IRB
Categories of Review
Under federal regulations, there
are three possible IRB review categories:
-
Exempt
-
Expedited
-
Full Board
The IRB
Administrator, IRB Chair, or the convened IRB, acting in accordance with federal
regulations, not the investigator, determines if an application meets the
criteria for each approval category.
The IRB does
not review research enrolling prisoners, therefore the three research categories
do not apply to prisoners.
Exempt Review
The
IRB uses the following criteria for reviewing and granting research under the
exempt category (as stated in 45 CFR 46.101(b) and 21 CFR 56.104):
-
Research conducted in established or
commonly accepted educational settings, involving normal educational
practices, such as (i) research on regular and special education instructional
strategies, or (ii) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods.
This category may not be applied to FDA regulated clinical
investigations.
-
Research involving the use of
educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can
be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects’ responses outside the research
could reasonably place the subjects at risk of criminal or civil liability or
be damaging to the subjects’ financial standing, employability, or
reputation. If the research includes children as participants, this
category is limited to educational tests and observations of public behavior
when the investigator(s) do not participate in the activities being
observed. This category may not be applied to FDA regulated clinical
investigations.
-
Research involving the use of
educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior that is
not exempt under item 2 of this section, if: (i) the human subjects are
elected or appointed public officials or candidates for public office; or (ii)
Federal statute(s) require(s) without exception that the confidentiality of
the personally identifiable information will be maintained throughout the
research and thereafter. This category may not be applied to FDA
regulated clinical investigations.
-
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. The reviewed materials must already exist at the time the
research is proposed and must not be prospectively collected. This
category may not be applied to FDA regulated clinical investigations.
-
Research
and demonstration projects which are conducted by or subject to the approval of
Department of Agency heads, and which are designed to study, evaluate, or
otherwise examine: (i) public
benefit or service programs; (ii) procedures for obtaining benefits or services
under those programs; (iii) possible changes in or alternatives to those
programs or procedures; or (iv) possible changes in methods or levels of payment
for benefits or services under those programs. The program under study must deliver a
public benefit (e.g., financial or medical benefits as provided under the Social
Security Act) or a service (e.g., social, supportive, or nutrition services as
provided under the Older Americans Act).
The research or demonstration project must be conducted pursuant to
specific federal statutory authority.
There must be no statutory requirement that the project be reviewed by an
IRB. The project must not involve
significant physical invasions or intrusions upon the privacy of
participants. This category
may not be applied to FDA regulated clinical investigations. Before granting this exemption, the IRB
Administrator or IRB Chair must communicate with OHRP to confirm that OHRP
agrees that this exemption category may be applied to the proposed
research.
-
Taste and food quality evaluation
and consumer acceptance studies, (i) if wholesome foods without additives are
consumed or (ii) if a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural chemical or
environmental contaminant at or below the level found to be safe, by the Food
and Drug Administration or approved by the Environmental Protection Agency or
the Food Safety and Inspection Service of the U.S. Department of
Agriculture.
Research
that meets the criteria for exemption may be referred for further review or
disqualified from exempt status if the IRB Chair determines at the time of
initial review that the research does not uphold SFHMC ethical standards and/or
there are concerns or issues with the protocol not related to the regulatory
requirements. Such protocols will
be reviewed by expedited or full board review, as determined by the IRB
Chair. If there is a question about
the potential for harm of participants in research exempt from federal
regulations, that research will not be granted exempt status, and will be
reviewed, approved and monitored by the IRB in a manner appropriate to ensure
the safety of the participants.
Expedited Review
The IRB uses
the following criteria for reviewing and approving research by the expedited
review category (as stated in 45 CFR 46.110 and 21 CFR 56.110):
Applicability
(A) Research activities that
-
Present no more than minimal risk to human subjects
-
Involve only procedures listed in one or more of the
following categories. 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.
(B) The categories in this
list apply regardless of the age of subjects, except as noted.
(C) 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.
(D) The expedited review
procedure may not be used for classified research involving human subjects.
(E) IRBs 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.
(F) Categories one (1)
through seven (7) pertain to both initial and continuing IRB review.
Research
Categories
-
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 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 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. -
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
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. -
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; excreta and external secretions (including
sweat);
(d) gum base or wax or by
applying a dilute citric solution to the tongue;
(e)
placenta removed at delivery;
(f) the time of rupture of the membrane prior
to or during labor;
(g)
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;
(h)
mucosal and skin cells collected by buccal scraping or swab, skin
swab, or mouth washings;
(i) sputum collected after
saline mist nebulization -
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 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;uncannulated saliva collected in an
unstimulated fashion or stimulated by chewing moderate exercise, muscular
strength testing, body composition assessment, and flexibility testing where
appropriate given the age, weight, and health of the individual.
-
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 DHHS regulations for the protection of human subjects [45 CFR
46.101(b)(4)]. This listing refers only to research that is not
exempt.)
-
Collection of data from voice, video,
digital, or image recordings made for research purposes.
-
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 DHHS 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.)
-
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; and (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.
-
Continuing review of research, not
conducted under an investigational new drug application or investigational
device exemption where categories 2 through 8 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
-
Minor changes in previously approved
research.
-
Other
categories added to this list by DHHS and published in the Federal Register
The Chairman
of the IRB reviews protocols qualifying for expedited approval. If the Chairman is unavailable to review
a protocol qualifying for expedited and exempt approval, a qualified member of
the IRB with expertise in the area of the study will be designated by the
Chairman of the IRB as a primary reviewer.
Studies involving vulnerable populations, such as children, that are
eligible for expedited or exempt approval will be reviewed by the Chairman of
the IRB. If there is a question
whether one of these protocols poses a greater than minimal risk, the study will
be reviewed by a consultant with expertise in that area. If there is a question
whether additional state or local laws are applicable to the protocol,
the IRB Chairman or qualified member of the IRB may ask Legal Services for
assistance in interpreting and applying appropriate laws.
Full Board Review
All research
protocols that do not meet the criteria for exempt or expedited review approval
will be reviewed by the full board at a convened IRB meeting. All decisions are rendered by a quorum
(majority of the assembled).
The IRB
Chair reviews or assigns a primary reviewer to assess each protocol to ensure
appropriate and complete review of submissions. A summary of
findings is presented by the IRB Chair or primary reviewer to the full board
at fully convened meetings. Investigators and study coordinators are
invited and encouraged to attend meetings at which their research protocol
will be presented in order to provide responses to questions that may arise
during the protocol’s review and discussion.
|