The Declaration of Helsinki ( DoH , Finnish : Helsingin julistus ) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics .
193-531: Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics ), including those emerging from advances in biology , medicine , and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment , well-being and public health . Bioethics
386-421: A "set of medical conditions" as opposed to the storied and spiritual beings that they are. Bioethics in the realm of Islam differs from Western bioethics, but they share some similar perspectives viewpoints as well. Western bioethics is focused on rights, especially individual rights. Islamic bioethics focuses more on religious duties and obligations, such as seeking treatment and preserving life. Islamic bioethics
579-426: A certain manner by being wholeheartedly committed to this manner. Virtues contrast with vices , which are their harmful counterparts. Virtue theorists usually say that the mere possession of virtues by itself is not sufficient. Instead, people should manifest virtues in their actions. An important factor is the practical wisdom, also called phronesis , of knowing when, how, and which virtue to express. For example,
772-428: A certain standpoint. Moral standpoints may differ between persons, cultures, and historical periods. For example, moral statements like "Slavery is wrong" or "Suicide is permissible" may be true in one culture and false in another. Some moral relativists say that moral systems are constructed to serve certain goals such as social coordination. According to this view, different societies and different social groups within
965-399: A characterization of what is good and then define what is right in terms of what is good. For example, classical utilitarianism says that pleasure is good and that the action leading to the most overall pleasure is right. Consequentialism has been discussed indirectly since the formulation of classical utilitarianism in the late 18th century. A more explicit analysis of this view happened in
1158-454: A child on fire for fun, normative ethics aims to find more general principles that explain why this is the case, like the principle that one should not cause extreme suffering to the innocent , which may itself be explained in terms of a more general principle. Many theories of normative ethics also aim to guide behavior by helping people make moral decisions . Theories in normative ethics state how people should act or what kind of behavior
1351-457: A clarification footnote. Article 27 expanded the concept of publication ethics, adding the necessity to disclose conflict of interest (echoed in Articles 13 and 22), and to include publication bias amongst ethically problematic behavior. The most controversial revisions (Articles 29, 30) were placed in this new category. These predictably were those that like the fourth revision were related to
1544-446: A considerable body of literature on these matters. In the case of many non-Western cultures, a strict separation of religion from philosophy does not exist. In many Asian cultures, for example, there is a lively discussion on bioethical issues. Buddhist bioethics, in general, is characterized by a naturalistic outlook that leads to a rationalistic, pragmatic approach. Buddhist bioethicists include Damien Keown . In India, Vandana Shiva
1737-519: A control group, if any—should be assured of the best proven diagnostic and therapeutic method."). Critics claimed that the Zidovudine trials in developing countries were in breach of this because Zidovudine was now the best proven treatment and the placebo group should have been given it. This led to the US Food and Drug Administration (FDA) ignoring this and all subsequent revisions. Following
1930-610: A controversy over a specific series of trials and their designs in Sub-Saharan Africa, now had potential implications for all research. These implications further came into public view since the Helsinki declaration had stated, "In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement, it offers hope of saving life, reestablishing health or alleviating suffering." Even though most meetings about
2123-470: A diversity of viewpoints. A universal moral norm is seen as valid if all rational discourse participants do or would approve. This way, morality is not imposed by a single moral authority but arises from the moral discourse within society. This discourse should aim to establish an ideal speech situation to ensure fairness and inclusivity. In particular, this means that discourse participants are free to voice their different opinions without coercion but are at
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#17327802695702316-558: A final rule was issued on April 28, 2008, replacing the Declaration of Helsinki with Good Clinical Practice effective October 2008. This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States. The NIH training in human subject research participant protection no longer refers to the Declaration of Helsinki. The European Union similarly only cites
2509-515: A fulfillment of the prophecy in Isaiah 53:5 : "He took up our infirmities and carried our diseases". Jesus endorsed the use of the medical assistance of the time (medicines of oil and wine) when he told the parable of the Good Samaritan (Luke 10:25–37), who "bound up [an injured man's] wounds, pouring on oil and wine" (verse 34) as a physician would. Jesus then told the doubting teacher of
2702-405: A fundamental part of reality and can be reduced to other natural properties, such as properties describing the causes of pleasure and pain . Declaration of Helsinki It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations. Its role
2895-471: A further note of clarification that was incorporated. In this clarification the issue of post trial care now became something to consider, not an absolute assurance. Despite these changes, as Macklin predicted, consensus was no closer and the Declaration was considered by some to be out of touch with contemporary thinking, and even the question of the future of the Declaration became a matter for conjecture. Considerable deliberation has taken place regarding
3088-479: A healthcare provider, it is important to know and understand varying world views and religious beliefs. Having this knowledge and understanding can empower healthcare providers with the ability to better treat and serve their patients. Developing a connection and understanding of a patient's moral agent helps enhance the care provided to the patient. Without this connection or understanding, patients can be at risk of becoming "faceless units of work" and being looked at as
3281-436: A human child can only be proper and legitimate via marriage. This does not mean that a child can only be reproduced via sexual intercourse between a married couple, but that the only proper and legitimate way to have a child is when it is an act between husband and wife. It is okay for a married couple to have a child artificially and from techniques using modern biotechnology as opposed to sexual intercourse, but to do this out of
3474-515: A lack of practical wisdom may lead courageous people to perform morally wrong actions by taking unnecessary risks that should better be avoided. Different types of virtue ethics differ on how they understand virtues and their role in practical life. Eudaimonism is the original form of virtue theory developed in Ancient Greek philosophy and draws a close relation between virtuous behavior and happiness. It states that people flourish by living
3667-549: A means to promote their self-interest. Ethical egoism is often criticized as an immoral and contradictory position. Normative ethics has a central place in most religions . Key aspects of Jewish ethics are to follow the 613 commandments of God according to the Mitzvah duty found in the Torah and to take responsibility for societal welfare . Christian ethics puts less emphasis on following precise laws and teaches instead
3860-536: A more expansive application, touching upon the philosophy of science and issues of biotechnology . The two fields often overlap, and the distinction is more so a matter of style than professional consensus. Medical ethics shares many principles with other branches of healthcare ethics, such as nursing ethics . A bioethicist assists the health care and research community in examining moral issues involved in our understanding of life and death, and resolving ethical dilemmas in medicine and science. Examples of this would be
4053-459: A noticeable trend toward more frequent changes in the Declaration of Helsinki (DoH). However, it's important to note that only two of the revisions, in 1975 and 2000, introduced significant alterations. This means that there was an 11-year gap between comprehensive revisions (from 1964 to 1975) and a 25-year gap (from 1975 to 2000), respectively. Consequently, the DoH, essentially in its 1975 version, had
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#17327802695704246-933: A number of available tools which compare these. Other countries have guides with similar roles, such as the Tri-Council Policy Statement in Canada. Additional international guidelines include those of the CIOMS , Nuffield Council and UNESCO . The Declaration was originally adopted in June 1964 in Helsinki , Finland , and has since undergone eight revisions (the most recent at the General Assembly in October 2024) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in
4439-428: A pathway of healing in which God uses both the natural and the supernatural to heal. Being healed has been described as a privilege of accepting Christ's redemption on the cross. Pentecostal writer Wilfred Graves Jr. views the healing of the body as a physical expression of salvation . Matthew 8:17 , after describing Jesus exorcising at sunset and healing all of the sick who were brought to him, quotes these miracles as
4632-550: A person should tell the truth even in specific cases where lying would lead to better consequences. Another disagreement is between actual and expected consequentialism. According to the traditional view, only the actual consequences of an act affect its moral value. One difficulty of this view is that many consequences cannot be known in advance. This means that in some cases, even well-planned and intentioned acts are morally wrong if they inadvertently lead to negative outcomes. An alternative perspective states that what matters are not
4825-401: A pleasurable experience has a high value if it has a high intensity and lasts for a long time. A common criticism of Bentham's utilitarianism argued that its focus on the intensity of pleasure promotes an immoral lifestyle centered around indulgence in sensory gratification. Mill responded to this criticism by distinguishing between higher and lower pleasures. He stated that higher pleasures, like
