Expedited Categories

Subcategories:

(a) Clinical studies of drugs when an investigational new drug (IND) application is not required

(b) Clinical studies of medical devices when an investigational device exemption (IDE) is not required, or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling

Subcategories:

(a)  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults who weigh>110 pounds where the amount drawn is <550 ml/8 week period and collection occurs at most 2 times/week

(b)  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected (at most 50 ml or 3 ml/kg/8 week period), and the frequency with which it will be collected (at most 2 times/week)

Non-invasive procedures include, but are not limited to: (1) vaginal swabs that do not go beyond the cervical os; (2) rectal swabs that do not go beyond the rectum; and (3) nasal swabs that do not go beyond the nares.

Examples:

(a) hair and nail clippings in a non-disfiguring manner;

(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;

(c) permanent teeth if routine patient care indicates a need for extraction;

(d) excreta and external secretions (including sweat);

(e) un-cannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum-base or wax or by applying a dilute citric solution to the tongue;

(f) placenta removed at delivery;

(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;

(h) 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;

(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

(j) sputum collected after saline mist nebulization.

Non-invasive procedures include, but are not limited to: (1) vaginal swabs that do not go beyond the cervical os; (2) rectal swabs that do not go beyond the rectum; and (3) nasal swabs that do not go beyond the nares.

Cannot involve general anesthesia or sedation.

Cannot include procedures involving x-rays or microwaves.

Where medical devices are employed, they must be cleared/approved for marketing.

Examples:

(a) 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;

(b) weighing or testing sensory acuity;

(c) magnetic resonance imaging;

(d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;

(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

This category allows for the research use any data, documents, records, or specimens which are already in existence at the time of submission of the protocol to the IRB for review. 

It also allows for the research use of any data, documents, records, or specimens which are not currently in existence at the time of submission of the protocol to the IRB for review, but which will be created/collected solely for non-research (i.e. "standard of care") purposes. 

Examples:

(a) Chart review studies

(b) Collection/use of discarded tissues 

(c) Studies using student records

This category allows for research procedures that involve the collection of data from voice, video, digital, or image recordings made for research purposes.

This category does not include collection of data from voice, video, digital, or image recordings made for non-research (i.e. "standard of care") purposes. Such uses would be covered under Expedited category 5 instead. 

Subcategories:

(a) 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.

(b) No subjects have ever been enrolled at a site under UCSD IRB purview and neither the investigator nor the IRB has identified any additional risks from any site or other relevant source.

(c) The remaining research activities are limited to data analysis.

NOTE: Long term follow-up includes research interactions that involve no more than minimal risk to subjects (e.g., quality of life surveys); and collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol. Long term follow-up excludes research interventions that would not have been performed for clinical purposes, even if the research interventions involve no more than minimal risk.

Requirements:

• Cannot be conducted under an IND application or IDE,
• The research activities don't fit into categories 2-8 above,
• 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.