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

Resource Topic: Clinical Issues, Operations

Resource Subtopic: Patient Engagement, Compliance.

Keywords: Case Studies, Chronic Diseases and Care, Community Engagement, Data Collection, Management, and Analytics, Legal Issues, Medical Legal Partnerships (MLPs), Research, Risk Management.

Year Developed: 2021

Resource Type: Publication.

Primary Audience: Administrative Staff; Board of Directors; C-Suites (CEOs, CFOs, CIOs, CMOs, COOs, etc.); Clinicians; Enabling Staff; Outreach Staff; PCAs

Language: English

Developed by: National Association of Community Health Centers (See other resources developed by this organization).

Resource Summary: 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.

Resource Details: 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.

This project is 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 $6,625,000 with 0 percentage 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.