HSCI705 Annotated Bibliography Philosophy of Ethics in Research

Liberty University

Annotated Bibliography

October 10, 2022

Introduction

By labeling behaviors as good, terrible, right, or wrong, ethics helps to pinpoint problems with morality. Ethics is the study of right and wrong, duty and virtue, in the context of our relationships with God, with ourselves, and with others (Heydt, 2018; 2017). After WWII, ethicists began applying their thinking to the field of biology, leading to the creation of documents like the Code of Nuremberg, the Declaration of Helsinki, and the Belmont Report. All clinical research involving humans in the United States must adopt and uphold the three essential ethical ideals of beneficence, justice, and respect for persons. These three ideas, drawn from the Belmont Report and exemplified in numerous ethical writings, form the foundation of the concept of research ethics. This assignment contains a literature review of 10 scholarly articles that lay the groundwork for a larger study of the philosophical underpinnings of research ethics.

Annotated bibliography

Anon. (2017). Issue Information‐Declaration of helsinki. Journal of Bone and Mineral Research, 32(3), BM i-BM ii. https://doi.org/10.1002/jbmr.2944.

The Declaration of Helsinki is presented here on two pages. There are nine bullet points in the introduction that provide context for the rest of the work. Initiating and supporting the Declaration of Helsinki, the World Medical Association was essential. When conducting an experiment on human subjects, doctors are reminded of their ethical obligations. Since “the health of my patient is my first consideration,” and “a physician shall work exclusively in the interest of the patient,” when providing medical care that could have the effect of weakening the patient’s physical and mental condition, the doctor has an obligation to put the patient’s needs first. Medical ethics stipulate that researchers must always protect their participants' lives, confidentiality, and respect for human dignity before, during, and after clinical trials. There are seventeen articles here that go into great length on how to do clinical research in an ethical manner, whether you’re a doctor, writer, or publisher.

Clark, K. R. (2019). Ethics in research. Radiologic Technology, 9;90;(4), 394-397.

The Clark document is a high-level introduction to the ethics of scientific inquiry. According to him, the Hippocratic Oath and the Ten Commandments provide for a compelling moral synthesis. The classroom, the family, and the church are all places he believes moral ideals can be learned and instilled. The Nuremberg Code provides the background for this discussion. There are three ethical principles for protecting human beings, all of which were outlined in the 1979 Belmont Report. One of the text’s primary themes is the importance of keeping research participants safe. All subjects must then give their informed permission, regardless of whether the project is exempt, accelerated, or requires a full review. Participants are obligated to maintain the privacy and confidentiality of their health information per the Health Insurance Portability and Accountability Act (HIPAA) of 1996, which established stringent criteria for the protection of such information. This essay serves as a starting point for the assigned topic.

Cocanour, C. S. (2017). Informed consent—It’s more than a signature on a piece of paper. The American Journal of Surgery, 214(6), 993-997. https://doi.org/10.1016/j.amjsurg.2017.09.015

He discusses merits of giving thoughtful consent. The patient must be competent, well-informed, and fearless in order to provide informed clinical consent. Second, doctors and patients alike should always behave with beneficence in mind. It’s not enough for the doctor to just provide the patient information; the patient must be able to evaluate and comprehend it. The United States government has mandated certain disclosures be made during the informed consent process. Details like the study’s coordinator, the location, the operation, the patient’s or legal guardian’s name and signature, and an explanation of the procedure’s advantages and disadvantages are all required. This essay discusses informed consent at great length, elaborating on its significance and outlining its structure. Before they can take part in a clinical experiment, human volunteers must give their written consent. Each person involved in a clinical trial needs to fill out this form.

Grady, C., Cummings, S. R., Rowbotham, M. C., McConnell, M. V., Ashley, E. A., & Kang, G. (2017). Informed consent. The New England Journal of Medicine, 376(9), 856- 867. https://doi.org/10.1056/NEJMra1603773.

There has been a significant decline in the use of the traditional informed consent form. As a result of technology developments, a new kind of informed consent is emerging, and it often proves to be more advantageous for therapists and participants. With the development of new research techniques, the concept of “informed consent” is also changing. The authors point out that “public and private researchers regularly utilize de-identified clinical biospecimens with consent,” despite the fact that “conventional laws may still apply to biospecimen research.” Electronic informed consent for web-based studies is becoming the norm as the world evolves toward a paperless society and data is kept in the “cloud,” to use internet parlance. Films and quizzes are increasingly being used in place of verbal or written informed consent in these new dispositions, which has certain significant drawbacks. Similar approaches are also used in the study of mobile health, which has benefited substantially from research conducted using mobile applications. This essay discusses how the digitization of society will affect research ethics.

Hofmann, B. (2021). The role of philosophy and ethics at the edges of medicine. Philosophy, Ethics, and Humanities in Medicine : PEHM, 16(1), 14-14. https://doi.org/10.1186/s13010-021- 00114-w

The goal of this essay is to make clear how philosophy, ethics, and the “edge of medicine” are related to one another. One can get various explanations of the phrase “cutting edge of medicine” by searching the internet. However, there does appear to be consensus on a single definition: According to popular belief, “the frontier of medicine” is the cutting edge of the medical field. When regarded from the perspective of “on the boundary between aesthetics and ethics,” terms like “border of medicine” are used to characterize practices like cosmetic surgery, the freezing of social gametes, and A-I (artificial intelligence) based diagnostics. The author argues that the use of cutting-edge technology in science necessitates a rethinking of the very meaning of language itself, making philosophy and ethics more important than ever. He agrees that the progress of medicine necessitates a rethinking of philosophical and ethical questions in tandem with technological development. This article will be useful in demonstrating the potential ethical problems that occur in clinical research when individuals are sometimes unaware that they are being researched.

