Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens that have been or will be collected for a nonrelated primary or initial activity, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
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 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 FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The full list of exempt categories can be found in 45 CFR § 46.107. Although research in exempt categories do not need to be approved by the full IRB, the Belmont Report principles of respect for persons, beneficence and justice still apply.
Research in categories 1-6 is not exempt if it involves prisoners. All research involving prisoners requires obtaining a certification from OHRP and must be reviewed by the convened IRB. Research that involves children and falls into categories 1 - 6 may be found to be exempt by the IRB. However, the exemption category 2, pertaining to survey or interview procedures or observations of public behavior, does not apply to research involving children, except for research involving public behavior when the researcher does not participate in the activities being observed.