Carle Connect - Human Subject Protection Education
CarleConnect

 

Education

Human Subject Protection

Updated January 27, 2012

Yearly One Hour Education Requirement

must be met before July 31, 2011

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Requirements

All Investigators and their key research personnel must complete requirements in human subject protection education before initiating their involvement in human subject research. Initial training should include, but is not limited to, biomedical human subject protection, HIPAA in research, and conflicts of interest in research. Documentation of this education must be on file in CHF Human Subject Protection Office before a study can receive Carle IRB approval. This applies to new projects and to ongoing projects at the time of IRB annual review.  Documentation of training should be submitted to: Carle CITI Administrator, Mary Lyman, (217) 326-4509, mary.lyman@Carle.com. Education Certificates from CITI are sent automatically sent to the Carle CITI Administrator.

 

Beginning January 1, 2009, all new study submissions to the Carle IRB (initial and continuing review) will require the investigator and all key research personnel to have completed the initial education requirements.  A delay in completing the education requirements will result in a delay in IRB review.

 

Initial Education

The initial educational requirement can be met by completing one of the following:
 

CITI Initial Education

CITI initial education can be met by registering as
a Carle Foundation Hospital affiliate (Carle affiliate) and completing the basic bio-medical CITI initial training module plus one elective at the CITI Web site (www.citiprogram.org)Depending upon your level of experience with the subject matter, course completion will take between 3 and 6 hours.

CITI job-aid: Click here for instructions for navigating the CITI training.
 

University of Illinois at Urbana-Champaign (UIUC) Education
 

Option 1, consisting of the completion of:

UIUC Human Subjects module and quiz

NIH human subject protection training

‘HIPAA and Human Subjects Research’ CITI module
 

Option 2, consisting of the completion of:

UIUC Human Subjects module and quiz

CITI modules that are required by UIUC

‘HIPAA and Human Subjects Research’ CITI module.

NIH Education
 

NIH human subject protection training completed after March 1, 2008, can be applied toward the completion of the education requirement.  The NIH certificate of completion must be forwarded to the Carle CITI Administrator at the Human Subject Protection Office.  In addition, the person must register with CITI as a Carle affiliate and complete the following five (5) CITI modules:
 

  1. Social and behavioral research for biomedical researchers

  2. FDA-regulated research

  3. HIPAA and human subjects research

  4. Conflicts of interest involving human subjects

  5. One CITI elective


 

Initial Exempt Research Education

Those investigators and key personnel who will only be conducting exempt research may opt to complete the shorter Exempt Research Education through CITI after logging in as a CFH affiliate.  For exempt research, there is only an initial education requirement, no continuing education is needed. The exempt research education will need to be updated to the full initial education should the investigator begin conducting research that is classified as expedited or full board.

 

Continuing Education

Once initial training requirements are met, all Carle affiliated investigators and key research personnel must complete continuing education in human subject protection yearly on Carle IRB policies, and once every two years on CITI Refresher course as a Carle affiliate per the  Education Policy.

  1. Yearly Continuing Education
    The one-hour per requirement must be met before July 31, 2011.  This yearly one-hour education requirement can be met in one of three options.
     

    Option 1

    Annual Human Subject Protection Conference held on September 30th, 2011.
     

    Option 2

    Attend one of the following seminars on Carle IRB policies from Noon-1pm in the Biomedical Research Center Conference Room (3rd floor Mills Breast Cancer Institute/Carle Cancer Center):

    Tuesday March 27, 2012

    Tuesday April 24, 2012

    Tuesday May 22, 2012

    Tuesday June 19, 2012

    Option 3

    View an online video of the presentation on Carle IRB policies from the 3rd Annual Human Subject Protection Conference and complete a Quiz in lieu of attendance. Slides from the presentation are also available as you view the video. Participants need to have at least 9 out of 12 questions correct to receive credit.  After completion of this quiz, send it to irb@carle.com and you will get a confirmation email with your results.
     


     

  2. Every Two Years Continuing Education
    The every two years continuing educational requirement can be met by registering as a Carle affiliate and completing the CITI refresher modules

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