As per the Tufts’ Human Research Protection Program Plan and the SBER IRB Investigator Manual, all investigators and research personnel must complete formal human subjects research protections training prior to taking part in any human subjects research activities, including but not limited to obtaining consent, collecting data, or analyzing identifiable data.

IRB approval or exemption will not be provided for new studies, modifications to existing studies, or continuing reviews of existing studies unless all members of the research team have completed HSR protections training and all certifications are current.

To comply with this requirement, all Principal Investigators (PI) must retain a copy of completed HSR protections training 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 every study in which they are involved. These certificates are subject to audit.

Certificates for Tufts personnel do not need to be provided with submissions to eIRB. eIRB is integrated with CITI and will automatically display current CITI certifications, as long as the Tufts individual has affiliated their CITI profile with Tufts University and the e-mail address associated with their CITI profile matches the one used by the eIRB system.

Documentation of HSR protections training for non-Tufts personnel should be uploaded with submissions to eIRB, specifically in Item #2 of the “Local Study Team Members” page.

The HSR protection training requirement applies to all faculty researchers, research staff, student researchers, faculty advisors, visitors, collaborators, or any other individuals who conduct research activities with human subjects or their identifiable data on behalf of Tufts University, regardless of their institutional affiliation.

To meet the Tufts HSR protections training requirement, most study personnel will complete training through the Collaborative Institutional Training Initiative, or CITI, Program. CITI is a third party service that hosts research-related training. In addition to fulfilling Tufts’ HSR protections training requirement, you may be required to complete additional trainings based on funding sources and the nature of your research.

To fulfill the Tufts HSR protections training requirement, two distinct “IRB Training” courses are available to Tufts researchers through the CITI Program, based on “learner group”:

• Biomedical Researchers
• Social-Behavioral-Educational Researchers

Researchers should register for the course offered to the learner group most representative of the type of research they primarily conduct. Please note that other trainings, such as Good Clinical Practice (GCP) training and Responsible Conduct of Research (RCR) training are also available through CITI; however, these courses do not meet the HSR protections training requirement.

The Good Clinical Practice (GCP) training is only required for researchers involved in the conduct, management or oversight of NIH-funded clinical trial research and must be completed in addition to the required Tufts HSR protection training.

CITI Training consists of a series of modules and quizzes. The course must be completed with a cumulative score of 80% or better to attain the relevant CITI certification. At Tufts, CITI certification is valid for 4 years, at which time a refresher course will need to be completed to remain CITI certified.

To register with CITI or affiliate an existing CITI account with Tufts University, follow the below instructions, based on whether you are a:

• New CITI User
• CITI User Transferring from Another Institution

Non-Tufts study personnel can meet Tufts HSR protections training requirement by leveraging one of the following three options:

1) CITI Certification – See above section “What Is CITI Training and How Is It Completed?” for more details.

2) CIRTification Training – This alternative HSR protections training is available ONLY to community research team members.

Community research team members (members of the research team who are neither affiliated with Tufts nor another institution that has its own HSR protections training requirements and are community-based research collaborators) can either complete standard CITI education through Tufts or an alternative program called the CIRTification training program.  The  CIRTification training program is a training program in human research protections that is tailored to the unique roles of community research team members.  

Tufts IRBs will not accept the CIRTification training for Tufts researchers or researchers from other universities or institutions that have their own human subjects education requirements. Only community research team members are eligible to complete the CIRTification training program as an alternative to CITI. The PI/Research team will need to post documentation of completion of the CIRTification training program in eIRB for community research team members who complete this alternative training.

To help your community research team members access this training, provide them with the following instructions:

1. Go to http://training.ccts.uic.edu/
2. Click “Register” (top right hand corner). Select “I am not from UIC.”
3. Complete the registration form. When asked to select a site, select “Tufts University/Tufts Medical Center”
4. Click “Register” to finish
5. Visit the Course Catalog. Information about CIRTification will appear. Click “Learn More” and “Enroll” to enroll in CIRTification,

3) Comparable Alternative Training – Accepted strictly on a study-by-study basis.

On a study-by-study basis, the Tufts SBER IRB may accept the completion of HSR protections training comparable to CITI training for non-Tufts study personnel.

To request that the IRB accept alternative training, include the following with your eIRB submission:

• A justification for the need for the use of the alternative training AND
• A research ethics training plan or curriculum to be provided to the non-Tufts research personnel by the researcher OR documentation that the non-Tufts institution’s IRB training requirements have been met.

Tufts SBER IRB Members need to complete the Tufts SBER IRB Members CITI course.