Research involving human participants does not always require the same type of IRB review. Depending on the nature of the study and the activities involved, some research may qualify for an exemption under the federal regulations governing human subjects research.
But the word “exempt” can be misleading.
Exempt research is not necessarily exempt from all oversight, ethical responsibilities, or regulatory requirements. Instead, exempt research refers to specific categories of human subjects research that may be exempt from certain requirements of the Common Rule when the applicable criteria are met. Some exemption categories may also require a limited IRB review.
Understanding exempt research can help researchers better prepare their studies and determine what information an IRB may need to make an exemption determination.
What Is Exempt Research?
Under 45 CFR 46.104, there are eight categories of research activities that may qualify for an exemption from certain requirements of the Common Rule.
These categories generally involve research activities that fit specific regulatory criteria. Depending on the category, the research may involve educational activities, surveys or interviews, benign behavioral interventions, secondary use of information or biospecimens, public benefit programs, food and taste studies, or certain research involving broad consent.
An important distinction is that exempt does not mean that a study is not human subjects research. A study may still involve human participants or identifiable information and qualify for an exemption.
Additionally, researchers should not assume that their own study qualifies simply because it appears to fit into one of the categories. OHRP recommends that investigators not make independent exemption determinations because of the potential for conflicts of interest.
An IRB or other authorized reviewer should determine whether the specific research activities meet the applicable exemption criteria.
Exempt Research vs. Expedited Review
Expedited and exempt research are sometimes confused, but they are not the same.
Exempt research falls within one or more specific exemption categories established in the regulations.
Expedited review is a review procedure that may be used for certain categories of research involving no more than minimal risk or for certain other qualifying activities.
In other words, expedited research is still subject to IRB review. Exempt research may be excluded from certain requirements of the regulations when the study meets all applicable criteria for an exemption.
Understanding this distinction is important when preparing an IRB submission. A minimal-risk study does not automatically qualify as exempt. A study that does not qualify for an exemption may still be eligible for expedited review.
The 8 Categories of Exempt Research
The federal regulations include eight categories of exempt research. Below is a general overview of each category. Click on a category for more information about it.
Category 1 applies to certain research conducted in established or commonly accepted educational settings that specifically involves normal educational practices.
This may include research involving:
- Instructional strategies
- Instructional techniques
- Curricula
- Classroom management methods
- Comparisons of educational approaches
To qualify, the research must meet the specific regulatory criteria and should not be likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
Research taking place in a school or classroom does not automatically qualify under Category 1. The specific research activities and educational practices involved must meet the applicable requirements.
Category 2 covers certain research involving:
- Educational tests
- Survey procedures
- Interview procedures
- Observation of public behavior
The research may qualify when it meets at least one of the specific criteria outlined in the regulations. Depending on how information is recorded and the potential risks associated with disclosure of participants’ responses, the study may qualify for an exemption.
Some research under this category may require a limited IRB review when identifiable information is involved and the applicable criteria require additional consideration of privacy and confidentiality protections.
There are also important limitations when children are involved in research under Category 2. Not every survey, interview, or observational study involving children can qualify for this exemption.
Because survey research and interview-based studies are common in social and behavioral research, Category 2 is one of the exemption categories researchers frequently encounter.
Category 3 applies to certain research involving benign behavioral interventions in conjunction with the collection of information from adult participants.
A benign behavioral intervention is generally brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact on participants.
The research must meet the specific requirements of the exemption, including applicable requirements related to the collection of information and the participant’s prospective agreement to the intervention and information collection.
Category 3 does not apply to research involving children.
Category 4 addresses certain secondary research involving identifiable private information or identifiable biospecimens for which consent is not required under the exemption.
Depending on the specific circumstances, qualifying research may involve:
- Publicly available information or biospecimens
- Information recorded in a manner that prevents investigators from readily ascertaining participant identities
- Certain research involving identifiable health information regulated under HIPAA
- Research conducted by or on behalf of a federal department or agency using information collected or generated by the government for certain purposes
Secondary research can be more complex than it initially appears. Whether a study qualifies may depend on what information the investigator obtains, whether the information is identifiable, how it is recorded, and what regulatory protections apply.
