Training

- Background

- Required Training for Clinical Researchers (effective June 30, 2010)
- Required Training for Investigators Conducting Research on Children

- AURA Training


Background

In order to ensure that human subjects are adequately protected from research risk, both the University of Chicago and certain funding agencies set requirements for the training of investigators and their research staff. This training generally involves education on some combination of aspects of federal regulations, ethical principles, and university-specific policies. Training is usually required for investigators both upon beginning work in research at this institution and on an ongoing basis as new guidance, regulations, and areas of concern in research emerge.

The training recommended or required by the IRB for persons involved in human subjects research at the University of Chicago is outlined below. Note that funding agencies, URA, or your department or section may require other training not described here prior to your assumption of a role on a research study.

Questions regarding training should be directed to James Lynch at 4-1613 or jlynch@bsd.uchicago.edu.

 


Required Training for Clinical Researchers

With the merger of the Office of Clinical Research (OCR) and the BSD Institutional Review Board (IRB), the previously required training for new Principal Investigators has been combined with human subjects protections training. The topics discussed in these previous two training requirements will now be offered in one on-line training course.

Faculty and Staff Training Requirements for the Conduct of Clinical Research

In summer 2009, the Clinical Research Policy Board approved the Medical Center policy (link below), “Faculty and Staff Training Requirements for the Conduct of Clinical Research.” This policy applies to all faculty and staff involved in the conduct of clinical research. Faculty and staff will be expected to complete on-going training with acceptable documentation every three years.

The Research Training Program Options document (link below) provides the various options for completing the training requirement. The OCR encourages the use of the online CITI training program to complete this requirement. Collaborative Institutional Training Initiative (CITI) is an on-line training program. CITI is not only a national standard, but also allows the Office of Clinical Research to easily monitor compliance.

Full IRB approval of any clinical research project after 6/30/10 will be contingent on all investigators and staff involved in the research completing the training.

Training Policy

Research Training Program Options (initial training)
Refresher Training Options

Email to all faculty sent 8/11/09

 

If you choose to use CITI, researchers will be asked to register on the CITI home page:

CITI home page: www.citiprogram.org

Be sure to select the University of Chicago as your “Participating Institution,” select a username/password, and fill out all other necessary registry information. Once this is completed you will be required to complete 4 enrollment questions. This will determine the modules you will need to complete.

The new CITI training also offers modules on Good Clinical Practices (GCP). Researchers have the opportunity to complete these modules for sponsors who require that this training be completed.

If you previously completed CITI training at another institution, be sure to log back into CITI using your existing account and affiliate with The University of Chicago. You will receive credit for courses you have completed in the past if they are the same courses the U of C requires.

As of April 10, 2015, you will need to use your University CNet ID and password to log into CITI and affiliate with University of Chicago. If you do not have a CNet ID, a UCHAD ID and password may be used. If you are an incoming faculty member and do not yet have a CNet or UCHAD ID, please contact University Research Administrator for assistance in early access to University resources. If you are not affiliated with the University of Chicago as an employee or student, you will not be able to use the U of C access to CITI. In this case, other training can be obtained, including the NIH training (see link below).

Please note that human subject protection training is mandatory for research staff on any NIH-funded project. An alternative to completing the U of C CITI modules is offered by the NIH. The NIH provides an on-line training program to fulfill this requirement (http://phrp.nihtraining.com/users/login.php).

 

Required Training for Pediatric Research

The required Training for Investigators and Research Staff Involved in Research with Children will no longer be offered on DVD. This training is now incorporated in the CITI training. As of 2014, the “Vulnerable Subjects - Research Involving Minors” module is required for all U of C users in CITI.

New faculty and current should complete pediatric training prior to the approval of any research protocols involving children. We also strongly recommend that all staff involved in research protocols that enroll children receive training on this topic.

CITI home page: www.citiprogram.org

 

AURA Training

AURA-IRB is the new electronic IRB submission and review system. This system has been implemented by the University across all Divisions. The University will be managing training sessions and materials for AURA. Registration is now open. These sessions are all held in a computer lab and attendees will have access to a computer to learn to navigate the system. Courses will be offered beginning March 13, 2012 and will continue throughout the year and into 2013.

Note: All users that will be working in the new AURA-IRB system are strongly encouraged to register for an AURA IRB - Initial Submission session. The first hour will be a fundamentals session that covers the basics of logging in, navigation, where to find studies, how to search, etc. along with where to find training resources on the AURA page and who to contact with questions. There will be a break before the second half of the session in the event you need/want to leave before the workflow/routing portion.

Please see the AURA website for information about upcoming training sessions:

http://aura.uchicago.edu