...During week four, my clinical instructor assigned me to a Cantonese patient and informed me on his inability to speak English. I was not however made aware of the fact that he was unable to understand English as well. As I walked in the room, it was just me and the patient. As per normal procedure, I began by introducing myself and continued with the assessment and vital signs. “How did you sleep last night?” is a question I ask during assessment, however when I asked my patient this question, he seemed to have a puzzled look on his face. As having previously dealt with patients, I understood that it was quite possible he did not want to talk to me, felt annoyed and just wanted to go back to sleep. However, after doing assessments, I concluded...
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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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...Informed consent Name Course Date Informed consent Informed consent is the procedure of getting permission to take part in a research study or medical procedure founded on access to all vital and easily understandable information about the consequences of participation in terms of benefits and harms (Dolgoff et al, 2009). A healthcare provider may demand informed consent from a patient before providing care or a researcher may request it from a participant before enrolling the individual into a research trial. Informed consent is based on guidelines provided by research and medical ethics. To give informed consent, the person involved must have sufficient reasoning faculties and have all the relevant facts. However, not all individuals may have capacities for informed consent due to impairments to reasoning and judgment such as mental immaturity, severe intellectual disabilities, mental illnesses, high stress levels, being in a coma, Alzheimer’s disease, and severe sleep deprivation. Medical and research actions may be carried out due to lack of informed consent. When a person is considered unable to give informed consent, another person can be authorized to give consent on behalf of that person (Manson & O'Neill, 2007). For instance, legal guardians or parents may give informed consent for young children and the mentally ill. In case a person is given insufficient information to make a reasoned decision, severe ethical issues may arise. In clinical trials...
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...The informed consent is a written document in which a person, whether client or participants in a research study, agrees with the course of treatment (for counseling) or to participate (in case of study) after having received specific and enough information on the procedures that would be subject to. The area of psychology that I will consider for this discussion is research. Informed consent in research involves many factors. Informed consent should be provided to participants prior the study takes place. This document should provide sufficient and clear information of the study: duration, any possible risks or discomforts participants may suffer, and if participants will be or not compensated (amount must be specified). Additionally, informed...
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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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...This type of condition is known as mosaicism. Jesse Gelsinger lived in Tucson, Arizona. He was the 18th and final subject in the study, and at age 18, he was the youngest person enrolled. He had learned about the trial in 1998 from his physician, and was only allowed into the study because another subject had dropped out. His father was stated in saying that he “was doing this for other people.”1 Jesse Gelsinger set aside his personal life to participate in the study, and took an unpaid leave from his job. On September 13, 1999, Gelsinger became the second subject to receive the highest dose of the adenovirus. In the other study participants, including the first to receive the highest dose, the adverse effects were only temporary muscle aches and fever. These side effects were not life threatening.1 About 18 hours after the infusion of the adenovirus vector, Gelsinger started to develop an altered mental status and jaundice. He then developed a systemic inflammatory response to the virus,...
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...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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...Profiles * My CEUs * My Reports * Support * Main Menu › VA Human Subjects Protection › Informed Consent Informed Consent Content Author * Diane Paul, M.S., RN National Comprehensive Cancer Network Introduction It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the consent document, continues throughout the subject's involvement in the research, and continues beyond study termination. It includes: * Recruitment efforts encompassing the means of first creating awareness or contact and spanning everything from medical record review to advertisements and other recruitment materials. * Providing specific information and answering questions about the study to subjects in a way that is understandable to them while giving subjects adequate time to consider participation. * Obtaining the voluntary agreement of subjects to take part in the study. While the subject may agree to participate in the study, subjects may withdraw at any time. Part of the ongoing nature of the consent process is verifying the subject's continued interest in participating in the study. * Making plans for the provision of new information to be shared with former subjects, even after the study ends. There is consensus regarding the importance of informed consent. Informed consent is a demonstration of how investigators and those involved in human subjects research show respect to...
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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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...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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...QUESTION TWO: ADULT CASE STUDY, AN ETHICAL ISSUE OF CONSENT. This essay presents a critical incident analysis of a 70 years old man refusing to give consent to a life saving treatment. The essay will discuss its impact by discussing the conflict between professional and the patient’s issues. It will go on to explain the main professional issues in the scenario, breach of any NMC code of conduct and show how they relate to the guidelines set by Nursing and Midwifery Council (NMC). It will also highlight on the relevant underlying legal or ethical principles that applies to the case study and its implications. For instance, ethical principles, such as beneficence, non-maleficence, autonomy, justice, human rights and the best interests of the patient will be explored, in the light of relevant laws, in order to show some of the legal and ethical complexities within this case study, and finally draw a conclusion. For confidentiality purposes, have been changed in accordance to the NMC guidelines. The main professional issue reflected in this case study is the issue of consent. Consent, means to give permission for something to take place or to agree to do something (oxford dictionary 1998). This does not necessitate that, the actions approved have been developed or permission given in the knowledge of possible consequences known as informed consent has been achieved. This goes to show that, for medical purposes, although the patient has the right to refuse treatment, he has to also...
