- In order to minimize the workload of the Committee, the Committee will accept as Exempt from review all types of human subject research deemed Exempt from review in Table 1.
- Similarly, lab studies of animal behavior which involve no invasive procedures on, physical deprivation of, or euthanasia of the animal(s) will also be considered exempt. Further, only studies of live vertebrate animals need to be submitted to the Committee for review.
- It is also recognized that individually designed research projects that would not ordinarily be Exempt from review under the guidelines in Table 1, but are completed by students on a one-time basis as part of a course requirement, will be difficult to both review and carry out within a 10-week term. Therefore, students may complete these projects subject to approval by the relevant department chair rather than by the Committee. Instructors are encouraged to use classmates as peer reviewers for such studies, prior to forwarding studies to the department chair. The department chair is encouraged to use criteria for acceptance similar to those provided in this document, and is encouraged to forward questionable studies to the Research Ethics Committee for review. Note that this exception does not apply to student independent studies, and such students doing independent studies involving non-Exempt research on human participants or animal subjects must obtain Committee approval before data collection can begin.
Table 1. Categories of Human Participant Research
Exempt from Review1
(from §46.101(b) of 45 CFR 46)
1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior,
unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any 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.
(3) 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 (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(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 through identifiers linked to the subjects.
(5) 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: (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 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
1. Note that these exemptions do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization. The exemptions described in section 2 of this table do not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
If your research is not exempt it is most likely eligible for Expedited Review.