Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:
Research involving the use of educational tests (cognitive, diagnostic aptitude, achievement), survey procedures, interview procedures, of observation of public behavior, unless:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, that is not exempt under the above criterion, if:
Research involving the collection 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 subjects cannot be identified, directly or through identifiers linked to the subjects.
Research and demonstration projects which are conducted by or subject to the approval of Department or agency heads, and which are designed to study, evaluate or otherwise examine:
Taste and food quality evaluation and consumer acceptance studies:
Research on drugs or medical devices for which an investigational new drug application or an investigational device exemption is not required.
Collection of blood samples by venipuncture, in amounts not exceeding 550 millimeters in an eight-week period and no more than two times per week from subjects 18 years of age or older, who are in good health and not pregnant and who weigh at least 110 pounds. Or other adults and children, considering the age, weight and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more than twice per week.
Prospective collection of biological specimens for research purposes by non-invasive means such as:
Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes:
The study of existing data, documents, records, pathological specimens, or diagnostic specimens that have been collected for non-research purposes.
Research on individual or group behavior or characteristics of individuals, such as:
All other studies, including those involving deception of subjects in ways that may lead to their distress or the collection of data in ways that may identify individual subjects.