Introduction
Ethics in the medical and pharmaceutical industry is a vital component of providing quality services and developing products that will benefit the patients. The interactions between a healthcare provider and a patient, or a researcher and study participants, should be based on the principles of ethics to ensure the safety and wellbeing of all parties involved. Any individual has a right to know what procedures and medications they can receive. Moreover, it is morally wrong for a healthcare provider to pressure a patient when accepting or declining a treatment plan, as it breaches their autonomy. These are the core principles of informed consent, which requires to disclose to patients all information that will help them make a decision. This paper aims to review informed consent as one of the central concepts of modern bioethics using the theories of paternalism and deontology and defend the idea that, in some cases, informed consent has to be omitted.
Background
Current ethical standards, which guide medical and pharmaceutical practice, imply that patients’ autonomy is essential. Informed consent is “educates a patient about the risks, benefits, and alternatives of a given procedure or intervention” (Shah). Based on this information, a patient can consider different options and choose the one that best suits their view of health and disease as well as their values. The standard of informed consent, similarly to other bioethics practice guidelines, was created as a response to violations and harm experienced by patients and human subjects (Rossfeld et al., 17). Informed consent, in particular, emerged as a response to coercion or withholding of information by medical professionals. Therefore, informed consent is an important element of the contemporary medical and pharmaceutical practice that allows people to get all relevant information about their health.
In pharmaceuticals and research studies, informed consent allows ensuring that the participants or potential medication users are aware of potential consequences. One notable example is the case of Grimes v. Kennedy Krieger Institute, where the latter was accused of knowingly subjecting children to lead contamination (Zhimin and Chuang, 10). The researchers tested the children’s blood and were able to track the increase of lead in their samples. This case highlights some of the core aspects of infrared consent, since, if the institute informed the participants of the potential danger, the children would not experience the harmful side effects of lead.
Despite the examples of informed consent violations, which highlight the importance of this practice, there are cases when informed consent can harm the medical practice or the patient. One aspect of informed consent that this paper will defend is the limitations of it when applied in practice. It is not always possible to follow this practice and provide full details to a patient or a study participant (Frunză and Sandu, 1). Although patient autonomy is crucial, there are cases when a person is incapable of making a serious health-related decision. For example, cognitive decline or mental health problems often result in an individual’s inability to understand information. Participation in research studies often involves the use of a placebo, which is a “form of deceit” (Schumacher et al., 1). However, without a placebo, it is impossible to conduct objective experiments. Although informed consent is the basis of modern medical practice, there are some limitations.
Ethical Theories
The theory of paternalism was widely adopted in the past as a model for interactions in the medical field. According to Chandran, this theory implies that medical or pharmaceutical professional acts in the best interest of their patient, and therefore, the consent of the latter is not necessary (3). This theory allows one to breach a patient’s autonomy based on the idea that a healthcare specialist acts for the benefit of an individual. With the paternalistic approach, the patient’s ability to make decisions is not considered as important. The main problem with this approach is that the values and cultural backgrounds of a patient and their healthcare provider can differ. Therefore, their choices in a particular case will be contradictory. In contrast to this, the deontological approach is guided by the patient’s right to autonomy and the idea that the outcomes do not justify the actions (Mandal et al., 5). With this approach, regardless of the benefit that the patient may have, a provider has to adhere to the individual’s decision.
Issues with Informed Consent
One issue regarding informed consent that generates debate is cases when individuals cannot provide informed consent. For example, a patient with Alzheimer’s who has issues with cognition and memory, cannot fully comprehend the implications of a study that tests a potential treatment. The moral dilemma that arises here is to either avoid having such studies or find other ways to justify the participation of this individual.
There are other limitations to informed consent as well, connected to the patient’s psychological wellbeing. Bester et al. focus on the issues of overwhelm – a state of an individual when they cannot make decisions because of emotions or information overwhelm (1). This is a common problem for patients in clinical settings because they face the type of language and information they are unfamiliar with, which can hinder their capacity to make adequate decisions. As a result, although they receive all the data they need to make a decision, they may struggle, because of stress and make a decision that will not benefit them. Bester et al.’s study provide evidence for the idea that in some cases, medical providers’ interference in the patient’s decision-making is necessary. However, the ethical dilemma of determining how the harm or benefit of such actions can be assessed remains unsolved.
Many research studies violate the basic principles of informed consent by using a placebo. Placebo is a common practice that allows the researchers to compare the actual impact that their medication or treatment method has (Schumacher et al., 1). To address this problem and ensure that participants understand that they may receive a placebo, individuals were asked to sign forms that detail this possibility. However, Schumacher et al. examined consent forms for oncology trial patients and, based on a survey, concluded that the complexity of the documents hinders the participant’s ability to understand them fully. As a result, the authors argue that modern clinical trial practices are not compatible with informed consent theories. This case further highlights that ethical standards of informed consent are difficult to follow, and in some scenarios, for example, in research studies, the true form of informed consent cannot be used.
Conclusion
Overall, this paper reviewed the issue of informed consent from the perspective of medical and pharmaceutical ethics. Although this practice is a result of deceit and failure to recognize a patient’s choices and their autonomy, in some cases, informed consent cannot be applied. In research studies or in cases when a patient is overwhelmed with information and cannot make a decision, it is difficult to apply the practice of informed consent.
Works Cited
Bester, Johan et al. “The Limits of Informed Consent for an Overwhelmed Patient: Clinicians’ Role in Protecting Patients and Preventing Overwhelm”. AMA Journal of Ethics, vol 18, no. 9, 2016, pp. 869-886.
Chandran, Suhas. “Paternalism vs Autonomy: Why Watching Our Words ss Important.” MDedge, 2020. Web.
Frunză, Ana, and Antonio Sandu. “Values Grounding the Informed Consent in Medical Practice: Theory and Practice.” SAGE Open, pp. 1-10.
Mandal, Jharna et al. “Utilitarian and Deontological Ethics in Medicine”. Tropical Parasitology, vol 6, no. 1, 2016, p. 5.
Rossfeld, Kara, et al. “Ethics (Informed Consent and Conflicts of Interest).” Clinical Trials. Success in Academic Surgery, edited by Pawlik Timothy and Julie Sosa, Springer, 2020, pp. 1-10.
Shah, Parth et al. “Informed Consent.” NCBI, 2020. Web.
Schumacher, Andrew et al. “Informed Consent In Oncology Clinical Trials: A Brown University Oncology Research Group Prospective Cross-Sectional Pilot Study”. PLOS ONE, vol 12, no. 2, 2017, pp. 1-10.
Zhimin, Li and Juang Chian. “The Application of Guardianship to Minors in Human Subject Research — From The Perspective of ohe Case of Grimes V. Kennedy Krieger Institute.” Medicine And Jurisprudence, 2020. Web.