Regulatory Agency Requirements

What’s the worst that can happen if I don’t request IRB approval?

Aside from potential ethical implications for the participants and for the investigator, bypassing IRB review brings other risks:

  • Funding may be withheld: Federal sponsors, and many private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which IRB review is not complete/pending at the time of proposal submission. Some sponsors will not release funds to the University for the investigator’s use without IRB approval.
  • Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
  • Dissertation or thesis work may not be accepted: Graduate students must present to the Graduate School evidence of IRB approval for their projects involving human subjects. Thesis or dissertation work may not be accepted without it. Degrees may not be awarded for work based on non-IRB-reviewed projects.
  • Credit may be withheld: The University may, at its discretion, refuse to grant students course credit for research conducted without IRB approval.
  • The University will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the University. The University will not, therefore, provide an investigator of unapproved research the resources to answer a liability complaint. The University may also pursue disciplinary action against individuals conducting unapproved research involving human subjects.

Are there specific reporting requirements once my IRB Protocol has been approved? 

Yes.  You must inform the IRB of any complaints from human subjects and any adverse events. Principal Investigators must also file a Continuing Review form at least every 365 days. Failure to return the Continuing Review form by the deadline results in the immediate suspension of the protocol. Such suspension requires that all activity on the project stop, not just the enrollment of subjects and collection of data. Research activities may not resume until you receive a new IRB approval letter.

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