Exempt Research Categories

Category 1 - Education Research

Research, conducted in established or commonly accepted educational settings, that specifically 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 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.

Notes about involving children

  • Children can be included in this category of research.

Examples:

  • Evaluating a new curriculum or delivery methodology
  • An evaluation of a continuing education workshop

Category 2 - Surveys, Interviews, Educational Tests, and Public Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if 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 subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
    • Data Identifiability: Research data is anonymous (identifiers are never collected), and participants cannot be re-identified.
  2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
    • Data Identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID), or anonymous (identifiers are never collected).
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
    • Data Identifiability: Research data is identifiable or de-identified (data is linked to identifiers using a study ID).

Notes about involving children:

  • Only criteria (i) and (ii) can include children; criterion (iii) cannot involve children.
  • Children can be included when research will involve the use of educational tests (cognitive, diagnostic, aptitude, achievement) or when the investigator will observe public behavior but does not participate in that behavior or activity.
  • Children cannot be included when research will involve the use of survey procedures, interview procedures, or observation of public behavior when investigators will be involved in the activity. .

Examples:

  • Conducting a quality of life survey
  • Conducting a focus group about an experience or program
  • Interviewing physicians about patient management practices
  • Administering a numerical aptitude test and a working memory cognitive test to children
  • Observing elementary children playground interactions, as long as the investigator has no involvement or does not manipulate the environment in any way

Category 3 - Benign Behavioral Interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject 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 subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
    • Data Identifiability: Research data is anonymous (identifiers are never collected), and participants cannot be re-identified.
  2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
    • Data Identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID), or anonymous (identifiers are never collected).
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
    • Data Identifiability: Research data is identifiable or de-identified (data is linked to identifiers using a study ID).

Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Notes about involving children:

  • Children cannot be included in this category of research.

Examples:

  • Having subjects play an online game and then answer questions about it
  • Video recording subjects solving puzzles under various noise conditions
  • Having subjects decide how to allocate a nominal amount of received cash between themselves and someone else

Category 4 - Secondary Data or Specimen Research that Does Not Require Consent

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:.

  1. The identifiable private information or identifiable biospecimens are publicly available;
    • VCU’s Interpretation of Publicly Available: “Publicly available” refers to situations where a member of the general public could request information or biospecimens. Examples include data and specimens that are commercially available, available upon request or for a fee, or available under other conditions (such as having to register for an account or sign a privacy agreement)
    • Data Identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID), or anonymous
  2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
    • Data Identifiability: Research data is anonymous, and participants cannot be re-identified. Neither identifiers nor key linking study ID with identifiers may be retained at any point during the conduct of the research.
  3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated by HIPAA (45 CFR 160, 164(A) and (E)) for the purposes of health care operations, research, or public health activities and purposes
    • Limitation: This category applies when information is obtained from an entity regulated by HIPAA and that information will continue to be maintained within either the same HIPAA-covered entity or another HIPAA-covered entity. If information is moved or shared to an outside entity NOT regulated by HIPAA the research will need expedited review.
    • Data Identifiability: Research data can be identifiable or de-identified (data is linked to identifiers using a study ID).
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with federal standards for safeguarding privacy
    • Data Identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID), or anonymous.

Notes about involving children:

  • Children can be included in this category of research.

Examples:

  • Analyzing publicly accessible Facebook posts (criteria i)
  • An investigator obtains a list of MRN from the Informatics Core of patients records that meet the eligibility criteria. The investigator uses the MRN only to look up the relevant charts but does not write the MRN down anywhere in or connected to the research data. No other identifiers are written down in the research data. There is no way to go back to that particular patient’s chart later to collect additional information. (criteria ii)
  • An investigator receives an anonymous dataset from a registry (criteria ii)
  • Analyzing anonymous waste tissue samples (criteria ii)
  • Analyzing medical records of patients when the data is not shared outside the VCU HIPAA Covered Entity and when consent is not required (criteria iii)
  • Conducting analyses of national student exam scores at the request of (or under contract to) the Department of Education (criteria iv)

Category 5 - Public Benefit or Service Program Research

Research and demonstration projects that 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,

AND that are

  • conducted by a Federal department or agency,
  • upported by a Federal department or agency, OR
  • that are otherwise subject to the approval of [Federal] department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated to conduct the project).

Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

See OHRP guidance on types of programs that qualify for this exemption.

Notes about involving children:

  • Children can be included in this category of research.

Examples:

  • Initiating and evaluating a program supported by a Federal grant that administers financial or medical benefits under the Social Security Act.
  • A state department received a federal award to administer a demonstration project with the state Medicaid services. The VCU investigator will evaluate the program as a consultant for the state department.

Category 6 - Taste and Food Quality Evaluation and Consumer Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level 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.

Notes about involving children:

  • Children can be included in this category of research.

At this time, VCU is NOT implementing exemption categories 7 and 8.