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
Source: PubMed


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.

1 Follower
6 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: The performance of the Integral Convolution and the Dual Energy Window scatter correction methods in 3D PET has been evaluated over a wide range of statistical content of acquired data (1 M to 400 M events). The order in which scatter correction and detector normalization should be applied has also been investigated. Phantom and human neuroreceptor studies were used with the following figures of merit: axial and radial uniformity, sinogram and image noise, contrast accuracy and contrast accuracy uniformity. Both scatter correction methods perform reliably in the range of number of events examined. Normalization applied after scatter correction yields better radial uniformity and fewer image artefacts
    No preview · Conference Paper · Dec 1996
  • [Show abstract] [Hide abstract]
    ABSTRACT: This paper proposes a method for simultaneous localisation and mapping (SLAM) in an indoor environment using stereo vision. Specially designed artificial landmarks distributed in the environment are observed and extracted from a camera image. The disparity map obtained from the stereo vision system is used to obtain the ranges to these landmarks. The main contribution of the paper is the formulation of the mathematical framework for SLAM for a robot moving on a planar surface among landmarks distributed in three dimensional space. The paper also presents the results of experiments conducted using a pioneer robot and a Triclops stereo vision system. It is demonstrated that accurate robot and feature locations can be obtained using the proposed technique.
    No preview · Conference Paper · Jan 2004
  • [Show abstract] [Hide abstract]
    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.
    No preview · Article · Feb 2004 · Methods in Enzymology
Show more