Effective May 2015, this chapter has been reorganized to include the new policy II-18.7 Institutional Conflict of Interest in Human Subjects Research. For the most current version without redlining, return to II-18.
Note: This chapter is one of several that address conflicts of interest of various types at The University of Iowa. Others include: II-5 Consensual Relationships Involving Students, which addresses faculty-student relationships that are either prohibited or discouraged due to role conflicts; and III-8 Conflict of Interest in Employment (Nepotism), which addresses role conflicts when there is a direct reporting line between two employees. See also II-18.7 below for a complete list of policies that address or are related to conflicts of interest.
The University of Iowa community is committed to the principle of free, open, and objective inquiry in the conduct of its teaching, research, and service missions. Further, The University of Iowa encourages its employees to engage in external activities that promote the University's mission, contribute to their professional fields, enhance their professional skills, and/or enhance the public good. However, the University also expects its employees to fulfill their University obligations first and foremost commensurate with their appointment requirements. To ensure that external activities are conducted in a manner consistent with institutional and public values, the following policy conveys expectations and procedures to ensure that University employees avoid improper conflicts whenever possible, or otherwise disclose activities for review and management.
After consultation with their relevant employees, individual units within the University may adopt more stringent rules, which must be approved by the vice president or Executive Vice President and Provost responsible for that unit. Other University policies that address conflicts of interest not covered by this policy are referenced at the end of this chapter.
It should be noted that the following rules governing outside professional activities do not apply to the intramural practice of medicine, nursing, and dentistry conducted in the Colleges of Medicine, Dentistry, and Nursing by members of those faculties according to the plan approved and regulated by the Board of Regents, State of Iowa, and specific provisions of the Iowa Code.
18.2 GENERAL DEFINITION.
(Amended 2/06; 10/1/13)
A conflict exists whenever personal, professional, commercial, or financial interests or activities outside of the University have the possibility (either in actuality or in appearance) of: 1) interfering with UI employees' ability to fulfill their employment obligations; 2) compromising a faculty or staff member's professional judgment; 3) biasing research or compromising, or giving the appearance of compromising, the sound professional judgment of its investigators; or 4) resulting in personal gain for the employee or employee's immediate family, at the expense of the University and/or the state.
18.3 PRINCIPLES OF DISCLOSURE, REVIEW, AND MANAGEMENT.
(Amended 4/05; 10/1/13)
Disclosure, review, and management are critical to the application of conflicts of interest and commitment policies. Under these policies, few activities that represent, or appear to represent, a conflict are actually prohibited. Rather, these rules require conflicts to be disclosed, reviewed, and managed appropriately. Disclosure may take the form of reporting a potential or actual conflict in advance of beginning an activity, at the time a conflict arises, and/or through an annual report of outside interests and activities. Depending on the type of conflict, review of a disclosure to determine whether a conflict exists may be conducted by an employee's DEO or supervisor, or by a University office or committee. If a conflict is identified, a written management plan is required to ensure that conflicts do not interfere with the integrity of employees' performance of University obligations. The appropriate method of disclosure and management varies with the type of activity as described in the Conflicts of Interest and Commitment Procedures Guidance document.
18.4 CONFLICTS OF COMMITMENT (EFFORT).
(Amended 4/05; 10/1/13; 1/14)
b. Scope of Policy.
(2) Professional and scientific or merit staff, or student employees, including graduate assistants. A member of the professional and scientific or merit staff, or a student employee, who engages in external activities, compensated or uncompensated, can do so during regularly scheduled work hours only if the employee uses vacation time, is on an unpaid leave of absence, or has made special arrangements with his or her supervisor.
(b) Serving as a referee for a scholarly journal or an academic press;
(c) Serving on a professional review board or peer review bodies;
(d) Attending or presenting at professional meetings, workshops, colloquia, symposia, seminars, or training programs;
(e) Visiting other sites in connection with accreditation, audits, sponsored project reviews, research, or like activities;
(f) Writing or producing academically related books, articles, software and similar materials, or other creative works ordinarily considered in decisions relating to the employee's employment status or salary; or
(g) University-related public engagement.
