Philadelphia University + Thomas Jefferson University

IRB Forms &
Submission Materials

Form Revised Description
First Steps - Intro to an IRB Submission 1/21/19 Help for those new to the IRB submission process
Overview of IRB Submissions for New Studies 11/1/18 Table of forms required for new submissions
New IRB Submission Checklist 4/12/19 Checklist of required forms to be included with new submissions
Form Revised Description
OHR-1 1/21/19 Proposal Transmittal and Approval Form
OHR-2 Submission Guidelines 10/2/17 Guidelines for Preparing and Submitting OHR-2
OHR-2 8/23/19 Summary of Interventional Human Subjects Research
OHR-2B 4/12/19 Summary of Non-Interventional Human Subjects Research
OHR-3 1/21/19 Request for Waiver of Subject Authorization to Collect Protected Health Information
OHR-4 11/1/18 Record/Chart Review/Computer Database Research Study
OHR-5 5/2015 De-identification of protected health information certification
OHR-9 4/12/19 Continuing or Final Review of Research Protocols Involving Human Subjects
OHR-10 2/2018  Only Use if You Do Not Have Access to the eSAEy System
OHR-12 8/23/19 Amendment to Research Protocol
OHR-12B 6/24/19 Adding Study Personnel
OHR-12C 6/24/19 Removing Study Personnel 
OHR-15 11/1/18 Human Biological Specimen, Tissue, and/or Genetic Research
OHR-16A 07/2006 Genetic Consent Guide
OHR-18 1/21/19 Application for Exemption from IRB Review
OHR-20 8/2014 Only Use if You Do Not Have Access to the eazUP System
Form Revised Description
HIPAA Authorization 4/12/19 Authorization to use and/or disclose PHI
OHR-8 6/21/19 Informed Consent Form - Consistent with Revised Common Rule
OHR-8B 11/1/18 Surrogate Consent for a Research Protocol
OHR-8D 4/9/15 Consent form addendum to be used when TJU is relying on another institution's IRB
OHR-8F 7/2006 Subject Recruitment Letter
OHR-8H 8/23/19 Verbal consent with optional use of disclosure of PHI
OHR-8K 2/27/19 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-Simple) 8/10/18 (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)
Abington Short Forms   For Abington Only
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
TransCelerate Biopharma Inc. Protocol Template   Use link to access the Basic Word Edition Template and Guidelines
Form Revised Description
OHR-6A 7/06 Limited Data Set Use Agreement (TJU Employees)
OHR-6B 7/06 Limited Data Set Use Agreement (Outside Entities)
Unaffiliated Investigator Agreement 5/6/19

For use with investigators who have no institutional affiliation (with Jefferson or other institution)
IRB Reliance Agreement 7/8/15 Used for IRB reliance situations where another IRB agreement does not take precedence (i.e., Smart IRB, Master or Network agreement). Please consult the IRB Reliance webpage.
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 8/23/19 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
     
Form Revised Description
OHR-25 11/1/18 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 11/1/18 IRB Approved Protocols and External Funding
OHR-34 1/21/19 Research Not Requiring IRB Review:  A Checklist
OHR-35 5/2018 Checklist for Undergraduate Research Study
OHR-36 3/6/19 Quality Improvement vs Human Research Decision Tool
Radiology Research Feasibility Assessment 10/7/16 Online form to be completed when a study needs Radiology approval prior to IRB submission
Local Context Questionnaire for Site Relying on Jefferson IRB 3/18/19 TJU Relying Site Survey for Multicenter Studies
TJU SMART IRB Acknowledgement Template 3/18/19 Acknowledgement of Site Agreement to Cede IRB Review and Reviewing IRB to Provide Oversight