Webinar: EU General Data Protection Regulations: What US Research Institutions Need to Know

Wednesday, April 25, 2018 | 1:00-2:00 PM ET

View the webinar recording:


Overview

On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) will become effective in 28 member states of the EU and the three additional countries (Iceland, Liechtenstein, and Norway) that also are members of the European Economic Area (EEA). The GDPR will affect US-based life science and academic research communities through various arrangements, such as US-sponsored clinical trials occurring in the EEA, or studies that involve transferring personal data from the EEA to the US. It’s critical that affected research institutions are equipped with strategies for coming into compliance when the new regulations take effect.

This webinar will provide an introduction to the potential application of the GDPR to the US-based research community; implications for individuals and institutions to which the GDPR applies, including issues regarding data subject consent; and recommended steps.

Specifically, the webinar will cover:

  • Effective reach of the GDPR compared with the currently effective EU Data Privacy Directive.
  • Types of data protected under the GDPR, including "personal data" and the subset of "special categories of personal data."
  • Potential application to the US-based research community through offering goods or services to data subjects in the EEA or monitoring behavior of EEA residents.
  • Regulations surrounding processing personal data under the GDPR, including issues with consent as a basis for processing personal data in the context of research.
  • Bases for transferring personal data from the EEA to the US.
  • Requirements for transferring personal data from the US to the EEA.
  • Implications when the GDPR applies to US-based entities, including data subject notices, access, and erasure requirements.
  • Recommended steps for US-based entities engaged in research.

What will I learn?

After attending this webinar, attendees will be able to:

  • Identify personal data that are subject to the GDPR.
  • Identify the jurisdictional hooks through which the GDPR may apply to members of the US-based research community.
  • Understand key bases for processing personal data and transferring personal data to the US.
  • Understand requirements applicable to entities that process personal data.

Who should attend?

This webinar will benefit research sponsors, institutions serving as clinical trial sites, IRBs, and privacy officials.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.0 continuing education credit towards CIP recertification. Learn More »

Speaker

Nick WallaceNick Wallace, JD is an associate in the San Francisco office of Ropes & Gray LLP. His practice focuses on a range of matters for health care and life sciences clients, including in the areas of research and privacy. In addition to assisting clients with preparing for the implementation of the GDPR, he has co-authored three articles regarding the application of the GDPR to the life sciences and health care sectors. He received a JD from Yale Law School.

Additional Resources

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Background Reading:

Barnes, M., Massey, R., Peloquin, D., Thornton, L., and Wallace, N. (2018). New Draft Guidelines on GDPR Consent Requirement's Application to Scientific Research. Bloomberg Law Medical Research Law and Policy Report.

Barnes, M., Massey, R., Peloquin, D., and Wallace, N. (2017). Reconciling Personal Data Consent Practices in Clinical Trials with the EU General Data Protection Regulation. Bloomberg Law Medical Research Law and Policy Report.

Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: a discounted registration fee to this webinar.

Individual rates
Member $95
Nonmember $135
Group rates
Member $225
Nonmember $300

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