Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 188
AAHRPP Elements: I-2, I.6.A., I.6.B., II.2.D., III.1.B..
The University of Illinois revised its University Policy on Conflict of Commitment and Interest and the campus processes to comply with the 2011 Public Health Services (PHS) Regulations, Department of Health and Human Services 42 CFR Part 50 and 45 CFR Part 94, on Financial Conflicts of Interest (FCOI) that go into effect on August 24, 2012. In addition, the processes are in compliance with the FDA regulation 21 CFR 54.2 regarding Financial Disclosure by Clinical Investigators. The revised policy and processes increase accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest. The primary goal is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from Investigator financial conflicts of interest. In accordance with the Human Subjects Protection Program (HSPP) Policy, the UIC Investigator Conflict of Interest Disclosure Policy for Human Subjects Research applies the University policy and processes for FCOI to ensure the protection of human subjects enrolled in research.
- Investigator: any person responsible for the design, conduct, or reporting of the research. In accordance with UIC HSPP policy, this includes, but is not limited to, the Principal Investigator, Faculty Sponsor, co-investigators, or other key research personnel. An investigator may be a faculty member (including those with the title of visiting, clinical, or adjunct), staff member (including those with the title instructor or lecturer), fellow (including post-doctoral associates), student, trainee, administrator, unpaid personnel (including volunteers) or other individual who engages the University in research involving human subjects pursuant to the review and approval of the IRB; or is otherwise identified as involved in research by a Principal Investigator, Unit Executive Officers, or other University administrative officer responsible for research activities. For purposes of this policy, “Investigator” includes the investigator’s family members.
- FAMILY MEMBERS: Includes the investigator’s spouse or domestic partner, parents, siblings, and children.
- FINANCIAL Conflict of interest (FCOI): The possibility that an investigator’s Significant Financial Interest (SFI) is reasonably related to the research or the investigator’s university responsibilities so that the SFI might compromise or be perceived to affect the design, conduct or reporting of the research, including the protection of the human research subjects.
- Significant financial interest (SFI) (42 CFR 50.603): Identified when:
- The value of any remuneration received from an external entity at present or in the 12 months preceding the disclosure that when aggregated for the investigator and family members totals or exceeds $5,000. The $5,000 threshold also applies to salary, royalties, and other payments aggregated for the investigator and family members.
- The value of a publicly-traded equity (plus any remuneration) meets or exceeds $5,000.
- Any level of ownership in a privately-held equity regardless of the dollar value.
- Intellectual property rights (e.g., patents, trademarks, copyrights, licensing agreements, and royalties from such rights)
- Any other relationships that might present a conflict of interest, such as fiduciary interests (paid or unpaid positions as director, officer, or other management role in a for-profit or not-for-profit entity sponsoring or related to the research) or interests in which compensation or the value of equity or property rights or the combination of interests might affect the outcome of the research.
The following SFIs are exempt (42 CFR 50.603) from the disclosure requirements:
- salary, royalties or other remunerations paid by the University of Illinois; including intellectual property rights assigned to the University of Illinois and agreements to share royalties related to such rights;
- income from investment vehicles (mutual funds or retirement account that are not managed directly by the individual);
- income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined by 20 U.S.C. 1001(a); an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
- income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined by 20 U.S.C. 1001(a). (e.g., NIH review panel)
- INSTITUTIONAL CONFLICT OF INTEREST: The possibility that financial interests of the university or a university official acting within his or her authority on behalf of the institution might affect or reasonably appear to affect institutional processes for the design, conduct, reporting, review, or oversight of human subjects research. Examples of institutional conflict of interest include but are not limited to:
- The university has an equity interest in a company or the university holds a patent, license, or some type of intellectual property interest related to the product that is the subject of the research.
- A university official acting within his or her authority on behalf of the institution has equity interest, serves on an advisory or other Board, or serves in a fiduciary role in an entity that has an interest in the outcome of human subjects research.
