All posts by Derana M Barnhart

Turning people into Numbers? Downsides and Possible Solutions to Clinical Research in a Global Context

Since the 1990s there has been rapid growth in the number of people participating in clinical research. Even though most clinical research is funded and controlled by more developed countries like the United States, the rise in human participants is primarily coming from developing low-income countries. There are a multitude of reasons why researchers are now going to low-income countries to find human subjects. Research guidelines may not be as strict, allowing researchers more freedom in conducting their studies. People may be more willing to partake in clinical trails because they are getting drugs they may not get under other circumstances. Lastly, the testing population in the United States has been gradually shrinking despite the increasing demand. Thus, compelling more researchers to adamantly search abroad from human participants (Petryna 185).

The United States drug testing pool has been shrinking since the 1970s. This was when the “use of prisoners as subjects was exposed and severely limited” (Petryna 185). Researchers had to turn directly to the American public to find human subjects since incarcerated individuals made up a large portion of their previous subject pool. The current issue at hand is slightly different. The US population has become a “treatment saturated” population (Petryna 185). Most individuals are on some sort of medication. Using medicalized individuals in clinical research could result in drug interactions and bias data. Some researchers have found a solution in using international individuals instead. Many individuals in less affluent countries have not had the same access and exposure to medications. This makes them naïve test subjects. This desire for the naïve subject is pushing American research initiatives abroad.

There are significant downsides to conducting medical researcher abroad. This current situation puts developed countries at risk for exploitation (Emanuel et al). In developed countries this risk is minimized because there is infrastructure that protects individuals. However, developing countries are less likely to have this framework in place, leaving individuals in these communities more susceptible. Ethical Variability by Adriana Petryna presents a good example. Researchers in developed countries usually target individuals in neighborhoods with easy access to hospitals and centralized healthcare. However, while searching for research participants abroad, many researchers seek out communities with broken health care systems. These areas are more likely to have more willing participants because the people there have no other access to healthcare. It is clear that the primary goal is getting as many subjects as quickly and cheaply as possible (Petryna 187). On a similar note, Petryna also discusses questionable clinical trials shortly after Chernobyl. She claims that chaos enabled researchers to perform trials they usually would not get permission to perform (Petryna 191). Even though some kind of attention was being directed toward the issue at hand, corners were likely cut and subjects were valued less as humans and more as unique testing opportunity. An element of humanity is definitely lost in this kind of approach.

Research projects themselves have become more about the numbers produced and less about the individuals themselves. This is a concern thoroughly discussed in When People Come First by Petryna and Biehl. Evidence Based Medicine, especially Randomized Controlled Trials, are now considered research standard (Petryna and Biehl 58). The issue is that these rigid research methods are not always applicable to the broad, complicated and unpredictable field of global health. Furthermore, studies resulting in defined measurements and statistical significance do not necessarily provide helpful conclusions or a useful platform for future initiatives (Petryna and Biehl 83). Recently, studies that actually aim to help individuals are often shut down because they will not produce the desired numerical results. Forcing determined NGOs to seek private funding if they want to implement effective projects.

When faced with such a problem, it is important to consider possible solutions. If companies desire to perform research beyond their own borders it is important that some regulatory system is established. As stated in the article What Makes Clinical Research in Developing Countries Ethical? such systems should prioritize participant protection. It should set guidelines to prevent researchers from taking advantage of research subjects. Another possible solution could be achieved through partnership. Although it was not completely perfect, the Leach and Fairhead article demonstrated a relatively effective solution: combining research and direct aid. Health workers provided new mothers with good health care and then performed research on the side (Leach and Fairhead 96). This approach allows beneficial research to done while still maintaining a humanistic element. If implemented correctly the motivation to perform research may even eventually foster more sustainable experimental and medical support systems.

Discussion questions:

  1. What do you think about the research performed after Chernobyl? Even if controversial research produces favorable results is still ethically acceptable? Should medical research guidelines be loosened in a state of emergency or crisis? Who would such an act benefit more: the researchers or the participating individuals?
  2. Not all countries have sustainable systems that can regulate medical research. Who should implement medical research regulations? What research guidelines would be essential in these scenarios?

Sources:

Petryna, Adriana. 2005. “Ethical Variability: Drug Development and the Globalization of Clinical Trials.” American Ethnologist 32(2): 183-197.

Biehl and Petryna. 2013. “Evidence Based Global Public Health.” When People Come First (Ch. 2).

Emanuel et al. 2004. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research.” Perspective.

Leach, Melissa and James Fairhead. 2011. “Being ‘with the Medical Research Council’: Infant Care and the Social Meanings of Cohort Membership in Gambia’s Plural Therapeutic Landscapes.” In Evidence, Ethos and Experiment: The Anthropology and History of Medical Research in Africa. P. Wenzel Geissler and Catherine Molyneux, eds. New York: Berghahn Books.