NOTIFICATION: Changes to Expedited Approvals and Resubmission Requirements
Expedited Action Decision Tool
Expedited Categories and WVU IRB Requirements
Applies to:
In general, a research protocol may considered expedited if
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The research presents no more than minimal risk to human subjects.
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The research is not classified.
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The research meets the requirements of one of the following expedited categories.
Expedited Category 1
Regulatory Requirements:
Clinical studies of drugs and medical devices only when condition (a) or (b) is met:/p>
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Research on drugs for which an investigational new drug application ( 21 CFR Part 312) is not required.
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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.
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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.
WVU IRB Guidance:
The WVU IRB has determined that any research involving the use of a device, whether FDA approved or not, must be reviewed at a convened full-board IRB meeting.
- Research on medical devices for which:
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An investigational device exemption application ( 21 CFR Part 812) is not required; or
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The medical device is cleared/approved for marketing, and the medical device is being used following its cleared/approved labeling.
Expedited Category 2
Regulatory Requirements:
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
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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 two 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 two times per week.
Expedited Category 3
Regulatory Requirements:
Prospective collection of biological specimens for research purposes by noninvasive means. Examples include:
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Hair and nail clippings in a non-disfiguring manner;
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Deciduous teeth at the time of exfoliation or if routine patient care indicates a need for extraction;
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Permanent teeth if routine patient care indicates a need for extraction;
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Excreta and external secretions (including sweat);
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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;
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Placenta removed at delivery;
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Amniotic fluid obtained at the time of rupture of the membrane before 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 following accepted prophylactic techniques;
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Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
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Sputum collected after saline mist nebulization.
WVU IRB Guidance:
This category includes the prospective collection of specimens by noninvasive methods. This includes methods not involving general anesthesia or sedation. Research involving tissue samples and body fluids requires approval from the WVU Institutional Biosafety Committee (IBC).
Expedited Category 4
Regulatory Requirements:
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 include:
- Physical sensors that are applied either to the surface of the body or at a distance and do not involve the input of significant amounts of energy into the subject or an invasion of the subject’s privacy;
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Weighing or testing sensory acuity; Magnetic resonance imaging;
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Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
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Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
WVU IRB Guidance:
WVU includes physical exercise (i.e.,research from C-PASS) and physical measurements (i.e.,some engineering studies) as Category 4.
Expedited Category 5
Regulatory Requirements:
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).
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.
WVU IRB Guidance:
Often, this category is used for medical record review when the researchers are recording identifiable information (see the Guidance on HIPAA Identifiers and Data Protection). This category can also be used for social and behavioral studies whenever the PI wishes to analyze previously recorded data that are identifiable, such as class grades and assignments.Expedited Category 6
Expedited Category 7
Regulatory Requirements:
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.
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.
WVU IRB Guidance:
Research qualifying for this category of expedited review usually involves intervention with a pre- and post-test instrument (i.e.,survey). Focus groups, surveys, and interviews are also common.
Expedited Category 8
Regulatory Requirements:
Continuing review of research previously approved by the convened IRB as follows: Where:
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The research is permanently closed to the enrollment of new subjects;
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All subjects have completed all research-related interventions; and
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The research remains active only for long-term follow-up of subjects; or
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Where no subjects have been enrolled and no additional risks have been identified; or
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Where the remaining research activities are limited to data analysis.
Expedited Category 9
Regulatory Requirements:
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 more than minimal risk and no additional risks have been identified.
WVU IRB Guidance:
This category applies to protocols that include a device that was initially reviewed by the convened IRB. If the Board determined that the research presented no more than minimal risk, and no additional risks have been identified,the protocol’s continuing review/renewal is eligible to be reviewed under the Expedited process.