Exempt Research at St. Norbert College

All research involving living human subjects or private information previously obtained about individuals is subject to IRB review.
 
Some research may, according to federal regulations (Sec. 45 CFR 46.101b), be exempt from review by the entire board. It may be reviewed and approved by the chairperson of the board.
 
Other research posing no more than minimal risk may, according to federal regulations (Sec. 45 CFR 46.110), receive expedited review. This research may be reviewed and approved by the chairperson after consulting at least one other member of the board.
 
All other research will be reviewed by the entire board at a properly scheduled meeting.
 
Unless otherwise required by the head of a federal department or agency, research activities in which the only involvement of human subjects will be in one of more of the following categories are likely to be classified as exempt from review by the entire IRB and as such will require only minimal documentation.
 
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:
 
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the participants; and
 
b. Any disclosure of the human subjects’ responses outside the research could reasonably place the participants at risk for criminal or civil liability or be damaging to the participants’ 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 (2) of this section if:
 
a. The human subjects are elected or appointed public school 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.
 
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 participants cannot be identified directly or through identifiers linked to the participants.
 
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:
 
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. (Sec. 45 CFR 46.101)