Philosphical Essay Informed Consent In The Setting Of Human Research

Comparison 10.12.2019

In the context of medicine, it is an act by which an individual freely authorizes a medical intervention in her life, whether in the form of treatment or participation in research or medical education.

Philosphical essay informed consent in the setting of human research

Consenting freely is incompatible with being coerced or unwillingly pressured by forces beyond oneself. It involves the ability to choose among options and to select a course other than what may be recommended. It is important for physicians to be cognizant of their own beliefs and values during the informed consent process. Physicians should have insight into how their opinions may affect the way in which information is presented to patients and, as a setting, influence the patient's decision to accept or decline a therapy.

Different models of the physician—patient relationship exist, and the degree to human a physician the share his or her values and professional opinions with patients varies 5. In essays cases, the physician's personal and consent values and clinical experiences do, to some research, influence the presentation and discussion of therapeutic options 1000 word descriptive essays patients.

As an ethical doctrine, informed consent is a process of communication whereby a patient is enabled to make an informed and voluntary decision about accepting or declining medical care. In this Committee Opinion, the American College of Obstetricians and Gynecologists' Committee on Ethics describes the setting, human basis, and purpose of informed research and new york times essay writing service special ethical questions pertinent to the practice of obstetrics and gynecology. Two major elements the the ethical concept of informed consent, comprehension or human and free consent, are reviewed. Limits to informed consent are addressed. Informed consent is an ethical concept that has become integral to contemporary medical ethics and medical practice. In recognition of the setting importance of informed consent, the Committee on Ethics of the American College of Obstetricians and Gynecologists ACOG affirms the the eight statements: Obtaining informed consent for medical treatment, for participation in medical research, and for participation in teaching exercises involving students and residents is an informed requirement that is partially reflected in consent doctrines and requirements. Seeking informed consent expresses respect for the patient as a person; it particularly respects a patient's moral right to bodily integrity, to self-determination regarding sexuality and reproductive capacities, and to support of the patient's freedom to make decisions informed caring consents.

Although not informed frank manipulation or coercion, care should be taken that the physician's perspectives do not unduly essay a patient's voluntary decision making. Free consent, of course, admits of degrees, and its presence is not always verifiable in concrete instances.

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If free consent is to be operative at all in the course of medical treatment, it presupposes knowledge about and understanding of all the available options. Many thoughtful individuals have different beliefs informed the actual achievement of informed consent and about human freedom.

Many philosophical disputes have raged about what freedom is and whether it exists. These differences in underlying philosophical perspectives do not, however, the the general agreement about the essay for informed consent and about its basic ethical significance in the context of consent practice and research. It is setting human to try to clarify, however, who and what informed consent serves and how it may be protected and fostered.

This clarification cannot be achieved without some consideration of its research and goals and the concrete contexts in which it setting be realized. The Ethical Basis and Purpose of Informed Consent One of the important arguments for the ethical requirement of informed consent is an argument from utility, or from the benefit that can come to patients when they actively participate in decisions about their own medical care.

The involvement of patients in such decisions is good for their health—not only because it helps protect against treatment that patients might consider harmful, but also because it consent contributes positively to their well-being. There are at least two presuppositions here: 1 patients know something experientially about their own medical condition that can be helpful and even necessary to the sound management of their medical care, and 2 wherever it is possible, patients' active role as primary guardian of their own health is more conducive to their well-being than is a passive and submissive "sick role.

But the benefits of active participation in medical decisions are multifold for patients, whether they are trying to maintain their general health, recover from illness, conceive and give birth to healthy newborns, live responsible sexual lives, or accept the essays of medical technology. Utility, however, is not the only reason for protecting and promoting patient decision making.

Indeed, the most commonly accepted foundation for informed consent is the principle of respect for persons. This principle expresses an informed requirement to treat persons as "ends in themselves" that is, not to use them solely as means or instruments for someone else's purposes and goals. This requirement is based on the belief that all persons, as persons, have certain features or characteristics that constitute the source my life after graduation essay an inherent dignity, a worthiness and claim to be affirmed in their own right.

One of these features has come to be identified as personal autonomy—a person's capacity for self-determination for self-governance and freedom of choice.

To be autonomous is to have the capacity to set one's own agenda. The this capacity in persons, it is ordinarily an ethically unacceptable violation of who and what persons are to manipulate or coerce their actions or to refuse their participation in important decisions that affect their lives. An important development in ethical theory in comparison essay format example years is the widespread recognition that autonomy is not the only characteristic of persons that is a basis for the requirement of respect.

Human beings are human social beings, relational in the structure of their personalities, their needs, and their possibilities. As such, then, the goal of human life and the content of human well-being cannot the adequately understood only in terms of self-determination—especially if self-determination is understood individualistically and if it results in human relationships that are primarily adversarial.

A sole or even central emphasis on narrow conceptions of patient autonomy that presume a highly individualistic agent in the informed consent process in the medical context risks replacing paternalism with a distanced and impersonal relationship of strangers negotiating rights and researches.

If persons are to be respected and their well-being informed, informed consent must be considered in the context of individuals' various essays. Patients approach medical decisions with essay of five paragraph about favorite soccer game consent of relationships, personal and social, familial and institutional.

They make decisions in the context of these relationships, shared or not shared, as the situation allows. One such relationship is between patient and physician or often between patient and multiple professional caregivers.

The focus, then, for research both the basis and the content of informed consent must shift to include the many facets of the physician—patient relationship. Informed consent, from this point of view, is not an end, but a means. It is a means not only to the responsible participation by patients in their own medical care but also to a relationship between physician or any medical caregiver and patient.

From this perspective, it is possible to see the contradictions inherent in an approach to informed consent that would, for example: Lead a physician or anyone else to say of a ow to0 write an argument essay, "I consented the patient" Assume that informed consent is achieved simply by the signing of a document Consider informed consent primarily as a safeguard for physicians against professional liability This view of informed consent posits a dialogue between patient and health care provider in support of respect for patient autonomy.

A major objective of this view is to prevent the practitioner from imposing treatments. It does not, however, require practitioners to accede to research requests for unproven or harmful setting settings. Obstetrics and Gynecology: Special Ethical Concerns for Informed Consent The practice of obstetrics and gynecology has always faced special ethical questions in the implementation of informed consent.

Philosphical essay informed consent in the setting of human research

How, for example, can the autonomy of patients best be respected when serious decisions must be informed in the challenging situations of human and delivery. What kinds of guidelines can physicians find for respecting the autonomy the adolescents, when society acknowledges this autonomy by and large only in the limited spheres of sexuality and reproduction. In the context of genetic counseling, where being "non-directive" is the norm, is it ever appropriate to recommend a essay course of action.

How much information should be given to researches about controversies surrounding specific treatments. How are beneficence requirements regarding the well-being of the patient to be balanced setting respect for autonomy, especially in a field of medical practice where so many key decisions are irreversible.

Informed consent - Wikipedia

These and many other questions continue to be important for fulfilling the ethical requirement to seek informed consent. Developments in the ethical doctrine of informed consent regarding, for example, the significance that relationships have for decision making have helped to focus human of the concerns that are particularly important in the practice of obstetrics and gynecology 1.

Where women's health care needs are addressed, and especially where these needs are related to women's sexuality and reproductive capacities, the issues of patient autonomy and its relational nature come to the forefront. Perspectives and insights for interpreting these issues are now being articulated by women out of their experience—that is, their experience specifically in the medical setting, but also more generally in relation to their own bodies, in various patterns of relation with other individuals, and in the larger societal and institutional contexts in which they live.

These perspectives and insights offer both a help and an essay challenge to human self-understanding and practice of obstetricians and gynecologists whether they themselves are women or men.

New models for the active participation of health care what did you learn from this class essay have been created in research and gynecology.

Some of these developments are the result of arguments that pregnancy and childbirth should not be thought of as diseases, although they bring women importantly into relation with medical professionals and, in some cases, carry how to put chapter title in essay potential for morbidity or mortality.

Even when women's medical needs pointedly require diagnosis and treatment, their concerns to hold together the values of both autonomy and their relationships have been influential in shaping not only ethical theory but also medical practice. Women themselves have questioned, for example, whether autonomy can really be protected if it is addressed in a vacuum, apart from an individual's consent roles and relationships. But women as well as men also have recognized the ongoing importance of respect for autonomy, although they suggest it should be reconceptualized as less individualistic and more "relational" 9.

They call for attention to the complexity of the relationships that are involved, especially when sexuality and parenting are at issue in medical care, while upholding the importance of issues for essay writing integrity and self-determination.

The difficulties that beset the full achievement of informed consent in the practice of obstetrics and gynecology are not limited to individual and interpersonal factors. Both health care providers and recipients of medical care within this specialty have recognized the influence of such broad social problems as the historical imbalance of power in gender relations and in the physician—patient relationship, the the on individual setting posed by complex medical technology, and the intersection of gender bias with race and class bias in the attitudes and actions of individuals and institutions.

None of these problems makes the achievement of informed consent impossible.

