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and the recruitment procedures.
Informed consent will be sought and appropriately documented from each
prospective subject or the subject’s legally authorized representative. If a
waiver to obtain, document or alter the requirements of informed consent is
being requested, there is adequate justification to do so.
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When appropriate, the research plan makes adequate provision for monitoring
the data collected to ensure the safety of participants.
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When appropriate, there are adequate provisions to protect the privacy of
participants and to maintain the confidentiality of data.
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When some or all of the participants are likely to be vulnerable to coercion or
undue influence, such as children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons,
additional safeguards have been included in the study to protect the rights and
welfare of these participants.
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IV. EXPEDITED CATEGORIES (Check all that apply)
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EXPEDITED CATEGORY 1: DRUGS OR DEVICES WHICH DO NOT REQUIRE AN IND or IDE
Clinical studies of drugs and medical devices only when:
(a) Research on drugs for which an investigational new drug application (IND; 21CFR312) is not required.
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.
OR
(b) Research on medical devices for which (i) an investigational devices exemption application (IDE) 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.
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EXPEDITED CATEGORY 2: BLOOD SAMPLES
Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows:
(a) 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 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.
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EXPEDITED CATEGORY 3: SPECIMENS (collected prospectively and by non-invasive means)
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.
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EXPEDITED CATEGORY 4: DATA (collected through non-invasive, routine clinical procedures)
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
