Adding Undergraduate Students to InfoEd
Click here to add undergraduate students to InfoEd prior to adding these students as key personnel on the Appendix A form.
The UConn IRB requires UConn faculty, staff, and students (graduates and undergraduates) at the Storrs and regional campuses, who are conducting research as investigators or key personnel, to take the research-appropriate course on the CITI Program website and complete certification before protocol applications for initial approval, amendment, or re-approval of such research will be approved by the IRB. The CITI Basic Course certification is good for three (3) years at which time, the CITI Refresher Course must be taken to maintain certification.
There are two basic CITI Courses for Human Subjects. Group 1 is the basic Biomedical Research course and it consists of the following [modules] and Group 2 is the basic Social and Behavioral Science course and it consists of the following [modules]. Please note that the Responsible Conduct of Research Courses DO NOT satisfy the human subjects training requirement.
The CITI Certification is accepted at hundreds of universities, hospitals and research facilities throughout the country. The IRB will accept CITI training taken at another institution in lieu of the UConn CITI Training. Evidence of having completed the CITI training at another institution must be provided to the IRB with the protocol submission. (See, Proof of Completion.) If the certification is more than three years old, the investigator will be required to take the UConn CITI Refresher Course. The IRB will only accept CITI training from another institution; no other forms of training will be accepted. However, if the IRB Chair or the Chair’s designee determines that the CITI Training from another institution is inadequate for the research for which approval is requested, he/she may require additional modules or that the UConn basic or refresher course be taken.
The IRB reserves the right to require that an investigator complete any or all of the optional training modules before approving a protocol.
Who Needs To Take The CITI Program Training?
All Investigators and “Key Personnel” who are “engaged in” research with living human beings, human tissue samples or identifiable private information, are required to take the CITI Program Training.
Key Personnel who are “engaged in research with human subjects” are UConn faculty, staff or students who:
- enroll individuals,
- obtain subjects’ informed consent by doing more than handing out or collecting forms or telling subjects how to get in touch with the Investigators;
- intervene or interact with subjects by performing invasive (e.g., drawing blood) or non-invasive (e.g., survey) procedures on them,
- collect data directly from or follow-up directly with participants
- collect identifiable private information from participants or
- have access to information that links participants’ names or other identifiers with their data, or
- act as authoritative representatives for the investigators.
How do I register?
Go to the CITI website and Log In through My Institution by choosing “University of Connecticut – Storrs & Regional Campuses” from the list and entering your UConn NetID username and password on the UConn netid login page. If you have never logged to the CITI Program with the UConn Single Sign On (SSO) before, it will ask whether or not you wish to associate an existing CITI Program account with your UConn Single Sign On (SSO) account or to create a new CITI Program account. Follow the prompts to either enter your existing CITI Program account username/password or Create a New CITI Program account. Add the appropriate course(s) by answering the CITI Course Enrollment Questions (e.g. Question 1 – Human Subjects Research) to complete the registration process.
If you are a graduate or undergraduate student conducting research that meets the criteria for filing an IRB-1 or IRB-5 Application, you need to complete the same basic CITI Training course as a faculty member. If you are a graduate or undergraduate student in a Research Methods or similar course that requires students to conduct minimal risk research projects your instructor will have submitted an IRB-7 Application to the IRB. If your project is approved under that IRB-7 protocol, it is up to the faculty member that teaches or supervises the course to instruct the students in the ethical practice of research and human subject protections. The faculty may do this in whatever way they see fit, however, the IRB recommends that they use all or part of the CITI Training program for the protection of human subjects to do so. If a faculty member wishes to require only certain modules of the CITI program, he/she should have their students register and select the IRB Reference Group (which contains all possible modules) and only take the modules their instructor requires them to take. The students can print out their Grade Book which will show what modules they have completed and the grades they received on those module quizzes. For more information, contact the IRB Office at (860) 486-0986 or 486-8802.
CITI Refresher Course
Sixty (60) days before your Completion Report expires, you will receive an automatically generated reminder notice via e-mail directly from CITI. The notice includes instructions about how to do the refresher course. If you have questions or experience difficulties, call (860) 486-0986 or (860) 486-8802 for assistance. If you have a CITI Completion Certificate from another institution and that certification has expired at that institution, you will be required to take the UConn CITI refresher course. Login to the CITI website with your UConn netid username and password. Select the Refresher Course in the appropriate learner group for your area of research. Call (860) 486-0986 or (860) 486-8802 for assistance.
NIH Good Clinical Practice Training Requirement (Effective January 1, 2017)
On September 16, 2016, the National Institutes of Health (NIH) issued a new policy for all NIH funded investigators and site staff who are involved in the conduct, oversight, or management of clinical trials (see Notice Number: NOT-OD-16-148). The policy establishes that these NIH awardees and clinical trial staff* should be trained in Good Clinical Practice (GCP) consistent with the principles for the International Conference on Harmonisation E6. Please note that this requirement pertains to trials of behavioral interventions as well.
The requirement will be satisfied through completion of an on-line training module approved by the Associate Vice President for Research Integrity and Regulatory Affairs. UConn will use on-line modules provided through the Collaborative Institutional Training Initiative (CITI) for GCP.
If you have any questions, please contact Doug Bradway at 6-0986 or by email at email@example.com.
Proof of Completion
When you complete the course, you can select “View Completion Report” at the top or the bottom of your Grade Book and print it for your records. A copy of your Completion Report will automatically be sent to the IRB Monitor at the Research Compliance Services. The fact of your completion will remain on the CITI database and may be accessed by you or by a UConn CITI administrator at any time. Therefore, in most cases investigators will not have to submit this report with a protocol application to the IRB. Sponsored Program Services (SPS) also has access to this information.