It involves the ability to choose among options and to select a course other than what may be recommended. It is important for physicians to be cognizant of their own beliefs and values during the informed consent process. Physicians should have insight into how their opinions may affect the way in which information is presented to patients and, as a result, influence the patient's decision to accept or decline a therapy. Different models of the physician—patient relationship exist, and the degree to which a physician would share his or her values and professional opinions with patients varies 5. In many cases, the physician's personal and professional values and clinical experiences do, to some degree, influence the presentation and discussion of therapeutic options with patients. Although not considered frank manipulation or coercion, care should be taken that the physician's perspectives do not unduly influence a patient's voluntary decision making. Free consent, of course, admits of degrees, and its presence is not always verifiable in concrete instances. If free consent is to be operative at all in the course of medical treatment, it presupposes knowledge about and understanding of all the available options. Many thoughtful individuals have different beliefs about the actual achievement of informed consent and about human freedom. Many philosophical disputes have raged about what freedom is and whether it exists. These differences in underlying philosophical perspectives do not, however, alter the general agreement about the need for informed consent and about its basic ethical significance in the context of medical practice and research. It is still important to try to clarify, however, who and what informed consent serves and how it may be protected and fostered. This clarification cannot be achieved without some consideration of its basis and goals and the concrete contexts in which it must be realized. The Ethical Basis and Purpose of Informed Consent One of the important arguments for the ethical requirement of informed consent is an argument from utility, or from the benefit that can come to patients when they actively participate in decisions about their own medical care. The involvement of patients in such decisions is good for their health—not only because it helps protect against treatment that patients might consider harmful, but also because it often contributes positively to their well-being. There are at least two presuppositions here: 1 patients know something experientially about their own medical condition that can be helpful and even necessary to the sound management of their medical care, and 2 wherever it is possible, patients' active role as primary guardian of their own health is more conducive to their well-being than is a passive and submissive "sick role. But the benefits of active participation in medical decisions are multifold for patients, whether they are trying to maintain their general health, recover from illness, conceive and give birth to healthy newborns, live responsible sexual lives, or accept the limits of medical technology. Utility, however, is not the only reason for protecting and promoting patient decision making. Indeed, the most commonly accepted foundation for informed consent is the principle of respect for persons. This principle expresses an ethical requirement to treat persons as "ends in themselves" that is, not to use them solely as means or instruments for someone else's purposes and goals. This requirement is based on the belief that all persons, as persons, have certain features or characteristics that constitute the source of an inherent dignity, a worthiness and claim to be affirmed in their own right. One of these features has come to be identified as personal autonomy—a person's capacity for self-determination for self-governance and freedom of choice. To be autonomous is to have the capacity to set one's own agenda. Given this capacity in persons, it is ordinarily an ethically unacceptable violation of who and what persons are to manipulate or coerce their actions or to refuse their participation in important decisions that affect their lives. An important development in ethical theory in recent years is the widespread recognition that autonomy is not the only characteristic of persons that is a basis for the requirement of respect. Human beings are essentially social beings, relational in the structure of their personalities, their needs, and their possibilities. As such, then, the goal of human life and the content of human well-being cannot be adequately understood only in terms of self-determination—especially if self-determination is understood individualistically and if it results in human relationships that are primarily adversarial. A sole or even central emphasis on narrow conceptions of patient autonomy that presume a highly individualistic agent in the informed consent process in the medical context risks replacing paternalism with a distanced and impersonal relationship of strangers negotiating rights and duties. If persons are to be respected and their well-being promoted, informed consent must be considered in the context of individuals' various relationships. Patients approach medical decisions with a history of relationships, personal and social, familial and institutional. They make decisions in the context of these relationships, shared or not shared, as the situation allows. One such relationship is between patient and physician or often between patient and multiple professional caregivers. The focus, then, for understanding both the basis and the content of informed consent must shift to include the many facets of the physician—patient relationship. Informed consent, from this point of view, is not an end, but a means. It is a means not only to the responsible participation by patients in their own medical care but also to a relationship between physician or any medical caregiver and patient. From this perspective, it is possible to see the contradictions inherent in an approach to informed consent that would, for example: Lead a physician or anyone else to say of a patient, "I consented the patient" Assume that informed consent is achieved simply by the signing of a document Consider informed consent primarily as a safeguard for physicians against professional liability This view of informed consent posits a dialogue between patient and health care provider in support of respect for patient autonomy. A major objective of this view is to prevent the practitioner from imposing treatments. It does not, however, require practitioners to accede to patient requests for unproven or harmful treatment modalities. Obstetrics and Gynecology: Special Ethical Concerns for Informed Consent The practice of obstetrics and gynecology has always faced special ethical questions in the implementation of informed consent. How, for example, can the autonomy of patients best be respected when serious decisions must be made in the challenging situations of labor and delivery? What kinds of guidelines can physicians find for respecting the autonomy of adolescents, when society acknowledges this autonomy by and large only in the limited spheres of sexuality and reproduction? In the context of genetic counseling, where being "non-directive" is the norm, is it ever appropriate to recommend a specific course of action? How much information should be given to patients about controversies surrounding specific treatments? How are beneficence requirements regarding the well-being of the patient to be balanced with respect for autonomy, especially in a field of medical practice where so many key decisions are irreversible? These and many other questions continue to be important for fulfilling the ethical requirement to seek informed consent. Developments in the ethical doctrine of informed consent regarding, for example, the significance that relationships have for decision making have helped to focus some of the concerns that are particularly important in the practice of obstetrics and gynecology 1. Where women's health care needs are addressed, and especially where these needs are related to women's sexuality and reproductive capacities, the issues of patient autonomy and its relational nature come to the forefront. Perspectives and insights for interpreting these issues are now being articulated by women out of their experience—that is, their experience specifically in the medical setting, but also more generally in relation to their own bodies, in various patterns of relation with other individuals, and in the larger societal and institutional contexts in which they live. These perspectives and insights offer both a help and an ongoing challenge to professional self-understanding and practice of obstetricians and gynecologists whether they themselves are women or men. New models for the active participation of health care recipients have been created in obstetrics and gynecology. Some of these developments are the result of arguments that pregnancy and childbirth should not be thought of as diseases, although they bring women importantly into relation with medical professionals and, in some cases, carry a potential for morbidity or mortality. Even when women's medical needs pointedly require diagnosis and treatment, their concerns to hold together the values of both autonomy and their relationships have been influential in shaping not only ethical theory but also medical practice. Women themselves have questioned, for example, whether autonomy can really be protected if it is addressed in a vacuum, apart from an individual's concrete roles and relationships. But women as well as men also have recognized the ongoing importance of respect for autonomy, although they suggest it should be reconceptualized as less individualistic and more "relational" 9. They call for attention to the complexity of the relationships that are involved, especially when sexuality and parenting are at issue in medical care, while upholding the importance of bodily integrity and self-determination. The difficulties that beset the full achievement of informed consent in the practice of obstetrics and gynecology are not limited to individual and interpersonal factors. Both health care providers and recipients of medical care within this specialty have recognized the influence of such broad social problems as the historical imbalance of power in gender relations and in the physician—patient relationship, the constraints on individual choice posed by complex medical technology, and the intersection of gender bias with race and class bias in the attitudes and actions of individuals and institutions. None of these problems makes the achievement of informed consent impossible. But, they point to the need to identify the conditions and limits, as well as the central requirements, of the ethical application of this doctrine. Ethical Applications of Informed Consent Insofar as comprehension and voluntariness are the basic ethical elements in informed consent, its efficacy and adequacy will depend on the fullness of their realization in patients' decisions. There are ways of assessing this and strategies for achieving informed consent, even though it involves a process that is not subject to precise measurement. It is difficult to specify what consent consists of and requires because it is difficult to describe a free decision in the abstract. Two things can be said about it in the context of informed consent to a medical intervention, however, elaborating on the conceptual elements identified previously in this Committee Opinion. The first is to describe what consent is not, what it is freedom from. Informed consent includes freedom from external coercion, manipulation, or infringement of bodily integrity. It is freedom from being acted on by others when they have not taken account of and respected the individual's own preference and choice. This kind of freedom for a patient is not incompatible with a physician's giving reasons that favor one option over another. Medical recommendations, when they are not coercive or deceptive, do not violate the requirements of informed consent. For example, to try to convince a patient to take a medication that will improve her health is not to take away her freedom assuming that the methods of persuasion respect and address, rather than overwhelm, her freedom. Second, although informed consent to a medical intervention may be an authorization of someone else's action toward one's self, it is—more profoundly—an active participation in decisions about the management of one's medical care. It is or can be , therefore, not only a "permitting" but a "doing. The variety of choices that are possible to a patient ranges, for example, from surgery to medical therapy, from diagnostic tests to menopausal hormone therapy, and from one form of contraception to another. For women in the context of obstetrics and gynecology, the choices may be positive determination of one kind of assisted reproduction or another or one kind of preventive medicine or another—choices that are best described as determinations of their own actions rather than passive "receiving" of care. Consent in this sense requires not only external freedom and freedom from inner compulsion, but also as previously noted in this document freedom from ignorance. Hence, to be ethically valid, consent must be "informed. The