Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy [45 CFR 46], whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

• working with humans directly (interaction or intervention) or indirectly (virtual/online/observational)
• obtaining, using, studying, or analyzing biospecimens from/about humans
• obtaining, using, studying, or analyzing data from/about humans (Note: If you are unsure about the type of data being obtained/used/created, select Yes).

• Microorganisms (e.g., bacteria, viruses, fungi, or parasitic agents), prions, or biological toxins (e.g., tetrodotoxin – Botox).
• Potentially infectious materials (e.g., soil, feces, wastewater, animal tissues, etc.)
• Human or non-human primate derived materials (e.g., cell lines, blood, tissues, sewage, etc.)
• Recombinant or synthetic nucleic acids

• Vertebrate animals (alive or dead)
• Vertebrate animal tissues
• Manipulating the behavior of vertebrate animals