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C H A P T E R 5 Data Management Human Subjects Protection scale field study, the protocols for the S05 pilot studies under- went the full board review process at Virginia Tech (VT). This Federal regulations and good research practice call for pro- allowed a wider range of reviewers to see the complete proto- tection of persons who participate in research studies ("human col and raise human-participant concerns and issues prior to subjects"). The Office for Human Research Protections running the NDS. The combination of full board review at (OHRP) in the U.S. Department of Health and Human Ser- VT and full board review at NAS resulted in a very robust vices (HHS) provides leadership in the protection of the protocol that serves as a good starting point for the NDS. rights, welfare, and well-being of subjects involved in research. Additionally, a Certificate of Confidentiality (CC) was OHRP does this by providing clarification and guidance, secured from the National Institutes of Health (NIH) for the developing educational programs and materials, maintaining S05 pilot study. A CC helps researchers protect the privacy of regulatory oversight, and providing advice on ethical and subjects in biomedical, behavioral, clinical, or other research regulatory issues in biomedical and behavioral research. projects against compulsory legal demands (e.g., court orders These protective policies are enforced at the local level by an and subpoenas) that seek the names or other identifying char- organization's institutional review board (IRB), an entity acteristics of a research subject. The CC covers the collection required by federal regulations. of sensitive research information for a defined time period (the Of paramount concern in the design of the SHRP 2 NDS term of the project); however, personally identifiable informa- was the need to maintain close coordination with nearly all of tion obtained about subjects enrolled while the CC is in effect the other project tasks, as virtually all tasks have some impact is protected in perpetuity. A CC will also be requested for the on the safety or privacy of the participants or their data. Key full-scale NDS. On the basis of the approval of the S05 CC, a issues include protection of participant confidentiality, pro- timely approval for the SHRP 2 NDS CC is anticipated. tection of unconsented passengers (e.g., no continuous audio Upon NDS inception, one of the first sets of tasks relates to recording can be employed since it may capture the conver- securing the IRB approvals from the S06 IRB, the NAS IRB, sations of unconsented passengers), informed consent (and and each S07 IRB before proceeding with any and all aspects of assent/parental consent for minor participants), protection of the research involving human participants. Similarly, all S06 potentially identifying information (e.g., face video and geo- and S07 project personnel who will interact with participants spatial identifying data), and the continued protection of par- or their data must certify that they have passed an approved ticipant confidentiality once the data are stored in a database IRB course or a course on protecting human participants. for post hoc analyses. Each individual site contractor (except any that have chosen to formally rely on the VT IRB) will have to receive approval from its own IRB on the basis of the research protocol and Institutional Review Boards and participant-consent documents approved by the VT IRB. It is Certificate of Confidentiality likely that modifications to the standard set of documents to Human subjects protection in the SHRP 2 NDS will be ensured meet local needs will be reviewed, but these are not expected by the review and approval of eight separate IRBs: those of to fundamentally change. IRB-related submission materials the S06 contractor, the six S07 contractors, and the National were shared with the various stakeholder IRB personnel early Academy of Sciences (NAS). To prepare as well as possible for in the process, including during a meeting of these stakehold- the human subjects protection review expected in the full- ers in Washington, D.C., in the summer of 2009. IRB approval 25