Institutional Review Board

Collaborative Institutional Training Initiative (CITI)

Collaborative Institutional Training Initiative (CITI)Human Subjects Research Educational Module

Introduction:
The Albert Einstein College of Medicine has contracted with the University of Miami for faculty and staff to take the Collaborative Institutional Training Initiative (CITI) computer-based training program. This web-based course is a mandated educational requirement for Einstein faculty and staff who participate in human subject research. It must be completed every 5 years (see Memorandum).

The CITI program has been developed in modules and will take 4-6 hours to complete. Faculty and staff who are required to complete this course must do so prior to approval of a protocol by either the Einstein CCI or the MMC IRB.

Einstein will receive notification that you have completed the course when you have reviewed all required modules and completed all required quizzes.

There are two sets of instructions:

 

Instructions for Individuals Taking CITI for the First Time

To register for this course, visit: http://www.citiprogram.org. Click on the "Register for the CITI Course" link, then select "Albert Einstein College of Medicine of Yeshiva University" under the "All Others:" category. Click the "SUBMIT" button, and proceed with the registration process. On the "Select Groups" page, check ONE box in the "Question 1" section. Skip "Question 2." Answer "No" to both "Question 3" and "Question 4." Upon the completion of the registration process, you will be granted immediate access to the tutorial.

ALBERT EINSTEIN COLLEGE OF MEDICINE INSTITUTIONAL INSTRUCTION PAGE
The University of Miami Collaborative Institutional Training Initiative (CITI) course content has been significantly revised and updated. The breadth of information provides a broad base of educational material for all individuals who are involved in the conduct of human subject research. The Albert Einstein College of Medicine requirements for completion of this tutorial have been structured to offer each researcher a program that has been tailored to address issues associated with their area of study. In this regard, please note that to fulfill the education requirement, you need to follow the instructions below.

Research staff who register for this course should indicate on both the initial registration page and on the final comments page their area(s) of research. The options are as follows:

  1. Biomedical Research (includes Epidemiological Research)
  2. Drug and/or Device Research
  3. Social & Behavioral Research - Ferkauf and Wurzweiler Students
  4. Social & Behavioral Research

The requirements for completion of the modules differ, depending on your category of research. There are now two sets of modules, one for Biomedical Research and the other for Social/Behavioral Research. Additionally, depending on your research interests, there is a set of three optional modules that you may complete. All of this detail is outlined in the tables below:

EINSTEIN CITI EDUCATION REQUIREMENTS REQUIRED MODULES FOR ALL RESEARCHERS

Modules Biomedical Research (includes Epide miological Research) Drug and/or Device Research Social & Behavioral Research: Azrieli, Ferkauf, IPHS and Wurzweiler Students Social & Behavioral Research
Introduction
History and Ethical Principles    
Albert Einstein College of Medicine
History and Ethical Principles - SBR    
Defining Research with Human Subjects - SBR    
The Regulations and The Social and Behavioral Sciences - SBR    
Assessing Risk in Social and Behavioral Sciences - SBR    
Informed Consent - SBR    
Privacy and Confidentiality - SBR    
Research with Prisoners - SBR        
Research with Children - SBR     *
Research in Public Elementary and Secondary Schools - SBR     *
International Research - SBR     *
Internet Research - SBR    
Basic Institutional Review Board (IRB) Regulations and Review Process    
Informed Consent    
Social and Behavioral Research for Bio-Medical Researchers    
Records-Based Research    
Genetic Research in Human Populations    
Research With Protected Populations, Vulnerable Subjects- An Overview    
Vulnerable Subjects- Research With Prisoners        
Vulnerable Subjects- Research Involving Minors    
Vulnerable Subjects- Research Involving Pregnant Women and Fetuses in Utero    
Group Harms: Research With Culturally or Medically Vulnerable Groups  
FDA-Regulated Research.      
Human Subjects Research at the VA        
HIPAA and Human Subjects Research
Workers as Research Subjects-A Vulnerable Population *
Hot Topics  
Conflicts of Interest in Research Involving Human Subjects
= Required
* = Required as applicable for Azrieli, Ferkauf, and Wurzweiler Students

For a printable version of this chart, click here.

