Informed consent is required for participation in FDA-regulated clinical investigations except under limited circumstances as described in 21 CFR 50

Subject:Health SciencePrice:20.89 Bought3

Share With

Informed consent is required for participation in FDA-regulated clinical investigations except under limited circumstances as described in 21 CFR 50.23 (involving certain life-threatening situations, military operations, or public health emergencies) and 21 CFR 50.24 (involving emergency research 7). See 21 CFR 50.20. so the informed consent is not required in a life-threatening situation as FDA regulation but in my presentation, I need to defend the opposite side (the informed consent is required in life-threatening situation ............... slides should include 1-definition of informed consent 2- the purpose 3- important elements or items 4- my opposite side 5- my reasons for the opposite side why it is required even in a life-threatening situation(my reason is: people have the full authority to choose their destiny and they should be responsible for their living way after implementation of any treatment for example before participating in any trial the worst-case scenario should be described and the participants should choose what to do for them in case of emergency cases in advance ) but I want you to do it professionally and to give valuble reason.

Final Presentation Informed consent. Jens Martensson Informed consent is required for participation in FDA-regulated clinical investigations except under limited circumstances as described in 21 CFR 50.23 (involving certain life-threatening situations, military operations, or public health emergencies) and 21 CFR 50.24 (involving emergency research 7). 2 21 CFR 50.25 Elements of informed consent Jens Martensson (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. 3 21 CFR 50.25 Elements of informed consent Jens Martensson (2) A description of any reasonably foreseeable risks or discomforts to the subject. 4 21 CFR 50.25 Elements of informed consent Jens Martensson (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. 5 21 CFR 50.25 Elements of informed consent Jens Martensson (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 6 21 CFR 50.25 Elements of informed consent Jens Martensson (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. 7 21 CFR 50.25 Elements of informed consent Jens Martensson (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. 8 Requirements for Obtaining Informed Consent of an Adult for Clinical Study Student’s Name Institutional Affiliation Requirements for Obtaining Informed Consent of an Adult for Clinical Study Informed consent refers to the process through which a physician or any health professional educates a prospective participant in a clinical study of the benefits, risks, and alternatives of participating in such study (Shah et al., 2020). Informed consent does not only involve securing the subject's oral or written signature affirming their participation in the research, but it entails providing adequate information to a potential subject to enable them to make informed choices. It also involves granting a potential participant a fair opportunity to ask questions about the trial. For informed consent to occur, the following elements must be either documented in the informed consent form or during the actual process of obtaining consent. They include a description of clinical investigation, risks and discomforts, benefits, voluntary participation, and contacts (U.S. Food and Drug Administration (FDA), 2014). Description of the clinical investigation is an essential element towards obtaining informed consent. The potential subject must be informed that the study involves research, the reasons for the research, the duration of the experiment, and disclosure of any procedure that may be experimental in nature (FDA, 2014). Informing them that the clinical test involves research is essential so that they understand their participation is aimed at contributing to research. Secondly, describing the clinical investigation helps potential participants understand procedures or tests that are part of usual care but will not be performed during the study. Such information helps them to make an informed decision, whether to participate or not. The second element of informed consent is the disclosure of inherent risks and discomforts that may arise from the research. The process of informed consent must outline all foreseeable and anticipated dangers and risks that may occur in the course of the study (FDA, 2014). For instance, the duration and severity of pain from a surgical operation. Such disclosure is essential because it makes the subject aware of the potential outcomes of participating in such a study. It also helps them weigh the risks involved and decide if they are ready for the worstcase scenario. As a result, a subject is able to make an informed choice. The third element for informed consent is the disclosure of any benefits that may be awarded to the subject for participating in the research (FDA, 2014). According to the FDA guidelines, participants can not be paid for their participation but are compensated for expenses and inconveniences. Disclosing any accruing benefits helps the subject know what to anticipate from the study and how helpful their participation is. For instance, a subject may be informed that their participation will help to benefit future patients. Secondly, disclosing benefits helps avoid disappointments among subjects, some of whom may expect some unrealistic benefits. Voluntary participation is another essential element of informed consent. The potential subject must be informed that participation is voluntary and nonparticipation will not be penalized or cause loss of benefits. Participants must be made aware that they can decline to participate in the study without any repercussions (FDA, 2014). The justification for this is that it helps eliminate undue influence or coercion that may force the subject to participate in the study against their wish Secondly, informing them of voluntary participation allows them to decide whether to participate in the trial or not, without being guilty conscious. Lastly, contacts are essential in an informed consent process. Subjects must be made aware of whom to contact for answers to pertinent questions about the study (FDA, 2014). The contact person must be outside the research team for independence purposes. A contact person is necessary because he/she gives directions and solutions in the case of a research-related injury to the subject. Secondly, a contact person offers independent and unbiased opinions to the potential subject. That helps in having informed consent. References Shah, P., Thornton, I., Turin, D., and Hipskind, J. (2020). Informed consent. Statpearls. https://www.ncbi.nlm.nih.gov/books/NBK430827/#:~:text=Informed%20consent%20is% 20the%20process,undergo%20the%20procedure%20or%20intervention. U.S. Food and Drug Administration. (FDA). (2014). Informed consent: Draft guidance for IRBS, clinical investigators, and sponsors. https://www.fda.gov/regulatory-information/searchfda-guidance-documents/informed-consent#:~:text=(21%20CFR%2050.20.),1.&text=Informed%20consent%20is%20required%20for,(involving%20emergency %20research%207)