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Informed Consent

Informed Consent

Response to Emily

Emily,

Great post! I am impressed by the discussion and the detail you have provided. Consent is critical for research activities. For instance, when dealing with social sciences and humanities, the topics usually affect the respondents directly. The questions asked during the research tend to touch on personal experiences. Obtaining consent is not only legal but also respectful. To add to your discussion, it is important to note that simple language use is critical for informed consent. The potential respondents should understand the content of the study clearly. Since there are different levels of education, it is essential to stick to plain and simple language. However, it is still important to tailor the consent forms to suit the targeted population. For instance, consent from nurses in a nursing study would be characterized by terms related to the profession. It is also important to include an agreement statement at the end of the consent form (University of Michigan, 2021). The document should also project the study’s content to avoid misleading respondents. Great Post!

Reference

University of Michigan. (2021). Informed Consent Guidelines & Templates. Retrieved from Research Ethics & Compliance: https://research-compliance.umich.edu/informed-consent-guidelines

Response to Jude

Jude,

Great work with your post! I want to emphasize the ethical role of informed consent in research. It was created to offer human respondents an opportunity to participate in research voluntarily. However, they should fully know the study’s aspects and the potential effects. Consent precedes analysis and undergoes two stages. First, the respondents receive the information regarding the study. They are given time to think through the information and ask questions when needed. Once they have decided, they contact the researcher, who reiterates the study’s requirements and terms. Consent can be given explicitly. However, respondents also sign documents to confirm this explicit consent. This process complies with the needs of the General Data Protection Regulation (GDPR) (University of Oxford, n.d). Adhering to the process projects a researcher as ethical and almost enhances the study’s validity because respondents provide valid information voluntarily.

Reference

University of Oxford. (n.d). Informed consent. Retrieved from Research Support: https://researchsupport.admin.ox.ac.uk/governance/ethics/resources/consent

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Question 


Emily,

Ethics are important in research because they preserve the rights of human study participants. Melnyk and Fineout-Overholt display a list of fifteen ethical principles in their writing, which are important to maintain to create and run honest research (2019). In this discussion, I would like to focus on the third principle in their list: consent. The process of obtaining informed consent for research requires someone with great communication skills to explain what the participant is signing up for and what the potential risks of participation are (Nusbaum et al., 2017). Discussing the study and its risks and benefits helps the potential participants determine if they are willing to participate (Nusbaum et al., 2017). The consent forms that participants read and sign must be in a simplified language so that all participants can understand the structure and ask relevant questions about any concerns they may have after reading it (Nusbaum et al., 2017). To effectively obtain informed consent from participants in research studies, a few steps should be taken. The participants should be provided with a written version of the consent form that includes study details along with potential risks and benefits of the study. The consent form should be written in a “simple, clear, and meaningful way” (Nusbaum et al., 2017). Then, this should be read aloud to the participants to ensure complete understanding and allow opportunity for them to ask questions. This individualizes the consent process for each participant and enables the researcher time to explain specific risks and benefits that the participant may be concerned about. The researchers should then have each participant repeat back in their own words what has been discussed to verify complete understanding before they sign the forms (Nusbaum et al., 2017). Going through this process, I should make certain that the participants fully consent to participating in the study and have all of the information necessary to make that decision.

Jude,

Every human being in this world has the right to live in peace and the pursuit of happiness. According to Melnyk & Fineout-Overholt (2019), one of the most important “fifteen ethical principles of the Universal Declaration on Bioethics and Human Rights” is the principle of informed consent. During the research study, informed consent refers to the participants’ freedom of choice whether or not they would consent to participate without being forced against their will (Polit & Beck, 2018). The essential of life is the promise of dignity with the pledge to acquire fair human rights. In the United States, where the main theme motto is “land of the free,” an appropriate formally designated governing body was formulated called the Institutional Review Board (IRB), which reviews any biomedical research ethical compliance (U.S. Food & Drug Administration (FDA), 2019). Moreover, “The Federal Policy for the Protection of Human Subjects” was published to protect all research participants, creating this law to mandate all to obtain consent before using an individual’s personal or health information in a study. This is important due to its principle to protect an individual’s freedom to make choices about what happens to their life and body (Office for Human Research Protections, 2016).

The principles that entail informed consent are the foundation and an essential building block of any research study. I concur with Melnyk & Fineout-Overholt (2019)  when they stated that “consent “s required to respect the ethical principle of autonomy.” This means that the term or principle of consent is often in conjunction with the words “informed” consent,” which is” the individual ability to receive all the necessary information, risks and benefits, which will enable them to make an appropriate decision with questions answered, to participate or agree for procedure or surgery (Polit & Beck, 2018).

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