Training Requirements

Every human subjects research project at CSUB must first be reviewed and then authorized by the CSUB HSIRB to ensure that the project contains the necessary elements so that when carried out, the persons serving as human subjects/participants will be treated ethically. However, as the project is carried out, it is the researchers associated with that project that actually interact with the human subjects and therefore must implement the ethical practices that the HSIRB has made sure are in place. At this point, the ethical treatment of subjects is in the hands of project personnel, not the HSIRB. This is why the key personnel of each project must be trained and certified in Human Subjects Protection Training. It is essential that the integrity of the HSPT certification process at CSUB be guarded, given this is how this institution is able to pledge, to the subjects that the HSIRB protects and to the "outside world," that persons doing human subjects research at CSUB have been adequately trained.

Persons without adequate training may end up engaging in unethical research practices, which would be considered "research misconduct." This is not only wrong in terms of the treatment of persons serving as research subjects, it can lead to federal sanctions.

Other Resources

• Required Course Guides
• Sample CITI HSPT Certificate
• Selecting the Appropriate CITI Learner Group
• CITI Revised Common Rule Course
• CITI Program Instructions 

Individual Investigators (Faculty, Staff or Students): To conduct research involving human subjects (including handling subject’s data), you must complete the appropriate training prior to receiving HSIRB approval. You will complete the designated CITI Human Subjects Research (HSR) Course Curricula to either receive approval on a new protocol or to receive a renewal of an active protocol upon expiration.   

Research Advisors (Faculty or Staff):  All individuals serving as student research advisors supervising student research activity either in or out of the classroom are required to complete one of the CITI Human Subjects Research (HSR) Course Curricula.  CSUB’s CITI Course Curricula, includes four “learner groups”.  You will need to self-identify into one group based on your role in the research project and complete the modules that are required for that learner group.

Research Method Courses Instructors (Instructors):  All individuals teaching a Research Methods course where the disciplines’ research falls under the category of research as defined by the HSIRB as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” are required to complete one of the CITI Human Subjects Research (HSR) Course Curricula.  CSUB’s CITI Course Curricula, includes four “learner groups”.  You will need to self-identify into the “Students Conducting No More Than Minimal Risk Research” and complete the modules that are required for that learner group.

The learner groups are:

• HSIRB Members & Staff (14 modules)
• Principal Investigators (PI)/Researchers for Biomedical Research & Biomedical Data or Specimens (11 modules)
• PI/Researchers for Social-Behavioral-Educational Research (9 modules)
• Students Conducting No More Than Minimal Risk Research (6 modules)             

Depending on your learner group, each module takes approximately 10-25 minutes per module to complete. Certification will be valid for four years; thereafter, PIs will be required to take a Refresher Course (an abbreviated version of the initial training) f or subsequent renewal training.

Resources

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