Although virtue ethics does not rank most of the virtues in constant hierarchy, most virtue ethicists from Aristotle on have recognized the primary role of practical wisdom. Resnik describes that there are ‘four ways of promoting research integrity in an institution: education, policy development, policy enforcement (also known as compliance), and leadership.’ (Resnik, 2012). It does, however, date back to the ancient Greek thinkers and is thus the oldest type of ethical theory in Western philosophy. Understanding the definitions of autonomy, justice, and beneficence does not suffice; rather, research ethics professionals must understand how and why these principles apply in diverse situations so that they can use them to resolve ethical dilemmas. It falls somewhat outside the traditional It persisted as the dominant approach in Western moralphilosophy until at least the Enlightenment, suffered a momentaryeclipse during the nineteenth century, but re-emerged inAnglo-American philosophy in the late 1950s. Other moral theories will give an overarching principle or rule to follow in order to resolve moral conflict. Consequentialism, by contrast, is based on the idea that right choices are those with the best overall consequences. A deontological, or rule-based, approach dominates modern, western, research ethics discourse. In addition, IRB members must be proficient in the design of protocols and the practical conduct of medical research, as they will frequently have the opportunity to identify modifications to study design that enhance protection of research subjects without hindering the acquisition of knowledge. When presenting or discussing their own research, IRB members have the opportunity to discuss ethics questions and their resolution so that a culture of thoughtful ethical deliberation will diffuse throughout each IRB’s institution. By practicing being honest, brave, just, generous, and so on, a person develops an honorable and moral character. Unfortunately, different principles frequently make contradictory demands of us. This is beneficial because although a person may have committed a bad act, it does not necessarily mean that the person is a bad person, the action may have been a consequence of ethical thinking and could lead to a better outcome. View or download all the content the society has access to. A virtue ethics approach begins with the understanding that no regulatory code or set of guiding principles is sufficient for optimal resolution of all ethical dilemmas. As facility with these studies evolves, a body of precedents will emerge, gradually defining best practices. In striving to achieve these goals, IRBs must often consider conflicting interests. In order to understand the principles of virtue ethics, we need to understand what virtue is. Examples of Virtue Ethics An employee who displays ethical behavior at work based on the virtues they hold dear are often seen as more reliable and dependable by their superiors. IRB members should be encouraged to share their expertise and advocate for the responsible conduct of research when they interact with their colleagues in the research community, outside of the IRB. This character-based approach to morality assumes that we acquire virtue through practice. Virtue ethics has no basic concepts to abide by and so can be seen as incapable of dealing with big issues, it does not always have a view about what makes an act right or wrong. The … Principle-based ethical theories provide guides to action. The approach we are advocating here is sharply at odds with that proposed by Knoppers et al. An IRB whose sole goal is to ensure compliance with regulations will fall short of its mission to protect human subjects and promote ethical and valuable medical research. Virtue ethics regained prominence in the latter half of the twentieth century, largely in response to Anscombe’s 1958 ‘Modern moral philosophy’ (Anscombe, 1958). As newly appointed IRB members develop a degree of mastery of the ethical principles involved in research regulation, they should begin participating actively in IRB sessions, so that they can gain further proficiency, learning from role models, and from their own experiences in deliberation. In this theory, it is believed that having a virtuous character leads to virtuous decisions. Our proposals that IRBs focus on virtue and that IRB members be given more autonomy should reinforce each other. Neither principles nor virtues provide sufficient guidance in and of themselves. Virtue theorists may retort that it is in fact possible to base a judicial system on the moral notion of virtues rather than rules (modern theories of law related to Virtue Ethics are known as virtue jurisprudence, and focus on the importance of character and human excellence as opposed to moral rules or consequences). The email address and/or password entered does not match our records, please check and try again. Powell and colleagues describe a method to evaluate a responsible conduct of research course, in which decision-making skills are evaluated through individuals’ responses to brief scenarios (Powell et al., 2007). Manuscript content on this site is licensed under Creative Commons Licenses, Complementary roles of virtues and principles, Specific changes