IRB Training Opportunities and Resources
This quarterly training typically lasts 45 minutes to an hour. Remember to bring your questions about the topic at hand!
Mark your calendars for future IRB Insights opportunities:
- Wednesday, October 29, 2014 – 12 p.m. - Registries, Databases, and Repositories (GEB A304)
Previous IRB Insights Materials
Understanding the IRB Process: Wednesday, July 30, 2014
Exempt vs. Expedited Projects: Wednesday, April 30, 2014
Form changes with the iMedRIS upgrade: We will review Form 2 and Form 3 changes and
changes to the PI Response form: January 29, 2014
I just submitted to the IRB. What now? (Beginner Session): July 31, 2013
Slides | Note: Video not available due to technical issue.
New Changes in Applications and Consent Form!: January 30, 2013
Note: The audio is not audible for the first few minutes of the presentation
Adverse Events, Unanticipated Problems, and other Reportable Information and which
Form 4 to Use
August 29, 2012
Creating Document Revisions – Creating revised study documents within iMedRIS, including hidden text instructions
in the consent form templates
May 20, 2012
IRB Auditing – Types of audits, what to expect during an audit, and how to respond to audit letters
November 20, 2011
IRB & iMedRIS Training
The IRB is happy to arrange a group training for your department or even a one-on-one training for an individual. Please contact Kimberly Prachniak at firstname.lastname@example.org if you are interested in scheduling one of the iMedRIS trainings below.
Beginner IRB & iMedRIS Training
This class is designed for Principal Investigators, Co/Sub-Investigators, and Coordinators who are not familiar with our IRB policies and/or have never submitted electronic studies to the IRB using iMedRIS. We will discuss practical issues, such as UT NetIDs, taking the CITI course, acquiring administrative approval from our affiliate institutions, obtaining access to iMedRIS, and navigating iMedRIS. We will also review many of our policies, common problem areas, and federal regulatory requirements for conducting research.
Advanced iMedRIS Session
Advanced sessions are designed for Principal Investigators, Co/Sub-Investigators, and Coordinators who have previously submitted forms in iMedRIS and have specific questions about iMedRIS functions, navigating iMedRIS, and relating the IRB processes to iMedRIS. This class can be purely instructional in nature, or hands-on if you have a particular form in iMedRIS that you need assistance in completing. In an effort to coordinate the time required and format of the training, please email your question(s) to Kimberly Prachniak at email@example.com along with the request for training.
The IRB can come to you and tailor our training to directly meet the needs of your department. We can conduct either of the 2 sessions above, or we can incorporate some of the beginner session with specific departmental issues, such as explaining the difference between exempt and expedited studies.
What Training is Required?
All employees, faculty, staff, students, and/or agents of UTHSC engaged in the conduct of human subjects research must have reviewed and be familiar with the principles of "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research," along with applicable Federal and State laws and institutional policies regarding Human Subjects Research. You can view The Belmont Report and other guidelines and regulations on our “Resources” page.
Prior to submitting research protocols for review and approval by the UTHSC IRB, all Key Study Personnel (KSP) listed on UTHSC IRB submission, regardless of their position, must complete the web-based Collaborative IRB Training Initiative (CITI) Program in the Protection of Human Subjects in Research available at http://www.citiprogram.org/ or the National Institutes of Health (NIH) online Course at http://phrp.nihtraining.com/users/login.php . Each course is described below.
Collaborative IRB Training Initiative (CITI) Program
What is CITI? The Collaborative IRB Training Initiative (CITI) Program is a leading online training program maintained by the University of Miami. It offers curricula in human subjects research, animal research, and the responsible conduct of research.
Who has to take CITI? The training requirement applies to IRB members and to anyone conducting human subjects research activities at UTHSC. This includes anyone working directly with human subjects or with identifiable data or biological specimens for research purposes under UTHSC auspices. Investigators, research nurses, coordinators, students, technicians working with identifiable data, and faculty advisors all need to obtain CITI certification. If you are a first-time CITI user, you will be asked to register using your UT Net ID as your username. If you do not have a UT Net ID, use your first initial and last name. If you are an employee of the University, you will also need to enter your UT employee personnel number (EPN); this will allow your training to be entered into the human resources mandatory training database. Contact your business manager if you do not know your EPN. If you are not paid by the University and do not have an EPN, please enter NOEPN in the appropriate field.
Which CITI course do I have to take? You must take the course that is the most appropriate to your research activities. For example, Research Administrators, IRB Chairs, and Office of Human Subjects Protection (OHSP) staff should take Group 1; IRB Members and Department Chairs should take Group 2; and Investigators and all KSP should take Group 3.
For how long is my certification effective? For IRB purposes, certification is good for three years for those conducting human subjects research at UTHSC or any institution affiliated with UTHSC. CITI offers refresher courses for recertification.
Need Assistance? If you need any assistance or have any questions regarding the CITI training, please contact Melanie Saucier at (901) 448-4824.
National Institutes of Health (NIH) Online Course
This is a free, online course that presents information about the rights and welfare
of human participants in research. The course satisfies the NIH human subjects training
requirement for obtaining Federal funds. Click the link below to be taken to the course
NIH Online Course: http://phrp.nihtraining.com/users/login.php .
UTHSC IRB office
Memphis, TN 38163
Phone: (901) 448-4824
Fax: (901) 448-5103