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ORSP: Definition of Exempt Research

Definition of Exempt Research

What types of research are exempt?

Research with human subjects may qualify for exemption if the project does not involve any of the following restrictions and if research procedures meet the criteria detailed in the exemption categories below:

Restrictions

Research is not exempt if any of the following are involved:

  1. Prisoners
  2. Survey or interview techniques with minors
  3. Observation of public behavior of minors where the researcher participates in the activities being observed
  4. The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are not publicly available or if the information is recorded by the investigator in such a manner that participants can be identified, directly or through identifiers linked to the participants
  5. Deception of participants
  6. Audio or video recording of participants
  7. Procedures which expose participants to more than minimum risk (greater than ordinary encountered in daily life)


Exemption Categories

Research is exempt only if procedures meet the criteria detailed in one 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.

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 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 (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 personally 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 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 (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 subjects cannot be identified, directly or through identifiers linked to the subjects (46.101(b)4).

Category 5: Federal agency evaluations are not conducted by Marywood University.

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).

 


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