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Policies & Guidelines

Federalwide Assurance and IRB Registration
PSU Policies
IRB Standard Operating Procedures
IRB Policies
IRB Guidelines
IRB Manuals

Federalwide Assurance and IRB Registration

  • An Assurance is the documentation of an institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human participants.
  • This is the principal mechanism for compliance oversight by the Office for Human Research Protections
  • Penn State has an approved FWA with the Department of Health & Human Services. This Assurance is for University Park and all campus locations with the exception of the College of Medicine located at the Hershey Medical Center. The College of Medicine has its own FWA.
    • FWA Number: FWA00001534
    • The expiration date for this assurance changes frequently. If you need the expiration date, please visit http://ohrp.cit.nih.gov/search/asurfnd.asp, enter the FWA Number above, and click "Search".
  • The PSU IRBs are registered with the Department of Health & Human Services. Registration numbers for Penn State's IRBs are:
    • IRB00000192 (IRB #1)
    • IRB00000193 (IRB #2)

PSU Policies

IRB Standard Operating Procedures

  • Unanticipated Problems Involving Risks to Participants or Others (PDF)
  • Handling Allegations of Non Compliance (PDF)
  • IRB Committee SOP Manual (RTF) - updated 14 July 2009

IRB Policies

  • Policy I - VACANT - Please refer to the Standard Operating Procedure Unanticipated Problems Involving Risks to Participants or Others (RTF) for more information
  • Policy II - Verification of Training on the Protection of Human Participants (HTML | PDF)

IRB Guidelines

  • Guideline I - Parental Consent and Child Assent (HTML | PDF)
  • Guideline II - International Research involving Human Participants (HTML | PDF)
  • Guideline III - Participant Recruitment and Advertising (HTML | PDF)
  • Guideline IV - Distinguishing Class-Related Pedagogical (Instructional) Assignments/Projects and Research Projects (HTML | PDF)
  • Guideline V - Research Using Penn State Students as Participants (HTML | PDF)
  • Guideline VI - Research Involving the Consumption of Alcohol by Human Research Participants (HTML | PDF)
  • Guideline VII - Biosafety Guidelines for Handling of Human Blood and Tissue Samples (HTML | PDF)
  • Guideline VIII - VACANT
  • Guideline IX - VACANT
  • Guideline X - Guidelines for Computer- and Internet-Based Research Involving Human Participants (HTML | PDF)
  • Guideline XI - Research Involving Audio, Video or Digital Recordings of Research Participants (HTML | PDF)

IRB Manuals

  • IRB Committee SOP Manual (RTF) - updated 14 July 2009