Regulatory and ethical considerations for linking clinical and administrative databases
Duke Clinical Research Institute, Durham, NC 27705, USA.American heart journal (Impact Factor: 4.46). 07/2009; 157(6):971-82. DOI: 10.1016/j.ahj.2009.03.023
Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database.
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ABSTRACT: Even complex allosteric enzymes can be analyzed in a manner guided by the principles of thermodynamic linkage. Apparent coupling parameters between pairs of ligands can be determined regardless of the oligomeric nature of the enzyme. Except in the simplest of cases the associated coupling free energies will be equal to the sum of the individual unique coupling parameters that exist between the multiple binding sites for each ligand. If the coupling free energy is divided by the stoichiometry, the average coupling free energy will be obtained. The overall value will include a contribution from homotropic interactions only if the degree of cooperativity changes in the presence of the other ligand. The sum or average nature of these coupling parameters compromises their utility only to the same extent as does the fact that K 0.5 represents an average dissociation constant. The coupling free energy, even if a composite of more fundamental couplings, still quantitatively describes both the nature and magnitude of the allosteric effect, and as such it provides a means of monitoring how another experimental variable, for example, the introduction of a site-specific mutation, might alter the action of an allosteric ligand. Thus, even without a precise understanding of the individual interactions that comprise the coupling free energy, it provides a model-independent basis for interpreting experiments. One might draw an analogy to the value of the kinetic parameter V/K in a kinetic analysis of a nonallosteric enzyme. Even before (or without) knowing the precise kinetic mechanism for an enzyme, the meaning of V/K is clear, and its evaluation assists in the eventual determination of that mechanism. Other principles of linkage are also useful to keep in mind-in particular, the principle of reciprocity, the principle of the independence of binding affinity and allosteric efficacy, and the principle that ultimately it is the poise of a disproportionation equilibrium, such as Eq. (13), that must be understood. In particular, the properties of the ternary complex are the key to understanding any structural basis for the allosteric function. The ternary complex is too important to leave its true nature to mere presumptions, or worse yet to the seemingly irrelevant ambiguity of a two-state model.
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