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.
If individuals have completed similar training at one of the Harvard institutions, the IRB will accept that training as long as he/she has evidence of completion.
Who Requires Training?
Staff/Personnel that Intervene or Interact with Research Subjects
Any individual listed as a principal investigator (PI) on a research protocol that involves any intervention or interaction with research subjects or any study staff member that will intervene or interact with study subjects, must complete the CITI Basic training course, regardless of whether or not they have completed similar training programs at other institutions. CITI Basic courses taken through other institutions may be transferred, on a case-by-case basis.
Interaction/intervention" with subjects includes such activities as obtaining informed consent, scheduling subjects, conducting interviews, etc.
Staff/Personnel with no Intervention or Interaction with Research Subjects
Individuals whose work on human subject research protocols is limited to review and analysis of research data/specimens, either through a limited role in a New Research Activity submission or listed on a New Research Activity Limited to Excess Human Biological Material and/or Review of Health Information on Patients, must complete, at a minimum, a reduced number of CITI modules. This basic course is titled “Group 2. Researchers Who DO NOT Interact with Subjects.
If, at any time, the research role changes to include intervention or interaction with subjects, an individual must complete the full CITI training course.
If personnel listed on a protocol perform the activities listed above at other institutions or locations but are listed as personnel on the Children's Hospital research protocol, they may either complete the CITI modules or provide evidence of completion of human subject training from another institution.
Effective September 1, 2006, Children's Hospital, Boston implemented a new human subject protection continuing education requirement. All principal investigators and research staff listed on all human subject protocols are required to complete continuing education in human subject protection, every three years. This new requirement is consistent with requirements at other local institutions. This question and answer document below provides detailed information on this new requirement.
Continuing Education Q & A
For specific instructions about how to access the training information, please click here: How Do I View Training Information for Myself or Research Team Members.
If you cannot access Training Database/Certificates application due to a permanent inability to access CHeRP, please call the IRB office at (617)355-7052 if you need a certificate and we will e-mail it to you.