There are times when the research being submitted by the PI is exempt from CPHS Review (HRP PP IV.02 Determine Research Exempt from Full Committee Review. The PI will submit the research to the committee by way of iRIS, at which time a Chair-appointed designee will review the submission and allow or disallow the exemption. It is, therefore, not the decision of the PI if the research involving human subjects is exempt from CPHS Review or not.

In iRIS, the PI may request exempt status in the section labeled “Information to be submitted to CPHS for its initial review of research protocols”. The following human research activities are considered exempt from review by the CPHS. Please note: These exemptions DO NOT APPLY when deception of human subjects may be an element of the research, when the activity might expose the human subjects to discomfort or harassment beyond levels encountered in daily life, or when fetuses, pregnant women, human in vitro fertilization, or individuals involuntarily confined or detained in penal institutions are subjects of the activity.

CATEGORY #1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

a. research on regular and special education instructional strategies,

b. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

CATEGORY #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 subjects; AND ,

b. 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.

(NOTE: The exemption under Category 2 DOES NOT APPLY to research involving survey or interview procedures or observation of public behavior when individuals under the age of 18 are subjects of the activity except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.)

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:

a. the human subjects are elected or appointed public 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.

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.

To qualify for this exemption, data, documents, records, or specimens must have been collected before the research project begins. Under this exemption, an investigator (with proper HIPAA Waiver or Alteration authorization) may inspect private, identifiable records, but may only record information in a non-identifiable manner. The data must be permanently and completely de-linked at the time of extraction. A code may be used to organize data as it is collected. However the code may not be a means of re-linking the data set to the original data source.

CATEGORY #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.

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.

The determination of exemption will be documented in the iRIS system, with notation of the category under which exemption is granted. The PI will be notified by the iRIS system in the form of a letter.