The term exempt does not mean exempt from review. Review must still be performed to ensure the protection of human participants in research. Exempt review is performed by trained individuals as part of, or assigned by, the Exempt Review Committee.
Any investigator who intends to conduct research involving human participants, and who on the basis of the categories described below believes that research to be exempt from formal review, must submit an Exemption Request application to Marywood University's Exempt Review Committee (ERC). Please note that the ERC makes the final determination regarding whether a protocol is eligible for exemption. Members of the Exempt Review Committee may exercise all of the authorities of the Institutional Review Board (IRB).
An exempt application's narrative is required to follow the narrative format shown on the exemption request form. Instead of a consent form, the application should include a "participant letter" or "information sheet". This document must contain the same information as an informed consent form, only it does not require a signature line.
Please see the Exempt Review Committee's website for forms and instructions.
Research is exempt only if ALL procedures meet criteria detailed in one or more of the Categories below.
Category 1: Research is 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 (46.101(b)1).
Note: This is the only category under which Marywood University allows for children to be participants. However, if the activity proposed is not typically a part of the classroom curriculum or instruction, the study is not exempt. Exemptions do not apply where children will be surveyed, interviewed or observed (where the researcher participates in the observation).
Category 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 participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation [46.101(b)2].
Note: Protocols that explore sensitive aspects of a person's own behavior or experience ( illegal conduct, abuse, alcohol or other drug use, sexual behavior, suicidal thoughts, etc.) are not exempt if personal identifiable information is collected.
Category 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 Category 2, if: (i) the human participants 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 [46.101(b)3].
Category 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 [46.101(b)4].
Category 5: Federal agency evaluations are not conducted by Marywood University, so this category does not apply.
Category 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 [46.101(b)6].