Not Human Research Determinations

Research involving human subjects must receive IRB approval to be conducted.

Certain research involving only de-identified human data or biospecimens may meet the definition of Not Human Research (NHR).

At Fred Hutch, in general, investigators may not independently decide their research does not involve human research. Investigators who believe their research does not involve human subjects should submit form HRP-262 - Not Human Research Determination to request consideration by the Institutional Review Office (IRO). This must be submitted in Hutch IRB as a new study. (The exception is for projects only using pre-reviewed sources of data/biospecimens; see below for more information).

Not Human Research (NHR) determinations are made by IRO only for investigators whose primary appointment is at Fred Hutch. If an investigator’s primary appointment is at another institution, they should contact that institution’s IRB for assistance. 

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

Not all activities using de-identified materials qualify for a Not Human Research (NHR) determination, as there are several nuances to the decision. Please review the information below and contact IRO@fredhutch.org if you have questions about whether your project may meet the criteria for an NHR determination.

1. Pre-Reviewed Not Human Research (NHR) Sources of Data/Biospecimens

The IRB has pre-reviewed some data/biospecimens providers to assess whether all projects using ONLY those sources would presumptively qualify for a Not Human Research determination. Therefore, if the research involves ONLY de-identified human data or biospecimens obtained exclusively from the providers on the following list, no paperwork is required to be submitted to the IRO. Fred Hutch considers your research is presumptively Not Human Research.

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

To request an additional provider be added to the Pre-Reviewed Providers list, contact IRO@fredhutch.org. To be added to the list, providers may not offer collection-on-demand services.

2. Not Human Research (NHR) Using Other Sources of Data/Biospecimens

If your project uses de-identified human data, biospecimens, or cell lines obtained from other sources not on the pre-reviewed list described above, please use the questions and flow chart on form HRP-262 - Not Human Research Determination to help determine if the project may qualify for a Not Human Research (NHR) determination by the IRO, or if the project involves human subjects requiring IRB review.

Not Human Subjects Research Determination Form

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

HHS regulation 45 CFR 46.102(e)(1) defines human subject as follows:

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

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

An activity is Not Human Research if:

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

OR

• the provider of the data/biospecimens is not an investigator or collaborator in the research activity (e.g., you are not returning the results of your project to them), and
• the data/biospecimens 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.