NIH Requirements on Education in the Protection of Human Subjects

Who must receive human subjects education/training?

Individuals who will be involved in the design or conduct of NIH-funded human subjects research must fulfill the education requirement, regardless of whether or not they receive compensation from the award and even if the human subjects research is exempt from Institutional Review Board (IRB) review. This includes key personnel:

  • Affiliated with consortium participants
  • Located at alternate performance sites
  • Involved in foreign awards and subcontracts, and
  • Employed by third parties
  • Serving as consultants.

Key project personnel who are not involved in the design and conduct of human subjects research do not need to comply with this requirement.

What are the PI’s responsibilities?

It is the responsibility of the named Principal Investigator (PI) of an NIH-funded project to:

  • Identify key project personnel involved in the design and conduct of research involving human subjects.
  • Ensure identified key project personnel receive human subjects training at least once during the project period.
  • Provide SPO with a statement at the Just-in-Time stage certifying that all key personnel have received training in the protection of human subjects or that the research is exempt from the training requirement.
  • Document that any key project personnel added to an award in a non-competing year have received the required human subjects education in the non-competing Progress Report.

What documentation does NIH require?

The NIH Institute/Center funding the project may request documentation that all key personnel responsible for the design or conduct of the study involving human subjects have received the required education prior to issuing the award. If such a request is made SPO will require that the PI complete and submit the Human Subjects Training Certification Form. Typically this occurs at the Just-in-Time (JIT) stage.

After the PI submits this form, SPO will affix the “authorized institutional signature” and provide this form to the Grants Management Official. Note: The award may be delayed in its entirety or NIH Staff may choose to issue an award restricting all human subjects research until documentation of completion of the education requirement has been received.

If Key Personnel are added to an award in a non-competing year, documentation that they have received the required education should be included in the non-competing Progress Report.

What type of education/training is required?

NIH does not require a specific course of study. See CITI Training: Required Human Subjects Research Training for UC Berkeley Faculty, Staff, and Students on the CPHS website for more information.