Large Simple Trials and Knowledge Generation in a Learning Health System Workshop Summary (2013) / Chapter Skim
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6 Ethical and Privacy Policy Issues
6 Ethical and Privacy Policy Issues
Pages 43-48
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From page 43... ...
Faden • The current ethical framework for clinical research focuses on the risks of research and ignores the risks of clinical care practices, most of which are based on weak evidence. • A new ethical framework is needed that allows the joining of regular clinical care and research activities, including LSTs, by appropriately balancing the risks and benefits of research when the safety and effectiveness of routine clinical practices are often unknown.
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From page 44... ...
Ruth R Faden, Philip Franklin Wagley Professor of Biomedical Ethics and executive director of the Johns Hopkins Berman Institute of Bioethics at The Johns Hopkins University, spoke about the shortfalls of the current ethical framework that guides oversight of clinical research and suggested that a new one might be necessary.
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From page 45... ...
Califf suggested that a window of opportunity to revise policies that impede LSTs and other clinical research exists, because the leaders of federal health agencies have shown that they are open to reforming the national clinical trials system, health care providers have proved willing to participate if the studies answer questions important to them and they do not lose money, and the experience with potential trial participants is that the majority of individuals will participate if they are asked. So, the question is, what policies will more quickly allow the selection of standardized, reliable data that could serve as a backbone for a learning system that, Califf would argue, includes LSTs?
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From page 46... ...
Faden and other health ethicists have been working for several years to develop new ethical guidelines that would support a learning health care system. She noted that these guidelines would have to include a sense of reciprocity in which researchers commit to respect for patients and patients commit to contribute to the process of knowledge generation.
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From page 47... ...
Patient data can be routinely used without additional authorization, for example, as a basis for patient treatment, as a basis for the treatment of another patient, or for health care operations (such as billing and quality improvement)
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From page 48... ...
48 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM McGraw noted that as different approaches are considered, piloting of their use and the study of their effects will be crucial to the development of practical approaches and to appeal to policy makers as well as patient and consumer groups to permit the use of patient data. Similar to the ethics guiding research with human subjects in a learning health care system, new ways of engaging patients that respect their right to have a say in what research is done and to learn how their data will be used to improve health care would be needed.
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