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Training
Mount Carmel holds a Federal-wide Assurance (FWA) allowing local review of human research. As a part of the assurance, Mount Carmel agrees to formal training and continued training of researchers working with human subjects. As you may be aware, training is a critical national priority for researchers, IRBs, IRB administrators, and Authorized Institutional Officials. Ongoing education and training in the protection of human subjects is a federal requirement. Enhanced oversight, new requirements, and recent guidance provided by the Office of Human Research Protections (OHRP) have required actions to strengthen human research protections.

Mount Carmel is implementing new training and education requirements for all individuals (including IRB members) who participate in the conduct of research using human subjects.

The new training requirement is the Collaborative IRB Training Initiative (CITI). CITI is a web-based training package on issues relating to human subject research. The CITI web site is maintained by the University of Miami, with content developed by a national consortium. The CITI training provides a comprehensive selection of educational modules appropriate for the nature of research in which an investigator and his/her research staff is engaged. The Modules include:

  • 14 basic modules focused on Biomedical Research
  • 11 basic modules focused on Social and Behavioral Research

Modules need not be completed in one setting. Researchers/research staff members can work at their own pace, and complete one module at a time or all of them at once. Each of the modules takes approximately 10-20 minutes to complete. A 3-4 question quiz concludes each unit and must be completed.

When you have completed the selected modules, print a hard copy of the completed Grade Book for your own records. It is not necessary to forward your completed CITI course information to the Human Subject Protection Office in order for it to be entered into the database. The Human Subject Protection Office is automatically notified once you have completed the CITI Course. Your name will appear in the Human Subject Protection Database within 48 business hours.

Accessing the CITI Training Program

  1. Go to www.citiprogram.org.
  2. Select Mount Carmel from the drop down menu labeled "Other."
  3. Create your user name and password.
  4. Register. You need only complete the sections highlighted in red.
  5. Select your required group. If your research involves Biomedical Research Mount Carmel requires Modules 1-12, and Modules 14 and 16. If your research involves Social/Behavioral Research Mount
    Carmel requires Modules 1-11.

Once you log in you will see the following:

Select a group

Group 1
Medical, physiological or pharmaceutical studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices, or other interventions.
Group 2
Studies on sociological, psychological, anthropological, or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.
Group 3
IRB Members
IRB Reference Resource
All CITI modules are available for ongoing use and reference when you join this Learner Group. However, if you are required to complete the CITI modules as a prerequisite for conducting human subjects research, you must enroll in Group 1, 2 or 3 and complete the required course content to receive "credit" for the course. You may change your Learner Group status later to "IRB Reference Resource" for ongoing access and resource use of all CITI modules.

Following is a list of the modules within each Group:

 
Group 1
Group 2
Module
Biomedical Research (Medical, physiological, or pharmaceutical studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices, or other interventions.)
Social / Behavioral Research (Studies on sociological, psychological, anthropological, or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.)
1
History and Ethical Principles
History and Ethics
2
Basic Institutional Review Board (IRB) Regulations and Review Process
Defining Research
3
Informed Consent
Regulatory Overview
4
Social Behavioral Research
Assessing Risks
5
Records-Based Research
Informed Consent
6
Genetics Research in Human Populations
Privacy and Confidentiality
7
Research With Protected Populations - Vulnerable Subjects: An Overview
Research with Prisoners
8
Vulnerable Subjects - Research With Prisoners
Research with Children
9
Vulnerable Subjects - Research Involving Minors
Research in Public Schools
10
Vulnerable Subjects - Research Involving Pregnant Women and Fetuses in Utero
International Research
11
Group Harms: Research With Culturally or Medically Vulnerable Groups
Research Using the Internet
12
FDA Regulated Research
 
13
Human Subject Research at the VA
 
14
HIPAA and Human Subjects Research
 
15
Workers As Research Subjects - A Vulnerable Population
 
 
Hot Topics
 
16
Conflicts of Interest in Research Involving Human Subjects
 

Group 3: IRB Members: All modules (Biomedical and Social/Behavioral Research)

Optional Modules:

  • Human Subject Research at the VA
  • Workers As Research Subjects - A Vulnerable Population
  • Hot Topics
  1. When you are ready to begin the course, you will need to chose the correct group and then hit the "submit" button. You do not have to complete all of the modules at one time. You may come and go from the site. To re-enter the site go to www.citiprogram.org and enter your username and password. Once in the site you will be able to look up which modules you still need to complete.
  2. After completing all the required materials, you must go to the Institutional page to complete the course. Your Institution has important information for your review. From your Institutional page, you will complete the course and send a confirmation of completion to the Human Subject Protection Office.
  3. In order to print your completion report and certificate you must click on "View completion report." A new window will open and you will see your certificate of completion.

CITI will send the Mount Carmel Human Subject Protection Office electronic notification of your completion; however, you should print your completion report for your records in case verification is needed.

A score of 80% must be achieved in order to obtain the training certificate.