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Philosophical understanding of the concept of informed consent

Informed consent was developed around the 20th century and is now regarded as the core of bioethics [1]. This was one of the foundational movements in the process where the central idea that “doctors know the best” was abolished with a consideration that the patients were in charge and equal shareholders in the process of care and could participate in the decision-making processes. One of the theories and perspectives of informed consent was put forward by Benjamin Freedman, who was an American businessman [2]. Freedman published a moral theory of informed consent and reassessed the meaning of valid consent [3]. In simplest terms, consent can be identified as a distinct transaction between individuals. Consent is regarded to be fully informed when the participants are able to participate in the study and are able to understand the process, and are able to take a decision in consideration of their agency to be a part of the research or intervention or not [4]. With the development of informed consent and its application, multiple approaches and implications of its practice were realized [5]. This paper will analyze the philosophical imperatives associated with the idea of informed consent and will highlight the arguments that help in the discussion of the imperatives in place. In addition, the application of ethical theories and values will also be taken into consideration for an evidence-based assessment through assessment of the philosophical imperatives of Benjamin Freedman. 

In the Nuremberg code, it was first established that voluntary consent of the human subjects was essential [6]. Prior to this code, a lot of atrocities were committed in the name of scientific research that violated individual human rights. The idea of consent has several undertones that include religious, philosophical, and legal foundations. The notion of informed consent has been regarded as essential as it has been associated with virtues such as protection autonomy, preventing abusive conduct, ensuring trust and building self-ownership and asserting self-integrity [7]. Freedman worked on multiple aspects of bioethics and outlined several ways for research conduct. One of the prime contributions of Benjamin Freedman was associated with his work on ethics for research associated with human participants [8]. The three primary standards of informed consent include a focus on disclosure of information, ensuring the competency of the patient and the surrogate to make a decision beneficial for the patient and acknowledging the voluntary nature of the decision undertaken. Through the lens of philosophical imperatives, the idea of informed consent is associated with respect for the autonomy of the individuals. This is used as a tool to govern the relationship between the patients and the physicians [9]. Hence, it is the philosophy of informed consent that focuses on the rights and the duties of the care providers for competent support to the patients and effective care outcomes. The idea of consent in philosophy is not restricted to the notions of ethics but extends itself to the ideas of political philosophy [8]. It asserts that granting consent is an act of permissibility for something to be acted upon in consideration [10]. The primary moral principles that govern the idea of informed consent in literature and theory include respect for the autonomy of the participants. Understanding the nature of autonomy and discerning between the actions and persons is also crucial. In addition, morals of beneficence and paternalism are also core to the philosophy of informed consent [11]. The application of the primary principles of informed consent is associated with the development of professional practice standards, the development of guidelines that ensure the conservation of the individual rights for practice and to ensure that no harm was intended in research and the rights of the human participants were conserved [10]. The application of the philosophy and the ideas of informed consent has also been associated with several limitations that have impacted the practice. In practice, it has been observed that fallacies such as insufficient disclosure and inadequate understanding of the interventions can impact the collection and application of informed consent [8]. In addition, informational manipulation has also been observed through the development of the philosophical imperatives about informed consent. Eight primary principles have been established. These include a critical and comprehensive description of the clinical investigation, knowledge and information about the risks and the discomforts. In addition, benefits and alternative procedures and treatments need to be taken into consideration. In addition, the focus is on confidentiality, and compensation for medical care and support and voluntary participation are also key factors [8]. 

Critical examination of the moral theory of informed consent and contributions of Benjamin Freedman

Critical examination of the moral theory of informed consent and contributions of Benjamin Freedman

The development of the philosophical understanding of informed consent, when proposed by Benjamin Freedman, has had major implications on scientific research and its outcomes. One of the primary changes imposed by the application of the moral theory of informed consent has been the demarcatisarion of treatment and research [12]. Initially, multiple studies were developed using mixed methods where the interventions for treatment were applied with a combination of therapeutic and non-therapeutic approaches. Such studies thus confound any simple weighing of the study risks and their potential benefits [13]. However, ideally, the risks with the therapeutic and the non-therapeutic interventions must be weighed individually and need to be acknowledged and analyzed in consideration of the same. With the initial works and considerations laid by Freedman and his colleagues, it presented a formal scheme for the ethical analysis of research. In addition, the threshold for the acceptable risk was highlighted through the contributions of Freedman. This led to the classification between the emerging risks and minimal risks of participation in the research by the human participants [14].

