The Charles River Campus (CRC) IRB requires all individuals involved in human subjects research to complete training in human subjects protection via the Collaborative Institutional Training Initiative (CITI) Program which must be completed by both the Principal Investigator and all study staff listed on the protocol before the protocol can be approved. This training includes an initial certification course and subsequent recertification every three years.
Who is required to take the training?
Required
All study staff with human subjects’ responsibilities (interactions/interventions with study participants, or access to their identifiable data, images, biospecimens) are required to complete this CITI training.
Not Required
BU CRC Staff who are performing their non-research job responsibilities (e.g., radiology technicians, phlebotomists, physical therapists, etc.). These individuals are not considered research personnel if they will be conducting the same services/practices that they conduct in their day-to-day jobs.
Investigators not affiliated with BU who are collaborating with BU investigators on a BU research study, and who will be covered under the review of their own IRB.
Training Requirements
All study staff must complete one of the following courses:
• Human Subjects Protection Training: Social and Behavioral Focus • Human Subjects Protection Training: Biomedical Focus
Additional training requirements
NIH-Funded Clinical Trials:
NIH-funded Investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials are additionally required to take the Good Clinical Practice (GCP) course.
• Please note that the “GCP – Social and Behavioral Research Best Practices for Clinical Research” course may not substitute for the Human Subjects Protection Training requirement.
Optional Modules: If the research involves working with one of the following populations, you will need to complete additional modules, which can be found under “Optional Modules” within the Human Subjects Protection Training course:
Research with Children: • Research with Children (ID 507) • If applicable: Research in Public Elementary and Secondary Schools (ID 508) Research with Prisoners: • Research with Prisoners (ID 506) International Research: • International Research (ID 509) • International Studies (ID 971)
CITI Training Instructions
For instructions with screenshots, please click here.
Click the “Register” icon on the top left corner of your screen
This will bring you to the “Learner Registration” page. In the text box provided, type “Boston University”. Select the “Boston University (Charles River Campus)” option (the other option is “Boston University Medical Campus/Boston Medical Center” which is for the Medical Campus).
Next, you must agree to the terms of service and affirm your affiliation with Boston University (Charles River Campus). Once you have done so, click on the “Continue” button.
Complete all the fields in the registration form and then click on “Next.”
In the “Select Curriculum” page, select the following:
Question 1: Everyone must select “Human Research Courses” • If your study is an NIH-Funded Clinical Trial, you will also need to select “Good Clinical Practice” course • After selecting the appropriate course(s), click “Next” Question 2: Select “basic” Question 3: The Boston University Charles River Campus IRB will accept either of the following courses: • Human Subjects Protection Training: Social & Behavioral Focus • Human Subjects Protection Training: Biomedical Focus
Log into your existing CITI account using the username and password you previously registered with. This should take you to the Welcome screen of your CITI account.
Under Institution Courses, next to “Would you like to affiliate with another institution,” click on “Add An Affiliation”.
In the text box provided, type “Boston University”. Select the “Boston University (Charles River Campus)” option (the other option is “Boston University Medical Campus/Boston Medical Center” which is for the Medical Campus).
Next, you must agree to the terms of service and affirm your affiliation with Boston University (Charles River Campus). Once you have done so, click on the “Continue” button.
Complete all the fields in the registration form and then click on “Next.” In the “Select Curriculum” page, select the following:
Question 1: Everyone must select “Human Research Courses” • If your study is an NIH-Funded Clinical Trial, you will also need to select “Good Clinical Practice” course • After selecting the appropriate course(s), click “Next” Question 2: Select “basic” Question 3: The Boston University Charles River Campus IRB will accept either of the following courses: • Human Subjects Protection Training: Social & Behavioral Focus • Human Subjects Protection Training: Biomedical Focus
Locating Optional Modules
Log into your CITI Profile
Click the “courses” tab at the top of your screen
Under “Boston University”, you will see another section that lists your “Completed Courses”. Under this subsection, you will see your (completed) course titled “Human Subjects Protection Training: Social and Behavioral Focus”.
Under this box that is for the “Human Subjects Protection Training: Social and Behavioral Focus” course, you will see that blue button that says “Review Course”. Click on this button.
This will bring you to the list of modules that you have completed in order to complete this specific course. If you begin to scroll down, you will see the list of “Required Modules”, all of which you were required to complete to obtain your CITI certification.
At the end of this list, you will see another list titled “Optional Modules”. Continue to scroll until you see the specific module you wish to complete.
Once you have located this module, there will be a box that either says “Review” or “Start” depending on whether or not you have previously completed this module
Course Modules
Human Subjects Protection Training: Social & Behavioral Focus
Belmont Report and Its Principles (ID 1127)
HIPAA and Research Data Security at Boston University (CRC) (ID 17347)
Conflicts of Interest in Human Subjects Research (ID 17464)
Students in Research (ID 1321)
History and Ethical Principles – SBE (ID 490)
Defining Research with Human Subjects – SBE (ID 491)
The Federal Regulations – SBE (ID 502)
Assessing Risk – SBE (ID 503)
Informed Consent – SBE (ID 504)
Privacy and Confidentiality – SBE (ID 505)
Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID 14928)
Conflicts of Interest in Research Involving Human Subjects (ID 488)
Boston University (ID 13950)
Human Subjects Protection Training: Biomedical Focus
Belmont Report and Its Principles (ID 1127)
Avoiding Group Harms- U.S. Research Perspectives (ID 14080)
Populations in Research Requiring Additional Considerations and/or Protections (ID 16680)
HIPAA and Research Data Security at Boston University (CRC) (ID 17347)
Conflicts of Interest in Human Subjects Research (ID 17464)
History and Ethics of Human Subjects Research (ID 498)
Basic Institutional Review Board (IRB) Regulations and Review Process (ID 2)
Informed Consent (ID 3)
Social and Behavioral Research (SBR) for Biomedical Researchers (ID 4)
Records-Based Research (ID 5)
Vulnerable Subjects – Research Involving Workers/Employees (ID 483)
Hot Topics (ID 487)
*Please note that it is the responsibility of the Principal Investigator to ensure that all study staff have completed the required training and that it is up to date.