Division of Human Subjects Protection (IRB)
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 |
| OHR1 | 11/2012 | Proposal Transmittal and Departmental Approval |
| OHR-2 Submission Guidelines | 12/2008 | Guidelines for Preparing and Submitting OHR-2 |
| OHR2 | 4/2013 | Protocol Application for Biomedical Research |
| OHR2A | 11/2008 | Protocol Application Addendum |
| OHR2B | 4/2013 | Protocol Application for Non-Biomedical Research |
| OHR3 | 1/2011 | Waiver of authorization to collect protected health information (PHI) |
| OHR4 | 11/2012 | Record/chart review/electronic database study |
| OHR5 | 11/2007 | De-identification of protected health information certification |
| OHR6A | 7/2006 | Limited Data Set Use Agreement (TJU Employees) |
| OHR6B | 7/2006 | Limited Data Set Use Agreement (Outside Entities) |
| OHR8 | 4/2012 | Universal Consent Form |
| OHR8A | 6/2012 | Consent form for blood draw |
| OHR8B | 11/2006 | Surrogate Consent Form |
| OHR8C | 11/2007 | Child Assent |
| OHR8D | 7/2009 | Consent form addendum to be used when TJU is relying on another institution's IRB |
| OHR8E | 02/2008 | Phone contact script |
| OHR8F | 7/2006 | Subject Recruitment Letter |
| OHR8H | 06/2008 | Verbal consent for use/disclosure of PHI |
| OHR8S (English) | 03/2008 | Short form consent (Contact IRB before using) |
| OHR8S (Spanish) | 1/2011 | |
| OHR8S (Italian) | 11/2011 | |
| OHR8S (Chinese) | 1/2011 | |
| OHR8S (Korean) | 1/2011 | |
| OHR8S (Vietnamese) | 1/2011 | |
| OHR8S (Russian) | 1/2011 | |
| OHR8S (Indonesian) | 1/2011 | |
| OHR8S (Arabic) | 3/2013 | |
| OHR-8S (Albanian) | 3/2013 | |
| OHR-8S (Cambodian/Khmer) | 3/3013 | |
| OHR9 | 12/2012 | Continuing Review |
| OHR10 ON-SITE | 7/2006 | Adverse Reaction On-Site |
| OHR10 OFF-SITE | 7/2006 | Adverse Reaction Off-Site |
| OHR12 | 5/2008 | Amendment to Research Protocol |
| OHR-12A | 5/2013 | Amendment Adding/Removing JKCCN Personnel & Sites |
| OHR-12B | 5/2013 | Amendment Adding Investigators/Key Personnel |
| OHR-12C | 5/2013 | Amendment Removing Investigators/Key Personnel |
| OHR15 | 12/2012 | Biological Specimen Use |
| OHR15A | 7/2006 | Biological Specimens Chart |
| OHR16 | 5/2011 | Genetic Research |
| OHR16A | 7/2006 | Genetic Consent Guide |
| OHR17 | 7/2006 | Certification for use of decedents' PHI for research |
| OHR18 | 11/2012 | Exemption Request |
| OHR19 | 3/2008 | Research involving coded or anonymous data/specimens |
| OHR20 | 5/2011 | Unanticipated Problem Report |
| OHR22 | 9/2008 | Collection of Discarded Tissue |
| OHR25 | 5/2011 | Investigational Devices Worksheet |
| OHR26 | 5/2012 | Research Involving Children |
| OHR27 | 5/2011 | Research Involving Pregnant Women, Fetuses, & Neonates |
| OHR28 | 5/2011 | In Vitro Diagnostic Device Research |
| OHR29 | 2/2012 | Preliminary review to assess feasibility of research |
| OHR-31 | 1/2013 | Waiver Request for Inclusion/Exclusion Criteria |
| 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. |
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| 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 |
