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Meriter's Clinical Research - IRB
Human Subject Protection
Training Requirement


Meriter's Institutional Review Board requires all research staff to complete ongoing education in human subject protection.

Why

Meriter IRB requires current and ongoing human subject protection training for researchers and IRB members. This is in compliance with our Federal Wide Assurance and is in keeping with our institutional mission for providing a Best Practice Environment.

Timeline

  • For New Protocol Applications, you and your research staff must complete human subject protection training before your protocol can be reviewed.
  • When your protocol is due for Continuing (Annual) Review you will have to show proof of human subject protection training in the last three years.

What

  • If you have taken a human subject protection training course in the past three years, then you will provide Meriter IRB with a dated completion certificate. Qualifying courses include:
    • University of Wisconsin's online Human Subject Protection Training
    • NIH human subject protection training modules
    • VA training modules
    • Other
  • For researchers' convenience, Meriter has subscribed to an on-line web based human subject protection training program from the University of Miami called CITI course. You can take training modules here to fulfill your training requirement if you are not required to take another institution's training modules.

    Which CITI course Modules should I take?
    • If you have never taken a human subject protection training course - take the basic modules (biomedical or social behavioral). Annual refresher modules are required after this.
    • If it has been more than three years since your last human subject protection training - take the basic modules (biomedical or social behavioral). Annual refresher modules are required after this.
    • If your current human subject protection training is about to expire (three years old) – take refresher modules 101 (biomedical or social behavioral)
  • Should I take the biomedical or social behavioral modules?
    These terms refer to the type of research that you are involved in.
    • Biomedical modules – Research that focuses on physical disease processes, the treatment and diagnosis of physical disease which may include the use of drugs and devices.
    • Social Behavioral modules – Research that focuses on human behavior, how people act, think, interact with others, make decisions, etc.
  • If you are still doing research at Meriter a year from now you will be required to take further human subject protection training before your protocol receives continuing review. Your choices are:
    • Annual refresher modules (1-2 hours) from the CITI course
    • Other equivalent qualifying course
  • If you have questions about the human subject protection training requirement, please contact the Meriter IRB office (267-6411) for clarification.

How

  • Log on to http://www.citiprogram.org/.
  • Register yourself.
  • Choose Meriter as your institution. You do not need an employee number.
  • Most researchers will choose the biomedical modules although some researchers may qualify for the behavioral modules. If you are not sure contact the Meriter IRB Office.
  • Each module has test questions at the end. You can take the modules at your own pace, stopping whenever you want. You can log back on to continue working.
  • Once you have finished all the modules, an electronic report is automatically sent to the Meriter IRB office.
  • Print your own copy of your completion report and keep for your records.

Who

All research staff must have active training records before your protocol receives Initial or Annual review.

Questions

Contact the Meriter IRB Office at (608) 417-6411 or lmichaels@meriter.com.
 

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3/21/2008