Open access peer-reviewed chapter - ONLINE FIRST
Abstract
The central idea of this paper is that in bioethics there are two types of discourses or approaches, one procedural and the other one substantive or content approach. The first one seems to be predominant because it responds better to the demand in contemporary times by offering procedures, rules, and guidelines to help healthcare professionals to find solutions to ethical issues, rather than the second one, which is focused on the trait of characters, attitudes, and the moral content. Since the digital era started, data as moral content and systems have become the most valuable resource. This has been manifested in multiple areas such as social network, business, and politics, among others. In medicine, the potential impact of novel technologies based on data like artificial intelligence and machine learning, among others, may bring preventive, diagnostic, and therapeutic benefits for patients as well as result in potential issues, and the majority are still unknown. In order to guarantee respect to the new moral content, and compliance with bioethics principles within procedures and systems in the digital era a third approach is required: bioethics by-design.
Keywords
- bioethics
- principles
- procedures
- content
- substantive
- data
- digital technologies
- by-design
1. Introduction
Ethics and medicine share the goal of finding solutions to issues, and the difference between the two disciplines is that while the first deals with those conflicts that are related to human’s values, interests, or preferences, the second deals with health problems. Like ethics and medicine, one of the main objectives pursued by bioethics has been to help healthcare professionals to resolve ethical issues that appear in their daily clinical practice.
Daniel Buchanan argued that bioethics has three main functions: identifying and defining existing ethical conflicts; providing systems or methods to think about new, emerging ethical conflicts in the field of medicine; and helping scientists and physicians to make decisions [1]. More than 50 years after Buchanan’s article was published, clear evidence exists that systems, methods, and procedures are the predominant key elements to support healthcare professionals in benefitting patients and the clinical research. Therefore, there is a greater interest and demand for procedures, leaving aside questions related to the content and moral foundation of the decisions, as stated by N. Kass years ago [2].
Interest toward the decision-making procedures in solving ethical conflicts has resulted in a bioethics concept defined by Pincoffs as quandary ethics [3]. This focuses on finding solutions to conflicts by asking questions such as “What should I do?” or “What is correct?,” leading to a significant reductionism: being moral simply means that you should be responsible for complying with a norm or an ethical principle.
Indeed, we are faced with two ways of understanding bioethics, the procedural approach and the content or substantive approach.
2. Procedural bioethics and content or substantive bioethics
In the second half of the twentieth century, the practice of medicine entered a stage where mistrust between physicians and patients became the predominant note. It was then that codes and declarations were formulated to achieve greater regulation of clinical research in humans to protect patients’ rights, like the Nuremberg Code (1947) or the Helsinki Declaration (1964).
Between the sixties and eighties, due to new technological advances applied in medicine for diagnosis and treatments, serious and unexpected ethical conflicts took place in the United States related to the practice of medicine. For example, the case in Seattle, and for the Karen Ann Quinlan case, see [5]. It was then that the first bioethics centers were created: the Institute of Society, Ethics and the Life Sciences, Hastings Center (1969), and the Joseph and Rose Kennedy Institute of Ethics for the Study of Human Reproduction and Bioethics (1971) in North America, and the Institut Borja de Bioètica (1975) in Europe. At this time, the Belmont Report was published, proposing three fundamental ethical principles that aimed to protect patients and justify actions in clinical research: the principle of autonomy, the principle of beneficence, and the principle of justice [6]. During the eighties, following this publication, the bioethical discourse was mainly built on formulating ethical principles to act as a basis for medical practice and clinical research.
Principles of Biomedical Ethics (1979) [7], Theory of Medical Ethics (1981) [8], and The Foundations of Bioethics (1986) [9] include the common feature to defend principles and procedures to solve ethical conflicts in the clinical field, in what at the bioethics discipline we understand as principlism. However, the most established procedural approach was the one defended by Beauchamp and Childress. The objective of their theory is to offer a reference framework for moral discernment and decision making and demonstrate how ethical theory can help to solve ethical issues in healthcare. They argue that not all areas of morality can be introduced within the theory of virtue’s framework and language without supposing to lose basic moral protection. Moral judgment based on virtue ethics tends to be less important than rights and procedures. This may happen in relationships between strangers, for example, when a patient meets their physician for the first time. Therefore, a reference moral framework was proposed, providing four ethical principles that facilitate a common moral language in the patient-physician relationship: the principles of autonomy, non-maleficence, beneficence, and justice.
