The IRB will make the final determination on level of review. Research that qualifies as non-research or exempt must receive formal exemption from the IRB. A request for exemption will be reviewed by the IRB chair. If the chair agrees, a formal exemption will be provided. If not, the chair will request that the primary investigator submit a full application including an Informed Consent Form for IRB approval.
The Office for Human Research Protections has provided decision charts to determine if a research project involving human subjects must be reviewed by an institutional research board. These charts are quite useful in determining whether to submit a Request for Exemption with the IRB.
- A Request for Exemption must be filed with the IRB if you are conducting research with human participants. An exemption approval from IRB is a safeguard that protects research participants, the investigators, and the institution.
- Exemptions are not allowed for research with vulnerable populations. Vulnerable populations include: pregnant women, fetuses, prisoners, minors/children (less than 18 years) and persons with cognitive disabilities.
The following exempt conditions have been developed and described within the Federal Common Rule (45 CFR 46):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods (Chart 3).
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside of the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation (Chart 4).
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior that is not exempt under #2 if: (i) the human participants are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter (Chart 4).
- 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 indirectly through identifiers linked to subjects (Chart 5). (NOTE: According to the OHRP, “to qualify for this exemption, the data, documents, records, or specimens must be in existence before the project begins. The principle behind this policy is that the rights of the individuals should be respected; subjects must consent to participation in research.”).
- Research and demonstration projects that 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 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 (Chart 6).
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient 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 of the U.S. Department of Agriculture (Chart 7).