Issues in data sharing and access: an industry perspective

Article Abstract:

In the area of industrial epidemiological research, there are many differences between data sharing and data access and many questions attendant to both processes. For example, will emerging data be available: (1) to all seekers, on a need-to-know basis or otherwise; (2) as required by law, based on grant conditions, or compliance regulations; (3) selectively, in response to a specific need; or (4) to no one, because of product secrecy? Accessibility assumes many forms, such as copies of published papers, data, product records, or tapes. If data is shared, should it be in the form of raw data, final data, or data that has been ''cleaned up'' for consumption? What data should be shared, to what extent should it be released, and when? Different modes of data access are suggested as part of a continuum of exchange and sharing. Access may be totally restricted for proprietary reasons. Data may be released and rereleased for audit and verification purposes. The data may provide the departure point for the evaluation of new hypotheses and causal associations. Similar data from multiple programs could be pooled for meta-analysis. Barriers to open and unrestricted data exchange are suggested because of the proprietary nature of products, ethical considerations, client confidentiality, personnel data and personal privilege. Publication of some data could hurt the investigator, professionally or otherwise - a condition to be avoided. There is an urgency to publish one's findings before others file similar data, but premature release of data can lead to inadequate and improper interpretation. Sharing could be beneficial, inasmuch as it exposes the data to scrutiny and an additional review of scientific, ethical and administrative issues. Sharing should be on a voluntary basis, governed by professional needs, judgments and the public benefit. Many rules and regulations requiring specific actions frequently generate more reasons and bases for noncompliance. Many approaches will be necessary to satisfactorily address the issues raised. (Consumer Summary produced by Reliance Medical Information, Inc.)

Methods

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Quality assurance and quality control in toxicology: how might these concepts apply to epidemiology?

Article Abstract:

Quality assurance (QA) and quality control (QC) are terms that are frequently interchanged, yet they have distinctly different meanings and functions. QA is the identified, planned, independent review function, which provides mechanisms for evaluation of program design and a product's conformance to production standards. Independent audits provide QA. QC may be defined as the portion of the daily tasks used to ensure that the functional process conforms to standards. QC is self-inspection. Good Laboratory Practices (GLPs), established by the federal government, were the among the beginnings of QA. Engineers began to develop QC procedures in the 1940s. The uncovering of fraudulent testing practices, in use by the largest testing laboratory in the world, for the toxicity of new chemicals for agriculture, synthetic fabrics, and other industrial and consumer product uses, added impetus to the initiation of minimum acceptable testing standards and procedures. This was accomplished by the application of GLPs to toxicology studies and testing. The GLPs require an independent QA component, and stipulate specific managerial functions. The external audit is a planned, precise function that is intended to review the final QA activity as presented in a final report. The report is examined according to specific principles and seeks to establish the completeness and clarity of the report, the consistency of the data, and the conformance to standards. The application of the GLPs used in toxicologic studies to the broader aspects of industrial procedures, including epidemiologic studies, would be beneficial. (Consumer Summary produced by Reliance Medical Information, Inc.)

Occupational health and safety, Occupational safety and health

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Quality assurance for epidemiologic studies

Article Abstract:

The Toxic Substances Control Act and the Federal Insecticide, Fungicide and Rodenticide Act, the most recent promulgations of the Environmental Protection Agency (EPA), include in their preambles the following stipulation: ''EPA wishes all studies, including epidemiology studies, where past exposure to a study population is determined or estimated retrospectively, to be performed under GLP /Good Laboratory Practices~ standards.'' It adds, ''It is EPA's position that the study itself can be conducted and submitted to EPA in accordance with the GLP standards.'' GLPs require that each study give assurances, via the action of a quality assurance (QA) unit, of conformance with GLP standards. This unit is separate from the group conducting the study, and provides management and the study group with a constant and ongoing evaluation, record retention system, and a master schedule of all studies and exposures related to the test material. The QA unit will monitor the studies by periodic inspections and status evaluations, and an audit process that will ensure adherence to the protocols. Adaptation of the QA criteria employed in toxicology studies to epidemiology studies would provide improved efficiency. Any study or protocol gaps would be identified more rapidly. Constant monitoring will assure standards adherence, program integrity, and cost effectiveness. (Consumer Summary produced by Reliance Medical Information, Inc.)

United States. Environmental Protection Agency

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