Medical Staff Affairs, Research

IRB Reminder: When Does a Research Project Need Review?

Federal regulations require that all research projects involving human subjects are reviewed by an Institutional Review Board (IRB). For randomized clinical trials of investigational drugs and devices, the need for IRB review and approval is clear. However, it is important to remember that all research projects that involve human subjects (including the use of medical records/data or specimens) must be submitted to the IRB for review prior to the start of any research activities.

The application of these regulations may be confusing to researchers who are planning to conduct a retrospective chart review or to publish their own clinical experiences. The Englewood Health IRB is always available to provide a consultation on the IRB requirements for any project under consideration. Please feel free to reach out for guidance early in the process, as the IRB cannot provide approval or determinations for research that has already been concluded.

Examples of projects that generally require IRB review:

  • Pilot studies that involve human subjects
  • Master’s or doctoral theses
  • Use of identifiable information from medical records
  • Research studies that collect data about human subjects through surveys (paper, online, telephone, etc.), interviews, focus groups, etc.
  • Research studies that include subjects to examine devices, products, drugs, etc.

Examples of projects that generally do not require IRB review:

  • Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc.
  • Activities designed solely for quality improvement or evaluation of a particular program, course, etc.
  • Training activities unless the training activity is conducted for research purposes
  • Single case studies

Contact the IRB team with any questions:

  • Jamie Ketas: x3418
  • Renee Lockwood x3852
  • Nicholas Cavalieri x2619