(3) "Business day" means every Monday through Friday during regular business hours and the time on any Saturday, Sunday, or evening when a faculty member is scheduled to work, but does not include any University holiday or day that the faculty member takes a vacation day or sick leave.
(4) "Compensation" is remuneration or valuable goods received for work performed and does not include reimbursement for reasonable expenses.
(5) "Disclose" means providing written notice of a specific external activity (see definition below) in advance of engaging in the activity or whenever the situation changes to provide an opportunity for the review and management of possible conflicts or commitment and interest in the workplace.
(6) "Entity" means a non-UI organization, whether public, private, or not-for-profit.
(7) "External activities" are services to a non-University entity, whether or not related to the faculty member's professional expertise. These activities may require disclosure in advance of engaging in the activity per paragraph e(1)(c) below.
(8) "Outside professional activities" are services to a non-university entity, whether compensated or not, which involve the use of a faculty member's expertise or the practice of their profession and are not a part of the employee's position responsibilities. These activities require disclosure per paragraph e(1)(a) below before engaging in the activity.
(b) Academic Activities shall be disclosed in advance only if the time required to conduct the activity interferes with the performance of assigned duties (e.g., faculty member will miss a class, regular office hours); or
(c) External Activities, which are not related to a faculty member's professional expertise, shall be disclosed in advance of undertaking the activity only if engaging in the activity requires a substantial commitment of time or compromises, or has the appearance of compromising, a faculty member's professional judgment in performing his or her University duties (e.g., teaching, research, business decision making) (see II-18.5 Conflicts of Interest in the Workplace below).
The existence of a conflict of commitment is not always clear-cut. University employees are expected to make a reasonable effort to determine whether their activities create, or appear to create, such conflicts. If there is any uncertainty, faculty members should consult their DEO or equivalent.
(2) Review by DEO or Equivalent: When an external activity is disclosed, the DEO or equivalent will evaluate the disclosure to determine whether: 1) a conflict of commitment exists and, 2) if yes, whether any further action is needed. The DEO or equivalent shall consider the following questions in the review:
(b) Has the faculty member engaged in "outside professional activities" during the current appointment year in excess of nine business days per academic term (i.e., Fall, Spring, Summer)?
(c) Does engaging in the professional activity advance the skills and abilities of the faculty member, with resultant benefit to the employing unit?
(d) Will engaging in the activity be detrimental to the unit or university?
(e) Is the faculty member in good standing and meeting expected standards of performance?
(f) Does the activity interfere or have the appearance of interfering with the faculty member's assigned duties?
(3) Management Plan: If the DEO or equivalent determines that engaging in the external activity poses a conflict of commitment, the DEO or equivalent will work with the faculty member to develop a written management plan using a template provided by the Provost Office (http://provost.uiowa.edu/conflict-commitment). Management plan actions will vary based on the situation and may include: requiring nothing beyond documentation of disclosure, arrangements to cover all university responsibilities during his or her absence, strategies to eliminate the conflictual elements of the activity, and/or prohibition of the activity. A management strategy for a conflict of commitment shall not include any reduction in an employee's salary and shall not otherwise take into account payments received by an employee for outside activities, unless the management strategy also includes a formal reduction in employee effort or a leave of absence from the University.
A copy of management plans related to Conflicts of Commitment shall be maintained in the employee's personnel file. No account of disclosures or management plans shall be taken into consideration at a later date when setting the annual salary of an employee, including any payments received by an employee from outside sources that are disclosed in connection with the employee's disclosure of any conflict of commitment or interest.
(4) Monitoring: An employee's disclosures and any existing management plans will be reviewed annually (e.g., at annual review), or as needed.
