Download IRB Levels of Review

Appendix A
Levels of IRB Review
I.
Exempt Review.
Some research activities involving little or no risk to human subjects may qualify for exempt status
under federal regulations for the protection of human subjects. Federal guidelines require that an
institutional officer other than the investigator determine the eligibility of studies for exempt status.
A.
Activities that qualify for exempt status:
1.
Activity does not constitute research: According to 45CFR46.102(d),
research is defined as “a systematic investigation…designed to develop or
contribute to generalizable knowledge”. Systematic investigation used for
internal program evaluation or quality assurance does not constitute “research”
under this definition, because it is intended only to evaluate a particular
program.
2.
Activity does not involve human subjects: Investigations may constitute
research, but qualify for exemption because they fail to involve human subjects
as defined in the federal regulations at 45CFR46.102(f). This section defines a
human subject as a “living individual about whom data are gathered for
research purposes”. Research involving dead individuals is exempt from IRB
oversight. The definition of human subject does not apply when data does not
contain “private identifiable information” or individual identity of persons cannot
be “readily ascertained” by the investigator. Although there is some confusion
about the meaning of “readily ascertained”, it is generally agreed that it applies
to data that comes to the investigator in genuinely anonymous form, i.e., when
no remaining linkage can be made between the data and the individual identity
of the persons whose data is used.
3.
Activity qualifies as existing records, survey research without risk: Under
section 45CFR46.101(b) of the federal regulations, studies using existing
records, data or specimens where data used are already in existence at the
time that the study is initiated. In addition, the information collected must be
“recorded by the investigator in such a manner that the subjects cannot be
identified, directly or through identifiers linked to the subjects”. According to this
regulation, records research is exempt provided that the investigator records
the data on worksheets in such a fashion that the information can no longer be
linked to identifiable individuals, even if the records form which the information
is drawn contain individual subject identifiers.
4.
Another category of exempt research frequently undertaken involves interview
or survey procedures. The federal regulations exempt such studies unless they
involve recording the individual identity of subjects and the information
gathered might, if publicly disclosed, place subjects at risk of criminal or civil
liability or be damaging to their financial standing, employability, or reputation.
Even if the subjects’ names were collected on the survey instrument, the study
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would remain exempt if nothing disclosed in the answers would place them at
risk of harm.
II.
Expedited Review.
A.
Expedited review is permitted when:
1.
The research involves no more than minimal risk and appears on the list of
categories of research eligible for expedited review.
2.
The proposal involves only minor changes in previously approved research.
Expedited review will be conducted by the IRB Chair or, in his/her absence, a
designee. Upon issuance of an approval by the Chair or designees, the project
may be initiated; however, the protocol must be reviewed by the full IRB at its
next regularly scheduled meeting. In the event the IRB requires modification or
revision in a protocol at that time, the approval will be rescinded temporarily and
the investigator shall cease to work on that portion of the project involving him
and subjects. The approval may be reinstated upon the investigator’s
satisfactory compliance with IRB’s modification requests. Expedited review
procedures may not be used to disapprove the proposed research. A research
activity may be disapproved only after a non-expedited review.
B.
Categories eligible for expedited review include:
1.
Collection of hair and nail clippings in a non-disfiguring manner, deciduous
teeth or permanent teeth.
2.
Collection of excreta and internal secretions, including sweat, saliva, placenta
removed at delivery and amniotic fluid at the time of rupture of the membrane
prior to or during labor.
3.
Recording of data from subjects, eighteen (18) years of age or older, using noninvasive procedures routinely employed in clinical practice; including the use of
Physical sensors applied to the body that do not involve the input of matter or
significant amounts of energy or invasion of the subject’s privacy, weighing,
testing sensory acuity, electrocardiography, electroencephalography, detection
of naturally occurring radioactivity, diagnostic echography and
electroretinography; but does not include exposure to MRI and x-rays.
4.
Collection of blood samples by venipuncture in amounts not exceeding 450 ml
in an eight (8) week period and no more than two (2) times per week from
subjects eighteen (18) years of age or older who are in good health and not
pregnant.
5.
Collection of both supra- and subgingival dental plaque and calculus.
6.
Voice recordings made for research purposes.
7.
Moderate exercise by healthy volunteers.
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8.
A study of existing data, documents, records, pathologic specimens or
diagnostic specimens.
9.
Research on individual or group behavior or characteristics of individuals, such
as studies of perception, cognition, gain theory or test development where the
investigator does not manipulate the subject’s behavior and the research will
not involve stress to the subjects.
10.
Research on drugs or devices for which an investigational new drug exemption
or investigational device exemption is not required.
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