Exempt Research

Introduction

Describing exempt research as “exempt” can be a little confusing. Research that is considered exempt is considered research with human subjects and is not exempt from review; it is exempt from the provisions of the regulations. However, exempt research is subject to the ethical principles adopted by the University for conducting research with human subjects.

Screenings for Exemption should include applicable informed consent processes as well other corresponding documents and materials.

Categories of Eligible Research Activity

Only research described in one of the below categories can be screened for exemption:

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least: (i) the information obtained is recorded by the investigator in such a manner that the identity of participants cannot readily be ascertained, directly or through identifiers linked to the subjects; or (ii) any disclosure of the responses outside the research would not reasonably place the subjects at risk.

3. Research involving benign behavioral manipulations (brief in duration, harmless, painless, not physically invasive, offensive or embarrassing; and not likely to have a significant adverse lasting impact on the subjects) in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least (i) the information obtained is recorded by the investigator in such a manner that the identity of human subjects cannot readily be ascertained, directly or through identifiers linked to subjects; or (ii) any disclosure of the responses outside the research would not reasonably place subjects at risk.

4. Secondary research for which consent is not required, including the secondary analysis of [existing] identifiable private information or identifiable biospecimens, if at least (i) the identifiable private information or identifiable biospecimens are publicly available; or (ii) information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.

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 methods and procedures of public benefit or service programs.

6. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, or if a food is consumed that contains a food ingredient, agricultural chemical, or environmental contaminant at or below the level and for a use found to be safe by the FDA, EPA or USDA.

At present, the IRB is not considering the exempt review of research studies that require limited review or broad consent.

Review of a Screening for Exemption

Screenings for Exemption are reviewed and recommended for approval by the Campus IRB Program Director or Associate Director. Generally, exempt research is approved for 364 days.

Amending an Approved Screening for Exemption

The Campus IRB policy on Amending an Approved Protocol is applicable to exempt research. Protocols approved as exempt are amended using the Request to Amend an Approved Protocol form.

While uncommon, it is possible that requested changes may not be meet one of the eligible categories for exemption. IRB staff will contact researchers to inform them if the proposed changes need to be submitted as a new protocol. In rare cases, IRB staff may recommend the research study be submitted on a Request for Protocol Approval.

Periodic Check-in of an Approved Screening for Exemption

Periodic Check-in forms do not need to be submitted for protocols that were approved as exempt. To extend an exemption's expiration date for an additional 364 days, simply inform the Campus IRB the research is ongoing.

If the research is completed, the protocol can be closed.

Restrictions on the Use of Exemptions

Exemptions cannot be secured for research that includes:

• Pregnant women when they are the targeted subject population
• Students participating in the Psychology & Neuroscience Subject Pool
• Students if the researcher is their instructor
• Employees if the researcher is their supervisor
• Direct interaction with children
• Prisoners
• Use of deception
• Risks that must be managed
• Broad consent
• Limited IRB review