IRB Member Review Resources
This page contains resources for members of the University of Pennsylvania’s 10 Institutional Review Boards.
eIRB Tools for IRB Members
Member Guide to Navigating eIRB Submissions
Please see the Member Guide on how to navigate eIRB when reviewing assigned submissions.
Downloading and Reviewing Submission Documents
Please review this guidance on how to download documents that study teams have uploaded to their eIRB applications for member review. This guidance shows you steps to allow you to download and view several documents at once.
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 Worksheet
Utilize this worksheet 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
Amendments
Utilize this worksheet when reviewing an amendment submission.
Continuing Reviews
Utilize this worksheet when reviewing a continuing review submission.
Deviations
Utilize this worksheet when reviewing a deviation to conduct an assessment of serious noncompliance and/or continuing noncompliance.
Reportable Events
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.
Devices
Utilize this worksheet if the IRB needs to make a device risk determination or IDE Exemption.
Drugs
Utilize this worksheet if the IRB needs to make an IND exemption determination.
Emergency Preparedness
IRB staff and members should utilize this guidance during an emergency/ disaster situation.
Ethical Principles
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.
Regulatory Guidance
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.