Lessons from the Trenches: Avoiding Common Legal Pitfalls in International Research
Wednesday, March 28
Presentation: 2:00-3:00pm ET
Q&A: 3:00-3:15pm ET
U.S. institutions and companies are increasingly conducting or collaborating in international research, but do not always have experience applying U.S. laws and regulations to the international context or assessing the application of ex-U.S. laws and regulations to their own organization and to a study. Failing to understand or attend to these issues can create significant legal risk for the organization and its investigators and jeopardize their ability to use data from the study. Avoiding these outcomes requires development of a plan and a process to identify, triage, and manage compliance with multiple sets of often unfamiliar legal requirements.
In this webinar, Emily Chi Fogler and Andrew Rusczek, attorneys practicing in the Academic and Clinical Research Group and Biopharma and Medical Device Group at Verrill Dana, LLP, discuss common legal issues for institutions and companies participating in international research, including the potential application of: the Common Rule, FDA regulations, and HIPAA; ex-U.S. research laws and regulations governing sponsor status, investigational products, human subjects oversight, and collection, use, and transfer of biospecimens; and ex-U.S. privacy laws and regulations governing collection, use, and transfer of subject data, including the EU’s General Data Protection Regulation (GDPR). The presenters will also provide practical strategies for identifying these issues and mitigating risks that organizations can adopt for particular studies or across their research enterprise.
Although the webinar is not exclusive to any particular foreign jurisdiction, a significant portion of the content will focus on EU laws and regulations given the extent of research conducted in the EU and the broad influence of those laws.
In this free webinar, we will:
- Explain why failure to appreciate the potential applicability of U.S. and ex-U.S. laws and regulations to international research can create legal and practical risk for organizations
- Review select common issues arising in international research studies under U.S. and ex-U.S. research and privacy laws and regulations
- Discuss ways that organizations can identify and address these issues for an international study or studies
- Representatives from institutions that conduct or collaborate in international research, including institutions that are funding or otherwise sponsoring international studies
- Representatives from biopharma and device companies conducting international research, particularly companies that are new to the international context
Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.