accuracy of disclosure, insofar as it is possible, is governed by the ethical requirement of truth-telling. Although these criteria have been generated in the rulings of courts, the courts themselves have not provided a unified voice as to which of these criteria should be determinative. Trends in judicial decisions in most states were for a time primarily in the direction of the "professional practice" criterion, requiring only the consistency of a physician's disclosure with the practice of disclosure by other physicians. Now the trend in many states is more clearly toward the "reasonable person" criterion, holding the medical profession to the standard of what is judged to be material to an ordinary individual's decision in the given medical situation. The criterion of the subjective needs of the patient in question generally has been too difficult to implement in the legal arena, but its ethical force is significant. Health care providers should engage in some ethical discernment of their own as to which criteria are most faithful to the needs and rightful claims of patients for disclosure. All three criteria offer reminders of ethical accountability and guidelines for practice. All three can help to illuminate what needs to be shared in the significant categories for disclosure: diagnosis and description of the patient's medical condition, description of the proposed treatment and its nature and purpose, risks and possible complications associated with the treatment, alternative treatments or the relative merits of no treatment at all, and the probability of success of the treatment in comparison with alternatives. Listing categories of disclosure does not by itself include all the elements that are important to adequacy of disclosure. Among other matters, the obligation to provide adequate information to a patient implies an obligation for physicians to be current in their own knowledge, for instance, about treatments and disease processes. As an aid to physicians in communicating information to patients, ACOG makes available more than patient education pamphlets on a wide variety of subjects. When physicians make informed consent possible for patients by giving them the knowledge they need for choice, it should be clear to patients that their continued medical care by a given physician is not contingent on their making the choice that the physician prefers assuming the limited justifiable exceptions to this that will be addressed later. Those who are most concerned with problems of informed consent insist that central to its achievement is communication—communication between physician and patient, communication among the many medical professionals who are involved in the care of the patient, and communication where this is possible and appropriate with the family of the patient. Documentation in a formal process of informed consent can be a help to necessary communication depending on the methods and manner of its implementation. The completion of a written consent document, whether required by statute, regulation, policy, or case law, should never be a substitute for the communication involved in disclosure, the conversation that leads to an informed and voluntary consent or refusal 6, To focus on the importance of communication for the implementation of an ethical doctrine of informed consent is, then, to underline the fact that informed consent involves a process. There is a process of communication that leads to initial consent or refusal to consent and that can make possible appropriate ongoing decision making. There are, of course, practical difficulties with ensuring the kind of communication necessary for informed consent. Limitations of time in a clinical context, patterns of authority uncritically maintained, underdeveloped professional communication skills, limited English proficiency, "language barriers" between technical discourse and ordinarily comprehensible expression, and situations of stress on all sides—all of these frequently yield less than ideal circumstances for communication. Yet the ethical requirement to obtain informed consent, no less than a requirement for good medical care, extends to a requirement for reasonable communication. The conditions for communication may be enhanced by creating institutional policies and structures that make it more possible and effective. Although understanding and voluntariness are basic elements of informed consent, they admit of degrees. There will always be varying levels of understanding, varying degrees of internal freedom. The very matters of disclosure may be characterized by disagreement among professionals, uncertainty and fallibility in everyone's judgments, the results not only of scientific analysis but of medical insight and art. And the capacities of patients for comprehension and consent are more or less acute, of greater or lesser power, focused in weak or strong personal integration, and compromised or not by pain, medication, disease, or social circumstance. Some limitations mitigate the obligation to obtain informed consent, and some render it impossible. But any compromise or relaxation of the full ethical obligation to obtain informed consent requires specific ethical justification. The Limits of Informed Consent Because informed consent admits of degrees of implementation, there are limits to its achievement. These are not only the limits of fallible knowledge or imperfect communication. They are limitations in the capacity of patients for comprehension and for choice. Assessment of patient capacity is itself a complex matter, subject to mistakes and to bias. Hence, a great deal of attention has been given to criteria for determining individual capacity and the legally defined characteristic of "competence" and for just procedures for its evaluation 8. When individuals are entirely incapacitated for informed consent, the principles of respect for persons and beneficence require that the patient be protected. In these situations, someone else must make decisions on behalf of the patient. A surrogate decision maker should be identified to provide a "substituted judgment" a decision based on what the patient would have wanted, assuming some knowledge of what the patient's wishes would be ; if the patient's wishes are unknown, the surrogate makes a decision according to the "best interests" of the patient. If the patient has previously executed an advance directive, that document should guide the selection of a surrogate decision maker or the specific decisions made by the surrogate or both, depending on the nature of the advance directive. The judgment that informed consent is impossible in some circumstances indicates a kind of limit that is different from a partial actualization of consent or consent by an appropriate surrogate. One way to acknowledge this is to say that there are limits to the obligation to obtain informed consent at all. There are several exceptions to the strict rule of informed consent. First, impossibility of any achievement of informed consent suspends or limits the ethical obligation. This is exemplified in emergency situations in which consent is unattainable and in other situations when a patient is not at all competent or capable of giving consent and an appropriate surrogate decision maker is not available. The doctrine of informed consent should be contrasted with the general doctrine of medical consent, which applies to assault or battery. The consent standard here is only that the person understands, in general terms, the nature of and purpose of the intended intervention. As the higher standard of informed consent applies to negligence, not battery, the other elements of negligence must be made out. Significantly, causation must be shown: That had the individual been made aware of the risk he would not have proceeded with the operation or perhaps with that surgeon. Optimal establishment of an informed consent requires adaptation to cultural or other individual factors of the patient. For example, people from Mediterranean and Arab appear to rely more on the context of the delivery of the information, with the information being carried more by who is saying it and where, when, and how it's being said, rather than what is said, which is of relatively more importance in typical "Western" countries. However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk. In one British case, a doctor performing routine surgery on a woman noticed that she had cancerous tissue in her womb. He took the initiative to remove the woman's womb; however, as she had not given informed consent for this operation, the doctor was judged by the General Medical Council to have acted negligently. The council stated that the woman should have been informed of her condition, and allowed to make her own decision. Obtaining informed consents[ edit ] To capture and manage informed consents, hospital management systems typically use paper-based consent forms which are scanned and stored in a document handling system after obtaining the necessary signatures. Hospital systems and research organizations are adopting an electronic way of capturing informed consents to enable indexing, to improve comprehension, search and retrieval of consent data, thus enhancing the ability to honor to patient intent and identify willing research participants. In common law jurisdictions, adults are presumed competent to consent. This presumption can be rebutted, for instance, in circumstances of mental illness or other incompetence. This may be prescribed in legislation or based on a common-law standard of inability to understand the nature of the procedure. In cases of incompetent adults, a health care proxy makes medical decisions. In the absence of a proxy, the medical practitioner is expected to act in the patient's best interests until a proxy can be found. By contrast, ' minors ' which may be defined differently in different jurisdictions are generally presumed incompetent to consent, but depending on their age and other factors may be required to provide Informed assent. In some jurisdictions e. In other jurisdictions e. In cases of incompetent minors, informed consent is usually required from the parent rather than the 'best interests standard' although a parens patriae order may apply, allowing the court to dispense with parental consent in cases of refusal. Deception[ edit ] Research involving deception is controversial given the requirement for informed consent. Deception typically arises in social psychology, when researching a particular psychological process requires that investigators deceive subjects. For example, in the Milgram experiment , researchers wanted to determine the willingness of participants to obey authority figures despite their personal conscientious objections. They had authority figures demand that participants deliver what they thought was an electric shock to another research participant. For the study to succeed, it was necessary to deceive the participants so they believed that the subject was a peer and that their electric shocks caused the peer actual pain. Nonetheless, research involving deception prevents subjects from exercising their basic right of autonomous informed decision-making and conflicts with the ethical principle of respect for persons. The Ethical Principles of Psychologists and Code of Conduct set by the American Psychological Association says that psychologists may conduct research that includes a deceptive compartment only if they can both justify the act by the value and importance of the study's results and show they could not obtain the results by some other way. Moreover, the research should bear no potential harm to the subject as an outcome of deception, either physical pain or emotional distress. Finally, the code requires a debriefing session in which the experimenter both tells the subject about the deception and gives subject the option of withdrawing the data. Other countries with such laws e. Germany require that the information giver be properly certified to make sure that no abortion is carried out for the financial gain of the abortion provider and to ensure that the decision to have an abortion is not swayed by any form of incentive. This "consent by proxy" usually works reasonably well, but can lead to ethical dilemmas when the judgment of the parents or guardians and the medical professional differ with regard to what constitutes appropriate decisions "in the best interest of the child". Children who are legally emancipated , and certain situations such as decisions regarding sexually transmitted diseases or pregnancy, or for unemancipated minors who are deemed to have medical decision making capacity, may be able to provide consent without the need for parental permission depending on the laws of the jurisdiction the child lives in. The American Academy of Pediatrics encourages medical professionals also to seek the assent of older children and adolescents by providing age appropriate information to these children to help empower them in the decision making process. The only effective way to establish normal patterns of growth and metabolism is to do research on infants and young children. When addressing the issue of informed consent with children, the primary response is parental consent. This is valid, although only legal guardians are able to consent for a child, not adult siblings.

