IRB (Institutional Review Board)

Worked examples

Is an instance

A principal investigator submits a Phase II oncology protocol with consent form and recruitment flyers to the IRB and receives a stamped approved consent before enrolling the first subject.

Is an instance

An IRB requires the PI to add a data-safety monitoring plan and resubmit before approval is granted for a high-risk drug-interaction study.

Looks similar, but isn't

Not an instance

A faculty member reviewing only de-identified secondary data already in the public domain that meets the regulatory definition of not-human-subjects research does not require IRB approval.

Not an instance

Internal departmental quality-improvement projects whose findings are not intended to be generalizable knowledge fall outside IRB jurisdiction.

An IRB is the US statutory body responsible for prospective and continuing review of human-subjects research to ensure that risks to participants are minimized and reasonable relative to anticipated benefits. Membership must include at least five members with varying backgrounds, at least one scientist, at least one non-scientist, and at least one member unaffiliated with the institution. Investigators may not enroll participants, collect identifiable data, or use identifiable biospecimens until they hold an unexpired IRB approval letter for the protocol version they intend to execute. Continuing review, amendment review, and reportable-event review are ongoing obligations for the life of the study.

References

Common Rule 45 CFR 46 (2018 revision), Subpart A §46.107 IRB membership and §46.109 IRB review
FDA 21 CFR Part 56 Institutional Review Boards
OHRP IRB Guidebook (Office for Human Research Protections)

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="IRB (Institutional Review Board)"
      vocab-term-identifier="https://casrai.org/dictionary/term/irb-institutional-review-board" />

Schema.org DefinedTerm (JSON-LD)

json

{
  "@context": "https://schema.org",
  "@type": "DefinedTerm",
  "name": "IRB (Institutional Review Board)",
  "identifier": "https://casrai.org/dictionary/term/irb-institutional-review-board",
  "description": "An institutionally designated committee constituted under 45 CFR 46.107 that reviews, approves, requires modification of, or disapproves research involving human subjects before any such research may be initiated at the institution.",
  "inDefinedTermSet": "https://casrai.org/dictionary/domain/compliance-and-regulatory/",
  "url": "https://casrai.org/dictionary/term/irb-institutional-review-board",
  "sameAs": [
    "Institutional Review Board",
    "human subjects committee",
    "ethics board (US)"
  ],
  "license": "https://creativecommons.org/licenses/by/4.0/"
}