Robert M. Veatch, influenced by John Rawls’ contractual theory, justified also a procedural bioethical theory on the basis of a triple contract [10]. In the face of ethical issues, the theory proposes a mixed strategy that includes a hierarchical or lexicographical order and weighting among several ethical principles. The lexicographical order is a serial order between principles that avoids having to level them, as there are those that have absolute value and remain without exception. These principles are a result of different contracts between people, and we add “between content,” who seek to find a moral foundation for human actions within the same society or moral community.
Another example of procedural approach is the one proposed by H. Tristram Engelhardt based on the assumption that a contemporary society is constituted by relationships between moral strangers—between people who do not share the same morality (not share the same content)—and procedural bioethics allows coexistence between moral strangers as well as the creation of a moral community with a certain consensus among all. In other words, there are two moral discourses: the one between moral friends (the ones who are sharing content) and the one between moral strangers [9]. To have a moral discourse accepted by all parties, it is necessary to reach an agreement between moral strangers. This agreement or moral consensus may be achieved with two principles of the first order: the principle of permission, also called the principle of moral authority, and the principle of beneficence.
Theories by Beauchamp, Childress, Veatch, and Engelhardt are clear examples of what we may call the procedural approach in bioethics: those focused on rules and principles governed by procedures, rather than on content. We can reduce such theories as follows: The correct human act should be the result of acting according to a procedure.
The concept of “virtue” held a special relevance in the philosophy of ancient Greece, of the Middle Ages, and later in the Scottish Sentimental School. However, interest then dropped so low that it has been described as a “neglected topic” [11], a concept forgotten by contemporary moral philosophy. It was not until 1958 when Elizabeth Anscombe wrote her article “Modern Moral Philosophy” [12] that new articles and books began to appear in which virtue returned to occupy the center of attention of ethical theories. After Anscombe’s article, several speeches were made that opposed the pre-eminence of concepts such as “moral duty” and “norm,” and, in general, those deontological theories that suffered from excessive formality. This criticism of defining the moral act as a fulfillment of a duty or moral rule, or with the calculation of consequences, gave rise to the rebirth of aretaic ethics theories. In such theories, the intention and will of humans precede any action, and hence, the pre-eminence of character and its content are the foundation of moral discernment, instead of a set of principles or rules. Thus, a good act is not the result of acting according to a rule or principle, or after calculating that the benefits of an action outweigh its risks, or in accordance with a procedure. Instead, it is the result of acting on a virtue to achieve the good, requiring prior knowledge about what is good, rather than what is right. As Rosemarie Hursthouse summarizes, the ethics of virtue is the one centered on the agent and considers aretaic concepts such as “good” or “virtue,” and not others, such as “right,” “duty,” and “obligation.” In addition, it rejects the idea that ethics can encode rules or principles that guide actions [13].
The same occurred in bioethics: Concepts like virtue and moral content were forgotten due to a preference for principles and procedures. Despite the danger of forgetting bioethics of content, there have been several authors who have focused their bioethics theories on the aretaic approach [14, 15].
One of the main bioethics theories focused on content and aretaic concepts is the moral philosophy of medicine defended by Edmund D. Pellegrino and David Thomasma: a theory based on phenomenology of medicine and research on medical phenomena and its own content, such as the nature of health and disease. For Pellegrino, the ethics of medicine based on principles has certain shortcomings: “It leaves an inferential gap between principles and their application in concrete clinical cases. It is not convincing to physicians, because it is derived from philosophies external to medicine” [16]. Therefore, a philosophy of medicine is needed to provide the basis to define what good medicine is, content, and how duties, obligations, and rules, so procedures, should be derived from the content.
