Expedited Research Approval Categories
Protocols submitted to the IRB will be reviewed and approved using one or more of
the following categories. The approval notice will show which category and subclass
was used in the approval. Most of MTSU protocols come under the category 7 of the
following list.
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.
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. 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 children2, 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.
3. Prospective collection of biological specimens for research purposes by noninvasive
means.
EXAMPLES:
(a) hair and nail clippings in a non-disfiguring 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
Collection of data through noninvasive procedures that do not require general anesthesia
or sedation. Procedures 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.
5. Research involving materials
Research using 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 media
Collection of data from, not limited to, voice, video, digital, or image recordings
made for research purposes.
7. Research on individual or group characteristics or behavior
Interventions or measurement practices that includes, 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.)
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;
(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.
9 Continuing review of research of non-traditional IND/ID
Continuing review of research not conducted under an investigational new drug (IND)
application or investigational device (ID) exemption where the expedited categories
two (2) through eight (8) listed above 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.
__________________________________________________________________________________________
1 An expedited review procedure consists of a review of research involving human subjects
by the IRB chairperson or by one or more experienced reviewers designated by the chairperson
from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
2 Children are defined in the HHS 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." 45 CFR 46.402(a).
Source: 63 FR 60364-60367, November 9, 1998.