Institutional Review Boards and Health Services Research Data Privacy A Workshop Summary (2000) / Chapter Skim
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1 Introduction
1 Introduction
Pages 5-11
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From page 5... ...
Another TOM committee (TOM, 1995) recently developed the following definition: Health services research is a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations.
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These quality assessment and quality improvement exercises are not defined as research but may involve similar types of data collection as HSR, as well as raising similar questions about the use of private information and the maintenance of confidentiality. So if similar data were to be collected or used by a health care provider or health product company in the course of day-to-day clinical care or business operations, such collection and use would not be subject to regulations requiring IRE review.
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The proposed regulations would create new requirements for privacy protection for all health care providers and health plans, and would establish research standards and oversight for all research. In addition, the proposed rule would permit the use and disclosure of personally identifiable health information for research without authorization by the subject, as long as the research protocol had been approved by an IRB or, if it does not fall under regulations requiring IRB review, then by an equivalent body.
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in making this assessment the fRB should take into account the purposes of the research and the seding in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
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To gather information on the current practices and principles followed by institutional review boards to safeguard the confidentiality of personally identifiable health information used for health services research purposes, in particular, to identify those IRB practices that are superior in protecting the privacy, confidentiality, and security of personally identifiable health information.
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SCOPE OF WORKSHOP REPORT This summary describes the presentations and discussions that took place at the March 1314, 2000 TOM Workshop on Institutional Review Boards and Health Services Research Data Privacy Protection. This summary reflects what transpired at the workshop and does not include committee deliberations, findings or conclusions.
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From page 11... ...
INTRODUCTION 11 . institutional Review Board administrative body established to protect the rights and welfare of human research subjects in research activities of the institution to which the board is affiliated, by reviewing proposed research protocols and approving or requesting changes prior to their inception.
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