Categories of IRB Review--Quick Reference
EXEMPT RESEARCH - Constitutes no more than minimal risk AND only involves human subjects in one or more of the following categories:
1. Research conducted in established
educational settings, involving normal educational practices, such as:
(i) research on education instructional strategies or (ii) research
on the effectiveness of or comparison among instruction techniques,
curricula, or classroom management methods.
2. Research involving the use of
(a) educational tests (cognitive, diagnostic, aptitude, achievement);
(b) surveys, interviews, or observation of public behavior* UNLESS (i)
information is recorded with identifiers linked to subjects and (ii)
subjects' responses could place subjects at risk (e.g., criminal or
civil liability, financial standing, employability or reputation).
*No exemptions are allowed under (b) when children are involved in survey/interview
procedures, or observations when investigator participates in activities
being observed.
3. Research involving educational
tests, surveys, interviews, or observation of pubic behavior is exempt
if: (I) the subjects are elected or appointed public officials or candidates
for public office; or (ii) federal statute requires confidentiality
of identifiable information to be maintained permanently.
4. Research involving the
collection or study of existing data, document, or records. Sources
must either be publicly available or information must be recorded without
identifiers linked to subjects.
5. Research conducted by or subject
to the approval of federal department or agency heads and designated
to evaluate possible changes in or alternatives to those programs or
changes in methods of payment for benefits under those programs.
6. Taste or food quality evaluation
involving wholesome/safe foods.
Note: Federal regulations indicate that certain research is exempt from
review. However, under Teachers College's Policy for the Protection
of Human Subjects, a research protocol proposing the use of human subjects
must be submitted to the IRB to determine if it qualifies for exempt
status. Exemptions do not apply to research conducted on pregnant women,
prisoners, or vulnerable populations.
EXPEDITED RESEARCH-- Constitutes
no more than minimal risk AND only involves human subjects in one or
more of the following categories:
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 subjects 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; 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.
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.
Note: Expedited review categories 1-3 apply to biomedical research not typically conducted at Teachers College, and consequently do not appear on this list.
STANDARD REVIEW OF RESEARCH:
If your project does not precisely fit under any of the categories under either the EXEMPT or EXPEDITED review sections listed above, then it must be submitted under STANDARD review procedures. Standard Review is used for all projects involving vulnerable populations, except some minimal risk research involving children. Research involving deception and any research that entails more than minimal risk to the subject, even if it otherwise appears to fall into one of the exempt or expedited categories, must be submitted under standard review procedures.