Training & Education

Human Subjects Training Requirements

All investigators and key study personnel must complete and submit certifications human subjects protection training (e.g., CITI Program) prior to IRB approval.

CITI Training Instructions

Franciscan employees have access to CITI training through Boston Children’s. You must complete a basic human subjects course first, and then may complete a refresher human subjects course every 3 years to satisfy the IRB’s continuing education requirement.

If you have completed CITI training at a different institution, please email the course certificate to the IRB to verify that it will be sufficient. You may be asked to complete the course again. You must email your CITI certificate from your prior organization to the IRB to be approved to take a refresher course through Boston Children’s.

For the basic course:

  1. Login to CITI: https://about.citiprogram.org
    • If you have an existing account from another institution, log into that account.
    • If you have never logged into CITI before, click “Register” instead.
  2. Add Boston Children’s as an affiliate.
    • If you have an existing account, click “My Courses” and “Add Affiliation.” Search for Boston Children’s Hospital.
    • If you are just making an account, search for Boston Children’s Hospital.
    • For ALL: Click the boxes to agree to the Terms of Service and to affirm that you are an affiliate of BCH.
  3. Complete your CITI profile to add the affiliation. Fill in all required fields.
    • For institutional email address, be sure to enter in your FC email.
    • Role: typically you will select Principal Investigator, Co-Investigator, Research Assistant, Clinical Researcher. Choose whichever role makes sense. The trainings available will be the same regardless of what you select.
    • CH ID Number: If you do not know your Boston Children’s ID number, look it up in PeopleSoft (myapps.childrens.harvard.edu, click on FCH PeopleSoft, then go to Company Directory à view my profile à job details à see the number listed by Employee ID)
  4. On the next page (Title of Page: IRB Human Subjects Education Requirement), select “IRB Human Subjects Basic Course.” Then, you will select the IRB Human Subjects Basic Course that best fits your needs:
    • Select Biomedical Researcher if you are conducting biomedical or health sciences research that involves medical devices, biological specimens, or biological or physiological interventions like drug trials.
    • Select Social/Behavioral Researcher if you are conducting psychology, education, speech and hearing, communication, or other research that involves behavioral observations, surveys, interviews, focus groups, or behavioral interventions.
    • Select Research Limited to use of Data and/or Specimens if your research project will not involve interacting or intervening with human subjects (e.g., chart reviews, analysis of existing identifiable data)
  5. The course will then appear in the “Courses Ready to Begin” section in your Boston Children’s Hospital Courses. Click “Start Now” and complete all the modules.
  6. After you have completed the course, click view/print your Completion Certificate (NOT your Completion Report, which will show your scores on all modules. All that is needed is the certificate showing you completed the course and with the expiration date on the top right corner). A copy of this CITI certificate must be submitted with your IRB applications for all involved team members. Certificates for the refresher course (see next section) must be emailed to the IRB every 3 years to keep records up to date.

For the refresher course:

NOTE: If you took the basic course through another organization, do not take a refresher course unless you have provided your prior CITI certificate to the IRB and have been approved to take the refresher course.

  1. Login to CITI: https://about.citiprogram.org
  2. If you have already added Boston Children’s as an affiliate, click “View Courses” next to Boston Children’s Hospital, then click “add a course” in the Learner Tools (bottom of page). Proceed to step 4.
  3. If this is your first time accessing CITI through Boston Children’s, add Boston Children’s as an affiliate:
    • Click “My Courses” and “Add Affiliation.” Search for Boston Children’s Hospital.
      1. Click the boxes to agree to the Terms of Service and to affirm that you are an affiliate of BCH.
    • Complete your CITI profile to add the affiliation. Fill in all required fields.
      1. For institutional email address, be sure to enter in your FC email.
      2. Role: typically you will select Principal Investigator, Co-Investigator, Research Assistant, Clinical Researcher. Choose whichever role makes sense. The trainings available will be the same regardless of what you select.
      3. CH ID Number: If you do not know your Boston Children’s ID number, look it up in PeopleSoft (myapps.childrens.harvard.edu, click on FCH PeopleSoft, then to Company Directory à view my profile à job details à see the number listed by Employee ID)
  4. Select “IRB Human Subjects Refresher Course/Continuing Education.” Then, you will select the IRB Human Subjects Refresher Course that best fits your needs:
    • Select Biomedical Researcher if you are conducting biomedical or health sciences research that involves medical devices, biological specimens, or biological or physiological interventions like drug trials.
    • Select Social/Behavioral Researcher if you are conducting psychology, education, speech and hearing, communication, or other research that involves behavioral observations, surveys, interviews, focus groups, or behavioral interventions.
    • Select Research Limited to use of Data and/or Specimens if your research project will not involve interacting or intervening with human subjects (e.g., chart reviews, analysis of existing identifiable data)
  5. The course will then appear in the “Courses Ready to Begin” section in your Boston Children’s Hospital Courses. Click “Start Now” and complete all the modules.
  6. After you have completed the course, click view/print your Completion Certificate (NOT your Completion Report, which will show your scores on all modules. All that is needed is the certificate showing you completed the course and with the expiration date on the top right corner). A copy of this CITI certificate must be submitted with your IRB applications for all involved team members. Certificates for the refresher course (see next section) must be emailed to the IRB every 3 years to keep records up to date.

Questions?

If you have any questions about these instructions, need to determine whether your CITI certificate from your prior institution is sufficient, or are wondering which CITI course to complete, please reach out to the IRB.

Continuing Education Requirements

Investigators must maintain current certification in human subjects protection training (renewal typically every 3 years).