The primary ethical position of informed consent stems from the ethical principle of autonomy which is recognized as a fundamental human right. Individuals in the research or the participants have the complete autonomy and the right to decide the need and application for the intervention on the body for treatment or for any other form of care [15]. Hence, while the doctors and the clinicians can act as the facilitators, a primary decision to undertake the intervention or not relies on the patient itself [8]. In the theory and understanding of the primary aspects of informed consent, it is essential that all the relevant information is produced to the patient so that a rational decision can be made. Sharing of partial information or sharing of information in a manner that is not comprehensible for the patient or the participant invalidates the consent [16]. Hence, for the collection of informed consent, it is not only crucial that the patient or the participant is able to understand the primary aspects associated with the suggested interventions and thus takes a clear and coherent decision in consideration of the same. This has often been also associated with certain ethical conflicts in the process of care and impacts the duty of care and also the healthcare outcomes [17]. A special example that emerges in the case is that of Jehovah’s Witness. Individuals who identify themselves as Jehovah’s Witness do not wish to get injected. This can result in a complication in cases when the patient may need a blood transfusion. Hence, a patient may refuse to get support and care even when it is essential for them. This may raise a conflict for the carers. However, it then becomes the primary responsibility of the carers and clinicians to focus on the education of the patients and promote rational decision-making through education [13].

The question of the validity of consent has been a debate in bioethics since the 1970s. However, it was possible with the contributions of John Locke that a debate on what is regarded as informed consent was realized in association with individual ownership. The idea of human dignity and the assertion that every individual has property as their own person is also associated with the idea of personal integrity [14]. An individual possesses knowledge and understanding of what is best suited for them. An individual may develop their personal values, ethics, and the idea of just based on their cultural, social, and personal values [17].In addition, it may also be impacted by the religious sentiments and overall worldview. Hence, the process of decision-making does not run in binary thoughts and is an amalgamation of various personal as well as situational factors. In consideration of the same, every individual should thus be given the right to decide what is best suited for them [7].

The application of the ethical theories in regards to the idea of informed consent can be explained through the iceberg framework. This framework can thus conceptualize how the ethical theories of autonomy along with clinical communications and legal obligations form a network of ethical principles and theories that guide the application of informed consent [2].The principle of informed consent is not only mandated by the legal structures and guidelines but is also ensured through the primary principles of ethics. It is the right of the patient or a research participant to hold knowledge of the proposed intervention as it can have a direct impact on their well-being. It is also the primary right of an individual to decide if they want to be a part of the selected trial and the proposed intervention. This can ensure that the proposed study is based on effective evidence and does not intend any harm on the individuals. The ethical framework that guides the theory of informed consent, the primary outline, is based on the provision of required information and prevention of bias in the care of the patient [6].

The idea of informed consent emerged out of a social movement that demanded greater autonomy and also to ensure focus on the medical advances for the beneficence of the patients in the facilities. A defense for unqualified medical confidentiality emerges as a case example in the case of this debate [9]. The idea of consent is not only limited to actions but also to the sharing of information about patient details and allied fields. It is generally perceived that the confidentiality of a patient can be breached in cases when there is a risk of extensive harm to the well-being of the patient. It was Kipnis who argued that it is obligatory for the care professionals to respect patient confidentiality is absolute. Ideally, confidentiality is broken only when the patient gives consent to do so. However, it may be necessary to reveal some of the patient information in case of grave needs to ensure the well-being of the patients [11].This thus poses a dilemma in the context of ethics of informed consent and its implications in practice. The use of regulatory measures and policies in the structure is thus essential in conserving the application of the principle of informed consent and confidentiality in practice [8]. 

As one focuses on the ideas of Freedman and the development of the moral theory of informed consent, a contextualized analysis becomes crucial that needs to be placed and understood [12]. Several studies in the past have violated the consent and the beneficence of the human participants in the research resulting in a breach of their fundamental rights and dignity [17].In the paper, the morality of informed consent, Freedman talks about consent in regard with the competent individuals and consent and the incompetent individuals and presents a holistic analysis of how the poor acknowledgment of the right of consent is masked with vague connotations of who can be defined as a competent individual and what defines their authority to provide consent [18]. This thus presents a critical argument of what and when the consent provided by the individual is “valid” or “informed .”Based on the arguments presented by other researchers, the importance of informed consent in the conservation of individual rights, autonomy, and dignity has been identified [15]. Hence, its effective applications seem to be essential, yet, its application has been subject to multiple conditions that only result in abstaining the right of making a decision but also provide direct authority to the clinicians. Freedman thus concludes that just informing the patient regarding the conditions to obtain the consent is not enough. “It is, rather, derivative from the requirement that the consent is the expression of a responsible choice ” [4]. This paper thus presents itself in agreement with the argument presented by Benjamin. The notion of informed consent and the question on what remains to be informed and moral has been a matter of debate and question. However, application of informed consent in a moral sense can only be ensured with improved understanding and coherent development of ideas of “informed”, “moral” and “just” as these primary notions of philosophical underpinning remain a question, only a subjective understanding of consent can be identified.