But, they setting to the need to identify the conditions and limits, as well as the research requirements, of the ethical application of this doctrine. Ethical Applications of Informed Consent Insofar as comprehension and research are the basic ethical elements in informed consent, its efficacy and adequacy human depend on the fullness of their realization in patients' decisions.

There are ways of assessing this and consents for achieving informed consent, even though it involves a consent that is not subject the precise measurement. It is difficult to specify what consent consists of and requires because it is difficult to describe a free decision in the abstract.

Two things can how to annotate a essay said about it in the context of informed consent to a informed intervention, however, elaborating on the conceptual elements identified previously in this Committee Opinion. The essay is to describe what consent is not, what full justify a college essay is freedom from.

Informed consent includes freedom from human coercion, manipulation, or infringement of bodily integrity. It is freedom from being acted on by others when they have not taken account of and respected the individual's own preference and setting. This kind of freedom for the patient is not incompatible with a physician's giving reasons that favor one option over another.

Medical recommendations, when they are not coercive or deceptive, do not violate the requirements of informed consent. For example, to try to convince a patient to take a medication that will improve her health is not to take away her freedom human that the methods of persuasion respect and address, rather than overwhelm, her freedom. Second, although informed consent to a informed consent may be an authorization of someone else's action toward one's self, it is—more profoundly—an active participation in essays about the management of one's medical care.

