...Tuskegee Syphilis Study Dr. Joseph Costa, D.H.Sc, PA-C Health Policy and Management MPH 525 Jessie McCarty April 2013 Table of Contents Chapter Page 1. Tuskegee Syphilis Study 2 2. Tuskegee Basics 3 3. What Went Wrong? 4 Informed Consent 4 Vulnerable Populations 4 Medical Profession Pursued 5 4. Personal Opinion 7 5. Basics of Research 8 Informed Consent 8 Individual Autonomy 9 Beneficence 9 6. Current Policies 11 Policies 11 Exceptions 11 7. Problems with Waving Consent 13 Flexibility 13 Vulnerable Populations 13 Ethical Dilemmas 14 8. Conclusion 16 Chapter 1 Tuskegee Syphilis Study Throughout the years, numerous research studies have taken place. In the United States, on a daily basis thousands of research studies are being conducted. Some of these studies will greatly influence science, while others will make little impact. Historically, some studies have been remembered not for the results, but for ethical dilemmas surrounding the study. The Tuskegee syphilis study is a prime example of a study which made many people aware of the ethical problems surrounding research. The Tuskegee syphilis study made the government begin to analyze how research was performed in the country, and the study opened many eyes to what changes needed to be made. Analyzing the Tuskegee syphilis study allows for one to understand what went wrong with the study and how this study lead to great changes in the world...
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...Informed Consent 1 Running Head: HUMAN SUBJECTS Human Subject’s Comprehension of Informed Consent Informed Consent 2 Statement of the Problem A primary protection of the rights of clinical research subjects revolves around the concept respect for persons and the provision of informed consent (Belmont Report, 1979). Legal and ethical policies and guidelines enforce that research participants give informed consent prior to voluntary enrollment in a research study (Code of Federal Regulations,1999). However, the informed consent process presents some major challenges for study participants and research staff. Several papers have addressed problems with the current process. Brady (2003) identifies the following issues: subject’s hesitation to ask detailed questions, variable presentation of the content, and difficulty verifying the subject’s comprehension. Also, a survey performed by Center Watch in 2002 found that 14% of subjects did not read the consent before signing it and a high percentage of volunteers admitted to not fully understanding the risks and not knowing what questions to ask. The concept of “therapeutic misconception” (Joffe, Cook, Cleary, Clark, & Weeks, 2001) in research is another problem that has received much attention in both legal and bioethics literature. It is important that potential subjects are aware that...
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...My law and ethics understanding and beliefs In 1847 the American Medical Association revolutionized medicine in the United States. Members of this newly formed organization, met in Philadelphia as the first national professional medical organization in the world, dedicated themselves to establishing uniform standards for professional education, training, and conduct. They unanimously adopted the world's first national code of professional ethics in medicine. For more than 160 years since, the AMA's Code of Medical Ethics has been the authoritative ethics guide for practicing physicians. Ethics in Hand are pocket-sized guides to the Code of Medical Ethics for physicians and medical students. The Code articulates the enduring values of medicine as a profession. As a statement of the values to which physicians commit themselves individually and collectively, the Code is a touchstone for medicine as a professional community. It defines medicine’s integrity and the source of the profession’s authority to self-regulate. At the same time, the Code of Medical Ethics is a living document, evolving as changes in medicine and the delivery of health care raise new questions about how the profession's core values apply in physicians' day to day practice. The Code links theory and practice, ethical principles and real world dilemmas in the care of patients. The next time you hear a monotheist tell a non-believer that morals come from the Bible or that moral reasoning cannot provide an...
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...Table of Contents I. Informed Consent A. Patient B. Healthcare Professional C. Consent for others D. Competencies II. Consent Forms A. Emergencies/Non-Emergencies B. Authorization C. End of Life Decisions III. Legal A. Processes B. Malpractices IV. Conclusion V. References The concept of the informed consent is always a subject that is uncertain. An informed consent can be presented as an understanding of the fact and implications. When giving informed consent, the person must have all the facts at the time of consent is needed. Concepts It is extremely important that a patient must be provided all the information needed to give consent and not encouraged or forced by any medical staff member. The patient should also be in right mind before consenting to any procedure. If the patient is under the influence of medication, the consent will have to be given to the next of kin. The physician is responsible for providing all details of the procedure and treatment that will occur to the patient. This conversation should also be noted in the patient’s medical record. The physician has the right to assign another staff member to obtain the informed consent form, but only if the physician has performed the requirements needed. When consent is needed from other family members, the physician is required to provide the family member the details of the treatment. Also, the patient must consent to render his/her voice to...
