A study may be 'exempt' from IRB requirements pursuant to 45 CFR 46 if it involves very little if any risk to human subjects and if it fits within an "exempt" category listed under 45 CFR 46.101(b)(1)-(6). The categories are:
EXEMPT CATEGORY 1. Research conducted in established or commonly accepted educational settings involving normal education practices, such as (i) 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 conducted in established or commonly accepted educational settings involving normal education practices, such as (i) regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
[NOTE – This exemption likely excludes research involving deception or withholding of information from subjects.]
EXEMPT CATEGORY 2. Research that is limited to the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior unless information obtained from these sources is recorded in such a manner that human subjects can be identified (directly or through identifiers linked to the subjects), and any disclosure of the subject's responses outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to his or her financial standing, employability, or reputation.
[NOTE – This exemption does not apply to research involving children except for research involving educational tests or observation of public behavior where the investigators do not participate in the activities being observed, or interact directly with the children.]
EXEMPT CATEGORY 3. Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior that is not exempt under exemption category (2) (above) if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statutes require, without exception, that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
EXEMPT CATEGORY 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 through identifiers linked to the subjects.
[NOTE – This exemption requires that the research material be existent (i.e. on the shelf) at the time the protocol is submitted to the IRB. The use of research material collected after the research is initiated will disqualify the study from exempt status.]
EXEMPT CATEGORY 5. Research and demonstration projects which are conducted by or subject to approval of [federal] 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 these programs; (iii) possible changes or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for benefits or services under those programs.
EXEMPT CATEGORY 6. Taste and food quality evaluations and consumer acceptance studies, (i) if wholesome food without additives is consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department Agriculture (USDA)
[NOTE – This exemption does not apply to studies involving alcohol, vitamins or food supplements.]