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Ethical Shortcomings in the Guatemala STD Study
The most prominent point of the Nuremberg Code, generated in 1947 post Nuremberg Trials, was that a subject must give “voluntary consent” to the study before becoming a participant. This means that the subject must be aware of all risks and benefits and willfully join the trial knowing that information. Not only are they required to know the risks and benefits of the study, but also the way the trial will be conducted and the rationale behind the experiment. The Guatemalan study, although conducted within the timeframe that the Nuremberg Code was published, adhered to none of these rules. The STD study in Guatemala never informed its subjects of the possible risks involved in the trial. These subjects were never given the opportunity to give consent, written or verbal, but were instead forced to participate against their will. They were also unable to withdraw their participation during the study, which clearly violates the 9th guideline of the Nuremberg Code. The Nuremberg Code was set up to be a general guideline for human subject research, and one strength, as noted in the test book is that it has “universal application” (Annas & Grodin, 138). This means that the guidelines set forth could be applied to a trial run in any part of the world and therefore should have been guiding factors in the conduct of the Guatemalan study. The organizations and lead investigators that ran the trial paid no mind to the Nuremberg Code, and almost every guideline set forth within the code was ignored. One rule set forth in the Nuremberg Code states that the study should be “based on the results of animal experimentation and a knowledge of the natural history of the disease.” As stated in her article, Scheperele notes that American researchers had previously studied reactions to infection within animals and were eager to explore the human reaction through natural or “normal exposure” to an infection (431). Does this justify the in-human experiment of purposefully inoculating humans with a disease, since it had been previously done in animals? Well, according to this one guideline from the Nuremberg code, it would seem so. But when all other codes are reviewed in conjunction with this one, the STD study was clearly unethical.
The Belmont Report, published officially in 1979 (with several appendices and volumes to follow at a later date), is a set of core moral principles that guide human subject research. the three principles are Respect for persons (requiring informed consent), Beneficence (explaining both the risks and benefits of the trial to a subject), and Justice (fair selection of the subjects). Again, the Guatemalan STD study fails to comply with these guidelines which were set forth after the trial had been conducted. The informed consent policy of the Belmont report requires that those individuals who can provide consent themselves do so prior to any research activity. It also protects those individuals who cannot provide consent themselves, by requiring an “authorized third party” to consent for the vulnerable subject. The consent must be given freely and without coercion, which is a standard for all informed consents today. This right was not afforded to any of the participants within the STD study. The participants in this study were not carefully or purposefully selected by the investigators either. The lead investigators chose their subjects based on the populations that were readily available and easier to inoculate. Once the first group of subjects did not produce the results they were looking for (prisoners), they moved on to a second vulnerable population to test their hypothesis on (children & mentally ill patients)
Another set of regulations that the Guatemalan study did not adhere to, albeit it was not around during the time of the study, are the CIOMS Guidelines. Guideline 1 states that “Research can be ethically justifiable only if it is carried out in ways that respect & protect, are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out” (Idanpaan-Heikkila & Fluss, 168). Although the Guatemalan government agreed to and played a part in conducting the STD study (making it partially compliant to Guideline 3), this research was surely not “ethically justifiable” as the participants were forced or coerced into taking part and were not given the ability to withdraw or deny their participation (168). This plays into the third guideline of the CIOMS Guidelines which discusses the concept of “externally sponsored research”. Surprisingly, The Guatemalan study is partially compliant with the third guideline, which states that a study sponsored by a third-party country must be reviewed and adhere to the regulations and culture of the country the experiment is conducted it. The Guatemalan study was largely funded and supported by the US government but it was conducted within Guatemala, which “was known for its relative freedoms immediately post-World War II” and was ruled by a General that could not be argued with (Scheperle, 440). The study was conducted with the approval of the Guatemalan government but not reviewed by an ethics committee before commencing, hence the partial compliance with the CIOMS Guideline #3. The study also would have needed to run in accordance with the needs and morals of Guatemala in mind to adhere to guideline 3. Since the Pan American Sanitary Bureau noted that the purpose of the trial was to “maintain(…) and improv[e] the health of all the people of the [twenty one] American publics and also to prevent(…) the occurrence and spread of transmissible diseases in international commerce” and Guatemala was eager to create an infrastructure for health and wellness, it seemed like the perfect country to host the STD Study. However, the lead investigator, an American physician, was not concerned with the Guatemalan natives he included in the participation of this study and as stated in the article by Rodriguez and Garcia, many of the subjects given an STD in the Guatemalan study never received any treatment or compensation for the diseases they acquired or pain they suffered. Clearly, Cutler (the lead Investigator) had no plan to help his participants or the rest of the Guatemalan community had the penicillin treatment proven effective in treating the STDs tested. According to the CIOMS guidelines, today the needs of the country in which the trial is carried out must be considered even if the trial is being funded by a third-party country or company. The Guatemalan study was deficient in following several other of the revised guidelines set forth by CIOMS in 2002, including “Research in Communities with Limited Resources”, “Informed Consent”, and “Vulnerable Persons, Children and Pregnant Women” (170). The study was conducted in a third world country with inadequate resources to support the trial, the subjects were never informed of the risks of the study and were not given the opportunity to agree or disagree to taking part. Finally, all the subjects included in the research were what is considered “vulnerable” today.
Marie Constance Scheperle, The Guatemala STD Inoculation Study as the Incentive to Change Modern Informed Consent Standards, 18 Wash. & Lee J. Civ. Rts. & Soc. Just. 425 (2012).
Emanuel, E. J. (2011). The Oxford textbook of clinical research ethics. Oxford: Oxford University Press.