IRB Types of Review

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Exempt, Expedited, Full IRB Review

The IRB follows three distinct review types while reviewing research involving human subjects. These types are based on the regulations governing research and relate to the degree of risk to research subjects. For Full and Expedited review, please use the Initial Protocol Application and for Exempt review, please use the Protocol Exempt Application.

Exempt Review

Some human subject research might fall under an Exempt review process. In order to assess if your research project fits one of the exemption criteria, please see list below or 45CFR 46 101 (b) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. The IRB office will make the final determination if your research project falls under an Exempt Review.

Research may be exempt from review when the only involvement of human subjects in the research falls into one of the following categories:

Expedited Review

Some human subject research might fall under an Expedited Review process. The categories for Expedited review process are noted below and can be found at http://www.hhs.gov/ohrp/policy/expedited98.html

Applicability

Research Categories

In addition, expedited review is appropriate for minor changes in protocols and consent forms proposed for previously approved research during the period (one year or less) for which approval is authorized. Changes affecting risk, benefit, discomfort, or subject protections are not “minor” changes. Minor modifications include, for example, administrative changes to the protocol, changes to add follow-up calls when gathering initial data by telephone, or certain changes in the scheduling of medications.

Full IRB Review

Human subject research that does not fit any of the Expedited or Exempt review categories will require a Full IRB review at a convened meeting. The IRB meets once a month or as requested by the IRB chairman. Research applications are placed on the agenda and will be discussed at the next scheduled meeting. The IRB chairman might cancel a full IRB meeting if

The IRB uses a primary reviewer system for full IRB review. Application materials are sent to the IRB members scheduled to attend a meeting at least one week in advance of the meeting. Two members are selected by the chair, one as the primary reviewer and the other as a secondary reviewer for a research project.

The primary reviewer leads the discussion of each project at the full IRB convened meeting. The secondary reviewer adds any other relevant comments or clarifications. The members determine whether the project meets the criteria for approval or whether revisions to the study design are required. The Informed Consent Document is reviewed for accuracy, clarity, and inclusion of required and optional elements of consent. During the meeting, voting is by show of hands. By a majority of those present at the meeting, each project is either: (1) approved as submitted; (2) approved pending receipt of required minor revisions to study procedures, Informed Consent Document(s), or other written materials; (3) tabled pending review at a subsequent full board meeting after receipt of significant additional information or revisions, or (4) disapproved.

Written minutes of each full IRB meeting include: (1) attendance, (2) the number of votes to approve, table, disapprove, or abstain (without individual identification), (3) the basis for requiring changes in or disapproving the research, (4) the length of time until the next review, and (5) a summary of the discussion of controverted issues and their resolution.