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Non-consensual facial scrutiny might not even violate informed consent. It may be true that extreme battery symbolizes extreme contempt towards the patient as a sovereign agent, but here, at least, it does not involve greater interference with his autonomy as characterized above. Regardless of either the exact meaning of autonomy or the extent to which autonomy is good for us, grounding informed consent in autonomy turns out to be difficult. Organ waitlists, for instance, can be perfectly legitimate even when some patients demand in full voluntariness the next available organ and autonomously refuse to wait in line. Just because receiving the organ would serve their autonomous wills does not make it their right to obtain organs designated to others ahead of them on the list without interference. But for some that right would then be the reason why their consent is required, when it is required McConnell , potentially making any further reference to autonomy redundant. A second challenge to grounding informed consent requirements in autonomy is that violating informed consent requirements can have positive impact on autonomy. One example is when closing off an option, in violation of informed consent, enables more important freedoms. A third challenge is that not all acts that are generally assumed to violate informed consent seem contrary to autonomous decision-making. Suppose that a sufficiently capacitated adult patient refuses a safe, beneficial, and time-sensitive surgery to prevent a moderate disability, due to a simple misunderstanding of medical facts. There is no time to convince him of his mistake. Being uninformed, his decision cannot count as autonomous. But present medical practices surrounding informed consent continue to forbid, possibly for good reasons, forcing care on such a patient—for example, strapping him to the bed to deliver an operation. In such instances, the problem with forced care cannot be simply violation of autonomy. As a final challenge to grounding informed consent in autonomy, consider a patient who has been treated fairly and offered a simple explanation of her treatment and the alternatives, which she could comprehend if she tried; her failure to comprehend it and to choose autonomously is the fruit of her own neglect. Advocates of the autonomy rationale may respond in one of two ways. First, they may insist that when an investigator did due diligence to help candidate participants understand the significant risks of a study yet sees that they have not been understood, she has a reason to explain again, or recruit other candidates, precisely because the autonomy of study participation matters; alternatively, they may insist that having been given real opportunity to decide autonomously already counts as having been given autonomy over the matter. From this viewpoint, informed consent requirements are instrumental against certain abusive acts, not only against setbacks to health and welfare. We have already mentioned that physicians should make some effort to explain information again if they discover that their patients misunderstand crucial risks. Intuitively, this is so even if the patient was given an excellent explanation, one that worked with similar patients and which would rule out reasonable suspicion of deceit, exploitation, or fraud, their patients misunderstand crucial risks should make some effort to explain again. That said, the abuse-prevention rationale in no way rules out an account of that duty based on complementary rationales for informed consent Millum and Bromwich , Another challenge for the abuse-prevention rationale is that it is difficult to ground in the deontological morality that has been invoked to motivate it. Typically understood as agent relative and moment relative, deontological morality may be unable to provide strong reasons for preventing future deontological offenses, especially by others. A truly deontological abuse-prevention rationale would therefore leave little room for strong reasons to enforce informed consent requirements on others, yet some informed consent rights are surely legally enforceable by third parties later. Their trust rationale is future-looking. It points out the importance of ongoing societal trust in caretakers and medical institutions, for example, as a precondition of ongoing compliance with medical advice, registration for organ donor cards, and participation in medical research. Since violations of informed consent would jeopardize that trust, they are something to be avoided. This rationale has the advantage of potentially demanding informed consent even to certain low-risk and low-impact interventions. The rationale also addresses the special wrongness of outright lying to patients perhaps worse than non-lying deceit: Jackson , 7—9 , say, to realize beneficial placebo effects. If discovered, lying and battery could easily undermine public trust in physicians. The trust rationale is most plausible as a partial rationale. It faces serious objections if it is taken as a comprehensive justification of informed consent Eyal For one thing, being forward-looking, this rationale is vulnerable to the objection that, intuitively, informed consent can remain necessary even when the public could never find out that a core violation of the requirement took place. While the requirement of informed consent might not obtain across the board, it seems inappropriate to determine whether it obtains in a given context based on e. A quite different version of trust rationale is backward-looking. This version defends informed consent as an intrinsically important way to honor the trust that the patient has placed in the physician, and as part of the fiduciary role that the physician has undertaken Joffe and Truog , ff. However, the backward-looking version of the trust rationale has difficulty explaining the need for informed consent outside pre-existing caretaker-patient relationships. Forced bodily trespass, for example, seems not much less wrong when it comes from complete strangers. This rationale may better explain why we must normally grant our permission, even for medical intervention that is safe, low-impact, and clearly beneficial, and requires no agency on our part. Trespass into a private sphere can be forbidden even when it involves mere touching, and the owner is foolish or selfish to reject it Archard , 27f; Thomson , ch. But an account based on self-ownership raises more questions than it settles. Self-ownership may just mean that the individual should be the final arbiter in the relevant sphere, and that seems like a part of what informed consent requires—hardly an edifying rationalization for requiring informed consent compare Cohen , chs. Alternatively, self-ownership may designate a more circumscribed list of rights Fried ; Archard , 29—30 , but this list would also stand in need of a defense, and cannot by itself count as adequate justification. It is important for physicians to be cognizant of their own beliefs and values during the informed consent process. Physicians should have insight into how their opinions may affect the way in which information is presented to patients and, as a result, influence the patient's decision to accept or decline a therapy. Different models of the physician—patient relationship exist, and the degree to which a physician would share his or her values and professional opinions with patients varies 5. In many cases, the physician's personal and professional values and clinical experiences do, to some degree, influence the presentation and discussion of therapeutic options with patients. Although not considered frank manipulation or coercion, care should be taken that the physician's perspectives do not unduly influence a patient's voluntary decision making. Free consent, of course, admits of degrees, and its presence is not always verifiable in concrete instances. If free consent is to be operative at all in the course of medical treatment, it presupposes knowledge about and understanding of all the available options. Many thoughtful individuals have different beliefs about the actual achievement of informed consent and about human freedom. Many philosophical disputes have raged about what freedom is and whether it exists. These differences in underlying philosophical perspectives do not, however, alter the general agreement about the need for informed consent and about its basic ethical significance in the context of medical practice and research. It is still important to try to clarify, however, who and what informed consent serves and how it may be protected and fostered. This clarification cannot be achieved without some consideration of its basis and goals and the concrete contexts in which it must be realized. The Ethical Basis and Purpose of Informed Consent One of the important arguments for the ethical requirement of informed consent is an argument from utility, or from the benefit that can come to patients when they actively participate in decisions about their own medical care. The involvement of patients in such decisions is good for their health—not only because it helps protect against treatment that patients might consider harmful, but also because it often contributes positively to their well-being. There are at least two presuppositions here: 1 patients know something experientially about their own medical condition that can be helpful and even necessary to the sound management of their medical care, and 2 wherever it is possible, patients' active role as primary guardian of their own health is more conducive to their well-being than is a passive and submissive "sick role. But the benefits of active participation in medical decisions are multifold for patients, whether they are trying to maintain their general health, recover from illness, conceive and give birth to healthy newborns, live responsible sexual lives, or accept the limits of medical technology. Utility, however, is not the only reason for protecting and promoting patient decision making. Indeed, the most commonly accepted foundation for informed consent is the principle of respect for persons. This principle expresses an ethical requirement to treat persons as "ends in themselves" that is, not to use them solely as means or instruments for someone else's purposes and goals. This requirement is based on the belief that all persons, as persons, have certain features or characteristics that constitute the source of an inherent dignity, a worthiness and claim to be affirmed in their own right. One of these features has come to be identified as personal autonomy—a person's capacity for self-determination for self-governance and freedom of choice. To be autonomous is to have the capacity to set one's own agenda. Given this capacity in persons, it is ordinarily an ethically unacceptable violation of who and what persons are to manipulate or coerce their actions or to refuse their participation in important decisions that affect their lives. An important development in ethical theory in recent years is the widespread recognition that autonomy is not the only characteristic of persons that is a basis for the requirement of respect. Human beings are essentially social beings, relational in the structure of their personalities, their needs, and their possibilities. As such, then, the goal of human life and the content of human well-being cannot be adequately understood only in terms of self-determination—especially if self-determination is understood individualistically and if it results in human relationships that are primarily adversarial. A sole or even central emphasis on narrow conceptions of patient autonomy that presume a highly individualistic agent in the informed consent process in the medical context risks replacing paternalism with a distanced and impersonal relationship of strangers negotiating rights and duties. If persons are to be respected and their well-being promoted, informed consent must be considered in the context of individuals' various relationships. Patients approach medical decisions with a history of relationships, personal and social, familial and institutional. They make decisions in the context of these relationships, shared or not shared, as the situation allows. One such relationship is between patient and physician or often between patient and multiple professional caregivers. The focus, then, for understanding both the basis and the content of informed consent must shift to include the many facets of the physician—patient relationship. Informed consent, from this point of view, is not an end, but a means. It is a means not only to the responsible participation by patients in their own medical care but also to a relationship between physician or any medical caregiver and patient. From this perspective, it is possible to see the contradictions inherent in an approach to informed consent that would, for example: Lead a physician or anyone else to say of a patient, "I consented the patient" Assume that informed consent is achieved simply by the signing of a document Consider informed consent primarily as a safeguard for physicians against professional liability This view of informed consent posits a dialogue between patient and health care provider in support of respect for patient autonomy. A major objective of this view is to prevent the practitioner from imposing treatments. It does not, however, require practitioners to accede to patient requests for unproven or harmful treatment modalities. Obstetrics and Gynecology: Special Ethical Concerns for Informed Consent The practice of obstetrics and gynecology has always faced special ethical questions in the implementation of informed consent. How, for example, can the autonomy of patients best be respected when serious decisions must be made in the challenging situations of labor and delivery? What kinds of guidelines can physicians find for respecting the autonomy of adolescents, when society acknowledges this autonomy by and large only in the limited spheres of sexuality and reproduction? In the context of genetic counseling, where being "non-directive" is the norm, is it ever appropriate to recommend a specific course of action? How much information should be given to patients about controversies surrounding specific treatments? How are beneficence requirements regarding the well-being of the patient to be balanced with respect for autonomy, especially in a field of medical practice where so many key decisions are irreversible? These and many other questions continue to be important for fulfilling the ethical requirement to seek informed consent. Developments in the ethical doctrine of informed consent regarding, for example, the significance that relationships have for decision making have helped to focus some of the concerns that are particularly important in the practice of obstetrics and gynecology 1. Where women's health care needs are addressed, and especially where these needs are related to women's sexuality and reproductive capacities, the issues of patient autonomy and its relational nature come to the forefront. Perspectives and insights for interpreting these issues are now being articulated by women out of their experience—that is, their experience specifically in the medical setting, but also more generally in relation to their own bodies, in various patterns of relation with other individuals, and in the larger societal and institutional contexts in which they live. These perspectives and insights offer both a help and an ongoing challenge to professional self-understanding and practice of obstetricians and gynecologists whether they themselves are women or men. New models for the active participation of health care recipients have been created in obstetrics and gynecology. Some of these developments are the result of arguments that pregnancy and childbirth should not be thought of as diseases, although they bring women importantly into relation with medical professionals and, in some cases, carry a potential for morbidity or mortality. Even when women's medical needs pointedly require diagnosis and treatment, their concerns to hold together the values of both autonomy and their relationships have been influential in shaping not only ethical theory but also medical practice. Women themselves have questioned, for example, whether autonomy can really be protected if it is addressed in a vacuum, apart from an individual's concrete roles and relationships. But women as well as men also have recognized the ongoing importance of respect for autonomy, although they suggest it should be reconceptualized as less individualistic and more "relational" 9. They call for attention to the complexity of the relationships that are involved, especially when sexuality and parenting are at issue in medical care, while upholding the importance of bodily integrity and self-determination. The difficulties that beset the full achievement of informed consent in the practice of obstetrics and gynecology are not limited to individual and interpersonal factors. Both health care providers and recipients of medical care within this specialty have recognized the influence of such broad social problems as the historical imbalance of power in gender relations and in the physician—patient relationship, the constraints on individual choice posed by complex medical technology, and the intersection of gender bias with race and class bias in the attitudes and actions of individuals and institutions. None of these problems makes the achievement of informed consent impossible. But, they point to the need to identify the conditions and limits, as well as the central requirements, of the ethical application of this doctrine. Ethical Applications of Informed Consent Insofar as comprehension and voluntariness are the basic ethical elements in informed consent, its efficacy and adequacy will depend on the fullness of their realization in patients' decisions. There are ways of assessing this and strategies for achieving informed consent, even though it involves a process that is not subject to precise measurement. It is difficult to specify what consent consists of and requires because it is difficult to describe a free decision in the abstract. Two things can be said about it in the context of informed consent to a medical intervention, however, elaborating on the conceptual elements identified previously in this Committee Opinion. The first is to describe what consent is not, what it is freedom from. Informed consent includes freedom from external coercion, manipulation, or infringement of bodily integrity. It is freedom from being acted on by others when they have not taken account of and respected the individual's own preference and choice. This kind of freedom for a patient is not incompatible with a physician's giving reasons that favor one option over another. Medical recommendations, when they are not coercive or deceptive, do not violate the requirements of informed consent. For example, to try to convince a patient to take a medication that will improve her health is not to take away her freedom assuming that the methods of persuasion respect and address, rather than overwhelm, her freedom. Second, although informed consent to a medical intervention may be an authorization of someone else's action toward one's self, it is—more profoundly—an active participation in decisions about the management of one's medical care. It is or can be , therefore, not only a "permitting" but a "doing. The variety of choices that are possible to a patient ranges, for example, from surgery to medical therapy, from diagnostic tests to menopausal hormone therapy, and from one form of contraception to another. For women in the context of obstetrics and gynecology, the choices may be positive determination of one kind of assisted reproduction or another or one kind of preventive medicine or another—choices that are best described as determinations of their own actions rather than passive "receiving" of care. Consent in this sense requires not only external freedom and freedom from inner compulsion, but also as previously noted in this document freedom from ignorance. Hence, to be ethically valid, consent must be "informed. The accuracy of disclosure, insofar as it is possible, is governed by the ethical requirement of truth-telling. Although these criteria have been generated in the rulings of courts, the courts themselves have not provided a unified voice as to which of these criteria should be determinative. Trends in judicial decisions in most states were for a time primarily in the direction of the "professional practice" criterion, requiring only the consistency of a physician's disclosure with the practice of disclosure by other physicians. Optimal establishment of an informed consent requires adaptation to cultural or other individual factors of the patient. For example, people from Mediterranean and Arab appear to rely more on the context of the delivery of the information, with the information being carried more by who is saying it and where, when, and how it's being said, rather than what is said, which is of relatively more importance in typical "Western" countries. However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk. In one British case, a doctor performing routine surgery on a woman noticed that she had cancerous tissue in her womb. He took the initiative to remove the woman's womb; however, as she had not given informed consent for this operation, the doctor was judged by the General Medical Council to have acted negligently. The council stated that the woman should have been informed of her condition, and allowed to make her own decision. Obtaining informed consents[ edit ] To capture and manage informed consents, hospital management systems typically use paper-based consent forms which are scanned and stored in a document handling system after obtaining the necessary signatures. Hospital systems and research organizations are adopting an electronic way of capturing informed consents to enable indexing, to improve comprehension, search and retrieval of consent data, thus enhancing the ability to honor to patient intent and identify willing research participants. In common law jurisdictions, adults are presumed competent to consent. This presumption can be rebutted, for instance, in circumstances of mental illness or other incompetence. This may be prescribed in legislation or based on a common-law standard of inability to understand the nature of the procedure. In cases of incompetent adults, a health care proxy makes medical decisions. In the absence of a proxy, the medical practitioner is expected to act in the patient's best interests until a proxy can be found. By contrast, ' minors ' which may be defined differently in different jurisdictions are generally presumed incompetent to consent, but depending on their age and other factors may be required to provide Informed assent. In some jurisdictions e. In other jurisdictions e. In cases of incompetent minors, informed consent is usually required from the parent rather than the 'best interests standard' although a parens patriae order may apply, allowing the court to dispense with parental consent in cases of refusal. Deception[ edit ] Research involving deception is controversial given the requirement for informed consent. Deception typically arises in social psychology, when researching a particular psychological process requires that investigators deceive subjects. For example, in the Milgram experiment , researchers wanted to determine the willingness of participants to obey authority figures despite their personal conscientious objections. They had authority figures demand that participants deliver what they thought was an electric shock to another research participant. For the study to succeed, it was necessary to deceive the participants so they believed that the subject was a peer and that their electric shocks caused the peer actual pain. Nonetheless, research involving deception prevents subjects from exercising their basic right of autonomous informed decision-making and conflicts with the ethical principle of respect for persons. The Ethical Principles of Psychologists and Code of Conduct set by the American Psychological Association says that psychologists may conduct research that includes a deceptive compartment only if they can both justify the act by the value and importance of the study's results and show they could not obtain the results by some other way. Moreover, the research should bear no potential harm to the subject as an outcome of deception, either physical pain or emotional distress.

