IRB Member Review Resources
This page contains resources for members of the University of Pennsylvania’s 8 Institutional Review Boards.
IRB Member Review Toolbox
Below are worksheets, tools, and guidance documents to guide the various reviews and determinations the committee must make when reviewing various submissions. Email your completed worksheet and revised documents to your IRB Administrator at least 2 days prior to the meeting.
Tools for Initial Reviews
Primary Reviewer Worksheet
Utilize this worksheet to review an initial submission, if you are assigned as the primary reviewer.
Secondary Reviewer Guidance
Utilize this guidance to review the informed consent, if you are assigned as a secondary reviewer.
Pragmatic-CE Clinical Trial Ethical Review Tool
Utilize this worksheet when reviewing a comparative effectiveness study.
Tools for Ongoing Reviews
Utilize this worksheet when reviewing a modification submission.
Utilize this worksheet when reviewing a continuing review submission.
Utilize this worksheet when reviewing a deviation to conduct an assessment of serious noncompliance and/or continuing noncompliance.
Utilize this worksheet when reviewing a reportable event to determine if it may be an unanticipated problem.
Other Review Tools
Subpart D: Inclusion of Children
Utilize this worksheet to assess parental permission and assent requirements if the protocol includes minors under the age of 18.
Subpart B: Inclusion of Pregnant Individuals
Utilize this worksheet to assess the acceptability of including pregnant women as participants.
Subpart C: Inclusion of Prisoners
Utilize this worksheet to assess the acceptability of including prisoners in research.
Utilize this worksheet if the IRB needs to make a device risk determination or IDE Exemption.
Utilize this worksheet if the IRB needs to make an IND exemption determination.
The Penn IRB recognizes and references the guiding ethical principles for human subject’s research that have been set forth in the following documents. Click each document to download a copy.
IRB Member Review Guidance
Below is supplemental regulatory guidance to assist with member reviews.
IRB Criteria for Approval
Federal regulations outline several criteria that must be satisfied in order for the IRB to approve research. When reviewing submissions, ensure all of the criteria have been considered and are met. Click below to review the Quick Reference for Criteria For Approval.
IRB Determination Guidance
The IRB may make a variety of determinations as a result of its review of research at initial review and ongoing reviews. The guidance below outlines and defines these various determinations.
Data & Safety Monitoring Plan (DSMP)
Research that is greater than minimal risk should have a Data & Safety Monitoring Plan (DSMP) designed based on complexity and risk of the protocol. Click below for guidance on data and safety monitoring.