Medicine is not just a theoretical science but also a practice and a moral activity, like each human activity, since actions must be good as well as correct and right. In the medical field, we always find uncertainty, and the good of the patient depends, ultimately, on the nature (content) of each patient. In fact, both in diagnosis and in treatment, this uncertainty is inevitable, since there is no direct connection between medical science and the patient, between theoretical knowledge and the nature of each patient, between procedures or good practices and the patient. The uncertainty is also felt by the physician and investigators as they may not always have full evidence, full content, and all data about the best treatment, and not all of them are equally capable of making the best decision or best incisions. That’s why neither a principle nor a procedure will help the physician or investigator to make the best decision or perform the incision, but a practical virtue to combat the medicine and clinical research uncertainty. As Pellegrino stated: “this irreducibility of the character of the moral agent, the physician in medical ethics, is a fact, regardless of the model of ethical reasoning one elects -principle- or rule-based, duty-based, casuistic, situational, emotivist, egoistic, intuitionist, and so on. In every ethical theory there comes a moment of opportunity, the use of the theory by a particular person in a particular circumstance. In that moment, the virtues will make the difference, making a good theory better in ameliorating the harm of erroneous theories” [15]. Thus, the content bioethics approach is focused on the content, on the actual interaction between the physician and the patient, rather than the formulation of procedures. A good act is the result of acting according to knowledge about what is good rather than following a principle, norm, rule, or procedure.
2.1 Procedural and content bioethics, toward a complementary approach
Despite the existence of multiple bioethical theories focused on virtue and content, such as the ethics of virtue by Pellegrino and Thomasma, the casuistic of Albert Jonsen [17], R. Tong’s feminist approach [18], or the pragmatism defended by J.J. Fins and G. McGee [19], there is greater interest and need in procedural approaches to address the persistent emergence of ethical conflicts in healthcare and clinical research. The pre-eminence of procedural discourses is evident in clinical research: Decisions in research are subordinated to the protocol and study procedures. The essential trait of the procedural bioethical approach is that it focuses on the formulation of procedures that help solve ethical conflicts in clinical practice while respecting the principles and rules. Thus, the right action is carried out according to the procedure, and the ultimate responsibility depends on the grade of compliance to the procedure; the responsibility does not fall on the person but on rules and procedures. That is, there are not good or bad decisions, but rather better or worse procedures; there are not human errors, but technical issues. However, as Frankena states, “principles without traits are impotent and traits without principles are blind” [20], and the same could be said for the procedural bioethical approach and the content approach, as both are complementary. In that sense, Beauchamp and Childress also agree to incorporate virtues and principles into the same discourse; for them, “a moral philosophy is simply more complete if the virtues are integrated with principles. We have grounds to declare virtue theory and principlism partners rather than competitors” [21].
As stated by E. Pellegrino, bioethics principles help create a common discourse between healthcare professionals by facilitating a
In summary, a disjunction between substantive or content and procedural approach is not recommended. Virtue discourse is what confers moral content to the procedural discourse, overcoming any emptiness of the principle, or as Leo R. Kass called it, its “procedural ingenuity” [23]. The first is the set of bioethical theories giving prominence to virtue and placing greater interest toward the questions of foundation and content rather than the formulation of principles and procedures. The second is the one defended by those bioethical theories that, given the presence of ethical conflicts, facilitate decision-making processes to help find solutions and correct ways to act through the formulation of principles or procedures. Rather than rivals, the approaches should be complementary, as the first overcomes any procedural ingenuity, while virtue ethics provides moral content, substantive approach, principlism, and the procedural approach provides normativity.
2.2 Procedural and substantive bioethics in the physician-patient relationship
Since the middle of the twentieth century, the way of understanding the physician-patient relationship has been changing due to the socialization of medicine, its specialization, and the continuous technological advances. Since then, the bioethical discourse has tried to describe the physician-patient relationship with different models or metaphors: the paternalistic or autonomy model, the contract, alliance, or negotiation model, and the mutual participation model, among others (For example, see [24, 25, 26, 27, 28, 29, 30, 31, 32]).
In the physician-patient relationship, the distinction between procedural and content, substantive, or aretaic discourse is reflected more specifically in the distinction that Pellegrino and Thomasma establish between the contractual model and the fiduciary model. In the first one, the relationship is supported by a contract and is based on the assumption that a physician and a patient are moral strangers. This would be the model in accordance with the procedural proposals of Veatch and Engelhardt, who from a contractual model assume that a physician and a patient hardly share the same system of moral values. In the second model, the relationship is established based on mutual trust, assuming that there is some friendship between the physician and the patient, hence Pellegrino’s critique: “autonomy-driven models of the doctor-patient relationship make the relationship largely instrumental and procedural. They are legalistic in spirit, and the ethics they engender is one minimal personal commitment and trust. Indeed, they are more based on distrust than trust” [22].
