Section 1580.50  Expedited Review

a)         Research that involves no more than minimal risk to human subjects and their privacy and confidentiality may be eligible for an expedited review procedure. If so requested by the researcher, the IRB chairperson shall examine the research application and applicable laws and regulations to determine whether the research project involves no more than minimal risk and is eligible for the expedited review procedure.  Research projects that are eligible for expedited review include those projects found in the list of research categories published as eligible for expedited review in the Federal Register by the Department of Health and Human Services (see 28 CFR 46.110(a)), and previously approved projects for which minor changes are proposed during the period for which the IRB has already given approval, when those projects or changes involve minimal risk.

b)         If a research project is eligible for an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Under an expedited review procedure, the reviewers must consider provisions of Section 1580.40(d) and may approve the research application if those provisions are adhered to.

c)         In reviewing the research application under an expedited review procedure, the reviewers may not disapprove the research application; a research application may be disapproved only after review in accordance with the non-expedited review procedure. Research applications that have been reviewed under, but not approved through, the expedited review procedure shall be subject to further review under the non-expedited review procedure described in Section 1580.40.

d)         The IRB chairperson shall keep all IRB members and the executive director of the Authority informed of research proposals that have been approved under the expedited review procedure.