December, 2013
Subject: New and Revised OHR Policies and Forms
In an effort to keep the research community informed of new and revised Office of Human Research
(OHR) policies and forms, a summary of recent changes is being provided. Please remember to always
access the most current policies and forms on the Division of Human Subjects Protection page of the
OHR website.
Thank you
The Office of Human Research
POLICIES
Number Title
GA 103
Maintenance of Policies, Procedures, and Internal Forms
Changes: Clarification of the review and approval process for OHR policies and forms.
Version
12/2013
Number
GA 129
Title
Version
Protection of Privacy Interests of Research Subjects and Confidentiality of
12/2013
Subject Data
Changes: Clarification of the use of the OHR-29, Review Preparatory to Research Request Form.
Clarification for providing records to sponsors and monitors.
Number
IC 705
Title
Informed Consent - Illiterate and Non-English Speaking Subjects and Subjects
Physically Unable to Sign
Changes: Clarification of the consent process for physically impaired individuals.
Version
12/2013
Forms
Number Title
Version
OHR-2
Summary of Interventional Human Subjects Research
12/2013
Changes: Updated data confidentiality and security section. Updated sections concerning payment for
test articles and procedures. Line numbers added.
Number Title
OHR-8B Surrogate Consent for a Research Protocol
Changes: Form has been revised and includes instructions for use.
Version
12/2013
Number Title
Version
OHR-9
Continuing or Final Review of Research Protocols Involving Human Subjects
12/2013
Changes: Update number of hardcopies required for IRB review. Clarification when consent form has
been revised. Clarification of information required for final reports.
Number Title
Version
OHR-12 Amendment to Research Protocol
12/2013
Changes: Update number of hardcopies required for IRB review. Add information regarding re-consent.
Number
OHR-30
Title
Version
Request to Hospital Information Systems (IS) for IRB-approved Patient
9/2013
Information
Changes: This is a new form to be used when requesting PHI from Hospital Information Systems (IS).
Number Title
Version
OHR-33 IRB-Approved Protocols and External Funding
10/2013
Changes: This is a new form to be used when a PI requests confirmation that a grant application falls
under an existing IRB approval.
If you have any questions or comments about these changes, please contact
patrick.herbison@jefferson.edu .