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Ethical principles in research studies
Ethical principles in research studies
Ethical principles in research studies
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Human research done in the United States nowadays is regulated by the Common Rule. The Common Rule is a policy on the topic of Human Subject Protection created by a number of agencies specifically the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research developed in 1974 to address detection of serious maltreatment of human subjects from the Syphilis Study at Tuskegee (Iltis, 2011). Some key requirements of the Common Rule are: assuring compliance by research institutions, obtaining and documenting informed consent, Institutional Review Board (IRB) membership, function, operations, review or research, and record keeping. It included additional safeguards for vulnerable subjects such as pregnant women and neonates, in vitro fertilization and fetuses, protection of prisoners, children and the mentally disabled (Department of Health and Human Services [HHS], 2009). The commission’s was best known for the Belmont Report, recognizing three ethical principles (respect, beneficence, and justice) which would serve as the foundation in developing rules and conduct of research.
The Belmont report or Title 45 contains the Code of Federal Regulations regarding the use of human subjects in research. It is this law under which the St. Francis University functions. The Federal regulation requires each institution engaged in research involving humans subject appoint members to form a review board. This Institutional Review Board (IRB) function is to review all projects created by any members of St. Francis University and verify the criteria in each research project protects the human rights under the federal and any other requirements specific to state or institution (NIH, January 15, 2009).
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...hical care is that which incorporates compassion, accountability, collaboration and trust. Each of these moral principles must be applied and understood by the researchers to ensure protection of all human subjects.
Works Cited
Guido, G. (2006). Introduction to Ethics. In M. Connor (Ed.), Legal & Ethical Issues in Nursing. (pp. 1-13). Upper Saddle River, NJ: Pearson Education Inc.
NIH Office of Extramural Reserach . (2011). Protecting Human Research Participants. Retrieved from http://phrp.nihtraining.com :
Regulations and Ethical Guidelines . (2011). Retrieved from http://ohsr.od.nih.gov/guidelines/belmont.html#gob1
The American Heritage Dictionary (Ed.). (n.d.). The American Heritage Dictionary.New York, New York : American Heritage Publishing .
Williams, A. (2000). “Health professionals have an ethical duty”. Journal of Medical Ethics, 26 (2), 87-88.
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
"Animal Testing Is Cruel and Does Not Benefit Medical Research." You Can Save the Animals: 251 Ways to Stop Thoughtless Cruelty. Rocklin, CA: Prima Publishing, 1999. Rpt. in Animal Experimentation. Ed. Cindy Mur. San Diego: Greenhaven Press, 2004. At Issue. Opposing Viewpoints in Context. Web. 7 July
To sum things up, the ethical demeanor of research involves respect for the safety and rights of subjects during the sequence of the trial. This includes protecting privacy and confidentiality, monitoring the condition of research subjects to assure their safety, terminating study participation in the case of hostile events, and notifying enrolled subjects about new risks, benefits, or other information that may bear upon subjects’ decisions to continue enrollment in the research. As new evidence shows itself, trial investigators and data safety monitoring boards (DSMBs) can alter the study plan, initiate notice of enrolled subjects, make changes to the informed consent policies, or stop the trials earlier than intended. Investigators should soon classify a technique for ensuring effective communication between the IRB and DSMB throughout these studies.
The basic significance of Belmont Report is to summarize the guidelines and ethical principles regarding the protection of human subjects involved in the research. The significance in terms of principles that guide human research today is as follows.
The Belmont Report was published in the Federal Register in 1979. It is a document written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which formed as a result to the Tuskegee Experiment scandal and serves to shape bioethics policy in the United States. This report outlines the ethical standards that research involving human subjects is required to follow.
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.
Yeo, M., 2010. Concepts and Cases in Nursing Ethics. 3rd ed. New York: Broadview Press
The reading on, “The ‘Four Principles’ Approach to Health Care Ethics” outlines the four principles of ethics. The reading first discusses the origins of principles and healthcare ethics. In the past, there were no rules on how physicians could treat their patient. In Europe and Asia they mainly focused on preventing disease and harm, while maximizing health benefits. During the 1970s and 1980s, principles for bioethics were formed. These principles were easy to understand and use for people with all different types of professional background. Beauchamp and Childress published a book called, Principles of Biomedical Ethics, which reviews the set of basic rules for bioethics. The rules are respect for autonomy, nonmaleficence, beneficence, and justice. Respect for autonomy means to recognize that the people have rights and choices.
In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research worked in establishing a set of ethical guidelines, called the National Research Act, in which those performing research are to follow (Office for Human Research Protections, 2016). This Belmont review while not only helping to establish a set of ethical principles it also discussed the way in which this can be correctly applied. As a whole it addresses three main areas. These include the boundaries between practice and research, basic ethical principles including respect for persons, beneficence and justice and lastly their applications which consists of informed consent, risk versus benefit and the selection of research participants (Office for Human Research Protections,
The APA ethical guidelines help to ensure that all psychological research maintains the integrity that it does not do harm or conflicts with the majority of the human populations moral ethical codes. However, in some situations the APA ethical guidelines must be viewed as just that: guidelines. If a study has the potential to benefit humanity as a whole and does not result in the permanent or irreparable harm to a human being then some guidelines must be permitted to be stretched or even broken in the interest of human advancement and scientific progression. After all the goal and responsibility of a psychologist is to enhance our understanding of human behavior as well as to find ways to use this information to better society and humanity as a whole. In a circumstance that has the potential to achieve this goal, violation of the APA ethical guidelines is acceptable on the condition that the research maintains the integrity of not inflicting irreparable damage or harm to the subjects being used. This includes psychological harm, physical harm, or social humiliation to any human being regardless of age, size, race, gender, disability or other determining characteristic.
In 1965 a finalized Code of Ethics for Nurses was published by ICN, which discuss the responsibility of nurse to patient instead of physicians. (Butts, 2011)
The healthcare providers are always required to maintain a high level of ethical standard when they are carrying out their activities. They have an obligation to follow the stipulated codes of ethics as well as perform their required responsibilities. Ethics are an essential and an integral part of the healthcare profession, and everyone involved should ensure that he or she adheres to them. It also encourages health professionals to report events that may cause or already causes a potential harm. There are several reasons such as making decisions, patient care and medical research that require the healthcare providers to practice a high level of ethics.
One of the main objectives that need to be addressed by the government is how to protect reproductive materials outside the body and protect individuals by making sure they give permission for their materials to be used. Consent plays a key factor in medical research due to the fact that failure to receive consent violates the principles of individual independence and respect for others.
The federal government requires that researchers follow these guidelines under persecution of the law. The Department of Health and Human Services (2009), states that pregnant women and their fetuses, children and prisoners are also protected under these rights. Ethics committies are also responsible for participant safety. According to Jacobsen (2014) “Review boards will not approve studies that do not meet the three main ethical considerations of health research: beneficence, respect for persons, and distributive justice” (p. 52). These three ethical considerations protect patient’s rights and
In every nurse's career, he or she will face with legal and ethical dilemmas. One of the professional competencies for nursing states that nurses should "integrate knowledge of ethical and legal aspects of health care and professional values into nursing practice". It is important to know what types of dilemmas nurses may face