Historical Issues in Human Research Presentation

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1 Historical Issues in Human Research Presentation Student's Name Institutional Affiliation Course Code and Name Instructor Name Due Date

2 Historical Issues in Human Research Presentation Introduction Human research is essential to the development of medical treatments and the advancement of science. However, it has a history fraught with unethical practices that have caused harm to research participants. This essay will examine historical issues in human research and how they relate to current research practices using the Thalidomide Trials as an example. Ethics in Human Research "Ethics in human research" describes the guiding moral concepts and criteria when discussing research on human subjects. Research participants' rights, welfare, and dignity must be respected. Any risks or harms must be minimized or justified by the possible benefits, which these principles aim to do. Several long-standing problems with human research are brought to light in this article, along with their relevance to modern methods. It is clear from the text that the ethics of researching humans were not adequately examined during the Thalidomide Trials, with devastating results. In the 1950s and 1960s, pregnant women were given the medication thalidomide to treat morning sickness. Unfortunately, it was later shown that the medicine caused severe congenital impairments, such as limb deformities, hearing, blindness, and organ damage, in their newborns (Thomas, 2020). The paper details how the Thalidomide Trials were done without using appropriate control groups, properly tracking any harmful effects, or obtaining informed permission from the participants. Because of these unethical decisions, thousands of children worldwide now have permanent problems because they were exposed to the medication during pregnancy. After this catastrophe, in 1962, the United States approved the Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, which included the need for

3 informed consent and the creation of institutional review boards to monitor research involving human beings. There were significant regulatory shifts in the United States and elsewhere as a result of the Thalidomide Trials. Informed consent and other requirements to assure the safety and efficacy of pharmaceuticals were created by the Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, as indicated in the article (Thomas, 2020). Ethical considerations should be used consistently across all areas of human research, as demonstrated by the lessons learned from the Thalidomide Trials. Historical Research Project Background and Hypothesis The late 1950s and early 1960s Thalidomide Trials examined the safety and efficacy of thalidomide for treating morning sickness in pregnant women. In 1957, Germany approved the drug, which quickly spread to the UK and Australia (Thomas, 2020). The drug's side effects weren't discovered until the early 1960s, causing one of the biggest medical disasters. Thalidomide was investigated to alleviate pregnant women's morning sickness without adverse effects in the Thalidomide Trials. The medication was frequently recommended to expectant mothers worldwide because it was promoted as a safe and efficient therapy for morning sickness and vomiting during pregnancy. The studies were designed to produce data that would support the safety and effectiveness of the medication and promote its broad usage. Unfortunately, competent control groups, effective monitoring of side effects, and participant agreement were all lacking throughout the Thalidomide Trials. As a consequence, the studies missed the medicine's negative effects, which included severe congenital impairments in the offspring of pregnant women who had taken the treatment (Thomas, 2020). The Thalidomide Trials took place during a period when inadequate regulations applied to medical research involving human beings. Many researchers at the time believed that the

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4 advantages of medical research exceeded any possible hazards to participants since few ethical rules controlled the conduct of the human study. Nonetheless, the Thalidomide catastrophe resulted in substantial modifications to the laws governing human research, such as the demand for informed consent, the creation of institutional review boards, and stricter requirements for the efficacy and safety of medications. The Thalidomide catastrophe had a significant social and political impact as well. The drug's congenital disabilities were a tragedy that impacted thousands of families worldwide (Thomas, 2020). The catastrophe made clear the need for more openness in the pharmaceutical sector and more public scrutiny of the medication approval process. Also, it encouraged more activity and support for consumer protection and patient rights. Role of the Institutional Review Board (IRB) Ethics in human research are upheld by the Institutional Review Board (IRB). IRBs are in charge of assessing research projects involving human subjects to make sure they are carried out ethically and with the fewest risks to the subjects. IRBs crucially protect the welfare, rights, and dignity of study subjects. The Thalidomide Trials are a prime illustration of why IRBs are essential for human research. The Thalidomide Trials lacked sufficient control groups, monitoring of side effects, and participant-informed permission. These unethical mistakes caused the medicine to be used widely, resulting in birth abnormalities that afflicted thousands of infants worldwide. The sad result may have been avoided if an IRB had been in existence during the Thalidomide Trials to assist in upholding moral standards (Thomas, 2020). IRBs are responsible for examining research studies to ensure they adhere to ethical and legal requirements. IRBs comprise people from different fields, such as scientists, medical experts, ethicists, and residents. The study design, permission form, and other research project

