Human subject research is categorized in one of three classifications based on the level of risk. These classifications include full board review, expedited review, and exempt status.
According to the US Department of Health and Humans Services, §45 CFR 46.102(i), minimal risk means that 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 Review | Expedited Review | Full Board Review |
|---|---|---|
| IRB Exempt Application | IRB Expedited Application | IRB Full Review Application |
| 1 Week Review | 2 Week Review | Monthly Review |
| Exempt protocols are administratively reviewed for research involving less than minimal risk to participants, but must meet the following conditions: The research must be conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; I) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior; unless the subjects can be identified and any data disclosure could reasonably place the subjects at risk; II) 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; III) Research and demonstration projects which are conducted by or subject to the approval of governmental department or agency heads to study public benefit or service programs; IV) Taste and food quality evaluation and consumer acceptance studies if the food is at or below the level found to be safe, by the Food and Drug Administration or approved by the and/or the Inspection Service of the U.S. Department of Agriculture. | Expedited review is appropriate for research that involves no more than minimal risk or for review of minor changes to previously-approved research projects. An expedited review may include the IRB chairperson alone, or one or more experienced reviewers. Protocols eligible for expedited review include: I) Collection of hair and nail clippings in a non-disfiguring manner; II) Collection of excreta and external secretions; III) Collection of data from subjects 18 years of age or older using non-invasive procedures that are routinely employed in clinical practice; IV) Collection of blood samples from subjects who are 18 years of age or older, in good health, and are not pregnant, such collection not to exceed twice weekly venipuncture and a maximum of 450 milliliters in an eight-week period; V) Anonymous voice recordings made for research purposes, such as investigations of speech defects; VI) Moderate exercise by healthy volunteers; VII) Study of existing data, documents, records, pathological specimens or diagnostic specimens; VIII) Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate the subject’s behavior and the research will not involve stress to subjects; IX) Research involving manipulation of the subject’s behavior which does not involve stress or risk; Expedited review may also be appropriate for minor changes or requests for extensions in previously-approved research during the period (one year or less) for which approval is authorized. | Full Board review is required for all research involving greater than minimal risk to subjects. IT is also required for research activities being performed outside of the United States. Only the full board can reject an application to conduct projects using human subjects. Full Board meetings are regularly held throughout the year. Please check the Full Board Meeting Schedule for FY2016 for submission deadlines. |