- Gifts to the university or university official from a company or other entity that has an interest in the outcome of human subjects research.
- DesignATED UniverSity Officials for Review of SFI-DMP: Include the Unit Executive Officer(s), COI Officer, Conflict Review Committee (CRC), the Conflict of Interest in Human Subjects Research (COI-HSR) subcommittee, IRB, and/or other institutional officials as relevant.
- SIGNIFICANT FINANCIAL INTEREST – DISCLOSURE AND MANAGEMENT PLAN (SFI-DMP): The SFI-DMP has two parts. Part I of the form is utilized to disclose the Significant Financial Interest (SFI) and determine if a SFI represents a Financial Conflict of Interest (FCOI) with an Investigator’s research. Part II is utilized to present a plan specific to the research project for managing the Investigator’s FCOI. The SFI-DMP serves to minimize the effect of FCOIs on the design, conduct, or reporting of the research and/or the integrity of the human subject protection program. The form and guidance can be found at www.research.uic.edu/conflict under the section “FORMS.” The COI Office assists the investigator in the SFI-DMP’s development. Once a SFI-DMP is determined to be acceptable by either the COI-HSR subcommittee or the CRC, the COI Office will communicate the recommendation to OPRS for review by the IRB. The IRB has final authority to approve the research, including the management mechanisms being implemented in the research protocol as described in the SFI-DMP.
- Rebuttable presumption: An assumption that an investigator with a Financial Conflict of Interest (FCOI) may not be involved in research that uses human subjects. The rule is not intended to be absolute; an investigator with a FCOI may rebut the presumption by demonstrating facts that constitute compelling circumstances, in the opinion of the reviewing bodies (Unit Executive Officers, Conflict of Interest Officer, CRC, COI-HSR subcommittee, and IRB). If compelling circumstances are found, the individual is allowed to design, conduct, report, or manage the research under conditions specified in an approved management plan (SFI-DMP) and in accordance with regulatory and ethical requirements. An investigator with a FCOI must provide both a sufficient reason detailing his/her unique contribution to the research and a reasonable plan that will protect human subjects, the research data, and the integrity of the HSPP.
- Federal regulations (Public Health Service, National Science Foundation, Food and Drug Administration, Veterans Health Administration) and University policies require that investigators disclose significant financial interests (SFIs) that are reasonably related to the research or to an investigator’s University responsibilities that in any way could bias the design, conduct or implementation, management, and reporting of research data. The regulations further require that the University have a mechanism for the investigators to disclose SFIs and University designated officials to determine if a SFI represent a Financial Conflict of Interest (FCOI) which requires the development of a University approved management plan to manage or eliminate the FCOI. The disclosure and management of the FCOI must occur before any funds are released by the University to investigators for expenditure.
- The IRB must consider in its review the disclosure of conflicts of interest that may affect the human subjects enrolled in the research, the integrity of the research, or the integrity of the HSPP. For the HSPP and the IRB, the disclosure of conflicts goes beyond investigator financial conflicts, and includes institutional conflicts of interest, real or apparent, that could affect the research, the rights or safety of the research subjects, or the integrity of the HSPP. The HSPP standards regarding conflicts of interest apply equally to all research whether the study is sponsored (i.e., funded by an external organization) or non-sponsored.
At UIC, Significant Financial Interests (SFIs) are reported through transactional and annual disclosure processes. The transactional disclosures are linked to specific funding proposals and research protocols.
- Transactional disclosures.
- Proposal Approval Form (PAF)
- The PAF includes a COI Certification section which must be completed as follows:
- FOR ALL SPONSORED RESEACH the University requires that all Investigators must indicate on the PAF COI Certification when a SFI is reasonably related to the sponsored research in the proposal or the investigator’s University responsibilities.
- FOR PHS SPONSORED RESEACH the University also requires senior/key research personnel to indicate on the PAF COI Certification when a SFI is reasonably related to the PHS-sponsored research proposal or their University responsibilities.