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...https://homeworklance.com/downloads/16173/ You are the risk manager for University Hospital. You have just been informed of an incident that occurred on your facility grounds. A patient came to your emergency department for chest pain. Unfortunately, he parked in a distant parking area around 100 yards away since parking was crowded directly in front of the Emergency Department. He collapsed behind his car in the parking lot. Security contacted the ED, whose charge nurse stated they were full and since the patient was not in the ED, to call 911 and have an ambulance transport the patient to the next closest facility. Security calls 911, but the EMS unit takes 14 minutes to respond. The patient expires due to a prolonged cardiac arrest “down time”. Question: Provide a list of at least 3 risk management issues from the scenario. Then provide a way to mitigate the risk in this scenario. Be specific and provide details. You just received notice of an issue in the surgical Unit of your facility. A 45 year old man was admitted through the ED for a myocardial infarction (heart attack) and evaluated by the cardiologist. The cardiologist told the patient that he needed an immediate balloon angioplasty. After a proper informed consent process the patient agreed to the procedure. One hour later the wife showed up angry and threatened to sue if they touch her husband. She read recently or saw on TV that this is not always a necessary procedure. The cardiologist performs...
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...U05a1 Case Study - Informed Consent Informed consent is still an important part of health care. It is believed that informed consent helps foster open communication between medical professionals and patients, in addition to contributing to patient autonomy (Cooper, 2000). The field of health care ethics determines the right and wrong of actions based on a systematic analysis of the values and conflicts involved in the health system. Culture influences how people interpret health, illness, and treatment options. The values patients hold with respect to quality of life, death and dying, and the decision-making frameworks are used to discuss treatment options (Cooper, 2000). Informed consent is the authorization of a medical intervention by an individual. Disclosure is defined as the provision of all relevant information by the physician and the patient. In a multicultural society where many disparate values are held in respect to health care decision making, obtaining informed consent, poses some challenges (Cooper, 2000). There are many debates whether ethical principles are universal and that all cultures should be held accountable (Cooper, 2000). It seems that informed consent does not fall into the category of a universal ethic. The principles such as autonomy and respect for persons, do apply across different cultures. The issue is that autonomy itself and respect for individuals ought to be demonstrated are concepts that are influenced by cultural tradition...
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...https://homeworklance.com/downloads/16173/ You are the risk manager for University Hospital. You have just been informed of an incident that occurred on your facility grounds. A patient came to your emergency department for chest pain. Unfortunately, he parked in a distant parking area around 100 yards away since parking was crowded directly in front of the Emergency Department. He collapsed behind his car in the parking lot. Security contacted the ED, whose charge nurse stated they were full and since the patient was not in the ED, to call 911 and have an ambulance transport the patient to the next closest facility. Security calls 911, but the EMS unit takes 14 minutes to respond. The patient expires due to a prolonged cardiac arrest “down time”. Question: Provide a list of at least 3 risk management issues from the scenario. Then provide a way to mitigate the risk in this scenario. Be specific and provide details. You just received notice of an issue in the surgical Unit of your facility. A 45 year old man was admitted through the ED for a myocardial infarction (heart attack) and evaluated by the cardiologist. The cardiologist told the patient that he needed an immediate balloon angioplasty. After a proper informed consent process the patient agreed to the procedure. One hour later the wife showed up angry and threatened to sue if they touch her husband. She read recently or saw on TV that this is not always a necessary procedure. The cardiologist performs...
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...Belmont Report: Informed Consent and Subject Selection In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general principles of research. Informed consent is broken down into three checkpoints: information, comprehension, and voluntariness. Assessment of Risks and Benefits has two similar components: identifying the nature and scope of the risks and benefits, and then the systematic assessment. Then there is the selection of subjects which is just an evaluation of the appropriateness of a group used in a research study. I will discuss these concepts as they apply to the infamous artificial heart case study. Informed consent is the application of the general principle of respect for persons. Remember, respect for persons requires that subjects be given the opportunity to choose what will or will not happen to them (Belmont Report, 1979). The first tier...
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...data protection and privacy Chaired by: Caroline Gans-Combe Special thanks to the Panel Members: Andrew Bottomley, Duarte Carvalho-Oliveira, Costas A. Charitidis, Eva Del Hoyo-Barbolla, Anne Demoisy, Anna Giovanetti, Walter Hannak, James Houghton, David Morton, François Moutou , Jane Lamprill, Antony Lebeau, David Townend, and Mary Sharp. - Very special thanks to the Ethics Team : Isidoros Karatzas, Mihalis Kritikos, Yamina Cheikh, Paulette Matkovic Ramirez, Marie Cocquyt, Marco Michelini, Stefan de Vos and François Hirsch General disclaimer: this document examines the major concepts of data protection and privacy from the point of view of research ethics. It aims at raising awareness about these concepts in the scientific community and at assisting applicants while preparing to submit their project proposals. It does not seek to discuss these concepts in-depth but provides a general overview of their main parameters and some basic suggestions regarding their handling for the purposes of the European Commission's Ethical Review procedure. This document represents an effort to reflect on the experience gained during the operation of the Ethics Review mechanism and to provide some practical guidance, thus it will be regularly updated. The document contains three sections: → 1. The first section consists of an awareness list which contains the main questions that need to be taken into account by applicants when dealing with the data protection and...
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...due to its potential to manipulate and control the human mind, while others believe it holds great promise for understanding and treating neurological disorders. Firstly, there are concerns about privacy and consent in neuroscience research. The use of advanced technologies to monitor brain activity raises questions about who has access to this information and how it is used. Without proper safeguards in place, individuals' privacy could be compromised. The ethical implications of using such technology without consent are profound. It raises questions...