(5) Annual Report of Outside Professional Activities and Interests: All regular UI faculty members with a 50% or greater appointment, including administrators with faculty appointments, are required to complete an Annual Report of Outside Professional Activities and Interests for the previous calendar year by April 30 of each year.
g. Noncompliance. Failure to disclose a conflict and/or comply with required management strategies constitutes a violation of University policy and may also violate state and federal law. Employees may be subject to sanctions for violation of this policy, including disciplinary action up to and including termination of employment.
h. Campus Education/Training. An annual notification will be sent to all UI employees by the Office of the Provost, University Human Resources, and the Office of Vice President for Research to remind the campus of the existence of conflicts of interest and commitment policies and the importance of campus compliance with the disclosure and management provisions. Additionally, campuswide resources will be available online for individuals and DEOs/supervisors regarding how to disclose, review, and manage conflicts.
i. Reporting. The University will provide initial and ongoing reports of its management of conflicts of commitment to external governance bodies as required by law and in accordance with this policy.
j. Records. Records relating to all employee disclosures and the University's review and management of such disclosures, will be maintained by the University for as long as the employee is engaging in the activity that is the subject of the disclosure and/or three years after the faculty member's termination.
Examples of conflicts of interest in the workplace that require disclosure, review, and management include, but are not limited to:
(2) Promoting or providing information about goods or services to the University community when the employee or his or her immediate family has a financial interest in or other relationship with the relevant business entity (see also III-17.17(3) Royalties from Course Materials);
(3) Assuming or accepting any non-University duties requiring, or appearing to require, the use of University data, processes, procedures, or proprietary or confidential information (see also III-17.17(1) Use of University Supplies);
(4) Assigning duties or offering employment to another faculty or staff member to participate in or benefit the assigning employee's outside professional activity;
(5) Assigning duties or offering employment related to the assigning employee's outside professional activities to a student, when the student is enrolled in a course being taught by the employee or the student's academic work (including work as a teaching or research assistant) is being supervised by the assigning employee;
(6) Teaching a University course for academic credit that includes a member of employee's immediate family or a person with whom the instructor has a relationship that may compromise, or have the appearance of compromising, his or her professional judgment (see also II-5 Consensual Relationships Involving Students).
c. Oversight of Policy. This policy is overseen by the Office of the Executive Vice President and Provost for faculty conflicts of interest and University Human Resources for staff-related conflicts of interest.
(2) "Compensation" means anything of value received in exchange for work performed and does not include reimbursement for reasonable expenses.
(3) "Immediate family" includes the employee's spouse/domestic partner and children for purposes of this policy. The definition may be different in the Conflicts of Interest in Employment (III-8) and Purchasing Conflicts of Interest (V-11.14) policies.
(4) "Prohibited activities" are activities that are impermissible in accordance with state law governing the behavior of state employees. These include, but are not limited to:
(b) Undertaking a business or research opportunity ordinarily conducted by or for the University before the University has been offered the right of first refusal. For faculty members and staff within a college, a written waiver of University interest must be obtained from the dean of the college. For other faculty or staff members, a written waiver must be obtained from the director of the unit in which the person is employed.
(c) Using University stationery or letterhead in connection with outside activities, other than activities having a legitimate relationship to the performance of the employee's University obligations.
(d) Receiving compensation without the approval of the President or the Board of Regents, State of Iowa, for serving on the board of directors of business entities when the employee is appointed to that position by the University or is serving as the representative of the University.
(e) Using University facilities or employee's position at the University, to advocate, endorse, or market a product or a service, unless in conjunction with employee's University duties or requested or approved by employee's dean or other appropriate University official.
(f) Other prohibited activities under related University policies may be found through the web links at the end of this policy (see II-18.7).
Additional disclosure may be required under different policies (see II-18.4 Conflicts of Commitment, II-18.6 Conflicts of Interest in Research, II-18.7 Other University of Iowa Policies Related to Conflict of Interest, and UI Health Care Conflict of Interest and Conflict of Commitment Policy).
