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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...
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.
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.
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
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
In July of 1974 The National Research Act was signed into law. Through this act, The Belmont Report was developed over 4 year period of time that included an intense four day conference followed by monthly meetings until it was completed in April of 1979. The Belmont Report sets out to define the ethical principles and guidelines for the protection of human subjects of research. The report was established prior to Barney Clark and the artificial heart and therefore was the guidelines that the doctors and researchers had to follow. The report highlights three essential ethical elements that are pertinent in human research and their applications. It was the professional responsibility of the doctors and researchers involved to abide by previously established ethical guidelines.
The Belmont Report distinguishes three center moral standards in regards to all human subject experimentation: autonomy, respect for persons, beneficence and justice. Autonomy alludes to the right of an individual to determine what they will or will not partake in. Respect for persons requires medical researchers to obtain informed consent from their subjects, which means that participants must be given precise information about their circumstances and treatment options so that they can decide what is best for them. Beneficence means that all test subjects must be informed about the advantages as well as all the possible risks of the treatment(s) they consent to participate in. The principle of justice includes individual and societal justice.
...man society of benefits and burdens of research involving human subjects. In particular, those participants chosen for such research should not be inequitably selected from groups unlikely to benefit from the work.
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.
Ethics refers to the values and customs of a community at a particular point in time. At present, the term ethics is guided by the moral principles that guide our everyday actions. These moral principles guide the researcher into deciding what is ‘right’ or ‘wrong’. The foundation of medical ethics is governed by two philosophical frameworks that are deontology, and utilitarianism. However ultimately the ethics committees need to balance the risks, and benefits for the participants and the community associated with the particular research proposal. This balance is quite important as the well being of participants is at risk.7
Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
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).
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145
Moreover, It is quite obvious that animal testing has done a lot for medical research in the past, and the use of an animal was needed. The main purpose of animal testing is to “Gain basic knowledge; for fundamental medical research; for the discovery and development of drugs and vaccines and medical advances” (Estimates for Worldwide Laboratory Animal Use in 2005 1). However, while that may have been true in the 1900’s, it is certainly not the case in the 21st century. With technology constantly advancing and expanding, researchers have found other alternatives that do not need a live animal body. Such alternatives, like computer models and in vitro testing, give the same amount of medical research without the nereed of harming an animal. Computer programs use specialized models to help design new products. These generated simulations are used to “predict the various possible biological and toxic effects of a chemical or potential drug candidate” (Alternatives to Animal testing: a review 225). It is unreasonable to assume that in the 21st century, animal testing is still the best option for medical research. With technology currently being used for many medical advances, future discoveries of medical research can and should be made without animal
The article titled “Contemporary Ethical Analyses: A Shortfall in Scientific Knowledge” describes the ethics through the public’s eye. One of the major ethical issues brought up is informed consent.