IRB Training

Human Subject Research Training
Initial CITI Training Course
CITI Training Refresher Course
Linking CITI Training
FCOI Training
HIPAA
Determination for Human Subject Research

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Human Subject Research Training

CITI Training for Investigators:

CITI (Collaborative Institutional Training Initiative) Training (CITI Program) is widely considered the gold standard in online human subject research training. Ongoing education and training in protection of human participants is a federal requirement. Enhanced oversight, new requirements, and recent guidance provided by the Office of Human Research Protections (OHRP) have required actions to strengthen human research protections programs.

Please review the CITI Training Completion Guide

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Initial Course

As of February 1, 2010, Principal Investigators, Co-PIs and research team members must complete CITI Training before the Initial Application, or Renewal Application can be fully approved, or they must be temporarily removed from the research team until the training has been completed. During the administrative review of these transactions, the IRB Office will be checking the CITI Training database to ensure that training has been completed. CITI Training will not be checked during Addenda transactions unless there are changes being made to the research team.

Log on to: www.citiprogram.org to complete the training. You will be able to create your own user name and password as this is not linked to your UMD ID. Be sure to select UNIVERSITY OF MARYLAND COLLEGE PARK as your institution. If you cannot complete the training in one sitting, you can save and finish at a later time (You can stop and start as many times as you need).

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Refresher Course

All members of the research community are required to complete the CITI Training Refresher every three years.

Log on to: www.citiprogram.org to complete the training. You will be able to create your own user name and password as this is not linked to your UMD ID. Be sure to select UNIVERSITY OF MARYLAND COLLEGE PARK as your institution. If you cannot complete the training in one sitting, you can save and finish at a later time (You can stop and start as many times as you need).

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Linking CITI Training Completion Report to your Project

As of February 15, 2013, your CITI Training Completion Report must be linked to your project in order to for the IRB to proceed with the approval process. This is a fairly simple process:

(1) Add CITI Completion Report to your IRBNet User Profile. Once you are logged into IRBNet, click USER PROFILE in the upper right corner of the screen. Scroll down to the bottom of the screen and click Add New Record. Follow the instructions to attach the PDF version of your completed CITI Training.

(2) Link your CITI Completion Report. During your Initial Application or next package submission in IRBNet, link your CITI Completion Report to the project. To do this, click Designer and then click Link/Unlink Completion Report near the middle of the page. Follow the instructions. This should be done for each member of the research team.

(3) PLEASE NOTE: You must link your training with EACH project of which you are a research team member. If the IRB Office receives your application without the CITI Completion Report of each research team member, the project will be unlocked so you may add them before we continue with the review process.

4) NOTE: You do not need to “submit” your training to a Committee in order to upload your Completion Report to your profile or to link your report to an IRBNet submission.

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FCOI Training

Click 'Add a Course or Update your learner groups'. For Question 4, Conflict of Interest Mini-Course, select Yes. Once completed, a Completion Report will be generated which can be added to your User Profile in IRBNet so you can link it to any future projects.

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HIPAA Training for Investigators

HIPAA (Health Insurance Portability and Accountability Act of 1996) Training ensures that national health information privacy standards issued by the U.S. Department of Health and Human Services (DHHS) are upheld. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. Covered entities may use and disclose protected health information (PHI) for research with authorization or without individual authorization under limited circumstances.

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Determination for Human Subject Research

Log into IRBNet and download the Human Subject Research Determination Form under Forms and Templates. Complete this form and submit to the UMD IRB Committee in IRBNet. We will review and make a determination as to whether an IRB Application is required because your project is human subject research or if your project does not qualify as human subject research. If your project does not qualify, we will generate an official document in IRBNet confirming that the UMD IRB Office has reviewed and made this determination.