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Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm, Valerie Gutmann Koch
Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm, Valerie Gutmann Koch
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Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in verseeing quality of care. Recent developments — the availability of comparative quality data, public reporting, and financial incentives for higher quality — have transformed expectations for board oversight. Enforcement of fraud and abuse laws based on poor quality of care, as well as federal standards …
Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch
Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch
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This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.