Expedited Review

Introduction

Research activities can be reviewed through expedited review procedures if they (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in expedited categories of review.

Research studies that present more than minimal risk to subjects or do not fit within one of the expedited categories undergo full board review by the convened IRB committee.

Categories of Eligible Research Activity

Only research described in one of the below categories can be reviewed through expedited procedures:

• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior).
• Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, for example, weighing, sensory acuity, electroencephalography.
• Prospective collection of biological samples, for example, saliva, hair clippings.
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. Blood drawls may not occur more frequently than 2 times per week; and are limited to 550 ml a week from a healthy, non-pregnant adult who weighs at least 110lbs, or 50 ml (or 3 ml per kg) in other adults or children. Additionally, a certified medical professional (e.g., phlebotomist) must draw the blood.
• Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected for research or non-research purposes.
• Collection of existing data from voice, video, digital, or image recordings made for research purposes.

Review of an Expedited Protocol

Protocols reviewed through expedited procedures are reviewed by at least one IRB member. IRB members conducting expedited reviews may either approve, require modifications (to secure approval), or refer the research to the convened IRB for full board review.

Consultants may assist the IRB in the review of issues which require expertise beyond, or in addition to, that available on the IRB.

Protocols approved through expedited review procedures are usually approved for 364 days.

Amending an Approved Protocol

Generally, requests to amend an approved nonexempt protocol are reviewed through expedited review procedures. In most cases, this is true even if the initial protocol was approved by the full board.

Non-substantive changes, such as changes to personnel, can usually be reviewed by the Campus IRB program director or associate director, unless the research is federally funded.

While uncommon, an amendment to a protocol approved through expedited review procedures may require review by the convened board at the recommendation of an IRB member

Periodic Check-in of an Approved Protocol

If the research study is complete, the protocol can be closed. For research that is ongoing, a Periodic Check-in form must be submitted by the protocol’s expiration date. Upon the processing of a Periodic Check-In form, the protocol will be assigned a new expiration date, 364 days from the previous expiration date.

Protocols for which no Periodic Check-In form is processed by the expiration date are automatically closed. Closed protocols can be re-opened within 5 days of the closure date using a Request to Re-open a Closed Protocol form. Protocols that are reopened are assigned new expiration dates.