IRB review of research

Generally, FDA regulations apply to all research that involves products regulated by the FDA, including research and marketing for:

  • Drugs
  • Biologic products
  • Medical devices for human use
  • Food and color additives
  • Electronic products

OHRP regulations for the protection of human subjects (The Common Rule) is broader and covers all research involving human subjects that is conducted or supported by HHS or regulated by any federal department or agency.

If a protocol is subject to regulations under both agencies, requirements of both must be met.

All research conducted in Children's affiliate facilities that involve children, parents, or staff must be reviewed and approved by the IRB. Scroll down for information on special situations.

Analyzing a project regarding IRB review needed

1. Is this project human subjects research or something else?

Start with the FDA regulations (must meet definition of both "clinical investigation" and "human subject")
  • 21 CFR 50.3(c): "Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(j) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions for part 58 of this chapter, regarding nonclinical laboratory studies."
  • 21 CFR 50.3(j):"Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).
  • 21 CFR 50.3 (g):"Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient."
  • 21 CFR 812.3 (p):"Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease."

Move to the HHS (OHRP) definitions (Common Rule) - if the project does not meet the FDA definitions, it may still meet the Common Rule definitions of human subject research. Under the Common Rule, to be human subject research, it must meet both the definition of research, and the definition of human subject.

  • 45 CFR 46.102 (d):"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
  • 45 CFR 46.102(f):"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention of interaction with the individual, or (2) identifiable private information."

Resources:

2. If the project is human subject research, is it eligible for expedited review (for both exempt or non-exempt projects)?

  • Expedited review procedures are allowed for certain types of research involving no more than minimal risk, and for minor changes in approved research. This means that rather than being reviewed by the full board at a regularly convened meeting, the review is conducted by an IRB chair, or their designee, outside of the regularly scheduled IRB meetings.
  • Expedited does not mean fast. Regulations require that an expedited review be given the same scrutiny that a submission to the full board would receive. Pre-review, modification requests, compliance review all still take place and can take time before approval is granted.
  • An expedited reviewer can approve or require modifications, but cannot disapprove a study. Full board vote is required for disapproval.
  • The IRB makes the determination whether a project qualifies for expedited review or requires full board review.
  • A proposed study that does not meet the requirements for exempt status may still undergo an expedited review it if meets the regulatory criteria for expedited review.