5018-456: A proposed revision in November that year, and a proposed revision (17.C/Rev1/99) was circulated the following year, causing considerable debate and resulting in a number of symposia and conferences. Recommendations included limiting the document to basic guiding principles. Many editorials and commentaries were published reflecting a variety of views including concerns that the Declaration
5211-526: A quarter-century to establish itself within the medical research community, and this has significantly contributed to its current status. One potential explanation is that it derives its legitimacy from being an official declaration of the World Medical Association (WMA). This organization represents the largest global assembly of physicians, and consequently, it could be argued that the WMA
5404-446: A requirement for treatment and compensation for injuries related to research. In addition, the updated version is felt to be more relevant to limited resource settings—specifically addressing the need to ensure access to an intervention if it is proven effective. The eighth revision of Helsinki (2024) newly highlights the roles of global inequities in medical research and includes a new statement that scientific integrity "is essential in
5597-683: A second draft in May. Further workshops were held in Cairo and São Paulo and the comments collated in August 2008. A final text was then developed by the Working Group for consideration by the Ethics Committee and finally the General Assembly, which approved it on October 18. Public debate was relatively slight compared to previous cycles, and in general supportive. Input was received from
5790-495: A shift in bioethics that utilizes indigenous African philosophy rather than western philosophy. Some African bioethicists also believe that Africans will be more likely to accept a bioethical approach grounded in their own culture, as well as empower African people. Masahiro Morioka argues that in Japan the bioethics movement was first launched by disability activists and feminists in the early 1970s, while academic bioethics began in
5983-464: A situation, regardless of their specific role or position. Immanuel Kant (1724–1804) is one of the most well-known deontologists. He states that reaching outcomes that people desire, such as being happy, is not the main purpose of moral actions. Instead, he argues that there are universal principles that apply to everyone independent of their desires. He uses the term categorical imperative for these principles, saying that they have their source in
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6176-725: A small set of basic rules that address all or at least the most important moral considerations. One difficulty for systems with several basic principles is that these principles may conflict with each other in some cases and lead to ethical dilemmas . Distinct theories in normative ethics suggest different principles as the foundation of morality. The three most influential schools of thought are consequentialism , deontology , and virtue ethics . These schools are usually presented as exclusive alternatives, but depending on how they are defined, they can overlap and do not necessarily exclude one another. In some cases, they differ in which acts they see as right or wrong. In other cases, they recommend
6369-425: A society construct different moral systems based on their diverging purposes. Emotivism provides a different explanation, stating that morality arises from moral emotions, which are not the same for everyone. Moral nihilists deny the existence of moral facts. They reject the existence of both objective moral facts defended by moral realism and subjective moral facts defended by moral relativism. They believe that
6562-506: A study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries. The wording of the fourth and fifth revisions reflect the position taken by Rothman and Michel and Freedman et al., known as 'active-control orthodoxy'. The opposing view, as expressed by Levine and by Temple and Ellenberg is referred to as 'placebo orthodoxy', insisting that placebo controls are more scientifically efficient and are justifiable where
6755-557: A virtuous life. Eudaimonist theories often hold that virtues are positive potentials residing in human nature and that actualizing these potentials results in leading a good and happy life. Agent-based theories, by contrast, see happiness only as a side effect and focus instead on the admirable traits and motivational characteristics expressed while acting. This is often combined with the idea that one can learn from exceptional individuals what those characteristics are. Feminist ethics of care are another form of virtue ethics. They emphasize
6948-524: A wide number of sources, some of which have been published, such as Feminist Approaches to Bioethics . Others include CIOMS and the US Government. The seventh revision of Helsinki (2013) was reflective of the controversy regarding the standard of care that arose from the vertical transmission trials. The revised declaration of 2013 also highlights the need to disseminate research results, including negative and inconclusive studies and also includes
7141-426: Is a credible and authoritative entity for issuing statements on behalf of the medical profession as a whole. However, a historical observation appears to challenge the notion that this explains the Declaration of Helsinki's authority. It can be argued that the Declaration was most widely accepted as an authoritative document during the period from the late 1970s (after the 1975 amendment had been widely promulgated) to
7334-541: Is a leading bioethicist speaking from the Hindu tradition. In Africa, and partly also in Latin America, the debate on bioethics frequently focuses on its practical relevance in the context of underdevelopment and geopolitical power relations. In Africa, their bioethical approach is influenced by and similar to Western bioethics due to the colonization of many African countries. Some African bioethicists are calling for
7527-487: Is a moral obligation to refrain from lying. Because it relies on consent, contractualism is often understood as a patient-centered form of deontology. Famous social contract theorists include Thomas Hobbes , John Locke , Jean-Jacques Rousseau , and John Rawls . Discourse ethics also focuses on social agreement on moral norms but says that this agreement is based on communicative rationality . It aims to arrive at moral norms for pluralistic modern societies that encompass
7720-412: Is about what people ought to do rather than what they actually do, what they want to do, or what social conventions require. As a rational and systematic field of inquiry, ethics studies practical reasons why people should act one way rather than another. Most ethical theories seek universal principles that express a general standpoint of what is objectively right and wrong. In a slightly different sense,
7913-420: Is also a controversial gene therapy called "germline gene therapy", in which genes in a sperm or egg can be edited to prevent genetic disorder in the future generation . It is unknown how this type of gene therapy affects long-term human development. In the United States, federal funding cannot be used to research germline gene therapy. The ethical challenges in gene therapy for rare childhood diseases underscore
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8106-531: Is another important approach. These latter research cover topics including connections between doctors and patients, coping mechanisms, and social support. The description of other important fields of medical sociology study emphasizes how theory and research have changed in the twenty-first century. Bioethicists come from a wide variety of backgrounds and have training in a diverse array of disciplines. The field contains individuals trained in philosophy such as Baruch Brody of Rice University , Julian Savulescu of
8299-476: Is better than an unequal distribution even if the aggregate good is the same. There are disagreements about which consequences should be assessed. An important distinction is between act consequentialism and rule consequentialism. According to act consequentialism, the consequences of an act determine its moral value. This means that there is a direct relation between the consequences of an act and its moral value. Rule consequentialism, by contrast, holds that an act
8492-410: Is between naturalism and non-naturalism. Naturalism states that moral properties are natural properties accessible to empirical observation . They are similar to the natural properties investigated by the natural sciences , like color and shape. Some moral naturalists hold that moral properties are a unique and basic type of natural property. Another view states that moral properties are real but not
8685-464: Is concerned with the ethical questions that arise in the relationships among life sciences , biotechnology , medicine , politics , law , theology and philosophy . It includes the study of values relating to primary care, other branches of medicine (" the ethics of the ordinary "), ethical education in science, animal, and environmental ethics , and public health. The term bioethics ( Greek bios , "life"; ethos , "moral nature, behavior")
8878-461: Is correct. They do not aim to describe how people normally act, what moral beliefs ordinary people have, how these beliefs change over time, or what ethical codes are upheld in certain social groups. These topics belong to descriptive ethics and are studied in fields like anthropology , sociology , and history rather than normative ethics. Some systems of normative ethics arrive at a single principle covering all possible cases. Others encompass
9071-593: Is credited with being one of the first full-length books published on the topic of feminist bioethics and points out the shortcomings in then-current bioethical theories. Sherwin's viewpoint incorporates models of oppression within healthcare that intend to further marginalize women, people of color, immigrants, and people with disabilities. Since created in 1992, the International Journal of Feminist Approaches to Bioethics has done much work to legitimize feminist work and theory in bioethics. By pointing out
9264-456: Is embedded in and relative to social and cultural contexts. Pragmatists tend to give more importance to habits than to conscious deliberation and understand morality as a habit that should be shaped in the right way. Postmodern ethics agrees with pragmatist ethics about the cultural relativity of morality. It rejects the idea that there are objective moral principles that apply universally to all cultures and traditions. It asserts that there