5 components must all be reviewed by the IRB to guarantee that the study is carried out ethically. The need for informed consent is one example of how study participants are protected. Human subjects research must always get their informed permission. It guarantees that participants are aware of the purpose of the research, any risks or benefits, and their ability to discontinue participation at any time (Thomas, 2020). The IRB ensures that the informed consent procedure is carried out ethically and that participants are aware of the advantages and dangers of the study. The obligation for secrecy is another illustration of how study participants are protected. The IRB ensures that study participants' privacy is safeguarded and that no unapproved parties can access their data. This safeguard helps to ensure that study participants are not stigmatized or subjected to discrimination due to their participation. The IRB also ensures that the research's advantages exceed any possible hazards to the participants. The IRB ensures the study is planned to reduce participant risk while delivering essential data. This safeguard aids in ensuring that research investigations are carried out morally and with the least harm to participants. IRBs are crucial in ensuring that vulnerable groups are safeguarded. Children, expectant mothers, and those with cognitive or mental disabilities are vulnerable groups (Thomas, 2020). The IRB ensures that disadvantaged groups are not taken advantage of and that their rights are upheld. The IRB also ensures that the study is carried out in a manner that is compatible with the fundamentals of scientific inquiry and that the study design is viable from a scientific perspective. The study's accuracy and dependability are ensured by the IRB, as well as the study's suitability for the research issue. The Violation of Ethical Principles in the Thalidomide Trials What happened in the Thalidomide Trials shows what may happen when researchers disregard ethical norms while working with human subjects. The Institutional Review Board

6 (IRB) sets standards for research involving human participants in the modern era (IRB). A few examples of these values include kindness, fairness, and justice. The Thalidomide Trials disregarded every one of these rules. While studying human beings, treating them with dignity and respect is essential. According to this tenet, people must be given the respect due to free agents when deciding whether to participate in a study. Many people who took part in the Thalidomide Trials had little say in whether or not they took part since they were not provided with complete information about the hazards involved. This callous disregard broke the idea of autonomy for individual rights. According to the beneficence principle, studies should only be conducted if their benefits outweigh their hazards. Participants in the Thalidomide Trials were exposed to grave dangers, including the increased likelihood of congenital disabilities. However, there was a lack of analysis and proof on the possible advantages. The concept of goodwill was disregarded due to the failure to weigh the advantages against the disadvantages. To the idea of fairness, the rewards and costs of scientific inquiry must be shared equitably. Participants in the Thalidomide Trials bore a disproportionate share of the study's costs since they were kept in the dark about the drug's potential side effects. Moreover, the volunteers did not share the study's prospective advantages equitably. This injustice goes against the whole idea of fairness. The Thalidomide Trials also failed to adhere to another ethical standard for human experiments. The informed consent process safeguarded a participant's right to withdraw from a study at any time, as well as their understanding of the study's nature, risks, and benefits. Many people who took part in the Thalidomide Trials had little say in whether or not they took part

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7 since they were not provided with complete information about the hazards involved. Because of this, the concepts of autonomy and beneficence were broken (Thomas, 2020). Participants' anonymity is an essential safeguard in scientific studies. Participants' anonymity was not effectively protected in the Thalidomide Trials, as many were formally recognized by name. The values of kindness and care for others were disregarded in this breach of trust. Avoiding Ethical Violations in Human Research: Principles and Practices Current research techniques may have prevented the breaches in the Thalidomide Trials. Nowadays, obtaining informed permission is essential for every study involving human beings. Before participants participate in the study, researchers must have their informed permission. This includes informing participants of the study's purpose, possible risks and rewards, and their ability to discontinue participation at any time. The subject must be given enough time to decide whether to participate in the study, and the material must be delivered in a language they can comprehend. Researchers must weigh the study's possible risks and rewards to uphold the beneficence principle. This necessitates carefully balancing the study's potential upsides against any hazards to participants. The study shouldn't be carried out if the possible hazards outweigh the potential advantages. Ensuring that the advantages and costs of research are dispersed equally may uphold the ideal of justice. This indicates that the participants should get an equitable share of the future research benefits (Thomas, 2020). Therefore, no one group or person should have to carry a disproportionate amount of the study's weight. Another essential safeguard for study participants is confidentiality. To preserve participant confidentiality and privacy, researchers must take appropriate precautions. To safeguard the identities of participants, pseudonyms or other

8 identifiers are used. Moreover, researchers must ensure that data are securely preserved and that only authorized individuals can access the data. Conclusion In conclusion, the Thalidomide Trials warn about the perils of using unethical research methods in human studies. The ethical lapses in the Thalidomide Trials serve as a reminder of the significance of contemporary research procedures mandated by IRB guidelines. It is impossible to overestimate the importance of the IRB in protecting the safety of research subjects and the integrity of research practices. Researchers must follow current research procedures and acknowledge the significance of ethical issues in a human study. Following these guidelines guarantees that research is done to minimize adverse effects on participants, maximize positive outcomes, and advance justice. The Thalidomide Trials need to warn about the terrible effects of unethical research procedures and the significance of sustaining moral standards in human research.

9 References Thomas, K. (2020, Mar 24). Thalidomide's legacy: [Correction]. The New York Times - Breaking News, US News, World News and Videos. https://www.nytimes.com/2020/03/23/health/thalidomide- drug-pharmaceuticals-united-states.html

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