suggested by a virtue ethics approach to research oversight, The importance of virtue ethics in the IRB, National Commission for the Protection of Human Subjects, 1979, http://classics.mit.edu/Aristotle/rhetoric.html, http://plato.stanford.edu/archives/fall2013/entries/ethics-virtue/%3E, http://classics.mit.edu/Plato/republic.html, Oversight: Community vulnerabilities in the blind spot of research ethics, Institutional review boards: A flawed system of risk management. You can be signed in via any or all of the methods shown below at the same time. Small-group discussions, led by IRB chairs or other experienced research-ethics professionals, should focus on the process of deliberation, on identifying salient factors and discussing the implications of the different ways one might adjudicate among them. As such, there is an increasing need to ensure articulate and robust research ethics deliberation. The fact that rule-based and duty-based ethical systems are complicated and difficult to employ also cannot make a person of good character more likely to make the right choices. Christians have continued to stress the fundamental importance of virtue in individuals’ lives. The virtue of empathy allows reviewers to envision a research study from the perspective of a research subject or surrogate, understanding what information is required for subjects to make appropriate and informed decisions about research participation. from virtue ethics, and this claim is often accepted by Protestant ethicists. protecting institutions from legal risk) threaten these primary missions. Clinical research comes with a long history of ethically poor decisions and inadequate oversight. As Martin and Lantos point out, ethics should aim to discriminate ‘between what is good and what is excellent’ (Martin and Lantos, 2005: 63). A review of scientific ethics training programs demonstrated that the effectiveness of many programs was low. In other words, virtue ethics places a strong importance on character and motivation in making ethical judgment. For more information view the SAGE Journals Sharing page. Undeniably, the call of one virtue or another may lead to different courses of action. The importance of the ‘responsible investigator’ was emphasized by Henry Beecher, and has been reiterated and reemphasized by MacFarlane (Beecher, 1966; MacFarlane, 2009). Beyond positing the centrality of practical wisdom, we will not attempt to create a definitive list of the virtues required for excellence in research oversight. As Annas explains, ‘The ability both to teach and to learn a skill thus depends on the ability to convey an explanation by giving and receiving reasons’ (Annas, 2011: 19). For example, IRBs struggle to determine the extent to which incidental or secondary findings of uncertain significance should be communicated back to subjects. Calls for less regulation must come from within a profession firmly committed to developing and maintaining the capacity to bear this trust. Virtue Ethics In The Army A Moral Outcome The army states in ADRP 1-0 "The Army" that, “The Army ethic is the evolving set of laws, values and beliefs, deeply embedded within the core of the profession’s culture and practiced by its members to motivate and guide the conduct of individual members bound together in common moral purpose.” Principle-based ethics systems do not make it clear how to adjudicate between these competing principles (MacFarlane, 2009). Properly trained IRB members will be best positioned to reach optimal decisions when they are given freedom to exercise their judgment as regulators of research ethics. Meetings of the convened board should focus on research ethics, directly informed by knowledge of the science. We expect that incorporating the lessons of virtue ethics into the training of IRB members will improve quantifiable decision-making skills. The ability to discern which ethical questions are most pertinent, and when the specifics of a case demand prioritization of one or another principle it is invaluable. Virtue ethics focuses on the importance of developing the habits of mind and character to engage and resolve ethical dilemmas while embracing, not forsaking, ethical principles. Similarly, principle-based ethical theories do not give clear instructions about how to handle conflicts between principles. These regulations are necessary to ensure that research meets a minimum acceptable standard for research conduct, and to provide a means to enforce that standard (Martin and Lantos, 2005). Several ethicists have described and criticized the variability in IRB ethics reviews (Freedman et al., 1993; Shah et al., 2004; Silverman et al., 2001), particularly because variability in review can hinder or complicate the conduct of multi-site studies (Kahn et al., 2014; Petersen et al., 2012; Ravina et al., 2010). The simple guide to ‘act virtuously’ does not always suggest a solution to an ethical dilemma (Resnik, 2012). Virtue ethics, in contrast, take a very different perspective. Connection Between Faith and Theism, Religion, Atheism, Ethics: Descriptive, Normative, and Analytic. This is by no means an obvious truth. According to Aristotle, when people acquire good habits of character, they are better able to regulate their emotions