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Human Subjects

Human Subjects? It's Yes or No

From the May 7, 2008, edition of NIAID funding news

We have been seeing applications that are incorrectly marked human subjects, which slows the processing of applications and awards.

Since the Office for Human Research Protections (OHRP) clarified what it considers as human subjects research, the six human subjects exemptions rarely apply to NIAID. Almost all research supported by NIAID is either "human subjects" or "not human subjects." See OHRP's Guidance on Research Involving Coded Private Information or Biological Specimens for more information.

So are you conducting human subjects research? Mark your application as "No Human Subjects Research" if your research involves human specimens or data from subjects and it meets all of the following conditions:

You are using coded private information, data, or specimens.
You are not collecting samples by interacting or intervening with living people.
None of the investigators or collaborators can identify subjects through coded private information or specimens (e.g., an investigator's access to identity is prohibited by a written agreement).

Follow the instructions for Scenario A: No Human Subjects Research in Part II of the Grant Application Guide. In the Protection of Human Subjects section of the Research Plan, remember to justify your claim that no human subjects are involved.

If you're not sure if your application proposes human subjects research, follow the decision tree for Research Involving Private Information or Biological Specimens or talk to your institutional review board.

For more information, see Are You Conducting Human Subjects Research? in our How to Write a Human Subjects Application tutorial and the Human Subjects in Research Requirements SOP.