Human Subjects

Required human subjects training

All key personnel and any researchers directly interacting with human subjects as part of a research study at IU must complete training requirements every five years.

You must complete one of the following courses through the Collaborative Institutional Training Initiative (CITI) program:

• If you are mainly engaged in biomedical research, complete Biomedical Researcher, Stage 1.
• If you are mainly engaged in social or behavioral research, complete Social/Behavioral/Educational Researchers, Stage 1.
• If you are a VA researcher, complete the VA CITI course, and affiliate your CITI account with Indiana University. The VA CITI course fulfills the Indiana University researcher education requirement for VA researchers. Note, this training is required every three years.

Access the Collaborative Institutional Training Initiative (CITI) program

For community collaborators engaged in research with an IU investigator, the CIRTification training can be an option in lieu of completing the above-named CITI program. Please contact the Human Research Protection Program at irb@iu.edu to find out if this training option is right for you. 

Access the CIRTification training

Required training for clinical practice

Good Clinical Practice is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. It also serves to protect the rights, integrity, and confidentiality of clinical trial subjects.

IU GCP requirements

IU requires that principal investigators and co-principal investigators of interventional clinical trials, regardless of funding, complete Good Clinical Practice training before the trial can begin. This may include any of the following:

• GCP course
• Academic training program
• Certification from a recognized clinical research professional organization.

NIH GCP requirements

The National Institutes of Health requires that all investigators and any clinical trial staff responsible for the conduct, management, and/or oversight of any NIH-funded clinical trials complete GCP training before the trial can begin. This may include any of the following:

• GCP course
• Academic training program
• Certification from a recognized clinical research professional organization.