Investigator Resources

IRB review and approval is required for all research involving human participants conducted by Penn State Milton S. Hershey Medical Center (HMC) or the College of Medicine (COM). 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.

IRB REVIEW

MAKING IRB SUBMISSIONS

IRB Submission Schedule

IRB Submission Instructions - PRAMS eSubmission and IRB Drop Box
- PRAMS Navigation Guide
- PRAMS Tips
  - Login to PRAMS
  - Access PRAMS from home

Other Forms and Guidance
- Signature Pages - for all types of submissions
- Submission Related Forms for Ongoing Studies
  - Modification Requests - for non-eSubmission studies
    - Guidance for Modifying Exempt Research
  - Continuing Review - for non-eSubmission studies
  - Protocol Exceptions - for all studies (eSub and non-eSub)
  - Reportable New Information - for all studies (eSub and non-eSub)
Research Plans
Data Security and Integrity (NEW requirement January 3, 2012)
- Policy - Security and Integrity of Human Research Data
- Help Resources - Help desk ext. 6281 or ResearchComputing@hmc.psu.edu
- REDCap - Research Electronic Data Capture System
Informed Consent - Guidance and templates
Privacy Protection, HIPAA and Confidentiality
Recruitment, Advertisements and Payments to Participants
Emergency Uses of Investigational Test Articles (single patient use)

OTHER REQUIREMENTS & RESOURCES

Additional Committee Reviews Required - Committee contacts list
- 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
Biostatistical Consultations
- PSH Biostatistics consults
- CTSI Consults
Ethics Consultation - CTSI Service Request Form
Investigational Drug Use Management - HMC Policy 1405 PAM (Internal link)
Study Related Resources
- Research Quality Assurance Office
- Clinical Trials Office - includes Clinical Research SOPs, Generic Study Management Forms
- Clinical and Translational Science Institute
- Clinical Research Center
- Office of Research Affairs
- Penn State Hershey Cancer Institute
- Web training for HMC electronic medical records
  - Powerchart View-Only Training
  - Connected Intranet site