Lantos, J. D. (2020). The belmont report and innovative clinical research. Perspectives in Biology and Medicine, 63(2), 389-400. https://doi.org/10.1353/pbm.2020.0026.

Lantos highlights the fundamental idea of the Belmont Report, which draws a sharp line between biological research and therapeutic treatment. He contends that doctors are sometimes ineffective and that ethical violations can easily occur, whether on purpose or by accident. One form of bias is when someone with an interest in the outcome uses their own data to judge quality and recommend next steps. However, these information-gathering initiatives are not considered research. The essay raises the age-old debate of whether a doctor’s loyalty should be to their patients or their employer. Institutional Review Boards are emphasized, as is the correct implementation of the Belmont Report’s first suggestions. As a fundamental example of the biases clinicians have regarding their patients as study subjects, this piece is quite helpful.

Lapid, M. I., Clarke, B. L., & Wright, R. S. (2019). Institutional review boards: What clinician researchers need to know. Mayo Clinic Proceedings, 94(3), 515- 525. https://doi.org/10.1016/j.mayocp.2019.01.020.

Without a shadow of a doubt, the Institutional Review Board (IRB) provides an essential safety foundation for honest and honorable conduct in clinical research involving human participants. In order to clarify the role and responsibilities of the IRB, this document presents a brief history of the circumstances that led to its creation. It is widely agreed that an IRB’s regard for human rights, morality, and fairness is bolstered by the diversity and composition of its members. The research defines “research” and explains the many IRB categories. Excellent emphasis is placed on the ability to consent and the essential significance of the informed consent agreement. Clinical studies are recommended for accurate population-based and prospective suicide assessment. Due to the unique nature of medical devices, it is essential to comprehend the FDA’s classification system for regulating these products. For a full understanding of the IRB and its development, this document is mandatory reading..

Rajab, M. H., Alkawi, M. Z., Gazal, A. M., Alshehri, F. A., Shaibah, H. S., & Holmes, L. D. (2019). Evaluation of a University’s institutional review board based on campus feedback: A cross-sectional study. Curēus (Palo Alto, CA), 11(10), e5829- e5829. https://doi.org/10.7759/cureus.5829.

This study’s goals include gauging the IRB’s (University’s Ethics Committee) level of efficiency. It’s unusual for there to be a review of the reviewers themselves. The Saudi National Committee of Bioethics initiated the study, and it was carried out with the help of email responses from instructors and students. The authors claim that just 8% of the invited off-campus individuals actually took part, with the total response rate coming in at 29.7%. The results of the study highlight several flaws in the current system for gaining Institutional Review Board approval. In actuality, many applications for research involving undergraduates were refused, and it usually takes some time before any are accepted. The research may be significant to our knowledge of research ethics as a whole because it shows how a non-American IRB operates. Furthermore, this highlights the value of the Nuremberg Principles and the Helsinki Declaration in the medical field.

Ulrich, C. M., Grady, C., Demiris, G., & Richmond, T. S. (2021). The competing demands of patient privacy and clinical research. Ethics & Human Research, 43(1), 25- 31. https://doi.org/10.1002/eahr.500076.

In order to protect patients' confidentiality, medical records must be kept secret. Moral clinical research is predicated on protecting the privacy and confidentiality of patients. In this essay, we take a closer look at the privacy invasion that can occur as a result of a data breach. These breaches are becoming more common as a result of hacking operations. There are serious ethical considerations involved with any data leak. Covered institutions may use patient authorizations and, in some situations, consent to use personal health information for research, as permitted by the Federal Privacy Rule which established nationwide standards. As numerous examples have proven, many researchers currently worry that a data hack may slow the advancement of their field. Patients' privacy will always be respected. When people don’t have faith in their doctors, medical studies can’t progress.

Weisleder, P. (2022). Leo alexander’s blueprint of the nuremberg code. Pediatric Neurology, 126, 120-124. https://doi.org/10.1016/j.pediatrneurol.2021.10.015

After the Nazi regime’s defeat at the hands of the Allies in World War II, the Code of Nuremberg was signed into law, and this document serves as historical proof of that fact.. The author dug into the past by studying archival materials and the “Alexander’s papers” collection at Duke University to write this book. Six of the twelve principles of the Nuremberg Code are revealed in three-page documents archived at the library. Images from the Nuremberg trials' evidence are also included to illustrate the heinous way in which Nazi scientists handled their human test subjects. Without a doubt, Alexander’s paper was considered as a resource when the final version of the Nuremberg Code was settled upon. It clarifies where the idea of the Nuremberg Code came from. It’s important to remember that an American doctor had some say in shaping this landmark piece of legislation regulating clinical research. Currently, you can find the document in Duke University’s medical library.

The Conclusion

Throughout the course of history, mistreatment of research subjects has resulted in rule and regulatory modifications, all of which have been implemented specifically with the intention of protecting people who participate in clinical research. The Bible makes a promise that a king will sit on an eternal throne if that monarch justly judges the poor, and fairness has always been the motivating factor for these changes (American Standard Bible, 2013, Proverbs 29:14). The values of justice and fairness ought to serve as the compass that directs our society as we work toward the establishment of a more ideal union.

Reference

American Standard Version. (2013). Bible Gateway. https://www.biblegateway.com.

Heydt, C. (2018;2017;). Moral philosophy in eighteenth-century britain: God, self, and other. Cambridge University Press. https://doi.org/10.1017/9781108363327