• How will the IRB review my research?

    ​The IRB reviews proposals for research and assigns them into one of four categories.

    Two of the categories require at least annual renewal of IRB approval:

    • Full Review
    • Expedited Review

    However, at its initial review, the IRB may assign one of two categories that do not require further review:

    • Exemption from Review
    • No Humans Designation.

    Full Review

    Full Review is required for protocols involving investigational drugs or devices and where certain vulnerable subject populations will be participating. Full review is also required if the protocol involves more than minimal risk to particicpants. See Section 11 of the IRB Guidebook and the Application for Full Review for complete information.

    Expedited Review

    See Section 10 of the IRB Guidebook and the Application for Expedited Review for complete information.

    Expedited review is applicable for research activities which (a) involve no more than minimal risk to the human participants and which (b) can be placed in one or more of the nine (9) categories listed on the application form. The first seven (7) categories are for new applications; the last two apply only to renewals.

    • Certain types of clinical studies on medical drugs and devices... [see application].
    • Collection of certain amounts of blood when the collection meets specified criteria... [see application].
    • Prospective collection of biological specimens for research purposes by noninvasive means such as hair and nail clippings, permanent teeth if routine patient care indicates a need for extraction, or cells collected on swabs or mouth washings... [see application].
    • Collection of data through noninvasive, nonradiological procedures (not involving general anesthesia or sedation) that are routinely employed in clinical practice. One example is a test given to assess one's ability to walk... [see application].
    • Research involving materials that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)... [see application].
    • Collection of data from voice, video, digital, or image recordings made for research purposes... [see application].
    • Research on the characteristics or behavior of an individual or group (such as research on perception, cognition, or motivation) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies... [see application].

    Exemption from Review

    See Section 9 of the IRB Guidebook and the Exemption Review Application for complete descriptions of the following 6 categories that may be eleigible for exemption from further IRB review.

    • Research conducted in established or commonly accepted educational settings, involving normal educational practices … [see application].
    • Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless (i) human subjects can be identified and (ii) any disclosure of the responses could place subjects at risk… [see application].
    • Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under category (2), if
      the human subjects are public officials or candidates for public office; or
      federal statute(s) require(s) without exception the maintenance of confidentiality… [see application].
    • Research involving the collection or study of pre-existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the Investigator in such a manner that subjects cannot be identified… [see application].
    • Research and demonstration projects that (a) are conducted by or must be approved by department or agency heads, and that (b) examine public benefit or service programs… [see application].
    • Taste and food quality evaluation and consumer acceptance studies, if
      wholesome foods without additives are consumed or foods are consumed that contain levels judged safe… [see application].

    No Humans Designation

    The IRB may assign a proposal to this category if it includes the use of only

    • Cadaveric materials
    • Outdated blood products (from the Red Cross or other blood banks)
    • Commercially available cell lines provided by nonfederal funding (Use Exemption Application if requesting funding from a federal agency to purchase cell lines.)

    See Section 8 of the IRB Guidebook for more information on the No Humans Designation. Contact the IRB before submitting any No Humans proposal that does not clearly meet the three requirements listed above.