HRPP Policy - Exempt research

Research activities in which the only involvement of human subjects will be in one or more of the following categories, described at 45 CFR 46.104(d) are exempt from IRB review unless noted below.

Category 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.

Category 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 one of the criteria is met:

• The information obtained is recorded by research personnel in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects
• Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation
• The information obtained is recorded by research personnel in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

This exemption does not apply to research involving children that uses survey procedures, interview procedures, or observation of public behavior when research personnel participate in the activities being observed. Research may qualify for exemption if it involves children as subjects and their participation is limited to educational tests (cognitive, diagnostic, aptitude, achievement) and observation of public behavior when research personnel do not participate in the activities being observed.

Category 3

Research involving benign behavioral interventions 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 one of the following criteria is met:

• The information obtained is recorded by research personnel in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects
• Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation
• The information obtained is recorded by research personnel in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and research personnel have no reason to think the subjects will find the interventions offensive or embarrassing.

If the research involves deceiving the subjects regarding the nature or purposes of the research, the subject must authorize the deception through a prospective agreement to participate in the research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Category 4

Secondary research for which consent is not required: secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable biospecimens are publicly available
• Information, which may include information about biospecimens, is recorded by research personnel in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, research personnel do not contact the subjects, and research personnel will not re-identify subjects
• The research involves only information collection and analysis involving use of identifiable health information when that use is regulated under the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E) for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b).
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and compliance with section 208(b) of the E-Government Act of 2002, 44 USC 3501 note, if all the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 USC 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 USC 3501 et seq.

Category 5

Research and demonstration projects that are conducted by or subject to the approval of a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Research in this category must be published on a list of such research by the Federal department or agency prior to commencement pursuant to 45 CFR 46.104(d)(5)(i).

Category 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 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 FDA or the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (See also 21 CFR 56.104[d])

Research supported by the Department of Justice is not eligible for exempt review under the above-listed categories. However, the research may be granted exemption under the categories described in 28 CFR 46.101. 

Category 7 and Category 8

Category 7 and Category 8 as described at 45 CFR 46.104(d) have not been adopted as categories of research eligible for exemption by Indiana University.

For proposed exempt research, the study team provides protocol-specific information via the human subjects application and submits the following additional materials, as applicable:

• Data collection instruments, including surveys, questionnaires, interview questions, etc.
• Recruitment methods and materials
• Other documents as applicable, e.g., letters of cooperation from research sites

Exemption may be granted by an IRB member or by a qualified HRPP staff member.  Qualified HRPP staff are those who have been involved in the review of human subjects research for more than six (6) months, have participated in the HRPP workshop for reviewing exempt research, have completed applicable CITI training, and have demonstrated experience in knowledge in the review of exempt research (as documented by HRPP leadership). Exemption may not be granted by anyone who has a conflicting interest in a submission. Conflicting interests include:

• Participation in the protocol
• PI of the protocol is an immediate family member
• Significant financial interest as defined by the IU Policy on Conflicts of Interest and Commitment
• Certain non-financial interests, including having supervision over the PI of the project or participating in a project that is in direct competition with the project
• Any other real or perceived conflict.

When the exemption requires the IRB conduct a limited IRB review, an IRB member must review and grant the exemption and determine whether there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. If the IRB reviewer determines that the research is greater than minimal risk, the reviewer must document the rationale for this determination and the rationale for review by the convened IRB. An IRB member may not disapprove the research; instead the research must be submitted to the convened IRB for review.

If the research is subject to HIPAA and research personnel request a waiver of authorization, a member of the Privacy Board will determine whether it is appropriate to waive the requirement to obtain authorization or documentation of authorization for the study.

The Exempt Approval Letter lists the specific category(ies) under which exemption is granted and any IRB determinations, as applicable. 

Exempt research is not required to undergo renewal.

Minor modifications to exempt studies do not require review and approval unless the modification may change the study's eligibility for exemption.

Substantive modifications that have the potential to change the nature of the research and, therefore, the study's eligibility for exemption, require review and approval prior to implementation of the modification.

Research personnel request review of substantive changes by submitting an amendment via Kuali Protocols. The changes are reviewed to ensure that they do not affect the exempt status of the research. If the changes do not affect the exempt status, research personnel will be notified. If the changes result in the research no longer qualifying for exemption, research personnel will be notified accordingly and instructed to submit an appropriate expedited or full board IRB submission.

Exempt research may be closed by an HRPP staff member.