2007: The Year of Regulatory Change

Transplantation Proceedings, Vol. 41, No. 1, pp. 6-25, 2009

Posted: 30 Jun 2009

See all articles by Michael Millis

Michael Millis

University of Chicago

Jeffrey Huang

affiliation not provided to SSRN

Andrew Millis

Rhodes College

Yong Liu

affiliation not provided to SSRN

Yilei Mao

affiliation not provided to SSRN

Mary Simmerling

Adler University; Cornell University, Weill Cornell Medical College

Date Written: 2009

Abstract

The two countries that performed the most organ transplants in 2006, the United States and China, initiated significant regulatory changes in 2007 that continue into 2008 and likely several more years. The purpose of this article is to highlight the reasons behind the regulatory initiatives, document the new regulations, and assess the impact thus far. Methods: We evaluated the changes with respect to equity and transparency; understanding transplant policy; field strength; and informed consent. We found a number of similarities between the US and Chinese regulatory changes. The changes in the United States introduced new members into the team (independent donor advocates) and improved documentation, while China began the process of regulation by defining the process and identifying practices that are not allowed. We found a number of similarities between the regulatory changes in the United States and China. Both countries have made significant progress in attempting to improve the process for both donors and recipients. The United States is a more mature system, while China is attempting to move toward an international standard. In the short term, there may be decreased overall access to transplantation while transplant centers and policies adjust to the new regulations in both countries.

Keywords: organ transplantation, ethics, China

Suggested Citation

Millis, Michael and Huang, Jeffrey and Millis, Andrew and Liu, Yong and Mao, Yilei and Simmerling, Mary, 2007: The Year of Regulatory Change (2009). Transplantation Proceedings, Vol. 41, No. 1, pp. 6-25, 2009, Available at SSRN: https://ssrn.com/abstract=1425180

Michael Millis (Contact Author)

University of Chicago ( email )

1101 East 58th Street
Chicago, IL 60637
United States

Jeffrey Huang

affiliation not provided to SSRN ( email )

Andrew Millis

Rhodes College ( email )

2000 N. Parkway
Memphis, TN 38112
United States

Yong Liu

affiliation not provided to SSRN

Yilei Mao

affiliation not provided to SSRN ( email )

Mary Simmerling

Adler University ( email )

17 N. Dearborn
Chicago, IL 60604
United States

Cornell University, Weill Cornell Medical College ( email )

1300 York Avenue
New York, NY 10065
United States

HOME PAGE: http://https://vivo.weill.cornell.edu/display/cwid-mcs2006

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