IRB Forms

Electronic Submissions: Intial Submission

The Human Subjects Electronic Research Application (HS-ERA) is now available to researchers at Penn.  HS-ERA is a new secure, web-based protocol application that may be used by members of the research community to create and submit IRB initial IRB Biomedical or Social and Behavioral Applications.

NOTE: The system may be used to create and submit NEW applications/protocols. Existing paper based applications will not be viewed, edited, or submitted via HS-ERA.

To access the application:

1. With a web browser, go to https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do.
2. Authenticate with your PennKey and PennKey password.

Electronic Submissions: Reportable Events  Submit all reportable events via HS-ERA

Reportable Events including Unanticipated Problems Involving Risks to Subjects or Others

APP-2       Claim of Exemption Form 

Biomedical Science Application:

• APP-3.1    Section I: Face Sheet
• APP-3.2    Protocol Summary
• APP-3.3    IRB Required Documents

Social and Behavioral Sciences Application:

• APP-4.1     Face Sheet
• APP-4.2     Protocol Summary
• APP-4.3     IRB Required Documents

Supplemental Forms:

• APP-5        Research Involving Pregnant Women, Fetuses, and Neonates (Subpart B)
  
• APP-6        Research Involving Prisoners (Subpart C)
  
• APP-7        Research Involving Children (Subpart D)
• APP-8        Research Involving Investigational Devices

Humanitarian Use Device (HUD) Application:

• APP-9.1     Face Sheet
• APP-9.2     Protocol Summary
• APP-9.3     IRB Required Documents

Prime or Umbrella Grant Application:

• APP-10.1    Request for Review of a Prime or Umbrella Grant
• APP-10.2     Continuing Review Form
  

Coordinating Center Application:

• APP-10.3    Application for Coordinating Center

CHOP/Penn Cooperative Agreement:

• CHOP/Penn Cooperative Agreement Determination Form

Instructions

Consent Form Templates:

• ICD-1     Biomedical Research
• ICD-2     Social and Behavioral Sciences Research
• ICD-3     Assent
• ICD-4    Cancer Study
• ICD-5     Humanitarian Use Device
• ICD-6     Tissue
• ICD-7    Financial Conflicts of Interest

Consent Form - Short Forms

• ICD-8.1 - English Template
• ICD-8.2    Chinese
• ICD-8.3    HaitianCreole
• ICD-8.4    Italian
• ICD-8.5    Korean
• ICD-8.6    Russian
• ICD-8.7    Spanish
  
• ICD-8.8    Vietnamese
  
• ICD-8-9    Arabic
• ICD-9.10  Portuguese
  
  

HIPAA Research Subject Authorization Forms

• HIPAA-1     Combined Informed Consent and HIPAA Authorization
• HIPAA-2     School of Medicine
• HIPAA-3     School of Dental Medicine
• HIPAA-4     Request for Waiver of HIPAA Authorization 

ClinicalTrials.gov is a directory of federally and privately supported research trials.  All U.S. drug or device clinical trials must be registered on the ClinicalTrials.gov website in accordance with requirements published by the International Committee of Medical Journal Editors (ICMJE) and the FDA Amendment Act of 2007. 

Protocol records are submitted through the Protocol Registration System (PRS) (http://register.clinicaltrials.gov) and are available to the public at ClinicalTrials.gov (http://clinicaltrials.gov).

If you require a login for ClinicalTrials.gov please contact the Clinical Trials Administrator at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it