Philadelphia University + Thomas Jefferson University

IRB Forms &
Submission Materials

Form Revised Description
Overview of IRB Submissions for New Studies 10/2/17 Table of forms required for new submissions
New IRB Submission Checklist 9/1/16 Checklist of required forms to be included with new submissions
IRB Submission Flow Diagram 8/5/16 Shows steps for IRB transaction
Form Revised Description
OHR-1 10/2/17 Proposal Transmittal and Approval Form
OHR-2
Submission Guidelines
10/2/17 Guidelines for Preparing and Submitting OHR-2
OHR-2 10/2/17 Summary of Interventional Human Subjects Research
OHR-2B 10/2/17 Summary of Non-Interventional Human Subjects Research
OHR-3 04/09/15 Request for Waiver of Subject Authorization to Collect Protected Health Information
OHR-4 9/1/16 Record/Chart Review/Computer Database Research Study
OHR-5 11/2007 De-identification of protected health information certification
OHR-9 10/2/17 Continuing or Final Review of Research Protocols Involving Human Subjects
OHR-10 ON-SITE   Form no longer available
Use the eSAEy system to report SAEs.
OHR-10 OFF-SITE 07/2006 Adverse Reaction Off-Site
OHR-12 10/2/17 Amendment to Research Protocol
OHR-12B 10/2/17 Adding Study Personnel
OHR-15 9/1/16 Request for Human Biological Specimens for Research
OHR-15A 07/2006 Biological Specimens Chart
OHR-16 01/2015 Tissue and Genetic Research
OHR-16A 07/2006 Genetic Consent Guide
OHR-18 12/2014 Application for Exemption from IRB Review
OHR-20 05/2011 Form no longer available, use the eazUP system to report UAPs.
*If experiencing difficulties with eazUP or a blank form is required, contact the OHR for assistance.
Form Revised Description
HIPAA Authorization 7/2003 Authorization to use and/or disclose PHI
OHR-8 10/2/17 Informed Consent Document for Human Subjects Research
OHR-8A 7/8/15 Consent Form for Blood Draw
OHR-8B 9/1/16 Surrogate Consent for a Research Protocol
OHR-8C 9/1/16 Child's Assent to Participate in a Clinical Trial
OHR-8D 4/9/15 Consent form addendum to be used when TJU is relying on another institution's IRB
OHR-8E 2/2008 Phone contact script
OHR-8F 7/2006 Subject Recruitment Letter
OHR-8H 6/2008 Verbal consent for use/disclosure of PHI
OHR-8I 12/11/13 Guidance for Completing the OHR-8 Universal Consent Template
OHR-8K 12/9/15 Consent Form Template for NCI CIRB Studies Only
OHR-8S (English) 10/2/17 Short Form Consent
(Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Albanian) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Arabic) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Cambodian) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Chinese - Traditional) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Greek) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Indonesian) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Italian) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Korean) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Polish) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Russian) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Spanish) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
OHR-8S (Vietnamese) 10/2/17 (Contact IRB and See OHR Policy IC 705 Before Using)
Cooperative Consent Form Addendum   Consent form addendum for institutions participating in a study at TJU through a cooperative agreement.
Form Revised Description
Research Protocol Template 11/2010 For use with investigator-initiated trials (IIT) in addition to the OHR-2
KCC Protocol Template   For use with investigator-initiated trials (IIT) involving cancer in addition to the OHR-2
Form Revised Description
OHR-6A 7/2006 Limited Data Set Use Agreement (TJU Employees)
OHR-6B 7/2006 Limited Data Set Use Agreement (Outside Entities)
Unaffiliated Investigator Agreement 6/29/17 For use with investigators unaffiliated with TJU/TJUH or any other entity
IRB Authorization Agreement 7/8/15 Agreement for an Institution with a Federalwide Assurance (FWA) to rely on an IRB outside its institution.
Instructions for Requesting an IRB Authorization Agreement (IAA) 9/1/15  
Confidentiality Agreement for Independent Study Monitors    
Form Revised Description
IDX Request Form   9/1/16 For obtaining JUP patient count for specific diagnosis code(s) to determine study feasibility
OHR-17 07/2006 Certification for use of decedents' PHI for research
OHR-19 07/08/15 Research Involving Coded or Anonymous Private Information and Biological Specimens
OHR-22 07/08/15 Collection of Discarded Tissue
OHR-29 02/2012 Preliminary review to assess feasibility of research
OHR-30 09/2013 Request to IS&T for IRB Approved Patient Information
JUP EMR Custom Report Request Form   For pre-screening records of patients who may qualify for an IRB-approved study
     
Form Revised Description
OHR-25 05/2011 Device Worksheet
OHR-26 05/2012 Research Involving Children
OHR-27 05/2011 Research Involving Pregnant Women, Fetuses, & Neonates
OHR-28 05/2011 In Vitro Diagnostic Device Research
Form Revised Description
IRB Invoice for Full Initial Review 03/2006 Invoice for IRB review  
IRB Invoice for Full Annuals &
Full Amendments
03/2006 Invoice for IRB review  
Form Revised Description
OHR-31 7/8/15 Waiver Request for Inclusion/Exclusion Criteria
OHR-32 8/2013 Radiation Research Review Form
OHR-33 7/8/15 IRB Approved Protocols and External Funding
OHR-34 10/2/17 Research Not Requiring IRB Review:  A Checklist
Radiology Research Feasibility Assessment 10/7/16 Online form to be completed when a study needs Radiology approval prior to IRB submission