Exempt research is research with human subjects. However, it is "exempt" from the
provisions stated in 45 CFR 46, Subpart A (Common Rule). An exempt research project
does not require ongoing review from the IRB unless the project is amended in such
a way that it no longer meets the exemption criteria. (However, institutional policy
may have different requirements for obtaining consent as well as continuing review
of exempted protocols. Student investigators should consult with their IRB regarding
these matters.) The IRB is required to determine if a research project falls under
one of the following six exempt categories listed in the federal regulations (45 CFR
46.101(b)):
Research conducted in established or commonly accepted educational settings, involving
normal educational practices, such as: Research on regular and special education
instructional strategies, ORResearch on the effectiveness or the comparison among
instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless:Information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects, ANDAny disclosure
of the human subjects' responses outside the research could reasonably place the subjects
at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, or reputation.
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 paragraph (2) ifThe human subjects are elected or appointed
public officials or candidates for public office, ORThe research is conducted for
the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National
Center for Education Statistics under Federal statute 20 U.S.C. 12213-1, which provide
certain legal protections and requirements for confidentiality
Research involving the collection or study of existing data, documents, records, pathological
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.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:Public benefit
or service programs, ORProcedures for obtaining benefits or services under those programs,
OR Possible changes in or alternatives to those programs or procedures, ORPossible
changes in methods or levels of payment for benefits or services under those programs.
Taste and food quality evaluation and consumer acceptance studies, if: Wholesome foods
without additives are consumed, ORA 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 Food and
Drug Administration or approved by the U.S. Environmental Protection Agency or the
Food Safety and Inspection Service of the U.S. Department of Agriculture.
