...Lesson 3 – Informed Consent, Substitute Decision-Making, and the Family Centered Approach * It should be noted that a choice might properly require only low/ minimal competence, even though its expected risks exceed its expected benefits or it is more generally a high-risk treatment, because all other available alternatives have substantially worse risk/benefit ratios. * Thus, according to the concept of competence endorsed here, a particular individual’s decision-making capacity at a given time may be sufficient for making a decision to refuse a diagnostic procedure when forgoing the procedure does not carry a significant risk, although it would not necessarily be sufficient for refusing a surgical procedure that would correct a life-threatening condition * The greater the risk relative to other alternatives—where risk is a function of the severity of the expected harm and the probability of its occurrence—the greater the level of communication, understanding, and reasoning skills required for competence to make that decision. * It is not always true, however, that if a person is competent to make one decision, then he or she is competent to make another decision so long as it involves equal risk. * Even if the risk is the same, one decision may be more complex, and hence require a higher level of capacity for understanding options and reasoning about consequences. * The evaluation of the patient’s decision-making will seek to assess how well...
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...• Analyze the legal issues related to informed consent and refusal Informed consent is an essential part of the treatment process in psychology. Legally it protects both the psychologist and the individual who will be receiving professional services. According to Pope and Vasquez (2007), informed consent provides the client and the therapist the opportunity to understand his or her legal rights and that they each have an equal vested interest in the treatment process. Pope and Vasquez (2007) also stated that informed consent is a decision making-process that gives the client the... The informed consent is the agreement between two parties to work collaboratively (Pope & Vasquez, 2007). In psychology, the client signs the consent form to allow treatment from the psychologist who may include testing, treatment, and initial psychological assessment. The patients have the right to their information; in terms of benefits, alternative treatments and about the risks. If the patient does not understand what he or she is giving permission to, he or she can allow an authorized decision-maker. The law requires that all persons take reasonable steps to clarify and communicate adequately with their patients about their risks and benefits. The informed consent is basically the understanding and justification of power that should not be abused intentionally or accidentally (Pope & Vasquez, 2007). The informed refusal is when a patient is refusing care; because of legal issues, trust, infectious...
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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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...Confidentiality and Informed Consent Claudia Lewis PSY/305 6/29/15 Dr. Daniel Williams Jr, PsyD, MSW Confidentiality and Informed Consent Introduction Dear client this paper is to inform you, of your right to confidentiality, and further more explain the process of informed consent. In the world of Psychology and counseling, confidentiality and informed consent has been the cornerstone to our practices (University of Phoenix, 1994). This paper will help you to understand how the things you say during the counseling sessions may have legal implications against you; by first explaining the decision of Tarasoff v. the board of Regents of the University of California, followed by how it relates to the therapist-client relationship in regards to confidentiality; then finally explaining the process of informed consent and refusal. Tarasoff v. Board of Regents of the University of California Decision According to University of Phoenix Confidentiality after Tarasoff (1994), the Tarasoff v. board of regents of the University of California case was heard before the California Supreme court, when Tatiana Tarasoff, a student at The University of California was killed by a fellow student. Her parents sued the University of California, the Police and the Therapist (University of Phoenix, 1994). The parents claim was that neither the School, Police or the Therapist warned them of the intentions of this fellow school mate to kill their daughter, Tatiana Tarasoff, as the fellow...
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...the 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...
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...There are many serious issues for families to consider when faced with the prospect of removing life support for a loved one. My objective is to identify the key medical ethical considerations that are faced when considering the removal of life support for a patient. Then, I will draw some conclusions about the choices I would make if faced with the decision of having to remove life support for a member of my family. It may be that the decision to withhold or withdraw life support is most likely to pit the hopes and fears of patients and their families against medical science and their physician. Patients are compelled by powerful emotions (such as guilt) or by adherence to religious or secular traditions to behave in certain ways that may conflict with medical advice.2 Honest discussions with patients and their families about the benefits and burdens of therapy and the medical uncertainty that exists are necessary to provide patients and families with the best opportunity to make informed decisions. We know that honest direct communication is most important for patients and families faced to make life determining decisions. These health care workers must communicate within the medical ethics of their profession. Medical ethics is based on a four prima facie moral principles and attention to these principles' scope of application. The four prima facie principles are respect for autonomy, beneficence, non-maleficence, and justice. “Prima facie,” a term introduced by the English...
