Is the research Expedited or Full Board?
The representative for the discipline in which the research is taking place (see Current IRB Membership) will review all IRB submissions within that discipline. The representative will decide if the research is Expedited or requires Full Board Review.
In order for research to qualify as expedited, it must meet the following federal criteria
- The research does not exceed minimal risk to the human participants. Minimal risk means that the probability and magnitude of harm or discomfort 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.
- The research activities must be listed among those that are detailed below. If an activity is not listed, it has not been deemed minimal risk by federal regulations and under 45 CFR 46.110 and 21 CFR 56.110. Studies including activities that are not considered minimal risk per these guidelines cannot be classified as expedited.
- The research population of interest does not include children under the age of 18.
- The research population of interest does not include individuals who are part of a special population (e.g. prisoners, individuals who are not minors but are unable to give informed consent).
- The research activities will not lead to the identification of the participants and/or their responses in such case where their responses would place them at risk of criminal, civil, or social liability. Social liability is defined as damages to the participant’s reputation, insurability, employability, or social standing due to stigmatizing responses or categorization.
- The research is not categorized by any government agency as “classified.”
If the research has met the above criteria,
Then it must further meet the following list of federally approved research activities:
- 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.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), measurements of human performance, non-invasive surveys (e.g. questionnaires), non-invasive interview procedures, or observations of public behavior.
Note: This research must meet the criteria for privacy as described above in item #5.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens provided that these sources are publicly available or that 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:
(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.
- Taste and food quality evaluation and consumer acceptance studies provided that the food consumed meets all safety standards of the Food and Drug Administration, Environmental Protection Agency, or US Department of Agriculture.