Clinical Research  in the Health Center Setting: Managing Legal  and Compliance Risks

Clinical Research in the Health Center Setting: Managing Legal and Compliance Risks


Publication Date: June 14, 2021


Description

This Issue Bulletin describes legal and compliance risks that health centers should consider before engaging in research opportunities, including an overview of the federal regulations that protect research participants; the application of federal fraud, waste and abuse laws in research; and the malpractice, insurance and Federal Tort Claims Act (FTCA) considerations. While there are risks to participating in research for health centers and their patients, there are also rewards that reach beyond the health centers and patients directly involved and provide benefits to the public. This Issue Bulletin provides health centers with a framework to evaluate research opportunities and suggests steps to mitigate the legal and compliance risk.

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This project was supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $7,287,500 with 0 percent financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government. For more information, please visit HRSA.gov.

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