Office of Human Research Affairs

Human Subjects Research Education

 IRB Education and Training | Introduction | Initial Registration | Refresher Registration | Additional Courses | CITI Certificates/Reports  

 


  OHRA Education and Training - July 2019 

 Seminar Title   Date and Time   Location 

 Single IRB 101 

 TBD

TBD

 iRIS 101  

 11/06/2019, 10:30 AM - 11:30 AM 

Montefiore (Moses Campus), TLC 3

 CT.gov   11/13/2019, 10 AM - 11 AM **by APPOINTMENT ONLY**  Albert Einstein College of Medicine, PRICE 251 

 

 

 

 

 

  Introduction: 

   Training and Consultation Request Form  Human subjects research education is required of all Key Personnel* who conduct human subjects research.  The Einstein IRB will not issue approval if any key personnel has not satisfied this requirement.

*Key Personnel is defined as individuals who contribute in a substantive way to the scientific development or execution of the project, or the consent process.

Initial training can be completed by completing either of the following:

  • CITI Basic Course in human subjects research (estimated to take 4-6 hours)
  • CRTP Students: Both semesters of Dr. Macklin's Research Ethics course

After the expiration of initial training (currently 5 years), the CITI refresher course is required.  As a courtesy the Einstein IRB sends monthly reminders as the expiration of your training approaches.

 Collaborative Institutional Training Initiative (CITI)  

The CITI Basic course offers a broad base of educational material for all individuals who are involved in the conduct of human subject research. The Einstein IRB 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.

 There are two sets of instructions: 

Please note that effective March 2015, CITI will only support Internet Explorer (IE) 8.0+, or use a current version of Chrome, Firefox, or Safari. Users at Montefiore whose computers only have IE 7.0 or earlier may contact the EHIT helpdesk to request that Firefox be installed on their computers.

 

 Instructions for Individuals Taking CITI for the First Time

  1. To register for this course, visit: http://www.citiprogram.org.
  2. Click on “Register”.
  3. Select “Albert Einstein College of Medicine, Inc.” under "Select Your Organization Affiliation".
  4. View the terms of agreement and privacy policy
  5. Check the boxes to agree with terms of agreement, privacy policy and to affirm affiliation with Albert Einstein College of Medicine, Inc., then click "Continue To Create Your CITI Program Username/Password".
  6. Enter your Name and Email address, then click "Continue To Step 3”.
  7. Enter your (new) Username and Password, select and answer your security question(s), then click “Continue To Step 4”.
  8. Enter country residence then click “Continue To Step 5”.
  9. Answer questions in step 5 then click "Continue To Step 6".
  10. Enter member information then click "Continue To Step 7". 
  11. Skip Question 1 if you have already completed basic CITI training at Einstein. 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 “Complete Registration”, then click "Finalize Registration".
  12. Congratulations – you’re registered! Click on the hyperlinked course name to enter the course.

 

Upon completion of the required modules in the refresher course, a Completion Report will sync to iRIS as long as the "preferred " e-mail address in CITI matches the e-mail address listed in your iRIS profile.

Einstein CITI Requirements

Modules Biomedical Research (includes Epidemiological Research) Drug and/or Device Research Social & Behavioral Research: Azrieli, Ferkauf,  Wurzweiler, and Undergraduate 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 Taking the CITI Refresher Course (For individuals who last completed CITI 5 years ago.)

Most users will be able to log into their existing CITI account and be prompted to take the refresher.  However if you last completed CITI before 5/2004, you will need to re-register, since CITI doesn’t have a record of those accounts. 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 “Register”.
  3. Select “Albert Einstein College of Medicine, Inc.” under "Select Your Organization Affiliation".
  4. View the terms of agreement and privacy policy
  5. Check the boxes to agree with terms of agreement, privacy policy and to affirm affiliation with Albert Einstein College of Medicine, Inc., then click "Continue To Create Your CITI Program Username/Password".
  6. Enter your Name and Email address, then click "Continue To Step 3”.
  7. Enter your (new) Username and Password, select and answer your security question(s), then click “Continue To Step 4”.
  8. Enter country residence then click “Continue To Step 5”.
  9. Answer questions in step 5 then click "Continue To Step 6".
  10. Enter member information then click "Continue To Step 7". 
  11. Skip Question 1 if you have already completed basic CITI training at Einstein. 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 “Complete Registration”, then click "Finalize Registration".
  12. Congratulations – you’re registered! Click on the hyperlinked course name to enter the course.

Upon completion of the required modules in the refresher course, a Completion Report will sync to iRIS as long as the "preferred " e-mail address in CITI matches the e-mail address listed in your iRIS profile.

 

Additional Courses Offered by CITI

In addition to the required courses listed above, CITI offers other courses of interest to those conducting human subjects research.  The following courses are may be required by some sponsors and/or the IRB on a case-by-case basis.

  • The CITI International Training Platform is a publicly available, providing basic, foundational information for researchers, research staff and research ethics committee members involved in international research. This program now includes two learner tracks. Track 1 targets the international investigator (International Modules) while Track 2 is intended for non US investigators, involved in U.S. Federally funded international research (US Federal Modules). To register for this account, log into your existing account, then select “Affiliate with another institution” link on the Main Menu. From the Participating Institution drop-down list, select “DEMO” and continue to register with our DEMO institution. From the Select Curriculum page, select the following option(s):
    I would like to review the International Modules, designed for an international audience, which are available in English, Spanish, Portuguese, Chinese, and French.
     
  • The Good Clinical Practice course was developed by experts in the field and has undergone extensive peer review. This course covers the best practices that apply to investigational drug and device studies, and has been required for all Key Personnel involved in drug or device studies since January 1, 2015. To register for this course, log into your existing CITI account, click “Add Course or Update Learner Groups”, choose “Yes” to question #3, scroll to the end and click “Submit”. Under your course list on the Main Menu, you’ll now have a “GCP” course available, consisting of 14 modules. More info about this requirement is available here.

If you need assistance with registration for these modules, or the basic CITI course, please contact the IRB at 718-430-2237, or iris-support@einstein.yu.edu.

 

CITI Certificates/Reports

CITI has updated completion certificate access instructions. There are some cases where the sponsor or PI will request CITI completion certificates/reports. To view the updated instructions click here.

 

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