Guidance on How, When, and Why to use these forms can be found here
To ensure that you are using the most current version of IRB forms, it may be necessary to clear you web browser's temporary files.
In Microsoft Internet Explorer, select the 'Tools' menu, then 'Internet Options'. Under the 'General' tab, find and press the button labeled 'Delete Files...'.
In Mozilla Firefox, select the 'Tools' menu, then 'Options'. Under the'Privacy' tab, find the submenu labeled 'Cache' and press the button labeled 'Clear Cache Now'.
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.
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.
Data Use Agreement This contract is required to be completed whenever Protected Health Information is being disclosed to a source outside of UPHS or the SOM.
IRB Authorization Agreement
Individual Investigator Agreement
Clinical Trials Registration Requirements
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.