Lana Gevorkyan Corporate Director Human Research Protection Program Expedited Review Lana Gevorkyan Corporate Director Human Research Protection Program

Introduction: Expedited Review Expedited Review is a type of review that can be done by: * The IRB Chair * Other IRB members * Subcommittee of the IRB Expedited Review should be performed based on the area of expertise

Introduction: Expedited Review (cont.) IRB member designated to conduct expedited review * Must be experienced reviewer * Must be a voting member of the IRB * May exercise all of the authority of the IRB to review and approve research * Does not have the authority to disapprove research

Introduction: Expedited Review (Cont.) The regulations prohibit disapproval of any research reviewed via expedited method “Proposed Disapproval” must be referred to the full board

Introduction: Expedited Review (Cont.) The full board must be notified for all projects approved via expedited method Research approved via expedited method must be communicated to the Full Board Expedited review can’t be used for classified research and research with prisoners

Expedited Review Eligibility Research that might qualify for expedited review includes: * Initial Review * Continuing Review * Revisions to an Approved Protocol

Expedited Review Eligibility (Cont.) Initial Review can be conducted via expedited method if they meet the following criteria: a. Research poses no more than minimal risk to subjects AND b. Research for which each of the procedure falls within one of the expedited review categories 1-7 as outlined by the DHHS and FDA

Expedited Review Eligibility (Cont.) Continuing Review can be conducted via expedited method if they meet the following criteria a. No more than minimal risk to subjects AND research met the criteria for expedited review during initial review and continues to meet those criteria AND all procedures continue to meet one or more of the expedited review categories (1-7) OR b. Research which was previously reviewed by convened IRB, but now meets category 8 (a), (b) or (c) or category 9 for expedited review

Expedited Review Eligibility (Cont.) ● Revisions to an Approved Protocol can be conducted via expedited method if they meet the following criteria: a. Modifications do not pose an increased risk to subjects b. Modifications constitute a minor changes to previously approved research c. All added procedures fall within categories (1) – (7)

Expedited Review Eligibility (Cont.) General Eligibility Criteria that can qualify for expedited review are: * research activities that present no more than minimal risk * minor changes in previously approved research during the period for which approval is granted * research for which each of the procedures falls within one of the expedited review categories 1-9 as outlined by the DHHS and FDA

Expedited Review Categories Category 1: ● Clinical Studies of drugs and medical devices only when a) IND application is not required b) research on medical devices for which (i) an IDE application is not required (II) the medical device is cleared for marketing and the medical device is being used in accordance with the approved labeling

Expedited Review Categories (Cont.) Category 2 ● Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: a) from healthy, non-pregnant adults who weight at least 110 pounds. The amount drawn may not exceed 550ml in an 8 wk. period and collection may NOT occur more frequently than 2 times per wk.

Expedited Review Categories (Cont.) Category 2 (cont.) ● b) from other adults and children, considering their age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, the frequency with which it will be collected. The amount drawn may not exceed the lesser of 50ml or 3 ml per kg in an 8 wk. period and collection may NOT occur more frequently than 2 times per wk.

Expedited Review Categories (Cont.) Category 3 ● Prospective collection of biological specimens for research purposes by non-invasive means. Some of the examples include: a) hair and nail clippings in a non-disfiguring manner b) permanent teeth extraction (if routine patient care indicates a need for it) c) placenta removal at delivery d) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor

Expedited Review Categories (Cont.) Category 4 Collection of data through noninvasive procedures, excluding procedures involving X-rays or microwaves. Some of the examples include: a) MRI b) Moderate exercise, body composition assessment c) Physical sensors that are applied either to the surface of the body or at the distance

Expedited Review Category (Cont.) Research involving materials that have been collected or will be collected solely for non-research purposes * data * documents * records * specimens

Expedited Review Category (Cont.) Collection of data made for research purposes * voice * video * digital * image recording ● IRB must ensure that appropriate safeguards are in place to prevent potential harm that may be associated with a breach of confidentiality.

Expedited Review Category (Cont.) Research on group characteristics or behavior Some of the examples include: * Questionnaire * Survey studies * Program evaluation

Expedited Review Categories (Cont.) Category 8 Continuing review of research previously approved by the convened IRB as follows: a) Where (i) the research is permanently closed to the enrollment of new subjects (ii) all subjects have completed all research-related interventions (iii) the research remains active only for long-term follow-up of subjects

Expedited Review Categories (Cont.) Category 8 (Cont.) b) Where no subjects have been enrolled and no additional risks have been identified c) Where the remaining research activities are limited to data analysis

Expedited Review Categories (Cont.) Category 9 Continuing review of research NOT conducted under an IND application or IDE where categories (2) – (8) do not apply, but the IRB has determined and documented at the convened IRB meeting that the research involved no greater than minimal risk and no additional risks have been identified

Conclusion Expedited reviews reduce the workload of the Full IRB Decreases IRB turnaround time Regardless of whether the research is approved via expedited method or via Full board, the same regulatory and ethically based standards must apply.

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