Exemptions

Some studies may require only an initial review and are EXEMPT from ongoing review. There are six categories of research exempt from continuing IRB review.

Exempt Categories*

Category 1

Research conducted in established or commonly accepted educational settings involving normal educational practices, such as a) research on regular and special educational instructional strategies, or b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Note: This exemption is applicable to individuals with mental handicaps only if research involved no change in the content, location, or procedures of instruction from those normally experienced by the subject. More Information

Category 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the following two conditions exist:

a) information is recorded in such a manner that the human subjects can be identified directly, or through identifiers linked to the subjects; and
b) any disclosure of the 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.

Note: This exemption applies to research with children or individuals with mental handicaps as follows:  i) research involving the use of educational tests is exempt; ii) research involving survey or interview procedures is not exempt; iii) research involving observations of public behavior is exempt only when the investigator does not participate in the observed activities. More Information

Category 3

All research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures or observation of public behavior that is not exempt under category 2 above, a) if the human subjects are elected or appointed public officials or candidates for public office; or b) federal code require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
More Information

Category 4

Research involving the collection or study of already 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. See Claim of Exemption-Category 4

Category 5

Research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services (DHHS), and which are designed to study, evaluate, or otherwise examine: a) public benefit or service programs; b) procedures for obtaining benefits or services under these 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 these programs.  Examples are Medicare, food stamps, and welfare benefits. More Information

Category 6

Taste and food quality evaluation and consumer acceptance studies, a) if wholesome foods without additives are consumed or b) 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. More Information

*Exempt status applies to research activities in which the only involvement of human subjects will fall in one or more of the categories listed above.

Note: These exemptions do not apply to research:
A) involving prisoners, fetuses, pregnant women, human in vitro fertilization;
B) when there is additional involvement of human subjects beyond the categories listed below;
C)when deception of subjects may be an element of research; or d) when the activity might expose the subject to discomfort or harassment beyond levels encountered in daily life.

To establish an individual research project as exempt, an investigator must complete a Claim of Exemption form. On the application the investigator should indicate the number of the category under which an exemption is claimed.  For research involving the collection or study of existing data, documents, records, pathological specimens a Claim of Exemption-Category 4 form should be completed.  Final determination as to whether a project is exempt rests with the IRB.

If a research project is certified as exempt, the investigator need not resubmit the project for continuing review as long as there are no modifications in the exempted procedures. In other words, the use of the term "exempt" refers to the requirement for continuing RCHS review but not to the general requirements for informed consent, if applicable to the study, and protection of subjects, including confidentiality.

The exempt categories do not apply to research involving deception of subjects (i.e., where the researcher deceives the subject with regard to the purpose of the research and/or the results of the subject's actions in the study), sensitive behavioral research, or to research involving pregnant women, prisoners, mentally disabled people, and other subject populations determined to be vulnerable.