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 light after a 2014 study by Facebook Inc. 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. Procedures for obtaining informed consent and parental consent should be designed in such a way as to inform the population of subjects or the relatives of the population concerned in a manner comprehensible to the research. Therefore, the language of informed consent and parental consent, as well as its documentation, should be provided in the accompanying forms (in particular an explanation of the purpose, duration, experimental procedures, alternatives, risks and benefits) in a language that is understandable and culturally sensitive to those who are invited to participate or give permission to participate in their child.
Many states use the “reasonable patient standard” because it focuses on what a typical patient would need to know to understand the decision to be made. However, it is the sole duty of the provider to determine which approach is appropriate for a particular situation. [4] [5] [6] [5] The Office for the Protection of Human Research (OHRP) states that informed consent should be considered an ongoing process for the duration of a research project. If a child enrolled in the research with the permission of the parent or guardian subsequently reaches the legal minimum age to consent to the procedures involved in the ongoing research, the subject`s participation in the research will no longer be governed by the requirements of Part 46.408 of 45 CFR regarding the permission and consent of the parent or guardian. It is important to note that informed consent requirements in regulations are not intended to prevent applicable federal, state, or local laws that require the disclosure of additional information for consent to be legally effective (45 CFR 46.116(e)). Research on children has helped society in many ways. The only effective way to establish normal growth and metabolic patterns is to study infants and young children. When it comes to the issue of informed consent with children, the main answer is parental consent. This is valid, although only legal guardians can consent for a child, not for adult siblings. [37] In addition, parents cannot order the cessation of treatment necessary to keep a child alive, even if they believe it is in the best interests. [37] Guardians are usually involved in children`s consent, but a number of doctrines have been developed that allow children to receive health treatment without parental consent. For example, emancipated minors may consent to medical treatment, and minors may also consent in an emergency.
[37] For most research, informed consent is documented through a written document containing important research information. The purpose of the declaration of consent is in part to provide information about the current and future reference of the potential subject and to document the interaction between the subject and the examiner. However, while a signed declaration of consent is required, this alone is not an adequate consent process. The informed consent process is an ongoing exchange of information between the reviewer and the subject and could include, for example, the use of question and answer sessions, community meetings and videotape presentations. In all circumstances, however, individuals should have the opportunity to have their questions and concerns addressed individually. If you have decided to refuse treatment or diagnostic tests, your doctor can inform you of the risks or likely outcomes of this choice so that you can make an informed rejection (that is, you understand what could happen to your health by refusing the recommended treatment, but you still do not want the treatment). In this case, you may be asked to sign a form stating that you have received this information and that you have always chosen not to be processed. According to the regulatory definition, children are “persons who have not reached the legal age to consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research is conducted” (45 CFR 46.402(a)).
In the United States, the legal age of adulthood is a matter of state and local law. This means that the person who is legally considered a child may vary from state to state; In a large majority of states, 18 is the legal age of adulthood, but this does not apply to all states, places or territories. State law may also apply to certain circumstances in which a person under adulthood is legally permitted to consent to medical procedures: for example, some states allow children under the legal age of adulthood to consent to the provision of contraceptives. Some States provide for a mechanism for the emancipation of minors, whereby a child younger than the legal age of adulthood can acquire certain civil rights, which may include the legal possibility of consenting to participation in research. .