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...| |Was the significance of the study adequately described? |1. The significance of the study was adequately described. | | |Family presence (FP) during resuscitation is a matter that | |Was the purpose of the study clearly described? |warrants more investigation as to whether or not it should, or | | |should not be allowed. Furthermore, the study proposes the | |Were the interpretations presented in a descriptive way that |necessity of protocols in place in institutions to guide | |illuminated more than the quotes did? |decisions on this matter. | | | | | |2. The purpose of the study is clearly described as to explore | | |the beliefs and experiences of RNs about FP during CPR. | |...
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...made about the strengths and weaknesses of the different parts, as well as of the whole, Burns (2000). Reflection follows on from this by encouraging the analysis of clinical practice, this in turn, helps the healthcare professional to develop his/her knowledge and to acquire a deeper level of understanding about the complexities of nursing practice. Boud et al (1985) suggests that this type of learning contributes to the development of clinical competence. The critical incident is taken from my recent clinical practice within the Endoscopy Unit. I will be reflecting upon and critically analysing gaining informed consent prior to the patient’s emergency Endoscopy and when to act within patient’s best interests. My rational for the chosen clinical incident is because of the impact it had on me. I realised I was not fully informed on the process of obtaining informed...
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... 1.1 Non-Discrimination. Marriage and family therapists provide professional assistance to persons without discrimination on the basis of race, age, ethnicity, socioeconomic status, disability, gender, health status, religion, national origin, sexual orientation, gender identity or relationship status. 1.2 Informed Consent. Marriage and family therapists obtain appropriate informed consent to therapy or related procedures and use language that is reasonably understandable to clients. The content of informed consent may vary depending upon the client and treatment plan; however, informed consent generally necessitates that the client: (a) has the capacity to consent; (b) has been adequately informed of significant information concerning treatment processes and procedures; (c) has been adequately informed of potential risks and benefits of treatments for which generally recognized standards do not yet exist; (d) has freely and without undue influence expressed consent; and (e) has provided consent that is appropriately documented. When persons, due to age or mental status, are legally incapable of giving informed consent, marriage and family therapists obtain informed permission from a legally authorized person, if such substitute consent is legally permissible. 1.3 Multiple Relationships. Marriage and family therapists are aware of their influential positions with respect to clients, and they avoid exploiting the trust and dependency of such persons. Therapists, therefore...
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...Which of the following is the most appropriate action to take for the investigator? Your answer : The investigator can go ahead and enroll the man without a signed consent. Correct Answer : Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. Comment : The IRB will not provide a waiver of consent under these circumstances and the man should not be excluded from the study simply because his legally authorized representative is temporarily unavailable to sign in person. Verbal approval does not satisfy the FDA requirement at 21 CFR 56.109(c) of signed informed consent document. When obtaining consent from a legally authorized representative (LAR) who is not able to provide signed consent in person, it is acceptable to send the informed consent document to the LAR by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed as noted in the FDA's FAQs. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile. Points Earned : 0 Question 2 Question : A general requirement for the informed consent is that no informed...
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...The words “informed consent” gives an understanding to what it is. As a professional it is our duty to inform the individuals we are serving of what is happening and what could happen. First, we must understand the why. Informed consent is an important concept that can be seen when looking back through history. It is a safe guard that protects both the professional and the individual that is receiving the service or treatment. Second, we have to understand the “what” and the “who”. When presenting the information that needs consent we have to fully understand what the information is that we are trying to communicate to the individual. So that we can explain in away the individual can understand. The individual must be given the full...