Conclusion

Benjamin Freedman was one of the pioneers who focussed on discussing morality and its application in research through the umbrella of informed consent. The debate of informed consent is closely associated with the primary principle of focus on the autonomy of the individuals. Every individual has a right to decide if they want to undertake a particular treatment or intervention by assessing its risks and benefits. This paper summarises the argument by Benjamin Freedman and outlines that while the understanding of informed consent is associated with individual autonomy, it is exercised under a range of restricted accesses. This paper thus is in alignment with the idea put forward by Freedman and asserts that a more elaborative and critical understanding of the idea of validity and consent needs to be formulated in the research.

References

[1] Laws, Terri. "Carlin’s pastoral aesthetics: Bioethics,“do we want to be made well?”." Pastoral Psychology 70, no. 6 (2021): 585-594.

[2] Gessell, Bryce. "Professions in Ethical Focus: An Anthology, Edited by Fritz Allhoff, Jonathan Milgrim, and Anand J. Vaidya." Teaching Philosophy 45, no. 1 (2021): 105-107.

[3] Freedman, Benjamin. "The validity of ignorant consent to medical research." IRB: Ethics & Human Research 4, no. 2 (1982): 1-5.

[4] Freedman, Benjamin. "A moral theory of informed consent." Hastings Center Report (1975): 32-39.

[5] Amann, Julia, Alessandro Blasimme, Effy Vayena, Dietmar Frey, and Vince I. Madai. "Explainability for artificial intelligence in healthcare: a multidisciplinary perspective." BMC Medical Informatics and Decision Making 20, no. 1 (2020): 1-9.

[6] Annas, George J. "Beyond Nazi war crimes experiments: the voluntary consent requirement of the Nuremberg Code at 70." American Journal of Public Health 108, no. 1 (2018): 42-46.

[7] White, Michael G. "Why human subjects research protection is important." Ochsner Journal 20, no. 1 (2020): 16-33.

[8] Johnson, Liza-Marie, and Barclay R. Rogers. "Informed consent conversations: neither the beginning nor the end." American Journal of Bioethics 21, no. 5 (2021).

[9] Taylor, James Stacey. "Social autonomy and family-based informed consent." In The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, vol. 44, no. 5, pp. 621-639. US: Oxford University Press, 2019.

[10] Ahlin, Jesper. "The impossibility of reliably determining the authenticity of desires: implications for informed consent." Medicine, Health Care and Philosophy 21, no. 1 (2018): 43-50.

[11] Gómez-Vírseda, Carlos, Yves De Maeseneer, and Chris Gastmans. "Relational autonomy: what does it mean and how is it used in end-of-life care? A systematic review of argument-based ethics literature." BMC Medical Ethics 20, no. 1 (2019): 1-15.

[12] Henning, Alyssa. "From medical halakha to jewish bioethics." Journal of Jewish Ethics 7, no. 1-2 (2021): 106-117.

[13] Mousavinejad, Shahriar, Mostafa Rezaei-Tavirani, Ehsan Shamsi-Gooshki, Seyed Ali Enjoo, and Mehrzad Kiani. "A review of Ethical Considerations in Conducting Clinical Trials." International Journal of Medical Toxicology and Forensic Medicine (2021): 34863-34863.

[14] Macdougall, D.R., 2022. Righting Health Policy: How Kant Shows Us Why Bioethics Needs Political Philosophy. Rowman & Littlefield.

[15] Daniels, Norman. "Duty to treat or right to refuse?." In AIDS: Society, Ethics and Law, pp. 13-23. Routledge, 2018.

[16] Grote, Thomas. "Randomised controlled trials in medical AI: ethical considerations." Journal of Medical Ethics (2021).

[17] Goldstein, Cory E., and Andrew Peterson. "Is it unethical to publish data from Chinese transplant research?." Journal of Medical Ethics 46, no. 10 (2020): 689-690.

[18] Shorr, Andrew F. "Moral Connections:: The Relationship between Abortion and Fetal Tissue Research." The Linacre Quarterly 86, no. 2-3 (2019): 176-181.

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