Applicability: General Requirements
Federally Funded Research
(A) 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...
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) 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.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review-expedited or convened- utilized by the IRB.
Expedited Review of Minimal Risk Research
The regulations at 45 CFR 46.110 contain provisions that permit the use of expedited review procedures for human subjects research that is both minimal risk and where the research procedures are limited to one of the Expedited Review Categories published by OHRP in the Federal Register.
The requirements for review using expedited procedures are identical to review by the convened board with two exceptions:
- instead of review by the full board, the chair, or an experienced member of the IRB designated by the chair, reviews the research and may request modifications and approve the research; but
- the chair can not disapprove the research.
About 80% of the new research protocols submitted to the IRB are reviewed using expedited procedures. An even greater percentage of the amendments and continuing IRB reviews use expedited procedures. The reviews are predominantly performed by the chairs.
This page enumerates the categories of research eligible for expedited review along with explanations for the most commonly used categories.
Additional Flexibility for Expedited Review
CHOP and approximately 50% of other IRBs, have opted to not adhere to all of the criteria of 45 CFR 46 for research that is not federally funded. One way that the CHOP IRB takes advance of this flexibility has been adopting an expanded list of procedures eligible for expedited review. The expanded categories are only applicable to research that is not federally funded or subject to FDA regulation.
Categories of Research Eligible for Expedited Review
Federally Funded or FDA-Regulated Research
The full text of the Expedited Review Categories that apply to federally funded research contain detailed discussion on OHRP's rationale for each of these categories.
|Initial Review Categories||Examples and Notes|
(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.
(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.
(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.; 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.
(a) For healthy non-pregnant adults, 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) for these subjects (all others including children), 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.||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 gumbase 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.|
|(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.||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.|
|(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.|
|Continuing Review Categories|
(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.
(a) The follow up procedures must be minimal risk for the IRB to approve under this category.
(b) No subjects have been enrolled means since the study was approved as opposed to in the past year. For multi-center research, no subjects have been enrolled means at CHOP.
(c) If the data analysis involves use of a dataset that has been stripped of all personal identifiers, then the study may be closed.
|(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.|
Expanded Categories of Research Eligible for Expedited Review
In addition to the categories listed above, the CHOP IRB can review research that involves the following procedures using expedited procedures provided that the research is not federally funded or subject to FDA regulations. Refer to IRB SOP 401: Expedited Review Procedures for the full text of the IRB's policy and to Appendix B for the expanded list of procedures.
|Expanded Expedited Review Categories||Examples|
|(1) Skin biopsy not requiring suturing||The CHOP IRB considers skin biopsy to be equivalent in risk to venipuncture or iv insertion.|
|(2) Ionizing radiation exposure that does not exceed 1 mSv (100 mrem) per year.||The IRB has guidelines for the level of radiation exposure and risk level on its webpage Risk of Common Procedures.|
|(3) Blood draws via an indwelling catheter, regardless of frequency.||The OHRP and FDA categories do not take into account the impact of minimizing pain and discomfort by drawing blood via an indwelling catheter.|
|(4) Blood sampling (that meets the NIH minimal risk policy) for children or adults||
Children: blood sampling not to exceed 5 mL/kg on a single day or 9.5 mL/kg over the course of 8 weeks
Adults: blood sampling not to exceed 10.5 mL/kg or 550 mL, whichever is less, over the course of 8 weeks
|(5) Additional blood, CSF, or bone marrow at the time of a clinically indicated blood draw|
|(6) Obtaining additional biopsies, other than esophageal biopsies, during the course of a clinically indicated gastrointestinal endoscopy.||
The risk of complications is believed to be higher with esophageal biopsies and very few procedures have been included in the largest series making it hard to assess the actual risk.
|(7) Bronchoalveolar lave in individuals with an existing artificial airway.||This procedure is equivalent to routine saline instillation and suctioning that are a part of usual care for an individual with an artificial airway.|
|(8) Prolongation of clinically indicated sedation or general anesthesia.||Although a single prolongation of sedation/GA is considered to be minimal risk, the IRB may consider repeated procedures (multiple prolongations) to constitute a greater than minimal risk depending on the frequency, the age of the subjects and the general medical condition of the subject population.|