Human Research Protection Program

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MCW Human Research Protections Certification Program

 

 

 

Introduction Requirements FAQ How Do I... Contact

 

 

To Login/Access CITI online program: https://www.citiprogram.org/Default.asp?

Introduction 

Welcome to the MCW Human Research Protections Certification Program.  In 2004 MCW announced the requirement to all individuals involved in the design, conduct or review of human subjects research to have been certified under a new educational program. 2004 Certification Letter

The program requirements include reading the Belmont Report and key MCW research documents and policies, completing the required modules of the Collaborative IRB Training Initiative (CITI) Program, maintaining CITI certification and additional annual educational requirements. The purpose of certification is threefold:

  1. Responsible Conduct in Research - to assure a thorough and universal foundation in the ethical and legal principles guiding human participant research.
  2. Scientific Integrity - to enhance the awareness of, and sensitivity to research integrity issues such as conflict of interest.
  3. Public Duty - to demonstrate to our study volunteers, the community, and research sponsors that we have the training and expertise necessary to protect the rights and welfare of research participants.

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Requirements

Initial
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must obtain CITI certification.  CITI certification is obtained by completing the required on-line modules with an overall score of 80%.  The initial CITI course can be completed in four to six hours.  Six CME credits are available from CITI.

  • New employees must complete the required modules and obtain CITI certification within 90 days from date of hire.
  • An investigator may not be a Principal Investigator until initial certification is complete. 
     

The required modules depend on the type of research and your role in that research.

  • Biomedical Research involves any type of clinical research studies, including those that involve investigational drugs and/or devices. 
  • Social/Behavioral Research involves observational and survey research, work with population and/or epidemiological studies. This type of research does not involve any drugs or devices (investigational or marketed).

 

Type of Research Biomedical Research Behavioral & Social Research
If your role is:  
PI or Co-Investigator Group 1 Modules Group 4 Modules
Study Coordinator Group 1 Modules Group 4 Modules
Other Research Staff Group 2 Modules Group 5 Modules
Community Research partner not in role as PI or Study Coordinator Group 6 Modules Group 6 Modules
Member of IRB or other review, IRB Staff, or Safety Committee Group 3 Modules Group 3 Modules

Ongoing
Annual

Additional human subject protection education is required each year for investigators and coordinators.

  • MCW investigators and coordinators must obtain three hours of human subject protection education annually.
  • Non MCW members of the research team must obtain one hour of human subject protection education annually.

CITI Refresher
In order to maintain CITI certification, everyone is required to complete the CITI Refresher course every three (3) years after initial certification is obtained.  Completion of the refresher modules can usually be completed in less than two hours. 

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FAQs

Who must complete requirements of the MCW Human Research Protections Certification Program?
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must be certified.

What modules must I complete?
The required modules depend on the type of research and your role in that research.

  • Biomedical Research involves any type of clinical research studies, including those that involve investigational drugs and/or devices. 
  • Social/Behavioral Research involves observational and survey research, work with population and/or epidemiological studies. This type of research does not involve any drugs or devices (investigational or marketed).

 

Type of Research Biomedical Research Behavioral & Social Research
If your role is:  
PI or Co-Investigator Group 1 Modules Group 4 Modules
Study Coordinator Group 1 Modules Group 4 Modules
Other Research Staff Group 2 Modules Group 5 Modules
Community Research partner not in role as PI or Study Coordinator Group 6 Modules Group 6 Modules
Member of IRB or other review, IRB Staff, or Safety Committee Group 3 Modules Group 3 Modules

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 How do I....?

What do I need to do?

  1. Register at www.citiprogram.org (Internet Explorer - recommended).
  2. Follow the instructions for CITI sign-on, and completion of course modules.        
  3. Print “Completion Report” and keep for your records.

What do I do if I forgot my user name or password?
If you have forgotten your user name and/or password, click on “Forgot username or password?” and follow instructions.  It is a very simple process to acquire either or both.

How do I access the CITI modules?