(2) Review: Each disclosure will be reviewed by the respective Associate Dean for Faculty (for faculty), the Senior HR Representative (for staff), or other appropriate HR executive or designee. When such individual determines that a potential conflict of interest exists, the disclosure also will be reviewed by the employee's supervisor and/or DEO. A copy of the disclosure form shall be retained in the college/organizational unit.
(3) Management: If it is determined that the disclosed external activity or interest poses, or appears to pose, a conflict of interest in the workplace, the employee's supervisor and/or DEO shall work with the respective Associate Dean for Faculty or the Senior HR Representative to develop a written management plan using templates provided by the Provost Office (see: http://provost.uiowa.edu/conflict-interest-workplace). The proposed plan will be forwarded to the respective collegiate dean or vice-president for review and approval. A copy of this management plan shall be shared with the appropriate parties and maintained in the employee's personnel file. Management plan actions may include: nothing beyond documentation of disclosure, strategies to eliminate the conflictual elements of the activity, and/or prohibition of the activity.
(4) Monitoring: An employee's conflict of interest disclosures and any existing management plans will be reviewed at least annually, or as needed, by the central administrative office, the employee's employing unit, and the respective Dean or Vice President.
(5) Annual Reporting: All 50% or greater regular faculty members, including administrators with faculty appointments, staff members in executive classifications, and Professional and Scientific classifications in pay levels 7-10 are required to complete an online Annual Report of Outside Professional Activities and Interests for the previous calendar year by April 30 of each year.
g. Noncompliance. Failure to disclose a conflict and/or comply with required management strategies constitutes a violation of University policy and may also violate state and federal law. Employees may be subject to sanctions for violation of this policy, including disciplinary action up to and including termination of employment.
h. Campus Education. An annual notification will be sent to all UI employees by the Office of the Provost, University Human Resources, and the Office of Vice President for Research to remind the campus of the existence of conflicts of interest and commitment policies and the importance of campus compliance with the disclosure and management provisions. Additionally, campuswide resources will be available online for individuals and DEOs/supervisors regarding how to disclose, review, and manage conflicts.
i. Reporting. The University will provide initial and ongoing reports of its management of conflicts of interest to external governance bodies as required by law and in accordance with this policy.
k. Records. Records relating to all employee disclosures and the University's review and management of such disclosures, will be maintained by the University for as long as the situation exists and/or three years from the employee's termination.
b. Scope of policy. This policy applies to all persons at the University who meet the definition of investigator (see paragraph d(7) below) and applies to all University activities meeting the definition of research where the activity is funded or, if unfunded, where the work involves human subjects. Designated provisions of this policy apply only to investigators applying for or conducting research funded by the Public Health Service (PHS) (including the National Institutes of Health). Investigators who conduct studies regulated by the Food and Drug Administration or who conduct research funded by the other federal agencies, including the National Science Foundation, are subject to agency-specific regulations relating to financial conflicts of interest in research. Affected investigators are advised to review such regulations prior to submission of a research proposal or application.
c. Oversight of policy. This policy is overseen by the Vice President for Research, who will appoint a Conflict of Interest Officer as the University's institutional official responsible for implementation of this policy and a Conflict of Interest in Research Committee to review and recommend to the Vice President for Research management plans for disclosed financial conflicts of interest.
(2) "Entity" means a non-UI organization, whether public or private. Examples include the following: a company, partnership, professional association, voluntary health organization, etc.
(3) "Financial conflict of interest" means a significant financial interest that is related to proposed University research (i.e., the interest reasonably appears to be affected by the research or is in an entity whose financial interest reasonably appears to be affected by the research) and that could directly and significantly affect the design, conduct, or reporting of research.
(4) "Financial interest" means anything of monetary value, whether or not the value is readily ascertainable, in any one of the following categories: compensation; equity (stock, stock options, or other ownership interest) in a public or private company; royalty/licensing income; a position in a non-UI entity giving rise to a fiduciary duty such as director, officer, partner, trustee, employee, or any position of management; or, for researchers with funding from the Public Health Service, any reimbursed or sponsored travel.
