Procedure 2: Human Subjects Research Eligible for Exemption

Effective Date: 23 April 2026
Responsible Office: Office of the Vice Provost for Research
Last Updated: 03 August 2026

I. Scope & Purpose

This procedure applies to all faculty, staff, students, and affiliated researchers working within the scope of their roles at William & Mary (W&M) who conduct human subject research as defined by federal regulations (45 CFR 46) and overseen by the W&M Institutional Review Board (IRB).

The purpose of this procedure is to outline W&M IRB’s standard operating practices for conducting administrative review that results in an exemption determination.

II. Definitions

1. Benign Behavioral Interventions: Benign behavioral interventions are brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the participants, and the investigator has no reason to think the participants will find the interventions offensive or embarrassing. Benign behavioral interventions can never be a clinical trial.
2. Deception: Deception refers to providing false information to prospective participants.
3. Exemption: Exemption from the federal regulations governing human subjects research at 45 CFR 46 includes activities in which the only involvement of human participants will be in one or more of the categories detailed in 45 CFR 46.104(d) and Appendix A of this procedure. Research studies that fall into the eligible categories are not required to adhere to the federal regulations governing research with human participants but are required to adhere to any other applicable laws, contractual obligations, and W&M University policies, procedures, and standards.
4. Exemption Determination: A determination made by the W&M IRB regarding a submitted human subjects research protocol.
5. FLEX Exemption: When a study is solely subject to the W&M policy for human subjects’ research and not subject to the federal regulations at 45 CFR 46 governing research with human participants, some research protocols may be reviewed and approved under the W&M special exemption category - “FLEX Exemption,” This review process and determination is designed to provide ethical protections equivalent to those found in 45 CFR 46, while also reducing administrative workload and regulatory excess. Refer to section B of this SOP for details.
6. Funded or Sponsored Research: A sponsored or funded research project has a defined scope of work and a set of objectives supported by external funds.
7. Incomplete Disclosure: Incomplete disclosure is when information about the real purpose or nature of the research is withheld from participants.
8. Limited Review: A limited review pertains to research in which the primary risks to participants relate to privacy and confidentiality. Research that qualifies for an exemption requiring limited IRB review would have required IRB review and approval either through the expedited review procedure or by a convened IRB review under the pre-2018 Requirements. A limited review is performed by an IRB board member where, as opposed to considering all the criteria for IRB approval, the reviewer must review specific, more limited aspects of a proposed research study related to participant privacy and confidentiality. A determination that there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data must be found.
9. Minimal Risk: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
10. Not Human Subjects Research: Research activities are considered “Not Human Subjects Research (NHSR)” when they do not meet the definition of “research” or “human subjects” as defined by 45 CFR 46, and the W&M University Policy for completing research with human participants.
11. Readily Ascertainable: Readily ascertainable is when the identity of the individual participant can be obtained, discovered, or determined without significant difficulty or effort. Identities of participants are considered “readily ascertainable” when the data are:
    • directly identifiable,
    • linked to a master list that the researcher(s) can access,
    • indirectly identifiable to any member of the research team due to their access, role, or expertise, or
    • identifiable from the content of the data, triangulation of data points, pairing with other data, or sample size.

III. Procedure

All W&M University researchers conducting human subjects research must submit an IRB protocol to the IRB for review and approval before implementation, including study protocols eligible for exemption.

When an IRB protocol is required to be reviewed under 45 CFR 46, the IRB Chair (or their designee(s)) will conduct reviews resulting in an exemption determination for minimal risk research eligible for exemption under 45 CFR 46 and the W&M University Policy, including this standard.

 When not obligated to apply 45 CFR 46 to an IRB protocol, the IRB Chair (or their designee(s) will conduct reviews resulting in an exemption determination for minimal risk research in accordance with only the W&M University Policy, including this standard.

A. Research subject to 45 CFR 46 and William & Mary University Policy

1. All Exemption Categories under 45 CFR 46 as noted in Appendix A and limitations detailed in Section E of this procedure, are applicable when research with human participants is considered:
   1. Subject to the DoD, USDA, FDA regulations, or any other signatories of the Common Rule, or
   2. Sponsored or Funded from any external source, or
   3. Contractually Obligated, or
   4. Associated with an Agreement, or
   5. Cooperative
2. All Exemption Categories under 45 CFR 46, as noted in Appendix A and limitations detailed in Section E of this procedure, are applicable when research with human participants may become funded. This includes a plan for future federal sponsorship (e.g., proof of concept studies for federal RFPs, pilot studies intended to support a federal grant application, training and program project grants, no-cost extensions).

