IRB Policy

• IRB Policies and Operating Procedures
  • IRB Policy Addenda
    • Facilitated Review Procedures for CIRB Trials
    • Reporting and Review of Unanticipated Problems Involving Risks to Participants or Others
    • Handling Allegations of Noncompliance
    • Human Research Protection Education Requirements
    • Recruitment of Research Participants
    • Research Activities in Emergency Situations
    • IRB Review of Protocol Exceptions
    • New Security and Integrity of Human Research Data    Effective January 3, 2012
      

The specific policies and standard operating procedures for the IRB are available at these links.

Review by the IRB is required for all human research to be conducted by, at or in collaboration with Penn State Milton S. Hershey Medical Center (HMC) or the College of Medicine (COM). Review and approval must be obtained prior to including human participants in an investigation.

The IRB reviews all human participant research regardless of sponsorship, if one or more of the following apply to all or part of the research:

1. The research is sponsored by PSU or COM/Penn State Hershey Medical Center (PSHMC), OR
2. The research is conducted by or under the direction of any employee or agent of PSU or COM/PSHMC in connection with his or her institutional responsibilities, OR
3. The research uses any property or facility of PSU or COM/PSHMC OR
4. The research involves the use of PSU's or COM/PSHMC's non-public information to conduct human participants research, OR
5. The research is conducted in accordance with an assurance filed with the Office of Human Research Protections (OHRP) in which a PSU IRB is designated as the IRB of record.

The IRB interacts with other institutions to ensure human subject protection standards are followed when HMC or COM personnel and students perform research at other institutions, or when personnel or students from other institutions perform research at HMC and COM facilities.