Checklist for Determining Relative Risk by AM3020p


									                                                   REB FILE # CDHA-RS/

                      Checklist for Determining Relative Risk
                       Based on the Initial REB Submission
            * To be completed for studies undergoing full-board review. *

Risk Assessment Checklist                                                     Yes or No

   Is this a single-centre study?

   Has the study received external review?

   Is this a Phase 1 or Phase 2 clinical trial?

   Are study procedures particularly invasive?

   Does the investigator expect to enrol 10 or more research participants?

   Will research participants be members of a vulnerable population*?

    Determination of Relative Risk

             Low Risk

             Moderate Risk

             High Risk

    * Vulnerable populations may include, but are not limited to:
        Persons with diminished competence and/or decision-making capacity;
        Patients in emergency situations;
        Patients with incurable diseases;
        Persons in nursing homes;
        Persons kept in detention;
        Subordinate hospital or laboratory personnel;
        Students;
        Unemployed, impoverished, or homeless persons;
        Ethnic minority groups;

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