Case Study: The Fenfluramine Case

They were not told the real purpose of the research being conducted or the factors which could place them in harm, or what the description of the illness was and what was truly being tested. The doctors and workers conducting the study were generally unconcerned with the welfare of the black men being used in the study.

Grady, C. (2010). Do IRBs protect human research participants? JAMA, 304(10), 1122-1123. Retrieved from http://jama.jamanetwork.com/article.aspx?articleid=186530

As the brand manager for Allround cold medicine, there were many decisions regarding product formulation, strategy, line extensions and product launches over the company’s last 10 periods. The brand was focused on remaining a profitable, mature product family within the cold medicine category, but also maintaining a premium brand image.

The issues that were involved in the violation of the ethical principles involving human subjects include racism, paternalism, informed consent, truth telling, scientism, and whistle blowing. There were other issues that were involved in this study: double standards, maleficence, and the use of deception in research among others. The issue of racism was seen clearly in this study. Four hundred black persons were infected and two hundred served as a control group. Caucasians were not enrolled in this study. This was a violation of justice because the subjects were not treated

In todays society, the common consensus about human experimentation is that it is unethical, however, people in the past believed it was necessary to advance scientific discoveries. The Tuskegee syphilis study is a prime example of how scientists in the past disregarded the ethics of human experimentation to enhance scientific research. The study was an experiment where four- hundred to six-hundred uneducated African American men were tricked into being tested. Most of the patients were injected with the disease and left without treatment to discover its effects, while the others were safe being used as controls. This experiment lasted for Forty years and was probably the biggest example of unethical human experimentation in America. Fortunatley, the contrivertial actions taken in the experiment lead future generations to create the law of informed consent where the patient understands what will happen during their treatment. The inspiration for researching this topic was how in “The Immortal Life of Henrietta Lacks”, by Rebecca Skloot, Henrietta was used for a scientific study without her consent. In relation to Henrietta, the men in the syphilis study were not aware of what was happening to them and were experimented on without their consent. Overall, the human experimentation in the Tuskegee syphilis study was unethical in many ways.

There are a multitude of constituents that could be modified to make these unprincipled studies ethical for subjects. The Tuskegee syphilis study was an unscrupulous experiment that illustrated the significance of morality in human experimentations. A noteworthy alteration that would be made is guaranteeing that every participant in experiments are given a full assessment of the dangers that can arise from the experiment. Consent was an element that was fundamentally nonexistent in the Tuskegee syphilis experiment, resulting in the study being expressively immoral. In addition, a momentous ethical and legal issue involved in the Tuskegee study were the counterfeited information given to the subjects and the community. David Smolin, the author of the “Tuskegee Syphilis Experiment, Social Change, and the Future

Ethical standards also require that researchers should make sure when they are conducting any research on a participant, the participant is put into danger. As

In current times, children are not getting infected with diseases in order to find curative vaccines, but they are being made part of clinical trials for studies of genetic screening, the enrollment of healthy children in studies of sibling bone marrow donation, and the use of hypothermia for neonates with asphyxia (Laventhal, Tarini & Lantos, 2012). These trial studies have become ethical dilemmas in pediatrics for various reasons, people believe that there are not strong enough regulations for these trials and also that children are not given the opportunity to make their own decisions, most of the time, because children are underage, parents are the ones who make the decision of making their children part of these studies. Current regulations for pediatric clinical trials only require the consent of one parent, unless they are high level risk trials, in which case both parents needs to give approval and the child must also assent. The issue of children given assent for high risk trials is controversial because how do we know that the children really understand the risks that are associated with the trials, do they fully understand that they could possibly get hurt and sometimes their lives can be in danger.

The publishing of the book, Immortal Life of Henrietta Lacks, not only brought light to an incredible story but also to the incredible need for change in legislation and governing bodies within the research system. Since its release in 2010, there have been various policy introductions coming from the United States Department of Health and Human Services. Among one of the greatest is titled, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.”

Justice represents two rights; the right to fair treatment and the right to privacy. The right to fair treatment consists of being treated in a nonjudgmental, nonprejudiced manner and with respect. Those that do not complete the experiment cannot be denied treatment that may be established from the information gathered, nor can they be denied treatment if they seek outside treatment. The right to privacy provides limits that “their research is not more intrusive than it needs to be, that

1. As each of you proceed in your careers, you will be faced with opportunities to read, evaluate and perform research. Read the USPHS Syphilis Study and pages 39-41 in Module 3. Describe what happened in the USPHS Syphilis study. What were the violations of human rights and ethics? What are your reactions to the events? Keeping in mind some of the information discussed on pages 39-41, what can you do to make sure vulnerable groups (uneducated, minors, disabled, etc.) are protected in research? If you discover a violation what can you do?

Now we have the Belmont Report and the Declaration of Helsinki to guide researchers in the most ethical direction when they are conducting their research for studies. Luckily now researchers have to basically write out their entire plan throughout the study step by step. They must write out any way that the human subject may be harmed, what they will do if someone is harmed, any potential costs, and much more. Once all of this is written out researchers then have to get their study approved before they can move forward with their study (Neutens & Rubinson, 2014). The steps that have to be taken to conduct research may seem like a lot, however, it may save a lot of time and energy in court if something happens to go wrong during the trial.

The first ethical principle stated by the Belmont Report is respect for persons. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (The Belmont Report). The researcher must respect the subjects decisions and be obliged to allow them to take part of the experiment voluntarily. The second

In order for researchers to uphold justice, they must not research on vulnerable subjects. Can children be any less vulnerable than prisoners? To clarify, it is prohibited for scientists to research on prisoners because they are institutionalized by the prison. Similarly, children are also institutionalized by any medical organization they belong to. In summary, it is ethically unacceptable to test an anthrax vaccine on young children in order to prepare for the possibility of a terrorist attack because it violates the three principles of autonomy, justice and

Conducting a study using humans as participants raises a variety of ethical concerns. This is why it is necessary to inform the participants of the purpose of the interview or focus group and what it plans to accomplish. Also, the privacy of each participant must be respected when publishing or distributing all research findings. If these requirements are not met, the study being conducted will in turn become unethical.