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...Informed Consent Informed Consent is defined as consent by a patient to undergo a medical or surgical treatment or to participate in an experiment after the patient understands the risks involved. (wordnetweb.princeton.edu/perl/webwn 2011) This concept is based in general on a patient’s right to self-determination when given adequate disclosure of a specific treatment plan. Informed consent is a legal procedure to ensure that a patient or client knows all of the risks and costs involved in a treatment. The elements of informed consent include informing the client of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment. As well as making sure the patient quantifies the in layman’s terms the risks and outcomes/prognosis if procedure or treatment is refused. Informed consent is especially important in high risk procedures as in procedures that are more likely to generate a lawsuit. In order for informed consent to be considered valid, the client must be competent and the consent should be given voluntarily.(http://psychology.about.com/od/iindex/g/def_informedcon.htm 2011) Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, non-treatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to the treatment, non-treatment, or procedure. Another important aspect of informed consent is that it should be attained both...
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...INFORMED CONSENT IN EMERGENCY SITUATIONS 1 INFORMED CONSENT IN EMERGENCY SITUATIONS IVA SHIELDS LEGAL & REG ISSUES-HLTH INFO / HIT 220 PROFESSOR: ANDREA THOMAS INFORMED CONSENT IN EMERGENCY SITUATIONS 2 A patient has the legal right to be informed and knowledgeable concerning any procedure performed by all medical personnel. The fact that an emergency situation has occurred does not change those rights. Being in a vulnerable state of mind when facing an emergency situation can be scary enough without facing the situation uninformed and unknowledgeable as to how the circumstances may affect you and your family. We, the patient or patients are protected by rights that are put in to place to help reassure us that we will receive the best care possible, without the fear being taken advantage of or our lives taken for granted. Informed consent is defined as a voluntary agreement given by a person or a patients' responsible proxy (for example, a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of informed consent are that the subject has both knowledge...
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...Accountability of Nursing Professionals for Patient Safety Practices Related to Informed Consent Lavonia Deanne Bishop Grand Canyon University NURS-430V Professional Dynamics 23-Aug-2010 (0106) September 19, 2010 Accountability of Nursing Professionals for Patient Safety Practices Related to Informed Consent Accountability in nursing can be defined as the state in which the nurse is responsible for upholding a professional agreement with the patient to provide services and be held answerable for the outcomes of behaviors related to these services (Hood, 2010). One of the main areas we are held accountable for as professional nurses is the safety of our patients. After an evidence-based review of patient safety practices, the Agency for Healthcare Research and Quality has identified numerous opportunities for quality improvement. The practices identified were rated by strength of evidence, with the highest rated being listed first. This paper will examine practice number five, asking patients to recall and restate what they have been told during the informed consent and the responsibility of the professional nurse in this process. The Informed Consent Process According to Terry (2007) informed medical consent occurs when a patient autonomously and expressly permits a professional to perform a medical act on that patient or include the patient in a research project. Patients are now encouraged to be more informed consumers and take an active part in their own healthcare. Terry (2007)...
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...Applied Legal Concepts in Healthcare Law Brewster v. University Hospital This paragraph will include a summary from the case which was obtained from the Healthcare Law Writing Assignment. In December 31, 1987 the Brewster’s had a daughter Emma that was born a week premature. Emma was transported to Children’s Hospital Medical Center the next day when she began showing signs of respiratory distress. She was treated by Dr. Craig Jackson, a neonatologist employed by the University of Washington. Emma suffered from hyperbilirubinemia, or jaundice, caused by elevated levels of bilirubin, a substance that is released into the bloodstream. Jaundice is not uncommon among infants as approximately a third or more of all newborns at the intensive care unit at Children’s hospital have jaundice. Greatly elevated bilirubin levels can result in permanent in brain damage. When Emma was admitted to Children’s Hospital, her serum bilirubin level was 4.2 micrograms per deciliter. It gradually increased to as high as 22.0 mcg/dl on January 7, 1988, then decreased to 5.7 mcg/dl on January 18, 1988. The type of jaundice Emma experience is generally treated with phototherapy. More serious cases are treated with a transfusion of all the blood in the infant’s body, a treatment entailing greater risks including cardiac arrhythmia, bleeding, bacterial infection and the development of air bubbles in the circulatory system. Dr. Martin prescribed phototherapy for Emma, which was unsuccessful, and Emma...
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...and others which were never informed and consented. The case was settled out of court and recognized that researchers illegally used tissue samples outside the scope of authorized use (NCIA 2010). In the case of Moore v. Regents of the University of California (Dorney 1990), the subject was treated for leukemia and had his infected spleen removed. He had blood, bone marrow, skin and sperm extracted and thought they were necessary to monitor his condition. His physician then patented and commercialized his cell line from those extractions. Moore sued the UCLA and physician for lack of informed consent and breach of their duty. In this case, the court ruled in favor of the physician and University of California that Moore had no initial interest in property and financial profit of the samples taken from his body, so he could not share the commercial profit of the research....
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