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• Some human subjects research may possibly be eligible for expedited review if it does not involve research with prisoners.
• Most minimal risk studies are reviewed by an expedited reviewer. The categories that allow for Expedited Review of Research are further described in this complete list from OHRP. The following is a summary of the categories:
  • Category 1: Clinical studies of drugs and medical devices only when either of the two conditions below is met.
    1. Research on drugs for which an investigational new drug (IND) application (21 CFR Part 312) is not required.
    2. Clinical studies of medical devices for which an investigational device exemption application (21 CFR Part 812) 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.
  • Category 2: Collection of blood specimens 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.
  • Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. See this category in OHRP document for more details: Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure
  • 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.
  • 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)
  • Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes

  • 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. 

    Footnote
    NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. See 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.

    NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. See 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.

  • Category 8: All greater than minimal risk studies will be reviewed by a fully convened IRB unless it falls under one of these Expedited Continuing Review Categories:
    1. Continuing review of research previously approved by the convened IRB where 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.
    2. Continuing review of research previously approved by the convened IRB where no subjects have been enrolled and no additional risks have been identified. (An example would be if there was a new risk added to the Investigational Brochure.)
    3. Continuing review of research previously approved by the convened IRB where the remaining research activities are limited to data analysis.
  • Category 9: Continuing review of research, not conducted under an IND or IDE where categories 2-8 above 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. (This means that this category applies if the protocol does not fit in one of the above categories and is minimal risk but was initially be reviewed by the Full Board to allow Category 9 to be used.)

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