For Other Institutions:
Anyone who has registered and completed a CITI Program Training Course can print out their own Completion Report when they need to do so, for example, to meet another institution’s HSP training requirement.
- Go to: https://www.citiprogram.org
- Log in by entering your CITI Program l user name and password.
- Select University of Connecticut-Storrs Regional Campus Courses.
- In the completion report column select the appropriate completion report and print.
If you have problems with this process, call the RCS/IRB at 860-486-0986 or 860-486-8802.
Department of Navy (DON) CITI Training Requirements
In order for the University to conduct human subjects research supported by the Department of Navy (DON) through contracts, grants, cooperative agreements, or through other arrangements such as collaborations with DON personnel, the UConn IRB obtained a DOD-Navy Addendum to the FWA held by UConn. The DON Human Research Protection Program requires training for Extramural Performers. To meet the requirements for continuing education, all personnel who conduct, review, approve, support, manage or oversee DON-supported human research must complete three to six hours of continuing research ethics and human subject protections training every three years.
UConn researchers (PIs, Postdoctoral Fellows, Research Assistants, Graduate/Undergraduate students) are considered Extramural Performers as are IRB Members, IRB Staff and the University’s Institutional Official. All Extramural Performers, regardless of their role in research, will complete the CITI training course “DON-Supported Extramural Performers.”
There are several options available to meet the continuing training requirement, including a new Refresher Course on the Collaborative Institutional Training Initiative (CITI) website. Personnel who completed initial training through CITI may now access and complete the Refresher Training course in order to fulfill continuing education requirements for Extramural Performers.
Investigators who plan to apply to the Department of Navy for funding are strongly encouraged to plan accordingly and to contact Research Compliance Services before the research proposal is submitted to discuss these and other requirements.
- Login to CITI using your UConn NetID username and password.
- Under the Main Menu second bullet select the link for “Affiliate with another institution.”
- Go to the “Participating Institutions” pull down menu and select “Department of The Navy” and click “Submit.”
- Complete the required member information fields. In the “Your Command” field select “DON Extramural Performers” and click “Submit.”
You will now be asked to answer a series of questions. Please select the following:
- What kind of research are you conducting? Select the first option ” I am conducting, planning to conduct, or am otherwise involved in research with human subjects, tissues from humans and/or patient records” and click “Next.”
- Social/Behavioral Science Question. Select “The Biomedical Sciences” since the UConn IRB reviews both Biomedical and Social and Behavioral Science research. Click “Next.”
- Are you taking initial or refresher? Select “Initial” and click “Next.”
- What is your role? Select “DON-Supported Extramural Performers – Biomedical” and click “Next.”
- Are you required to complete the CITI Good Clinical Practice Course? Select “No, not at this time” and click “Next.”
- Are you required to complete the RCR training? Select “No, not at this time” and click “Next.”
- Do you want to review IRB Reference Resource materials? Select “NO – Perhaps some other time” and click “Next.”
- Now, you should be back to the Main Menu and the Department of the Navy “DON-supported Extramural Performers, Initial Training” course should be listed as “Incomplete.” Click the “Re-enter” link.
- The required modules should be listed. You may receive credit for prior modules completed at UConn. If so, the module name and completion date will be listed in green. Click “The Integrity Assurance Statement” link, read the statement and select the appropriate assurance statement. Click “Submit.”
- Now, you should be back to the required modules list. The first module you’ll need to complete should be underlined. Click this link and complete the module. Continue to complete all the modules until the course is completed. Note that some modules do not have an exam.
As of September 26, 2018, the NIH Office of Extramural Research (OER) will no longer offer the Protecting Human Research Participants course (NOT-OD-18-221). Investigators are still required to comply with all aspects of the NIH policy Required Education in the Protection of Human Research Participants. Frequently asked questions about the protection of the NIH human subjects education requirement are available at https://humansubjects.nih.gov/requirement-education.
EHS Safety Training
By visiting http://ehs.uconn.edu/training/ individuals and supervisors can view full safety training histories for themselves and their supervisees.
Preparing IRB Forms for Human Subjects Research
The Office of the Vice President for Research (OVPR) will be holding workshops for students and faculty to offer guidance on completing forms related to Institutional Review Board (IRB) submissions. Dates of the workshops are listed below. They will be held on level 1 of the Homer Babbidge Library in Instruction Room 1136 (EC-1) at 369 Fairfield Way, Storrs, CT. This workshop will begin with a brief introduction of the human subjects regulations (45 CFR 46) and UConn policies as they relate to the content and preparation of protocol submissions to the IRB. OVPR staff will then assist attendees in beginning their individual submissions and will provide guidance and feedback about how to successfully complete their proposal and accompanying forms.
Space is limited to 12 participants. Sessions will be offered during the academic year. Advanced registration is required. Please register by visiting prodev.uconn.edu (NetID login required).
This workshop will also be available to small groups in individual departments upon request. For additional information, please contact Joan Levine, Post Approval Monitor at firstname.lastname@example.org or 860-486-7145.
Completion of the CITI course and InfoEd electronic submission training is recommended prior to attending this workshop.
Monday, September 24, 201810:00 a.m. – 12:00 p.m.Monday, October 22, 20182:00-4:00 p.m.Thursday, November 15, 20189:00-11:00 a.m.