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Part 1: Exporting from China for Research: Biospecimens, DNA, and Data - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

August 1, 2019 @ 9:00 am 2:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

China’s new Regulation of Human Genetic Resources (HGR) took effect on July 1, 2019. The regulation closely scrutinizes all HGR-related activity from upstream collection of human biospecimens to downstream exploitation and sharing of the biomaterials and any data obtained therefrom. The regulation additionally formalizes the approval requirements pertinent to research collaborations between Chinese and foreign-owned (including both partially and wholly foreign-owned) entities to avoid uncertainty during the approval process. It also significantly increases and expands penalties for various violations of the regulation. This session will provide an overview of the changes made by the regulation and then discuss some practical strategies for complying with the regulation’s requirements.

Participants reviewed updates to China’s Human Genetic Resources (HGR) regulation and discussed how the changes will alter work with Chinese biospecimens and biospecimen data. The HGR updates were contextualized within China’s broader evolving legislation that aims to protect national security by protecting data.


Meeting Summary

Released on: August 1, 2019

Topics: (1) Exporting from China for Research: Biospecimens, DNA and Data, and (2) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies.