Approval
Types - Definitions
In an attempt
to help you navigate through the regulatory process, the IRB office
has assembled this list of our “approval types” and their
definitions. If you have any questions about this list, or any
suggestions for additions, please call our office (885-8240).
New
Human Subject Research Proposals that may be Expedited:
The MMC
IRB may review certain human subject’s research using an expedited
review procedure, if it meets the requirements of the federal regulations. This
document is divided into the following sections:
- From
45 CFR 46.110 (these regulations are mirrored in 21 CFR 56.110)
Definition:
An IRB may use the expedited review procedure to review some or all
of the research appearing on the list (below) if it is found by the
reviewer(s) to involve no more than minimal risk.
Please note:
1) The
activities listed should not be deemed to be of minimal risk simply
because they are included on this list. Inclusion on this list merely
means that the activity is eligible for review through the expedited
review procedure when the specific circumstances of the proposed research
involve no more than minimal risk to human subjects.
2) The
categories in this list apply regardless of the age of subjects, except
as noted.
3) 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.
4) The
expedited review procedure may not be used for classified research
involving human subjects.
5) Investigators
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.
Research
Categories
(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 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. 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 subjects 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.)
New
Human Subjects Proposals that may be Exempt from IRB Review:
All human
subject research is subject to federal regulations, with a few exceptions. These
exceptions may be granted an “exemption” from IRB review. The
following is a list of the most common categories of research that
are considered exempt. Please keep in mind that only the IRB
may grant an exemption, the investigator must go to the IRB to receive
an exemption.
1) Research
conducted in established or commonly accepted educational settings,
involving normal education practices. This category may include
children
2) Research
involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement) for which subjects cannot be identified,
or release of the information would not be harmful to the subject. This
category may include children
3) Research
involving the use of survey procedures or interview procedures or observation
of public behavior for which subjects cannot be identified,
OR release of the information would not be harmful to the subject. This
category may not include children. If subjects are 18 years of
age or younger parental consent is required. Research may be
reviewed by expedited procedures – do not use this form.
4) Research
involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if these
sources are publicly available OR if the information is recorded by
the Investigator in such a manner that subjects cannot be identified,
directly or through identifiers linked to the subjects
5) Unidentifiable
human body parts, sections or samples obtained from a morgue
New
Human Subject Research Proposals that may not be reviewed via an
expedited procedure, and are not exempt:
If your
new, human research proposal does not fit the definition of what may
be reviewed via an expedited procedure, and it is not exempt from IRB
regulations, it must be reviewed by the fully convened committee (i.e.
at an IRB meeting). Typically these protocols involve novel medications
or devices, which are under the Food and Drug Administration’s
(FDA’s) jurisdiction (i.e. are under IND or IDE, or are not approved
for marketing). Some other protocols, in which the risk is perceived
to be “more than minimal” will also be reviewed by the
fully convened committee. The fully convened committee must also
review humanitarian Use Devices (HUD or HDE’s).
If you
have any questions about the type of review your new, human subject
research project may need, please contact our office (885-8240). Kristen
Sullivan is the IRB coordinator.
