The regulations for the protection of human subjects (the Common Rule) were revised in 2019. One of the major revisions was the expansion of the exempt research categories and the creation of Limited IRB Review for exempt categories 2(iii) and 3(i)(C). These expanded provisions allow for more flexibility for exempt research that collects identifiable, sensitive information. 

But what are those exempt categories, what are their requirements and limitations, and how does Limited IRB Review come into play? Read the rest of the article to learn more!

What is Exempt Research?

Exempt research represents classes of research activities that we, as a research and regulatory community, have agreed are low enough risk that the full set of regulations need not apply to these types of research studies. Such research activities include things like surveys and interviews with adults only, and most secondary data research.

In order for a study to qualify for review at the exempt level, the study must (1) represent no more than minimal risk; (2) fit into one or more of the exempt categories; (3) comply with institutional standards for exempt research.

You can view a previous ORI-HS Education Corner article to learn more about exempt research, and in particular how it differs from “excluded” research.

What are Exempt Categories 2(iii) and 3(i)(C)?

The changes to the Common Rule in 2019 included changes to the exempt categories. In this article, we will specifically focus on exempt categories 2(iii) and 3(i)(C). 

The Expanded Exempt Category 2

In the Common Rule Revisions, exempt category 2 – surveys and interviews with adults only – was expanded to include 3 subcategories. Each subcategory represents a slightly different design for a survey/interview study. The subcategories are:

• 2(i) Unidentifiable Data: The information obtained 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
• 2(ii) Benign Data: 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
• 2(iii) Limited IRB Review: The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review

The main limitation on exempt category 2 is that exempt category 2 may not apply to surveys or interviews with children. Studies using surveys and interviews of children (anyone under 18 in the state of Nevada) must be reviewed at the expedited or full board level, as appropriate.

The New Exempt Category 3

The other significant change to the exempt categories made in the 2019 Common Rule revisions was the creation of a brand-new Category 3. This category is for research that utilizes “benign behavioral interventions,” and is split into 3 subcategories, just like exempt category 2.

The 3 subcategories are:

• 3(i)(A) Unidentifiable Data: The information obtained 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, and an IRB conducts a limited IRB review
• 3(i)(B) Benign Data: 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
• 3(i)(C) Limited IRB Review: The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review 

For the purposes of this exemption category, “Benign Behavioral Interventions”:

• Involve the use of 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
• Require the prospective agreement of the subject to the intervention and data collection
• Are brief in duration (the intervention itself should be brief; the data collection surrounding the intervention itself may be more lengthy)
• Are harmless, painless, and not physically invasive; do not involve the use of physical sensors placed on the body (i.e.: the use of a FitBit would not be allowed under this category)
• Are not likely to have a significant adverse lasting impact on the subjects
• The investigator has reason to think the subjects will find the interventions offensive or embarrassing
• If the intervention involves deception, then the subjects must prospectively agree to being deceived or provided with incomplete information

Examples of such benign behavioral interventions might include:

• Playing an online economics game to see how participants allocate sums of virtual currency
• Solving a puzzle under various noise conditions
• Engaging in a mindfulness exercise

Besides these narrow conditions for what constitutes a benign behavioral intervention, in addition, exempt category 3 may not be utilized when the research involves children. Any research involving benign behavioral interventions with children (anyone under 18 in the state of Nevada), must be reviewed at the expedited or full board level, as appropriate.

What is Limited IRB Review?

Limited IRB Review is required by exempt subcategories 2(iii) and 3(i)(C). The purpose of Limited IRB Review for these categories is to ensure sensitive, identifiable data are protected, while still allowing a project the flexibility afforded to exempt research.

Limited IRB Review is conducted using the expedited review procedure outlined in the regulations; this means that Limited IRB Review must be conducted by an IRB member. The IRB member conducting a Limited IRB Review must consider the research study and must make the following finding in order to approve the exempt study:

• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

Studies subject to the Limited IRB Review requirement are not subject to continuing review requirements. 

Collaborative research projects that require Limited IRB Review may be subject to Single IRB review requirements, depending on the circumstances. If you are conducting a collaborative research project that qualifies for exemption but requires Limited IRB Review, ORI-HS recommends consulting with ORI-HS Staff to determine if reliance agreements are appropriate, or if another approach is needed to address the collaborative nature of the project.

Where Can I Learn More?

ORI-HS recently updated its SOP on exempt research to include provisions for the use of Limited IRB Review. You can find all of the ORI-HS SOPs on the ORI-HS SOP website. You can also contact IRB@unlv.edu for general questions.