The following page was extracted by Albert Schorsch, Associate Dean of UIC College of Urban Planning & Public Affairs (CUPPA) from federal regulations, as an aid to CUPPA faculty in their preparation of IRB forms. It is not definitive, but simply an aid to the selection of the correct IRB form. The following are subject to decisions and revisions of IRB committees, and of the HHS Department.
WHICH IRB FORMS SHOULD I USE?
Is my project IRB exempt or expedited?
If your project meets one of the following criteria, you should use the "exempt" forms:
(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.
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(3) 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 paragraph (b)(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.
(4) 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.
(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food isconsumed 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 or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
If you have further questions about the Exempt categories, first go to "Exempt" regulations, then contact the designated person in the Dean's office.
If your project does not meet the "Exempt" conditions above, then Examine the "Expedited" categories below--
If your project meets one of the following criteria, you should use the "expedited" forms:
(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
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.
(2) 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
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 children2, considering the age, weight, and health
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.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous
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.
(4) 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.
(5) 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 from the HHS regulations for the protection
of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) 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 from the HHS regulations for the protection of human subjects. 45
CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
(8) 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;
(b) where no subjects have been enrolled and no additional risks have been identified;
(c) where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under
an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do not apply but the IRB
has determined and documented at a convened meeting that the research involves no greater than
minimal risk and no additional risks have been identified.
If you have further questions about the Expedited categories, first go to "Expedited" regulations, then contact the designated IRB liaison in the Dean's office.
If your research project meets none of the conditions
above, you should submit your project for "full" IRB review.