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...critique a qualitative research study about how nurses manage patients who refuse nursing care procedures. These articles also explains how nurses view informed consent as not being essential to nursing care procedures. PROBLEM STATEMENT The clinical problem being examined in the research study is the way in which nurses obtain consent prior to administering nursing care procedures, and the way nurses manage patients who refuse any nursing care procedures. By stating that nurses “do not regard obtaining consent as an absolute requirement” also stating that “consent is preferred but no considered essential” the significance is established and a clinical problem identified (Aveyard, 2004). The author identifies the need for further education of nurses on the need to obtain informed consent for nursing care procedures, and the need for more research of this topic. The role of persuasion in situations of informed consent has been widely commented on. Many commentators argue that the health care provider has a duty not only to give information but also to persuade the recipient of care to accept the course of action considered most appropriate for the patients’ safety. PURPOSE and RESEARCH QUESTIONS The study clearly identifies the aim of the study as “to examine the way in which nurses manage patients who refuse nursing care procedures (Aveyard, 2004).” The study identifies two main purposes for the research study as: To examine how consent is obtained prior to nursing...
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...importance of informed consent in research. Most people have the expectation that they will be treated with respect and as autonomous individuals. They also expect that they have the right to make decisions about what will and will not be done to them and about what personal information they will share with others. However, researchers also are aware that there are circumstances in which obtaining and documenting consent in social and behavioral research may be a complex, and often challenging process. For instance, potential subjects may be fluent in a language but not literate. Researchers may need to deceive research subjects in order obtain scientifically valid data. Asking subjects to sign consent forms linking them to a study about illegal activities could put them at risk of harm. The federal regulations provide sufficient flexibility to address some of these concerns, particularly for research posing no more than minimal risk of harm. For example, the regulations allow waivers of and alterations in the requirements for the consent and documentation processes. Learning Objectives By the end of this module you should be able to: • Distinguish between consent as a process and the documentation of consent. • Recognize the elements of consent. • Determine when waivers are appropriate. • Identify methods for ensuring comprehension of consent. Overview of Informed Consent Federal regulations require researchers to obtain legally effective informed consent from the subject...
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...seek to regulate, the mere existence of another document trying to get right the vexing question of how to assure the proper ethical conduct of qualitative researchers through organisational oversight is a symbol and symptom of a deep misunderstanding of the realities of ethnographic research and an even deeper misapprehension about how conduct is effectively governed( Mark 2004). Case study 1 The key ethical issue raised in Research Case Study 1 is confidentiality and privacy. On face- to- face interviews of 50 young men case on their experiences and attitudes to violence. In many cases, the young men had not been arrested for their violence and revealed involvement in homicide. The researchers have to ensure the information is private and is voluntarily offered to the researcher is confidence http://www.bocsar.nsw.gov.au/agdbasev7wr/bocsar/documents/pdf/r55.pdf (page18). Also, maintaining confidentiality is a best way to avoid collected data to get publication, exposed and make sure. They also claimed that given that areas excluded from confidentiality were central to the research study, the limited assurance compromised the research to the point of rendering the data obtained invalid. They suggested that the researchers should either have made an unlimited guarantee of confidentiality and stuck to that or not undertaken the research (Lowman and Palys, 2001a; 2001b, Professor Mark Israel, 2004). Various State and Federal privacy...
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...This essay is based on adult case study two a 70 year old male patient called Mr James. All names have been change in this essay in order to comply with the NMC (2008). Code professional conduct on confidential. The case study highlights a number of principle, legal issues and professional value. These will be identified and some will be discuss in details. Ethics is concerned with the study of social morality and philosophical reflection of norms and practice (Burckhardt and Nathaniel 2003). These ethical issues are those based on basic and essential to social values that include respect for life, liberty and to be cared for. There will be a demonstration of understanding the theory of deontology while recognizing the importance of ethical principles in relation on the delivery of individual patient care. Informed consent will be highlighted in detail to provide validity and factors involved. A reflection will be provided to detail the understanding of how ethical theories contribute to the ethical decision making process in clinical area. Also a brief discussion will be given to show what has been gained from producing this essay. Consent can be defined as an agreement to allow something to happen based on full disclosure of facts needed to make an intelligent decision (Hazel 2002). This includes the knowledge of risks involved, benefits and consequence of refusal. Informed consent not only requires that a person be given all relevant information required...
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