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CSU Human Research Review: Expedite Criteria (45 CFR 46.101)

Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018

The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019. Learn more about the regulations.

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 categories, may be reviewed by the IRB through the expedited review procedure 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.

Federal Definition Examples
Category 1 Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
  • 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.)
  • 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.
Category 2 Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
  • From Healthy, non-pregnant 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
  • 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.
  • hair and nail clippings in a nondisfiguring manner;
  • deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
  • permanent teeth if routine patient care indicates a need for extraction;
  • excreta and external secretions (including sweat);
  • uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
  • placenta removed at delivery;
  • amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
  • 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;
  • mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
  • sputum collected after saline mist nebulization.
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    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. (Studies intended to evaluate the safety and effectiveness of the medical devise are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
  • 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;
  • weighing or testing sensory acuity;
  • magnetic resonance imaging;
  • electrocardiography; electroencephalography
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    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). (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.)
    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. 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)
  • Surveys
  • Interviews
  • Focus groups
  • Program evaluation that will be disseminated
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    Category 8 Continuing Review Criteria Continuing Review of research previously approved by the convened IRB as follows:
    • where
      • 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; or
    • where no subjects have been enrolled and no additional risk have been identified; or
    • where the remaining research activities are limited to data analysis.
    Category 9 Continuing Review Criteria 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.