(5) "Human subjects research" means research (see paragraph d(9) below) conducted with a living individual about whom an investigator obtains 1) data through intervention or interaction with the individual or 2) identifiable private information.
(6) "Institutional responsibilities" means an investigator's professional responsibilities on behalf of the University, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
(7) "Investigator" means the principal investigator or project director and any other person, whether faculty, staff, or student and regardless of title or position, who has the authority to make independent decisions related to the design, conduct, or reporting of University research. Also includes subgrantees, contractors, collaborators, or consultants of the University.
(8) "Manage" means to take action to address a financial conflict of interest, which includes reducing or eliminating the financial conflict of interest, to ensure that the design, conduct, and reporting of research are free from bias or the appearance of bias.
(9) "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge and encompasses basic and applied research and product development.
(10) "Senior/key personnel" means a PHS project director or principal investigator and any other individual who contributes to the scientific development or execution of a project in a substantive, measurable way, and who is included in the grant application, progress report, or any other report submitted by the institution, whether or not they receive salaries or compensation under the grant.
(11) "Significant financial interest" means anything of monetary value or potential monetary value held by an investigator (and by the investigator's spouse and dependent children), and that reasonably appears to be related to the investigator's institutional responsibilities, as follows:
(b) With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds $5,000, or any equity interest (e.g., stock, stock option, or other ownership interest);
(c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or
(d) A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.
(e) For investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel related to the investigator's institutional responsibilities (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available). Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.
When an investigator not covered above reasonably concludes or reasonably should conclude that his/her research presents or appears to present a financial conflict of interest, the investigator must disclose that fact to the University's Conflict of Interest Officer.
In those cases where the University has determined that a financial conflict of interest exists, no research funds may be expended and no research may begin until the investigator has agreed in writing to any management plan required by the University for this research.
(b) Annual update to disclosure. Each investigator who submits a financial interest disclosure form to the University is required to update that disclosure annually during the period of the award or, for non-sponsored research, annually during the conduct of the project.
Annual updates must be submitted by April 30 of each calendar year.
It is the responsibility of the principal investigator or project director of a research project to ensure that each investigator working on/who will work on the project submits a timely annual update to a previously submitted disclosure form.
The annual update will be submitted to the University's Conflict of Interest Officer, who will then review any updated financial interest disclosed as provided in paragraph e(2) below.
(c) Updating or submitting a new disclosure in an ongoing project. When changes occur related to a financial interest in an ongoing research project, the investigator is required to update the disclosure describing that interest. This may occur, for example, where the investigator acquires a new financial interest or has changes to a previously-disclosed financial interest. A disclosure is also required when a new investigator is added to an existing project. Such disclosures must be submitted to the Conflict of Interest Officer within 30 days of the event requiring the disclosure. The Conflict of Interest Officer will then review any such interest disclosed as provided in paragraph e(2) below.
Disclosure Forms are available at http://ecoi.uiowa.edu.
(b) Determination of financial conflict of interest. Upon concluding that the disclosed financial interest constitutes a significant financial interest, the Conflict of Interest Officer will review the disclosed significant financial interest to determine whether a financial conflict of interest exists and thus whether further review and management is required.
In this review, the Conflict of Interest Officer will notify the relevant dean and/or departmental executive officer of the existence of the financial conflict of interest. This notification will alert the dean and/or DEO to the existence of the financial conflict of interest in the event he or she does not support the conduct of the research project in the collegiate/departmental facilities with collegiate/departmental resources.
(b) Management strategies may include, but are not limited to:
(ii) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
(iii) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias, or the appearance of bias, resulting from the financial conflict of interest;
(iv) Modification of the research plan;
(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
(vi) Reduction or elimination of the financial interest (e.g., sale of an equity interest); and
(vii) Severance of relationships that create actual or potential financial conflicts.
