Training

Human Subjects CITI Training

Boston Children's Hospital policy requires that all individuals involved in clinical research are trained in human research protection issues. CITI (Collaborative IRB Training Initiative) training must be completed. HIPAA training is included in this course.

Who requires training?

All principal investigators and research staff listed on all human subject protocols are required to have training in human subjects protection and must complete continuing education every three years on Collaborative IRB Training Initiative

Staff/Personnel that Interact with Research Subjects: If you will interact with research subjects (obtain consent, schedule subjects, conduct interviews), please complete the human subjects course and enroll in either the Social/Behavioral or Biomedical section.

Staff/Personnel that DO NOT Interact with Research Subjects: If you will not interact with research subjects (limited to review and analysis of research data/specimens, limited to excess human biological material and/or review of health information of patients), please complete the human subjects course and enroll in the Research Limited to use of Data and/or Specimens section

If, at any time, the research role changes to include intervention or interaction with subjects, the individual must complete the Social/Behavioral or Biomedical section of the CITI human subjects course.

Do I take the IRB human subjects basic or refresher course?

CHeRP will block a human subjects refresher course from counting without a basic human subjects course on file. You must complete a basic human subject course first and then may complete a refresher human subjects course every 3 years later to satisfy the IRB’s continuing education requirement. If individuals have completed similar training at a different institution, please email the course certificate to irb@childrens.harvard.edu.

For the basic course:

  1. Login to: www.citiprogram.org
  2. Select the “courses” tab. Then click Boston Children’s Hospital “view courses.” If you do not see BCH listed as an affiliate, you can manually add BCH as an “institutional affiliation.”
  3. Click “add a course” in the Learner Tools for BCH (bottom of the page).
  4. Answer question 1 by selecting “IRB Human Subjects Basic Course.” Depending on your role, please select the appropriate sections — biomedical researchers, social/behavioral researcher, or research limited.
  5. The course will appear in the “courses ready to begin section” on the courses page. Select “start now” and complete all the modules. If you completed the course through BCH and have a CHeRP account, the training will automatically upload to your CHeRP profile. To create a CHeRP account, please email cherp.support@childrens.harvard.edu.

For the refresher course:

  1. Login to: www.citiprogram.org
  2. Select the “courses” tab. Then click Boston Children’s Hospital “view courses.” If you do not see BCH listed as an affiliate, you can manually add BCH as an “institutional affiliation.”
  3. Click “add a course” in the Learner Tools for BCH (bottom of the page).
  4. Answer question 1 by selecting “IRB Human Subjects Refresher Course/Continuing Education.” Depending on your role, please select the appropriate sections — biomedical researchers, social/behavioral researcher, or research limited.
  5. The course will appear in the “courses ready to begin section” on the courses page. Select “start now” and complete all the modules. If you completed the course through BCH and have a CHeRP account, the training will automatically upload to your CHeRP profile. To create a CHeRP account, please email cherp.support@childrens.harvard.edu.

Continuing Education — How can I fulfill continuing education credit?

CITI Refresher Course: Collaborative IRB Training Initiative has developed refresher modules for continuing education. The Human Subjects and Good Clinical Practice (GCP) refresher courses satisfy the continuing education requirement. Unfortunately, the Conflict of Interest (COI) course, Responsible Conduct of Research (RCR) and Hound Dog courses do not count as refreshers. Please email CITI Refresher courses from other institutions to irb@childrens.harvard.edu for the certificate to be uploaded to your CHeRP profile.

Attendance at lectures and seminars: Attendance at institutional presentations or lectures on topics related to human subjects protection can satisfy the continuing education requirement. The IRB and EQuIP offices often provide lectures, seminars, and round table discussions. Please contact the IRB if you have questions about whether a certain event is recognized by the IRB office and will count for continuing education credit.

The following list represents currently recognized activities.

  • Introduction to Clinical Research Course for Junior Faculty, Fellows, Nurse Investigators
  • New Study Coordinator Orientation
  • Research Coordinators Rounds at which human subject protection issues are discussed.
  • Human subjects related presentations at department/division faculty meetings organized by the IRB or requested by Department Chairs and Division Chiefs.
  • Human subject case presentations to faculty/staff groups that are organized by the IRB.
  • Completion of continuing education requirements at another Harvard affiliated institution.

Education and Quality Improvement Program (EQuIP) Reviews: Any investigator who undergoes an EQuIP review (either an audit of an existing study, New PI training) will receive automatic continuing education credit. In addition, any research staff listed on the protocol who attends the initial and exit interviews of EQuIP study reviews will also receive continuing education credit.

How do I view my training certificates?

Training Database/Certificates: CITI trainings will automatically upload to CHeRP if taken through the Boston Children’s Hospital affiliation and if you have a CHeRP profile at the time of completing the CITI course. To create a CHeRP profile, please email cherp.support@childrens.harvard.edu. Please email CITI certificates to irb@childrens.harvard.edu for your training to manually be entered by IRB staff if you completed training at a different institution or before your CHeRP profile was created.

To view training records, please follow the instructions below:

  • Step 1: Login to CHeRP. Select “Account Profile” on the top blue bar.
  • Step 2: Search by “Active BCH User Profiles” or “NonBCH User Profiles.” You can “Filter By” in order to narrow down the profile matches. Select “Go” and a new result set will display.
  • Step 3: Select the name of the user profile to access their profile workspace where all training will be displayed.