B. Research Solely Subject to William & Mary University Policy

1. All Exemption Categories under 45 CFR 46 as noted in Appendix A of this procedure, are applicable to this section. 
2. W&M FLEX Exemption Category: 
   1. W&M’s FLEX special exemption category is designed to provide protections equivalent to those found in 45 CFR 46, while also reducing administrative workload and regulatory excess.
3. Research Protocol Eligibility for W&M FLEX Exemption: Research that is eligible for FLEX exemption are those that are not listed in Section II.A of this policy and are no more than minimal risk to participants. Participants can be adults and/or minors, and the research can include one or more of the following research procedures:
   1. benign behavioral interventions;
   2. observations of behavior, surveys, interviews, or focus groups;
   3. non-invasive collection of human body data such as weight measurement using a scale, height measurement using a tape measure, or tracking eye movement with an eye tracker; or
   4. use of secondary private identifiable or indirectly identifiable data for research.
4. Post-Approval Obligations for FLEX Special Exemption Category Studies
   1. After a study is approved by the W&M IRB office under the FLEX special exemption category, the Principal Investigator is responsible for submitting project revisions to the W&M IRB office in advance of initiating any changes
   2. If the proposed revisions render the study ineligible for the FLEX special exemption category, the PI must revise the protocol to bring it into compliance with 45 CFR 46. It is the responsibility of the PI to notify the W&M IRB office of any changes related to eligibility for the FLEX special exemption category.
   3. Adherence to post-approval requirements for exemptions as stated in D of this document.

C. Submission and Approval of Research Eligible for Exemption

1. Exempt Protocol Submission: Submission of an exemption request entails submitting a “Request for Exemption” application to the W&M IRB with appropriate materials. All applications must include the following materials:
   1. Consent information (use the appropriate W&M IRB consent template for exempt research)
   2. All stimuli, measures, and instruments (e.g.: surveys, interview protocols, focus group protocols, observation protocols, benign behavioral intervention protocols, taste test protocols)
   3. Any additional documentation required by the IRB office such as IRB required conditional procedures applicable to all W&M researchers
   4. Recruitment information such as email templates, phone scripts, social media posts, SONA descriptions, etc.
   5. Proof of human subjects research training completion for all research team members who recruit and consent participants, collect data from participants, implement the intervention with participants, or analyze private identifiable data used in the research project.
      • The lead PI is responsible for tracking undergraduate researchers and their training. The IRB application should be updated when students leave or join research protocols.
   6. Where applicable, exemption applications must also include:
      1. A NIH Data Management and Sharing Plan if the study is funded or supported by NIH
      2. When the research involves the use of “sensitive data,” an attestation that the researchers will work with W&M IT to ensure compliance with applicable laws and university policies. 
      3. Any relevant agreements such as a data use agreement
      4. An implemented “broad consent addendum” form used at primary data collection if the research team wishes to use secondary data from a project where “broad consent” was sought and given by participants
      5. Debriefing materials if deception or incomplete disclosure will occur in the study
      6. Forms sent to participants/guardians regarding recordings in classrooms.
      7. The HIPAA authorization form that was used/will be used with participants/guardians or the submission of a HIPAA waiver request form.
      8. The FERPA permission information used with participants and guardians (which can be integrated into the Consent process).
2. Exempt Protocol Approval: The IRB office will review and approve exemption requests in accordance with 45 CFR 46 and the W&M FLEX special exemption category as noted in this document. Once the IRB office approves a study as exempt, approval for the protocol does not expire. Modifications must be submitted in accordance with section D of this procedure. At initial approval, some exemption requests require the IRB to complete a “limited review” for issues related to participant privacy and confidentiality.
   1. A limited review is part of the federal regulations requiring that “there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data” for research studies qualifying for exemption.
   2. When conducting a limited review for studies eligible for exemption under 45 CFR 46(d)7, the IRB office must ensure that:
      1. adequate provisions to protect the privacy of participants and to maintain the confidentiality of data are in place;
      2. broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained;
      3. broad consent is appropriately documented, or waiver of documentation is appropriate; and
      4. if there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
   3. At W&M, a limited review may be performed by an IRB board member. The following elements will be evaluated during a limited review: An assessment of the procedures and information shared with participants regarding their personal privacy during the implementation of research procedures and their confidentiality during data management.
      1. The IRB reviewer may require specific information to be disclosed to participants during the consent process.
      2. The IRB reviewer may require additional procedures be implemented to ensure adequate participant protections or disclosure
   4. Data sensitivity and classification
      1. Data classified by the IRB as sensitive may be associated with a study that is eligible for exemption. There are some situational exclusions.
      2. For all studies involving sensitive data, it is expected that the researcher will attest that the researchers will work with W&M IT to ensure compliance with applicable data laws and University policies.

