Biomedical Research
Social Behavioral Research
Access HSERA
IRB Members
Staff Directory
About
Biomedical Research
Home
How to Submit
Initial Submission
Is IRB Review Required?
QI/PI Project Guidance
IRB Review for Federal or State Grants
Levels of IRB Review
Biomedical Submission Completion Guidance
Data and Safety Monitoring
Other Penn Reviewing Entities
2018 Common Rule
Focused Biomedical Initial Submission Guidance
Single IRB
Request for Penn to Serve as sIRB
IRB Reliance Agreements
Requests to Rely
Modifications
Continuing Review
Respond to Conditional Re-approval
Deviations
Respond to a Compliance Audit Report
Exception Requests
Reportable Events
Reportable Event Guidance
Closure
Treatment Use of Investigational Agent
Humanitarian Use Devices
Forms & Templates
Biomedical Guidance
Types of Biomedical Research
Research Collecting Blood
Research with Device Products
Research with Drug Products
Clinical Trials
Certificates of Confidentiality
NIH Data Sharing Policies
Research During a Public Health Emergency
Research with Penn Patients
HIPAA in Research
Release of Information to the EMR
Sharing Data & Specimens
Recruitment and Consent
Recruitment of Human Participants
Social Media in Recruitment
Informed Consent
Participants Not Fluent in English
Waivers of Consent
Student Researchers
FAQs
HSERA FAQs
IRB Review and Submission FAQs
CITI Training FAQs
Research Personnel FAQs
Continuing Review FAQs
Reportable Event FAQs
QI FAQs
Search
Requirements for Research Involving the Use of Protected Health Information (PHI)
View and Download
