Human Guinea Pigs: Testing & Consent in Underprivileged Groups
By Caroline Santoro
Human testing done on underprivileged groups, such as in third world countries, presents a risk of exploitation of those considered unable to give informed consent. Analyzing the effects of human testing in these groups is important when considering whether policy should be created to protect them.
In Guatemala during the 1940s, 700 prisoners, soldiers, and psychiatric patients were deliberately infected with Syphilis without being informed or asked for their consent. They were infected with the goal of testing Penicillin as a preventative measure for this deadly disease. The disregard for the welfare and self-determination of hundreds of people exemplifies the injustice of unethical testing in third world countries. However, the issue has not been exclusive to places outside of the United States. In a study called the “Tuskegee Study of Untreated Syphilis in the Negro Male,” 600 African-American men with Syphilis were recruited with the promise of free health care. The men were never told that they had the venereal disease, just that they had “bad blood.” The study began in 1932 when no cure for Syphilis existed, but after Penicillin was recognized as a cure for Syphilis, the men were given placebos and left untreated to test the disease’s progression. Researchers continued the study as the men went blind, became mentally ill, and eventually died. Today, presidential apologies, settlements, and new ethical standards cannot undo the tragedy, but they can and should motivate ethical testing, particularly for underprivileged patients.
Testing in underprivileged groups, when done ethically, is beneficial to both the researchers and the subjects of the study. For the researchers, it is a way to collect data on a large scale, and for underprivileged subjects, it might be the only potential cure to their ailments. However, underprivileged groups are at a high risk for exploitation, especially in third world countries. For example, women in Africa may participate in HIV treatment studies without being able to read or understand the details of the study.
For every successful life-saving drug, patients in the control group may have to suffer and die to prove that the drug is the actual cure. For unsuccessful drugs, those given the medication can die prematurely of complications caused by the drug, and all patients in the study suffer from a false hope and lost time. These tradeoffs are inherent to clinical trials, but studies done to underprivileged groups deserve greater attention to ensure that the research is done ethically, as researchers who stand to profit from a successful drug may be inclined to oversell the benefits and downplay the risks in the hope of convincing an ill-informed patient. Moreover, some patients, particularly in third-world countries, may be ignorant of their legal options and likely lack the resources to pursue them in the event of malpractice.
An illiterate person signing an “X,” consenting to a study he or she cannot understand, is participating in an unethical study. Regardless of the difficulties of language and culture barriers, researchers must fully inform subjects of clinical trials about the potential benefits and risks. While drug companies frequently have the attitude that by offering these drugs they are giving people a better chance than they would have without them, the potential billion-dollar drugs developed by these studies should provide ample money to compensate subjects for their risk. However, these uninformed and ill patients are in no position to negotiate with multinational pharmaceutical companies. As a result, governments must better protect their citizens by giving them a voice and a stake in these studies.
- Fogarty International Center @ NIH. (2011, Nov. & Dec.)Bioethics: protecting lives in service to research. Retrieved December 26, 2017, from https://www.fic.nih.gov/News/GlobalHealthMatters/nov-dec-2011/Pages/bioethics-research.aspx
- Nix, E. (2017, May 16). The Infamous, 40-Year Tuskegee Study. Retrieved December 26, 2017, from http://www.history.com/news/the-infamous-40-year-tuskegee-study
- Weigmann, K. (2015, April 7). The ethics of global clinical trials: In developing countries, participation in clinical trials is sometimes the only way to access medical treatment. What should be done to avoid exploitation of disadvantaged populations? Retrieved December 26, 2017, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4428044/