Education

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IRB Meeting Dates and DeadlinesIs It Human Subject Research?Templates and Samples

  • CITI Training Program

    CITI Course in The Protection of Human Research Subjects: http://www.citiprogram.org/  

    General Introduction

    The purpose of the CITI program is to develop, implement and maintain a web based educational program in the protection of human subjects in research. Currently there are 18 basic modules for Biomedical Research and 17 basic modules for people in Social and Behavioral Research

    To Begin go to http://www.citiprogram.org/ and register for the course.

    User creates username and password. The course takes two (2) to six (6) hours to complete, but it does not have to be completed in one session. Each module is followed by a quiz. A minimum score of 85% is required for each module to advance.

    Biomedical Research Modules

    •Introduction
    •History and Ethical Principals
    •Basic Institutional Review Board 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
    •HIPAA and Human Subjects Research
    •Workers as Research Subjects-A Vulnerable Population
    •Hot Topics
    •Conflict of Interest in Research Involving Human Subjects
    •University of Mississippi Medical Center Social

    Behavioral Research Modules 

    •Introduction
    •History and Ethical Principals
    •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
    •International Research-SBR
    •Internet Research
    •HIPPA and Human Subjects Research
    •Workers as Research Subjects-A Vulnerable Population
    •Hot Topics
    •Conflicts of Interest in Research Involving Human Subjects
    •University of Mississippi Medical Center Continuing Education for Investigators and Key Research Personnel

    All investigators and key research personnel must meet the IRB continuing education requirement of two (2) hours each year for as long as they are involved in research with human participants. Key research personnel include research staff responsible for the design of the study and all those who come in contact with human participants and/or identifiable data. There are no exceptions to this requirement. The designated CITI Continuing Education (Refresher Course) will offer the opportunity to fulfill this requirement. Additional options will be added to this web page as they become available.

    If the principal investigator has not met the continuing education requirement research, protocols for that investigator will not be accepted and will be returned to the investigator.
    If there are co-investigators or key research personnel who have not met the continuing education requirement, submissions will be accepted; however, those personnel who have not met the continuing education requirement will not be allowed to participate in the conduct of the research until this requirement is up to date.

    Time Commitment
    Our users tell us that, on average, it takes about 6 hrs to complete a basic course of 18 Biomedical or 17 SBR modules. Learners normally do not complete the course in one session. On average our learners use 5-6 sessions to complete the course.

    Quizzes
    Upon completion of each module the learner is directed to take a short quiz of the material. YES... we do keep score. The software will grade the quizzes and collate the scores. In addition, each institution can established a minimal level of achievement to "pass" the course.
    When the learner submits the quiz, the software will display the correct and incorrect responses and feedback to support the correct answer. Learners my retake the quizzes until they are satisfied with their score. The software will remember the highest score. The Grade Book and Completion Report will reflect your best scores on the quiz.

    Software Requirements
    Note that you will need to have either MS Explorer (preferred) or Netscape Navigator 4.0 or higher, MS Word or other word processing software capable of viewing files in the RTF format and Adobe Acrobat Reader software, Version 5.0. The adobe acrobat reader can be downloaded at the ADOBE site for FREE.

    Getting Started
    The course software will keep track of the learners progress through the instructional requirements prescribed by your institution. When the learner finishes a module the software will give them a link to the next module or the opportunity to view the grade book on the quiz feed back page. The learner my also access the next module from the Grade Book.
    Go to the Top

    After All Required CITI Course Modules Have Been Completed.
    The Learner will be directed to a module that displays human subjects research information specifically provided by your institution. Institutions can post materials at this "Institutional Page" and even quiz the user.

    When all requirements have been completed , the user will be able to download a Course Completion Report. This "Report" will provide a detailed record of th user's accomplishments. A copy of this file will be sent to the IRB administrator and the IRB office will issue you a certificate.

    The user will be asked to complete a voluntary, anonymized survey about the course. This will help the CITI developers improve the course and correct errors and/or imperfections. Please be as specific as possible.

    Links will be provided to apply for CME / CEU credits through the U of Miami CME Office. To be eligible for 6 CME credits the learner must complete a minimum of 12 modules in the Basic Course and achieve an aggregate score of 70% correct or better. There is a handling fee of $60 for 6 CME credits. Completion of the Refresher / Re-certification Course provides the opportunity to obtain 2 credit hrs. The handling fee is $30. A link will appear in the grade book when you become eligible for CME /CEU. If you want more information about CME / CEU follow the link in the footer of this page.
    HELP!!! If you have problems moving through the software or course content you should first call your IRB office for assistance and then if necessary contact the CITI help at CITIsupport@med.miami.edu..

    Acknowledgements
    The CITI Program was founded by Karen Hansen at the Fred Hutchinson Cancer Research Institute and Paul Braunschweiger Ph.D. at the University of Miami in March 2000. The program would not have been possible with the generous support from both institutions and the time and expertise provided by the content authors, the content editors and the CITI Working Group. The current software platform, leased through an agreement with AALAS, has undergone extensive renovation. CITI is indebted to Dr. Mike Fallon and Ms. Stephanie Manuel from the VA for making the changes necessary to adapt the software to the needs of the CITI learners. The current course site is hosted by the University of Miami Medical IT and CITI would like to thank Mr. Chris Bogue for his help and support in this project. The CITI program administration is supported through institutional subscription fees.