Expedited Review Categories To qualify for expedited review, the research must fall within one or more of the following categories. Categories 1 through 7 as authorized by 45 CFR 46.110 and 21 CFR 56.110 and expanded categories 10 through 17 as established by Connecticut Children’s Medical Center IRB pertain to both initial and continuing IRB review. The categories apply regardless of the age of subjects, except as noted. The expanded categories apply to research that is neither federally funded nor subject to FDA regulations. Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) 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); (b) 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: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. (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 (b) 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. [NOTE: Children are defined in the DHHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”] Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. 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 device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. Category 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 DHHS regulations for the protection of human subjects. See Exempt Categories and 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 DHHS regulations for the protection of human subjects. See Exempt Categories and 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.] Category 8: Continuing review of research previously approved by the convened IRB as follows: (a) 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 (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis. [Note: Category (8) identifies three situations in which research that is greater than minimal risk and has been initially reviewed by a convened IRB may undergo subsequent continuing review by the expedited review procedure. For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever the conditions of category (8)(a), (b), or (c) are satisfied for that site. However, with respect to category 8(b), while the criterion that “no subjects have been enrolled” is interpreted to mean that no subjects have ever been enrolled at a particular site, the criterion that “no additional risks have been identified” is interpreted to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source.] Category 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. [Under Category (9), an expedited review procedure may be used for continuing review of research not conducted under an investigational new drug application or investigational device exemption where categories (2) through (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. The determination that “no additional risks have been identified” does not need to be made by the convened IRB.] B. ADDITIONAL APPLICABILITY CRITERIA FOR EXPEDITED REVIEW – NOTE: Research activities should not be deemed minimal risk simply because they fall within one of the expedited review categories above. The following also must apply: The specific circumstances of the proposed research involve no more than minimal risk to human subjects The research does not involve activities in which the 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) The standard requirements for informed consent (or its waiver, alteration, or exception) will apply to the research The research does not involve classified research involving human subjects Expanded Categories of Minimal Risk Research Procedures as Established by Connecticut Children’s IRB ***For research that is neither federally funded nor subject to FDA regulations*** Category 10: Skin biopsy not requiring suturing. Category 11: Ionizing radiation exposure that does not exceed 100 mrem (1mSv) per year. Category 12: Blood draws via a peripheral indwelling catheter that has been placed under standard of care, regardless of frequency. Category 13: Blood sampling (that meets the NIH policy) for children that, when combined with routine standard of care blood collection, is limited to no more than 5 mL/kg on a single day or 9.5 mL/kg over the course of 8 weeks and for adults to no more than 10.5 mL/kg or 550 mL, whichever is less, over the course of 8 weeks. Category 14: Obtaining additional CSF or bone marrow at the time of a clinically indicated procedure in pediatric patients weighing no less than 10 kg. Additional CSF samples are not to exceed 2mL, and additional bone marrow samples are not to exceed 5mL. No additional needle placements/insertions for research purposes are permitted under this expedited category. Category 15: Obtaining additional endoscopic biopsies (not to exceed 6 additional biopsies for research purposes) during the course of a clinically indicated gastrointestinal endoscopy (lower and upper). Category 16: For procedures performed for clinically indicated purposes, the excess fluid not needed for diagnostic or treatment purposes that would otherwise be discarded, obtained through the following: Gastric Lavage, nasogastric tube, or gastrostomy tube; Broncheoalveolar lavage (BAL) or in individuals with an existing artificial airway; endotracheal tube lavage and/or suction, or tracheostomy lavage and/or suction. Category 17: Prolongation of clinically indicated sedation or general anesthesia, not to exceed 5 additional minutes and no more than once within a 52 week period (annually).