Friday, January 3, 2020

Regulation of Human Subject Research in the United States and China

By Alexander Wynkoop
Alexander Wynkoop, a member of the Albany Law School class of 2020, is the Executive Editor of the Albany Government Law Review. In law school, he focuses on Health Law, and he currently interns with the Health Law Department at O’Connell & Aronowitz P.C., working primarily on Medicaid, Medicare, and private pay insurance compliance. 
Alexander prepared this paper for Professor Bonventre’s International Law of War and Crime seminar.

The deep and inhumane history of human-subject research across the world has only been addressed in a meaningful way in the last half-century. Where, traditionally, medicine was seen as paternalistic, following the trials of Nazi doctors who experimented on human prisoners, there was a drastic shift to focus on a patient-centered approach to human subject research and medicine in general. Despite this, as recently as the 1970s in the United States, and even currently in China, human subject research has been performed that would be categorized as inhumane by ethicists and even laypersons.

However, ethicists and lawmakers in the United States are finally catching up with the decades of proposed guidelines, requiring informed consent and review from independent review boards by creating unified rules across multiple regulatory agencies.

Where there is a will, there is a way. Certain places, such as China, do not have such a well-defined system of oversight, which creates openings for unethical practices. While ethical guidelines exist in China, and may be growing in strength, there is a lack of enforcement and oversight to ensure those guidelines are followed. But, because such openings still exist, physicians from countries who subscribe to more strict regulation of human subject research may attempt to circumvent strict regulation by outsourcing their research to less restricted researchers in China.
____________________________
To read the entire paper, open HERE.