Webinar On-Demand: Exploring Inherent Conflicts for IRBs
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In this On-Demand Webinar, discover the inherent conflicts that Institutional Review Boards (IRBs) face in balancing ethics, safety, and compliance. In this session, we discuss the pitfalls of rubberstamping compliance without addressing the underlying ethical and safety concerns.
Our presenters also explore the challenges external IRBs encounter, particularly the potential conflicts of interest between profitability and ethical decision-making, and provide strategies for managing these issues to uphold the highest standards of ethical reviews.
By the end of this webinar, you can expect to learn the following:
- The significance of prioritizing ethics and safety alongside compliance requirements
- Managing the delicate balance between profit and ethics in external IRBs
- The history and evolution of IRBs, highlighting the shift from institutional to commercial entities and the ongoing conflicts of interest
Exploring Inherent Conflicts for IRBs
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About the presenters
Stephen Rosenfeld, M.D., M.B.A.
Review Board Executive Director – North Star
Dr. Stephen Rosenfeld is the Executive Director and Review Board Chair of North Star Review Board, a unique 501(c)(3) nonprofit independent learning IRB; the President of Freeport Research Systems, LLC; and the Director of Strategy for the Stanford Pediatric Stem Cell and Gene Therapy Clinical Trials Program. Dr. Rosenfeld also currently serves as a chair of the board of directors of AAHRPP. Dr. Rosenfeld trained at Cornell, Dartmouth, and NHLBI as a hematologist. He spent 19 years at the NIH doing clinical research, working in medical informatics, and hospital administration. He ended his time at the NIH as the Clinical Center’s Chief Information Officer. Previously, Dr. Rosenfeld was the CIO of MaineHealth, a large independent delivery network and then the CEO of the Western Institutional Review Board (WIRB). After leaving WIRB, he spent 7 years as the Executive Board Chair of Quorum Review.
Roman Ryabtsev, M.D.
Medical Director – Sitero
As Medical Director at Sitero, Dr. Roman Ryabtsev oversees Sitero’s medical operations while also contributing to Sitero’s Institutional Review Board (IRB). He is a distinguished infectious diseases and liver physician with a rich background in both academia and the pharmaceutical industry. In 2015, Dr. Ryabtsev joined Yale University, where he made significant contributions and served as a voting member of the Yale IRB starting in 2018. His expertise in hepatology led to his recruitment by Alexion Pharmaceuticals in 2020 as a specialist in Wilson Disease, a role that transitioned into AstraZeneca in 2021. Dr. Ryabtsev then joined Takeda in 2022 as a Medical Director, focusing on late-phase clinical development for Alpha-1 Antitrypsin Deficiency (AATD).
Curt Naser, Ph.D.
Vice President of Product for Mentor eCompliance – Sitero
As Vice President of Product Management, Dr. Curtis Naser manages the development, implementation, and support teams for Sitero Mentor eCompliance platform, which provides management software for IRB, IACUC, IBC, COI, and Grants Management. Dr. Naser was a co-founder and Chief Product Officer of Axiom Mentor prior to the acquisition by Sitero. He has spent over 25 years working with Institutional Review Boards (biomedical, corporate, and social science) as a bioethicist, consultant, programmer, and development manager of the Mentor platform. Curt received his Ph.D. from Stony Brook University in Philosophy and was a professor of philosophy and health care ethics for 26 years.
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