(d) CIRC meetings are closed to the public.
(e) Specific provisions applicable to human subjects research. As a general policy, the University will not allow an investigator with a financial conflict of interest to conduct a clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment. In such cases, disclosure or standard conflict management strategies may be inadequate and adequate monitoring plans may be difficult or impossible to implement. This prohibition applies not only to the principal investigator of a clinical research project, but also to any investigator involved in the design, conduct, or reporting of the research. A principal investigator would thus be prohibited not only from serving in that role, but in any investigator role on the study.
The University may waive this prohibition only where the investigator provides a compelling justification for its waiver. In considering an investigator's request for waiver, the CIRC at a minimum will require the investigator to address the following points:
(ii) The size and nature of the investigator's financial interest;
(iii) The degree to which the financial interest is related to the research;
(iv) The extent to which the interest is or may be affected by the research;
(v) The degree of risk to participants in the research;
(vi) The investigator's proposed role in the research, including protocol design, selection of participants, administration of informed consent, performance of protocol-mandated clinical procedures, evaluation of the effectiveness of the drug, device, or treatment, and evaluation of adverse effects; and
(vii) The existence of unique circumstances that would require the research to be performed at this institution as opposed to another (such as the unique qualifications of the investigator and/or unique resources/capabilities of the University).
If the committee finds a compelling justification for waiver of the prohibition in a particular case, a stringent management plan, including a plan for rigorous oversight of the study, will be implemented to ensure the safety of study participants and the integrity of the research.
(ii) Subrecipients. If the University carries out the PHS-funded research through a subrecipient, the University will incorporate as part of a written agreement with the subrecipient terms that establish whether the University's or the subrecipient's policy on conflict of interest in research will apply to the subrecipient Investigators.
If the subrecipient's policy will apply, the subrecipient will certify as part of the agreement that its policy complies with the PHS Regulations on Objectivity in Research. Additionally, the agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the University to enable the University to provide timely reports to PHS.
Alternatively, if the University's policy on conflict of interest will apply, the agreement shall specify time period(s) for the subrecipient to submit all subrecipient Investigator disclosures of significant financial interests to the University. Such time periods shall be sufficient to enable the University to comply with timely review, management, and reporting obligations under the PHS regulations.
(iii) Retrospective review. In the event the University identifies a significant financial interest that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed by the University during an ongoing research project, and where the COIO has determined that the undisclosed significant financial interest constitutes a financial conflict of interest related to a PHS-funded research project, the CIRC will review the financial conflict of interest and the University will implement a management plan for the project within 60 days of identification of that interest. In addition, the CIRC will, within 120 days of its determination of noncompliance, complete a retrospective review of the investigator's research activities associated with the project to determine whether the research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research.
(iv) Mitigation plan. If the CIRC determines in the conduct of its retrospective review of PHS-funded research that the research or any part of it was biased, the CIRC will recommend a mitigation plan to the Vice President for Research to address any such issues. The University will notify the PHS Awarding Component of its determination and subsequently follow up with the mitigation report for the project.
(v) Public access of disclosed significant financial interest. The University will make available to the public upon request information concerning any significant financial interest disclosed to the University that meets the following three criteria:
(B) The University determines that the significant financial interest is related to the PHS-funded research; and
(C) The University determines that the significant financial interest is a financial Conflict of Interest.
The information request must be made to the Conflict of Interest in Research Officer who will respond within five business days of receipt of the request. Disclosed information will be provided to the extent required by applicable PHS regulations and state law.
