Clinical Research Support
Clinical Trials Education Office (CTEO)
Human Subject Protection Training (CITI)
DF/HCC policy requires that all individuals involved in clinical research are trained in human research protection issues. DF/HCC has selected the Collaborative Institutional Training Initiative (CITI) course as the required form of training. This is an on-line course accessible via: https://www.citiprogram.org
All DF/HCC investigators and research personnel must complete the education program before being added to a research protocol and must continue to supplement this training by completing a refresher course every three years. Members of the Institutional Review Board and Scientific Review Committee must also complete human research protection training.
If individuals have completed training at one of the Harvard-affiliated institutions, DF/HCC will accept that training as long as there is evidence of completion.
To access a list of individuals that have completed human subject protection training (HSPT) click the link below. If an individual does not appear on the list, please contact the Clinical Trials Education Office at firstname.lastname@example.org.
CITI Course Options
The CITI course contains modules that include history and ethical principles of research, IRB regulations and review processes, informed consent requirements, research conduct with vulnerable study populations, conflicts of interest in research, investigator responsibilities in biomedical (drug and device) and social science studies, safety monitoring and adverse event reporting.
There are 4 different course options. Investigators and research personnel are required to complete one of the course options. The specific course to be taken depends on the nature of your research. For example, an individual involved with clinical trials, retrospective chart reviews, tissue banking or similar types of research involving human participants, should complete the BioMedical Course (Group 1). Whereas an individual whose research overlaps two areas (e.g., therapeutic clinical and behavioral research) should complete the combined Social/Behavioral and BioMedical Course (Group 4).
For all courses, all modules must be completed and users must score at least 80% on all appliable quizzes to satisfy the DF/HCC requirement.
To access the CITI course: https://www.citiprogram.org
Frequently Asked Questions
What are the requirements?
Who needs training?
Which user group do I select?
Individuals involved soley with quality of life studies and community-based research should take the Social/Behavioral Course (Group 2).
Individuals involved solely with biomedical research involving human subjects that is minimal risk or exempt should take the BioMedical Minimal Risk or Exempt Course (Group 3).
Individuals involved in both biomedical research and social/behavioral research should take the combined Social/Behavioral and BioMedical Course (Group 4).
IRB and SRC members should take the course that corresponds to the type of research they are reviewing.
How often do I need training?
How do I know if I have successfully finished the CITI training requirement?
Does DF/HCC accept completion of other training courses?
I completed the CITI course but my name does not appear on the HSPT list. What should I do?
I have forgotten my username and/or password for the CITI website. What do I do?
How often is the DF/HCC HSPT List updated?
A funding agency (sponsor, grant, etc.) requires verification of human subject protection training. How do I obtain this verification?
Are individuals reminded when their human subject protection training is due to expire?
I received a reminder, what to I do?
What happens if an individual does not complete initial or continuing education?
A Research Team Update Form must be submitted to the DFCI IRB once the individual has completed training for them to be officially added back to the study.
What if I need help?