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Session 2B: Patient Participation in Clinical Trials
Session Chair(s)
Barbara E Bierer, MD
Faculty Director, MRCT Center; Professor of Medicine
Harvard Medical School, United States
This session will focus on the important ethical issues and practical logistics (for example, travel from rural areas) affecting the participation of patients in clinical trials in India, the stricter applicable regulations (for example, videotaped informed consents), the protection of the rights on trial participants and of the validity of the data, and the oversight of clinical investigators.
Speaker(s)
Participant Understanding and Informed Consent
Kimberly Hensle Lowrance
Public Responsibility in Medicine and Research (PRIM&R), United States
Managing Director
Barbara E Bierer, MD
Harvard Medical School, United States
Faculty Director, MRCT Center; Professor of Medicine
International Clinical Trials Data Sharing: Principles and Mandate
Mark Barnes, JD, LLM
Ropes & Gray, LLP, United States
Partner
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