Oakland City University’s
Institutional Review Board
Expedited Review Status Criteria
Federal guidelines identify those research activities
that may qualify for Expedited Review Status (i.e. receive an expedited
review by the IRB and do not require a Full Review by the IRB).
If a proposed research activity meets the applicability requirements
set forth below and falls under one of the expedited review categories
identified below, submit the Universal Research Application as an
Expedited Review Status. The following information on expedited
review applicability requirements and review categories is from
the Federal Register (63 FR 60364-60367, November 9, 1998) is subject
to revision.
Applicability Requirements
1. The research activities present no more than
minimal risk to human subjects and involve only procedures listed
in only one (1) of the expedited review categories listed below.
(Note: The activities and procedures listed in the following expedited
review categories below are NOT to be deemed minimal risk simply
because they are included in the list of categories. Inclusion on
the list merely means that the activity is eligible for review through
the Expedited Review Status when the specific circumstances of the
proposed research activities actually involve no more than minimal
risk to human subjects.)
2. The expedited review categories listed below apply regardless
of age of the subjects.
3. Expedited Review Status may not be utilized for proposed research
activities that may include any classified research involving human
subjects.
4. The standard requirements for informed consent apply to an expedited
review of a proposed research activity applying for approval under
the Expedited Review Status.
5. The expedited review of a proposed research activity 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, employment,
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.
6. All categories listed below (A through G) pertain to initial
and continuing IRB review.
If all the above criteria/conditions are applicable
to the research proposal/activities, then the research proposal/activities
must qualify to be classified in only one (1) of the following research
categories:
Research Categories:
A. Clinical studies of drugs and medical devises only when one of
the following conditions is met:
(1) research on drugs for which an investigational
new drug application (21 CFR 312) is not required, or
(2) research on medical devices for which (a)
an investigational device exemption (21 CFR 812) is not required;
or (b) the medical device is cleared/approved for marketing and
the medical device is being used in accordance to its cleared
and approved labeling.
B. Blood sample collection by utilizing finger stick, heel stick,
ear stick or venipuncture collection methods; provided the blood
samples are taken from:
(1) healthy, non-pregnant adults who weigh at
least 110 pounds, and the amounts drawn on such subjects may not
exceed 550 ml in an 8 week period and collection may not occur
more frequently than 2 times per week; or
(2) other adults and children (anyone under
the age of 19 years) considering 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.
C. Noninvasive collection of biological specimens (i.e. hair and
nail clippings, saliva, sweat,) may be used in a study.
D. 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 medical
devices are not generally eligible for expedited review, including
studies of cleared medical devices for new indications
E. 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) may be used in
research. This listing refers to only items not listed in the exempt
status criterion.
F. Collection of data from voice, video, digital or image recordings
made for research purposes.
G. Research on individual or group characteristics or behavior or
research that uses surveys, interviews, oral histories, program
evaluations, human factor evaluations, or quality assurance methodologies.
(NOTE: Some research in this category may be exempt in accordance
to 45 CFR 46.101(b)(4) and that this listing refers only to research
that is not exempt)
H. Review of continuing research that has been previously been approved
by the
IRB if the research qualifies under one of the following:
(1) the research is closed permanently to new enrollment of subjects,
all subjects have completed all research related interventions,
and the research remains active only for long-term follow-up of
subjects; or
(2) where no new subjects have been enrolled
and no new risks have been added or been identified; or
(3) where the remaining research activities
are limited to data analysis.
I. The research is a continuing review of data collected in the
research study, not conducted under an investigational new drug
application or investigational device exemption where categories
B through H above do not apply, but the IRB has determined and
documented at a meeting of the IRB that the research involves
no greater than minimal risk and no additional risks have been
identified.
IRB
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