Wait a second!
More handpicked essays just for you.
More handpicked essays just for you.
Principles in biomedical research ethics
Ethics in biomedical research
Ethics in biomedical research
Don’t take our word for it - see why 10 million students trust us with their essay needs.
Recommended: Principles in biomedical research ethics
Given the increasing complexity of current biomedical research involving ethical, technical, human, and administrative factors, ethics review committees have also had to evolve. Of course, none is perfect. However, the primary and occasionally unique objective of all of them is the protection of research subjects. Understanding this term as all individuals involved in a research project: patients, controls and researchers alike. This is a concept that is sometimes forgotten by the researchers themselves and it is common for them to feel uncomfortable with some of the opinions produced by the aforementioned committees. An unpublished analysis of the Institute's projects showed that the main reason why projects are not approved during the first …show more content…
“The research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards”. (Lynch. 2014) This is a problematic false assumption that people tend to undertake, which creates fear and opposition to these beneficial investigations. Seemed as unethical, clinical trials are consistently repudiated by the IRB which is always protecting and keeping alive patients’ rights, although patients’ right are always present when an investigation is performed. There are certain general ethical principles considered and followed at every moment a clinical trial is performed to a group of patients. These ethical principles include autonomy, which is when it is required that people who are capable of making autonomous decisions in according to their beliefs, idiosyncrasies or perceptions are previously taken into account. The ethical obligation not to harm and maximize potential benefits in terms of research risks must be reasonable in the light of benefits: relevant objective, appropriate methodological design, to obtain some knowledge on health aspects. “Beneficence refers to the ethical obligation to maximize …show more content…
They represent the design with the highest level of causality, where the researcher has control over exposure, are prospective, have the advantage that in theory biases can be avoided, they have a high level of population comparability (confusion) and information. Their practice, however, is very complex and in developing countries priority must be given, in addition to methodological aspects, to ensuring the rights of patients. However, on every occasion people hear “randomized clinical trials” the assumption of forced individuals to participate is always made. Randomized clinical trials is not choosing people out of nowhere and force them to participate, furthermore, is a long process of study trying to concur with all the needs required for the study to be successful. A failure to appreciate these risks could jeopardize the research effort. (Dresser. 2012) These false and negative assumptions are affecting the way clinical trials are seen by the community, generating more controversial arguments and causing review boards and institutions conduct new and extra strict regulations for investigators trying to find a
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
Therefore, he states he wants to “focus the paper on the arguments offered in support of the claim that these trials were unethical,” (302). The first criticism states,” injustice was done to the control group…second, the participants in the trial were coerced into participating…third, the countries in question were exploited,” (302). Against the first criticism, he argues that if the clinical trials were not conducted the participants would not have received proper treatment. For the second criticism, he states that coercion, “involves a threat to put someone below their baseline unless they cooperate with the demands of the person
Southam’s practice, beginning with the Code’s number 1 rule, “The voluntary consent of the human subject is absolutely essential.” Other rules under the Nuremberg Code were broken as well, however all of these egregious behaviors of researchers, more so than just Southam, have influenced the tight research protocols in place today. As Dr. Hardy shared information on research protocols, she consistently referred back to a strict system of regulations that, at times, may seem a little extreme. The alternative, a system permitting researchers like Southam, would be a far harder bullet to bite. In the end, I am glad these systems are in place to try to ensure a trust between patients and
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 ...
The four major ethical principles in health care are: Autonomy – to honor the patient’s right to make their own decision (the opposite is paternalism - the health care provider knows best for the patient), Beneficence – to help the patient advance his/her own good, Nonmaleficence – to do no harm (many bioethical controversies involves this principle), and Justice – to be fair and treat like cases alike. All 4 principles are considered to be in effect at all times. In theory, each is of equal weight or importance. Ethical responsibilities in a given situation depend in part on the nature of the decision and in part on the roles everyone involved play.
There are ethical implications at every stage of the research process, including the choiceof topic to research, the selection of the design and the publication of the findings. There are 6 etical principles (ICN 2003) the health care professionals can use to guard their patients (or) clients from harm.
Tuberculosis is an air-borne disease, hence, it can be passed from an infected person to a healthy individual through coughing, sneezing and other salivary secretions. Tuberculosis is caused by the transfer of Mycobacteriun Tuberculosis (M. Tuberculosis) also known as Tubercle Bacillus, a small particle of 1-5 microns in diameter, due to the small size, when an infected person sneezes or coughs, about 3,000 particles are expelled. M. Tuberculosis responsible for tuberculosis is able to stay in the air for a long period of time (about 6hoursAnother way of acquiring Tuberculosis is by drinking unpasteurized milk, milk straight from cow, although this is not a common mode of transmission, it can be found in rural areas. Ingestion of contaminated cow milk transmits Mycobacterium Bovis, the animal form which is still potent enough to cause tuberculosis in humans. ). Tuberculosis transmission is affected by exposure, socioeconomic status of person, proximity, immune status of uninfected individual (%&&%&? CDC).
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.
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)
..., beneficence, non-maleficence and justice help us understand and explain which medical practices are ethical and adequate. These principles are used to protect the rights of a patient and the physician from being dishonored. The principle autonomy allow an individual to act freely in accordance to their self-chosen plan. This means that healthcare providers must always get the patients consent before making any decision about patient’s life. The of non-maleficence states one must cause no harm to an individual. This means that we must always restrain from harming others. The principle of beneficences say that one must always promote good. This means that healthcare providers must always do what is good for the patient. Lastly the principle of justice promote fairness and equally. This mean that healthcare providers cannot act in a prejudice manner toward patients.
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
Paul J., Seib R., Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e5
Ethics is the study of moral values and the principles we use to evaluate actions. Ethical concerns can sometimes stand as a barrier to the development of the arts and the natural sciences. They hinder the process of scientific research and the production of art, preventing us from arriving at knowledge. This raises the knowledge issues of: To what extent do moral values confine the production of knowledge in the arts, and to what extent are the ways of achieving scientific development limited due to ethical concerns? The two main ways of knowing used to produce ethical judgements are reason, the power of the mind to form judgements logically , and emotion, our instinctive feelings . I will explore their applications in various ethical controversies in science and arts as well as the implications of morals in these two areas of knowledge.