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

7/2006

Adverse Reaction On-Site

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.
 

Cooperative Consent Form Addendum

 

Consent form addendum for institutions participating in a study at TJU through a cooperative agreement.

IRB Statement of Compliance (PDF)

7/8/15

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