Form |
Revised |
Format |
Description |
| Overview of IRB Submissions for New Studies |
12/2008 |
|
Chart of submisson forms and categories |
Checklist for New Submissions |
2/2008 |
|
Checklist for New Submissions |
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 |
OHR1 |
4/2009 |
|
Proposal Transmittal and Approval |
OHR-2 Submission Guidelines |
12/2008 |
|
Guidlines for Preparing and Submitting OHR-2 |
OHR2 |
7/2009 |
|
Protocol Summary |
OHR-2A |
11/2008 |
|
Protocol Summary Addendum |
| OHR3 |
11/2007 |
|
Waiver of authorization to collect protected health
information (PHI) |
| OHR4 |
5/2008 |
|
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 |
7/2009 |
|
Universal Consent Form |
OHR8A |
3/2009 |
|
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 |
2/2008 |
|
Phone contact script |
OHR8F |
7/2006 |
|
Subject Recruitment Letter |
OHR8H |
6/2008 |
|
Verbal consent for use/disclosure of PHI |
OHR8S |
3/2008 |
|
Short form consent (Contact IRB before using) |
OHR9 |
10/2009 |
|
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 |
OHR15 |
5/2008 |
|
Biological Specimen Use |
OHR15A |
7/2006 |
|
Biological Specimens Chart |
OHR16 |
7/2008 |
|
Genetic Research |
OHR16A |
7/2006 |
|
Genetic Consent Guide |
OHR17 |
7/2006 |
|
Certification for use of decedents' PHI for research |
OHR18 |
4/2008 |
|
Exemption Request |
OHR19 |
3/2008 |
|
Research involving coded or anonymous data/specimens |
OHR20 |
4/2008 |
|
Unanticipated Problem Report |
| Unaffiliated Investigator Agreement |
|
For use with investigators unaffiliated with TJU/TJUH or any other entity |
| Review Preparatory to Research Request Form |
|
For conducting preliminary review to assess feasibility of research |
| Electronic Submission for Federalwide Assurance (FWA) |
| 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. |
