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Aug 01, 2019

Meeting of the Research, Development, and Regulatory Roundtable (R3)

9:00 AM to 2:00 PM

Location: Ropes & Gray, Boston, MA

Discussion 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.

Topic Summary:

  1. Exporting from China for Research: Biospecimens, DNA and Data

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.

  1. Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and Students in Research Studies

An increasing number of companies and research institutes wish to enroll their own employees and students in research studies.  While employees can serve as a convenient source of potential study participants, enrolling one’s own employees and students in research can raise several legal and ethical issues, including the following:

  1. Coercion, undue influence and subject/employee privacy considerations
  2. Maintenance of health information on employees in compliance with the American with Disabilities Act, the Genetic Information Nondiscrimination Act of 2008, and corresponding state laws
  3. Notifying employees of actionable health conditions
  4. Unlicensed practice of medicine
  5. Licensure of health care facilities
  6. Mandatory reporting of notifiable diseases to departments of public health

This session will provide an overview of each of these issues.  Following a review of the legal and ethical issues, we will provide practical suggestions for minimizing the legal risk involved in each of these areas.  We will also invite audience members to share their experiences with the use of employees and students in research studies.

If you have questions, please contact mrct@bwh.harvard.edu.