IRB Intructions and Forms

Downloads (Documents may be viewed by clicking on the names below):
FORMS
TEMPLATES
INSTRUCTIONS
CHECKLISTS (for IRB Reviewers)

** All documents revised after 9/1/13 include updates to add new HRPP staff for office use only and the new @hhchealth.org email address

FORMS
Request for Determination that a Proposed Activity is Not Research or is Not Human Subjects Research (UPDATED 9/1/13)
Protocol Modification/Amendment Request (UPDATED 11/27/13)
Study Personnel Change Request (UPDATED 11/27/13)
Request for Continuation (Progress Report) (UPDATED 11/27/13)
Unanticipated Problem Report (UPDATED 2/4/13)
Request for Protocol Exception (UPDATED 9/1/13)
Protocol Deviation Report (UPDATED 9/1/13)
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 (UPDATED 9/1/13)
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