CITI IRB Training Requirements
Prior to initiating research involving human subjects, all researchers must complete an on-line human subjects research ethics and regulations training course and accompanying quizzes via the Collaborative Institutional Training Initiative (CITI) Program.
The training requirement applies to all faculty researchers, research staff, student researchers, faculty advisors, visitors or any other individuals who conduct research activities with human subjects or their identifiable data.
To meet the needs of the diverse researchers at Tufts University/Tufts MC, there are 2 IRB User Groups in CITI for researchers:
- Biomedical Researchers
- Social-Behavioral-Educational Researchers
Researchers should register for the learner group according to the type of research they conduct. Researchers who conduct both Biomedical and SBE research should register with the learner group most closely related to the majority of their research activities
Biomedical Researchers should complete the Biomedical Research Basic Course or the Biomedical Research Refresher Course.
Social-Behavioral-Educational Researchers should complete the Social & Behavioral Research Basic Course or the Social and Behavioral Research Refresher Course.
The course must be completed with a cumulative score of 80% or above to attain certification. Once researchers have completed all the required modules in their course, they will have access to a completion certificate, and their education will be valid for 4 years. The expiration date of an individual’s certification is based on the day the last required module was completed. As their individual expiration date approaches, CITI will prompt investigators via email to complete a refresher course.
Please note that Good Clinical Practice (GCP) Training and Responsible Conduct of Research (RCR) Training do not meet the IRB’s training requirements. GCP Training is only needed if working on a clinical trial funded by NIH.
Click below for step-by-step CITI registration instructions:
Please note: CITI is a third-party website that hosts many research-related trainings in addition to IRB training. You may be required to complete additional trainings based on funding sources and the nature of your research.
Update on June 30, 2022
The training requirement applies to all faculty researchers, research staff, student researchers, faculty advisors, visitors or any other individuals who conduct research activities with human subjects or their identifiable data.
Examples include but are not limited to: Obtaining informed consent; conducting surveys, interviews, or focus groups; collecting or analyzing subjects’ identifiable data or biological samples; conducting study procedures that contribute to the research in a substantive way.
PIs must retain a copy of completed education certificates for all research team members in their study files. Records of past and current education certificates should be retained for every research team member, for each study in which he/she is involved. Education certificates are subject to audit.
Individuals who are currently listed as research team members on approved Tufts University protocols are required to complete the education requirements before the IRB can approve new studies, modifications, or continuing reviews on which they are listed research team members. Compliance with educational requirements will be monitored by Tufts SBER IRB office staff.
On a case-by-case basis, the Tufts SBER IRB may accept the completion of comparable education for community research partners or researchers employed by other institutions.
To request that the IRB accept alternative training, either submit:
- A rationale for alternative training and a research ethics training plan or curriculum that the research team will provide.
- Documentation that the non-Tufts institution’s IRB training requirements have been met.
See below for comprehensive information about completing the requirements for current researchers, new researchers, Recently Transferred Researchers, and IRB Members.
New researchers must create a CITI account. During registration, choose “Tufts University/Tufts Medical Center” as your Participating Institution. Please list your “@tufts.edu” email address (if you have one) as the preferred email address.
Please refer to Requirements for CITI Certification section above for guidance on how to choose the correct IRB Training course and respond to other curriculum requests as appropriate.
Please Note: IRB Training and Responsible Conduct of Research (RCR) Training are not interchangeable. RCR training does not fulfill the IRB education requirements.
Researchers transferring to Tufts University must add or transfer their institutional affiliation (within CITI) to the Tufts University/Tufts Medical Center affiliation. Upon log-in, select “Click here to affiliate with another institution.”
Please refer to Requirements for CITI Certification section above for guidance on how to choose the correct IRB Training course and respond to other curriculum requests as appropriate. Individual modules completed at a former institution will be applied toward initial certification with Tufts education requirements, if the module coincides with Tufts University requirements for the Tufts IRB learner group. Any outstanding modules must be completed before you can conduct human subjects research activities, as part of a new study or an existing IRB protocol.
Please Note: IRB Training and Responsible Conduct of Research (RCR) Training are not interchangeable. RCR training does not fulfill the IRB education requirements.
RB members should not register as Biomedical or Social-Behavioral-Educational researchers. Instead, IRB members will register for a learner group according to the IRB on which they serve:
- Health Sciences IRB Members
- SBER IRB Members
When registering for a learner group, IRB members should respond to the curriculum question regarding IRB Chairs/Vice-Chairs. IRB members will respond “Yes” or “No” as appropriate.