Principal Investigators (PIs) are responsible for determining the appropriate application required for their proposed research projects. However, all exempt protocols will undergo review by the IRB chair to verify correct classification. Expedited proposals will be reviewed by at least two members of the IRB. Full proposals will be reviewed by all members of the IRB at regularly scheduled meetings. Researchers should consult the criteria for evaluation when completing the application process. Applications and relevant IRB forms here.
Research may be classified as exempt if it poses minimal risk as defined by the OHRP. Specifically, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Exempt protocols should fit into one of the categories below and cannot involve vulnerable populations.
- Research conducted in established or commonly accepted educational settings, involving normal minimal risk or 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.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, observation of public behavior that result in minimal risk, unless the information is obtained and recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and 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.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under item (3) above; if the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require 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 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.
- 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 methods and procedures of public benefit or service programs.
- Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, or a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or an agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the USDA.
Some risk is acceptable under expedited review provided it is something that at least a majority of reasonable people might agree to do, the negative effects are short-lived (normally less than an hour), or the subject agrees to the risk beforehand. Notably, per OHRP, risks are minimized by “(i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.”
Expedited review cannot be used if the research involves: major deceptions, vulnerable populations (children, pregnant women, prisoners, mentally disturbed etc.); placing subjects under risk of being harmed physically or psychologically; invasive means of obtaining biological samples (blood, DNA, etc.); having subjects report about highly sensitive issues (drugs, sex, crime, cheating, etc.), or if the research question prevents subjects from giving informed consent.
Also note that expedited review will be used for amendments to currently approved protocols if the amendments involve minor modifications. Major modifications will require full board review.
All research that does not qualify as exempt or expedited will be considered by full board review. In short, protocols with any of the following features must undergo full review:
- Research that involves more than minimal risk.
- Research that involves more than minimal deception.
- Research that involves vulnerable populations.
- Research that involves intrusive or stressful (including but not limited to physical stress, psychological stress, and social stress).