What Your Research Investigators and IRB May Not Know: Regulatory and Ethical Implications for Human Subjects Research

Barbara Vimont, Director, Compliance and Privacy, Akron Children's Hospital. Patricia Blount MD, MSL, CIP, CHRC, Managing Director, ProtocolsByDesign, LLC.

June 15, 2021

  • Understand the fundamental difference between the practice of medicine and clinical research: The confusing roles of physician and clinical investigator

  • Understand the FDA regulatory landscape of sponsor-investigator INDs, nutraceuticals, and devices

  • Understand the fundamental difference between an interventional and observational study: Misperceptions concerning research interventions considered "standard of care" procedures

About SCCE

The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

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About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

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