Sponsored Programs Administration
Institutional Review Board (IRB)
...for the protection of human participants in research
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Training
NDSU IRB policy requires all investigators conducting human subjects research to complete training on protecting the risks and welfare of research participants (documentation of training is verified when a protocol is submitted for review). This requirement applies to all those who will interact or intervene with research participants, obtain informed consent, or handle identifiable data (ie, project directors, co-investigators, key personnel, research team members, assistants, or outside collaborators). The training requirement may be satisfied by attendance at an on-campus session, or completion of a series of online modules.
New policy for refresher training beginning July 1, 2008: A new policy for continuing education was recently approved by the IRB, in order to ensure that researchers and IRB members maintain continuing knowledge of ethical principles and policies related to human research. Beginning July 1, 2008, 1 hr of additional training in research protections will be required every 3 years.
Options for refresher training include: online sessions (CITI, NIH), on-campus sessions, CDs, VHS tape, or other equivalent documentation from a course, seminar or conference. IRB staff are also available to give a presentation to your group, department, or class. Visit the IRB Updates Blackboard Course to look up your most recent training date, or contact the IRB office at ndsu.irb@ndsu.edu.
Campus sessions:
Intro and refresher sessions now scheduled for Fall 2008. A variety of introductory and topical sessions will be offered throughout September and October. Please pre-register for the session you wish to attend.
Online sessions - 2 options are available: CITI and NIH
CITI: https:// www.citiprogram.org
When registering, select 'North Dakota State University', and create your own username and password; also include your NDSU department affiliation. In addition to the human research modules, you will notice that the CITI site also contains training for animal research, responsible conduct of research, good clinical practices, and HIPAA. These modules are available for the NDSU community on a voluntary basis, but are not a part of the training requirement for IRB projects.
In the 'Human Research' section, you will select one of 4 possible categories of learner groups. There are short descriptions of each to help you select the group that best fits your role and the type of research being performed. Each learner group has a pre-selected list of applicable modules to complete. Select either 'social/behavioral research', 'biomedical research', or 'research assistant' as a learner group, and enter the gradebook for 'Human Research Curriculum' to begin the course modules. Note that the 'research assistant' learner group is only applicable for those who will have no direct contact with participants. The 'IRB Reference' learner group contains the entire set of modules and is not required for investigators (although is available if interested, or wishing to view modules out of a set sequence).
Most modules can be completed in about 20 minutes, and contain several quiz questions. The course may be completed in multiple sessions; an overall passing score of 80% will be required for completion of the set of modules. The CITI site will automatically notify the IRB of completions, and there is no need to send the IRB office a copy of your certificate.
Please note that the following optinal modules should also be completed if applicable to your project:: Research with Prisoners, Research in Public Elementary and Secondary Schools, International Research, Records-based Research, Genetic Research in Human Populations, Group Harms, FDA-regulated research, HIPAA and Human Subjects Research, Workers as Subjects and Conflicts of Interest in Research involving Human Subjects.
The CITI refresher course is available for continuing education, but only if you have already completed the initial CITI course.
National Institutes of Health::
These course modules are available at: http://phrp.nihtraining.com/users/login.php
Registration is free and open to anyone. The course requires about 1 - 1 1/2 hrs, but may be completed in multiple sessions. Print out the completion certificate and forward to the IRB Office for documentation.
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