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Required Education in the Protection of Human Subjects

Prior to initiating research involving human subjects, researchers must complete an on-line tutorial and related exams via the Collaborative Institutional Training Initiative (CITI) Program.

On September 4, 2014, revised education requirements were announced by the Institutional Officials at both Tufts Medical Center and Tufts University (click here for the full text of the announcement).

See below for comprehensive information about completing the requirements for:

Who Must Complete Education Requirements

The training requirement applies to all faculty researchers, research staff, student researchers, faculty advisors, visitors or any other individuals who conduct research projects with human subjects or their identifiable data. Some examples include individuals who: obtain informed consent; conduct surveys, interviews, or focus groups; collect or analyze subjects’ identifiable data or biological samples; or conduct study procedures that contribute to the research in a substantive way.

This policy applies to all individuals working with human subjects on behalf of Tufts University, whether on site or at another location, regardless of their institutional affiliation or source of funding.

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.

Compliance with Education Requirements

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 revised 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.

Requirements for CITI Certification

In order 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.

All researchers will complete the CITI “Basic Education Course” for their user group. For Biomedical researchers, this consists of 16 modules. For SBE researchers, this consists of 13 modules. All of the required modules within that group must be completed with a score of 80% or above in order to attain certification.

Once researchers have completed all the 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 re-certification course.

Current Researchers—Transitioning to the Revised Education Requirements

All current researchers must update their learner group. Upon log-in, select the “Add a Course or Update Learner Group” under Tufts University/Tufts Medical Center Courses.

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. If an individual has previously completed a module found in the Basic Course, regardless of when the module was completed, this module will be applied toward initial certification with the new CITI requirements.

Please Note: IRB Training and Responsible Conduct of Research (RCR) Training are not interchangeable. RCR training does not fulfill the IRB education requirements.

A step-by step instruction sheet (with photos) for registering with CITI and completing updated initial certification requirements at Tufts can be found here.

New Researchers

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.

A step-by step instruction sheet (with photos) for registering with CITI and completing updated initial certification requirements at Tufts can be found here.

Recently Transferred Researchers

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.

A step-by step instruction sheet (with photos) for registering with CITI and completing updated initial certification requirements at Tufts can be found here.

IRB Members

IRB 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.



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