Methods such as extended consent forms and multimedia interventions during informed consent have yielded mixed results, while only the additional time spent on one-on-one interviews has significantly improved the understanding and retrieval of information.28 Obtaining consent is not only an ethical constraint, but also a legal one. The degree of disclosure must be case-specific. There can be nothing called a standard consent form. No doctor can sit comfortably believing that “consent” can certainly avoid legal liability. This is highlighted by the California Supreme Court note:[12] OâShea T. Consent in history, theory and practice. The Essex Autonomy Project, report on the Green Paper. University of Essex; 2012. www.academia.edu/3228192/consent_in_history_theory_and_practice/.
Retrieved 15 June 2016. Kimberly Randall was born on January 19, 1987. As an apparently healthy girl, she was later diagnosed with juvenile laryngeal papillomatosis (MPA), a disease that causes warty growths from the nose to the lungs in children`s airways and has an estimated mortality rate of 5%. The disease is treated by removing warts from the throat with laser surgery, but they grow back immediately after removal. During her pregnancy, Kimberly`s mother complained of vaginal discomfort and seeing tissue coming out of her vaginal area. It later turned out that Kimberly had contracted MPA in her mother`s birth canal because Ms. Randall was infected with the human papillomavirus (HPV). Randall`s doctors were aware of HPV, the risks associated with vaginal delivery, and the treatment of pregnant women with genital HPV, but did not warn them of the risks [1].
One can only take reasonable precautions and act with care and care. Maintaining a good relationship with the patient often works better than the best informed consent! The patient`s right to autonomy must always be respected and steps must be taken to truly inform consent. However, there is no absolute right to consent on the basis of philosophical, ethical, legal and practical considerations. The principle of the absolute right to consent could easily be undermined by partial information. This depends to a large extent on the willingness to provide complete information and the patient`s ability to understand it and weigh options. In our daily lives, we agree with many different things. In the field of healthcare, we may consent to professionals receiving private information about us, performing examinations for diagnostic purposes and performing treatments of various types, including surgery and medication administration. The paradigmatic case of consent is the execution of a medical procedure or examination, which can lead to a significant risk for the patient. If, in this context, consent is the active approval of treatment, and not just passive consent to what a doctor or healthcare provider advises, we should logically also have the right to refuse treatment on the basis of the right to self-determination. In fact, this is the case in many, but not all, health facilities.
A review of the practical aspects of consent shows that the information provided is often misunderstood and retained. Patients who give their consent do so without being really informed. In other words, they cannot give informed consent due to their lack of understanding. As the practical aspects chapter shows, this is often not noticed by the attending physician or researcher. It is difficult to imagine an absolute right to consent in practice when the attempt to provide the information necessary for informed consent so often fails. It is assumed that every adult patient is capable, unless the contrary can be clearly demonstrated.3, 10 patients who are not effective due to acute illness (e.g., loss of consciousness after an accident or patients on mechanical ventilation) or chronic illness (e.g., dementia) cannot make their own treatment decisions. In these situations, it is the physician`s duty to act in the “best interests of the patient.” Opinions about the patient`s preferences may come from third parties (for example, relatives). However, this third party cannot accept or oppose the treatment.3 If a patient has clearly issued an advance directive within the appropriate time, the attending physician is obliged to observe it (see living will). A person`s competence may vary from situation to situation and from time to time. For example, someone may be competent to approve a simple first aid measure, but not more complex treatments. While some people are permanently incompetent, whether due to congenital or acquired diseases, some people`s competence may only be temporarily impaired, for example, by the effects of illness, drugs or alcohol. In many cases, restoring temporarily impaired competence is an important clinical responsibility.
In Australia, the guidance document for the regulation and conduct of human research is the “National Declaration on Ethical Conduct in Human Research”. It states that obtaining consent should include: (a) providing participants with information about the purpose, methods, requirements, risks, disadvantages, complaints and possible results of the research (including the likelihood and form or publication of the research results) at their level of understanding; and (b) the exercise of a voluntary decision to participate. An individual may refuse to participate in a research project and is not required to provide a justification or justification for that decision. Consent must be given for any research involving individuals who do not have the capacity to make decisions, but it is generally accepted that, in such circumstances, this should not only be contrary to the best interests of the individual, but that the risks of the research should not be greater than those that would occur in routine clinical practice. and its results may contribute to improved treatment. Informed consent must be preceded by the disclosure of sufficient information. Consent may be challenged on the basis that sufficient information has not been provided to enable the patient to make an appropriate and informed decision. Therefore, accurate, appropriate and relevant information must be provided honestly in a form (using non-scientific terms) and in language that the patient can understand.
It cannot be a patient`s signature on a dotted line regularly received by a staff member. The court then examined the policy behind Moore`s cells, which were considered property. Since the exchange of goods is a no-fault liability offence, the court was concerned that the extension of property rights in tissues or organs would have a deterrent effect on medical research. Laboratories that conduct research receive a large amount of medical samples and cannot be expected to know or find out if their samples were obtained illegally anywhere in all fields. Moore could only sue his doctor for not disclosing any information and no one else. Since the predominance of medical paternalism gave way to the emphasis on patient autonomy, the need to act in the patient`s best medical interests, especially in the case of incompetent patients, has been largely replaced by “substitute judgments”, in which a relative of the patient, usually a spouse or family member, becomes the decision-maker. Alternate decision-makers are usually mandated by law to decide in a way that they believe the person would have decided if he or she had remained competent. Many jurisdictions now require people to write “living wills” that directly or indirectly expand patients` right to refuse medical treatment (and sometimes to agree in advance). Although the above regulations are clearly established by law, a physician may encounter situations where clear instructions are not given. If a patient confesses to a crime or planned crime to a doctor, it is up to the patient to decide whether to pass this information on to the police. This decision requires careful consideration of whether the right to consent to the disclosure of information is more important than the public`s right to be protected.
GMC`s guidelines (Confidentiality: Protecting and Providing Information, 2004) provide general guidance on disclosure, but leave the final decision to the physician.18 In addition, an approach that emphasizes skill levels does little to help with practical help, as what we need to know is whether a particular decision meets the competency requirements, that is, if a threshold has been reached in a particular case.
