Professor Dean Harris, Clinical Associate Professor of Health Policy and Management at the University of North Carolina Gillings School of Global Public Health, spoke on bioethics in research at the North Carolina Journal of International Law & Commercial Regulation Symposium on Friday, February 1, 2013. Professor Harris explored the issue of bioethics in research through a case study from China involving golden rice, a genetically modified grain. The research project was conducted by researchers at Tufts University who sought out Chinese children to periodically consume a small amount of the genetically modified rice to test the nutritional results of the rice. The issue of informed consent was at the heart of the research study. Debate continues as to whether the researchers obtained informed consent when the parents of the children signed the consent form, as it is unclear if they completely understood the implications of the form they were signing because of translation difficulties. Professor Harris ended his presentation asking the question if researchers from the United States should be required to do more to protect participants of research studies such as the children involved in the golden rice study. These issues were also explored in different contexts in Protecting a Vulnerable Population with Little Regulatory Framework, an article appearing in the Journal of Contemporary Health Law and Policy.
While it may be tempting to conclude that additional regulatory measures extending beyond the requirement of informed consent are necessary, there are problems with practicality of implementation and effectiveness post-implementation. For the regulatory scheme of clinical research to move beyond the standard of informed consent, it would require massive amounts of collaboration between American authorities and authorities of the countries with the desired populations for the research. This would in turn require authorities in all of the countries involved to achieve the same level of compliance, which may prove difficult considering the differences in culture and infrastructure between the United States and the country of the would-be study population. While these difficulties could be overcome, it would likely be costly to streamline communications and regulatory processes. If this could be achieved, there would still be problems with effectiveness in implementing some standard beyond informed consent. For example, cultural differences in China may require that in order to achieve true consent, familial, or even communal consent must be obtained before proceeding with a research study. This is only one example of another obstacle in the way of greater regulation. For these reasons the best option may be to encourage greater collaboration and communication between research universities and their funding partners throughout the world to check for ethical standards, but not move beyond informed consent.
 Heather L. Mullins-Owens, et al., Protecting a Vulnerable Population with Little Regulatory Framework: a Comparative Analysis of International Guidelines for Pediatric Research Ethics, 29 J. Contemp Health L. & Pol’y 36 (2012).
 See id. at 49.
Posted by Charles E. Walsh on Mon. March 25, 2013 9:22 PM
Categories: Medical Markets, Symposium