Large Simple Trials and Knowledge Generation in a Learning Health System by Claudia Grossmann

Author:Claudia Grossmann
Language: eng
Format: epub
Tags: ebook
Publisher: The National Academies Press
Published: 2013-12-11T00:00:00+00:00

6

Ethical and Privacy Policy Issues

KEY SPEAKER THEMES

Califf

• Policy constraints are currently a greater barrier to large simple trials (LSTs) than technical limitations, which have largely been resolved.

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.

McGraw

• Current privacy regulations may unnecessarily hinder the needed reuses of clinical data for learning purposes because they more stringently regulate activities that fall under the definition of research intended to contribute to generalizable knowledge and only minimally regulate activities considered to be routine, such as treatment and internal operations.

• A new, more rational approach to the oversight of the use of patient data should depend on trade-offs between expected benefits and risks to patients and should be developed through the use of the basic principles of fair information practices.

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