February, 2014
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
GA 120
Title
Reporting and Reviewing Unanticipated Problems Involving Risks to Subjects or
Others
Changes: Clarification of reporting time frame for AEs and SAEs and administrative changes.
Version
1/2014
Number Title
Version
GA 127
Subject Screening and Enrollment
2/2014
Changes: Clarification of requirements for screening and enrollment logs and subject eligibility
checklists. Subject numbering requirements moved from Conducting Screening Activities section to
Subject Numbering section.
Number Title
Version
OP 202
Recruiting and Appointing IRB Members, Chairs and Vice Chairs
1/2014
Changes: Clarification of member appointment, responsibilities, renewal of term, self-assessment and
the evaluation of the Chair and Vice Chair.
Forms
Number Title
Version
OHR-2
Summary of Interventional Human Subjects Research
2/2014
Changes: Addition to Location/Collaboration section: TJU as part of an NCI Cooperative Group study.
If you have any questions or comments about these changes, please contact
patrick.herbison@jefferson.edu .