Level of Review: Expedited

The IRB has established three levels of review for approval:  1) exempt, 2) expedited, and 3) full board review.

Expedited

 Research activities that involve no more than minimal risk, minor changes in previously approved research during the period (of one year or less) for which approval is authorized, and research that has been approved by the IRB of another institution may be considered for expedited review.

 Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure (63 FR 60364-60367, November 9, 1998).

 Applicability:

  1. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following Research Categories (see below), may be reviewed by the IRB through the expedited review procedures authorized by 45 CFR §46.110 and 21 CFR §56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
  2. The categories in this list apply regardless of the age of subjects, except as noted.
  3. 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.  
  4. The expedited review procedure may not be used for classified research involving human subjects.
  5. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review.

Research Categories:

  1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
    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 as follows:
    1. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or 
    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. 
  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. (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.)
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR §46.101(b)(4). This listing refers only to research that is not exempt.) 
  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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR §46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
  8. Continuing review of research previously approved by the convened IRB as follows:
    1. 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; or
    2. where no subjects have been enrolled and no additional risks have been identified; or
    3. where the remaining research activities are limited to data analysis.
  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.