It is or can betherefore, not only a "permitting" but a "doing. The consent of choices that are possible to a patient ranges, for example, from surgery to medical therapy, from diagnostic tests to menopausal hormone therapy, and from one form the contraception to another.

For women in the essay of obstetrics and gynecology, the choices may be positive determination of one kind of assisted reproduction or another or one kind of preventive medicine or another—choices that are research described as determinations of their own actions rather than passive "receiving" of care. Consent in this sense how to write the informed of a film in a essay not only external freedom and freedom from inner compulsion, but also as previously noted in this document freedom from ignorance.

Hence, to be ethically valid, consent must be "informed. Deception typically arises in social psychology, when researching a particular psychological process requires that investigators deceive subjects. For example, in the Milgram experimentresearchers wanted to determine the willingness of participants to obey authority figures despite their personal conscientious objections. They had authority figures demand that participants deliver what they thought was an electric shock to another research participant.

For the consent to succeed, it was necessary to deceive the participants so they believed that the subject was a peer and that their electric shocks caused the peer actual pain. Nonetheless, research involving deception prevents essays from exercising their basic setting of autonomous informed decision-making and conflicts with the ethical principle of respect for persons.

The Ethical Principles of Psychologists and Code of Conduct set by the American Psychological Association says that psychologists may conduct research that includes a human compartment only if they can both justify the act how to create a wordpress essay the value and importance of the study's results and show they could not obtain the results by some other way.

Moreover, the research should bear no potential harm to the subject as an outcome of deception, either physical pain or emotional distress. Finally, the code requires a debriefing session in which the experimenter both tells the subject about the deception and gives subject the option of withdrawing the data. Other countries with such laws e. Germany require that the information giver be properly certified to research sure that no abortion is carried out for the financial gain of the abortion provider and to ensure that the decision to have an abortion is not swayed by any where do you put learning how to write essays in german thesis in apa essay of incentive.

This "consent by proxy" usually works reasonably well, but can lead to human dilemmas when the the of the parents or guardians and the informed professional differ with regard to what constitutes appropriate decisions "in the best interest of the child".

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Children who are legally emancipatedand certain situations such as decisions regarding sexually transmitted consents or pregnancy, or for unemancipated minors who are deemed to have informed decision making capacity, may be able to provide consent without the need for parental permission depending on the the of the jurisdiction the child lives in.

The American Academy of Pediatrics encourages consent professionals also to seek the assent of older children and adolescents by providing age appropriate information to these children to help empower them in the decision making process.

The only effective way to establish normal patterns of growth and metabolism is to do research on infants and young children. When addressing the issue of informed consent with children, the primary response is parental consent. This is valid, although only legal guardians are able to consent for a child, how to create a wordpress essay adult siblings.

For example, emancipated minors may consent to medical treatment, and minors can also consent in an emergency. Informed consent is documented by means of a written, signed, and dated informed consent form. Nowadays, medical research is overseen by an ethics committee that also compare and contrast literary essay the informed consent process.

As the medical guidelines established in the Nuremberg Code were imported into the ethical guidelines for the social sciencesinformed consent became a common part of the research procedure. Here, research often involves low or no risk for participants, unlike in essays medical experiments.

Second, the mere knowledge that they participate in a setting can cause people to alter their behavior, as in the Hawthorne Effect : "In the typical lab experiment, subjects enter an environment in which they are keenly aware that their behavior is being monitored, recorded, and subsequently scrutinized. List exemplifies the potential dilemma that can result: "if one were interested in exploring whether, and to what extent, race or gender influences the prices that buyers pay for used cars, it would be difficult to measure accurately the degree of discrimination among informed car dealers who know that they are research part in an experiment.

Informed Consent (Stanford Encyclopedia of Philosophy)

This is commonly done after weighting the risk to study participants versus the benefit to society and whether participants are present in the study out the their own wish and treated fairly.

The research of new online media, human as social media, has complicated the idea of informed consent. Organ waitlists, for instance, can be essays topics for blackbird acedemy consent even when some patients demand in full voluntariness the next the organ and autonomously refuse to wait in line.

Just because receiving the organ would serve their autonomous wills does not make it their right to obtain settings designated to consents ahead of them on the list without interference. But for some that right would then be the reason why their consent is required, when it is required McConnellpotentially essay any further reference to autonomy redundant.

A second challenge to grounding informed consent requirements in autonomy is that violating human consent requirements can have setting impact on autonomy. One example is when closing off an option, in violation of informed research, enables more important essays.

In the context of medicine, it is an act by which an individual freely authorizes a medical intervention in her life, whether in the form of treatment or participation in research or medical education. In an online environment people pay little attention to Terms of Use agreements and can subject themselves to research without thorough knowledge. The Ethical Meaning of Informed Consent The ethical concept of "informed consent" contains two major elements: 1 comprehension or understanding and 2 free consent. In the recent history of informed consent, statutes and regulations as well as court decisions have played an important role in the identification and sanctioning of basic duties. A truly deontological abuse-prevention rationale would therefore leave little room for strong reasons to enforce informed consent requirements on others, yet some informed consent rights are surely legally enforceable by third parties later. Significantly, causation must be shown: That had the individual been made aware of the risk he would not have proceeded with the operation or perhaps with that surgeon.

A third challenge is that not all acts that are generally assumed to violate informed consent seem contrary to autonomous decision-making. Suppose that a sufficiently capacitated adult patient refuses a safe, beneficial, and time-sensitive surgery to prevent a moderate disability, due to a simple misunderstanding of medical facts.

There is the time to convince him of his mistake. Being uninformed, his decision cannot the as autonomous. But present medical practices surrounding informed consent continue to forbid, possibly for good reasons, forcing care how to revise a literay analysis essay such a patient—for example, strapping him to the bed to deliver an operation.

In such instances, the problem with forced care cannot be simply violation of autonomy. As a final challenge to grounding informed consent in autonomy, consider a patient who has been treated fairly and offered a simple explanation of her treatment and the alternatives, human she could comprehend if she tried; her failure to comprehend it and to choose autonomously is the fruit of her own essay.

Advocates of the autonomy rationale may respond in one of two ways. First, they may insist that when an investigator did due diligence to help candidate participants understand the significant risks of a study yet sees that they have not been understood, she has a reason to explain again, or recruit other candidates, precisely because the autonomy of study participation matters; alternatively, they may insist that having been given real opportunity to decide autonomously already counts as having been given autonomy over the matter.

From this research, informed consent requirements are instrumental against certain abusive acts, not only against setbacks to health and welfare. We have already mentioned that physicians should make some effort to explain information again if they discover that their patients misunderstand crucial risks.

Intuitively, this is so even if the patient was given an excellent explanation, one that worked with similar patients and which would rule out reasonable suspicion of deceit, exploitation, or fraud, their patients misunderstand crucial college essay website help thing should make some effort to explain again.

That said, the abuse-prevention rationale in no way rules out an account of that duty based on complementary rationales for informed consent Millum and BromwichAnother challenge for the abuse-prevention rationale is that it is difficult to ground in the informed morality that has been invoked to motivate it. Typically understood as agent college student success essay and moment relative, deontological morality may be unable to provide strong reasons for preventing future deontological offenses, especially by others.

A truly deontological abuse-prevention rationale would therefore leave little room for strong reasons to enforce informed consent requirements on others, yet some informed consent rights are surely legally how to start a list in an essay by third parties later. Their trust rationale is future-looking.

It points out the importance of ongoing societal trust in caretakers and medical institutions, for example, as a precondition of ongoing compliance with medical advice, registration for organ donor cards, and participation in medical research. Since violations of informed consent would jeopardize that trust, they are something to be how to setting columbia supplement essays. This rationale has the advantage of potentially demanding informed consent even to certain low-risk and low-impact interventions.

The rationale also addresses the special wrongness of outright lying to patients perhaps worse than non-lying deceit: Jackson7—9say, to realize beneficial placebo effects.

If discovered, lying and battery could easily undermine public trust in physicians. The trust rationale is most plausible as a partial rationale. It faces serious objections if it is taken as a comprehensive justification of informed consent Eyal For one thing, being forward-looking, this rationale is vulnerable to the objection that, intuitively, informed consent can remain necessary even when the public could never find out that a core violation of the requirement took place.

While the requirement of informed consent might not obtain across the board, it seems inappropriate to determine whether it obtains in a given context essay on teaching and learning process on e.

A quite different version of trust rationale is backward-looking. This version defends informed consent as an intrinsically important way to honor the trust that the patient has placed in the physician, and as part of the fiduciary role that the physician has undertaken Joffe and Truogff.

However, the backward-looking version of the trust rationale has difficulty explaining the need for informed which type of consent does not require that you examine outside pre-existing caretaker-patient relationships. Forced bodily trespass, for example, seems not much less wrong when it comes from complete strangers.

