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Institutional Review Board : When do I need IRB approval?

What requires IRB review and approval?

Brescia University has determined that all human subject research, whether funded or not funded, or subject to Federal regulations or not, must be reviewed and approved by the University’s Institutional Review Board.  The IRB reviews all research projects involving humans to ensure that the ethical considerations contained in the federal regulations are met and that research procedures do not infringe upon the safety, health, or welfare of participants.

What does not require IRB review and approval?

Research is defined as a systematic investigation, including testing and evaluation, designed to develop or contribute to generalizable knowledge. All human participant activities meeting this definition are within the jurisdiction of the IRB. As such, research involving human participants must be reviewed and approved. Exceptions to IRB approval would be those projects or activities that do not meet the federal definition of research based on the U.S. Department of Health and Human Services’ decision tree.

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IRB Review Categories

Full Review

Full review is required in all cases where research exposes subjects to more than minimal risk. Examples may include (but are not limited to) research involving deception, individuals with cognitive disabilities, prisoners, or the infirmed, as well as any protocols where body specimens are obtained, or sensitive information requested. All full reviews must be approved at a scheduled meeting of the IRB. The IRB may vote to

  1. approve;
  2. approve with minor revisions;
  3. request additional information or clarifications for consideration at later meeting; or
  4. not approve the research protocol.

Ordinarily, full reviews (not necessarily approval of the protocol per se) should be completed within twenty-eight (28) working days of receiving a completed submission, depending upon the timeliness of investigator responses to IRB (or IRB Chair) inquiries.

Expedited Review

Expedited reviews require an IRB Submission Form, including a comprehensive protocol description, proposed Informed Consent Form, any instruments proposed for use and/or a list of interview questions, and any materials to be distributed to potential or actual participants. Studies that entail non-exempt research involving minimal or less than minimal risk to subjects, or non-invasive research, may be eligible to undergo an expedited review at the discretion of the IRB Chair and will be reviewed by the Chair or an assigned IRB member. As part of the expedited process, the reviewer and/or the Chair may make inquiries of the PI and suggest revisions prior to issuing a decision. The assigned reviewer may recommend to the Chair that the protocol receive one of three possible designations:

  1. approved;
  2. approved with minor amendments; or
  3. forwarded to the committee for a full IRB review.

Ordinarily, expedited reviews are completed within ten (10) working days of receiving a completed submission, depending upon the timeliness of an investigator to IRB inquiries.

Exempt Review

Exempt reviews require a PI to submit an Exempt Review Short Form. The short form is an abbreviated process whereby the PI can demonstrate the research meets the criteria for an exemption. The Chair or her/his designee may decide upon one of three actions:

  1. approve the protocol;
  2. approve with minor revisions; or
  3. request a full protocol be submitted pursuant to the expectations and requirements of either expedited or full review.

Ordinarily, an exempt review is completed within seven (7) working days of receiving a completed submission.