TABLE OF CONTENTS
a. Investigators (including the Investigators of subrecipients for whom the University has contractual responsibility for Conflict of Interest compliance) are required to submit a disclosure of significant interests regardless of whether the Investigator has significant financial interests to disclose. The disclosure statement may be found online at the COI "Forms" page.
Each Investigator is required to submit an initial disclosure and then to update and recertify this disclosure:
(1) Annually; and
(2) Within 30 days of acquisition of a new significant financial interest not previously disclosed; and
(3) As may be required by the University’s Human Subjects Protection Program for new or continuing IRB review applications; and
(4) For projects that have received from PHS (including NIH) on or after August 24, 2012, a Notice of Award or noncompeting continuation with funding (except Phase I SBIR/STTR grants):
(a) For new awards, at least 45 days prior to access to funds;
(b) For ongoing projects, at least 105 days before the start of the new budget period; and
(c) For Investigators newly joining an existing sponsored project, no later than 45 days in advance of their first day of participation as an Investigator in the project.
a. Course content
The content of the University’s required “Investigator Conflict of Interest in Research” course includes discussion of Conflict of Interest (COI) in general, federal regulations regarding COI in research, and the specifics of the University’s COI policy and procedures for research.
b. Who must complete this course
Every Investigator must complete the University’s required training course on “Investigator Conflict of Interest in Research”:
(1) Prior to engaging in any PHS-funded (including NIH) research project with an award issuance date on or after August 24, 2012 (except Phase I SBIR/STTR grants); and
(2) Prior to January 1, 2013; and
(3) At least every four years; and
(4) As directed by the University when one of the following applies:
(i) the University revises the requirements for Investigators pursuant to this policy;
(ii) the Investigator is new to the University;
(iii) the Investigator is found not to be in compliance with this policy or a University management plan for the Investigator’s Financial Conflict of Interest (FCOI).
c. How to complete this course
Instructions for completing the “Investigator Conflict of Interest in Research” training, along with a link to the course, is located online at the COI "Training" page.
(1) prior to the University’s expenditure of PHS project funding; and
(2) at the time of a submission of an extension notification for the PHS-supported project; and
(3) at the time of submission of the annual progress report for a continuing PHS-supported project.
(1) Option 1
(a) For subrecipients who are listed on the FDP Institutional Clearinghouse website or those approved for Option 1 by the University of Arizona COI Program Office, ORCA will require the subrecipient to sign a certification of compliance indicating that the subrecipient is aware that the award requires compliance with PHS rules, and agrees that:
(b) ORCA retains the right to refuse signature and/or payment on any subaward if subrecipient has not completed the requirements of this Option 1.
(2) Option 2
(a) For subrecipients not listed on the FDP Institutional Clearinghouse website and not approved for Option 1 by the University of Arizona COI Program Office, ORCA will require the subrecipient to sign a certification of compliance indicating that the subrecipient is aware that the award requires compliance with PHS rules and that subrecipient must comply with the University of Arizona’s PHS-compliant COI policy and process. The contract terms will require the subrecipient to agree that:
(b) ORCA shall provide subrecipient with a copy of the University’s COI policy and procedures, as well as information and guidance about completing the requirements set forth in this Option 2.
(c) ORCA retains the right to refuse signature and/or payment on any subaward if subrecipient has not completed the requirements of this Option 2.
The University is responsible for the review, assessment, management, and reporting of Financial Conflict of Interest in Research (FCOI). The Office of the Senior Vice President for Research performs this set of responsibilities for the University through its COI Program Office and the Institutional Review Committee.
a. Institutional Review Committee (IRC)
(1) The Institutional Review Committee (IRC) shall be a University-wide committee, consisting of at least 10 voting members who are appointed by the Senior Vice President for Research: 3 faculty from the Health Sciences; 1 faculty from the College of Engineering; 2 faculty from the College of Science; 4 faculty from other academic units. Members should be active researchers with an understanding of their respective disciplines’ research practices and activities.
(2) The committee shall also include non-voting, ex-officio members, including, as necessary: the Assistant Vice President for Research Compliance and Policy; Director of Technology Transfer; Director of Office of Research Contracts and Analysis; a representative from Sponsored Projects; the Human Subjects Protection Program; Procurement and Purchasing. Office of the General Counsel shall provide legal advice to the committee. The committee may invite other non-voting, ad hoc members to assist in discussions and decisions as needed.
(3) A quorum required to conduct the business of the IRC shall consist of half-plus-one voting members in attendance at a meeting. In the absence of a quorum, the voting members in attendance may review agenda items and recommend IRC action. Recommended actions must be subsequently ratified by a majority of the remaining IRC members prior to implementation. Ratification may take place via an electronic mail vote after IRC members are given the opportunity to review the draft meeting minutes. Member ratification of a recommended action shall constitute official IRC action on the agenda item.
(4) The Senior Vice President for Research shall appoint members to renewable 3-year terms and shall appoint the Chair to a renewable 4-year term. The IRC shall elect a Vice Chair to assume the duties of Chair in the absence of the Chair.
b. IRC Review
(1) Review and management of an FCOI related to a project currently or previously funded by PHS must be completed by the University and reported to PHS by the COI Program Office on the following timeline:
(i) prior to the University’s expenditure of PHS project funding; and
(ii) within sixty (60) days of a disclosure of a previously unreviewed significant financial interest (SFI), either because of new Investigator added to project or new SFI reported for existing Investigators; and
(iii) at the time of a submission of an extension notification for the PHS-supported project; and
(iv) at the time of submission of the annual progress report for a continuing PHS-supported project.