Category 5 applies to certain research and demonstration projects that are conducted or supported by a federal department or agency or otherwise subject to the approval of the appropriate department or agency officials.
The projects must be designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including areas such as procedures for obtaining benefits or services and potential changes to those programs or procedures.
There are additional requirements associated with this category, including a requirement related to the public posting of qualifying research and demonstration projects by the relevant federal department or agency.
Because this category applies in specific circumstances, researchers should carefully review the applicable requirements before assuming a study qualifies.
Category 6 covers certain taste and food quality evaluation and consumer acceptance studies.
Research may qualify when participants consume wholesome foods without additives or when the food contains ingredients, agricultural chemicals, or environmental contaminants at levels determined to be safe or otherwise approved by the appropriate federal agencies.
While this category is narrower than some of the other exemptions, it may apply to certain consumer research and food-related studies.
Category 7 applies to the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use when the applicable requirements for broad consent are met.
The IRB must make the required determinations related to privacy and confidentiality protections, and the applicable requirements for broad consent must also be satisfied..
Category 8 addresses certain secondary research involving identifiable private information or identifiable biospecimens when broad consent has been obtained for the storage, maintenance, and secondary use of that information or those biospecimens.
In addition to the privacy and confidentiality considerations required during limited IRB review, the IRB must make certain determinations related to whether the proposed secondary research falls within the scope of the broad consent.
Because Categories 7 and 8 involve broad consent and identifiable information or biospecimens, they can be more complex than some of the other exemption categories.
Can Research Involving Children Be Exempt?
Some exempt categories can apply to research involving children, but important limitations exist.
For research subject to Subpart D of the federal regulations, Categories 1, 4, 5, 6, 7, and 8 may apply when the applicable requirements are met. Certain portions of Category 2 may also apply to research involving educational tests or the observation of public behavior when the investigator does not participate in the activity being observed.
However, some provisions of Category 2 do not apply to research involving children. Category 3 does not apply to research involving children.
Researchers should carefully consider the population involved in their study when evaluating whether an exemption may apply.
Does Exempt Mean There Are No Researcher Responsibilities?
The short answer: no.
Even when research qualifies for an exemption, researchers may still have important ethical, institutional, legal, and regulatory responsibilities.
Depending on the research, this may include:
- Protecting participant privacy
- Maintaining the confidentiality and security of research information
- Following applicable institutional policies
- Complying with HIPAA or other privacy requirements when applicable
- Following additional protections for vulnerable populations
- Obtaining any required permissions or authorizations
- Following the requirements associated with the specific exemption category
An exemption determination does not give researchers permission to disregard participant protections or other applicable requirements.
Preparing an Exempt Research Submission
When submitting research for an exemption determination, it is important to clearly describe the proposed study and all research activities.
The IRB may need information about:
- The purpose of the study
- The participant population
- Recruitment procedures
- Study procedures
- Surveys, interview guides, questionnaires, or other data collection materials
- The information or biospecimens being collected or analyzed
- Whether information is identifiable
- How information will be stored and protected
- Whether sensitive topics are involved
- Whether children or other populations requiring additional protections will participate
Providing complete and consistent information helps the reviewer understand the study and evaluate whether the research meets the criteria for an exemption.
Understanding Which Exemption May Apply
The eight exemption categories cover a wide range of research activities, but eligibility depends on the specific details of each study.
A survey does not automatically qualify for an exemption. Research involving secondary data does not automatically qualify under Category 4. Simply conducting research in a classroom does not automatically make the study eligible for Category 1.
The best approach is to carefully review the study procedures, participant population, information being collected, and the applicable regulatory requirements before submitting the research for review.
This guide provides an overview of the eight categories of exempt research. In upcoming articles, we will take a closer look at some of the most common exemption categories, including:
- Exempt Category 1: Educational Research
- Exempt Category 2: Surveys, Interviews, and Educational Tests
- Exempt Category 4: Secondary Research
Understanding the requirements behind each category can help researchers better prepare their studies. Ultimately researchers can better understand what an IRB may need to determine whether an exemption applies.