Human Subjects Research Protection Education Requirements
Tufts Medical Center and Tufts University are committed to the continuing education of persons engaged in human subject research at the institutions to ensure that high quality research is conducted with integrity. As a result, the institutions require that all researchers involved in human subjects research must receive formal training in the protection of human subjects.
The Collaborative Institutional Training Initiative (CITI) program has been chosen as the option for the required education at both institutions. Investigators and research team members conducting human subject research must complete mandatory training via the CITI program prior to beginning any human subjects research and must undergo continuing education.
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). Comprehensive information about initial and continuing education requirements, for NEW and CURRENT researchers, can be found below.
Basic step-by-step instructions for registering with CITI and completing initial certification can be found here.
Registering with CITI and Adding Your Institutional Affiliation
All research team members must register with the CITI program to complete their education requirements. For more information about who is considered a research team member, read Who Must Complete Education Requirements.
During registration, choose “Tufts University/Tufts Medical Center” as the Participating Institution. If you already have a CITI account from another institution, you will need to change or add your affiliation to Tufts University/Tufts Medical Center—do NOT create a new account. List your “@tuftsmedicalcenter.org” or “@tufts.edu” email address (if you have one) as the preferred email address.
Requirements for Initial Certification
In order to meet the needs of the diverse researchers at Tufts University/Tufts MC, there are 2 User Groups in CITI for researchers:
Researchers will register for a learner group according to the type of research they conduct. Researchers who conduct both Biomedical and SBE research will 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.
PIs must retain a copy of completed education certificates for all research team members in their study files. These are subject to audit. For more information about the PI’s responsibilities, read Compliance with Education Requirements.
Requirements for Re-certification
All researchers must complete a re-certification course every 4 years. Re-certification courses will be available in CITI according to user group (e.g. “Biomedical Refresher Course” or “SBE Refresher Course.”
CITI will send automated emails to notify researchers when the expiration date of their CITI certification is near. Notices will be sent 90, 60, and 30 days prior to expiration, and 1 day after research certification has expired.
Current Researchers—Transitioning to the Revised Education Requirements
Individuals who are currently listed as research team members on approved Tufts Medical Center or Tufts University protocols will be required to complete the revised education requirements by January 1, 2015.
Individuals at both institutions must update their learner group. Upon log-in, select the “Add a Course or Update Learner Group” under Tufts University/Tufts Medical Center Courses. Choose either the Biomedical Researchers or Social-Behavioral-Educational Researchers learner group. Respond to the other curriculum questions as appropriate.
For researchers previously registered under the Health Sciences campus learner group: 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.
Recently Transferred or New Researchers
Individuals who are new to research and those researchers who have recently transferred from another institution must comply with the institutions’ education requirements prior to conducting human subjects research activities.
Individuals new to research should follow the instructions provided above for registering with CITI and completing initial certification.
Researchers transferring to Tufts MC or Tufts University must add or transfer their institutional affiliation (within CITI) to the Tufts University/Tufts Medical Center affiliation. This will allow the researcher to have access to the required training courses and ensure that he/she will receive renewal reminder notices from CITI. Individual modules completed at a former institution will be applied toward initial certification, if the module coincides with Tufts MC/Tufts University requirements.
Current and New 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.
Who Must Complete Education Requirements
The training requirement applies to all faculty, staff, students, visitors or any other individuals who pursue research projects with human subjects or their identifiable data. Some examples include: individuals who obtain informed consent, administer interventions or conduct procedures that contribute to the research in a substantive way, collect/analyze subjects’ identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects’ personal information. All research staff including, but not limited to, Principal Investigators, Co-Investigators, Study Coordinators, Research Assistants, and Data Analysts must undergo the education process.
This policy applies to all individuals working with human subjects on behalf of Tufts Medical Center or 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 Health Sciences IRB and Tufts SBER IRB may accept the completion of comparable education for community research partners or researchers employed by other institutions.
Compliance with Education Requirements
As of January 1, 2015, the Principal Investigator and any study staff listed on a study must complete the revised CITI education requirements before the protocol can be approved. This applies to both initial and continuing review of the protocol, and amendments to add research team members. The IRB will compare the IRB application against completion certificates within CITI to ensure that all members of the research team have current certification.
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 records are subject to audit.
Common Questions About CITI Education
1. How do I register for a CITI account?
Click here for step-by-step instructions:
• Registering with CITI
• Affiliating with Tufts University/Tufts Medical Center
• Completing initial certification
• Printing a completion report
2. I conduct both biomedical and SBE research, which learner group should I choose?
Choose whichever group is most closely related to the majority of your research activities:
• Biomedical Researchers
• Social-Behavioral-Educational Researchers
3. Will I lose credit for all of my previously completed work?
If you have completed a module that corresponds to a module within the new Basic Course (either SBE or Biomedical), you will receive credit for that module. It will count towards overall completion of the Basic Course (Initial CITI certification).
4. How do I check my CITI expiration dates (i.e. SBE, Biomedical, and GCP), and how do I access my CITI Completion Certificate?
When logged into your CITI account under “My Learner Tools”, click “View Previously Completed Coursework”. The expiration dates for your completed modules will be displayed along with an option to “View-Print-Share” your CITI Completion Certificate.
5. Can submissions (new, CR, AMD, etc.) be submitted while research team members CITIs and eligibility is still pending, and can a study be approved with pending CITI/GCP training?
Submissions can be submitted while research team member’s CITIs and eligibility is pending; however, final approval will not be granted until the CITI education requirements are completed.
6. I work with community research partners and/or off-site collaborators. Do they have to complete our education requirements? What are the CITI requirements for an investigator affiliated with another institution whose activities will be covered by the Tufts Health Sciences IRB?
The Tufts IRB may accept the completion of comparable education for community research partners or researchers employed by other institutions. (e.g. PI provides tailored education to community research partners; a researcher from another institution provides documentation of completing educational requirements at their home institution). Research team members from collaborating institutions must provide documentation of completing educational requirements at their home institution (i.e. email from their IRB confirming this information OR a completion report and a policy from their IRB confirming that provided education meets their institution’s requirements).