and their reason. We do not propose that moral action need be motivated exclusively or even primarily by a desire to increase in virtue, though we recognize that living virtuously is often rewarding and generally habit-forming. It is often contrasted with deontology, which emphasizes following moral rules, and consequentialism, which determines the permissibility of an action from its consequences. The value of discussing challenging cases is enhanced when members are taught to pinpoint areas of conflict and to articulate how they would resolve the conflict. Given these dual goals of protecting human subjects and of supporting valuable research, IRBs must often consider conflicting interests in determining whether to approve a particular research study. Following role models, or doing what a virtuous person would do, is not mere mimicry. Real-life cases that challenge IRBs offer valuable opportunities for education. Investigators are a further potential source of quantifiable feedback for the IRB. Sign in here to access free tools such as favourites and alerts, or to access personal subscriptions, If you have access to journal content via a university, library or employer, sign in here, Research off-campus without worrying about access issues. These individuals are already sufficiently interested in research ethics to contribute significant time and energy toward helping to ensure that valuable research is carried out in a context that protects human subjects. Training in the virtues, particularly in the virtue of practical wisdom, helps us to assign the proper weight to competing claims in a particular context so that we can most appropriately adjudicate between them. Virtue ethics is a moral theory that emphasizes the role of an individual's character and virtues in evaluating the rightness of actions. Rather than trust in edicts, virtue ethics would encourage us to put our trust in IRBs staffed by people who are well-trained in the virtues and dedicated to navigating the best possible path through a complex and changing landscape. For example, the IRB staff should identify special populations affected by the research, prompting the board to make the required determinations regarding inclusion of vulnerable populations. To say that certain virtues are necessary for correct moral decisions is to say that correct moral decisions require correct motives. The value of a clear report of the IRB deliberation process and careful articulation of the IRB’s reasoning in this context should not be overlooked. It is often contrasted with deontology, which emphasizes following moral rules, and consequentialism, which determines the permissibility of an action from its consequences. Annas describes that the virtuous moral actor ‘responds directly to the situation in an intelligent way, one which takes account of all the relevant factors’ (Annas, 2011). Many common moral decisions may indeed come more easily to a person of the “right” moral character. IRB chairs also have the opportunity to educate investigators when they communicate the decisions of the IRB. For example, in Normative Virtue Ethics, Hursthouse (2003) writes "honesty points to telling the hurtful truth, kindness and compassion (point us) to remaining silent or even lying" (p. 28). Regulations can then be put in place to ensure that minimal standards are met, allowing for IRBs and researchers to customize approaches when appropriate. These not only shrink professional latitude, as noted above, but also diminish the professional as a person’ (Pellegrino, 2007: 178). Virtue theory accepts the importance of intentions and consequences but rejects as rationalistic and unrealistic view of ethics in the other approaches and sees ethical actions as combining reason and emotions. It is one of three major moral theories. We are optimistic that eudaimonia will motivate and guide IRB members to engage in the thoughtful practice necessary to cultivate the virtues and skills that IRB work requires. What actions will be characteristic of the sort of person I want to be. Virtue-based ethical theories place less emphasis on which rules people should follow and instead focus on helping people develop good character traits, such as kindness and generosity. Instead, virtue theories of ethics should be treated as ways to understand how we become moral creatures. Some have criticized virtue ethics on the grounds that virtue ethics is not sufficient to explain why people should act rightly, that virtue ethics is not necessary to account for the intrinsic value of the virtues, and that virtue ethics focuses on the agent’s flourishing or ‘admirability’ when, intuitively, our ethics should be motivated by the opportunity to improve the lives of others (Hurka, 2001). Virtue ethics is a philosophy developed by Aristotle and other ancient Greeks. Austin Cline, a former regional director for the Council for Secular Humanism, writes and lectures extensively about atheism and agnosticism. Rather, principles and regulations present often-conflicting claims for the IRB to adjudicate. How do institutional review boards apply the federal risk and benefit standards for pediatric research? “Be virtuous” isn’t very practical. IRB review is made up of three overlapping and interactive components: