Week 6 Discussion 1

Patrick Dale Granados posted Apr 9, 2020 6:46 AM


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The principle that I will be discussing is consent. According to the U.S. Food and Drug Administration (FDA), informed consent is not as simply as acquiring the participant’s signature on the consent form. A research participant’s verbal or written signature is just a part of the process. A proper informed consent is providing adequate information to allow the participant to make an informed decision in the investigation (2018). The potential participant must understand that they may not benefit from the trial, may be exposed to unknown risks, and practices being performed in the study may be different from current practices they know. A description of what will be done to them, how the research works, how long it will take, and possible discomforts must be communicated thoroughly. After providing adequate information, we also need to make sure that the participants truly understand the information being presented. The researcher must ask the participants if he or she finds anything confusing or unclear. Any concerns must be brought up and the participant must be provided with an adequate amount of time to consider and discuss it with his/her family or friends if needed. The informed consent form may not include any language that releases the investigator, sponsor, or institution from liability of negligence, The researcher can ensure that this principle is protected at all times by making sure that the decision is voluntary and that the participants know that they can end their participation at any time. Participants are vital in research and must be treated with respect at all times.
Informed consent for clinical trials. (2018, January 4). Retrieved from https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials
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