SONOMA
STATE UNIVERSITY—INSTITUTIONAL REVIEW BOARD FOR THE RIGHTS OF HUMAN
SUBJECTS
|
Note to
Investigators: Federal regulations governing the
protection of human research subjects contain exemptions for broad categories
of research which involve little or no risk to subjects (see A below), and
provide expedited review of research activities involving no more than
minimal risk and in which the only involvement of human subjects will be one
or more of ten specified categories (see B on reverse side). Sonoma State University’s
Institutional Review Board (IRB) follows the procedures set forth in these
regulations. Please review
the research activities described in this appendix. If your project fits one of the categories, indicate your
claim for exemption from review or claim for expedited review in the first
box on page two of the application form (e.g., Exemption A-3; Expedited
Review B-9). If your
project does not appear to fit any of the categories, indicate N/A in that
box. In such cases, the IRB’s
decision regarding approval of your application will be stated in the
“Comments” section at the bottom of page two. A copy of the form, duly signed and dated, is your
approval to proceed with the proposed research. |
A.
Exemption
Categories [45 CFR 46.101(b)]
Research activities in
which the only involvement of human subjects will be in one or more of the
following categories: 1.
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. 2.
Research
involving survey or interview procedures, except where all of the following
conditions exist: (i) responses are recorded in such a manner that the human
subjects can be identified, directly or through identifiers linked to the
subjects; (ii) the subject’s responses, if they became known outside the
research, could reasonably place the subject at risk of criminal or civil
liability or be damaging to the subject’s financial standing or
employability; and (iii) the research deals with sensitive aspects of the
subject’s own behavior, such as illegal conduct, drug use, sexual behavior,
or the use of alcohol. All
research involving survey or interview procedures is exempt, without
exception, when respondents are elected or appointed officials or candidates
for public office. 3.
Research
involving the observation (including observation by participants) of public
behavior, except where all of the following conditions exist: (i)
observations are recorded in such a manner that the human subjects can be
identified, directly or through identifiers linked to the subjects; (ii) the
observations recorded about the individual, if they became known outside the
research, could reasonably place the subject at risk of criminal or civil
liability or be damaging to the subject’s financial standing or
employability; and (iii) the research deals with sensitive aspects of the
subject’s own behavior such as illegal conduct, drug use, sexual behavior, or
use of alcohol. 4.
Research
involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), if information taken from these sources is recorded in such a
manner that subjects cannot be identified, directly or through identifiers
linked to the subjects. 5.
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. |
B. Research Activities Which May Be
Reviewed Through Expedited Review Procedures
Research activities
involving no more than minimal risk and in which the only involvement of
human subjects will be in one or more of the following categories (carried
out through standard methods) may be reviewed by the IRB through the
expedited review procedure authorized in 46.110 or 45 CRF, Part 46. 1.
Collection
of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and
permanent teeth if patient care indicated a need for extraction. 2.
Collection
of excreta and external excretions including sweat, uncannulated saliva,
placenta removed at delivery, and amniotic fluid at the time of rupture of
membrane prior to or during labor. 3.
Recording
of data from subjects 18 years of age or older using noninvasive procedures
routinely employed in clinical practice. This includes the use of physical sensors that are applied
either to the surface of the body or at a distance, and do not involve input
of matter or significant amounts of energy into the subject or an invasion of
the subject’s privacy. It also
includes such procedures as weighing, testing sensory acuity,
electrocardiography, electroencephalography, thermography, detection of
naturally occurring radioactivity, diagnostic echography, and
electroetinography. It does not
include exposure to electromagnetic radiation outside the visible range (for
example, x-rays, microwaves). 4.
Collection
of blood samples by venipuncture, in amounts not exceeding 450 milliliters in
an eight-week period and no more often than two times per week, from subjects
18 years of age or older and who are in good health and not pregnant. 5.
Collection
of both supra- and sub-gingival dental plaque and calculus, provided the
procedure is not more invasive than routine prophylactic scaling of the teeth
and the process is accomplished in accordance with accepted prophylactic
techniques. 6.
Voice
recordings made for research purposes such as investigations of speech
defects. 7.
Moderate
exercise by healthy volunteers. 8.
The study
of existing data, documents, records, pathological specimens, or diagnostic
specimens. 9.
Research
on individual or group behavior or characteristics of individuals, such as
studies of perception, cognition, game theory, or test development, where the
investigator does not manipulate subject’s behavior and the research will not
involve stress to subjects. 10. Research on drugs or devices for which
an investigational new drug exemption or an investigation device exemption is
not required. |