What is Expedited review?

Expedited review (Level II review), is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, but fewer reviewers are required for approval.

In general, research may be considered for Expedited review if it involves no more than minimal risk*, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures.

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*.

To qualify for review via expedited procedures, the research must not be greater than minimal risk* and fall into at least one of the expedited categories defined by the federal regulations.

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

Researchers engaged in human subjects research that qualifies for Expedited (Level II) review will need to complete a full application form and prepare a consent form, using our template.

Click here for forms.

*Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons