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Required Education in the Protection of Human Research Participants

Individuals who will be involved in the design or conduct of human subjects research must fulfill the education requirement. These individuals are considered to be "key personnel" and include Principal Investigator(s) on research involving human subjects, all individuals responsible for the design or conduct of the study, and those individuals identified as key personnel of consortium participants or alternate performance sites if they are participating in research that involves human subjects. 

All IRB applications to the Committee must contain a copy of the Assurance Training Certificate for all personnel who are to participate in the proposed research. Certificates must be current within 5 years.

Caltech accepts Assurance Training Certificates from CITI and current NIH certificates.

CITI (available through access.caltech)

Caltech also provides training via the Collaborative Institutional Training Initiative (CITI). 

You may access the CITI Protection of Human Research Subjects course by logging into access.caltech and clicking "Research Ethics Education (CITI)."  To add the Human Research Subjects courses, click "View Course."  On the next page you will see your active courses, and at the bottom of the page you will see "Learner Tools For California Institute of Technology."  Click on "Add A Course" and complete the questions that will guide you to taking the appropriate courses and modules that Caltech requires for the type of research you will be conducting. 

Please choose one learner group based on your role and the type of human subjects activities you will conduct. You will be enrolled in the Basic Course and Caltech specific modules (required) for that group.  If applicable, you will be instructed to complete additional supplemental modules based upon your research. 

IF YOU WILL BE RECRUITING ON CAMPUS and expect to recruit Caltech students or staff, you will be required to take the following additional Modules:  Vulnerable Subjects - Research Involving Workers/Employees (ID: 483) and Students in Research (ID: 1321).

Social, Behavioral and Educational (SBE) Research.  This studies human motivations, activities, psychological processes and interactions.  Most researchers in the Division of Humanities and Social Sciences will take this course.

Biomedical  (BIO) Research.  These studies include working with human subjects and patients, receiving samples/specimens or medical data from a collaborator, and device testing.  Most researchers in the Divisions of Engineering and Applied Science, Chemistry and Chemical Engineering, and Biology and Biological Engineering will take this course.

 If you have any questions about which courses you are required to take, please contact the IRB Administrator at irb@caltech.edu or  626-395-4699

The Course Options availble are:

  • Social & Behaviorial Research - Basic/Refresher  
  • Biomedical Research - Basic/Refresher
  • Students - Class Projects (for students conducting no more than minimal risk research)
  • Good Clinical Practices (GCP) for Clinical Investigations of Devices 
  • GCP -  Social and Behavioral Research Best Practices for Clinical Research

Please see CITI Modules for Human Subjects Research for a list of the modules for each course. Basic modules are assigned by CITI.  The IRB may ask you to compled additional Supplemental modules (as required by your research). 

In addition, if you are receiving DARPA, DOD, or DON support for your human subjects research at Caltech, you may be obligated to take additional CITI training specific to your sponsor. Please contact orc@caltech.edu if you think you need this training.

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NIH Protecting Human Research Particpants

This option is no longer availble from the NIH as of September 26, 2018.  Please see the follwing announcment from the NIH: 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-221.html

Current certificates are valid.  

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