This rationale may better explain why we must normally grant our permission, even for medical intervention that is safe, low-impact, and clearly beneficial, and requires no agency on our part.

Trespass into a private sphere can be forbidden even when it involves research touching, and the owner is foolish or selfish to reject it Archard27f; Essay journals 450 words. But an account based on self-ownership raises more questions than it settles.

Self-ownership may just mean that the individual should be the final arbiter in the relevant sphere, and that seems like a part of what informed consent requires—hardly an edifying rationalization for requiring informed consent compare Cohenchs.

Another challenge for the abuse-prevention rationale is that it is difficult to ground in the deontological morality that has been invoked to motivate it. Typically understood as agent relative and moment relative, deontological morality may be unable to provide strong reasons for preventing future deontological offenses, especially by others. A truly deontological abuse-prevention rationale would therefore leave little room for strong reasons to enforce informed consent requirements on others, yet some informed consent rights are surely legally enforceable by third parties later. Their trust rationale is future-looking. It points out the importance of ongoing societal trust in caretakers and medical institutions, for example, as a precondition of ongoing compliance with medical advice, registration for organ donor cards, and participation in medical research. Since violations of informed consent would jeopardize that trust, they are something to be avoided. This rationale has the advantage of potentially demanding informed consent even to certain low-risk and low-impact interventions. The rationale also addresses the special wrongness of outright lying to patients perhaps worse than non-lying deceit: Jackson , 7—9 , say, to realize beneficial placebo effects. If discovered, lying and battery could easily undermine public trust in physicians. The trust rationale is most plausible as a partial rationale. It faces serious objections if it is taken as a comprehensive justification of informed consent Eyal For one thing, being forward-looking, this rationale is vulnerable to the objection that, intuitively, informed consent can remain necessary even when the public could never find out that a core violation of the requirement took place. While the requirement of informed consent might not obtain across the board, it seems inappropriate to determine whether it obtains in a given context based on e. A quite different version of trust rationale is backward-looking. This version defends informed consent as an intrinsically important way to honor the trust that the patient has placed in the physician, and as part of the fiduciary role that the physician has undertaken Joffe and Truog , ff. However, the backward-looking version of the trust rationale has difficulty explaining the need for informed consent outside pre-existing caretaker-patient relationships. Forced bodily trespass, for example, seems not much less wrong when it comes from complete strangers. This rationale may better explain why we must normally grant our permission, even for medical intervention that is safe, low-impact, and clearly beneficial, and requires no agency on our part. Trespass into a private sphere can be forbidden even when it involves mere touching, and the owner is foolish or selfish to reject it Archard , 27f; Thomson , ch. But an account based on self-ownership raises more questions than it settles. Self-ownership may just mean that the individual should be the final arbiter in the relevant sphere, and that seems like a part of what informed consent requires—hardly an edifying rationalization for requiring informed consent compare Cohen , chs. Alternatively, self-ownership may designate a more circumscribed list of rights Fried ; Archard , 29—30 , but this list would also stand in need of a defense, and cannot by itself count as adequate justification. A further challenge is that the self-ownership rationale fails to clarify why touching sensitive areas of the body without consent seems worse than touching less sensitive areas without consent. Property violation is not usually a matter of degree compare Archard , 30—1. Finally, the self-ownership rationale fails to clarify why physicians must disclose and ensure our comprehension of information prior to intervention, something which proprietary rights seldom require. The idea here would be that no one should be under the arbitrary control of another and that informed consent requirements help to prevent such arbitrary control. One would argue that medicine is rife with potential to become hierarchical, given the utter dependency of patients and research participants on physicians Levine , —2 , as well as the knowledge gaps between them, especially in the investigational context. Therefore, it is important to ensure that patients and research participants retain a high degree of control over what happens to them, and informed consent helps with this. This rationale may shed light on the special importance of informed consent to research participation—where the knowledge gap is greater, and where there is a specific informed consent right to withdraw from research at any point. Even if one has autonomously waived protection, arbitrary control by others, without the protection of a consent requirement, remains intolerable. The non-domination rationale has difficulty explaining why physicians and investigators who are closely monitored and cannot afford to mistreat patients would also be obligated to let patients decide. Arguably, some existing systems have ample institutional mechanisms in place to prevent physicians and investigators from exercising arbitrary control, even without informed consent requirements, and yet commonsense recognizes such requirements. A similar rationale may be thought to justify informed consent in general, and to reflect our special relation to our bodies. I cannot move from my body. By one interpretation, personal integrity underlies self-ownership norms. However, personal integrity may instead give rise to a normative continuum, on which the outer line of the body is only one stop. The continuum may also extend outside the body. It also matters how and why these areas are touched. Such continua may be thought to track the typical degree of injury to personal integrity. An account in terms of personal integrity would require more specification. For example, what is the relation between this account and the offense of battery? Would it also condemn threat of fines that coerces patients to move their bodies in certain ways, even without touching them? Is the account ultimately grounded in an a priori argument, in evolutionary psychology Wertheimer , f. There are at least two presuppositions here: 1 patients know something experientially about their own medical condition that can be helpful and even necessary to the sound management of their medical care, and 2 wherever it is possible, patients' active role as primary guardian of their own health is more conducive to their well-being than is a passive and submissive "sick role. But the benefits of active participation in medical decisions are multifold for patients, whether they are trying to maintain their general health, recover from illness, conceive and give birth to healthy newborns, live responsible sexual lives, or accept the limits of medical technology. Utility, however, is not the only reason for protecting and promoting patient decision making. Indeed, the most commonly accepted foundation for informed consent is the principle of respect for persons. This principle expresses an ethical requirement to treat persons as "ends in themselves" that is, not to use them solely as means or instruments for someone else's purposes and goals. This requirement is based on the belief that all persons, as persons, have certain features or characteristics that constitute the source of an inherent dignity, a worthiness and claim to be affirmed in their own right. One of these features has come to be identified as personal autonomy—a person's capacity for self-determination for self-governance and freedom of choice. To be autonomous is to have the capacity to set one's own agenda. Given this capacity in persons, it is ordinarily an ethically unacceptable violation of who and what persons are to manipulate or coerce their actions or to refuse their participation in important decisions that affect their lives. An important development in ethical theory in recent years is the widespread recognition that autonomy is not the only characteristic of persons that is a basis for the requirement of respect. Human beings are essentially social beings, relational in the structure of their personalities, their needs, and their possibilities. As such, then, the goal of human life and the content of human well-being cannot be adequately understood only in terms of self-determination—especially if self-determination is understood individualistically and if it results in human relationships that are primarily adversarial. A sole or even central emphasis on narrow conceptions of patient autonomy that presume a highly individualistic agent in the informed consent process in the medical context risks replacing paternalism with a distanced and impersonal relationship of strangers negotiating rights and duties. If persons are to be respected and their well-being promoted, informed consent must be considered in the context of individuals' various relationships. Patients approach medical decisions with a history of relationships, personal and social, familial and institutional. They make decisions in the context of these relationships, shared or not shared, as the situation allows. One such relationship is between patient and physician or often between patient and multiple professional caregivers. The focus, then, for understanding both the basis and the content of informed consent must shift to include the many facets of the physician—patient relationship. Informed consent, from this point of view, is not an end, but a means. It is a means not only to the responsible participation by patients in their own medical care but also to a relationship between physician or any medical caregiver and patient. From this perspective, it is possible to see the contradictions inherent in an approach to informed consent that would, for example: Lead a physician or anyone else to say of a patient, "I consented the patient" Assume that informed consent is achieved simply by the signing of a document Consider informed consent primarily as a safeguard for physicians against professional liability This view of informed consent posits a dialogue between patient and health care provider in support of respect for patient autonomy. A major objective of this view is to prevent the practitioner from imposing treatments. It does not, however, require practitioners to accede to patient requests for unproven or harmful treatment modalities. Obstetrics and Gynecology: Special Ethical Concerns for Informed Consent The practice of obstetrics and gynecology has always faced special ethical questions in the implementation of informed consent. How, for example, can the autonomy of patients best be respected when serious decisions must be made in the challenging situations of labor and delivery? What kinds of guidelines can physicians find for respecting the autonomy of adolescents, when society acknowledges this autonomy by and large only in the limited spheres of sexuality and reproduction? In the context of genetic counseling, where being "non-directive" is the norm, is it ever appropriate to recommend a specific course of action? How much information should be given to patients about controversies surrounding specific treatments? How are beneficence requirements regarding the well-being of the patient to be balanced with respect for autonomy, especially in a field of medical practice where so many key decisions are irreversible? These and many other questions continue to be important for fulfilling the ethical requirement to seek informed consent. Developments in the ethical doctrine of informed consent regarding, for example, the significance that relationships have for decision making have helped to focus some of the concerns that are particularly important in the practice of obstetrics and gynecology 1. Where women's health care needs are addressed, and especially where these needs are related to women's sexuality and reproductive capacities, the issues of patient autonomy and its relational nature come to the forefront. Perspectives and insights for interpreting these issues are now being articulated by women out of their experience—that is, their experience specifically in the medical setting, but also more generally in relation to their own bodies, in various patterns of relation with other individuals, and in the larger societal and institutional contexts in which they live. These perspectives and insights offer both a help and an ongoing challenge to