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...Autonomy and Terminal Illness “Make Me Less Short Of Breath” Sally was a competent 62-year-old, who called paramedics because she was becoming more short of breath. The paramedics brought Sally to emergency room because she wanted to be “less short breath.” (Section 6 of the Hippocratic Oath, right base ethics: Sally should be treated as an individual person and not as a cancer patient.) People get scared and panic when they cannot breathe. Sally has the right to informed consent in treatment decisions. The attending physician should not sign the DNR without informing Sally. The attending physician should inform Sally that CPR is a potential treatment option, and that it entails certain benefits and risks (informed consent). CPR manually performs to maintain oxygenate blood flow to keep vital organs alive. Sally has the right to make decision about own care and the outcome of the treatment. “Sally wants to live.” I would suggest consult a pulmonologist on Sally case (Section 4 Hippocratic Oath). “A physician should act only in the patient's interest when providing medical care, which might have the effect of weakening the physical and mental condition of the patient” (World Medical Association Declaration of Helsinki). Ethical rules bind you to your duty (deontological ethics). The rights and responsibilities of the physician and the oncologist is to improve the quality of life for Sally, “make her less short of breath”, Sally should have the tharacentesis and...
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...only benefits the larger society Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".) Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.) Which of the following is included in the Nuremberg Code? Voluntary Consent Informed consent is considered an application of which Belmont principle? **** Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent) How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence & research records? For a minimum of three years after completion of the study. (May be required to keep them longer than 3 years) According to federal regulations, which of the following best describes when expedited review of a new, proposed...
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...be found in Doc Sharing. Title: RRL#2 Name: [replace this text with your name] The following questions pertain to: Sanford, J., Townsend-Rocchicciolli,J.,Horigan, A., & Hall, P. (2011). A process of decision making by caregivers of family members with heart failure. Research & Theory for Nursing Practice, 25(1), 55-70. 1) Describe the population for this study. The population that this study utilized was caregivers who took care of family members who had HF in the Southeastern part of the U.S. 2) How was the sample selected? What are the strengths and weaknesses of this sampling strategy? The sample was recruited from adult day care facilities, cardiology offices, and inpatient hopitals. The strength of this sample was the amount of variation it included, which accounted for caregivers from each of the four stageso f HF, and spanned a variety of nationalities, employment statuses, and genders. The only weakness in th sampling strategy was that there were only 20 participants. 3) Were the subjects in this study vulnerable? Were there any risks for them as the result of participation in the research study? The caregivers interviewed in the study were not vulnerable at all They simply explained their experiences regarding their process of decision making in the comfort of their own homes. The only potential risk was possibly causing emotional trauma by having caregivers discuss various ramifications of this condition...
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...class slides; there are four principles that need to be addressed in order to reach an ethical decision. • Medical Indications – diagnosis, prognosis, treatment option o Dax had severe burns to 65% of his body, including his face, hands, eyes o Without treatment and allowed to return home, would likely result in death from infection • Patient Preferences – preferences and values, capacity to decide, informed o Repeatedly demanded that treatment be discontinued o Demanded to be discharged to home o Informed of risks and refused treatment o Had capacity to make and communicate decisions • Quality of Life – as experienced by patient o Excruciatingly painful treatments o Amputation of several fingers – minimal use of hands o Blind o Dependent on others • Contextual Factors – family, law, financial o Legal right to refuse treatment At issue is Dax’s ethical right to refuse care. While he may not have made the choice that physicians and/or hospitals would, he has a fundamental right to make choices concerning his treatment and there should be respect for his autonomy in doing so. Physicians, who take an oath to “First do not harm...,” may struggle with their ethical viewpoints, however, this decision is about Dax’s ethical right, not theirs. Since Dax is presumed competent, he does have the ethical right to refuse care, even when doing so will most certainly lead to his death. Informed consent is the principle that Justice Benjamin Cardozo spoke of in 1914, “Every human being of...
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