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CONTINUINGREVIEWEXPEDITEDCHECKLIST IRB COMMITTEE

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Page 1 of 4 November 19, 2012
Institutional Review Board
Office of Research Compliance
Continuing Review Checklist
V.1
CONTINUING REVIEW EXPEDITED CHECKLIST
Directions: The purpose of this checklist is to provide documentation of determining whether a project meets the
criteria for expedited review of certain kinds of research involving no more than minimal risk to human subjects and
one or more procedures listed in categories 1- 9 below. Please contact the IRB staff if you are unable to review this
study or have a conflict of interest related to this research or review.
I. GENERAL
Project Title:
Principal Investigator:
MU IRB#: HR-
Reviewer:
Review Date:
II. EXCLUSIONS: All must be “No”.
1.
Does the study involve an investigational drug or medical
device?
☐
YES
☐
☐
NA
2.
Do the study activities present more than minimal risk?
A risk is minimal where the probability and magnitude of
harm or discomfort anticipated in the proposed research
are not greater, in and of themselves, than those
ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests [45 CFR 46.102(i)]. For example, the
risk of drawing a small amount of blood from a healthy
individual for research purposes is no greater than the risk
of doing so as part of routine physical examination.
☐
YES
☐
☐
NA
3.
Could identification of the subjects and/or their
responses reasonably place them at risk of criminal or
civil liability or be damaging to the subjects’ financial
standing, employability, insurability, reputation, or be
stigmatizing? (The answer is No if there are reasonable
and appropriate protections implemented so that risks
related to invasion of privacy and breach of
confidentiality are no greater than minimal.)
☐
YES
☐
☐
NA
III. REVIEW CRITERIA:
1.
Risks to participants are minimized by using procedures
which are consistent with sound research design and do
not unnecessarily expose participants to risk.
☐
YES
☐
☐
NA
2.
Risks to participants are minimized whenever
appropriate, by using procedures already being
performed on the participants for diagnostic or treatment
purposes.
☐
YES
☐
☐
NA
Page 2 of 4 November 19, 2012
3.
Risks to participants are reasonable in relation to
anticipated benefits, if any, to participants, and the
importance of the knowledge that may reasonably be
expected to result.
☐
YES
☐
☐
NA
4.
Selection of participants is equitable taking into account
the purposes of the research, the setting in which the
research will be conducted, the special problems of
research involving vulnerable populations, the selection
criteria and the recruitment procedures.
☐
YES
☐
☐
NA
5.
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.
☐
YES
☐
☐
NA
6.
When appropriate, the research plan makes adequate
provision for monitoring the data collected to ensure the
safety of participants.
☐
YES
☐
☐
NA
7.
When appropriate, there are adequate provisions to
protect the privacy of participants and to maintain the
confidentiality of data.
☐
YES
☐
☐
NA
8.
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.
☐
YES
☐
☐
NA
IV. EXPEDITED CATEGORIES (FOR INTIAL AND CONTINUING REVIEW) Check all that apply
A.
☐
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.
B.
☐
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.
C.
☐
EXPEDITED CATEGORY 3: SPECIMENS (COLLECTED PROSPECTIVELY AND BY NON-INVASIVE MEANS)
Page 3 of 4 November 19, 2012
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.
D.
☐
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
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.)
E.
☐
EXPEDITED CATEGORY 5: MATERIALS (COLLECTED RETROSPECTIVELY OR PROSPECTIVELY, DEPENDING ON
CIRCUMSTANCE)
Research involving materials (data, documents, records or specimens) that have been collected, or will be
collected solely for non-research purposed (such as medical treatment diagnosis). This category includes
research involving materials (data, documents, records, or specimens) that (a) will be prospectively collected
solely for non-research purposes such as medical treatment or diagnosis, OR (b) have already been collected
for either non-research or research purposes, provided the materials were not collected for the currently
proposed research.
F.
☐
EXPEDITED CATEGORY 6: VOICES, VIDEO, DIGITAL OR IMAGE RECORDINGS
Collection of data from voices, video, digital or image recordings made for research purposes.
G.
☐
EXPEDITED CATEGORY 7: INDIVIDUAL OR GROUP CHARACTERISTICS OR BEHAVIOR; SURVEYS, INTERVIEWS,
ETC.
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.
H. ☐
EXPEDITED CATEGORY 8: CONTINUING REVIEW OF RESEARCH PREVIOUSLY APPROVED BY THE CONVENED
IRB
Continuing review of research previously reviewed and approved by the convened IRB as follows:
(a) (i) The research at this site is permanently closed to the enrollment of new subjects; and
(ii) All subjects at this site have completed all research-related interventions; and
(iii) The research at this site remains active only for long-term follow-up of subjects; or
(b) No subjects have been enrolled at this site and no additional risks have been identified anywhere; or
(c) The remaining research activities at this site are limited to data analysis.
I. ☐
EXPEDITED CATEGORY 9: CONTINUING REVIEW OF PREVIOUSLY APPROVED RESEARCH NOT CONDUCTED
UNDER AN IND OR IDE
Continuing review of research previously reviewed and approved by the IRB as follows:
(a) The research is not conducted under an investigational new drug application (IND) or
investigational device exemption (IDE); and
(b) The IRB has determined and documented at a convened meeting that the research involves no
greater than minimal risk; and
(c) No additional risks have been identified since IRB review at a convened meeting.
V. DETERMINATION
Page 4 of 4 November 19, 2012
☐
Approve with no changes or stipulations
☐
Disapprove (recommend for Full Board)
☐
Approve with the following changes or stipulations:
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Completed 11 February 2020

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