Exempt from review
Research that poses minimal risk to participants and falls into one of several specific categories of research identified as exempt in the federal regulations (see below). Once a departmental representative has confirmed that the level of risk and category requirements are met, the project is exempt from further review.
If any ONE of the following apply, your research is exempt from further review. This status needs to be recorded by the departmental reviewer so that the College has a record of it. Data collection may not begin until the departmental reviewer has notified you that the research has been deemed exempt.
The research is conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on instructional techniques, curricula, or classroom management methods).
The research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (1) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (2) 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.
(In other words, anonymity is required for exemption ONLY if disclosure outside the research "could reasonably place the subjects at risk." Conversely, in this context, anonymity satisfies the criterion for exemption even if disclosure outside the research could reasonably place the subjects at risk. [§46.101.B2])
The research involves public officials, either elected or appointed, or candidates for public office, using survey procedures, interview procedures or observation of public behavior. This includes research that is not anonymous and that involves sensitive questions.
The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available OR the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, either directly, or through identifiers linked to the subject).
The research (including demonstration projects) is conducted by, or subject to, the approval of federal department or agency heads, and designed to study, evaluate, or otherwise examine (i) public benefit or service programs (e.g., social security, welfare, etc.); (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.
The research involves taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives, or foods which contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Note: Research on vulnerable populations including pregnant women, children, prisoners, and others not in a position to give informed consent, may not be exempt. Consult with your departmental reviewer for guidance in specific cases.
Research which is not exempt, but poses minimal risk to participants is eligible for expedited review. Research submitted by the departmental reviewer or IRB chair for expedited review will be examined by two members of the IRB as assigned by the chair. Those two reviewers can either approve the research or, if one or both chooses, can forward the proposal to the full board for review. They cannot disapprove the research in expedited review.
Projects eligible for expedited review include:
The research involves non-public materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes.
[NB: These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or-video-tapes, names will be recorded, even if they are not directly associated with the data).]
The research involves the collection of data through use of non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, but not procedures involving x-rays or microwaves.
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 echocardiograph; e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate consideration is given to the age, weight, and health of the individual.
The research involves the collection of data from voice, video, digital or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability or reputation.
The research involves the collection of data on individual or group characteristics or behavior (including, but not limited to, research involving perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing surveys, interview, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
The research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
[NB: Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).]
The research involves the prospective collection of biological specimens for research purposes by noninvasive means, such as hair and nail clippings, deciduous teeth, excreta and external secretions (including sweat), uncannulated saliva, mucosal and skin cells collected by buccal scraping or swab).
The research comprises a review of previously approved research 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 the remaining research activities are limited to data analysis; or
(c) where no subjects have been enrolled and no additional risks have been identified.
Research which poses more than minimal risk to participants or meets any of the following criteria:
Any research in which either of the two initial IRB reviewers (a) concludes that a full review is required or (b) concludes that the research should not be approved.
The research involves individuals under the age of 18.
The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability, be stigmatizing, or be damaging to the subjects’ financial standing, employability, insurability, or reputation.
The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior) AND the confidentiality of a participant’s responses cannot be assured. (E.g., audio or videotaped interviews, or a “key” which would allow someone to match a set of responses with a particular participant.)
The research involves prisoners, fetuses, pregnant women, and the seriously ill, or mentally or cognitively compromised adults as subjects.