HUMAN SUBJECT PROTECTION COURSE REQUIRED

Effective December 1, 2005, the Office of Research Compliance is requiring that UConn faculty, staff, and students/grads and undergrads at the Storrs and regional campuses making an IRB submission (new protocol, amendment, request for re-approval) complete the research-appropriate course on the CITI website and secure certification before protocols for such research will be approved by the IRB. For those with ongoing human subjects research protocols, training must be completed prior to the annual re-approval of the protocol.

The IRB will accept CITI training taken at another institution in lieu of the UConn CITI Training. Evidence of having completed the CITI training must be provided to the IRB with the protocol submission. See, Proof of Completion. If the certification is more than two 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.

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 Training Program.

Key Personnel who are "engaged in research with human subjects" are staff or students who:

1. enroll individuals,
2. obtain subjects' informed consent by doing more than handing out or collecting forms or telling subjects how to get in touch with the Investigators;
3. intervene or interact with subjects by performing invasive (e.g., drawing blood) or non-invasive (e.g., survey) procedures on them,
4. collect data directly from or follow-up directly with participants
5. collect identifiable private information from participants or
6. have access to information that links participants' names or other identifiers with their data, or
7. act as authoritative representatives for the investigators.

If you are a graduate or undergraduate student conducting research that meets the criteria for filing an IRB-1 or IRB-5 Application ( Link: Information for Investigators: FAQs Which form do I use?), 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 860-486-9428 or 486-8802.

For UConn:

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 Office of Research Compliance. The fact of your completion will be entered into the IRB protocol database. Therefore, in most cases investigators will not have to submit this report with a protocol application to the IRB. The OSP 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.

1. Go to: https://www.citiprogram.org/default.asp
2. Log in by entering your user name and password.
3. Select Completion Reports.
4. It will list your Completion Report(s) by the name of the Learner Group(s) for which you registered. (Biomedical, Social Behavioral, IRB Reference, IRB Member)
5. Select the Completion Report(s) and print.
6. If you have problems with this process, call the ORC/IRB at 860-486-9428 or 860-486-8802.