Policies Governing Human Subjects’ Research
The University of Pennsylvania’s Institutional Review Boards (IRBs) are established and empowered under the authority of the Trustees of the University of Pennsylvania. The University of Pennsylvania requires that all research projects that meet the definition of human participants’ research be reviewed and approved by one of the University of Pennsylvania’s IRBs prior to initiation of any research related activities.
Penn IRB Standard Operating Policies (SOP)
The purpose of the SOP is to outline the policies governing the conduct of human subjects’ research. Research teams should be familiar with these policies and reference them as needed.
Perelman School of Medicine Policies and Procedures
Perelman School of Medicine policies and procedures apply when research involves Penn Medicine patients and / or PSOM faculty. This includes research that is led by Faculty from non-Penn Medicine schools such as School of Nursing or SAS.
Supplemental IRB Policy Memos
IRB ICH GCP Compliance
This policy describes the Penn IRB’s position on compliance with ICH GCP.
IRB Electronic Signature Validation
This policy documents the validity of IRB staff and member electronic signatures.
IRB Membership Non-Disclosure Statement
This policy documents that the IRB does not disclose IRB membership lists to Sponsors.
IRB Stamp / Watermark Policy Statement
This policy documents what documents the IRB will stamp.
IRB Policy on Reporting Outcomes of Independent Safety Monitoring Reviews
IRB Policy on Expired Research
This policy documents IRB procedures surrounding late-submitted continuing reviews and research that has lapsed in approval.
IRB Policy on Document Lists
This policy documents when document lists are required from study teams for IRB letters.