9457-537: Is found in Jainism , which has non-violence as its principal virtue. Duty is a central aspect of Hindu ethics and is about fulfilling social obligations, which may vary depending on a person's social class and stage of life . Confucianism places great emphasis on harmony in society and sees benevolence as a key virtue. Taoism extends the importance of living in harmony to the whole world and teaches that people should practice effortless action by following
9650-637: Is founded on the Qur'an, the Sunnah, and reason (al-'aql), much like any other inquiry into Islam. Sunni Muslims may use terms like ijmaa' (consensus) and qiyas in place of reason (analogy). Ijmaa' and qiyas as such are not recognized by Shi'a since they are insufficient proofs on their own. In Christian bioethics it is noted that the Bible, especially the New Testament , teaches about healing by faith. Healing in
9843-490: Is heavily influenced and connected to the teachings of the Qur'an as well as the teachings of Muhammad . These influences essentially make it an extension of Shariah or Islamic Law. In Islamic bioethics, passages from the Qur'an are often used to validate various medical practices. For example, a passage from the Qur'an states "whosoever killeth a human being ... it shall be as if he had killed all humankind, and whosoever saveth
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#173278026957010036-400: Is how social stratification (based on SES, gender, class, ethnicity, and age) affects patterns of behavior related to health and sickness, illness risk, disability, and other outcomes related to health care. The study of health care organization and provision, which encompasses the evolving organizational structures of health care organizations and the social psychology of health and health care,
10229-455: Is in compliance with the Declaration (Article 14). Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Information regarding the study should be publicly available (Article 16). Ethical principles extend to publication of the results and consideration of any potential conflict of interest (Article 27). Experimental investigations should always be compared against
10422-470: Is morally right. Its main branches include normative ethics , applied ethics , and metaethics . Normative ethics aims to find general principles that govern how people should act. Applied ethics examines concrete ethical problems in real-life situations, such as abortion , treatment of animals , and business practices . Metaethics explores the underlying assumptions and concepts of ethics. It asks whether there are objective moral facts, how moral knowledge
10615-736: Is no one coherent ethical code since morality itself is irrational and humans are morally ambivalent beings. Postmodern ethics instead focuses on how moral demands arise in specific situations as one encounters other people. Ethical egoism is the view that people should act in their self-interest or that an action is morally right if the person acts for their own benefit. It differs from psychological egoism , which states that people actually follow their self-interest without claiming that they should do so. Ethical egoists may act in agreement with commonly accepted moral expectations and benefit other people, for example, by keeping promises, helping friends, and cooperating with others. However, they do so only as
10808-520: Is not against Islamic law but is nonetheless condemned by Islamic ethics. Or there can be circumstances that, while not required by Islamic law, are essential from an ethical standpoint. For instance, while idle conversation is not strictly forbidden by Islamic law, it is morally unacceptable since it wastes time and is detrimental to one's spiritual growth. The night prayers are another illustration (which should be performed after midnight and before dawn). Islamic bioethics' first influences Islamic bioethics
11001-651: Is not interested in which actions are right but in what it means for an action to be right and whether moral judgments are objective and can be true at all. It further examines the meaning of morality and other moral terms. Metaethics is a metatheory that operates on a higher level of abstraction than normative ethics by investigating its underlying assumptions. Metaethical theories typically do not directly judge which normative ethical theories are correct. However, metaethical theories can still influence normative theories by examining their foundational principles. Metaethics overlaps with various branches of philosophy. On
11194-446: Is one of the earliest forms of consequentialism. It arose in the 5th century BCE and argued that political action should promote justice as a means to increase the welfare of the people. The most well-known form of consequentialism is utilitarianism. In its classical form, it is an act consequentialism that sees happiness as the only source of intrinsic value. This means that an act is morally right if it produces "the greatest good for
11387-443: Is possible, and how moral judgments motivate people. Influential normative theories are consequentialism , deontology , and virtue ethics . According to consequentialists, an act is right if it leads to the best consequences. Deontologists focus on acts themselves, saying that they must adhere to duties , like telling the truth and keeping promises. Virtue ethics sees the manifestation of virtues , like courage and compassion , as
11580-422: Is primarily concerned with normative statements about what ought to be the case, in contrast to descriptive statements , which are about what is the case. Duties and obligations express requirements of what people ought to do. Duties are sometimes defined as counterparts of the rights that always accompany them. According to this view, someone has a duty to benefit another person if this other person has
11773-407: Is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor (Articles 23, 24), then allowance should be considered for surrogate consent by an individual acting in the participant's best interest, although his or her consent should still be obtained if at all possible (Article 25). Research should be based on a thorough knowledge of
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#173278026957011966-438: Is right if it follows a certain set of rules. Rule consequentialism determines the best rules by considering their outcomes at a community level. People should follow the rules that lead to the best consequences when everyone in the community follows them. This implies that the relation between an act and its consequences is indirect. For example, if telling the truth is one of the best rules, then according to rule consequentialism,
12159-617: Is seen as acceptable ethics now may not be so one hundred years ago. The hospital administrator is required to have a thorough awareness of their moral and legal obligations. The practice of bioethics in clinical care have been studied by medical sociology . Many scholars consider that bioethics arose in response to a perceived lack of accountability in medical care in the 1970s. Studying the clinical practice of ethics in medical care, Hauschildt and Vries found that ethical questions were often reframed as clinical judgments to allow clinicians to make decisions. Ethicists most often put key decisions in
12352-460: Is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the participant's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9). The recognition of the increased vulnerability of individuals and groups calls for special vigilance (Article 8). It
12545-480: Is spelt out in Articles 18–9, and they are referred to in Article 8 ('those who will not benefit personally from the research') as being especially vulnerable. The scope of ethical review was increased to include human tissue and data (Article 1), the necessity to challenge accepted care was added (Article 6), as well as establishing the primacy of the ethical requirements over laws and regulations (Article 9). Amongst
12738-418: Is that Islamic ethics seeks to teach those with higher desires how to become more perfect and closer to God, but Islamic law seeks to decrease criteria for perfection or pleasure in both realms that are doable for the average or even lower than average. So whatever is deemed essential or required by Islamic law is undoubtedly viewed the same way by Islamic ethics. However, there may be situations where something
12931-533: Is the field of feminism; the International Journal of Feminist Approaches to Bioethics has played an important role in organizing and legitimizing feminist work in bioethics. Many religious communities have their histories of inquiry into bioethical issues and have developed rules and guidelines on how to deal with these issues from within the viewpoint of their respective faiths . The Jewish , Christian and Muslim faiths have each developed
13124-422: Is the only thing with intrinsic value is called ethical or evaluative hedonism . Classical utilitarianism was initially formulated by Jeremy Bentham at the end of the 18th century and further developed by John Stuart Mill . Bentham introduced the hedonic calculus to assess the value of consequences. Two key aspects of the hedonic calculus are the intensity and the duration of pleasure. According to this view,
13317-408: Is the philosophical study of ethical conduct and investigates the fundamental principles of morality . It aims to discover and justify general answers to questions like "How should one live?" and "How should people act?", usually in the form of universal or domain-independent principles that determine whether an act is right or wrong. For example, given the particular impression that it is wrong to set
13510-604: Is the study of moral values and judgments as they apply to medicine . The four main moral commitments are respect for autonomy, beneficence, nonmaleficence, and justice. Using these four principles and thinking about what the physicians' specific concern is for their scope of practice can help physicians make moral decisions. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology. Medical ethics tends to be understood narrowly as applied professional ethics; whereas bioethics has
13703-414: Is thought to create power imbalances that favor men. These power imbalances are theorized to be created from the androcentric nature of medicine. One example of a lack of consideration of women is in clinical drug trials that exclude women due to hormonal fluctuations and possible future birth defects. This has led to a gap in the research on how pharmaceuticals can affect women. Feminist bioethicists call for
13896-437: Is to have a good will. A person has a good will if they respect the moral law and form their intentions and motives in agreement with it. Kant states that actions motivated in such a way are unconditionally good, meaning that they are good even in cases where they result in undesirable consequences. Divine command theory says that God is the source of morality. It states that moral laws are divine commands and that to act morally
