Research activities involving human subjects in the following categories may be exempt
from review by MCC’s Institutional Review Board. The principal investigator/project
director is authorized to make the first determination of eligibility for exemption;
however, the College bears the responsibility for concurring in that determination
based on notice provided by the principal investigator to the Institutional Review
Board.
The following exemptions do NOT apply when (a) deception of subjects may be an element of the research; (b) subjects are under the age of eighteen; (c) the activity may expose the subject to discomfort or harassment beyond levels encountered in daily life; or (d) fetuses, pregnant women, human in vitro fertilization, children, or individuals involuntarily
confined or detained in penal institutions are subjects of the activity.
EXCEPT FOR THE ABOVE EXCLUSIONS, the federally-approved Categories of Exemption are:
- Research conducted in established or commonly accepted educational settings involving
normal educational practices, such as: (a) research on regular and special education
instructional strategies; (b) research on the effectiveness of 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: (a) information obtained is recorded in such a manner that human subjects
can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research 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,
or achievement), survey procedures, interview procedures, or observation of public
behavior that is not exempt under Category 2 if: (a) the human subjects are elected
or appointed public officials, or candidates for public office, or (b) federal statute(s)
require(s) without exception that the confidentiality of the personally identifiable
information will be maintained throughout the research and thereafter.
- 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.
- 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: (a) public benefit or service programs; (b) procedures for obtaining benefits
or services under those programs; (c) possible changes in or alternatives to those
programs or procedures; or (d) possible changes in methods or levels of payment for
benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome
foods without additives are consumed, or (b) if a food is consumed that contains a
food ingredient or 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
U.S. 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.
Exempting an activity from review does not absolve the investigator(s) of the activity
from ensuring that the welfare of subjects in the activity is protected and that methods
used and information provided to gain subject consent are appropriate to the activity.
Questions about whether a research activity may be exempt from human subjects review
can be directed to Carolyn Hunt, Director, Strategic Resource Development & Grant Management (Grants@monroecc.edu), or William Dixon, Chair of the Institutional Review Board (wdixon5@monroecc.edu).
Download the Exempt Protocol Summary Form (PDF)
