Guidance Tab Content

IRB submissions can be complex and we try to offer as much guidance as possible. The Guidance Tab is broken up into separate pages. Below is a breakdown of the Guidance Tab sub-pages and content to help you find what you are looking for. You may also use the search bar in the top right corner of the site to search for guidance. Many of these topics are abbreviated to provide quick reference rather than in-depth explanation. Since the nature of research dictates that no two studies are exactly alike, please feel free to reach out to an IRB staff member for further information about how the guidance applies to your particular project.

  • Common Rule Update 2018

     - Up to date information about the change to the Common Rule regulations and what they mean for Penn researchers

  • CITI Training
    - Guidance for completing the required CITI training including:
    - How to access and register in CITI
    - Taking CITI for the first time or renewing
    - Submitting CITI training from other institutions
    - Troubleshooting problems in CITI
  • QI/QA Project Guidance

     - Description of what constitutes QI/QA research and how to request formal IRB assessment and tools/documents for download

  • Types of Research

     - Is IRB review required?
     - Expanded access for investigational products (including emergency use, compassionate use, single patient treatment use and expanded access)
     - Information about investigational drugs and devices
     - Social media guidance
     - Government funded research
     - Issues with pregnancy in greater than minimal risk research

  • Other Elements of Research

     - Community Partner Training
     - Principal Investigator Compliance Assessment (for greater than minimal risk research when reporting annually to the IRB)
     - Electronic Data (PHI) Protection/Storage/Transmission Plan Requirements
     - Clinical Trials Registration
     - Certificates of Confidentiality (COC)
     - Conflicts of Interest (COI)
     - Data & Safety Monitoring (DSM)
     - NIH Genome Wide Association Study (GWAS) registry
     - Scientific and Scholarly Validity
     - ICH Good Clinical Practice (ICH/GCP) Compliance

  • Recruitment and Consent

     - Payment to Research Subjects
     - Payment for Recruitment of Subjects
     - Community Research Partners (training link)
     - Pennsylvania Law
     - Recruitment Materials
     - Research Results and the Electronic Medical Record (EMR)
     - Required Elements of Consent
     - Template HIPAA Language
     - Requirements for reporting certain diseases/infections

  • Agreements

     - PI acknowledgement of responsibilities when Penn is asked to rely on an external IRB
     - CHOP/Penn agreement
     - IRB Authorization Agreements
     - Individual Investigator Agreements
     - Data Use Agreements
     - Good Shepherd Penn Partner Research

  • Human Research Participants

     - Contact information about how to request information about rights as a research participant
     - FAQ for common questions about research participation:
     - What is research?
     - Why would I want to participate?
     - How is research at Penn reviewed and regulated?
     - Where can I find research studies to participate in?
     - How can I get additional information about my rights as a research participant?

  • Research Resources

     - Links to available resources for the conduct of research at Penn