- FOR PHS SPONSORED RESEACH the University requires that all PHS investigators and senior/key research personnel must complete Part I of the SFI-DMP annually, regardless of whether they have any SFIs to disclose; Part II must be completed when a SFI is determined by designated University officials to represent a FCOI with the proposed research. Annually or at the time of continuing review of the grant, Part I must be updated for all PHS funded investigators and senior/key research personnel while Part II may require updating if a change to the SFI disclosure is determined by University designated officials to require additional management or elimination of the FCOI.
- FOR NON-PHS SPONSORED RESEARCH the University requires that when an Investigator indicates on the PAF COI Certification that there is a SFI reasonably related to the sponsored research or the Investigator’s University responsibilities, then the Investigator must complete Part I of the SFI-DMP form; Part II must be completed when a SFI is determined by designated University officials to represent a FCOI with the proposed research.
The PI submits the PAF to ORS Grants and Contracts Pre-Awards. ORS forwards all PAF forms with disclosed SFIs to the campus COI Office for review.
- The COI Office contacts the Investigator to obtain the SFI-DMP: Part I. A Part II of the SFI-DMP is subsequently requested if the SFI disclosed in Part I is determined by University designated officials to represent a Financial Conflict of Interest (FCOI) with the research.
- When a PAF with a FCOI determination indicates that the research involves human subjects, the campus COI Office will notify the OPRS of the existence of a potential conflict of interest in accordance with the COI/OPRS Coordinating SOP.
- The OPRS will match the sponsored research project identified by the campus COI Office with the applicable research protocol. The OPRS will ensure that initial IRB approval is not granted until the COI Office has communicated the recommendation for a management plan, the SFI-DMP, to the IRB for its review and approval.
- OPRS/IRB Application Form.
- The Principal Investigator is responsible for identifying significant financial interests (SFIs) that may exist for all investigators associated with a research protocol. In addition, institutional conflicts of interest that may affect human subject protections or the integrity of the HSPP must be disclosed by the PI.
- SFIs must be disclosed on the initial review, amendment, and continuing review OPRS application forms, whether the research is eligible for exempt, expedited, or full review.
- The PI must disclose SFIs on the initial review application. The PI is also required to promptly disclose all real or apparent SFIs discovered or acquired after the initial approval of the research within 30 days of acquiring or discovering the SFI or when an existing SFI has not been fully disclosed.
- When the application form discloses a SFI on a human subjects research protocol, the OPRS will notify the COI Office in accordance with the COI/OPRS Coordinating SOP. The COI Office will ask the PI to complete Part I of the SFI-DMP.
- If the disclosure on Part I of the SFI-DMP is determined by University designated officials to represent a Financial Conflict of Interest (FCOI), then the COI Office will contact the Principal Investigator to complete Part II. The COI Office will assist in the development of a SFI-DMP for FCOIs, and, if requested by OPRS, a management plan for institutional conflicts of interest.
- Once a SFI-DMP is determined to be acceptable by either the COI-HSR subcommittee or the CRC, the COI Office will communicate the recommendation to OPRS, including the SFI-DMP, to be reviewed by the IRB.
- The OPRS will match the SFI-DMP with the applicable research protocol. The OPRS will ensure that initial IRB approval is not granted until the COI Office has communicated its recommendation for a management plan, the SFI-DMP, to the IRB for its review and approval.
- The IRB has final authority to approve the research, including the management mechanisms being implemented in the research protocol as described in the SFI-DMP. The IRB will make a determination regarding the level of disclosure required in the consent process, as well as other measures to manage or eliminate the potential conflict. If the IRB determines additional disclosure or measures to protect subjects are necessary, revisions will be requested to the research protocol, protocol application, and/or consent document/process as part of the review.
- Annual Disclosure.
The annual disclosure is reported through the Report of Non-University Activities process.
- Illinois Law and University statutes and regulations require each salaried member of the academic staff complete a Report of Non-University Activities (RNUA). The RNUA must be completed at least annually, and updated if activities change during the year. The Unit Executive Officer is responsible for reviewing the RNUAs submitted by academic staff within their department and for forwarding the RNUAs with disclosed conflicts to the next administrative level (e.g., Dean, Vice Chancellor, Provost) for additional review. RNUA forms disclosing conflicts of interest are then forwarded to the campus COI Office. The RNUA serves as the University management plan for the academic staff member’s non-University income producing activities in most cases. In cases when a faculty start-up company will license University intellectual property, then a more detailed RNUA-Management Plan (RNUA-MP) for the faculty start-up company is reviewed and approved by the CRC and approved by the Vice Chancellor for Research.
- The disclosure of potential conflicts through the RNUA process represents the sum total of an individual’s external activities over a 12-month academic year rather than a SFI with a specific research protocol. On an as-needed basis, the campus COI Office will communicate with the OPRS. In accordance with the COI/OPRS Coordinating SOP, the offices work together to ensure that potential FCOIs relating to human subjects research are reported to the IRB and any information that is pertinent to the IRB’s review of the research is made available to OPRS.
- Development of Management Plan (SFI-DMP) and IRB Review.
- The SFI creating the FCOI need not always be eliminated; however, the FCOI must be managed in order to reduce the potential for the conflict to adversely affect the conduct of the research, including the protection of human subjects or the integrity of the research data. A research protocol with an identified FCOI will not receive approval from the IRB until a recommendation for a management plan (SFI-DMP) is received from the COI Office. The SFI-DMP is composed of two parts, Part I represents disclosure of SFI and management when disclosure is sufficient. Part II represents additional management mechanisms when disclosure alone is not sufficient to manage a FCOI.
- The main elements of the SFI-DMP: Part I include:
- Description of the financial relationship with the non-University entity.
- Description of how the financial interest is or may be related to the Investigator’s research or University responsibilities.
- The four main elements of the SFI-DMP: Part II include:
- Description of the nature of the conflict.
- Description of conflicted investigator’s role and function in the research.
- Justification for the inclusion of the conflicted investigator/conflict in the research which must address the principle of rebuttable presumption.
- Description of the proposed management techniques/mechanisms.
- The SFI-DMP may include one or more specific techniques or strategies including, but not limited to, the following:
- Implementing an impartial review prior to the submission of a manuscript;
- Disclosure of the conflict in writing or orally, as is appropriate, to the public, the sponsor, the IRB, researchers and other participants, PI of other study sites, publishers, or conference organizers and attendees;
- Disclosure of the conflict to potential research subjects through the informed consent process (sample disclosure language for the consent document is available from the COI web page referenced in the definitions section, above).
- Monitoring and/or auditing of the conduct of the research by independent overseers or a panel (e.g., data safety monitoring board) who have no professional ties to the research or direct reporting relationships to the investigators;
- Modification of the research plan, methodology, or performance to add additional protections or to minimize the role of the conflicted individual;
- Disqualification from participation in the conduct of the research or restriction of a researcher’s role in all or a portion of the research (e.g., cannot conduct data analysis, restricted from recruiting human subjects, and/or conducting the informed consent process);
- Requirement that a monitor or research subject’s ombudsperson be present during recruitment and/or the informed consent process;
- Divestiture or restructuring of the significant financial interest;
- Modification of the significant financial interest or severance of relationships that create actual or perceived potential conflicts of interest.
- Following the acceptance of the SFI-DMP by either the COI-HSR subcommittee or the CRC, the recommendation for a management plan will be forwarded to the IRB. The submission (either initial review or an amendment related to the conflict of interest) will not be considered for final approval until a SFI-DMP is forwarded by the COI Office. Continuing Review submissions may be considered for final IRB approval if a lapse in the approval period would increase harm to subjects or affect the integrity of the research. SFI-DMPs that are not finalized when the Continuing Review submissions are reviewed may be addressed through the submission of a separate amendment. The IRB has the authority to put into place restrictions of research activities to prevent harm to subjects until the FCOI has been adequately managed.