14089-489: Is to obey and follow God's will . While all divine command theorists agree that morality depends on God, there are disagreements about the precise content of the divine commands, and theorists belonging to different religions tend to propose different moral laws. For example, Christian and Jewish divine command theorists may argue that the Ten Commandments express God's will while Muslims may reserve this role for
14282-421: Is wrong to break a promise even if no harm comes from it. Deontologists are interested in which actions are right and often allow that there is a gap between what is right and what is good. Many focus on prohibitions and describe which acts are forbidden under any circumstances. Agent-centered deontological theories focus on the person who acts and the duties they have. Agent-centered theories often focus on
14475-399: Is wrong. This observation is sometimes taken as an argument against moral realism since moral disagreement is widespread in most fields. Moral relativists reject the idea that morality is an objective feature of reality. They argue instead that moral principles are human inventions. This means that a behavior is not objectively right or wrong but only subjectively right or wrong relative to
14668-543: The American Medical Association presented the subsequent clarifying statement: The WMA reaffirms its stance that it is imperative, within the study planning phase, to identify provisions for post-trial access by research participants to prophylactic, diagnostic, and therapeutic procedures deemed beneficial in the study or to access to other appropriate healthcare. The specifics of post-trial access arrangements or alternative care should be outlined in
14861-409: The ancient period with the development of ethical principles and theories in ancient Egypt , India , China , and Greece . This period saw the emergence of ethical teachings associated with Hinduism , Buddhism , Confucianism , Daoism , and contributions of philosophers like Socrates and Aristotle . During the medieval period , ethical thought was strongly influenced by religious teachings. In
15054-402: The modern period , this focus shifted to a more secular approach concerned with moral experience, reasons for acting , and the consequences of actions. An influential development in the 20th century was the emergence of metaethics. Ethics, also called moral philosophy, is the study of moral phenomena. It is one of the main branches of philosophy and investigates the nature of morality and
15247-454: The "application of moral philosophy to concrete medical dilemmas". The discipline of bioethics has addressed a wide swathe of human inquiry; ranging from debates over the boundaries of lifestyles (e.g. abortion , euthanasia ), surrogacy, the allocation of scarce health care resources (e.g. organ donation , health care rationing ), to the right to refuse medical care for religious or cultural reasons. Bioethicists disagree among themselves over
15440-407: The 'risk of serious or irreversible harm' was considered low. Effectively this shifted the WMA position to what has been considered a 'middle ground'. Given the previous lack of consensus, this merely shifted the ground of debate, which now extended to the use of the 'or' connector. For this reason the footnote indicates that the wording must be interpreted in the light of all the other principles of
15633-728: The 1996 version in the EU Clinical Trials Directive published in 2001. The European Commission , however, does refer to the 2000 revision. While the Declaration has been a central document guiding research practice, its future has been called into question. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents. Another is whether it should concentrate on basic principles as opposed to being more prescriptive, and hence controversial. It has continually grown and faced more frequent revisions. The recent controversies undermine
15826-476: The 2024 version. The Declaration is an important document in the history of research ethics as it is the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents. Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a]. The Declaration developed
16019-532: The 20th century, virtue ethics experienced a resurgence thanks to philosophers such as Elizabeth Anscombe , Philippa Foot , Alasdair MacIntyre , and Martha Nussbaum . There are many other schools of normative ethics in addition to the three main traditions. Pragmatist ethics focuses on the role of practice and holds that one of the key tasks of ethics is to solve practical problems in concrete situations. It has certain similarities to utilitarianism and its focus on consequences but concentrates more on how morality
16212-404: The 20th century, when the term was coined by G. E. M. Anscombe . Consequentialists usually understand the consequences of an action in a very wide sense that includes the totality of its effects. This is based on the idea that actions make a difference in the world by bringing about a causal chain of events that would not have existed otherwise. A core intuition behind consequentialism is that
16405-826: The Ancient Greek word ēthikós ( ἠθικός ), which was translated into Latin as ethica and entered the English language in the 15th century through the Old French term éthique . The term morality originates in the Latin word moralis , meaning ' manners ' and ' character ' . It was introduced into the English language during the Middle English period through the Old French term moralité . The terms ethics and morality are usually used interchangeably but some philosophers distinguish between
16598-541: The Bible is often associated with the ministry of specific individuals including Elijah , Jesus and Paul . The largest group of miracles mentioned in the New Testament involves cures, the Gospels give varying amounts of detail for each episode, sometimes Jesus cures simply by saying a few words, at other times, he employs material such as spit and mud. Christian physician Reginald B. Cherry views faith healing as
16791-557: The Declaration. Article 30 was debated further at the 2003 meeting, with another proposed clarification but did not result in any convergence of thought, and so decisions were postponed for another year, but again a commitment was made to protecting the vulnerable. A new working group examined article 30, and recommended not amending it in January 2004. Later that year the American Medical Association proposed
16984-453: The US (CMAJ 2003, Blackmer 2005). The 2002 clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. As WMA states in the note, there appeared to be 'diverse interpretations and possibly confusion'. It then outlined circumstances in which a placebo might be 'ethically acceptable', namely 'compelling... methodological reasons', or 'minor conditions' where
17177-616: The US had essentially unrestricted access to the drug, while those in developing countries did not. Justification was provided by a 1994 WHO group in Geneva which concluded "Placebo-controlled trials offer the best option for a rapid and scientifically valid assessment of alternative antiretroviral drug regimens to prevent transmission of HIV". These trials appeared to be in direct conflict with recently published guidelines for international research by CIOMS , which stated "The ethical standards applied should be no less exacting than they would be in
17370-598: The United States to champion precisely such goals. Examples include the Ohio State Bioethics Society and the Bioethics Society of Cornell. Professional level versions of these organizations also exist. Many bioethicists, in particular scientific scholars, accord the easiest precedence to autonomy. They trust that every affected person ought to decide which direction of motion they think about most in line with their beliefs. In other words,
17563-686: The University of Oxford , Arthur Caplan of NYU , Peter Singer of Princeton University , Frances Kamm of Rutgers University , Daniel Callahan of the Hastings Center , and Daniel Brock of Harvard University ; medically trained clinician ethicists such as Mark Siegler of the University of Chicago and Joseph Fins of Cornell University ; lawyers such as Nancy Dubler of Albert Einstein College of Medicine or Jerry Menikoff of
17756-430: The actual consequences but the expected consequences. This view takes into account that when deciding what to do, people have to rely on their limited knowledge of the total consequences of their actions. According to this view, a course of action has positive moral value despite leading to an overall negative outcome if it had the highest expected value , for example, because the negative outcome could not be anticipated or
17949-529: The agent. It is controversial whether agent-relative moral theories, like ethical egoism , should be considered as types of consequentialism. There are many different types of consequentialism. They differ based on what type of entity they evaluate, what consequences they take into consideration, and how they determine the value of consequences. Most theories assess the moral value of acts. However, consequentialism can also be used to evaluate motives , character traits , rules, and policies . Many types assess
18142-494: The areas of clinical / medical ethics and research ethics . Slowly internationalizing as a field, since the 2000s professional bioethics has expanded to include other specialties, such as organizational ethics in health systems, public health ethics, and more recently Ethics of artificial intelligence . Professional ethicists may be called consultants , ethicists , coordinators , or even analysts ; and they may work in healthcare organizations, government agencies, and in both
18335-506: The authority of the document, as does the apparent desertion by major bodies, and any rewording must embrace deeply and widely held values, since continual shifts in the text do not imply authority. The actual claim to authority, particularly on a global level, by the insertion of the word "international" in article 10 has been challenged. Carlson raises the question as to whether the document's utility should be more formally evaluated, rather than just relying on tradition. There appears to be
18528-586: The autonomy of others ought to be respected. For people unable to exercise their autonomy, special measures ought to be taken to protect their rights and interests. In US, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was initially established in 1974 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. However,
