Regulatory Agency Questions

What IRB records should the principal investigator keep?  The principal investigator must maintain a protocol file. This file must include: 1) The original IRB application and all subsequent revision and renewal applications; 2) All correspondence between the investigator and the IRB, as well as communications regarding the study from a sponsor; 3) The signed IRB approval letter(s); 4) Signed Consent Forms obtained from all participants or information where these documents can be found; 5) Progress reports; and 6) Reports of all adverse effect incidents and any follow-up to these incidents. This file will act as the investigator’s documentation regarding the proper performance of the study. This file may be audited as part of the IRB's post-approval monitoring, which is conducted by the Office of Research Integrity.

What’s the worst that can happen if I don’t request IRB approval? Aside from potential ethical implications for the subjects 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  • Articles may not be published: Many professional journals require evidence of IRB approval when considering articles for publication.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.