Stanford IRB • SCRO • APLAC
IRB • SCRO Institutional Review Board IRB • SCRO • APLAC
IRB • SCRO • APLAC

Exempt Research

Overview

Research involving human subjects that is minimal risk and that falls under one or more categories defined below is considered exempt from many of the federal requirements for human subject research.  Studies that qualify for exemption must still be submitted to the IRB for an exempt determination before the research can begin. Exempt research typically includes one or more of the following activities: surveys or interviews; public observation; benign behavioral interventions; and analysis of existing data or specimens.

This page includes:

Exempt Categories

Although the federal regulations list eight exemption categories, Stanford has opted to implement six of those categories at this time.

CategoryDefinitionExamples

 

Category 1 - Educational Practices

 

Research conducted in established or commonly accepted educational settings, such as schools, colleges, libraries, after-school programs, and involves normal educational practices that are unlikely to negatively affect student learning or educator assessment.  This includes research on:

  • regular and special education instructional strategies; or
  • the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Limitations:

  • Excludes prisoners as a study population.
  • A study evaluating the effectiveness of a commonly used science curriculum.
  • A study comparing a new curriculum against a traditional curriculum by analysis of student course evaluations.
  • A study evaluating a new activity-based teaching strategy to see if it improves student engagement and learning.
  • A study comparing the effectiveness of online versus in person learning based on student engagement.

 

 

Category 2 - Educational Tests, Surveys, Interviews, Observation of Public Behavior

 

Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (where there is no expectation of privacy), if at least one of the following criteria is met:

i) information is collected in a manner so that subjects cannot be identified, and it is not possible to link the information with individual subjects directly or indirectly using a code;  

ii) sharing the subjects' responses outside the research would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation; or

iii) information is collected in a manner so that subjects can be identified, or it is  possible to link the information with individual subjects directly or indirectly using a code, and the IRB conducts a privacy and confidentiality (limited) review.

Limitations:

  • Excludes prisoners as a study population;
  • Children can only be included if study procedures are limited to educational tests or observations of public behavior, and the PD does not participate in the activity being observed.
  • A study conducting an anonymous online survey about spending habits (Category 2i).
  • A study observing children at a public park to evaluate social behaviors (Category 2i).
  • A study conducting a focus group on people’s opinions on the environmental impact of sustainable agriculture (Category 2ii).
  • A study conducting interviews with adults from a senior living facility that asks their opinions about local political issues (Category 2iii).

 

 

 

 

Category 3 - Benign Behavioral Interventions*

 

 

 

*Benign behavioral interventions are brief in duration (minutes to hours in a single day), harmless, painless, not physically invasive, don’t have a significant negative impact on subjects, and would not be considered offensive or embarrassing.  Examples include online games, solving puzzles under various noise conditions, or subjects deciding how to allocate cash received between themselves and someone else.

Research involving benign behavioral interventions and the collection of information, with the permission of the subject, through verbal or written responses or audiovisual recordings if at least one of the following criteria is met:

i) information is collected in a manner so that subjects cannot be identified, and it is not possible to link the information with individual subjects directly or indirectly using a code; 

ii) sharing the subjects' responses outside the research would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation; or

iii) information is collected in a manner so that subjects can be identified, or it is  possible to link the information with individual subjects directly or indirectly using a code, and the IRB conducts a privacy and confidentiality (limited) review. If the research involves deceiving or misleading subjects about the nature or purpose of the research, subjects must be informed of the deception and agree to participate in the study.

Limitations:

  • Excludes prisoners and children as a study population;
  • Information can only be collected from verbal and written responses, observation, and audiovisual recording.
  • A study that places educational materials about healthy eating practices in pediatric clinic waiting rooms and asks parents to complete anonymous pre- and post-surveys after reviewing the materials to assess whether they increase knowledge about healthy eating. The surveys will be placed in a box after completion (Category 3i).
  • A study that involves solving word puzzles while listening to world news reports (Category 3ii).
  • A study that includes asking subjects to memorize lines from a movie while being distracted by app notifications on a phone provided by the researcher.  Subjects are told they will not be informed about the purpose of the research (Category 3ii).
  • A study that includes completion of two 1-hour-long assessments of memory in which subjects are presented and must recall the order in which words are presented.  Subjects date of birth, cognitive status, and email will be collected (Category 3ii).
  • A study where subjects complete an executive function task before and after writing about a personal topic such as a job or a relationship. (Category 3iii)
Category 4 - Secondary Use of Data and Biospecimens

Secondary research (i.e. the re-use of identifiable information and identifiable biospecimens for research when they are initially collected for some other purpose) when consent is not required and if at least one of the following criteria is met:

i) The identifiable private information or identifiable biospecimens are publicly available; or

ii) Information, including information about biospecimens, is collected in a manner so that subjects cannot be identified, it is not possible to link the information with individual subjects directly or indirectly using a code, and the researchers will not contact or re-identify the subjects; or

iii) the research includes only the collection and analysis of identifiable health information that is protected by HIPAA or that is public health activity described under 45 CFR 164.512(b); or

iv) the research is conducted by or on behalf of the federal government using government generated or collected information that was obtained for non-research purposes. 

