IRB — Who Must Apply?
Who must submit a protocol to the IRB for approval
The following persons must complete a request to Centre's IRB for approval of human subject research:
- Anyone formally affiliated with Centre College (faculty, staff, students) who engages in scholarly research involving human subjects, either on or off campus.
- Researchers who are not affiliated with Centre College but who want to conduct research with human subjects on Centre's campus, or want to collect data specifically from Centre College faculty, students or staff.
- Anyone using data from human subjects that was collected at Centre College under the provisions of this document. For example, this includes graduates who intend to continue working with data that was originally collected as a student at Centre College.
Certain categories of research are classified by the Office of Human Research Protection exempt from IRB review (as defined by 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 or research on the effectiveness of 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. However, such research IS NOT exempt from IRB review if the human subjects can be identified directly or through identifiers, and in the case where disclosure of the responses outside of 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 of elected or appointed public officials or candidates for public office.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens that 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; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies in cases where
- wholesome foods without additives are consumed.
- food is consumed that contains a food ingredient at or below the level found to be safe for that particular use.
- the use of an agricultural chemical or environmental contaminant is 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.