Expedited Review

Background

Expedited review does not mean a quick review. A proposal that does not fulfill the criteria for Exempt status may undergo an Expedited review if it involves no more than minimal risk to the participants and meets the standards below. Expedited review may also be used when minor changes are proposed to an approved research project during the period for which approval is authorized.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk.

Summary of Expedited Categories

1. Clinical studies of drugs and medical devices only when certain conditions are met
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
3. Prospective collection of biological specimens for research purposes by noninvasive means
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
6. Collection of data from voice, video, digital, or image recordings made for research purposes
7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Expedited categories in detail

Category 1

Clinical studies of drugs and medical devices only when:

• Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required OR
• 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.

Category 2

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

• from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur more frequently than 2 times per week.
• 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 eight-week period and collection may not occur more frequently than two times per week.

Category 3

Prospective collection of biological specimens for research purposes by noninvasive means.

Examples:

• hair and nail clippings in a non-disfiguring manner
• deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
• permanent teeth if routine patient care indicates a need for extraction
• excreta and external secretions (including sweat)
• un-cannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
• placenta removed at delivery;
• amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
• 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;
• mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
• sputum collected after saline mist nebulization

Category 4

Collection of data through noninvasive 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.

Note: 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.

Examples:

• 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
• weighing or testing sensory acuity
• magnetic resonance imaging
• electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography
• moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual

Category 5

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)

This category includes materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.

The phrase “…or will be collected solely for non-research purposes” pertains to the origin of the materials. For example, blood samples that were collected for a clinical test or the results of a course driven exam given in a history class.

Category 6

Collection of data from voice, video, digital, or image recordings made for research purposes.

Expedited Review does not apply if identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Category 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

Category 8

Continuing review of research previously approved by the convened IRB as follows:

• where:
  • (i) the research is permanently closed to the enrollment of new subjects
  • (ii) all subjects have completed all research-related interventions, and
  • (iii) 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 limited to data analysis

Category 9

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not 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.

Research that doesn’t fit an Expedited Category

Any proposed research not qualifying for Exempt status or Expedited review requires a Full Review, in which a majority of IRB members review and vote on the proposal. These typically involve projects that place human subjects at more than minimal risk, or that involve sensitive topics or vulnerable populations such as prisoners, terminally ill patients, children, pregnant women, veterans, or cognitively impaired persons.

Please note that all research projects are reviewed to determine whether full board review is required.