- The IRB will evaluate the SFI-DMP in the context of the research protocol. The IRB may approve the research with the SFI-DMP, or the IRB may modify the SFI-DMP by requiring additional measures to manage or eliminate a potential FCOI. Any revisions of the SFI-DMP initiated by the IRB will be communicated by the OPRS staff to the PI and the COI Office.
- The IRB has final authority to approve the research, including the management mechanisms being implemented in the research protocol as described in the SFI-DMP. The IRB will make a determination regarding the level of COI disclosure required in the consent process. The IRB may require other measures to manage or eliminate the potential FCOI. If the IRB determines additional disclosure or measures to protect subjects are necessary, revisions will be requested to the research protocol, protocol application, and/or consent document/process. Any revisions of the SFI-DMP initiated by the IRB will be communicated by the OPRS staff to PI and the COI Office.
- Research at the JBVAMC.
- Research involving human subjects engaging the JBVAMC will be reviewed by the Collaborative JBVAMC/NU/UIC IRB (UIC IRB#4). Conflicts of interest will be handled in accordance with this policy. NU and UIC will manage financial and institutional conflicts of interest for research involving their respective faculty in accordance with their own policies.
- The disclosure of the conflict will occur on the respective NU or UIC IRB application form. In addition, the VA form Research Financial Conflict of Interest Statement must be submitted as part of the R&D application and be reviewed by the Collaborative IRB.
- For investigators with a UIC appointment or a JBVAMC-only appointment, when a potential conflict of interest is disclosed, the UIC COI Office will work with the investigators to develop a management plan (SFI-DMP) for financial conflicts of interest, which will be processed in accordance with the COI/OPRS Coordinating SOP.
- For investigators with a NU-only or a NU/JBVAMC-only (no UIC appointment) appointment disclosing a potential conflict of interest, NU will be responsible for the evaluation and provision of a conflict management plan, as appropriate, to the Collaborative IRB.
- Institutional conflicts of interest for JBVAMC are reported to the ACOS for R&D by UIC and NU and evaluated by the ACOS for R&D or designee at the time of the IRB pre-review by the JBVAMC R&D office. If an institutional conflict of interest is found, the Medical Center Director consults with the ACOS for R&D and regional counsel to develop a management plan.
- The IRB has the final authority to decide whether the conflict of interest and management plan are acceptable and to allow the research to be approved.
- The IRB has final authority to approve the research methods and the management mechanisms being implemented in the protocol, including, but not limited to, the means and level of disclosure to subjects.
- The protocol is not forwarded to the JBVAMC R&D Committee until after IRB approval of the research, including any conflict of interest management plan. The IRB will inform the JBVAMC R&D Committee of the conflict of interest management plan by means of the correspondence to PI, the approved consent document(s), and/or the IRB meeting minutes.
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Revised definitions, inclusion of definition of institutional COI, addition of SEAM form and review process, references to COI/OPRS Coordinating SOP, clarification of the recommendation provided by the SEAM, inclusion of the VA Research Financial Conflict of Interest Statement, and update of JBVAMC section to ensure consistency with the Operating and Coordinating Policy of the Collaborative IRB.
||Pages 5, 6, 7 change the word ‘final’ to ‘initial.’
Page 6, Section III A: added “unless concerns for the protection of human subjects warrants otherwise.” Clarification of the IRB’s process for approving a protocol in relation to the SEAM.
||Update definition of institutional conflict of interest
Update thresholds for financial disclosures and definition of significant financial interest.. Replaced “SEAM” with Significant Financial Interest – Disclosure and Management Plan (SFI-DMP)