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Essay of informed consent
Essays on Ethical Research
Ethical issues in health research
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The issue discussed by Ron, Williams’s ad Dickens is the conditions in which the use of human subjects in medical research justified. Roy and his colleagues believe that the health, life and dignity of persons involved as subjects in medical research must be protected in order for the research to be ethically justifiable.
Roy and his colleagues believe four conditions should be met for a medical research or clinical trial to be ethically justified, the research have to be scientific adequate; the rights of human subjects protected; clinicians obtain informed consent from patients; patients must be informed about randomization.
First, Roy et al. stated that adequate preliminary experimentation must be carried out on animal models before human subjects are used in a clinical trial. Medical researches or clinical trials with human subjects must conform to the principle of scientific method. Medical professionals and investigators involved in these researches must have adequate qualification.
Second, Roy and his colleagues proposed that in clinical trials, human subjects are to be pr...
Those who were affected by the testing in hospitals, prisons, and mental health institutions were the patients/inmates as well as their families, Henrietta Lacks, the doctors performing the research and procedures, the actual institutions in which research was being held, and the human/health sciences field as a whole. Many ethical principles can be applied to these dilemmas: Reliance on Scientific Knowledge (1.01), Boundaries of Competence (1.02), Integrity (1.04), Professional and Scientific Relationships (1.05), Exploitative Relationships (1.07, a), Responsibility (2.02), Rights and Prerogatives of Clients (2.05), Maintaining Confidentiality (2.06), Maintaining Records (2.07), Disclosures (2.08), Treatment/Intervention Efficacy (2.09), Involving Clients in Planning and Consent (4.02), Promoting an Ethical Culture (7.01), Ethical Violations by Others and Risk of Harm (7.02), Avoiding False or Deceptive Statements (8.01), Conforming with Laws and Regulations (9.01), Characteristics of Responsible Research (9.02), Informed Consent (9.03), and Using Confidential Information for Didactic or Instructive Purposes (9.04), and Debriefing (9.05). These particular dilemmas were not really handled until much later when laws were passed that regulated the way human subjects could be used for research. Patients
Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles that consider the ethical standards that should prevail in such circumstances. Should researchers be upheld to universal standards, or are the standards more applicable in a “local” sense, where the conditions and the constraints of the location provide the context for how the principles should be applied?
However, in this case, the medical researcher’s committed an ethical taboo by using a person’s corpse without theirs or their family’s knowledge or consent. In the article, “Henrietta Lacks and the HeLa Cell: rights of patients and Responsibilities of Medical Researchers”, written by Jessica L. Stump, the author acknowledges the collapse of individual post-mortem rights. To aid the advancements in medical research, “[her] cells have become the standard laboratory workhorse”(Stump 131) even to this day. As a result of the success of the researchers’ medical findings “the rights of her [own] family, [feel they are being] violated” (Stump 131) because they were never notified of Henrietta’s historical contribution. An Executive Director of the Presidential Commissions Lisa M. Lee, makes a harsh but valid comment in saying that “[t]he benefits of research have to outweigh the risks to the individuals involved” (Stump 131). Without the cures HeLa cells have done as a result of the denial of her individual post mortem rights, we could have faced countless more deaths to date, including the possibility of losing our loved
During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure assures that all human rights are safeguarded during the entire research process.
Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris. "Is Informed Consent Always Necessary For Randomized, Controlled Trials?" The New England Journal of Medicine 340, (March 1999): 804-807.
