IRB NON-MED EXEMPT FORM - Human Subjects - Stanford - humansubjects stanford 2025

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Exempt Categories: Education research. Surveys, interviews, educational tests, public observations (that do not involve children) Benign behavioral interventions. Analysis of previously-collected, identifiable info/specimens. Federal research/demonstration projects. Taste and food evaluation studies.
Research on Decedents: research that uses only human cadavers, cadaveric tissue, decedent medical/educational record information, or discarded decedent specimens from clinical use is not subject to prior review and approval by the IRB UNLESS the research study includes BOTH living and deceased individuals.
Research Involving Deceased Persons or Cadavers Under federal law, research involving deceased persons generally is not human subjects research and does not require review IRB review and approval. However, there are three exceptions. If the data or samples contain personal identifiers, the research is subject to HIPAA.
Examples of research that does not require IRB approval include: Internal management projects, such as program evaluation, quality assurance, quality improvement, or marketing studies.
A case report is a medical/educational activity that does not meet the DHHS definition of research, which is: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Therefore, the activity does not have to be reviewed by a

People also ask

Do I have to submit an application to the IRB? Studies that meet the definition of Human Subject Research must be submitted to the IRB and must receive IRB approval before any study activities take place.
Human subjects research studies that do not qualify for an exemption are referred to as non- exempt human subjects research. Unless there is a Secretarial waiver, they must comply with the Common Rule regulatory requirements, including IRB review and approval, before the research can begin.
Not Human Subjects Research Description In such cases, IRB review is not required. The PI makes and certifies this determination. In order for your use of data and/or biological specimens to not meet the definition of a human subject, all of the following conditions must apply: The research is not FDA-regulated.

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