Informed consent is the process of requesting, receiving, and giving information that allows critical thinking about risks, benefits, and alternative options. It is an essential part of a relationship between two or more people where the participants are involved in research, testing, investigating, or therapy (Cruzado-Álvarez et al., 2023). Some researchers have argued that informed consent is ethically necessary as it ensures that the individual understands the risks involved with their participation in a particular trial, which may not be apparent at first glance. However, some argue for exceptions to this rule, such as when minors are involved and consent can be given by family members who are aware of what the participant has been doing and agree with those risks (Rodríguez-Soberado et al., 2022). This does not protect the participant from unforeseen harm. Even if the participant is fully informed of the risks, it still does not guarantee that they will be protected from those risks. The roles of informed consent in the protection of the study participants are to prevent harm to the participants, protect an individual’s interest in self-determination and autonomy, and to allow them to have a say on what happens to their bodies.
According to the U.S. Department of Health and Human Services, informed consent prevents harm to participants by addressing the interests of both the individual and the community. This can be divided into two. The first is the individual’s interest in preventing harm to themselves. This can range from having a dehiscence of the stomach or cervix, or to traveling overseas for surgery (Cruzado-Álvarez et al., 2023). The second is the community’s interest in protecting the individual from harm to themselves and others. This can include laws against disfigurement or other types of health risks that could occur during surgery, such as getting one’s hand stuck on a door handle after a brain surgery that caused paralysis (Leñero-Cirujano et al., 2022). The community also has a vested interest in preventing harm to the individual’s integrity and reputation (Cruzado-Álvarez et al., 2023). For example, if a victim of sexual abuse has been assaulted by someone they know, a friend or family member, they may be hesitant to publicly come forward with that information because of their integrity or reputation.
Moreover, informed consent protects an individual’s interest in self-determination and autonomy by allowing them to make their own decision regarding what they decide to do with their body. This is important as it allows an individual to make decisions that will affect their body without outside influence, preventing a third party from taking control of their bodies (Llorente-Pérez et al., 2022). This can be seen in cosmetic surgeries, where the individual may have a preference to increase the size of their lips. They can do so by using whatever method they choose, whether it be injections or surgery. This allows them to control what happens with their body without being subjected to someone else’s decisions (Esan et al., 2022). Further arguments for informed consent include the notion that it protects an individual’s right to make choices over their body, and that people should have a say in what happens to their bodies (Leñero-Cirujano et al., 2022). This is especially important considering the high prevalence of unconscious bias and stereotype threats in modern society.
Further, according to the Belmont Report, the primary principles that are part of informed consent include the participant’s right to consent, the promises to inform participants about the risks and benefits of a procedure, or alternatives, and not to consent unless they have sufficient information. It is also important that participants have opportunities to ask questions and have a say in what happens to their bodies (Department of Health, Education, and Welfare, 1979). The report states that participants are also to be informed of their right to withdraw consent at any time before they give consent, even if the study is already underway. Researchers are also not allowed to rely on an individual’s failure to respond or allow them to withdraw as a means of starting the study (Tíscar-González et al., 2022). If there is any question of whether or not the individual understands what they are consenting to, researchers must stop and pause until they understand. If an individual repeatedly refuses to give consent or continually withdraws their consent, researchers are to cease the study because they have no choice but to honor the individual’s wish (Ros-Sánchez et al., 2022). The report also states that informed consent should not be used as a means of deceiving participants or using them as guinea pigs in studies (Department of Health, Education, and Welfare, 1979). Researchers should not use the information they are given to coerce participants into participating in a study, and they should inform them of the nature of the research and how it will be done before they decide whether or not to participate.
Nonetheless, the National Center for Biotechnology Information state that for informed consent to be valid, it must meet certain criteria. The three criteria that must specifically be met by informed consent include information, capacity to understand the information given and competence, and voluntariness (Morales-Valdivia, 2023). In other words, the individual must voluntarily agree to participate in a procedure without coercion or pressure from either the researcher or an outside source with their interest in mind. If these criteria are not met, then the individual’s consent is not considered valid, and their decision to participate in a procedure is not viewed as independent (Esan et al., 2022). Some groups are vulnerable and may be subject to coercion by a researcher or an outside source that has some additional interest in them (Vidal & Millán, 2023). Vulnerable groups that require additional protection in research include children, the elderly, and the mentally ill.
Vidal & Millán (2023) state that children are vulnerable and therefore require additional protection in research because they can’t understand what is going on around them and make their own decision about participating. For them to give valid consent, those who are charged with their care must make decisions in their place, acting as guardians in their stead (Cruzado-Álvarez et al., 2023). If a child is under the age of 18 but can demonstrate the capacity and competence to understand what is going on around them and make a decision about whether or not they want to participate in a study of some kind, then they can also give consent, acting as guardians in their stead (Martín-Ojeda et al., 2022). Just as a child still needs guardians, the elderly also can make their own decisions but do require additional protections because they may be more susceptible to coercion or persuasion (Agustini et al., 2023). They are required to have a guardian, who will make any decisions on their behalf in the event they aren’t capable of doing so themselves (Ros-Sánchez et al., 2022). The mentally ill generally cannot understand what is going on around them and make a decision, which is why they also require additional protection (Vidal & Millán 2023). In some situations, it may be possible to get informed consent, but they will most likely require additional protections to be able to give consent.
Also, according to the U.S. Food and Drug Administration, the role of the Institutional Review Board (IRB) in research is to protect the rights and welfare of human research subjects. This is no longer limited to medical research but has expanded to all types of human studies where potential risks are inherent (Tíscar-González et al., 2022). There are several specific roles that IRBs play in the process, including review of proposals for human research; prompt notification to potential participants when activities such as consent or suspension of their participation have occurred; and regular monitoring of the progress and purposes of those studies in which they intervene (Llorente-Pérez et al., 2022). IRBs are also to ensure that research is conducted by well-qualified investigators in a manner that does not unnecessarily expose subjects to risk. To accomplish this, IRBs are required to evaluate the risks and benefits of each subject before they decide whether or not they will allow any research at all to take place (Esan et al., 2022). This includes looking into the actual procedures that may be involved in the study, as well as considering all potential sources of bias and conflicts of interest (Rodríguez-Torres et al., 2022). If researchers are researchers who are the subject of their study, then this conflict of interest does not have to be examined.
To protect study participants from harm, informed consent must safeguard each participant’s right to self-determination and autonomy as well as provide them control over how their bodies are used. An individual’s right to self-determination and autonomy must be respected in any research they undergo. In other words, they should always be allowed to give consent or refuse participation in a study of some kind. Researchers must be careful not to pressure the individual into participating in a study. Informed consent should not be used as a means of deceiving participants or using them as guinea pigs in studies. They should not use the information they are given to coerce participants into participating in a study, and they should inform them of the nature of the research and how it will be done before they decide whether or not to participate.
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Informed Consent Essay Example