(ii) In the case of either paragraph (i) above or paragraph e(6)(c), and depending on the nature of the financial conflict of interest, the University may determine that additional interim measures are necessary with regard to the investigator's participation in the research project between the date of disclosure and the implementation of the University's management plan. Particular consideration will be given to any additional interim measures that the University's Institutional Review Board views as necessary for the protection of human participants in any ongoing research.
g. Appeal. Any investigator may appeal the decision of the Vice President for Research regarding management of a financial conflict of interest in writing to the President of the University and thereafter to the Board of Regents, State of Iowa.
h. Noncompliance. Failure to file a complete and truthful disclosure as required by this policy or to comply with the conditions or restrictions imposed in the resolution, management, or elimination of financial conflicts of interest constitutes a violation of University policy and may violate state and/or federal law. In such cases, the investigator will be subject to appropriate sanctions consistent with University policies relating to faculty, staff, or other applicable disciplinary policies. In addition, the University may suspend an ongoing research project, halt the expenditure of funds, or suspend technology transfer activity to prevent continued violation of this policy. In any case in which the investigator does not comply with any applicable conditions or restrictions imposed pursuant to this policy, the University will withdraw any affected applications for funding if the project cannot otherwise be completed without the services of the investigator.
In the event the University discovers that a failure to comply with this policy has biased the design, conduct, or reporting of the research in accordance with the process outlined in paragraph e(3)., the University will promptly notify the sponsor of the research as required by applicable law and describe the corrective action(s) taken or to be taken.
i. Training. Prior to engaging in any research project, all investigators must complete training on the investigator obligations under this policy. This training must be repeated at least every four years and must be completed immediately if this policy is revised so as to affect the investigator obligations, if an investigator is new to the University, or if the University finds an investigator to have violated this policy or any applicable management plan.
j. Reporting. The University will provide initial and ongoing reports of its management of financial conflicts of interest to external sponsors of University research as required by law and in accordance with this policy.
k. Records. Records relating to all investigator disclosures of significant financial interests and the University's review and management of such disclosures, will be maintained by the University in the case of externally funded research for three years from the date of submission of the final expenditures report (in the case of grants and cooperative agreements) or three years from the final payment (in the case of research contracts), or as otherwise required by law. Such records in the case of research with no external funding will be maintained for three years from the close of the study.
l. Significant financial interests held by institutional officials. University officials who have a significant financial interest in an externally sponsored research project may not participate in the solicitation, negotiation of contract terms and conditions, oversight of the research (unless named as a member of the research team), or management of any financial conflict of interest held by members of the research team.
Effective May 2015, this is a new policy. The former II-18.7 Other University of Iowa Policies Related to Conflict of Interest has been renumbered below. For the most current version without redlining, return to II-18.7
b. Scope of policy.
(2) This policy does not require the University to refrain from conducting business with companies which have financial relationships with the University and also sponsor human subjects research, but such relationships must be appropriately managed by making reasonable efforts to address potential conflicting interests prior to finalization of the proposed University transaction (e.g., prior to the gift, contract, or sponsored project being executed or accepted) that may give rise to a potential institutional conflict of interest (ICOI).
(3) It is the policy of the University to address institutional conflicts of interest (ICOIs) held by the University and/or its University officials through disclosure, review, elimination, or, where appropriate, management to avoid all such conflicts that are contrary to its mission as a public institution of higher education.
(2) "University official" includes the following individuals who, because of their respective positions with the University, have the capacity to affect, or can reasonably appear to affect, University processes for the design, conduct, reporting, review, or oversight of human subject research: the University President, provost, vice presidents, associate provosts, associate vice presidents, treasurer, controller, deans, associate and assistant deans, departmental executive officers, and the heads of centers and institutes.
(3) "Institutional oversight committees" means University committees that make decisions or recommendations regarding human subject research covered by this policy (e.g., the Institutional Review Board, the Conflict of Interest in Research Committee, and other ancillary review committees). Members are required by conflict of interest policies specific to those committees to recuse themselves from the review in the event of a conflict of interest.
(4) "University" means The University of Iowa, any of its major units, and any of its affiliated organizations as that term is defined in University policy in I-3 Affiliated Organizations.
