Conflict of Interest Disclosure by 4hRKVe0C

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									Significant Financial Interest – Disclosure and                           COI official use only:
Management Plan (SFI-DMP): Part II
Conflict of Interest (COI)
Office of Vice Chancellor for Research
Telephone: (312) 996-3642 / 996-4070
Email: COI@uic.edu
Mail Code: M/C 672


  Principal Investigator / Project Director Name:
  Protocol/Proposal Title:
  Project Sponsor:
  Date:

  Explanation prepared for (check all that apply; provide protocol/proposal numbers if available):
  PAF/ORS                        IRB/OPRS

   For FAQs and guidelines: http://tigger.uic.edu/depts/ovcr/research/conflict/COI_statements.shtml


    1. Name of Conflicted Investigator:
          Project Director / Principal Investigator
          Co-Investigator
          Key Research Personnel
          Consultant
          Other, describe:

    2. Describe the Significant Financial Interest (SFI) related to the above named protocol/proposal.
       Name of Non-University of Illinois entity:
          Remuneration (e.g. salary or any payment for services when aggregated equals $5,000 or more)
          Equity interest (e.g. any stock, stock option, or other ownership interest for publicly traded entity that has a value of
          $5,000 or more; or privately traded represents any ownership interest.)
          Intellectual Property (e.g. patents, licenses, copyrights, royalties that are not paid by the University)
          Reimbursed or sponsored travel. ($0 de minimis)
          Other, describe:

    3. Describe how the SFI is related to the above named protocol/proposal.
          Entity is the research sponsor.
          Entity’s product or service will be utilized, tested, evaluated, or otherwise in the research.
          Entity licenses University intellectual property that will be utilized, tested, evaluated or otherwise in the research.
          Investigator’s university responsibilities may involve or require interacting with the external entity.
          Other, describe:

    4. Describe the conflicted investigator’s role and function in the research.
       (check all that apply and describe principal duties below)
           Design
           Conduct
           Reporting (including authorship)

       Describe:

    5. Provide justification for the conflicted investigator’s involvement in the research.
       (check all that apply and describe below)



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FORM – Significant Financial Interest – Disclosure and Management Plan (SFI-DMP)                           Updated: August 2012


                The conflicted investigator poses special skills, knowledge, techniques, resources, etc.
                The nature of the work is such that the conflict cannot have an effect on the outcome.

           Describe:

        6. Describe the conflict management techniques.
           A. Standard Management Mechanisms (required, unless there is a special circumstance):

                The relationship with the above-named external entity has been disclosed on the academic staff member’s RNUA
                (Report of Non-University Activities) and has been approved by the unit executive officer.
                 The above-named external entity will not have access to non-publicly available information unless agreed to by the
                University.
                No University resources will be utilized for the benefit of the above-named external entity without prior written
                agreement from the University.

            B. Additional Management Mechanisms (check all that apply):

            (required in most cases)
                 The researchers will employ an impartial review mechanism.*
                 The conflict will be disclosed in manuscripts, publications, presentations, etc. according to the norms of each
                publication venue.
                 The conflict will be disclosed to other research personnel (e.g., co-investigators, fellows, students).

            (these may be specific to the study’s design - check all that apply)
                 The COI will be disclosed to the PIs of all study sites. The UIC PI will disclose the potential COI to the PIs of the other
                study sites (if UIC is primary site) or to the PI at the primary institution, who will follow their institutional policies
                pertaining to notifying their IRB (human subjects) or IACUC (animal subjects) as applicable of potential conflicts of
                interest and follow the recommendations of their IRB/IACUC.
                 The conflicted person will not be involved in data collection or data entry.
                 The conflicted person will not be involved in data analysis or the dataset will be given to an independent statistician
                for analysis.
                 The protocol is an analysis of existing data, if human subjects research (check a box below):
                        data is de-identified         limited data set          Other (describe):
                 Non-conflicted individuals will be involved in study development (design, conduct, reporting).
                 This is a multi-center trial, at which UIC is just one site.
                   What percent of the total study population will be enrolled at UIC?          %
                 The study uses a blinded design (e.g., double- or triple-blind).
                 The study includes oversight by an independent advisory board that will monitor the data (e.g. Data Safety
                Monitoring Board, Scientific Advisory Board).
                 The study includes use of a clinical research organization/associate (CRO/CRA) which will monitor the conduct of the
                research.
                A monitoring board has a priori rules (e.g., safety and efficacy) for stopping the study.
                Report of Non-University Activities Management Plan (RNUA-MP) approved by the Vice Chancellor for Research.
                 All researcher personnel on this study have completed and are up-to-date on Conflict of Interest training; or will
                complete training prior to engaging in research related to any PHS/HHS/NIH sponsored research. (required for NIH
                sponsored research)

            C. Additional management mechanisms pertaining to human subjects research (check all that apply):

                The conflict has been/will be disclosed to the IRB and the investigators agree to follow all IRB recommendations




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FORM – Significant Financial Interest – Disclosure and Management Plan (SFI-DMP)                          Updated: August 2012


                regarding conflict management. (required for human subjects research)
                The COI will be disclosed to the sponsor of the research (required for clinical trials and HHS/PHS sponsored research).
                The conflict will be disclosed to potential research participants during the informed consent process.* (required for
                human subjects research when subjects will be enrolled)
                The conflicted person will not solicit informed consent. (typically required)
                The study design includes a non-conflicted medical monitor.
                A non-conflicted individual serves as research subjects’ advocate or ombudsperson.
                The protocol presents no more than minimal risk to research subjects.
                The protocol will undergo increased frequency of continuing review and/or monitoring by the IRB.

            D. Management mechanisms to reduce or eliminate the FCOI. (check all that apply and describe below)

                Modification of the research plan.
                Change of research personnel or personnel responsibilities.
                Reduction or elimination of the financial interest. (e.g., sale of any equity interest)
                Severance of relationships that create financial conflicts of interest.
                Other



   * Resources, including description of impartial review management mechanism, sample language for COI disclosures on consent
   forms, is available at: http://tigger.uic.edu/depts/ovcr/research/conflict/RNUA/forms/index.shtml

                                           PI/Conflicted Investigator: Acknowledgement
        By signing below, the principal investigator and any conflicted investigators in the above-named study attests that:
              He/She agrees to comply with the management mechanisms described herein.
              The information presented in this document is complete, accurate, and true to the best of his/her
                 knowledge.
              He/She will update the management plan annually if there are any changes or within 30 days of
                 discovering or acquiring any new significant financial relationships or changes in the reported
                 relationship(s).

        __________________________________                                         Date: ___________________
        Principal Investigator's Name
        Title, Department

        __________________________________                                       Date: ___________________
        Conflicted Investigator's name (if different from PI)
        Title, Department
                                                 Administrative Review and Approval
        By signing below, the unit executive officer acknowledges that:
              He/She has read and agrees to monitor the management mechanisms described herein.
              The management plan is deemed to include management mechanisms which are sufficient means to
                 manage or eliminate financial conflicts of interest disclosed on the above-named study.

        ______________________________                                    Date: ___________________
        Name, Unit Executive Officer (usually Dept. Head)
        Title, Department/College




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FORM – Significant Financial Interest – Disclosure and Management Plan (SFI-DMP)   Updated: August 2012




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