18721-570: The basic assumptions underlying moral claims are misguided. Some moral nihilists conclude from this that anything is allowed. A slightly different view emphasizes that moral nihilism is not itself a moral position about what is allowed and prohibited but the rejection of any moral position. Moral nihilism, like moral relativism, recognizes that people judge actions as right or wrong from different perspectives. However, it disagrees that this practice involves morality and sees it as just one type of human behavior. A central disagreement among moral realists
18914-417: The best action for someone with a good salary would be to donate 70% of their income to charity, it would be morally wrong for them to only donate 65%. Satisficing consequentialism, by contrast, only requires that an act is "good enough" even if it is not the best possible alternative. According to this view, it is possible to do more than one is morally required to do. Mohism in ancient Chinese philosophy
19107-462: The best available care as a comparator (Article II.2), and access to such care was assured (Article I.3). The document was also made gender neutral. Subsequent revisions between 1975 and 2000 were relatively minor, so the 1975 version was effectively that which governed research over a quarter of a century of relative stability. The second revision (1983) included seeking the consent of minors where possible. The third revision (1989) dealt further with
19300-480: The best methods, but under certain circumstances a placebo or no treatment group may be utilized (Article 29). The interests of the participant after the study is completed should be part of the overall ethical assessment, including assuring their access to the best proven care (Article 30). Wherever possible unproven methods should be tested in the context of research where there is reasonable belief of possible benefit (Article 32). Investigators often find themselves in
19493-403: The biological, issues raised in public health such as vaccination and resource allocation have also encouraged the development of novel ethics frameworks to address such challenges. A study published in 2022 based on the corpus of full papers from eight main bioethics journals demonstrated the heterogeneity of this field by distinguishing 91 topics that have been discussed in these journals over
19686-521: The case of research carried out in country", referring to the sponsoring or initiating country. In fact a schism between ethical universalism and ethical pluralism was already apparent before the 1993 revision of the CIOMS guidelines. In retrospect, this was one of the most significant revisions because it added the phrase "This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists" to Article II.3 ("In any medical study, every patient--including those of
19879-505: The circumstances are what ethics is all about. It discusses the difference between what is proper and wrong at a certain moment and a particular society. Medical ethics is concerned with the duties that doctors, hospitals, and other healthcare providers have to patients, society, and other health professionals. The health profession has a set of ethical standards that are relevant to various organizations of health workers and medical facilities. Ethics are never stagnant and always relevant. What
20072-549: The claims that the continuing trials in developing countries were unethical, and pointing out a fundamental discrepancy in decisions to change the study design in Thailand but not Africa. The issue of the use of placebo in turn raised questions about the standard of care in developing counties and whether, as Marcia Angell wrote "Human subjects in any part of the world should be protected by an irreducible set of ethical standards" (1988). The American Medical Association put forward
20265-434: The common good, and the rights of the individual. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards. The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine was removed to emphasize the more general application of ethical principles, but the application of the principles to healthy volunteers
20458-534: The community as a whole by stating that 'research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research'. This new role for the Declaration has been both denounced and praised, Macklin R. Future challenges for the Declaration of Helsinki: Maintaining credibility in the face of ethical controversies. Address to Scientific Session, World Medical Association General Assembly, September 2003, Helsinki and even considered for
20651-455: The complexity of initiating trials, determining dosage levels, and involving affected families. With over a third of gene therapies targeting rare, genetic, pediatric-onset, and life-limiting diseases, fair participant selection and transparent engagement with patient communities become crucial ethical considerations. Another concern involves the use of virus-derived vectors for gene transfer, raising safety and hereditary implications. Additionally,
20844-537: The concept of oversight by an 'independent committee' (Article I.2) which became a system of Institutional Review Boards (IRB) in the US, and research ethics committees or ethical review boards in other countries. In the United States regulations governing IRBs came into effect in 1981 and are now encapsulated in the Common Rule . Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into
21037-459: The conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct". The controversies and national divisions over the text have continued. The US FDA rejected the 2000 and subsequent revisions, only recognizing the third (1989) revision, and in 2006 announced it would eliminate all reference to the Declaration. After consultation, which included expressions of concern,
21230-421: The consequences. A related approach is to characterize consequentialism not in terms of consequences but in terms of outcome, with the outcome being defined as the act together with its consequences. Most forms of consequentialism are agent-neutral. This means that the value of consequences is assessed from a neutral perspective, that is, acts should have consequences that are good in general and not just good for
21423-572: The context of marriage would be deemed immoral. Islamic bioethics is strongly against abortion and strictly prohibits it. The IOMS states that "from the moment a zygote settles inside a woman's body, it deserves a unanimously recognized degree of respect." Abortion may only be permitted in unique situations where it is considered to be the "lesser evil". Islamic bioethics may be used to find advice on practical matters relating to life in general and human life in particular. As we will see later, Islamic bioethics must take into account both moral concerns and
21616-577: The debate more carefully, exploring the broader social and ethical issues and the lived realities of potential subjects' lives as well as acknowledging the limitations of absolute universality in a diverse world, particularly those framed in a context that might be considered elitist and structured by gender and geographic identity. As Macklin points out, both sides may be right, since justice "is not an unambiguous concept". Eventually Notes of Clarification (footnotes) to articles 29 and 30 were added in 2002 and 2004 respectively, predominantly under pressure from
21809-423: The deficient state of cowardice and the excessive state of recklessness . Aristotle held that virtuous action leads to happiness and makes people flourish in life. Stoicism emerged about 300 BCE and taught that, through virtue alone, people can achieve happiness characterized by a peaceful state of mind free from emotional disturbances. The Stoics advocated rationality and self-mastery to achieve this state. In
22002-463: The end of life. In 1936, Ludwig Bieler argued that Jesus was stylized in the New Testament in the image of the "divine man" (Greek: theios aner ), which was widespread in antiquity. It is said that many of the famous rulers and elders of the time had divine healing powers. Contemporary bioethical and health care policy issues, including abortion, the distribution of limited resources, the nature of appropriate hospital chaplaincy, fetal experimentation,
22195-486: The equitable distribution of the burdens of research. As with much of the Declaration, there is room for interpretation of words. 'Best current' has been variously held to refer to either global or local contexts. Article 30 introduced another new concept, that after the conclusion of the study patients 'should be assured of access to the best proven' intervention arising from the study, a justice issue. Arguments over this have dealt with whether subjects derive benefit from
22388-504: The ethical dilemma in gene therapy explores the potential harms of human enhancement, particularly regarding the birth of disabled individuals. Addressing these challenges is vital for responsible development, application, and equitable access to gene therapies. The experience with human growth hormone further illustrates the blurred lines between therapy and enhancement, emphasizing the importance of ethical considerations in balancing therapeutic benefits and potential enhancements, especially in
22581-540: The ethics of the life sciences in general, expanded from the encounter between experts in medicine and the laity, to include organizational and social ethics, environmental ethics. As of 2019 textbooks of green bioethics existed. Gene therapy involves ethics, because scientists are making changes to genes, the building blocks of the human body. Currently, therapeutic gene therapy is available to treat specific genetic disorders by editing cells in specific body parts. For example, gene therapy can treat hematopoietic disease. There
22774-476: The fact of interconnectedness of the Islamic regulation and the Islamic ethics, the Islamic bioethics has to reflect on consideration on necessities of the Islamic regulation (Shari‘ah) in addition to ethical considerations. To react to new technological and medical advancements, informed Islamic jurists regularly will hold conferences to discuss new bioethical issues and come to an agreement on where they stand on
22967-497: The family, community, and individual are all interdependent of each other, so it is common for the family unit to collectively make decisions regarding healthcare and medical decisions for a loved one, instead of an individual making an independent decision for his or her self. Some argue that spirituality and understanding one another as spiritual beings and moral agents is an important aspect of bioethics, and that spirituality and bioethics are heavily intertwined with one another. As
23160-410: The federal Office for Human Research Protections ; political scientists like Francis Fukuyama ; religious studies scholars including James Childress ; and theologians like Lisa Sowle Cahill and Stanley Hauerwas. The field, formerly dominated by formally trained philosophers, has become increasingly interdisciplinary , with some critics even claiming that the methods of analytic philosophy have harmed
