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The Ancillary Studies Subcommittee (ASSC) of the Steering Committee will evaluate protocols that enhance the ability of Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) consortium to:
Ancillary studies propose questions and test hypotheses that are relevant to the goals and purposes of Teen-LABS but are not addressed by the Teen-LABS-funded core or other substudy protocols. An ancillary study, by definition, derives its financial support from sources other than the funds awarded by NIDDK for support of the Teen-LABS consortium. While ancillary studies will generally utilize information about or specimens obtained from patients already enrolled in the Teen-LABS core database, they may involve additional study sites, investigators, specimen and data collection, procedures, patients or other treatments. By contrast, substudies are projects conducted by Teen-LABS investigators at participating Teen-LABS sites with costs that are covered by the funds allocated to Teen-LABS.
The Teen-LABS consortium will collect a large and uniquely well-characterized sample of obese adolescents and will follow them before, during and after bariatric surgery. To make the best possible use of this extraordinary resource, members of the Teen-LABS Consortium encourage other investigators to develop ancillary studies in conjunction with other investigators within and outside of Teen-LABS. Each ancillary study must include at least one Teen-LABS coinvestigator.
The ASSC will conduct a review of all proposed ancillary studies and must approve all ancillary studies recommended for its consideration to ensure that they do not impose an unacceptable burden on Teen-LABS staff or participating patients or conflict with the aims of Teen-LABS. Data collection for funded ancillary studies may not proceed without the approval of the ASSC.
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