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IRB Forms & Submission Materials

Form    Revised Description
Overview of IRB Submissions for New Studies 12/2008 Chart of submission forms and categories
Checklist for New Submissions 10/2010 Checklist for New Submissions
OHR-1 3/2014 Proposal Transmittal and Approval Form
OHR-2 Submission Guidelines 12/2008 Guidelines for Preparing and Submitting OHR-2
OHR-2 2/2014 Protocol Application for Biomedical Research
OHR-2A 11/2008 Protocol Application Addendum
OHR-2B 11/2011 Protocol Application for Non-Biomedical Research
OHR-3 1/2011 Waiver of authorization to collect protected health information (PHI)
OHR-4 11/2012 Record/chart review/electronic database 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 12/2013 Universal Consent Template
OHR-8A 6/2012 Consent form for blood draw
OHR-8B 12/2013 Surrogate Consent Form
OHR-8C 11/2007 Child Assent
OHR-8D 7/2009 Consent form addendum to be used when TJU is relying on another institution's IRB
OHR-8E 02/2008 Phone contact script
OHR-8F 7/2006 Subject Recruitment Letter
OHR-8H 06/2008 Verbal consent for use/disclosure of PHI
OHR-8I 12/2013 Guidance for Completing the OHR-8 Universal Consent Template
OHR-8S (English) 03/2008 Short form consent (Contact IRB before using)
OHR-8S (Spanish) 1/2011  
OHR-8S (Italian) 11/2011  
OHR-8S (Chinese) 1/2011  
OHR-8S (Korean) 1/2011  
OHR-8S (Vietnamese) 1/2011  
OHR-8S (Russian) 1/2011  
OHR-8S (Indonesian) 1/2011  
OHR-8S (Arabic) 3/2013  
OHR-8S (Albanian) 3/2013  
OHR-8S (Cambodian/Khmer) 3/2013  
OHR-9 2/2014 Continuing Review
OHR-10 ON-SITE 7/2006 Adverse Reaction On-Site
OHR-10 OFF-SITE 7/2006 Adverse Reaction Off-Site
OHR-12 12/2013 Amendment to Research Protocol
OHR-12B 10/2013 Amendment Adding Investigators/Key Personnel
OHR-12C 4/2012 Amendment Removing Investigators/Key Personnel
OHR-15 12/2012 Biological Specimen Use
OHR-15A 7/2006 Biological Specimens Chart
OHR-16 5/2011 Genetic Research
OHR-16A 7/2006 Genetic Consent Guide
OHR-17 7/2006 Certification for use of decedents' PHI for research
OHR-18 11/2012 Exemption Request
OHR-19 3/2008 Research involving coded or anonymous data/specimens
OHR-20 5/2011 Unanticipated Problem Report
OHR-22 9/2008 Collection of Discarded Tissue
OHR-25 5/2011 Investigational Devices 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 Hospital IS for IRB Approved Patient Information
OHR-31 1/2013 Waiver Request for Inclusion/Exclusion Criteria
OHR-33 10/2013 IRB Approved Protocols and External Funding
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
CCRRC Protocol Cover Sheet 9/2010 For any studies involving cancer
HIPAA Authorization 7/2003 Authorization to use and/or disclose PHI
IRB Invoice for Full Initial Review 03/2006 Invoice for IRB review  
IRB Invoice for Full Annuals and
Full Amendments
03/2006 Invoice for IRB review  
Unaffiliated Investigator Agreement   For use with investigators unaffiliated with TJU/TJUH or any other entity
IRB Authorization Agreement   Agreement for an Institution with a Federalwide Assurance (FWA) to rely on an IRB outside its institution.
Cooperative Consent Form Addendum   Consent form addendum for institutions participating in a study at TJU through a cooperative agreement.
IRB Statement of Compliance (PDF)   Statement details regulatory compliance of IRB
Conflict of Interest Disclosure - Attachment C   COI disclosure form for TJU/TJUH employees, faculty & volunteers
Conflict of Interest Disclosure - Attachment D   COI disclosure form for non-TJU/non-TJUH employees
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