- IRB review and approval is required for all research involving human participants conducted by Penn State Milton S. Hershey Medical Center or Penn State College of Medicine. Approval must be obtained prior to including human participants in an investigation. Below are helpful resources for researchers preparing an IRB submission. New researchers are encouraged to request a Consultation with an IRB coordinator.
For recent announcements and new procedures see HSPO Updates.
- Frequently Asked Questions (FAQs)
- Penn State Hershey IRB Assurance & Representation Statement and DHHS Registration
- IRB Policies and Operating Procedures
- PSU Policy RA14 - The Use of Human Subjects in Research
- PSU Guideline RAG 16 - The Responsible Conduct of Research
- PSU Procedure CR 2078 - Payments to Research Participants
CATS IRB SUBMISSONS
- CATS IRB Library - The online IRB Library contains all of the required templates and resources needed to make a submission, as well as an IRB Study Submission Guide, and the Investigator Manual for reference.
- CATS Help link - Provides an Introduction to navigation, accessing a study, updating your training records, understanding My Inbox, plus sections on Submitting a Study and more Help for Specific Pages.
- For a list of drop-in CATS IRB HELP HOURS and WORKSHOPS times see Educational Resources.
- Steps for PRAMS Studies that Convert to CATS IRB
Once a PRAMS study converts to CATS IRB, at the next modification or continuation review for the study complete the steps outlined in these documents (which are available from the Templates tab in the CATS IRB Library).
- HRP-503b How to Upload a Protocol for a Converted Study HY
- HRP 503d Next Steps for Converted Studies - For Researchers
- Updating Consent Forms and Converting Parental Permission Forms - Follow these instructions to update older consent forms to the new format, and to convert Parental Permission Forms to Consent Forms.
OTHER FORMS AND REFERENCE
- Additional forms
- Reportable New Information (for PRAMS studies only) RNI Form HRP 214 RNI Template HRP 508
- Confidentiality: Confidentiality Agreement
- Consent Suggested Wording
- Data Security and Integrity Policy REDCap - Research Electronic Data Capture System
- Ancillary Reviews
- Conflict of Interest Review Committee (CIRC) - For details contact Office of Administration
- Institutional Biosafety Committee (IBC) - Required if using potential biohazards
- Radiation Review Form - Required if radiation is administered for research
- Use of Human Tissue for Research Form - Required if collecting tissue or specimens
- Scientific Review Requirement - Required for all investigator written human research studies
- PSHCI Scientific Review - Reviews all research involving cancer patients/data/specimens
- Research Consults and Support
- Research Quality Assurance Office
- Biostatistics consults
- CTSI Consults
- Clinical Trials Office - includes Clinical Research SOPs, Generic Study Management Forms
- Clinical and Translational Science Institute
- Clinical Research Center
- Ethics Consult - CTSI Service Request Form
- Marketing and Communications (link accessible internally only) - for research recruitment materials development
- Office of Research Affairs
- Penn State Hershey Cancer Institute