Exempt studies

Exempt: Studies are exempt from full review if they have the following characteristics as described under the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.101).

 

1.     Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (1) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of, or the comparison among instructional techniques, curricula, or class management methods.

2.     Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects.

3.     Research involving survey or interview procedures and research involving observation of public behavior (including observation by an investigator who is also a participant in such behavior). All research involving survey or interview procedures is exempt without exception, when all the respondents are elected or appointed public officials or candidates for public office)

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 or through identifiers linked to the subjects.

5.     Research and demonstration on projects which are conducted by or subjects to the approval of department or agency heads and which are designated to study, evaluate, or otherwise examine: (i) Public benefit or service programs (ii) procedures for obtaining benefits or services 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.

6.     Taste and food quality evaluation and consumer acceptance studies (i) if wholesome foods without additives are consumed (ii) if a food is consumed that contains a food ingredient at or below the level the 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 EPA.

 
Andrews University is a Seventh-day Adventist institution of higher education
Phone: 1-800-253-2874   E-mail: enroll@andrews.edu
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Berrien Springs, Michigan 49104