What Is Exempt Research?

Research activities are exempt from the requirements of the Common Rule when the only involvement of human participants will be in one or more of the eight categories detailed below. Studies that are exempt involve minimal-risk activities that are not FDA-regulated, are ethically consistent with the principles of the Belmont Report, and generally do not involve minors or prisoners as participants, with limited exceptions. In addition to exempt research, a study may also involve activities that are considered research not involving human participants, or activities that are not research.

Exempt research categories include:

1. Education Research
   1. This is a research activity conducted in established or commonly accepted educational practices (e.g., classroom, doctors office, professional meeting, church, support group,).
   2. This research 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 instructions, such as an evaluation of an educational practice, or an assessment of program designed to assist instructors with classroom management.
   3. May include minors if it the research meets other criteria.
2. Interactions
   1. This research only includes interactions involving educational tests (e.g., aptitude, diagnostic, cognitive, or achievement), survey procedures, interview procedures, or observation of public behavior. This can include visual or auditory recordings.
   2. The research must protect privacy by:
      1. Recording the information in such a way that the identity of any participants cannot be ascertained readily (either directly or indirectly); OR
      2. Ensure that any disclosure of the responses outside the research would not reasonably place any participants in danger, facing criminal/civil liability, or be possibly damaging to the participants’ financial standing, employability, educational advancement, or reputation; OR
      3. Have other adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
   3. May include minors if it is limited to educational tests and observation of public behaviors where the investigator does not participate in the activity being observed.
3. Behavioral Interventions
   1. This can involve behavioral interventions in conjunction with the collection of information through verbal or written responses or audiovisual recording.
   2. Participants must all prospectively agree to the behavioral intervention/recording.
   3. Must be brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact on the participants (e.g., playing a game online, solving a puzzle under various levels of noise conditions, or decision-making such as dividing an amount of cash between themselves and another person).
      1. Brief in duration is intended to refer to the intervention as opposed to the intervention and the data collection activities together. To be brief in duration, the intervention should last a few minutes to a few hours. The entire time for the intervention should occur in a single day and not exceed a few hours in its entirety.
   4. The investigator has no reason to think the intervention will be embarrassing or offensive to participants.
   5. The research must protect privacy through:
      1. Recording the information in such a way that the identity of any participants cannot be ascertained readily (either directly or indirectly); OR
      2. Ensure that any disclosure of the responses outside the research would not reasonably place any participants in danger, facing criminal or civil liability, or be possibly damaging to the participants’ financial standing, employability, educational advancement, or reputation, OR
      3. Have other adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
   6. The research cannot involve deceiving the participants regarding the nature or purposes of the research unless the participant has been informed they will be unaware or misled regarding the nature and/or purpose of the research.
   7. Cannot include data gathering with devices (EEG, ECG, MRI, etc.).
4. Secondary Research Without Consent
   1. This is for research that involves the use of either identifiable private information or identifiable biospecimens.
   2. This information or biospecimens must meet one of the following criteria:
      1. Publicly available; OR
      2. Recorded in such a way that the identity of the participants cannot readily be ascertained, the investigator will not contact the participants, and the investigator will not re-identify the participants; OR
      3. Involves only information collection and analysis involving the investigator’s use of identifiable health information when the use is regulated under §§45 CFR 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).
      4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information provided for non-research activities and meets specific criteria if there is identifiable information to be generated.
5. Federal Demonstration Projects
   1. This is research conducted or supported by a federal department or agency, or otherwise participant to the approval of Federal department or agency heads.
   2. The research or demonstration is 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.
   3. The research or demonstration project will be published on a list of research and demonstration projects exempted under this category prior to commencing the research.
6. Taste and Food Research
   1. This category involves taste and food quality evaluation and consumer acceptance studies where wholesome foods without additives are consumed, or 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
7. Collection of Data for Secondary Research with Consent
   1. This requires limited IRB review, but WCG processes it through the exempt submission pathway.
   2. This category involves storage or maintenance of identifiable private information or identifiable biospecimens collected for either research studies other than the proposed research or non-research purposes for potential secondary research use.
   3. Must either:
      1. Make no changes to the way the identifiable private information or biospecimens are stored or maintained; OR
      2. Ensure adequate protections to protect the privacy of participants and to maintain the confidentiality of data.
   4. Legally effective informed consent must be obtained using a standard consenting process as described for research that requires IRB review.
   5. The consent document requires the following elements of consent: risks, benefits, confidentiality, investigator contact information, independent contact information, injury contact information, a statement that the research is voluntary, information about the right to refuse participation, information about how to withdraw consent, disclosure of what types of research will be done, disclosure of what interventions might be used, the duration of the research, details of the research, and any information about return of results.
      1. If appropriate, the consent will include a statement that the participant’s biospecimens may be used for commercial profit and whether or not the participant should expect to share in this commercial profit.
      2. If appropriate, whether the research will or might include whole genome sequencing.
   6. The consent must be documented in writing or documentation must be waived in accordance with 45 CFR §46.117.
8. Use of Data for Secondary Research with Consent
   1. Consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens must have been obtained in a study that was reviewed in accordance with Category 7 above.
   2. The research must have adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
   3. The research must be within the scope of the consent.
   4. The investigator must not include returning individual research results to participants as part of the study plan.

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