In 1968, the San Antonio Contraceptive Study raised many ethical issues violating the study subjects, ultimately leading to a lifetime of historic fear, trauma, and mistrust. Despite this experiment happening decades ago, it is essential and relevant never to forget the horror this experiment instilled in women and science. The experimenters raised racist, discriminatory, and ethical violations in this study. As a result, it is imperative to do research when dealing with contraceptive medical advice, prescriptions, or procedures.
Purpose, Methodology, & Findings
The study was conducted on seventy poverty-stricken Mexican-American women to evaluate the efficiency of different kinds of female oral contraceptive pills. The women consented to participate with the understanding that they would receive a full dosage of the contraceptive. So, the indigenous and previously pregnant Hispanic women, who had no other way of obtaining contraceptives, visited the birth control clinic. The study was a randomized, double-blind trial in which they gave half of the female patients active contraceptives and half of them placebos. Midway through the study, the two halves were switched unknowingly among the participants. None of the women on the placebo were informed they weren't on the active contraceptive. As expected, out of the 76 subjects, 11 became pregnant, ten while on placebo, and one on the active contraceptive.
The San Antonio Contraceptive Study was highly unethical and a complete injustice, mainly due to a lack of informed consent and the mistreatment of a vulnerable group of subjects. The Belmont Report was also violated regarding respect for a person, beneficence, and justice. First, informed consent involves information, comprehension, and voluntariness. The women with diminished autonomy were unprotected because of the targeted research and specific selection. So, considering few women were willing to risk whether or not their birth control was placebo, especially before Roe v. Wade, the clinic got "volunteers" because of a lack of transparency and deception.
Next, the researcher did not minimize harm and even went as far as to conduct intentional medical damage by testing the contraceptives. Also, the researchers did not consider the welfare of the participants. Again, since the subjects were poor women, it is reasonable to assume they could not afford another child, let alone their firstborn. So, such disrespect directed at an unplanned pregnancy would result in a lifetime of socio-economic and personal struggles. Finally, benefits and burdens were not distributed fairly. In other words, there was a miscellaneous issue of withholding benefits from the control group. This extremely selective group stood no chance against fairness, and therefore justice could not be served at the expense of a child.
Alterations Toward an Ethical Study & Considerations on Justifying Harm
Since the San Antonio Contraceptive Study was a clinical research study tragedy, there are several ways in which the researchers could have altered their procedure to be tested more ethically and therefore follow guidelines that consider the justification of harm. The Hawthorne Effect -in which subjects behave atypically if aware of being studied- would not be present in this study because the researchers are testing a pill to discover biological changes. So, if the researchers were to use complete transparency and implemented informed consent, the women would not have behaved differently or swayed the results. Therefore, the consideration of using informed consent is practical and partially justifies the use of harm.
Yet, as a result of informed consent, the study may not have been able to be put into effect because many, if not all, of the women would decline to be subjects because they are not willing to risk another pregnancy. So, for the study to be more ethical, the researchers should have implemented screening subjects. By eliminating women from a study who are especially vulnerable to harm, the researchers would obtain more willing participants who are wealthier and can afford health care at the cost of potentially becoming pregnant.
Similarly, if the researchers were to follow the guideline of ameliorating harm or having a plan to "fix" the damage, they could potentially pay for child care. Harm would be slightly justified if the research team gave these women money and support to raise the baby.
Cost-Benefit Analysis
The benefits of the San Antonio Contraceptive Study did not outweigh the ethical problems surrounding the researcher's approach and simply the entirety of the experiment. The researcher believed that the scientific findings behind the use of female contraceptives were more important than the well-being of these women. However, when putting the life of another human being at risk, assuming these women could not afford proper treatment when giving birth, there is no justification strong enough to defend the work of these researchers.
Without others reviewing this research, it seems obvious how unethical this study was back then and to this date. So, the potential benefits in the medical field did not outweigh the hazards to subjects and therefore did not abide by the protection of human subjects guidelines.
So, despite a skewed environment considering this was an experiment from years ago, the relevancy today lies in the fact that contraceptives must be taken seriously. Proper care when taking contraceptives is important to ensure the effectiveness of one's overall health.
Read the package insert and follow the instructions provided by your healthcare provider or the manufacturer. Consistency is key with most contraceptives. Skipping doses or using them irregularly can reduce their effectiveness. Some contraceptives may require additional backup methods. Keep your healthcare provider informed about any changes in your health, medications, or concerns. Be aware of any side effects associated with your contraceptive method.