obligations of university employees to report to other departments using the appropriate disclosure mechanisms, as each situation warrants. In particular, any University employee or student who knows or suspects fiscal misconduct is required to report such misconduct as set forth in the Administrative Policy Statement on Fiscal Misconduct Reporting. In addition, the Procurement Service Center (PSC) has a disclosure form that should be employed when less than arms-length business transactions are conducted. The Technology Transfer Office should be contacted when new technology discovery/development occurs as part of, or overlaps with, the employee’s university activities. The Compliance Director for the Office of Conflicts of Interest will act as a resource to employees with inquiries about such types of reporting.
Examples of Potential Conflicts of Interest Situations
The following three categories are examples of activities and situations related to actual or potential conflicts of interest or commitment:
This section focuses on the procedures to be followed to identify and resolve potential conflicts of interest or commitment.
Step 1. Disclosure by-Research Personnel (discloser)
All faculty, and any other employee, student, consultant, collaborator, or any other person acting as an agent of, or affiliated by contract or agreement with the university who has responsibility for the design, conduct or reporting of research are considered essential to the research process and must disclose any significant financial interests and external professional activities that could compromise university decision making or duties (here forward to be referred to as a "discloser")(See an expanded list of Research Personnel for whom this disclosure policy applies in Section I. Definitions). The disclosure must be submitted annually through a web-based form (Disclosure of External Professional Activities [DEPA] and updated within 30 days of a status change).
The disclosure report must be revised whenever there is a significant change in outside interests or activities (e.g., new purchase of stocks, forming a new company, entering a new partnership, agreeing to consult, accepting a position on a board or review panel, travel for PHS/NIH sponsored researchers, etc.)
Disclosures will go automatically to the Conflict of Interest Compliance Director. Disclosures also can be used to satisfy the conflict of interest reporting requirements of the Office of Contracts and Grants (OCG), the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), 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 the activities disclosed are clearly permissible or not. If the disclosed activities are clearly permissible, the Compliance Officer will notify the discloser and all relevant University offices. If the activities are not clearly permissible, the Compliance Director, in consultation with the discloser 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 Director will also develop possible management plans to address the identified conflicts (See Section E: Management Plans for COIC Situations). On difficult issues, the Compliance Director may want to consult with an Advisory Committee (See Section F: Conflict of Interest Personnel).
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 discloser 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 discloser 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.
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.
The Committee will consider appeals by reviewing the written materials; consulting with the Compliance Director, the discloser, 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 discloser and Provost.
If, at the conclusion of a risk analysis, it is determined that a real or potential conflict of interest and/or commitment exists, a management plan, focused on the areas of university responsibilities at risk, will be developed. The management plan will address one or more of the following areas:
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:
This informal committee (consisting of the Associate Vice Chancellor for Research Integrity and Compliance [AVCR], University Legal Counsel, Director of OCG, and senior management 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 — 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. The committee members will elect one of the faculty as the chair. The Associate Vice Chancellor for Research Integrity and Compliance (AVCR),University Legal Counsel and Director of OCG, senior management for Technology Transfer, and Director of the Office of Conflict of Interest will serve as non-voting members to 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:
A committee member shall be recused from discussion and voting on a particular matter if:
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 Handbook, Part IV. REVIEW OF FACULTY CONDUCT AND SANCTIONS FOR UNPROFESSIONAL CONDUCT BY A FACULTY MEMBER.
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. In some cases, the order of this process may vary. Investigative activities regarding a potential conflict may involve any number of experts and these may be consulted prior to meeting with the subject of the allegation if there is concern that notification of an investigation may disrupt another ongioing University process, for example, corroborating evidence may be altered by the subject, subordinates might feel threatened by the subject etc. Although the order of the process of inquiry and investigation may vary, in all instances the subject of the allegation will have an opportunity to explain, in full, his/her activities relevant to the case, and provide evidence supporting his/her statements.
For violations of this policy, the Committee may recommend one or more of the following disciplinary and/or administrative actions:
Company/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 form used by University of Colorado Boulder employees, students and other persons of interests (POIs) to report information regarding significant financial and personal interests outside of the university that might present conflicts of interest or commitment.
Discloser means a person who is required to submit a conflict of interest and commitment disclosure in the form of the DEPA. Refers to all faculty, and any other employee, or student, consultant, collaborator, or any other person acting as an agent of, or affiliated by contract or agreement with the university who has responsibility for the design, conduct or reporting of research. (See Research Personnel for an expanded list detailing to whom this disclosure policy applies).
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.
Family means, for the purposes of this policy, any family member with whom you have a close relationship. Examples include, but are not limited to: spouse, parents (yours or spouse's), child, sibling, son/daughter-in-law, step relatives, domestic partner, relatives of domestic partner in any relationship stated above.
Income means the amount of money or its equivalent received during a period of time in exchange for labor or service, from the sale of goods or property, or as profit from financial investments (e.g., salary, consulting fees, honoraria, royalties, and dividends).
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, biological materials, and other forms of intellectual property legally recognized now or in the future.
Investigator/Principal Investigator/Principal Director is traditionally limited to the principal investigator and co-principal investigators; some federal regulations include this to mean any research personnel or other key personnel, regardless of title or position at a university, who is responsible for the design, conduct, or reporting of research, proposed research, or educational activities.
Key Personnel means an individual involved in research and who is supported in salary, supplies, space or other resources by grant funding.
PHS means Public Health Services agencies including NIH. An expanded list of agencies can be found at the following website: http://www.hhs.gov/about/orgchart/.
POI is an acronym for "Person of Interest." In order to access the DEPA reporting system, individuals who are not university employees must be established in the payroll system as POIs. POI status may also be necessary to access the conflict of interest educational training modules.
Research means a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development.
Significant Financial Interest (SFI) includes anything of monetary value received from an entity outside the university that meets or exceeds established thresholds. Examples include, but are not limited to, salary or other payments for services from a third party/financially interested company; dividends, equity interest; intellectual property rights (and royalties from such rights). (See income, payments for services, equity interests, etc.). Thresholds are set in accordance with current funding agency regulations:
Note: While SFI literally denotes a financial interest, personal/family gain other than strictly financial is also considered in reviewing potential conflicts of interest.
The term Significant Financial Interest does NOT include:
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).
Technology Transfer Office (TTO) A university department that “pursues, protects, packages and licenses to business the intellectual property generated from research at CU. The TTO provides assistance to faculty, staff and students, as well as to businesses looking to license or invest in CU technology.”