(2) An IRC committee member shall be recused from discussion and voting on a particular case if the committee member has a compelling personal interest in the case (such as research or academic affiliation or collaboration with the Investigator whose case is under consideration) or if the committee member has a financial or other interest in the entity or asset involved in the case under consideration.
(3) Some disclosures of significant financial interests are eligible for expedited review, which means that they can be reviewed outside of the IRC meeting by delegation from the IRC Chair, and then the results of the expedited review will be reported to the IRC at the next committee meeting and will be open to any IRC member questions that may arise.
Disclosure of significant financial interests that meet both of the following criteria may be handled in expedited review:
(4) The first tasks in the review and evaluation process are to determine whether there are significant financial interests that constitute an FCOI and if so, whether the FCOI is permissible with a management plan. These evaluations are performed by the IRC with the support of the University’s COI Program Office. This first task encompasses a variety of determinations for each disclosure:
(5) If the IRC identifies an FCOI, what does the IRC consider an appropriate management plan to effectively mitigate against the potential for direct and significant effect(s) on the design, conduct or reporting of the research?
Management plans that the IRC may determine to be feasible and effective could include, but are not limited to, one of more of the following components:
(6) As part of the IRC’s review, the committee may determine that disclosed SFI do not constitute FCOI for the design, conduct or reporting of a research project but may represent potential conflicts of commitment or interest as those that are defined in other University of Arizona or Arizona Board of Regents policies (see http://orcr.arizona.edu/coi/uapol) or otherwise merit guidance to the disclosing investigator. The IRC may respond with a letter providing some standard directives or guidance to the Investigator, or it may submit more substantial recommendations to the Senior Vice president for Research, who will make the final determination regarding specific actions on a case-by-case basis.
c. Reporting IRC Review
(1) If the IRC determines that there is an FCOI, the IRC will report that determination and any IRC-specified management plan to the Investigator, the Investigator’s immediate supervisor, and the Investigator’s dean.
(2) If the Investigator certifies in writing his or her commitment to the IRC’s management plan, then the affected research will be permitted to proceed.
(3) Unless the identified FCOI is eliminated prior to any expenditure of PHS project funding, the FCOI and associated management plan related to a PHS-funded project must be reported to PHS by the COI Program Office through the electronic Research Administration (eRA) Commons FCOI Module (See NIH Guide for Grants and Contracts, Notice No. NOT-OD-09-072) on the following timeline:
(a) prior to expenditure of any PHS project funding; and
(b) within sixty (60) days of a disclosure of a previously unreviewed SFI; and
(c) at the time of an extension to the PHS-supported project; and
(d) at the time of submission of the annual progress report for a continuing PHS-supported project.
(4) The University’s report to PHS will include the following information:
(5) The annual FCOI report shall address the status of the FCOI and any changes to the management plan. The annual FCOI report shall specify whether the financial conflict is still being managed or include an explanation why the FCOI no longer exists.
(6) For projects currently or previously funded by PHS, the University is required to respond within five (5) business days to requests from members of the public for information about any identified FCOI of the Project Director or Principal Investigator or Senior/key personnel in the project by providing: the Investigator’s name, title and role in the research project, the name of the entity in which the FCOI is held by the Investigator, the nature of the FCOI and its approximate dollar value.
(1) Upon receipt of an allegation of non-compliance, the IRC will review the allegation and determine whether there is cause for investigation. If there is cause for an investigation, the IRC will provide information about the allegation to the Investigator and his/her Unit Supervisor or Department Head. The Investigator shall have the opportunity to present a written response and may request to meet with the IRC.
(2) If the IRC finds no violation, it shall inform the Investigator and his/her Unit Supervisor or Department Head in writing. A copy of the notice will also be sent to the Office of the Senior Vice President for Research.
(3) If the IRC finds noncompliance, it shall make a written finding and recommendation for appropriate action and send a copy of the letter to the Investigator, the Unit Supervisor or Department Head, and the Office of the Senior Vice President for Research.
(4) The Investigator may present a written response and meet in person with a representative from the Office of the Senior Vice President for Research within thirty (30) business days of the finding. The Senior Vice President for Research (or designee) shall then decide upon an appropriate action. The Investigator will receive the decision in writing (with a copy to the Unit Supervisor or Department Head). The Senior Vice President for Research (or designee) will also notify the party making the allegation of the final disposition of the matter.
(5) The Investigator may appeal by sending written notice to the Provost within 30 business days after the decision of the Senior Vice President for Research (or designee). The appeal proceedings shall be conducted in accordance with the procedures of the University Committee on Ethics and Commitment, UHAP 2.13.09. Copies must be submitted to the Provost, the Office of the Senior Vice President for Research and the University employee’s Unit Supervisor or Department Head.
(6) After receipt of these materials, the Provost may make a determination or convene an Appeals Panel consisting of representatives from the University Committee on Ethics and Commitment, the Senior Vice President for Research (or designee) and the Provost. If convened, the Panel will evaluate all materials presented and allow the Investigator to address questions in person. The Panel may either confirm the decision under review or refer the case back to the Office of the Senior Vice President for Research for further consideration. The Provost’s or the Panel’s decision, as applicable, shall be final.
The COI Program Office, on behalf of the Office of the Senior Vice President for Research, will act as staff to the IRC and, in keeping with Arizona State Records Retention laws, will maintain all report forms and related files (including disclosures with no significant financial interests), a database of all reports, allegations of noncompliance, and sanctions related to research transactions. Records related to federally-sponsored research are subject to the federal records retention regulations as well. All records will be maintained for six (6) years following elimination of any disclosed significant financial interest or the completion of all related UA research, or in accord with University record retention policy, whichever is latest.