Chapter 1: Research Integrity

1.5 Protection of Research Subjects

Research involving either human subjects or laboratory animals 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 or animal subjects, regardless of the funding source. There are additional regulatory requirements for research procedures that may present safety issues such as biohazards or radiation.

Human Subjects in Research

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.

The 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 the 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.

Laboratory Animals

The Children's Hospital of Philadelphia Research Institute has one Institutional Animal Care and Use Committee (IACUC), charged with reviewing all research protocols involving lab animals. No research involving the use of vertebrate animals can proceed without the approval of this panel.

In addition to concern for the humane care and use of the animals, research with laboratory animals can also raise environmental health and safety issues. Training on the care and use of animals and routine submission of Occupational Health and Safety assessments is required of anyone working with laboratory animals in any capacity. The Office of Research Safety in collaboration with the Office of Responsible Research Training manages the training requirements for all researchers working with lab animals.

Any institution conducting research with animals faces the possibility of an animal extremist activity or related event. Every CHOP researcher must be familiar with the Disaster Response Plan Policy.

Ask the Experts

Barbara Engel, MD, PhD
Chair, CPHS
Institutional Review Board (IRB)

Laurence Eisenlohr, VMD, PhD
Chair Institutional Animal Care and Use Committee (IACUC)

Matthew Hodgson
Research Compliance and Regulatory Affairs

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