IRB Supplement Form X by 0QR83h

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									                                                                                          Protocol # _____________


                                              HRRB Appendix H
                                     Research Involving Conflicts of Interest


UCR SOP Sections 7.5.10 and 13.7
Conflict of interest occurs when project personnel, their spouses, dependent children, or domestic partners have a
personal financial interest in the outcome of the research. For example, sometimes a research sponsor also serves
as a director, officer, partner, or consultant for the research; or the researcher may own stock options, receive
personal income, or receive loans or personal gifts from the research sponsor. This appendix helps the HRRB
evaluate whether there may be conflicts of interest in this research. Please see the UCR Office of Research
Integrity Conflict of Interest web site for additional information.


1. Description of Conflict
   a. Who on the research team has or may have the conflict?
            Principal Investigator (PI)
            PI’s immediate family. Please specify and describe their role in the research.
            Non-PI Member of the research team. Please specify and describe their role in the research.
            Family member of the non-PI research team member. Please specify and describe their role in the
            research.


    b. Who is (are) the Sponsor(s) with whom the PI or research team member(s) has/have (or may have) a
       personal financial relationship?


    c. What is the nature of the relationship:
            Received or will receive payments from the organization noted above that exceed the specified
            monetary threshold in the University Conflict of Interest Policy in one year
            A financial interest in the research with value that exceeds the specified monetary threshold in the
            University Conflict of Interest Policy
            A proprietary interest in the research, such as a patent, trademark, copyright, or licensing agreement
            Serves as an executive or director of the organization noted above
            Income from seminars, lectures or teaching engagements sponsored by the organization noted above
            Income from service on advisory committees or review panels for the organization noted above
            A financial interest that requires disclosure to the sponsor or funding source
            A personal financial interest in the research with a value that cannot readily be determined. Please
            specify.

            Any other personal financial interest that the investigator believes may interfere with his or her ability
            to protect participants. Please specify.


    d. What is the amount of this personal financial relationship (amount of equity, annual compensation, etc.)?


2. Relationship to the Research
                                                                                        Protocol # _____________

    a. How is the organization or business noted above related to the research?


    b. Could the personal financial relationship described above be affected by the outcome of the study?
          No
          Yes. Please explain


3. Disclosure & Management
   a. Has this personal financial relationship been disclosed to the University Conflict of Interest Committee?
            No. For non-governmental entities please complete the 700U form and Supplemental Information
            questionnaire. For NIH and NSF, please complete the Federal Disclosure of Financial Interests Related
            to Sponsored Projects Form.
            Yes. Has a conflict management plan been approved?
                 No
                 Yes. Please describe the plan.


    b. What mechanisms are in place to manage conflict of interest? (Please check all that apply.)
            None. Mechanisms to manage conflicts of interest must be utilized. Please contact the Office of
            Research Integrity, 951-827-4810 or coic@ucr.edu.
            Ad hoc committee review
            Divestiture of personal holdings
            Resignation of management position
            Outside data analysis
            Data safety monitoring
            Blinded trial
            Other. Please specify.


    c. How is this personal financial relationship disclosed to research participants from which data will be
       collected for the proposed research? (Please check all that apply.)
            None. Disclosure of conflicts of interest must be made to participants. Please contact the Office of
            Research Integrity, 951-827-4810 or coic@ucr.edu.
           Via a written consent form
           Via an oral presentation
           Via an information statement (when deception is being used in the study)
           Other(s). Please specify.

								
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