Basic Exempt Criteria 45 CFR 46.101(b)(2)
Research includes evaluation of individuals using educational or cognitive tests, surveys, questionnaires, structured or open-ended interviews, or systematic observations of public behavior.
NOTE: Studies cannot be exempt if the participant's name (or other identifiers like birth date and initials, social security number, phone number, etc.) is linked to "private" or "sensitive" information (i.e., any information that could possibly affect the individual's reputation, employability, or financial standing). For example, if questions about medical history, substance use, mood state, sexual behaviors, and possible criminal activity are asked, identifiers cannot be linked to responses.
- If subjects are children, only educational tests and/or passive observation of behavior is permitted; investigators cannot interact with child subjects.
- If subjects are adults, tests, surveys, interviews or behavioral observations can be included.
- Data should ordinarily be recorded without identifiers.
- If appropriately justified, identifiers may be recorded, but only if no sensitive information is collected.
- Subjects (or their parents, if subjects are minors) should be provided with overview of project ("script") that contains basic elements of informed consent, but no formal written consent is obtained.
Additional Requirements or Considerations
- If subjects are followed over time and assessed repeatedly, written informed consent should be obtained (and the study submitted for expedited review) unless it is truly impracticable (e.g., the only contact with subjects is over the phone).
- Focus groups can be considered to be open-ended interviews, and may be approved for adults, provided the basic exempt criteria are met.
- If children are studied, investigators must provide a rationale for why a particular age range was selected, indicate their expertise in working with children, describe the adequacy of their facilities for pediatric research, and indicate whether they will have sufficient numbers of children to adequately address the research question.
- Copies of all measures must be attached for IRB review.
- When studies are conducted in foreign countries, written authorization to conduct the research at that location must be attached to this application. If identifiers are collected as part of that research activity, the investigator has the responsibility to ensure that responses to questionnaires or interviews about political, economic, cultural, or religious topic will not affect the participant's reputation, employability, or financial standing. This may require additional documentation from someone with first-hand familiarity with the country's laws and mores.
Exempt Form: Tests, Surveys, Interviews, Observations