CLINICAL TRIALS & RESEARCH
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Part 2: Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and Students in Research Studies

August 1, 2019 @ 10:00 am August 2, 2019 @ 9:00 am

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

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:

Coercion, undue influence and subject/employee privacy considerations
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
Notifying employees of actionable health conditions
Unlicensed practice of medicine Licensure of health care facilities
Mandatory reporting of notifiable diseases to departments of public health

Attendees identified the ethical concerns with an institution conducting research on its own employees or students- undue influence, coercion, and risk to privacy. Relevant legislation was introduced, and participants were provided with a set of recommendations for conducting this type of ethically complex research.

Deliverables

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.