Chapter 1: Research Integrity

1.5 Protection of Research Subjects

Research involving human subjects is regulated by government agencies and by the CHOP Research Institutes' policy. The CHOP Research Institute extends the same regulatory requirements to all research activities that involve human subjects, regardless of the funding source. There are additional regulatory requirements for research procedures that may present safety issues such as biohazards or radiation.

There are two federal agencies that regulate human subject research at the CHOP Research Institute: the Office for Human Research Protections (OHRP), and the Food and Drug Administration. Both are part of the U.S. Department of Health and Human Services. Children's Hospital's Federalwide Assurance (FWA) with OHRP assures institutional compliance with national and international ethical principles and federal, state and local laws on the involvement of human subjects in research.

TThe regulations define a human subject as a living individual about whom an investigator (faculty, staff or student) obtains data either through intervention or interaction with the individual; or identifiable private information, e.g., school transcripts or medical records. All protocols involving human subject research must be reviewed and approved by an Institutional Review Board (IRB) prior to the conduct of any research activities. Only the IRB can determine whether a protocol is exempt from IRB oversight.

The Children's Hospital of Philadelphia Research Institute requires that all investigative team members complete training in human subject protections as a condition of IRB approval of a protocol. At CHOP Research Institute, there are several IRBs charged with the review of protocols involving the use of human subjects. Meeting dates, submission instructions and deadlines are provided on IRB Web site.

When research involves biohazards and/or radiation, the IRB will require approval by the appropriate administrative panel before research can begin. A complete list of regulatory committees and instructions for submitting applications can be found on the IRB Web site.

Ask the Experts

Mark Schreiner, MD
Overall Chair
Institutional Review Board (IRB)



Robert Kalb, MD
Chair
Institutional Animal Care and Use Committee (IACUC)



Deborah Barnard
Director
Research Compliance and Regulatory Affairs



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CHOP Research Resources

  • Responsible Departments: Office of Research Compliance and Regulatory Affairs, Office of Responsible Research Training
  • IRB Web Site
  • Human Subjects Protection Training (CITI)
  • Disaster Response Plan

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More Information

  • OHRP Web Site
  • Belmont Report

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Developed by the Office of Responsible Research Training

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