IRB Forms

Electronic Submissions:

The Human Subjects Electronic Research Application (HS-ERA) is now required for researchers at Penn for IRB review.  HS-ERA is a 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 and needs to be used to manage all future submissions (continuing reviews and modifications) for studies that were initially submitted electronically.

Existing paper based applications cannot 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.

Please note: New submissions will not be received or viewable by the IRB until they have been signed off on by the principal investigator and the department chair. 

HS-ERA Frequently Asked Questions

HS-ERA Reference Guide

HS-ERA User Satisfaction survey https://www.surveymonkey.com/s/WP38C8Q

Reportable Events  Submit all reportable events via HS-ERA regardless of whether the study is a paper or electronic submission

Reportable Events including Unanticipated Problems Involving Risks to Subjects or Others

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

CHOP/Penn Cooperative Agreement:

• CHOP/Penn Cooperative Agreement Determination Form

Instructions

APP-11.0      Continuing Review Form (Prime/Umbrella Grants) 

APP-11.1      Continuing Review Form Biomedical Science

APP-11.2      Continuing Review Form Social & Behavioral Science   

APP-11.3      Self Assessment form (for HS-ERA CR submissions only) 

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     Financial Conflicts of Interest
• ICD-7     Single Patient Treatment Use

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
• ICD- 8.11 Polish
   
  

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 

 Other templates and guides

• Sample Focus Group Moderator Guide 

Pathology and Laboratory Medicine Services:

Beginning in December 2010, all studies using the services of William Pepper Clinical Laboratory, Division of Anatomic Pathology and Division of Transfusion Medicine are required to complete the forms below for the services desired.  The forms must be uploaded into HS-ERA in the specified sections. Any questions or concerns that arise from Path/Lab Medicine (P&LM) Committee review will be communicated, by letter, to the study contact.  Information on requested services will also be communicated to Michael Weinberg, to initiate the creation of family account services.Please see their website for additional information: http://www.med.upenn.edu/pathresearch/

Clinical Lab Services Form

For samples collected by UPHS phlebotomy and/or analyzed by the hospital laboratory.

Anatomic Pathology Services Form

For tissue specimens [other than blood] either (1) collected for clinical, diagnostic, or research purposes OR (2) processed through surgical pathology.

Transfusion Medicine Form

For either (1) blood product collection and/or the use of apheresis for treatment, (2) the collection of cells or other blood components, OR (3) transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for research purposes.

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