23353-820: The field's development. Leading journals in the field include The Journal of Medicine and Philosophy , the Hastings Center Report , the American Journal of Bioethics , the Journal of Medical Ethics , Bioethics , the Kennedy Institute of Ethics Journal , Public Health Ethics , and the Cambridge Quarterly of Healthcare Ethics . Bioethics has also benefited from the process philosophy developed by Alfred North Whitehead . Another discipline that discusses bioethics
23546-405: The first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'. The duty to the individual was given primacy over that to society (Article I.5), and concepts of publication ethics were introduced (Article I.8). Any experimental manoeuvre was to be compared to
23739-413: The fourth revision in 1996 pressure began to build almost immediately for a more fundamental approach to revising the declaration. The later revision in 2000 would go on to require monitoring of scientific research on human subjects to assure ethical standards were being met. In 1997 Lurie and Wolfe published their seminal paper on HIV trials, raising awareness of a number of central issues. These included
23932-526: The function and structure of the independent committee. However, from 1993 onwards, the Declaration was not alone as a universal guide since CIOMS and the World Health Organization (WHO) had also developed their International Ethical Guidelines for Biomedical Research Involving Human Subjects . The AIDS Clinical Trials Group ( ACTG ) Study 076 of 100 Zidovudine in maternal-infant transmission of HIV had been published in 1994. This
24125-531: The fundamental principle of morality. Ethics is closely connected to value theory , which studies the nature and types of value , like the contrast between intrinsic and instrumental value . Moral psychology is a related empirical field and investigates psychological processes involved in morality, such as reasoning and the formation of character . Descriptive ethics describes the dominant moral codes and beliefs in different societies and considers their historical dimension. The history of ethics started in
24318-582: The fundamental principles announced in the Belmont Report (1979)—namely, respect for persons , beneficence and justice —have influenced the thinking of bioethicists across a wide range of issues. Others have added non-maleficence, human dignity , and the sanctity of life to this list of cardinal values. Overall, the Belmont Report has guided lookup in a course centered on defending prone topics as properly as pushing for transparency between
24511-405: The future should be shaped to achieve the best possible outcome. The act itself is usually not seen as part of the consequences. This means that if an act has intrinsic value or disvalue, it is not included as a factor. Some consequentialists see this as a flaw, saying that all value-relevant factors need to be considered. They try to avoid this complication by including the act itself as part of
24704-429: The greatest number" by increasing happiness and reducing suffering. Utilitarians do not deny that other things also have value, like health, friendship, and knowledge. However, they deny that these things have intrinsic value. Instead, they say that they have extrinsic value because they affect happiness and suffering. In this regard, they are desirable as a means but, unlike happiness, not as an end. The view that pleasure
24897-920: The hands of physicians rather than patients. Communication strategies suggested by ethicists act to decrease patient autonomy. Examples include, clinicians discussing treatment options with one another prior to talking to patients or their family to present a united front limited patient autonomy, hiding uncertainty amongst clinicians. Decisions about overarching goals of treatment were reframed as technical matters excluding patients and their families. Palliative care experts were used as intermediaries to guide patients towards less invasive end-of-live treatment. In their study, Hauschild and Vries found that 76% of ethical consultants were trained as clinicians. Studying informed consent , Corrigan found that some social processes resulted in limitations to patients choice, but also at times patients could find questions regarding consent to medical trials burdensome. The most prevalent subject
25090-421: The human mind and culture rather than as subjective constructs or expressions of personal preferences and cultural norms . Moral realists accept the claim that there are objective moral facts. This view implies that moral values are mind-independent aspects of reality and that there is an absolute fact about whether a given action is right or wrong. A consequence of this view is that moral requirements have
25283-415: The importance of interpersonal relationships and say that benevolence by caring for the well-being of others is one of the key virtues. Influential schools of virtue ethics in ancient philosophy were Aristotelianism and Stoicism . According to Aristotle (384–322 BCE), each virtue is a golden mean between two types of vices: excess and deficiency. For example, courage is a virtue that lies between
25476-478: The individual being deceased. On the contrary, the Islamic Organization of Medical Sciences (IOMS) states that brain death is an "intermediate state between life and death" and does not acknowledge a brain dead individual as being deceased. Islamic bioethicists look to the Qur'an and religious leaders regarding their outlook on reproduction and abortion. It is firmly believed that the reproduction of
25669-411: The intellectual satisfaction of reading a book, are more valuable than lower pleasures, like the sensory enjoyment of food and drink, even if their intensity and duration are the same. Since its original formulation, many variations of utilitarianism have developed, including the difference between act and rule utilitarianism and between maximizing and satisficing utilitarianism. Deontology assesses
25862-472: The issue from an Islamic perspective. This allows Islamic bioethics to stay pliable and responsive to new advancements in medicine. The standpoints taken by Islamic jurists on bioethical issues are not always unanimous decisions and at times may differ. There is much diversity among Muslims varying from country to country, and the different degrees to which they adhere by Shariah. Differences and disagreements in regards to jurisprudence, theology, and ethics between
26055-401: The latter. Investigators still have to abide by local legislation but will be held to the higher standard. The fundamental principle is respect for the individual (Article 8), his or her right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty
26248-576: The law (who had elicited this parable by his self-justifying question, "And who is my neighbor?" in verse 29) to "go, and do likewise" in loving others with whom he would never ordinarily associate (verse 37). The principle of the sacredness of human life is at the basis of Catholic bioethics. On the subject of abortion , for example, Catholics and Orthodox are on very similar positions. Catholic bioethics insists on this concept, without exception, while Anglicans , Waldensians and Lutherans have positions closer to secular ones, for example with regard to
26441-609: The level of ontology , it examines whether there are objective moral facts. Concerning semantics , it asks what the meaning of moral terms are and whether moral statements have a truth value . The epistemological side of metaethics discusses whether and how people can acquire moral knowledge. Metaethics overlaps with psychology because of its interest in how moral judgments motivate people to act. It also overlaps with anthropology since it aims to explain how cross-cultural differences affect moral assessments. Metaethics examines basic ethical concepts and their relations. Ethics
26634-739: The life of one, it shall be as if he saved the life of all humankind." This excerpt can be used to encourage using medicine and medical practices to save lives, but can also be looked at as a protest against euthanasia and assisted suicide. A high value and worth are placed on human life in Islam, and in turn, human life is deeply valued in the practice of Islamic bioethics as well. Muslims believe all human life, even one of poor quality, needs to be given appreciation and must be cared for and conserved. The Islamic education on sensible problems associated to existence in normal and human lifestyles in unique can be sought in Islamic bioethics. As we will see later, due to
26827-507: The link between biology, ecology, medicine, and human values. Sargent Shriver , the spouse of Eunice Kennedy Shriver, claimed that he had invented the term "bioethics" in the living room of his home in Bethesda, Maryland, in 1970. He stated that he thought of the word after returning from a discussion earlier that evening at Georgetown University, where he discussed with others a possible Kennedy family sponsorship of an institute focused around
27020-588: The male marking of its purportedly generic human subject and the fact that the tradition does not see women's rights as human rights, feminist bioethics challenges bioethics. This article explores how the other gender becomes mute and invisible as a result of this unseen gendering of the universal. It demonstrates how the dehumanization of "man" is a root cause of illness on a social and personal level. Finally, it makes many recommendations for how representations of women's experience and bodies could help to constructively reconsider fundamental ethical principles. Bioethics,
27213-413: The many changes was an increased emphasis on the need to benefit the communities in which research is undertaken, and to draw attention to the ethical problems of experimenting on those who would not benefit from the research, such as developing countries in which innovative medications would not be available. Article 19 first introduces the concept of social justice, and extends the scope from individuals to
27406-586: The mid-1980s. During this period, unique philosophical discussions on brain death and disability appeared both in the academy and journalism. In Chinese culture and bioethics, there is not as much of an emphasis on autonomy as opposed to the heavy emphasis placed on autonomy in Western bioethics. Community, social values, and family are all heavily valued in Chinese culture, and contribute to the lack of emphasis on autonomy in Chinese bioethics. The Chinese believe that
