Experts: Healthcare Research Needs Overhaul

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BALTIMORE—In two recent articles, a prominent group of interdisciplinary healthcare experts, led by bioethicists at Johns Hopkins, rejected an ethical paradigm that has guided the American system since the 1970s. This group calls for morally obligatory participation in a "learning healthcare system" more in step with the digital age. The group has authored a pair of articles outlining their arguments and proposal for a new ethical framework, which appear in a special report from The Hastings Center Report, along with seven commentaries from other experts responding to their ideas.

In today's healthcare system, the labels "research" and "practice" are poor proxies for what should be our central moral concerns, the authors argue, and no longer serve as an effective guideline for what requires ethical oversight. They point out, for example, that more than 50 percent of medical treatments are used without sufficient proof of their effectiveness, and approximately 100,000 die annually from healthcare acquired infections.

"Far too often, doctors do their best but simply don't have the information to tell them which approaches or treatments work best, and patients are suffering for that lack of knowledge," said Nancy Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, and lead author of the article.

"We're finding that patients are both underprotected from risks in medical treatment and over-protected from low-risk quality-improvement research, bringing progress to a dangerous stalemate that is costing lives," the authors wrote.

In one article, the authors reject the bright-line distinction between medical research and patient care that has been central to the ethical underpinnings of federal human subject research regulations for decades. They argue that it is increasingly difficult to distinguish clinical research from practice and the daily operations of healthcare organizations, and that widely held assumptions about how research differs ethically from practice may be incorrect.

Specifically, the authors challenge the assumption that participation in clinical research by definition offers patients less potential benefit and puts them at greater overall risk than clinical practice, as well as the assumption that research imposes more irrelevant burdens on patients.

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