IRB

Research Assistance

Department Specific Information

Expedited Review

Overview

The following guidelines are used by the IRB to determine whether or not a study falls into the expedited review category. These categories are provided to give you insight into the review process.

Please note: The IRB carefully reviews each application to determine the level of review required. Only the IRB can make this determination.

General Approval Timeline: 1-2 Months


Expedited Categories

1. Clinical Studies of Drugs and Medical Devices

  1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review).
     
  2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

2. Collection of Blood Samples by Finger Stick, Heel Stick, Ear Stick or Venipuncture

  1. From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts withdrawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week
     
  2. From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

3. Prospective Collection of Biological Specimens for Research Purposes by Noninvasive Means

  1. Hair and nail clippings in a non-disfiguring manner
  2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
  3. Permanent teeth if routine patient care indicates a need for extraction
  4. Excreta and external secretions (including sweat)
  5. Un-cannulated saliva collected either in an un-stimulated fashion or stimulated by chewing gumbase or wax by applying a dilute citric solution to the tongue
  6. Placenta removed at delivery
  7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
  8. Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
  9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
  10. Sputum collected after saline mist nebulization

4. Collection of Data through Noninvasive Procedures

Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.

Procedures not involving general anesthesia or sedation, routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.

  1. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy
  2. Weighing or testing sensory acuity
  3. Magnetic resonance imaging
  4. Electrocardiography, electroencephalography, thermography detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography
  5. Moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual

5. Research Involving Materials that have been Collected or will be Collected Solely for Non-Research Purposes

  • This includes data, documents, records or specimens, such as medical treatment or diagnosis.

6. Collection of Data from Voice, Video, Digital or Image Recordings made for Research Purposes

7. 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 or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

8. Continuing Review of Research Previously Approved by the Convened IRB

  • Where the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects
  • Where no subjects have been enrolled and no additional risks have been identified
  • Where the remaining research activities are related to data analysis

9. Continuing Review of Research Not Conducted Under an Investigational New Drug Application or Investigational Device Exemption

  • Where categories 2 through 8 do no apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified