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346 A p p e n d i x S Note that Amendments 1â6 were related to the Study Design phase of the SHRP 2 NDS. Only amendments that were rel- evant to the Data Collection phase are summarized here. Amendment 7 allowed for the use of vehicles not owned by the research participant as long as the vehicle owner signed a permission form. This greatly enhanced the ability to recruit young drivers. Compensation was also increased to $500 per year following a distribution scheme similar to that described in Chapters 2 and 7 for the initial $300 per year compensation. Amendment 8 revised the owner permission letter per a NAS IRB request, and also included items to bring forms into compliance with the consistency review. Amendment 9 revised the exit survey, discussed the Battelle call center (a parallel recruitment effort to the main study call center recruiting), and revised an e-mail/letter sent to current participants to inform them of the increased payment. Amendment 9a was for Battelle only and was for approval of their call center. Amendment 10 added the slogan of Crowley Webb (an advertising firm hired by the Erie County, New York, site) to recruiting materials. Amendment 11 added materials to allow participants to extend their scheduled participation for up to 12 additional months. Amendment 12 added materials to allow for variable enroll- ment periods of from 8 to 24 months (this was in March 2012, when the data collection was about halfway complete and the study was beginning to wind down). Amendment 13 added a phrase to the variable enrollment consent forms (in its review of the Amendment 11 exten- sion of enrollment for currently enrolled participants, the NAS IRB requested that the current phrase on the last page of each consent form, âThe Participant Must Be Provided With A Copy Of This Re-Consent Form,â include the added phrase, âWith a Copy of the Original Signed Consent Form Attachedâ). Amendment 14 added language to the consent forms informing participants that vehicles with persistent tire pres- sure monitoring system (TPMS) issues would be removed from the study. Amendment 15 added promotional materials such as pens and cups to the recruitment section of the protocol. Amendment 16 allowed for variable enrollment periods of 4 to 7 months (to maximize data collection as the study wound down); removed mention of the âblanket processâ from the protocol and consent forms (this was a method of captur- ing images of the drivers in simulated darkness to improve the driver identification process); and provided for a $25 gift card for a primary driver who was able to provide pictures of consented secondary driver(s). Amendment 17 increased the number of primary partic- ipants to 3,300 (given that some participants dropped out fairly early in their scheduled enrollment, it became clear that the 3,000 number would be surpassed at some point late in the data collection period). Amendment 18 allowed sites to contact secondary drivers for a photo and asked these drivers whether their contact infor- mation could be retained for follow-on studies. Summary of Amendments
