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Not Human Subjects Research Determinations

Relevant IRB Policies/Procedures

The IRO keeps track of research activities which use de-identified human data or specimens but do not meet the definition of Human Subjects Research. The Fred Hutch IRB determines whether the research activity involves human subjects or not. If the research activity involves human subjects, it will require IRB review.

Investigators who believe their research with de-identified human data or specimens does not involve human subjects should submit an IRB Application (No Contact) to the IRO.

How Can I Tell if My Research Activity Involves Human Subjects or Not?

1. Research using de-identified human data, specimens, or cell lines from certain sources are presumptively determined to be Not Human Subjects research: The IRB has pre-reviewed a number of de-identified data and specimen providers. If your research involves de-identified human data or specimens obtained exclusively from providers on the following list, then your research is "presumptively" considered Not Human Subject's research and no additional paperwork is required to be submitted to the IRO.

* IRB Pre-Reviewed Sources of De-identified Human Specimens and/or Data

To request an additional source be added to the Pre-Reviewed Providers list please contact the IRO department.

2. Research using de-identified human data, specimens, or cell lines obtained from other sources not on the pre-reviewed list: Investigators should use the questions and flow chart on the Not Human Subjects Research Determination Form to determine if their research project may qualify for a Not Human Subjects (NHS) determination or if IRB review will be required.

Not Human Subjects Research Determination Form

Following is a brief summary of how the IRB will determine if your project is or is not human subjects research requiring IRB review.

HHS regulation 45 CFR 46.102(f) defines human subject as follows:

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

  1. data through intervention or interaction with the individual, or
  2. identifiable private information.

An activity is Research not Involving Human Subjects if:

  • there is no interaction or intervention with living individuals, and
  • neither the provider of the specimens/data nor the recipient can link the specimens/data with identifiable individuals (living or dead)

OR

  • the provider of the specimens/data is not an investigator or collaborator in the research activity, and
  • the specimens/data have no code linking them with identifiable individuals, or it would be impossible for the recipient to use the code to identify someone because the provider of the specimens/data is prohibited from releasing identifiers.

For an even more complete explanation, see the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens.

Why is This Determination Necessary?

The Office for Human Research Protections (OHRP) requires institutions to have a process for tracking research involving coded human biologic specimens and data. For more information, see the OHRP Guidance on Research Involving Coded Private Information or Biologic Specimens.