Researchers (or approved builders) must take the following steps to guide the potential subject to the research objective and take into account the reasons why they wish to participate: in the last six bites, the recognition of the moral right of subjects to choose or to choose for themselves or to decide on participation in research has been one of the most important developments in the field of ethics related to biomedical research on humans. The rules and guidelines for conducting clinical research require informed consent, which must be essentially collected by all human matter before the start of research, and all researchers are required to comply with these rules. In addition, before clinical research is carried out, it is essential to have the research reviewed and approved by a competent and properly trained institutional audit committee (IRB) or an independent ethics committee (IEC). It is the responsibility of IRC/IECs to review a research proposal and ensure that appropriate consent procedures are implemented ethically without endangering the rights, safety and well-being of individuals. [1ÔÇô4] Skilled subjects who may understand research information should personally decide whether to participate in the research and agree. Conditions that involve practical difficulties for which informed consent cannot be obtained from the actual subject may include medical emergencies or obtaining consent from incompetent subjects. Incompetent subjects (such as minors or patients with serious mental disorders that impair their mental capacity for consent, etc.) may only be included in research with the consent of their legally eligible representative (LAR), preferably guardian. In such situations, it is increasingly necessary to have a tailored informed consent procedure tailored to the capabilities and understanding of the subject. The person concerned should be informed of the review to the extent that it is consistent with the person`s understanding and, if the person is entitled, the person concerned must also personally give written consent and can only be registered with the agreement of the ARA. Appropriate approaches, such as the use of simplified and easy-to-understand language, can be adopted. B the disclosure of information in small, successive pieces of information centered on important information, the provision of repeated information in small units and the ability to ask questions and clarify doubts. Under the conditions of approval of the ARA, the potential person concerned should be informed of the ARA`s consent and any objections should be considered. [18.19] Problems related to emergency research are described elsewhere in this article.
The ethical complexity of consenting to substitutes and replacements is particularly important for research on patients with mental disorders. [20.21] Emergency research involves the most vulnerable, those who are unable to control what is happening to them and who do not have the capacity for approval, in an environment where emergencies require rapid action, and generally do not provide sufficient time and opportunity to locate the individual`s ARLs and obtain consent.