Type of Research Review - Policy Statement Part Two
Determining the Type of Research Review
The type of review that a research project undergoes is determined
by the level of risks to the participants and the types of participants
involved in the research. There are three types of initial reviews
for research, exempt, expedited, and full. The researcher must
evaluate risk and type of participants to determine which type of
review may be appropriate for the project. If the risk and participant
type is appropriate for exempt or expedited review, the researcher
must determine if the research falls in one of the categories under
that type of review. Most of the research conducted at MSSU is expected
to fall in the exempt or expedited categories. Approval of research
under these policies is for a one year period, unless the IRB determines
the risk is sufficiently high to require more frequent review. Any
research project that lasts for more than one year must petition
the IRB for continuing approval.
Level of Risk
Researchers should make every effort to minimize the amount of
risk involved in the research design. The IRB will evaluate
the risk and determine if the risks are reasonable in relationship
to the anticipated benefits of the research to the subjects,
if any, or the knowledge that may reasonably be expected to result.
 Less-than-minimal-risk - is research in which there is no known physical, emotional, psychological,
or economic risk. This research can qualify as exempt if it does
not involve a vulnerable population and falls in an exempt category.
- Minimal-risk
- is research that presents only the kind of risks encountered
in daily life by most people (e.g., moderate exercise testing, minor
stress from psychological tests, or surveys involving sensitive topics).
This research can qualify as expedited if it does not involve a vulnerable
population and falls in an expedited category.
- Greater-than-minimal-risk
- is research procedures that may include
risk beyond that ordinarily encountered by subjects (e.g.,
maximal exercise testing, stressful psychological testing, questions
about illegal activities). This type of research requires a full
review.
Type of Participants
Vulnerable populations require a higher level of protection,
thus a higher level of scrutiny for the research procedures.
Prisoners, mentally disabled persons, and children are considered
vulnerable because their ability to give truly voluntary and
informed consent may be limited. Pregnant women are considered
vulnerable in the case of research procedures that pose any
hazard to the fetus. Research considered to be less-than-minimal-risk
for nonvulnerable adults is considered as minimal-risk for
vulnerable populations, thus only research on nonvulnerable
adults qualifies for the exempt category.
Qualifications for Exempt Status
Exempt review is used for studies presenting less than minimal
risk to nonvulnerable subjects.
Even research that you believe to be exempt must be reviewed
under the exempt process to assure that it really is exempt from
further review. The categories of research that qualify for exempt
review are listed below. Note that even if research falls into
one of the general categories that is normally exempt, it is
not exempt if it involves sensitive topics (e.g., recreational
drug use, sexual practices, use of alcohol by minors, criminal
behavior) or vulnerable participants (e.g., children, victims,
persons with mental retardation). Exempt protocols are reviewed
by a Departmental Review Panel or reviewer selected by the IRB
manager (see the section on Research Review Procedures). The
researcher must not begin contacting research participants or
collecting data until written approval is received from the IRB.
This usually requires three working days for processing after
the exempt projects are submitted.
Research activities in which the only involvement of human subjects
is in one or more of the following categories qualify for review
under the exempt category:
- Research conducted in established or commonly
accepted educational settings, involving normal educational practices,
such as (a) research on regular and special education instructional
strategies, or (b) research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom management
methods.
- Research involving the use of educational
tests (e.g., cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior,
unless: (a) data obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked
to the subjects; and (b) any disclosure of the human subjects'
responses outside the research could reasonably place the participants
at risk of criminal or civil liability or be damaging to the
participants' financial standing, employability, or reputation.
Note: When videotaping and/or photography
is used for data collection, the research no longer meets the
exempt requirements. This is because information is recorded
in such a manner that participants can be identified. Audio
taping may fit under this same category, depending upon how the
recording is made and its intended use. If the recording is to
facilitate accurate record keeping and will be erased following
transcription, it may go in the exempt category. If it is to be
used for purposes that would make the recording part of the reporting
process it would not be exempt.
- 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 category (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.
- Research involving the collection
or study of existing information, 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.
- Research and demonstration projects
that are conducted by or subject to the approval of supporting
agencies, and which are designed to study, evaluate, or otherwise
examine: (a) public benefit or service programs; (b) procedures
for obtaining benefits or services under those programs; (c)
possible changes in or alternatives to those programs or procedures;
or (d) possible changes in methods or levels of payment for
benefits or services under those programs.
- Taste and food quality evaluation and consumer
acceptance studies, (a) if wholesome foods without additives
are consumed or( b) 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 and approved by the Environmental Protection
Agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture.
Qualifications for Expedited Status
Expedited reviews are used for research
presenting minimal risk to nonvulnerable participants or less-than-minimal
risk to vulnerable participants.
Expedited reviews do not require a convened meeting of the IRB.
Two reviewers, one from the Departmental Review Panel and one
IRB member outside the department review the protocol. The reviewers
will send the completed review to the IRB manager, who will notify
the principal investigator or supervisor of the results of the
review. This may require up to one week for review after it is
received by the IRB.
Research involving no more than minimal risk and in which the
involvement of (nonvulnerable) participants is in one or more
of the following categories may be reviewed through the expedited
review procedure. The categories in this list are exempt regardless
of the age of the subject, except as noted.
- 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. 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 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. This listing refers only to research that is
not exempt.)
- 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;
(e) moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given
the age, weight, and health of the individual.
- 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.
- 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.
- 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 Part 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 Part 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.
- 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.
Qualifications for Full Review
Any research that does not meet the qualifications listed under
exempt or expedited review will be reviewed by the IRB at a regular
meeting.
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