Exempt Research
Exempt research involves human subjects and meets the requirements of one or more exemption categories within federal regulations for protecting human subjects in research.
Exempt research involves human subjects and meets the requirements of one or more exemption categories within federal regulations for protecting human subjects in research.
The Revised Common Rule includes eight categories of exempt human subjects research. NIH currently allows six of these categories, with four commonly applicable to NIH research (exemption categories 1-4). These research activities are considered low risk and do not need to meet the criteria for IRB review and approval as outlined in the Common Rule. Therefore, they are exempt from these requirements. Only the IRB can make exempt determinations at NIH. Sometimes, a project may qualify for an exemption under multiple categories depending on its nature and activities.
Exemption Categories 1-3
If your project involves only collecting new data from humans, it may qualify for an exemption if all research methods fall into one of these categories:
- Exemption Category 1 - Educational Research involving the Study of Normal Educational Practices.
- Exemption Category 2 - Interactions involving Educational Tests, Survey or Interview Procedures, or Observation of Public Behavior.
- Exemption Category 3 - Benign Behavioral Interventions.
Research under Exemption Categories 1-3 may include collecting and maintaining identifiable information. If the project involves collecting sensitive data with identifiers, the protocol must include a plan to protect privacy and confidentiality. An IRB member must conduct a "limited IRB review" to ensure these requirements are met.
Exemption Category 1: Educational Research
- Cannot target prisoners.
- Must be conducted in established or commonly accepted educational settings.
- Cannot likely impact the student's opportunity to learn or the assessment of educators.
Exemption Category 2: Educational Tests, Survey or Interview Procedures, or Observation of Public Behavior
- Cannot include existing, identifiable data.
- Survey or interview subjects must be adults.
- Cannot target prisoners.
- If observing minors' public behavior, the researcher cannot participate.
- Must include a privacy and confidentiality plan if collecting sensitive data with identifiers.
Exemption Category 3: Benign Behavioral Interventions
- Must collect data via verbal or written responses, data entry, or audio/video recordings.
- Subjects must be adults.
- Cannot target prisoners.
- Intervention must be brief, harmless, painless, not physically invasive, and not likely to have a significant adverse impact.
- Must have no reason to think subjects will find the intervention offensive or embarrassing.
- Must include a privacy and confidentiality plan if collecting sensitive data with identifiers.
- Subjects must agree to participate and to the collection of information.
- If involving deception, subjects must authorize the deception in advance.
Exemption Category 4
If your project involves accessing identifiable data or biospecimens for secondary research but not recording or retaining identifiers, it may qualify for an exemption. If personal identifiers or links to identifiers are accessible throughout the project, an exemption is not permissible. Data and biospecimens do not need to exist before the research starts to meet Exemption Category 4.
Exemption Category 4: Collection of existing data, documents, records, or specimens
- Data or biospecimens are publicly available (anyone can access them anytime).
- Data will be recorded in a de-identified manner (no identifiers retained).
- Data and biospecimens are protected under HIPAA Privacy and Security Rules (NIH is not a HIPAA-covered entity, so this does not apply).
- Data originally collected or generated by the government for non-research purposes
Writing an exempt research protocol
For exempt research, you should use one of the following templates:
- Prospective Data Collection Template: For research involving the collection of new data from participants.
Protocol Template For Prospective Data Collection From Humans(Request For An Exemption)
- Retrospective Data Collection/Biospecimen Review Template: For research involving the review of previously collected data or biospecimens.
Protocol Template For A Retrospective Data Or Biospecimen Review(Request For An Exemption)
Related documents
Your exempt protocol will be submitted for review in PROTECT. Review the following guide for specific instructions about exempt submissions.
Related Resources
Related documents
Determining Whether Your Project Might Require an Exemption or IRB Review
Presented by Julie M. Eiserman