Downloads (Documents may be viewed by clicking on the names below): FORMS TEMPLATES INSTRUCTIONS CHECKLISTS (for IRB Reviewers)
FORMS Request for Determination that a Proposed Activity is Not Research or is Not Human Subjects Research Protocol Modification/Amendment Request (UPDATED 5/24/13) Study Personnel Change Request (UPDATED 4/9/13) Request for Continuation (Progress Report) (UPDATED 2/4/13) Unanticipated Problem Report (UPDATED 2/4/13) Request for Protocol Exception Protocol Deviation Report (UPDATED 2/4/13) Agreement to Act as PI for Student or Non-HH Researcher Emergency (Compassionate) Use Request Limited Data Set Verification & Transmission Form Request to Re-Open a Study IRB Closure Report IACUC Project Renewal IACUC Project Termination TEMPLATES Elements of a Research Protocol Informed Consent Form for Research Research-HIPAA Authorization Information Sheet-GENERAL Information Sheet-SURVEY Informed Assent for Children Informed Assent for Internet Surveys Verbal Consent (Telephone Script) Grant-IRB Protocol Reconciliation Tracking Sheet Tool for Investigators: ICF Revisions Tracking Sheet Delegation of Responsibility Log Drug Accountability Log Device Accountability Log INSTRUCTIONS Completing the Request for Waiver of Consent/Authorization Guidelines for Students and Non-HHC Collaborating Investigators Using the Limited Data Set Transmission Form CHECKLISTS (for IRB Reviewers) NON-RESEARCH/HUMAN SUBJECTS RESEARCH DETERMINATION New Protocol (Exempt) New Protocol (Full Board) (UPDATED 2/4/13) New Protocol (Expedited) (UPDATED 2/4/13) Request for Continuation (Full Board) (UPDATED 2/4/13) Request for Continuation (Expedited) (UPDATED 2/4/13) Request for Amendment/Modification (Full Board) Request for Amendment/Modification (Expedited) Unanticipated Problem Report Subpart B – Pregnant Women/Neonates/Fetuses Findings Worksheet Subpart C – Prisoner Findings Worksheet Subpart D – Minor Findings Worksheet Decision Impairment Worksheet Significant Risk/Non-Significant Risk Device Determination IND Exemption Determination IDE Exemption Determination