D. Post Approval Obligations for Exempt Research

1. All exempt protocols are subject to the W&M SOP for Amendments, Renewals, Transfers, and Closures.
2. Amendments to Exempt Protocols
   1. Protocol modifications that require an amendment to the approved exempt protocol:
      1. Change in engaged research personnel
      2. Addition of funding and/or subsequent changes in the project’s funding.
      3. Additions or changes to participant groups. Examples include addition of minors, pregnant people, incarcerated people, participant populations that are contextually vulnerable, or participant group(s)not initially described in the approved protocol.
      4. Addition or changes to data collection procedures. Examples include new surveys, interviews, or observations protocols or changes to existing surveys, interviews, or observation protocols.
      5. Addition of a dataset that requires a data use agreement, material transfer agreement, or addition of any identifiable or indirectly identifiable data that is not publicly available. For example, records may be subject to FERPA even if a member of the research team already has access to the data due to their role as an educator.
      6. Addition of any information that will be collected that directly links the participant to the study or the study data. For example, the collection of identifiable information to provide compensation to one or more participant
      7. Addition of audio or video recording of participants, use of photography, screen recording, and/or motion tracking.
      8. Addition of multimedia such as videos and/or images that participants will view.
      9. Addition or change to compensation.
      10. Addition or changes to any procedures that are physical in nature.
      11. Correction of documents beyond spelling, grammar, background pictures, or one-word replacements that do not affect the meaning of the sentence or study.
   2. Protocol modifications that do not require IRB approval for Exempt protocols
      1. Change in participant numbers if the change is no more or less than 10% of the approved amount listed in the IRB application and supporting documents.
      2. Minor editorial changes (such as punctuation, single word changes, or grammar) or re-ordering of questions
   3. Approval Renewal for Exemptions
      • Unless otherwise specified, research studies that qualify for an exemption do not require annual renewal. There may be exceptions based on study-specific contextual factors. Exempt studies will be assigned an “administrative check-in date” that serves as a reminder for the research team to review their protocol and ensure that no updates are needed.

E. Participant Group(s) Eligible to Participate in Exempt Research

1. People who are pregnant can be involved in all research categories eligible for exemption under both the 45 CFR 46 and the W&M FLEX special exemption category.
2. People who are incarcerated may only be involved in research eligible for exemption under both the 45 CFR 46 and the W&M FLEX special exemption category if the research is aimed at involving a broader participant population that only incidentally includes people who are incarcerated
3. People who are under the age of 18 years of age (or are legally considered a minor) have restrictions regarding involvement in research
   1. When subject to 45 CFR 46, minors may be involved in the following research procedures:
      1. Minors may be involved in research considered normal educational research in educational settings, under exemption category d.1.
      2. Minors may be involved in research involving observations for research purposes in public when the investigator(s) do not participate in the activities being observed, under category d.2.
      3. Minors may be involved in research use where secondary information is used as research data, under category d.4.
      4. Minors may be involved in research considered a taste and food quality evaluation and consumer acceptance, under category d.6.
      5. Minors may be involved in research including the storage, maintenance, and use of secondary research data when broad consent was initially sought and documented, under categories d.7 and d.8
   2. When subject to 45 CFR 46, minors may not be involved in the following research procedures:
      1. Minors may not be involved in research involving surveys, interviews, focus groups, or observations of private activities.
      2. Minors may not be involved in research involving surveys, interviews, focus groups, and observations of private activities. Minors may be observed for research purposes in public when the investigator(s) do not participate in the activities being observed.
      3. Minors may not be involved in research involving benign behavioral interventions. 
   3. When not subject to 45 CFR 46, the research may be reviewed under the William & Mary FLEX special exemption categories, allowing the use of the following procedures with minors:
      1. Surveys, interviews, and focus groups;
      2. Benign behavior interventions;
      3. Non-invasive collection of human body data such as weight measurement using a scale, height measurement using a tape measure, or tracking eye movement with an eye tracker;
      4. Use of secondary private identifiable/indirectly identifiable data for research.

IV. Authority & Amendment

This procedure was approved by the William & Mary IRB on April 4, 2026. This procedure will be reviewed every 2 years to ensure it remains relevant, usable, and in compliance with university policy and relevant law.