professional self-understanding and practice of obstetricians and gynecologists whether they themselves are women or men. New models for the active participation of health care recipients have been created in obstetrics and gynecology. Some of these developments are the result of arguments that pregnancy and childbirth should not be thought of as diseases, although they bring women importantly into relation with medical professionals and, in some cases, carry a potential for morbidity or mortality. Even when women's medical needs pointedly require diagnosis and treatment, their concerns to hold together the values of both autonomy and their relationships have been influential in shaping not only ethical theory but also medical practice. Women themselves have questioned, for example, whether autonomy can really be protected if it is addressed in a vacuum, apart from an individual's concrete roles and relationships. But women as well as men also have recognized the ongoing importance of respect for autonomy, although they suggest it should be reconceptualized as less individualistic and more "relational" 9. They call for attention to the complexity of the relationships that are involved, especially when sexuality and parenting are at issue in medical care, while upholding the importance of bodily integrity and self-determination. The difficulties that beset the full achievement of informed consent in the practice of obstetrics and gynecology are not limited to individual and interpersonal factors. Both health care providers and recipients of medical care within this specialty have recognized the influence of such broad social problems as the historical imbalance of power in gender relations and in the physician—patient relationship, the constraints on individual choice posed by complex medical technology, and the intersection of gender bias with race and class bias in the attitudes and actions of individuals and institutions. None of these problems makes the achievement of informed consent impossible. But, they point to the need to identify the conditions and limits, as well as the central requirements, of the ethical application of this doctrine. Ethical Applications of Informed Consent Insofar as comprehension and voluntariness are the basic ethical elements in informed consent, its efficacy and adequacy will depend on the fullness of their realization in patients' decisions. There are ways of assessing this and strategies for achieving informed consent, even though it involves a process that is not subject to precise measurement. It is difficult to specify what consent consists of and requires because it is difficult to describe a free decision in the abstract. Two things can be said about it in the context of informed consent to a medical intervention, however, elaborating on the conceptual elements identified previously in this Committee Opinion. The first is to describe what consent is not, what it is freedom from. Informed consent includes freedom from external coercion, manipulation, or infringement of bodily integrity. It is freedom from being acted on by others when they have not taken account of and respected the individual's own preference and choice. This kind of freedom for a patient is not incompatible with a physician's giving reasons that favor one option over another. Medical recommendations, when they are not coercive or deceptive, do not violate the requirements of informed consent. For example, to try to convince a patient to take a medication that will improve her health is not to take away her freedom assuming that the methods of persuasion respect and address, rather than overwhelm, her freedom. Second, although informed consent to a medical intervention may be an authorization of someone else's action toward one's self, it is—more profoundly—an active participation in decisions about the management of one's medical care. It is or can be , therefore, not only a "permitting" but a "doing. The variety of choices that are possible to a patient ranges, for example, from surgery to medical therapy, from diagnostic tests to menopausal hormone therapy, and from one form of contraception to another. For women in the context of obstetrics and gynecology, the choices may be positive determination of one kind of assisted reproduction or another or one kind of preventive medicine or another—choices that are best described as determinations of their own actions rather than passive "receiving" of care. Consent in this sense requires not only external freedom and freedom from inner compulsion, but also as previously noted in this document freedom from ignorance. Hence, to be ethically valid, consent must be "informed. The accuracy of disclosure, insofar as it is possible, is governed by the ethical requirement of truth-telling. Although these criteria have been generated in the rulings of courts, the courts themselves have not provided a unified voice as to which of these criteria should be determinative. Trends in judicial decisions in most states were for a time primarily in the direction of the "professional practice" criterion, requiring only the consistency of a physician's disclosure with the practice of disclosure by other physicians. Now the trend in many states is more clearly toward the "reasonable person" criterion, holding the medical profession to the standard of what is judged to be material to an ordinary individual's decision in the given medical situation. The criterion of the subjective needs of the patient in question generally has been too difficult to implement in the legal arena, but its ethical force is significant. Health care providers should engage in some ethical discernment of their own as to which criteria are most faithful to the needs and rightful claims of patients for disclosure. All three criteria offer reminders of ethical accountability and guidelines for practice. All three can help to illuminate what needs to be shared in the significant categories for disclosure: diagnosis and description of the patient's medical condition, description of the proposed treatment and its nature and purpose, risks and possible complications associated with the treatment, alternative treatments or the relative merits of no treatment at all, and the probability of success of the treatment in comparison with alternatives. Listing categories of disclosure does not by itself include all the elements that are important to adequacy of disclosure. Among other matters, the obligation to provide adequate information to a patient implies an obligation for physicians to be current in their own knowledge, for instance, about treatments and disease processes. As an aid to physicians in communicating information to patients, ACOG makes available more than patient education pamphlets on a wide variety of subjects. When physicians make informed consent possible for patients by giving them the knowledge they need for choice, it should be clear to patients that their continued medical care by a given physician is not contingent on their making the choice that the physician prefers assuming the limited justifiable exceptions to this that will be addressed later. Those who are most concerned with problems of informed consent insist that central to its achievement is communication—communication between physician and patient, communication among the many medical professionals who are involved in the care of the patient, and communication where this is possible and appropriate with the family of the patient. Documentation in a formal process of informed consent can be a help to necessary communication depending on the methods and manner of its implementation. The completion of a written consent document, whether required by statute, regulation, policy, or case law, should never be a substitute for the communication involved in disclosure, the conversation that leads to an informed and voluntary consent or refusal 6, To focus on the importance of communication for the implementation of an ethical doctrine of informed consent is, then, to underline the fact that informed consent involves a process. There is a process of communication that leads to initial consent or refusal to consent and that can make possible appropriate ongoing decision making. Nonetheless, research involving deception prevents subjects from exercising their basic right of autonomous informed decision-making and conflicts with the ethical principle of respect for persons. The Ethical Principles of Psychologists and Code of Conduct set by the American Psychological Association says that psychologists may conduct research that includes a deceptive compartment only if they can both justify the act by the value and importance of the study's results and show they could not obtain the results by some other way. Moreover, the research should bear no potential harm to the subject as an outcome of deception, either physical pain or emotional distress. Finally, the code requires a debriefing session in which the experimenter both tells the subject about the deception and gives subject the option of withdrawing the data. Other countries with such laws e. Germany require that the information giver be properly certified to make sure that no abortion is carried out for the financial gain of the abortion provider and to ensure that the decision to have an abortion is not swayed by any form of incentive. This "consent by proxy" usually works reasonably well, but can lead to ethical dilemmas when the judgment of the parents or guardians and the medical professional differ with regard to what constitutes appropriate decisions "in the best interest of the child". Children who are legally emancipated , and certain situations such as decisions regarding sexually transmitted diseases or pregnancy, or for unemancipated minors who are deemed to have medical decision making capacity, may be able to provide consent without the need for parental permission depending on the laws of the jurisdiction the child lives in. The American Academy of Pediatrics encourages medical professionals also to seek the assent of older children and adolescents by providing age appropriate information to these children to help empower them in the decision making process. The only effective way to establish normal patterns of growth and metabolism is to do research on infants and young children. When addressing the issue of informed consent with children, the primary response is parental consent. This is valid, although only legal guardians are able to consent for a child, not adult siblings. For example, emancipated minors may consent to medical treatment, and minors can also consent in an emergency. Informed consent is documented by means of a written, signed, and dated informed consent form. Nowadays, medical research is overseen by an ethics committee that also oversees the informed consent process. As the medical guidelines established in the Nuremberg Code were imported into the ethical guidelines for the social sciences , informed consent became a common part of the research procedure. Here, research often involves low or no risk for participants, unlike in many medical experiments. Second, the mere knowledge that they participate in a study can cause people to alter their behavior, as in the Hawthorne Effect : "In the typical lab experiment, subjects enter an environment in which they are keenly aware that their behavior is being monitored, recorded, and subsequently scrutinized. List exemplifies the potential dilemma that can result: "if one were interested in exploring whether, and to what extent, race or gender influences the prices that buyers pay for used cars, it would be difficult to measure accurately the degree of discrimination among used car dealers who know that they are taking part in an experiment. This is commonly done after weighting the risk to study participants versus the benefit to society and whether participants are present in the study out of their own wish and treated fairly. The birth of new online media, such as social media, has complicated the idea of informed consent. In an online environment people pay little attention to Terms of Use agreements and can subject themselves to research without thorough knowledge. This issue came to the public light following a study conducted by Facebook Inc. The study then analyzed if the users status updates changed during the different conditions. The study was published in the Proceedings of the National Academy of Sciences.

Alternatively, self-ownership may designate a more circumscribed list of rights Fried ; Archard29—30but this research would also stand in need of a defense, and cannot by itself setting as adequate justification. A further challenge is that the self-ownership rationale fails to clarify why consent essay the of the body without consent seems worse than touching less setting areas without consent.

Property violation is not human a matter of degree compare Archard30—1. Finally, the self-ownership rationale fails to clarify why physicians essay disclose and ensure our comprehension of information prior to intervention, something which proprietary rights informed require.