  1. Go to http://www.citiprogram.org
  2. Click on “Register Here”
  3. In the 1st section under “Participating Institutions” select Medical College of Wisconsin
  4. Enter information for all other registration questions and “Submit”
  5. Select Curriculum Page
  6. Select the group that most closely matches your role and type of research (Group 1 –  6)
  7. Choose “No I have not completed my Basic Course Training Previously.”
  8. Click on Submit
  9. Under “My Courses” you should see Human Research   Not Started-Enter
  10. Click on Enter, and begin course work.

How do I access the refresher modules?
1. Go to http://www.citiprogram.org
2. There are two ways to gain access to the refresher course.

  1. Click on the Gradebook link from the Learner’s Menu.  The Refresher Course should be listed.
  2. If you do not see a link for the Gradebook or if the Gradebook does not list the Refresher Course, go to View/Update your Learner Group, answer questions 1 & 2, and click on “Submit”.  The Refresher course should now show under “My Courses”.

How do I change/transfer from an affiliated institution or add MCW as my institution?

  1. Go to  http://www.citiprogram.org
  2. Enter username & password used to register with CITI at previous or other institution.
  3. Once on the Learner’s Menu, edit or change your email address as needed. 
  4. On the “Learners’ Menu” select “Affiliate with another institution”
    1. In the 1st section under “Participating Institutions” select Medical College of Wisconsin
    2. Enter information for all other registration questions and “Submit”
  5. You will now be on the “Select Curriculum – Medical College of Wisconsin” page
    1. Select the group that most closely matches your role and type of research (Group 1 – 6)
    2. Choose “No I have not completed my Basic Course Training Previously.”
  6. Submit
  7. Go to the “Learner’s Menu” page
  8. Under “My Courses” you should see a new grade book for MCW, Human Research Not Started-Enter (or Incomplete-Re-enter).
  9. Click on Enter, and verify previous CITI completed modules are displayed and then begin course work for modules which still require to be completed for MCW.
  10. Please note:  Institutions choose from a wide variety of modules and overlap with MCW modules will vary.  All modules required for MCW certification must be completed. 

 How do I change learner groups on CITI?

  1. Go to  http://www.citiprogram.org
  2. Enter username & password
  3. On the “Learners’ Menu” select “Add a course or update your learner groups for Medical College of Wisconsin
  4. You will now be on the “Groups” page and it will confirm the group(s) you are currently enrolled in for MCW.  If this is incorrect – click on “Update Groups”
  5. You will now be on the “Select Curriculum – Medical College of Wisconsin” Page
    1. Select the group that most closely matches your role and type of research (Group 1 – 6)
    2. Choose “No I have not completed my Basic Course Training Previously.”
  6. Submit
  7. Go to the “Learner’s Menu” page
  8. Under “My Courses” you should see a new grade book for MCW, Human Research  Not Started-Enter (or Incomplete-Re-enter)
  9. Click on Enter, and verify previous CITI completed modules are displayed and then begin course work for modules which still require to be completed for the new learner group which was selected.

Who must complete requirements of the MCW Human Research Protections Certification Program?
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must be certified.

Will my training that I completed at another institution be accepted?
If you are involved in human subject research at either Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and are current in your human subject protection training, MCW will accept this training.

If you have completed human subject protection training at an institution other than Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and request MCW acceptance of the training, please contact _citihelpdesk@mcw.edu .

How long will it take to complete the certification program?
The total time is approximately 4 to 6 hours for the basic course and less than 2 hours for the refresher course.  You may complete it multiple sittings.  The certification program is web-based and can be accessed from any computer via the internet.

What are some available options for the required annual education/training?

  • Annual Research Conference
  • MCW program, clinical research workshop or seminar regarding human research
  • Human Research Professionals Meeting
  • CITI Core Course module not done for initial certification CITI Refresher Course module not required for biennial recertification
  • Clinical Research Scholars Program
  • Non-MCW sponsored courses regarding human subject research
  • NIH computer based training

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Contact

Whom should I contact if I have questions about logging on, updating institution or learner information?
    For these, technical questions, and acceptance of equivalent training, please contact _citihelpdesk@mcw.edu .

 


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Page Updated 12/03/2013