Indeed, Pellegrino and Thomasma maintain that there is no need for a contract or procedure to guarantee that the physician will act to achieve the good of the patient, something already implicit in the therapeutic relationship. They themselves recognize that, despite the fact that trust between a physician and a patient is replaced by a procedure in the contractual model, this does not mean that trust continues to be an essential element in the physician-patient relationship. Not only do they claim that contractual models replace friendship with a contract, but also, they can create a climate of mistrust between physicians and patients.
As summary, we can affirm there is no single model of the physician-patient relationship that contemplates all the variability of clinical practice as there is no single approach in bioethics. Moreover, in current times, both contractual elements, like informed consent procedures, protocol procedures, and good clinical practices, and fiduciary elements, like trust, attitude, and good intentions, are living together with.
2.2.1 Procedural and substantive bioethics approach in the field of ethics committees
The presence of ethics committees in hospitals began between the 60s and 70s in the United States, due to the emergence of new ethical issues as a result of scientific and technical advances in medicine. One of the first committees was the one created in Seattle, in 1961, with the purpose of deciding which patients would be given access or not to a new dialysis treatment, given the large number of patients and the scarcity of resources. Another committee was the Optimum Care Committee, which was created at the Massachusetts General Hospital in 1974 to help physicians to deal with ethical conflicts that arise in borderline situations, such as cardiopulmonary resuscitation [33]. Two years later, following the Quinlan case, the New Jersey Supreme Court recommended that hospitals have ethics committees [34]. Committees in Seattle, Massachusetts, and New Jersey were created on an
Years ago, as part of our initial research, an empirical study on healthcare ethics committees, the CEA-CAT study, was conducted in Catalonia with two main objectives: to know their structure and complete a self-assessment, and to find out what is more relevant for their members, such questions regarding procedures or questions regarding to the content of bioethics. The results showed that there was indeed a slight preeminence of procedural bioethical discourse with two main indicators: the recognition by the ethics committees themselves of being in greater possession of procedural skills rather than skills related to ethical content and interpersonal skills, and secondly, almost all committees have some kind of decision-making procedure [41]. However, in favor of the aretaic or content discourse, the same members that acknowledge having more procedural skills have the opinion that skills related to ethical content and interpersonal skills, like the attitude and character, are more important than procedural ones. In order words, one is more competent as more interest and intention is possessing, which reinforces the importance of the aretaic or substantive discourse to the detriment of the procedural one: that someone has an interest and the good redounds in their competence.
We demonstrated that there was a greater presence of procedural aspects: Almost all healthcare ethics committees have a decision-making process, and committee members are more in possession with procedural skills rather than content or interpersonal skills. However, the fact that there is a greater predominance of procedural aspects does not diminish the importance of aretaic or content aspects. Despite the indications that indicate a preference for procedural aspects, there is no evidence of theoretical forgetfulness of those aspects that have to do with the content and virtues. Thus, we can conclude there is a good coexistence between procedural and content or substantive aspects in the field of ethics committees also.
3. Digital health and data, toward a new era
Since the digital era started, there is no doubt that data and metadata have become the most valuable resource, as published in The Economist: “The world’s most valuable resource is no longer oil, but data” [42]. This has been manifested in social networks, communication, business, education, and politics, among other fields and disciplines.
In medicine and clinical research, data must be reliable, robust, and credible in benefit to the patient and guarantee the best treatment, and multiple guidelines, regulations, and procedures have been established to achieve this goal, as for example, the ICH E6 Guidelines for Good Clinical Practice (GCP). ICH E6 Guidelines for GCP are legally enforceable to encourage the implementation of improved approaches to conduct clinical trial designs, data recording, and reporting. Guidelines for GCP are defined as “an international ethical and scientific quality standard for
In the new digital health era, in order to pursue the best treatment for a patient and make effective a medicine based on the evidence, data must be reliable and credible, and the GCP ALCOA mantra, now ALCOA ++ [44], becomes a moral imperative in order to guarantee the integrity of data: Data should be attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available when needed, and traceable throughout the data life cycle after its creation; data are generated during their processing and are maintained or destroyed to develop new or to update drugs for emerging diseases and provide the best treatment available to the patient. The GCP skeleton consists of 13 principles with a main goal: to protect the rights and safety of patients and data reliability; therefore, the abovementioned good of the patient depends not only on the nature of each patient, but also on the data collected and processed throughout the practice of medicine across multiple patients.
