Two articles in the Hastings Center Report, entitled “Ethical Oversight of Learning Health Care Systems” challenge the current ethical practices for protecting human volunteers in medical studies, according to a recent article on medicalnewstoday.com. The Hastings special report indicates that there are different guidelines governing human volunteers in activities termed “medical research” and “medical treatment,” and advances in medicine are creating disparity between the two areas. According to Mildred Solomon, President of the Hastings Center a study deemed “medical research” must include IRB review and other review boards which guarantee patient participation is voluntary, informed and protected. However, “medical treatment” performed by learning healthcare systems has no such framework, with agreements between clinicians and patients not subject to IRB scrutiny. The lack of structure for medical treatment can lead to complications and confusion in institutional oversight.. One of the articles in the Hastings special report addresses these concerns by outlining a new ethical framework for learning health care systems. In addition to the articles, the report contains seven commentaries written by ethical oversight leaders. The commenters ultimately agree that updates to the current framework are crucial, yet debate still remains on how to appropriately carryout the changes. To read the full article on medicalnewstoday.com, click here.
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