The above mentioned six ethical principles have been synthesised into 4 rights of subjects considering participation in research. These are
and Europe, which include reduction of animal use, refine animal study techniques, and animal testing replacement. According to Dana ,Bidnall, “Animals are also used, and subsequently killed, every year in many other types of laboratory experiments, from military testing to simulated car crashes to deliberately introduced diseases such as AIDS and Alzheimer 's”(49). Bidnal also states that, “These experiments take place in labs at universities, pharmaceutical companies, and testing agencies, and on farms and military bases around the world”(49). The author suggest,”Researchers who conduct experiments on animals argue that it would be unethical to test substances with potentially adverse side effects on humans; animals are good surrogates because their responses are similar to humans”(49).Bidnal contends with ,”However, some animals are chosen for other reasons”(49). According to Bindal, “Animal testing is not the only option in toxicity testing”(50). Bidnal states, “Alternatives are widely available and include human clinical and epidemiological studies; experiments with cadavers, volunteers,and patients; computer simulation and mathematical models; and in vitro (test tube) tissue culture techniques, to name just a
1. Capp, Marshall B. "Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me? -- Kapp 59 (4): 335 -- Journal of Clinical Pathology." BMJ Journals. J Clin Pathol, 18 Jan. 2006. Web. 11 Feb. 2012.
When a person seeks medical attention they go with the hope that their personal rights will not be violated with the belief that doctors will uphold their personal standards. Unfortunately, this is not always so for people who visit the hospital. There are documented cases in United States history involving African Americans being experimented on for the greater good without their knowledge or consent, and some of the most heinous cases involve doctors injecting their study groups with life threatening diseases. What happens when good science goes bad and who has the right to relegate the status of another human being as less than? In this research paper we will examine a clinical testing case study featuring the violation and exploitation
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
There is very much controversy surrounding the case of the very popular Henrietta Lacks. One of the major implications on the situation that people have a problem with is the lack of consent obtained by Johns Hopkins University and the doctors involved. All though it was not common place as it is in today’s society, many feel that it was not ethical to perform medical procedures without the patient and their family being given all of the knowledge regarding the situation. The tissue sample taken by doctor Howard W. Jones was unbeknown to the family which violates the ethical respect for the person that should be held. A sample of someone’s DNA is not anything that should be taken lightly or regarded as unimportant. It should have been a decision made by Henrietta, and had she of known of the procedure she may have voted against donating to research. This lack of incorporating Henrietta and her family caused there to be a dismal amount of respect for persons shown by the University and all
O'Brien (2013) defines RCT as a research technique that has been through the ages. It first was applied in medical studies. Today, it is a quantitative method widely used in clinical trials where participants answer or confirm a research question. Clinical trials that are designed with RCT in a medical context focus on prioritizing the protecting of human participants with the aid of ethical criteria; however, at the discretion of the researcher (O'Brien, 2013).
Informed consent is a very serious decision a patient has to make when it comes to their health and consenting to procedures that are believed to cure or treat their current health status. It is important to address the effectiveness of the role a physician play in the informed consent process assuring that the patient has given truly informed consent and what safeguards can be put in place to assure the patient is exercising informed consent. Informed consent is based on the fact that the person consenting is a rational individual that is aware of the action to which he/she is consenting. Allen and McNamara (2011) notes that "On the standard understanding, the important elements of informed consent are the provision of information, the voluntariness of the choice and the competence of the chooser to make the choice— so the potential research participant should be provided with information relevant to the decision to participate, they should be able to choose freely about their participation and they should be competent to decide.
Throughout centuries medical research has been conducted on animals. “Animals were used in early studies to discover how blood circulates through the body, the effect of anesthesia, and the relationship between bacteria and disease” (AMA 59). Experiments such as these seem to be outdated and actually are by today’s means, scientists now study commonly for three general purposes: (1) biomedical and behavioral research, (2) education, (3) drug and product testing (AMA 60). These three types of experiments allow scientists to gain vast amounts of knowledge about human b...
The growth of the medical research field is a significant development for the human species. New treatments are established to treat many diseases. Although the expansion of the medical research field benefits the human society in many areas, the ethical issue of using animals as testing subjects is often neglected. During this procedure, animals are used to experiment on in the place of humans to ensure the effectiveness of the discoveries and treatments. These processes are not always successful and therefore will often cause excessive pain and distress to the animals. Many animals suffer greatly and may even result in death. It is morally wrong to cause pain or distress to animals in the course of medical research because animals should have the right for welfare and live a pleasurable life thus; we should not harm them during the research process. In this paper I will defend this argument and provide a discussion on this issue by providing arguments supporting my thesis and as well as addressing a counterargument.