Institutional Review Board (IRB) Forms and Instructions

** 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

*The Word versions for the forms below are for REFERENCE ONLY. To submit a formal request to the IRB, the forms must be submitted via the iRIS system (https://iris.hhchealth.org/)

SMART IRB Forms (HHC as IRB of Record)

Relying Site Study Personnel Log
Acceptance and Flexibility Acknowledgement
Relying Site (local context) Information Sheet
Acknowledgement of Site Agreement to Cede IRB Review and Reviewing IRB to Provide Oversight
Principal Investigator Responsibilities for Reviewing and Relying Sites

Request for Determination that a Proposed Activity is Not Research or is Not Human Subjects Research (UPDATED 9/1/13)
Request for Waiver or Alteration of Consent
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)
Verification of Use Form
IACUC Application
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 and Parental Permission Form Combined (for minors ages 12-17)
Informed Assent for Children (minors ages 7-11)
Informed Assent for Internet Surveys
Verbal Consent (Telephone Script)
Grant-IRB Protocol Reconciliation Tracking Sheet

Tools for Investigators:
Documentation of Consent Template
ICF Revisions Tracking Sheet
Delegation of Responsibility Log
Drug Accountability Log
Device Accountability Log
Event Accumulative Tracking Log
Adverse Event Source Document

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)

Significant Risk/Non-Significant Risk Device Determination
IND Exemption Determination
IDE Exemption Determination

Research