Charles River Campus

The Charles River Campus (CRC) IRB requires all individuals who are involved in human subjects research to complete training in human subjects protection. Training includes completion of an initial certification course and subsequent periodic (every three years) recertification course. The CRC IRB has selected* the Collaborative Institutional Training Initiative (CITI) Program as the required form of training.

*Individuals who have NIH funding may complete the NIH training for the initial training course, but will need to complete the CITI training course at the time of recertification.

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  • All members of the research team, including the Principal Investigator and all other individuals (faculty, staff, and students) who have contact or interactions with research subjects or with their private, identifiable information. Examples of research team members are: co-investigators, research assistants, lab managers, statisticians, and data managers
  • Faculty advisors of student research projects
  • Investigators who are not affiliated with BU but who are engaged in a BU research study and whose IRB of record will be BU
  • IRB office staff
  • IRB board members
  • Technicians whose only part in the research is to perform standard procedures (as part of his/her job) that are part of the research protocol. Examples include radiology technicians, phlebotomists, etc.
  • 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

Charles River Campus Only. See BUMCBoston University Medical Campus IRB Training for required Medical Campus trainings.

The online CITI training program was launched in 2000. CITI is used by over 1,300 participating institutions and facilities around the world. CITI has become the standard in regards to human subjects training. Because CITI is so widely used, BU investigators who complete these requirements will likely meet the training requirements that are mandated at other institutions. This is important for investigators who collaborate with colleagues outside of BU.

In addition, the CITI program has various modules that allow us to adapt the training to meet the needs of researchers here at BU. CITI has developed both a Biomedical and a Social & Behavioral program. The content of the CITI program is evaluated semi-annually and updated as appropriate. This will allow BU researchers to remain current on the latest regulations and guidelines that affect human subjects research.

Check your Training Records

Search the CITI Spreadsheet Study Personnel Training List to review training records and expiration dates. If your most recent training date is missing, please email the IRB to let us know.

To access the CITI training program, please visit the link here: https://www.citiprogram.org/

The Principal Investigator and any study staff listed on the protocol must be certified before the protocol can be approved. Individuals who complete CITI certification will not need to submit their completion report to the IRB. The IRB will access this information from CITI.
In order to meet the needs of the researchers at BU, there are three User Groups in CITI:

  • Social & Behavioral Focus (Basic Course)
  • Biomedical Focus (Basic Course)
  • GCP (required for investigators and study staff who are involved in FDA-regulated research)

Individuals will choose the group that is most appropriate to their research. Within each group, there are several modules or training topics. All of the required modules within that group must be completed in order to attain certification. Individuals are responsible for reviewing the other modules and completing the ones that are appropriate for their research. The IRB will review the completion certificates to ensure that all the appropriate modules have been completed.

Required Modules:

  1. Belmont Report and CITI Course Introduction
  2. History and Ethical Principles
  3. Defining Research with Human Subjects
  4. The Regulations and the Social and Behavioral Sciences
  5. Assessing Risk in Social and Behavioral Sciences
  6. Informed Consent
  7. Privacy and Confidentiality
  8. Conflicts of Interest in Research Involving Human Subjects
  9. Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
  10. Students in Research

Other modules (as applicable):

Choose those that apply to your research. At the time of IRB review, the IRB will determine if additional modules need to be completed based on the type of research being conducted.

  1. Research with Prisoners
  2. Research with Children
  3. Research in Public Elementary and Secondary Schools
  4. International Research
  5. International Studies
  6. Internet Research
  7. Human Subjects Research at the VA
  8. Research and HIPAA Privacy Protections
  9. Vulnerable Subjects
  10. Hot Topics
  11. The IRB Member Module—“What Every New IRB Member Needs to Know” (Required for all IRB members)

Log in to CITI training site

Audience: Principal Investigator and any study staff listed on the protocol
 
Duration: 15–30 minutes to complete each module
 
Teaching Medium: Online
 
Prerequisite: None
The Biomedical Basic Course includes the following modules:

Required Modules

  1. Belmont Report and CITI Course Introduction
  2. Avoiding Group Harms–U.S. Research Perspectives
  3. Research and HIPAA Privacy Protections
  4. Vulnerable Subjects—Research Involving Workers/Employees
  5. Hot Topics
  6. Conflicts of Interest in Research Involving Human Subjects
  7. and Ethical Principles
  8. Basic Institutional Review Board (IRB) Regulations and Review Process
  9. Informed Consent
  10. Social and Behavioral Research (SBR) for Biomedical Researchers
  11. Records-Based Research
  12. Research with Protected Populations—Vulnerable Subjects: An Overview

Other modules (as applicable):
Choose those that apply to your research. At the time of IRB review, the IRB will determine if additional modules need to be completed based on the type of research being conducted.

  1. Vulnerable Subjects—Research Involving Prisoners
  2. Vulnerable Subjects—Research Involving Children
  3. Vulnerable Subjects—Research Involving Pregnant Women, Human Fetuses, and Neonates
  4. FDA-Regulated Research
  5. Genetic Research in Human Populations
  6. The IRB Member Module–:What Every New IRB Member Needs to Know”
  7. International Studies
  8. I have Agreed to be an IRB Community Member: Now What
  9. Stem Cell Research Oversight (Part 1)

Log in to CITI training site

Audience: Principal Investigator and any study staff listed on the protocol
 
Duration: 15–30 minutes to complete each module
 
Teaching Medium: Online
 
Prerequisite: None
Investigators and co-investigators/study staff must complete a recertification course every three years. Recertification includes completing Refresher Modules in the CITI program. Individuals who completed the CITI for initial certification will receive expiration reminders from CITI via email 30 days and 7 days before his/her certification expires.

Individuals who completed the NIH training for the initial certification will need to complete the CITI Basic Course module for their first recertification. Subsequent recertification will be done by completing the Refresher Modules as described in the paragraph above.

Individuals who have recently transferred from another institution must comply with the policy above. If certification at the prior institution was obtained within the past three years, the individual must submit the completion report to the IRB.

If you received CITI certification at another institution, you will need to add or transfer your institutional affiliation (within CITI) to the BU CRCCharles River Campus. This will allow you to have access to the BU-required training courses and ensure that you receive renewal reminder notices from CITI.

Medical Campus

The Boston University Medical Center (BUMC) IRB requires that all researchers involved in human subjects research must receive formal training in the protection of human subjects. For more information on certification and recertification, see the BUMC IRB Training page.