Multiple scenarios showed the importance of data and big data in medicine such as artificial intelligence and its subset, machine learning. The potential benefits of big data on clinical settings are evident, resulting in preventive and personalized medicine; providing accurate diagnosis and novel therapeutic benefits; supporting development of new drugs; bringing more effective drugs to the patients; and improving vaccination effectiveness (For example, see [45, 46]). Artificial intelligence using algorithms may act in the physical or digital environment through data collected and processed to perform tasks like making decisions, may decide what is the best action, and may make predictions as well. Machine learning enabled in medical devices can create algorithms and take decisions without programming data, with an impact on the diagnosis procedure across diseases and propose treatments in patient benefit. Another novel digital technology is the new language prediction Generative Pre-trained Transformer, the so-called GPT, supporting healthcare by detecting health conditions and common symptoms, such as language impairment in patient speech using speech markers, supporting early diagnoses of neurodegenerative diseases, like dementia, among others. The use of Real Word Data is another example of the importance of data: data routinely collected from multiple sources like electronic medical records and medical devices, among others. Digital health technologies are increasing on a daily basis to guarantee the best treatment for patients in the real-world clinical settings and may support regulatory decision making and generate new guidelines for clinical practice [47].
The importance of integrity of data is also a key element in pandemic times. The coronavirus disease (COVID-19), declared as pandemic on March 11, 2020, with an enormous impact on the entire globe, especially on healthcare and clinical research, increasing demands on nurses, physicians, restrictions of study visits to the hospitals, and difficulties in distributing the drugs and investigational medicinal products, among others was a challenge for the current procedures in healthcare and clinical trials. In order to minimize the impact of COVID-19, new and updated guidelines and procedures were generated by multiple regulatory agencies like the European Medicine Agency and the Food and Drug Administration, among others, in order to facilitate decisions in benefit of patients and protect data integrity in the field of clinical research (For example, see [48, 49, 50]). The maintenance of data integrity was a key element to decide whether a clinical trial should continue despite the pandemic scenario and its difficulties or should be put on hold due to the difficulties to maintain data reliability and robustness. When it is not possible to guarantee data and their robustness, results are questioned as data are not credible, with an impact on drug development. Hence, there is no doubt data has become a
Indeed, the digital novel technology brings benefits in medicine, but it also may be a disruptive technology with a potential harmful impact, for example, in mental integrity or psychological profiling, by classifying groups based on their behavior and preferences, replacing human decision-making, among others [51], and also potential misuses via security, economic or politics. Ransomware attacks on hospitals for business purposes have increased, with a direct impact on healthcare [52], algorithms may predict criminal recidivism [53] and may involve risks of stigmatization or discrimination in societies, or spyware tools designed to secretly turn mobile phones phones into means of repression means of repression, with an impact on the privacy of Presidents, legislators, and members of civil society organizations, as occurred in the Pegasus case (e.g., see the Pegasus case [54]), putting in question the protection of the confidentiality and privacy of political opinions, philosophical beliefs, and personal data, although protected by multiple regulations [55, 56].
