Thomas Jefferson University

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IRB Forms &
Submission Materials

Form Revised Description
Overview of IRB Submissions for New Studies 7/8/15 Chart of submission forms and categories
Checklist for New Submissions 10/2010 Checklist for New Submissions
OHR-1 4/9/15 Proposal Transmittal and Approval Form
OHR-2 Submission Guidelines 12/2008 Guidelines for Preparing and Submitting OHR-2
OHR-2 4/9/15 Protocol Application for Biomedical Research
OHR-2A 11/2008 Protocol Application Addendum
OHR-2B 8/2014 Protocol Application for Non-Interventional Research
OHR-3 4/9/15 Request for Waiver of Subject Authorization to Collect Protected Health Information
OHR-4 7/8/15 Record/Chart Review/Computer Database Research Study
OHR-5 11/2007 De-identification of protected health information certification
OHR-6A 7/2006 Limited Data Set Use Agreement (TJU Employees)
OHR-6B 7/2006 Limited Data Set Use Agreement (Outside Entities)
OHR-8 7/8/15 Universal Consent Template
OHR-8A 7/8/15 Consent Form for Blood Draw
OHR-8B 4/9/15 Surrogate Consent Form
OHR-8C 11/2007 Child Assent
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 12/2013 Guidance for Completing the OHR-8 Universal Consent Template
OHR-8K

4/9/15

Consent Form Template for NCI CIRB Studies Only
OHR-8S (English) 12/2014 Short Form Consent (Please Contact IRB Before Using Short Form)
OHR-8S (Spanish) 1/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Italian) 11/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Chinese) 1/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Korean) 1/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Vietnamese) 1/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Russian) 1/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Indonesian) 1/2011 (Please Contact IRB Before Using Short Form)
OHR-8S (Arabic) 3/2013 (Please Contact IRB Before Using Short Form)
OHR-8S (Albanian) 3/2013 (Please Contact IRB Before Using Short Form)
OHR-8S (Cambodian/Khmer) 3/2013 (Please Contact IRB Before Using Short Form)
OHR-8 WIRB 1/2015 Consent form template for WIRB-approved studies
OHR-9 4/9/15 Continuing Review
OHR-10 ON-SITE   Form no longer available.  Use the eSAEy system to report SAEs.
OHR-10 OFF-SITE 7/2006 Adverse Reaction Off-Site
OHR-12 4/9/15 Amendment to Research Protocol
OHR-12B 7/8/15 Amendment Adding Investigators/Key Personnel
OHR-12C 7/8/15 Amendment Removing Investigators/Key Personnel
OHR-15 1/2015 Request for Human Biological Specimens for Research
OHR-15A 7/2006 Biological Specimens Chart
OHR-16 1/2015 Tissue and Genetic Research
OHR-16A 7/2006 Genetic Consent Guide
OHR-17 7/2006 Certification for use of decedents' PHI for research
OHR-18 12/2014 Application for Exemption from IRB Review
OHR-19 7/8/15 Research Involving Coded or Anonymous Private Information and Biological Specimens
OHR-20 5/2011 Unanticipated Problem Report
OHR-22 7/8/15 Collection of Discarded Tissue
OHR-25 5/2011 Device Worksheet
OHR-26 5/2012 Research Involving Children
OHR-27 5/2011 Research Involving Pregnant Women, Fetuses, & Neonates
OHR-28 5/2011 In Vitro Diagnostic Device Research
OHR-29 2/2012 Preliminary review to assess feasibility of research
OHR-30 9/2013 Request to IS&T for IRB Approved Patient Information
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 6/2014 Research Not Requiring IRB Review:  A Checklist
Research Protocol Template 11/2010 For use with investigator-initiated trials (IIT) in addition to the OHR-2
KCC Protocol Template 3/2011 For use with investigator-initiated trials (IIT) involving cancer in addition to the OHR-2
HIPAA Authorization 7/2003 Authorization to use and/or disclose PHI
IRB Invoice for Full Initial Review 3/2006 Invoice for IRB review  
IRB Invoice for Full Annuals and
Full Amendments
3/2006 Invoice for IRB review  
Unaffiliated Investigator Agreement   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  
Cooperative Consent Form Addendum   Consent form addendum for institutions participating in a study at TJU through a cooperative agreement.
IRB Statement of Compliance (PDF) 8/31/15 Statement details regulatory compliance of IRB
Confidentiality Agreement for Independent Study Monitors    
IDX Request Form    For obtaining JUP patient count for specific diagnosis code(s) to determine study feasibility
JUP EMR Custom Report Request Form   For pre-screening records of patients who may qualify for an IRB-approved study
TJUH Imaging Research Request Form   Online form to be completed for human research involving radiology imaging