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Expedited Categories

Category 1

Clinical studies of drugs and medical devices when specific conditions are met

Category 2

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

Category 3

Prospective collection of biological specimens for research purposes by noninvasive means

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

Category 5

Research involving materials (data, documents, records, or specimens) that:

  1. have been collected, or
  2. will be collected solely for non-research purposes (such as medical treatment or diagnosis. (This listing refers only to research that is not exempt 46.104)

Category 6

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

Category 7

Research on:

  1. 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
  2. research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (This listing refers only to research that is not exempt. 46.104

Category 8

Continuing review of research previously approved by the convened IRB:
(a) where

  1. the research is permanently closed to the enrollment of new subjects;
  2. all subjects have completed all research-related interventions; and
  3. the research remains active only for long-term follow-up of subjects; or

(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) 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.