(5) "Significant financial interest" is an interest held by or on behalf of the institution or a University official (including the University official's immediate family, individually or in aggregate) and defined below:
(ii) Gifts/gifts-in-kind and donations in excess of $100,000 received within the past twelve months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
(iii) Through technology licensing activities or investments related to such activities, the University has obtained an equity or ownership interest (other than a mutual fund) in a publicly traded company worth more than $100,000 as determined by reference to publicly listed prices, received within the past 12 months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy; or
(iv) Any equity interest or an entitlement to equity of any value, including options or warrants, in a nonpublicly traded company whose value cannot be determined by reference to publicly listed prices (i.e., equity interest in a start-up company) and which is supporting or proposing to support a sponsored project/activity that falls within the scope of this policy.
(ii) Payments, e.g., salary, consulting fees, honoraria, or gifts, in excess of $25,000 and received within the past twelve months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
(iii) Any equity or other ownership interest in a nonpublicly traded company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
(iv) A position giving rise to a fiduciary duty in a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy.
(ii) A list from the UI Foundation of corporate donors that gave gifts/gifts-in-kind in excess of $100,000, including an indication, where known, how such gifts/gifts-in-kind are to be used to support sponsored projects/activities that fall within this policy. The list will also contain the names of those University departments and/or individuals who were recipients of disclosed gifts.
(b) In the case of an ICOI held by the institution, the identified ICOI is referred to the Institutional Conflict of Interest Committee.
(c) In the case of an ICOI held by a University official, the ICOI Officer shall notify the University official that he or she must recuse her- or himself from any business decision, allocation of University resources or personnel, oversight or approval process that involves a company with which he or she has an ICOI that is conducting human subject research covered under this policy. If recusal is not possible in order to carry out her or his University obligations, she or he must divest the ICOI. If the University official does not wish to take the divestment route, the identified ICOI is referred to the ICOI Committee.
(b) This policy presumes that the University will not conduct research in the presence of an Institutional Conflict of Interest. In the event the ICOI is not eliminated, this presumption can only be rebutted where a compelling justification is presented for waiver of this policy and where an effective management plan can be implemented to fully protect human subjects and the integrity of the research.
(c) When proposing to conduct human subjects research for which an institutional conflict of interest exists, the principal investigator (PI) shall be responsible for preparing and submitting to the ICOI committee a detailed explanation of the compelling circumstances that justify allowing the research to be conducted under the auspices of the University. The PI should address specifically the following elements:
(ii) The degree of risk posed by the ICOI to participants in the research; and
(iii) The existence of unique circumstances that would require that the research be performed at the University as opposed to another site, such as unique qualifications of the investigator and/or unique resources/capabilities of the University. The rebuttable presumption/compelling justification standard is intended to be a high bar, not readily overcome.
(ii) How closely the interest is related to the research, and whether the interest could be directly and substantially affected by the research.
(f) In developing case-specific management plans, the ICOI Committee may at its discretion include one or more of the following management strategies among any others it may devise:
(ii) Use of an external Institutional Review Board;
(iii) Use of an independent study monitor, Data Safety Monitoring Board (DSMB), or external reviewer;
(iv) Disclosure of the ICOI to the other research centers in a multicenter trial;
(v) In cases where an ICOI involves a University official, the following should be considered:
(B) Whether the University official should be recused from decisions affecting the research, including but not limited to decisions over salary, promotion, and space allocations affecting the investigator;
(C) The designation of a "safe haven" (e.g., a nonconflicted senior individual) with whom the investigator can address ICOI concerns.
(vii) Disclosure to sponsor of the research as required by the sponsor and all applicable regulations and laws.
Effective May 2015, this policy has been moved. The former II-18.8 Federal Conflict of Interest Regulations has been renumbered below; no other changes have been made.
l. Start-Up Company Conflict of Interest Issues/Policies
Effective May 2015, this policy has been moved from II-18.8. No other changes have been made.
b. National Science Foundation
c. Food and Drug Administration