Limitations:

  • Cannot include any interaction with subjects;
  • Biospecimens are not covered under category 4iii.

 

  • A study involving the analysis of emails of a public figure made publicly available by the Department of Justice (Category 4i).
  • A study that analyzes coded blood samples obtained from a biobank to identify a link between a specific biomarker and a disease, where the researcher cannot re-identify subjects (Category 4ii).
  • A study where an investigator accesses identifiable educational records in a secure data center but is not allowed to remove identifiable information from the data center premises. (Category 4ii).
  • A study conducting a medical records review to analyze surgical outcomes (Category 4iii).
  • A study supported by the U.S. Department of Commerce involving the analysis of Census Bureau records available in a public registry (Category 4iv).

Category 5 - Public Service Programs

 

 

Research and demonstration projects which are conducted by or require the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs.

Limitations:

  • Research and demonstration projects must be federally supported or approved.
  • A study conducted by a federal department analyzing healthcare benefits offered to veterans, to improve efficiency and quality of care.
  • A study where the federal government funds and provides access to data for an assessment of Social Security benefits to be done by a Stanford researcher.
Category 6 - Taste and Food Quality

Taste and food quality evaluation and consumer acceptance studies, if food consumption includes:

a) wholesome foods without additives; or

b) a food ingredient at or below the level and for a use found to be safe by a federal agency.

Limitations:

  • Does not apply to research on vitamins or nutritional supplements.
  • A study assessing consumer acceptance of various types of plant-based meat products.
  • A study involving taste-testing of various cereal products that do not contain additives to determine consumer preference. 

Review of Exempt Research

After verifying that the research qualifies for exemption, the IRB will confirm the following additional requirements are met:

  1. The research is minimal risk;
  2. The selection of subjects is appropriate for the research;
  3. There are appropriate measures in place to maintain confidentiality when identifiable information is required for the research;
  4. There are appropriate measures in place to maintain privacy when there is interaction with subjects; and
  5. There is a consent process in place when there is interaction with subjects.  

Students may assume the role of Protocol Director on exempt studies, however an Academic Sponsor must also be included.

Exempt studies have no expiration date and do not require continuing review after the initial determination. The study should be closed out in eProtocol after the research is completed.

If the exempt research involves interaction with subjects, there should typically be a process to ask subjects for their agreement to participate in the research. An Exempt Research Information Sheet should include the following:

  • An explanation that the individual is being asked to participate in a research study
  • A clear description of the study procedures to be performed
  • A statement that participation is voluntary
  • The contact information of the researchers and the Stanford IRB for questions and concerns

Changes to Exempt Research

For exempt research, minor changes that do not change the risk level of the research and stay within what is permissible under the exempt categories can be made without requiring additional IRB review. Any significant changes to the research must be submitted with a Modification form to the IRB for review before implementing.

 Type of ModificationExamples
Significant Changes to Exempt research that REQUIRE IRB review
  • changing the Protocol Director (PD)
  • updating conflict of interest disclosures, funding source, or collaborators
  • addition of procedures that could affect risk to subjects
  • addition of study populations that would be considered vulnerable (i.e., children, prisoners, cognitively impaired)
  • collection of new subject identifiers or information protected by HIPAA
  • changing the method by which privacy and confidentiality will be maintained
  • Adding potentially sensitive questions to existing questionnaires. Examples of potentially sensitive topics include:
    • Questions about mental health or personal trauma
    • Illegal activities the subject may be involved in
    • Questions that may place subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, educational advancement, or reputation
  • Collection of new or additional information that could potentially be used to identify an individual
  • Adding the use of deception
  • Removing the consent process
  • Adding children as a study population
Minor Changes to Exempt Research that DO NOT REQUIRE IRB review
  • changes to (or the addition of) procedures that still fall under Exempt review
  • changes to study personnel (other than the PD)
  • changes to the consent form and/or process (i.e. how/when consent is obtained)
  • removing study population(s)
  • revisions to the recruitment method or materials
  • Addition of non-sensitive questions to a survey
  • Revising the study to remove children as participants
  • updating recruitment materials to better explain certain study details

Researchers should contact their IRB Manager for any questions about whether a change to the exempt research may require IRB review.