Types of Human Subjects ReviewExpedited ReviewApplicabilityResearch activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. Examples of expedited review include, but are not limited to:
IRB Review ProcessUnder an expedited review procedure, the review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b). Application SubmissionPlease submit one (1) original hard copy of the IRB Application for review with all accompanying materials (i.e., Informed Consent Form, instrumentation, debriefing statement) and required signature(s). Please submit the IRB application to Siena Hall, Room 219 in care of Alfredo Medina. Full Board ReviewApplicabilityFull board review involves a convened meeting at which the majority of the membership of the IRB are present, including at least one member who primary concerns are in nonscientific areas. IRB applications that involve the following areas may require full board review:
IRB Review ProcessUnder the full review procedure, this type of review is first determined by the IRB chairperson after careful examination of the application submitted. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. The PI may be requested to attend a full board meeting to discuss the proposal and answer questions posed by the IRB. A typical full review may take between 1-3 months before a decision is rendered. Application SubmissionPlease submit one (1) hard copy with original signature(s) and eight (8) hard copies of the IRB Application with all accompanying materials (i.e., Informed Consent Form, instrumentation, debriefing statement). Please submit the IRB applications to Siena Hall, Room 219 in care of Alfredo Medina.
As of December 1, 2011
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