Digital health technologies bring benefits and risks, thanks to their systems and algorithms creating multiple complex scenarios based on data gathered, and their metadata, during the entire data life cycle. However, as principles have an inherent limitation, data also have their inherent limitation: Algorithms are learning on the basis of historical data entered in multiple sources by humans with their values and preferences and access to computers; therefore, data gathered contain biases and mistakes. However, despite the inherent limitation, data are used and processed. Data are not virtual and are real, and as the mantra says: If something is not documented, it does not exist; if facts are not documented, it did not happen; in other words, data are moral content
4. Conclusion: bioethics by-design
As stated by Edmund Pincoffs, the nature of time dictates what ethics there must be [3]. Indeed, bioethics is linked to the current times, and this is not an exception in the current digital era. In medicine, despite the advantages of novel digital technologies, the impact on patients and society is still unknown. Digital technologies and the added moral content, data, raise novel ethical challenges and bring new ethics debates at all stages of the data life cycle, from their creation, use, and management, until they are destroyed. Data are registered in millions of systems through multiple sources such as internet browsers, applications, online platforms, and devices, among others, and then are processed, analyzed, and controlled through multiple systems and procedures until they are destroyed or saved for future process, increasing zettabytes of data with their biases.
In April 2019, the EU’s High-Level Expert Group (HLEG) on artificial intelligence published its Ethical Guidelines, identifying key requirements that artificial intelligence systems should meet to be trustworthy. Among them, human oversight, data governance, and principles of bioethics like the principle of autonomy or the principle of nonmaleficence have been adopted as ethical guideline [57]. Indeed, bioethical principles help create a common discourse between by facilitating a
At present, changes in healthcare management and organization, the creation of new hospital complexes, changes in morbidity, the increase in chronic diseases, greater longevity, the increase in home care and decentralized clinical trials, the existence of patients with multiple pathologies that require the intervention of different teams and different specialties, plus the impact of digital technologies on health, are generating ethical conflicts that have more to do with organization, resource management, systems, and data than with clinical practice itself. Thus, ethics consultants and ethics committees must deal with issues that are related to the structure and functioning of healthcare organizations; the well-functioning of digital technologies, however, may not yet be ready to address the new emerging ethical conflicts raised or having the root cause in systems and algorithms.
While the era when ethics consultation was immersed into organizational ethics was defined as the second stage of bioethics [58, 59], the current digital era brings the bioethics community to a third stage. While during the second stage, issues occurring in medicine had an organizational nature and were closely linked to the management of resources, now issues are systems and design related, linked to the nature of data.
Since the implementation of ethics committees in hospitals, the debate on which profile is the most suitable to be part of it has been a constant. It was a dispute whether philosophers or physicians are recommended to deal with ethical issues in the practice of medicine. The majority of surveys showed that physicians and nurses were the groups with the most representatives on ethics committees in the US, in detriment of other profiles such as social workers, psychologists, lawyers, or philosophers [60, 61, 62, 63]. In the digital era, the role of the Data Privacy Office has been established in multiple organizations as a result of the implementation of multiple regulations, and the same question can be raised: Who is the most preferable profile to guarantee data are processed and controlled as expected during their entire life cycle? Knowledge on data protection law seems to be a prerequisite, plus communication skills, and preferably knowledge of information technologies, including security and organizational aspects [64], but given the increase of novel digital technologies and their potential misuse, we are forced to continue investigating about the best skills, knowledge, and abilities needed to properly address novel issues in the digital era.
In the second stage of bioethics, given the need to deal with aspects of an organizational nature, ethics consultants and committees were forced to rethink their approach. If at the first stage of bioethics, the main task of the ethic consultants and ethics committees was directed to the resolution of ethical issues, with a reactive attitude, the second stage has been marked by the ethics of the organizations, with a more preventive attitude, and the function of the committees was more focused to the prevention of ethical issues, rather than its resolution; this was possible by efforts made toward training and promoting an ethics that encompasses clinical ethics and the ethics of the organization. The jump from clinical ethics to organizational ethics not only entailed changes in the structure of ethics committees, but also impacted their functions. In the current digital era, multiple procedures and systems have been established, and trainings seem not to be sufficient either to solve or to prevent issues due to the complexity and recurrence of novel issues. In the digital era, issues are not always related to the human nature, nor to the organization nature, but in the system and its design. Thus, the third bioethics stage cannot be limited to a reactive approach or preventive approach, but efforts must be made to adopt a proactive approach to avoid errors in systems or process where data gathered are managed and used by algorithms to make decisions with a direct or indirect impact on humans, in medicine, patients.
