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Opening stem cell research and development: a policy proposal for the management of data, intellectual property, and ethics.

INTRODUCTION 54 I. BOTTLENECKS IN THE TECHNICAL, PROPRIETARY, AND ETHICAL DOMAINS 59 A. TECHNICAL DOMAIN: SCIENTIFIC DATA AND MATERIALS SHARING ......... 61 B. PROPRIETARY DOMAIN: PATENT RIGHTS AND INNOVATION 72 C. ETHICAL DOMAIN: ETHICAL AND REGULATORY COMPLEXITY 75 D. CURRENT EFFORTS TO ADDRESS THESE PROBLEMS 81 1. ETHICS AND REGULATION 81 2. SHARING DATA AND MATERIALS ACCESS 84 3. PATENTS AND INNOVATION 88 II. DESIGN ELEMENTS FOR OPENING UP STEM CELL R&D 89 A. INTEGRATION ACROSS TECHNICAL, PROPRIETARY, AND ETHICAL DOMAINS 89 B. BALANCING ACCESS AND PROPERTY THROUGH A PROTECTED COMMONS 94 1. PIPRA AS A MODEL OF A PROTECTED COMMONS 96