Guatemala, the GDR and Research Ethics Policy Development

Note: The Bioethics Program blog will be moving to its new home on April 1, 2015. Be sure to change your bookmarks to http://bioethics.uniongraduatecollege.edu/blog/

by Andrei Famenka, Bioethics Program Alum (2013)

When it was first announced, I was particularly intrigued by a recent webinar called, ‘Gonorrhea, Guatemala and Gung-Ho Researchers: The Role of Controversy in Shaping Research Ethics Practice and Policy’. This particular topic was of special interest to me because of my interests in research ethics policymaking and the role of social, cultural, and economic factors in this process.

As good as the webinar was, it highlighted a peculiar fact: although a good deal of attention has been paid to unfair research conducted in developing countries, such as Guatemala Gonorrhea study, such analyses have primarily focused on the impact of these controversial studies on research ethics policy development in the United States. Missing from these analyses is the impact that the scandals have had on research ethics policies in developing and transitional countries where the unfair practices have occurred. This lack of analysis is significant because these controversies often fail to lead to policy changes in developing and transitional countries.

One of the latest examples of unethical research which didn’t result in any policy modification comes from Eastern Europe. It has recently come to light that just before the fall of the ‘iron curtain’, some major Western pharmaceutical companies conducted hundreds of controversial drug trials in the German Democratic Republic (GDR, the Communist former country of East Germany), in which more than 50,000 East German patients served as guinea pigs—many without their knowledge or consent. More than 600 drugs were tested on unwitting East German patients, including prematurely born infants, alcohol addicts, and people diagnosed with depression. Moreover, despite suspicions that some of the trials resulted in several fatalities, the participating hospitals were reluctant to investigate.

Despite hot debates in the media, the controversy over this unethical research didn’t push policymakers in the countries of Eastern and Central Europe to revise the current policies and programs on the protection of human subjects. And yet, recent research on Baltic countries, Belarus, and Poland clearly demonstrates these policies are lacking.

Although it has become almost a proverb that research ethics was ‘born in scandal’, a closer look at the history of research ethics provides evidence that no matter how big a scandal might be, it can result in policy change only if it resonates with broader social movements or shifts in public views, ideas, and values. In fact, outrageous scandals, hot debates, and profound controversy can serve only as triggers or catalyzers of change under the right socio-political, cultural, and economic conditions. This reflects the views presented by Ezekiel Emanuel and Christine Grady when they argue that over the past 70 years, the system of research oversight in the United States has evolved through four distinct stages. These stages embodied different values and perspectives on research and reflect dominant views in general society. Research oversight changed as these dominant views evolved over time.

Central and Eastern European countries still lack a strong civil society and sufficient levels of political freedom, economic and social opportunities, and transparency guarantees. The enabling conditions for a strong set of research ethics policies is not sufficiently in place. Attempts to force these policies would only create confusion about the underlying ethical values and the goals of the research oversight.

The way to ensuring the protection of human research subjects in transitional countries is most likely to be a long and difficult one, as it involves efforts to reshape some basic elements of society. In this regard, training programs are an important part of the process, but these will only be successful when they are coupled with broader social changes.

[The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

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