27599-571: The mid-to-late 1990s when increasing demands for changes to the Declaration began to emerge. Notably, this period was marked by significant internal unrest within the WMA. In the 1980s, a group of countries, known as the 'Toronto Group,' which included the UK , withdrew from the WMA due to persistent objections related to the South African Medical Association's failure to denounce apartheid . Historical events eventually led to
27792-569: The moral rightness of actions based on a set of norms or principles. These norms describe the requirements that all actions need to follow. They may include principles like telling the truth, keeping promises , and not intentionally harming others. Unlike consequentialists, deontologists hold that the validity of general moral principles does not directly depend on their consequences. They state that these principles should be followed in every case since they express how actions are inherently right or wrong. According to moral philosopher David Ross , it
27985-477: The moral value of acts only depends on the pleasure and suffering they cause. An alternative approach says that there are many different sources of value, which all contribute to one overall value. Before the 20th century, consequentialists were only concerned with the total of value or the aggregate good. In the 20th century, alternative views were developed that additionally consider the distribution of value. One of them states that an equal distribution of goods
28178-625: The morality of all moves that would possibly assist or damage organisms successful of feeling fear. The scope of bioethics has evolved past mere biotechnology to include topics such as cloning , gene therapy , life extension , human genetic engineering , astroethics and life in space, and manipulation of basic biology through altered DNA, XNA and proteins. These (and other) developments may affect future evolution and require new principles that address life at its core, such as biotic ethics that values life itself at its basic biological processes and structures, and seeks their propagation. Moving beyond
28371-514: The most effective approach to address the concerns related to paragraph 30. Two distinct working groups have explored this matter and put forth various suggestions, which encompass potential revisions to the paragraph, the inclusion of a preamble, and the introduction of a clarifying note (similar to what was incorporated into paragraph 29). At a gathering of the WMA Council in France in May 2004,
28564-431: The motives and intentions behind people's actions, highlighting the importance of acting for the right reasons. They tend to be agent-relative, meaning that the reasons for which people should act depend on personal circumstances. For example, a parent has a special obligation to their child, while a stranger does not have this kind of obligation toward a child they do not know. Patient-centered theories, by contrast, focus on
28757-476: The natural flow of the universe . Indigenous belief systems, like Native American philosophy and the African Ubuntu philosophy , often emphasize the interconnectedness of all living beings and the environment while stressing the importance of living in harmony with nature. Metaethics is the branch of ethics that examines the nature, foundations, and scope of moral judgments , concepts, and values. It
28950-480: The necessity of feminist approaches to bioethics because the lack of diverse perspectives in bioethics and medicine can cause preventable harm to already vulnerable groups. This study first gained prevalence in the field of reproductive medicine as it was viewed as a "woman's issue". Since then, feminist approaches to bioethics has expanded to include bioethical topics in mental health, disability advocacy , healthcare accessibility, and pharmaceuticals . Lindemann notes
29143-513: The need for the future agenda of feminist approaches to bioethics to expand further to include healthcare organizational ethics, genetics , stem cell research , and more. Notable figures in feminist bioethics include Carol Gilligan , Susan Sherwin , and the creators of the International Journal of Feminist Approaches to Bioethics , Mary C. Rawlinson and Anne Donchin. Sherwin's book No Longer Patient: Feminist Ethics in Health Care (1992)
29336-418: The ongoing debate in international health research. The discussions indicate that there was felt a need to send a strong signal that exploitation of poor populations as a means to an end, by research from which they would not benefit, was unacceptable. In this sense the Declaration endorsed ethical universalism. Article 29 restates the use of placebo where 'no proven' intervention exists. Surprisingly, although
29529-485: The past half a century. One of the first areas addressed by modern bioethicists was human experimentation. According to the Declaration of Helsinki published by the World Medical Association , the essential principles in medical research involving human subjects are autonomy, beneficence, non-maleficence, and justice. The autonomy of individuals to make decisions while assuming responsibility for them and respecting
29722-434: The patient should always have the freedom to choose their own treatment. Medical ethics is a utilized department of ethics that analyzes the exercise of clinical medicinal drug and associated scientific research. Medical ethics is based on a set of values. These values consist of the appreciation for autonomy, beneficence, and justice. Ethics affects medical decisions made by healthcare providers and patients. Medical ethics
29915-430: The people affected by actions and the rights they have. An example is the requirement to treat other people as ends and not merely as a means to an end. This requirement can be used to argue, for example, that it is wrong to kill a person against their will even if this act would save the lives of several others. Patient-centered deontological theories are usually agent-neutral, meaning that they apply equally to everyone in
30108-440: The person possesses and exercises certain capacities or some form of control . If a person is morally responsible then it is appropriate to respond to them in certain ways, for example, by praising or blaming them. A major debate in metaethics is about the ontological status of morality, questioning whether ethical values and principles are real. It examines whether moral properties exist as objective features independent of
30301-411: The person would want everyone to follow the same maxim as a universal law applicable to everyone. Another formulation states that one should treat other people always as ends in themselves and never as mere means to an end. This formulation focuses on respecting and valuing other people for their own sake rather than using them in the pursuit of personal goals. In either case, Kant says that what matters
30494-470: The position of having to follow several different codes or guidelines, and are therefore required to understand the differences between them. One of these is Good Clinical Practice (GCP), an international guide, while each country may also have local regulations such as the Common Rule in the US, in addition to the requirements of the FDA and Office for Human Research Protections (OHRP) in that country. There are
30687-479: The practice of selfless love , such as the Great Commandment to "Love your neighbor as yourself". The Five Pillars of Islam constitute a basic framework of Muslim ethics and focus on the practice of faith , prayer , charity , fasting during Ramadan , and pilgrimage to Mecca . Buddhists emphasize the importance of compassion and loving-kindness towards all sentient entities. A similar outlook
30880-441: The precise limits of their discipline, debating whether the field should concern itself with the ethical evaluation of all questions involving biology and medicine, or only a subset of these questions. Some bioethicists would narrow ethical evaluation only to the morality of medical treatments or technological innovations, and the timing of medical treatment of humans. Others would increase the scope of moral assessment to encompass
31073-430: The principles that govern the moral evaluation of conduct , character traits , and institutions . It examines what obligations people have, what behavior is right and wrong, and how to lead a good life. Some of its key questions are "How should one live?" and "What gives meaning to life ?". In contemporary philosophy, ethics is usually divided into normative ethics , applied ethics , and metaethics . Morality
31266-471: The proposed revisions failed to achieve consensus, and many argued that the declaration should remain unchanged or only minimally altered, after extensive consultation the Workgroup eventually came up with a text what that was endorsed by WMA's Council and passed by the General Assembly on October 7, 2000, and which proved to be the most far reaching and contentious revision to date. The justification for this
31459-482: The public and private sectors. They may also be full-time employees, unbiased consultants, or have cross-appointments with educational institutions, such as lookup centres or universities. According to Igor Boyko's book "Bioethics", there are three models of bioethics in the world: Ethics Ethics is the philosophical study of moral phenomena. Also called moral philosophy , it investigates normative questions about what people ought to do or which behavior
31652-537: The rapidly advancing field of genomic medicine. As gene therapies progress towards FDA approval, collaboration with clinical genetics providers becomes essential to navigate the ethical complexities of this new era in medicine. Bioethics as a subject of expert exercise (although now not a formal profession) developed at the beginning in North America in the Nineteen Eighties and Nineteen Nineties, in
31845-545: The requirements of the Islamic law (Shari'ah) due to the interdependence of Islamic law and Islamic ethics. In order to avoid making a mistake, everything must be thoroughly examined, first against moral criteria and then against legal ones. It appears that many writers on Islamic bioethics have failed to distinguish between the two. Despite the fact that Islamic law and morality are completely in agreement with one another, they may have distinct prescriptions because of their diverse ends and objectives. One distinction, for instance,
32038-401: The researcher and the subject. Research has flourished within the past 40 years and due to the advance in technology, it is thought that human subjects have outgrown the Belmont Report, and the need for revision is desired. Another essential precept of bioethics is its placement of cost on dialogue and presentation. Numerous dialogue based bioethics organizations exist in universities throughout