In other words, bioethics and their main tool, ethics consultants, and ethics committees, changed upon the context within which it operates, and required knowledge, skills, and abilities are changing as well. As stated by the UNESCO, because we are living in digitalizing society, responsible design practices and new skills are required [46, 65]. If in the second stage of bioethics, knowledge about organization structure or business by ethics consultants was questioned; in this third stage, without minimal knowledge and skills of digital technologies, ethics consultants and also regulators may have difficulties to manage the new emerging issues properly and propose adequate ethical guidelines and regulations. In medicine, a third element has been incorporated to the nature of the patient and the nature of the organizations: the nature of systems. The good and right decision depends on the human nature, on the compliance to procedures, and the good design of systems governing data gathered and created by humans and non-humans. Thus, in clinical bioethics, the moral responsibility to make good decisions not only falls on healthcare professionals or procedure, but also falls on the system and its design, to guarantee outcomes to benefit the patient. A new third approach is required, which may be called integrative bioethics by-design.
Integrative, both procedural and substantive approaches, bioethics should be the centric approach to how systems should be designed without omitting the real and cyber moral content and its context. As stated by experts, artificial intelligence can be trustworthy if the system, during its entire life cycle, is “ethical, ensuring adherence to ethical principles and values” [57], and systems should be designed in order to be able to respect and implement bioethics and data protection principles by-design, and by default to meet requirements of current regulations and ethical guidelines. If the essential trait of the procedural bioethics approach is that it focuses on the formulation of procedures that help solve issues while respecting principles, the essential trait of integrative bioethics by-design approach is it focuses on the generation of systems to allow procedures to solve issues in the current digital era while respecting bioethics and data privacy principles. The impact of novel digital technologies applied in health is still unknown, and an integrative bioethics by-design approach may support bioethicists and experts on systems and digital technology to make the right and good decision; meanwhile, regulations and guidelines need to be developed and put into effect across human disciplines, like medicine, and multiple fields.
Patients, organizations, and systems are interrelated and complement each other being difficult to work separately. While the substantive bioethics approach provides content, and principlism and the procedural approach provide normativity, integrative bioethics by-design provides ethical robustness to the systems. Errors are inherent to humans, gaps are inherent to the procedures, and both process gaps and human errors are inherent to the systems and as such can be avoided by an integrative bioethics by-design approach by providing the right approach to systems throughout their development. Systems, like procedures, have their inherent ingenuity, and an integrative bioethics by-design approach may overcome system ingenuity, as substantive bioethics approach overcomes the procedural ingenuity. While the substantive approach provides content, and the procedural approach provides normativity, integrative bioethics by-design provides normativity while respecting substantive approach.
When developing regulations for digital technologies and systems, integrative bioethics by-design must be considered as technological readiness level is considered when new technologies are developed prior to their implementation. The integrative bioethics by-design approach may guarantee bioethics principles are respected and linked properly to the systems and algorithms during the entire life cycle, having an impact on their correct use.
After what has been said, we can conclude that procedural, substantive, and integrative by-design approaches are and must be interrelated to deal with the new emerging ethical dilemmas in the digital era. From now on, a new mantra is coming: bioethics by-design.
Notes
The beginning of our research started from a personal interest in the physician-patient relationship. After a bibliographical review on the subject and reading texts on medical history, ethics, and anthropology, we realized that concepts such as “trust,” “virtue,” or the “good of the patient” are essential as the basis for an ethics of medicine. This is where our interest in virtue ethics and Aristotle’s ethical theory came from, given its constant allusion to the practice of medicine and because is one of the most important references in the debate on the concept of “virtue.” At that point, there were two decisive factors that influenced the direction of our research: the observation of the defenders of virtue ethics that for a long period of time, the concept of virtue in contemporary ethical theories became a forgotten concept, giving greater importance to other concepts of ethics such as “duty” or the “consequences,” and the formulation of and impact on the development of the bioethical discourse of the four bioethics principles of Tom L. Beauchamp and James F. Childress. We therefore wanted to delve deeper into different bioethical theories, such as that of Robert M. Veatch and Hugo T. Engelhardt and in the philosophy of medicine by Edmund D. Pellegrino and David C. Thomasma, to determine whether or not the impact of proceduralism on bioethics led to a forgetfulness of content or virtue.
The digital era brings benefits and risks thanks to their systems and algorithms, creating multiple complex scenarios and requiring a third key approach: by-design.
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