Ethical Issues In The Belmont Report

For the most part the study on infant contraction of HIV was ethical. It followed most of the guidelines that were presented in the Belmont Report. This study would fall under the guidelines of research according to the Belmont Report. According to the Belmont Report “the term "research' designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective” (). The study in the article was designed to test the safety and effectiveness of the drug

The first application is informed consent. “Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied” (). The article does not directly say what information the participants were given or if they were informed if that there was a chance that they would receive a placebo. The article does mention a few women who were allowed to withdraw from the study because they felt that they or their babies’ health were in jeopardy. There could have been more information in the article about what information participants were given before they agreed to the

“The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed” (). There were a few methods in place to test the safety of the drug and mentioned before the mothers were given regular ultrasounds and tests. And the infants were tested regularly after their birth. The researchers appeared to do what they could to avoid risks to the mothers and infants. Infants with health issues were not given the drug. “The study drug was not instituted if an immediately life-threatening condition or any of the following conditions developed: hyperbilirubinemia that required treatment other than phototherapy, an absolute neutrophil count below 750 cells per cubic millimeter, a hemoglobin concentration below 8.0 g per deciliter, a platelet count below 50,000 cells per cubic millimeter, and an alanine aminotransferase concentration more than five times the upper limit of age-adjusted normal values. Newborn therapy was discontinued if any of the above conditions or any type of severe toxic effect developed in the infant, or if the infant received an experimental anti-HIV