Human Subject Protection Training (CITI)

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

What are the requirements?
Investigators, study coordinators and other research staff are required to complete human subject protection training or an equivalent prior to their IRB approved research activities.

Each CITI curriculum consists of a series of required modules and each module has a short quiz. You must achieve a compiled score of 80% to pass the course. A running tally is compiled in the Grade Book.  If you want to improve a score, you may repeat any quiz in which you did not score 100% correct.

Upon completion of all required modules, print or download a Course Completion Report as evidence that you have met the requirements. It is important to keep a copy for your records.

Who needs training?
Human subjects training is required for anyone working directly with human research participants, data or tissue that can link back to individual research participants.  This includes all individuals listed on a research protocol and those whose work on a research protocol is limited to any of the following:

• Chart/medical record reviews
• Database inquiries
• Discarded biological specimens
• Data analysis or statistical support

Which user group do I select?
The user group you are required to complete depends upon the nature of your research work.

Individuals involved in controlled clinical trials, retrospective chart reviews, tissue banking or similar types of research involving human subjects should take the BioMedical course (Group 1).

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?
You need a basic course, if you have not had one.  Then continuing education in human subject protection issues is required every three years.  This requirement is consistent with other Harvard-affiliated institutions.

How do I know if I have successfully finished the CITI training requirement?
On the Learners Menu screen, under the word "Status" it will say "Passed" and list your training completion date.  On this same page, you can print your completion certificate.  Just click on the link called "Print" to the right of "Status".

Does DF/HCC accept completion of other training courses?
Yes.  DF/HCC accepts completed training at one of the Harvard-affiliated institutions, as long as there is evidence of completion.  Other human subjects training courses are accepted on a case-by-case basis.  Please contact the CTEO at cteo@dfci.harvard.edu to determine if another program qualifies.

I completed the CITI course but my name does not appear on the HSPT list.  What should I do?
Contact the CTEO at cteo@dfci.harvard.edu if your name does not appear on the list.  If you did not complete the course under the DF/HCC institutional account, you will need to supply the CTEO with a copy of your completion record to be added to the list.

I have forgotten my username and/or password for the CITI website.  What do I do?
Automatically retrieve your username and/or password by clicking "Forgot login information" on the CITI main page. 

How often is the DF/HCC HSPT List updated?
Generally, the list is updated once per week.

A funding agency (sponsor, grant, etc.) requires verification of human subject protection training.  How do I obtain this verification?
Users should download their individual certificates directly from the CITI site. Under special circumstances (i.e., grant submissions), the CTEO can supply copies of completion certificates or a signed letter stating the completion of human subject protection training for groups of individuals.  Grants managment personnel should contact the CTEO at cteo@dfci.harvard.edu with a list of requested individuals.

Are individuals reminded when their human subject protection training is due to expire?
The CITI website does generate automatic reminders to individuals when their training is due to expire.  In addition, individuals that appear on the DF/HCC HSPT List will receive a reminder 30 days prior to their expiration date from the CTEO.

I received a reminder, what to I do?
To continue to participate in research, you must log on to the CITI website (https://www.citiprogram.org) and complete the indicated refresher course before the training expires.

What happens if an individual does not complete initial or continuing education?
Individuals who do not meet the training requirement may not be involved in human research activities. 

• If the Overall PI of a study fails to meet the training requirement, the DFCI IRB will temporarily close the study until the training requirement is met. 
• If the Site Responsible PI of a study fails to meet the training requirement, the DFCI IRB will temporarily close the study at that site until the training requirement is met. 
• If a co-investigator of a study fails to meet the training requirement, the DFCI IRB will temporarily remove them from the study until the training requirement is met. 

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?
If you encounter technical issues, please contact the CITI Support Desk (University of Miami) at citisupport@med.miami.edu or 305-243-7970.