32231-468: The right to receive that benefit. Obligation and permission are contrasting terms that can be defined through each other: to be obligated to do something means that one is not permitted not to do it and to be permitted to do something means that one is not obligated not to do it. Some theorists define obligations in terms of values or what is good . When used in a general sense, good contrasts with bad . When describing people and their intentions,
32424-430: The risk of harm is low. This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. The utilitarian argument held that the disadvantage to a few (such as denial of potentially beneficial interventions) was justifiable for the advantage of many future patients. These arguments are intimately tied to the concept of distributive justice ,
32617-417: The same course of action but provide different justifications for why it is right. Consequentialism, also called teleological ethics, says that morality depends on consequences. According to the most common view, an act is right if it brings the best future. This means that there is no alternative course of action that has better consequences. A key aspect of consequentialist theories is that they provide
32810-401: The same ontological status as non-moral facts: it is an objective fact whether there is an obligation to keep a promise just as it is an objective fact whether a thing is rectangular. Moral realism is often associated with the claim that there are universal ethical principles that apply equally to everyone. It implies that if two people disagree about a moral evaluation then at least one of them
33003-423: The same time required to justify them using rational argumentation. The main concern of virtue ethics is how virtues are expressed in actions. As such, it is neither directly interested in the consequences of actions nor in universal moral duties. Virtues are positive character traits like honesty , courage , kindness , and compassion . They are usually understood as dispositions to feel, decide, and act in
33196-437: The scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ethical review and oversight by a properly convened committee (Article 13). The protocol should address the ethical issues and indicate that it
33389-409: The structure of practical reason and are true for all rational agents. According to Kant, to act morally is to act in agreement with reason as expressed by these principles while violating them is both immoral and irrational. Kant provided several formulations of the categorical imperative. One formulation says that a person should only follow maxims that can be universalized . This means that
33582-527: The study protocol, enabling the ethical review committee to evaluate these provisions during its assessment. The sixth revision cycle commenced in May 2007. This consisted of a call for submissions, completed in August 2007. The terms of reference included only a limited revision compared to 2000. In November 2007 a draft revision was issued for consultation until February 2008, and led to a workshop in Helsinki in March. Those comments were then incorporated into
33775-595: The teachings of the Quran . Contractualists reject the reference to God as the source of morality and argue instead that morality is based on an explicit or implicit social contract between humans. They state that actual or hypothetical consent to this contract is the source of moral norms and duties. To determine which duties people have, contractualists often rely on a thought experiment about what rational people under ideal circumstances would agree on. For example, if they would agree that people should not lie then there
33968-478: The ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term ' Human Experimentation ' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which
34161-455: The term evil rather than bad is often employed. Obligations are used to assess the moral status of actions, motives , and character traits . An action is morally right if it is in tune with a person's obligations and morally wrong if it violates them. Supererogation is a special moral status that applies to cases in which the agent does more than is morally required of them. To be morally responsible for an action usually means that
34354-580: The term ethics can also refer to individual ethical theories in the form of a rational system of moral principles, such as Aristotelian ethics , and to a moral code that certain societies, social groups, or professions follow, as in Protestant work ethic and medical ethics . The English word ethics has its roots in the Ancient Greek word êthos ( ἦθος ), meaning ' character ' and ' personal disposition ' . This word gave rise to
34547-462: The topic of equality in medicine, the intersection of cultural practices and medical care, ethical distribution of healthcare resources in pandemics, and issues of bioterrorism . Medical ethical concerns frequently touch on matters of life and death. Patient rights, informed consent, confidentiality, competency, advance directives, carelessness, and many other topics are highlighted as serious health concerns. The proper actions to take in light of all
34740-557: The trial and are no worse off at the end than the status quo prior to the trial, or of not participating, versus the harm of being denied access to that which they have contributed to. There are also operational issues that are unclear. Given the lack of consensus on many issues prior to the fifth revision it is no surprise that the debates continued unabated. The debate over these and related issues also revealed differences in perspectives between developed and developing countries. Zion and colleagues (Zion 2000) have attempted to frame
34933-413: The two main branches of Islam, Sunni, and Shia, lead to differences in the methods and ways in which Islamic bioethics is practiced throughout the Islamic world. An area where there is a lack of consensus is brain death. The Organization of Islamic Conferences Islamic Fiqh Academy (OIC-IFA) holds the view that brain death is equivalent to cardiopulmonary death, and acknowledges brain death in an individual as
35126-402: The two. According to one view, morality focuses on what moral obligations people have while ethics is broader and includes ideas about what is good and how to lead a meaningful life. Another difference is that codes of conduct in specific areas, such as business and environment, are usually termed ethics rather than morality, as in business ethics and environmental ethics . Normative ethics
35319-508: The use of fetal tissue in treatment, genetic engineering, the use of critical care units, distinctions between ordinary and extraordinary treatment, euthanasia, free and informed consent, competency determinations, the meaning of life, are being examined within the framework of traditional Christian moral commitments. Feminist bioethics critiques the fields of bioethics and medicine for its lack of inclusion of women's and other marginalized group's perspectives. This lack of perspective from women
35512-399: The value of consequences based on whether they promote happiness or suffering. But there are also alternative evaluative principles, such as desire satisfaction, autonomy , freedom , knowledge , friendship , beauty , and self-perfection. Some forms of consequentialism hold that there is only a single source of value . The most prominent among them is utilitarianism , which states that
35705-423: The wording was virtually unchanged, this created far more protest in this revision. The implication being that placebos are not permitted where proven interventions are available. The placebo question was already an active debate prior to the fourth revision but had intensified, while at the same time the placebo question was still causing controversy in the international setting. This revision implies that in choosing
35898-439: Was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1). The 1975 revision was almost twice the length of the original. It clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society." It also introduced
36091-499: Was a placebo controlled trial which showed a reduction of nearly 70% in the risk of transmission, and Zidovudine became a de facto standard of care . The subsequent initiation of further placebo controlled trials carried out in developing countries and funded by the United States Centers for Disease Control or National Institutes of Health raised considerable concern when it was learned that patients in trials in
36284-539: Was being weakened by a shift towards efficiency-based and utilitarian standards (Rothman, Michaels and Baum 2000), and an entire issue of the Bulletin of Medical Ethics was devoted to the debate. Others saw it as an example of Angell's 'Ethical Imperialism', an imposition of US needs on the developing world, and resisted any but the most minor changes, or even a partitioned document with firm principles and commentaries, as used by CIOMS. The idea of ethical imperialism
36477-408: Was brought into high attention with HIV testing, as it was strongly debated from 1996 to 2000 because of its centrality to the issue of regimens to prevent its vertical transmission. Brennan summarises this by stating "The principles exemplified by the current Declaration of Helsinki represent a delicate compromise that we should modify only after careful deliberation". Nevertheless, what had started as
36670-456: Was coined in 1927 by Fritz Jahr in an article about a "bioethical imperative" regarding the use of animals and plants in scientific research. In 1970, the American biochemist, and oncologist Van Rensselaer Potter used the term to describe the relationship between the biosphere and a growing human population. Potter's work laid the foundation for global ethics , a discipline centered around
36863-504: Was described by a Brazilian forum in 2000 in these words: "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity." The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than
37056-476: Was partly to take account of expanded scope of biomedical research since 1975. This involved a restructuring of the document, including renumbering and re-ordering of all the articles, the changes in which are outlined in this Table Archived 2010-06-05 at the Wayback Machine . The Introduction establishes the rights of subjects and describes the inherent tension between the need for research to improve
37249-475: Was unlikely. A further difference is between maximizing and satisficing consequentialism. According to maximizing consequentialism, only the best possible act is morally permitted. This means that acts with positive consequences are wrong if there are alternatives with even better consequences. One criticism of maximizing consequentialism is that it demands too much by requiring that people do significantly more than they are socially expected to. For example, if
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