Instructions for Individuals Refreshing Their CITI Completion
(For individuals who last completed CITI 5 years ago.)

In order to take the CITI Refresher course, you must re-register, since CITI doesn’t have a record of accounts created before 5/2004. Download a visual guide to registering for the CITI refresher here (PDF 232 KB).

To register for this course:

  1. Browse to http://www.citiprogram.org.
  2. Click on “New Users Register Here.”
  3. Select “Albert Einstein College of Medicine of Yeshiva University” in the Participating Institutions list, then click “Submit.”
  4. Enter your (new) Username and Password, then click “Submit.”
  5. Enter your Name and Email address, then click “Submit.”
  6. Enter your Member Information, then click “Submit.”
  7. Skip Question 1. In Question 2, check the appropriate “Yes” box for your type of research. Questions 3-4 are optional – you may select “No, not at this time.” Click “Continue.”
  8. Your screen should look like the sample (below). Click “No.”
  9. Congratulations – you’re registered! Click on the “Grade book link” to enter the course.

There are two refresher courses, Biomedical and Social/Behavioral. You will automatically be registered in one based on your choice of groups during the registration process.

Upon completion of the required modules in the refresher course, a Completion Report will automatically be sent to Einstein.


MEMORANDUM

To: Human Subject Research Community
From: Barbara A. Levy
Assistant Dean of Academic Affairs

Victor B. Hatcher, Ph.D.
Associate Dean for Continuing Medical Education

Date: December 20, 2006
Subject: New Education Requirements: Human Subject Research

Einstein and MMC have required that all individuals utilizing the CCI and/or IRB for the conduct of human subject research complete the Collaborative IRB Training Initiative (CITI) web-based training program. This program has provided us with a comprehensive and convenient method to educate staff about the legal and ethical considerations of subject protection.

New Requirement: Continuing Education To Be Completed Every 5 Years

National trends (funding agencies and certifying bodies) now require that certifying programs be completed within the past five years. In keeping with these standards, we are now requiring (for those who have previously completed the CITI 101 Course), a CITI Continuing Education course every 5 years.

CITI offers two Continuing Education courses. Depending upon your area of research, you should complete the appropriate module every 5 years, either:

  • Refresher 101 – Biomedical
  • Refresher 101 – Social/Behavioral

You will be notified separately as the five-year anniversary approaches (or has passed – there is an initial catch-up period). For those who will be notified in the first round, you will have six months (until June 1, 2007) to complete a Continuing Education module. Following that initial round, Principal Investigators and Key Personnel will routinely be notified 90 days prior to their certification expiration date, they are required to take a refresher course. Please note that new protocols will not be approved, nor existing protocols recertified, unless individuals have completed the required course.

To register for these courses, visit: http://www.citiprogram.org 

New Requirement: International Research

Researchers involved in research in foreign countries are now required to complete CITI’s International Course, in addition to the standard CITI requirement.

To register for the International Course, visit: http://www.irbtraining.org 

Recommended Course: Good Clinical Practice

CITI also offers a course in Good Clinical Practice. This course was developed by experts in the field and has undergone extensive peer review. While not a requirement, this course is available to our research community and should be particularly valuable to those involved in investigational drug and device studies.

To register for the GCP Course, visit: http://www.citiprogram.org 

Registration

To register for any of these courses, visit the address specified above. Click on the “Register for the CITI Course” link, then select “Albert Einstein College of Medicine of Yeshiva University” under the “All Others:” category. Click the “SUBMIT” button, and proceed with the registration process. IN ORDER TO GAIN ACCESS TO THE REFRESHER COURSE, YOU MUST ANSWER “YES” TO THE FOLLOWING QUESTION DURING REGISTRATION:

Have you completed an institutionally approved Basic Course in the Protection of Human Research Subjects (e.g. a previous version of the CITI Course?) If you know that you are specifically required to complete the Refresher Course at this time, choose “yes.”

During this process, you will have the opportunity to specify which course you would like to take. Upon the completion of the registration process, you will be granted immediate access to the tutorial.

If you need assistance with registration for these modules, or the basic CITI course, please contact David Wallach at 718-430-2234, or dwallach@einstein.yu.edu.

 

Should you have any questions about these requirements, please contact levy@einstein.yu.edu.

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