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In preparing their local IRB applications, staff at the six study center sites incor- porated information provided by VTTI into the application at their own institution. All staff at each of the study centers who interacted with the participants were required to receive Human Subjects Training in a manner approved by the cognizant IRB. This certifi- cate, obtained by VTTI, covered all six study centers.Ī copy is provided in Appendix C.
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If there are any changes to the protocol during the course of the study, a formal modification, or amendment, describing the change must be submitted and reviewed by the IRB staff and possibly by the full IRB committee as well. The role of the IRB is to review all research protocols involving human subjects before the project start and then periodically while the project is under way to ensure that the rights of the participants are protected, that participants are not subject to unreasonable harm either physical or emotionaland that data and information about the participants are kept confidential.įor multiyear projects like the NDS, an annual continuing review is also conducted.
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Deinstallations In addition to describing the process and issues encountered as volunteer drivers were enrolled and monitored during this 3-year study, lessons learned during each step are summarized. Participant management and fleet maintenance includ- ing crash investigations 6. The topics covered in the following sections include 1. Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Not a MyNAP member yet? Register for a free account to start saving and receiving special member only perks.