regulatory, scientific, and ethical. This is because they focus entirely on the actions which a person performs. Below, we reframe research oversight, drawing specifically on this complementary relationship between principles and virtues. Sharing links are not available for this article. Research regulations can prevent much wrongdoing, but they cannot address the specifics of every case, so they do not always suffice in novel situations. IRB members should be selected in large part on the basis of scientific expertise and research experience in addition to a commitment to research ethics. Our proposal that excellence in research ethics requires limited regulation and greater latitude for IRBs to exercise their judgment can only be considered in the context of a firm commitment to IRB training and education and to deliberating within a virtue ethics framework. Another problem with virtue-based ethical systems is the question of what the “right” sort of character is. This product could help you, Accessing resources off campus can be a challenge. Ethics, Morals, and Values: How Do They Relate? This can differ from one society to another. We need the negative traits to admire the positive ones. Specifically, IRBs should be organized so that IRB members educated in research ethics principles and trained in the relevant virtues can best deliberate and resolve major ethical issues (Figure 2). In our discussion below, we describe how the lessons of virtue ethics can help us reshape and reform IRBs to ensure that all research undergoes careful ethical review. Beliefs and Choices: Do You Choose Your Religion? In their 2002 report, Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct, the Institute of Medicine concludes that ‘the principal mode for evaluation of the effectiveness of an integrated program should be based on self-assessment and peer review … in the context of institutional accreditation’ (Institute of Medicine, 2002: 112). Susan Wolf claims that if everyone is virtuous there will be no variety or excitement in the world. In the following sections, we argue for virtue ethics inspired revisions to (i) how IRBs are structured, (ii) how IRB members are trained and educated, and (iii) how we determine the appropriate limits of regulations in research ethics oversight. The usual on-line training courses for human subject protections and good clinical practice provide an important basic exposure to research regulations and research ethics. On this matter, virtue ethics can be attractive. What this means is that virtue theories should not be contrasted with theories about how to make moral choices, like the teleological theory of John Stuart Mill or the deontological theory of Immanuel Kant. If you want someone to learn ethics, show them an ethical person. In addition, how we develop the means by which we make moral decisions and the process by which moral attitudes develop. The importance of virtue ethics in the IRB Marilyn C Morris Columbia University, USA Jason Z Morris Fordham University, USA Abstract Institutional review boards have a dual goal: first, to protect the rights and welfare of human research subjects, and second, to support and facilitate the conduct of valuable research. This self-assessment and peer-review approach is consistent with that used by the IRB accrediting organization, Association for the Accreditation of Human Research Protection Programs (AAHRPP, http://www.aahrpp.org). Consequentialism makes an appearance in research regulations and research ethics when we stipulate that the potential benefit of research (including future benefits to individuals not involved in the research) must be proportionate to the risks borne by study subjects. Even though that behavior is to be expected on the job, seeing examples of it at work can make an employee stand-out from their colleagues. Practical wisdom develops through experience and manifests as excellence in deliberation, helping people discern when a situation calls out for which particular virtues (Annas, 2011; Hursthouse, 2006; Russell, 2009). Adherents of principle-based ethics recognize the importance of practical wisdom as well, because correct application of principles ‘requires situational appreciation—the capacity to recognise, in any particular situation, those features of it that are morally salient’ (Hursthouse, 2013). An excellent IRB staff will ensure that all required components of the protocol and the consent form are present before the protocol proceeds to board review. In addition to training IRB members, a robust research ethics education program must include the broader community of researchers. This goes beyond simply obeying the rules or seeking an optimal outcome. So the virtue is only justified because of the consequences it brings about. In the discussion below, we characterize research oversight as having three elements: (i) research regulations, which establish a minimum acceptable standard for research conduct; (ii) ethical principles, which help us identify and define relevant ethical issues; and (iii) virtue ethics, which guides the prioritization of relevant issues. All investigators must successfully complete these before their research on human subjects is approved. Furthermore, an individual can deem something to be morally good while the society may not. As medical technology and research methodologies evolve, IRBs are continually faced with novel research ethics quandaries. The administrative staff should also take primary responsibility for ensuring that all approved protocols are fully compliant with research regulations. In the West, virtue ethics’ founding fathers are Plato andAristotle, and in the East it can be traced back to Mencius andConfucius. Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Board reviewers are primarily responsible for understanding and evaluating these risks and potential benefits. Virtue ethics emphasizes the central role played by motives in moral questions. IRBs must review proposed research that impacts two distinct groups of stakeholders: the future subjects of the research and the investigators conducting the research. A clinical research ethics consortium, convened by the Berman Institute of Bioethics, identifies the lack of an ‘effective mechanism for IRBs to address major ethical issues’ as among the foremost problems with the current research review system in the United States (Emanuel et al., 2004). This is one reason why they can be popular and why they make an important contribution to our understanding of morality. Nevertheless, when someone chooses which actions to carry out, those choices reflect his or her character. The training of new IRB members should consist of practice in the following: (a) identifying the principles at stake in a particular case; (b) identifying how these principles may come into conflict; and (c) discussing how different decisions might adjudicate these conflicts. Some more modern ethicists posit that ‘role-differentiated virtues’ exist for different professions (Oakley, 2013). The importance of this point of eudaimonistic virtue ethics is that it reverses the relationship between virtue and rightness. The Advantages of Virtue Ethics . Education of IRB members should be designed to foster the virtues that promote excellence in research review. A resolute chair will engage directly and extensively with the researchers as well as with his or her board to resolve problems, but will not yield to expediency if an ethically sound approach cannot be found. Virtue ethics also strongly emphasizes that individuals can be trained in the virtues so that they develop excellent habits of mind. Key questions which virtue ethical systems ask include: The reality of virtue ethics isn’t as neat and simple as some might imagine. To act from virtue is to … The Institute of Medicine (IOM) has pointed out that other responsibilities that fall to IRBs (e.g. Surveys have been used to assess the utility of training in the responsible conduct of research in preparing participants to recognize, avoid, and respond to research misconduct (Plemmons et al., 2006). Virtue theories promise that once we are successful in creating the sort of person we want to be, arriving at the correct moral decisions will come naturally. Login failed. Virtue ethics is based in Aristotelian philosophy and was a dominant influence in the classical period, though it was later eclipsed by principle-based ethical philosophies. The first systematic description of virtue ethics was written down by Aristotle in his famous work "Nichomachean Ethics.". Research regulations are explicit rules that guide IRBs in their determinations. They say its principles aren’t specific enough to help us overcome difficult ethical conundrums. FundingThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Pellegrino emphasizes the critical need for a ‘moral foundation’ for professionalism. Virtue ethics, by contrast, focuses on the development of the character of the individual who must confront ethical dilemmas. Other moral theories share a common difficulty not found in virtue ethics. This, in turn, helps us reach morally correct decisions when we are faced with difficult choices. Aristotle’s virtue ethics theory is important in addressing many ethical problems in business and organization management because virtue and moral character “provides the wisdom necessary for applying rules in particular instances” (Hinman, 2006). Perhaps a key to understanding virtue theories of ethics is to regard them as ways to approach moral psychology rather than moral epistemology, or knowledge. There are almost as many lists of important virtues as there are philosophers interested in the concept of virtue. Variability among institutional review boards’ decisions within the context of a multicenter trial, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (last amended 2008), Revista Iberoamericana de Educación Superior, SAGE Publications Ltd unless otherwise noted. Plato identified wisdom, temperance, justice and courage as cardinal virtues (Plato, 360 BCE). Calming the ‘perfect ethical storm’: a virtue-based approach to resear... Aristotle (350 BCE) Rhetoric. More importantly, virtue theories may be able to teach us how morals themselves should be taught. We do believe it would be valuable for IRB members, however, perhaps as a yearly group session. Find out about Lean Library here, If you have access to journal via a society or associations, read the instructions below. 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