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Research

Expedited Review

Federal regulations carve out some research that do not require the review of the convened IRB Executive Committee. At ISU, these protocols are typically reviewed by only the IRB Chair or by the Chair in conjunction with one or more IRB Executive Committee member. Protocols reviewed by Expedited Review still must meet the criteria for approval as Full Board review protocols and standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review.

In order to qualify for Expedited Review, projects must present no more than minimal risk to human subjects and involve only procedures in one or more of the categories listed below. These activities should not be deemed to be of minimal risk simply because they are included on this list, just that they are eligible for expedited review if they involve no more than minimal risk to human subjects. The categories in this list apply regardless of the age of subjects, except as noted.Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

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.
  • For classified research involving human subjects.

Expedited Review Research Categories

  1. Clinical studies on drugs or medical devices for which an investigational new drug application or an investigational device exemption is not required.
    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 subject, 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 non-invasive means. Examples:
    1. hair and nail clippings, in a non-disfiguring manner;
    2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
    3. permanent teeth if routine patient care indicates a need for extraction;
    4. excreta and external secretions (including sweat);
    5. uncannulated saliva collected either in an unstimulated fashion or stimulation by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
    6. placenta removed at delivery;
    7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
    8. supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished with accepted prophylactic techniques;
    9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
    10. sputum collected after saline mist nebulization.
  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. Examples:
    1. physical sensors that are applied to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy;
    2. weighing or testing sensory acuity;
    3. magnetic resonance imaging;
    4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
    5. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from HHS regulations for the protection of human subjects. 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 of this may be exempt depending on the identifiability and risk.)
  8. Continuing review of research previously approved by the convened IRB as follows:
    1. 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
    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.