V. Related Policy & Procedures

• Federal Regulations Governing Research with Human Subjects 45 CFR 46
• The Belmont Report
• Nuremberg Code of 1947
• Office for Human Research Protections (OHRP)
• Code of Virginia, Research with Human Subjects
• William & Mary Policy for Conflicts of Interest
• William & Mary Policy for Financial Conflicts of Interest
• William & Mary Research Compliance Website
• William & Mary Data Classification and Protection Policy
• DoD Regulations Governing Research with Human Subjects 32.CFR.219
  •  DoD Instructions 3216.02
• NIH Website for Human Subjects’ Research
• NSF Website for Human Subjects’ Research
• William & Mary’s Policy for Research with Human Subjects

Appendix A

Studies Eligible for Exemption under 45 CFR 46

 The sections below detail the exemption categories from 45 CFR 46 for minimal risk research activities. The W&M IRB makes all exemption determinations.

1. Exempt category d.1 includes research conducted in established or commonly accepted educational settings that involve normal educational practices that do not adversely influence students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
   • The research procedures must take place in an established or commonly accepted educational setting and involve normal educational practices.
   • Researchers must justify how the proposed research setting qualifies as an “established” or “commonly accepted” educational setting and how the research activity is a “normal educational practice on behalf of educational agencies or institutions to develop, validate, or administer predictive tests; administer student aid programs; or improve instruction.”
   • Example settings: school, after school clubs, distance and online learning environments, conferences, study abroad programs, a place where formal training or learning occurs, and other settings deemed culturally appropriate for education and training to occur
   • Example activities: classroom observation, use of assessment/evaluation information, most action research, access to some FERPA data if developing or validating tests or instruction, professional development workshops, massive open online courses (MOOCs), and experiments with instructional design (as long as they are not radically innovative)
2. Exempt category d.2 is research that includes educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   • The information obtained is recorded by the investigator in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participants.
   • Any disclosure of the research participants’ responses would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, educational advancement, or reputation.
   • Readily ascertainable: if the data are directly identifiable linked to a master list that the researcher(s) can access, indirectly identifiable to anyone on the research team where an individual can be identified from the data due to researcher(s) access, role, or expertise, or participant can be identified from the content of data, triangulation of data content, pairing the research data with other data, or participant group/subgroup size
   • The information obtained is recorded by the investigator in such a manner that the identity of the participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB conducts a limited IRB review.
3. Exempt category d.3 is research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participants;
   2. Any disclosure of the participants’ responses would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, educational advancement, or reputation;
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB conducts a limited IRB review;
   4. If the research involves deceiving the participants (including leaving out pertinent information) regarding the nature or purposes of the research, in order for the study to be eligible for exemption, the participant must prospectively agree (via consent) to participate in research where they will be unaware of or misled regarding the nature or purposes of the research.
4. Exempt category d.4 is secondary data research for which consent is not required: Secondary research uses identifiable private information and/or identifiable biospecimens when at least one of the following criteria is met:
   1. The identifiable private information and/or biospecimens are publicly available;
   2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human participants cannot readily be ascertained directly or through identifiers linked to the participants, the investigator does not contact the participants, and the investigator will not re-identify participants;
   3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA.
   4. This identifiable private data is considered under W&M data categorization as either “protected” or “sensitive” data for which a data access and security plan must be submitted with the exemption application.
   5. If the data are a “limited data set” under HIPAA, a data use agreement (DUA) is likely required by the data provider, and it must be uploaded to the exemption application.
   6. If the data are covered under HIPAA and identifiable as defined by HIPAA, a Business Associate’s Agreement (BAA) is likely required by the data provider and it must be uploaded to the exemption application.
5. Exemption category d.5 is a review category rarely used at W&M because it includes “research and demonstration projects conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads […] and are 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.”
6. Exemption category d.6 are studies on taste and food quality evaluation and consumer acceptance studies if they include:
   1. Consumption of wholesome foods without additives or
   2. Consumption of a food 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. Exemption category d.7 for storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review
   • This review category allows for the storage and maintenance of private identifiable data or biospecimens.
   • A limited review must be completed by the IRB for this category to be used.
8. Exemption Category d.8 for secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
   1. Broad consent for the storage, maintenance, and future use of the identifiable private information or identifiable biospecimens was previously obtained;
   2. Documentation of informed consent or a full waiver of documentation of consent was previously obtained;
   3. An IRB conducts a limited IRB review and makes the determination that the research to be conducted is within the scope of the broad consent; and
   4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prohibit an investigator from complying with legal requirements to return individual research results.