Research is reviewed by the CPHS at convened meetings unless it is “minimal risk” and qualifies for “expedited” review. Minimal risk, according to 45 CFR 46.102 (i), means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
An expedited review procedure consists of a review of research involving human participants by the CPHS Executive Chairperson, Panel Chairperson, or by one or more experienced CPHS members (Reviewer) designated by the Executive Chairperson from among the members of the CPHS
To qualify for expedited review, research must meet all of the following criteria:
1. The research presents no more than minimal risk to human participants. These risks include the probability and severity of possible harm to the subjects’ physical, psychological, social, legal or economic welfare.
2. Identification of the participants and/or their responses does not reasonably place them at risk of criminal or civil liability or be damaging to the participants 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.
3. The research is not classified,
In addition to the above criteria, research eligible for expedited review must involve procedures listed in one or more of the following categories.
Category 1: Clinical studies of drugs and medical devices only when condition (1) or (2) is met.
1. Research on drugs for which an investigational new drug application is not required. (Note: research on marketed drugs that significantly increase 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;
- An investigational device exemption application is not required; or
- 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:
1. From healthy, non-pregnant adults who weigh at least 50 kg. For these participants, the amounts drawn may not exceed 1 pint or 500 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 participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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. Examples include:
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 stimulated 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 sub-gingival 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;
9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
10. 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).
- 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 participant or an invasion of the participant’s privacy.
- Weighing or testing sensory acuity.
- Magnetic resonance imaging.
- Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography.
- 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).
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 groups, program evaluation, or quality assurance methodologies.
Expedited Continuting Review Status
Continuing review of research may undergo expedited review if it meets the following criteria:
- The research is not classified and
- Category 1-7 as defined above still apply; or
- Category 8a
The research is permanently closed to the enrollment of new participants.
• All participants have completed all research-related interventions; and
• the research remains active only for long-term follow-up of participants; or
- Category 8b:
• No participants have been enrolled (at this site)
• No additional risks have been identified (neither the investigator nor the CPHS at this site has identified any additional risks from any site or other relevant source)
• The remaining research activities are limited to data analysis; or
- Category 9:
• The research is not conducted under an investigational new drug application or investigational device exemption.
• Categories two (2) through eight (8) do not apply, but the CPHS has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
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