Research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the federal regulations that define the categories of review, which are exempt, expedited, and full board review. The determination of what level of review is required is determined by the IRB staff, NOT the researcher. Whatever the level of review, the ethical treatment of human participants is always a requirement.
Research activities that fall into this category fit one of six categories as designated by federal regulations.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular or special educational instructional strategies, or
- 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 or observation of public behavior, unless:
- Information is recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants;
- Any disclosure of the human participants' responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability or reputation.
- Research involving the use of educational tests, (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior the is not exempt under bullet two of this section, if:
- The human participants are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
- Research and demonstration projects which are conducted by or subject to the approval of federal government department or agency heads, and which are designed to study, evaluation or otherwise examine:
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies,
- If wholesome foods without additives are consumed or
- If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural; chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
It is important to remember that a research activity qualifies as exempt if it is limited to the kind of activities listed above and only after review of the proposal. If the project includes such activities but also involves other activities that are more intrusive, more personal, or more risky than the above, it most likely will not qualify as exempt.
Research activities that fall into this category present no more than minimal risk to human participants, and involve only procedures listed in one or more categories approved through federal regulations.
- Recording of data from participants 18 years or older using noninvasive procedures;
- Video/Audio recording;
- Study of existing data;
- *Research on an individual or group behavior that involves no manipulation of the participants and is not stressful.
Full Board Review:
Research that involves greater than minimal risk is reviewed by the IRB board. Research that requires full board review includes but is not limited to:
- Certain types of research involving children, pregnant women, fetuses, and other vulnerable populations;
- Research involving prisoners;
- Research that involves deception;
- Survey research that involves sensitive questions or is likely to be stressful for the participants; or
- Collection of blood samples in minimal amounts.