Research not Involving Human Subjects: Frequently Asked Questions

The IRO keeps track of Research not Involving Human Subjects. Investigators who believe they are carrying out this kind of activity should submit the proper forms (described below) to the IRO. The FHCRC IRB determines whether research involves human subjects or not.

How can I tell if my activity is Research not Involving Human Subjects?

For a complete explanation, see our Human Subjects Research Determination Form 

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

Here is a brief summary. HHS regulations define 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.

45 CFR 46.102(f).

An activity is Research not Involving Human Subjects if it exclusively involves one or more of the following:

• human cells obtained from a commercial provider
• human cells about which the accompanying information is publicly available
• unidentifiable specimens or information/data obtained from a commercial provider
• unidentifiable specimens or information data obtained from a provider that is prohibited from releasing identifiers by established regulations or policies

Other possibilities for making this determination include studies where

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

or

• the provider is not an investigator in the 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.

If I think my activity is Research not Involving Human Subjects, what should I do?

• Fill out the Human Subjects Research Determination Form 
  Submit with a Protocol Disposition Form updated August 05, 2009.
  
• Submit a letter from the company or institution providing samples or data, documenting that the samples or data were gathered in compliance with regulations of human subjects research. The IRO will keep the Flow Chart and letter on file.

Why is this necessary?

Making this distinction before submitting funding applications has helped clear up confusion between investigators and the NIH project officers evaluating new proposals. Note: the FDA does not recognize this distinction.

What if I should have submitted an application for exemption instead?

IRO staff will help you to re-submit the appropriate forms before the IRB reviews the activity.

Questions?  Contact James Riddle (IRO Assistant Director) at 667-6501 or Karen Hansen (IRO Director) at 667-4867.