Spruit SL, Van de Poel I, Doorn N. Informed consent in asymmetric relationships: an investigation of the relational factors that influence the margin of reflection. U.S. National Library of Medicine National Institutes of Health; 2016;10:123-138. Waiver of consent may be applied in certain circumstances where no foreseeable harm is expected from the study, or where permitted by law or federal law, or where an ethics review board has approved the non-disclosure of certain information. [6] Katz AL, Webb SA, Bioethics Committee. Informed consent in decision-making in pediatric practice. AAP News & Magazines; 2016; 138(2):e1-e13. The birth of new online media such as social media has complicated the idea of informed consent. In an online environment, people pay little attention to the terms of use and can be searched without in-depth knowledge. This problem came to the public after a study by Facebook Inc. in 2014 and published by that company and Cornell University.
[43] Facebook conducted a study in which they modified the Facebook news feeds of about 700,000 users to reduce the number of positive or negative posts they had seen for a week. The study then analyzed whether user status updates changed during the different conditions. The study was published in the Proceedings of the National Academy of Sciences. Research involving deception is controversial given the requirement for informed consent. Deception usually occurs in social psychology when research into a particular psychological process forces investigators to deceive subjects. In Milgram`s experiment, for example, the researchers wanted to determine participants` willingness to obey authority figures despite their personal conscientious objection. They had authority figures demanding that participants deliver what they thought was an electric shock to another participant in the research. For the study to be successful, it was necessary to deceive the participants into believing that the subject was a peer and that their electric shocks caused real pain at par. Informed consent is mandatory for all human clinical trials. The consent process must respect the patient`s decision-making capacity and adhere to each hospital`s rules for clinical trials. Adherence to ethical standards in the design and implementation of studies is usually monitored by an Institutional Review Committee (IRB). The IRB was created in the United States in 1974 by the National Research Act, which called for regulating human research triggered by dubious research tactics used in the experiments of Tuskegee Syphillis and others.
Since then, ethical and safe research standards have been an area of federal and presidential interest, with many organizations and working groups devoted exclusively to this topic since 1974. Valid informed consent for research must include three main elements: (1) disclosure of information, (2) the competence of the patient (or surrogate mother) to make a decision, and (3) the voluntariness of the decision. U.S. federal regulations require a complete and detailed explanation of the study and its potential risks. The doctrine of informed consent refers to professional negligence and is a violation of the duty of care to the patient (see Duty of Care, Breach of Duty and Respect for Persons). The doctrine of informed consent also has a significant impact on medical studies using drugs, devices or procedures. Provides free and confidential information and resources on cancer-related legal issues The following should be discussed and included in the written consent form. If this is not the case, you should ask for this information: Since the medical guidelines set out in the Nuremberg Code were imported into the Ethical Guidelines for the Social Sciences, informed consent has become an integral part of the research process.
[39] Although informed consent is the norm in medical institutions, it is not always required in the social sciences. Here, research often carries little or no risk to participants, unlike many medical experiments. Second, simply knowing they are participating in a study can cause people to change their behavior, as with the Hawthorne effect: „In a typical laboratory experiment, subjects enter an environment where they are aware that their behavior is being monitored, recorded, and then questioned.“ [40]:168 In such cases, obtaining informed consent directly affects the ability to conduct the research, since simply revealing that a study is being conducted is likely to change the behaviour being studied. List illustrates the potential dilemma that can arise: „If you want to determine whether and to what extent race or gender affect the prices buyers pay for used cars, it would be difficult to accurately measure the degree of discrimination between used car dealers who know they are participating in an experiment.“ [41] In cases where such interference is likely, a researcher may, after careful consideration, waive the informed consent procedure. This is usually done after weighing the risk to study participants against the benefits to society and if participants are present in the study at their own request and are treated fairly. [42] Researchers often consult an ethics committee or institutional review body to make a decision. The doctrine of informed consent should be juxtaposed with the general doctrine of medical consent that applies to bodily injury or battery. The standard of consent here is only that the individual generally understands the nature and purpose of the intended intervention. Since the higher standard of informed consent applies to negligence and not to assault, the other elements of negligence must be identified.
Significantly, causality must be proven: if the person had been informed of the risk, he would not have carried out the operation (or perhaps with this surgeon). The consent process ensures that your doctor has given you information about your condition, as well as testing and treatment options, before deciding what to do. Exceptions to the request for informed consent include (1) the patient`s inability to work, (2) life-threatening emergencies with insufficient time to obtain consent, and (3) voluntary renunciation of consent. If the patient`s decision-making capacity is questioned or unclear, an assessment by a psychiatrist may be requested to determine competence. A situation may arise in which a patient cannot make decisions independently, but has not appointed a decision-maker. In this case, the hierarchy of decision-makers determined by the laws of each state must be sought in order to determine the next substitute legal decision-maker. If this is not successful, a legal guardian may need to be appointed by the court. Patient safety is an important priority in healthcare, and effective informed consent is considered a patient safety issue. The Joint Commission recently addressed the challenges of ensuring effective informed consent. The emphasis on the patient`s signature as an indication of understanding is questioned.
The informed consent process focuses more on disclosure and less on signatures. Studies on informed consent have shown that there are many barriers to obtaining effective informed consent. A major obstacle is that some consent forms contain language that is too high for many patients. The use of visual and digital means of communication will be encouraged to address some of the inefficiencies in obtaining consent. Patients should actively participate to improve communication and ensure patient safety and understanding. The 21st Century Cures Act, passed by the 114th U.S. Congress in December 2016, allows researchers to waive the requirement for informed consent when clinical trials „present minimal risk“ and „contain appropriate safeguards to protect the rights, safety, and well-being of the human subject.“ [9] In addition to minimal risk studies, consent may also be waived in the military. Under Section 10 OF THE UNITED STATESC 980, Limitations on the Use of Humans as Experimental Subjects, the Secretary of Defense may grant a waiver of extended informed consent if a research project does the following:[7] Informed consent is a technical term first used by attorney Paul G. Gebhard in a 1957 lawsuit in the United States. [10] To trace its history, some researchers have suggested following the review history of any of these practices:[11]:54 The informed consent process occurs when communication between a patient and a physician leads to the patient`s approval or consent to undergo a particular medical procedure. When obtaining informed consent from a patient (or consent from the patient`s surrogate mother if the patient does not have the capacity to make decisions or refuses to participate in decisions), physicians should: While it is generally in your best interest to be informed of your care and give your consent, it is not always feasible or advisable. For example, doctors may need to perform a vital procedure if you are unconscious and therefore unable to give your consent.
Decision-making capacity is often referred to by the legal term competence. This is one of the most important elements of informed consent. The ability to make decisions is not black and white. You may have the ability to make some decisions, but others may not. Informed consent is the process by which a health care provider educates a patient about the risks, benefits and alternatives of a particular procedure or intervention. The patient must be able to make a voluntary decision as to whether to undergo the procedure or procedure. Informed consent is both an ethical and legal obligation of physicians in the United States and stems from the patient`s right to determine what happens to their body. .
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