Office of Clinical Investigation
Human Subjects/CITI Training
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 training at one of the Harvard- based institutions, the CCI 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
An extensive online human subjects training course is required for:
- Any individual who is listed as a principal investigator on a research protocol that involves intervention or interaction with research subjects
- Any individual who is listed as study personnel on a protocol and whose role in the study involves intervention or interaction with research subjects.
"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
A less extensive online training course is required for those individuals whose work on research protocols is limited to the following:
- Chart/ medical record reviews
- Database inquires
- Discarded biological specimens
- Data analysis or statistical support
Continuing Education
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
Training Database/Certificates
Access to the Training Database and ability to print certificates is only available through the Children's Hospital intranet site. To access the database or to print your training certificate, please click on: Print Certificates
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 can not access Training Database/Certificates application, please call the CCI office at (617)355-7052 if you need a certificate and we will mail it to you.
