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Informed Consent

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If you were to do research on various Bioethics issues, you would most likely come across the term “informed consent” without there being a definition. It is one of those terms that people often assume everyone knows and understand, the sad reality being that many people do not fully understand informed consent, especially understanding this within an Orthodox context. In his book, The Sacred Gift {{cleanup|Removal of Life, Fr. John Breck says, “matters of ‘informed consent’ and ‘patient’s rights’ need to be evaluated in the light of the Gospel’s teaching on freedom and responsibility.” Our first step will be to define informed consent and look briefly at the historyperson, and then attempt to struggle with this issue and what it means for Orthodox Christiansclear opening definition, and hopefully come to some conclusionetc. }}
== Definition & History =='''Informed consent''' is a term often used in medical environments in terms of 'patient's rights', but is seldom considered in the Orthodox Christian context of [[Gospel]]'s teaching on freedom and responsibility. In a book, Fr. [[John Breck]] has attempted to struggle with this issue.
What is informed consent? According If one were to do research on various bioethics issues, one would most likely come across the Merriam-Webster’s Medical Dictionary, term ''informed consent is a noun which means “consent to surgery by a patient or to participation in a medical experiment by '' without there being a subject after achieving an understanding of what is involveddefinition.” Vital to this understanding It is one of those terms that people often assume everyone knows and understands. Yet, the patient sad reality is supplied with the necessary facts but also that many people do not fully capable to understand these factsinformed consent, especially understanding this within an Orthodox Christian context. In other words, the patient needs to be mentally competent. This brings about legal ramifications whichhis book, ''The Sacred Gift of courseLife'', cloud the issueFr. When there is an absence John Breck says, "matters of 'informed consent, ethical issues arise' and 'patient's rights' need to be evaluated in the light of the Gospel's teaching on freedom and responsibility. "{{ref|1}} Legally, certain procedures cannot The first step will be allowed to happen. If the patient is unable to give define informed consent him or herselfand look briefly at history, and then attempt to struggle with the issue and what it means for example in the case of a mentally incompetent patient or a childOrthodox Christians, then someone else is usually in a position and hopefully come to give consentsome conclusion.
The American Medical Association (AMA) defines informed consent slightly differently on their website, which has a banner saying “Helping Doctors Help Patients.” They say “Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient == Definition and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.” The AMA implores Doctors on its website to focus on the communication process and also to document it as well. The AMA provides steps for proper communication with a patient, saying at the end of this list, “this communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states.” According to the AMA, the legal ramifications of informed consent are recent, although the ethical guidelines have been understood for a long time. Informed consent as such only began appearing on the legal scene in the 1950’s, before that it was lumped into the tort law category of battery. The emphasis placed on informed consent by the AMA is not only to protect the doctor legally, but also to protect the rights of the patients. history ==
The National Cancer Institute describes two key elements for What is informed consent? According to the ''Merriam-Webster's Medical Dictionary'', informed consent means "consent to surgery by a patient or to participation in the case a medical experiment by a subject after achieving an understanding of a clinical trial: the document and the processwhat is involved. "{{ref|2}} The document Vital to this understanding is what that the patient is supplied with the participant actually signs necessary facts and lists a summary of the clinical trial – “including its purposeis also fully capable to understand these facts—in other words, the treatment procedures and schedule, potential risks and benefits, alternatives patient needs to participationbe mentally competent. This brings about legal ramifications which, etc.” – and also the rights of course, cloud the participantissue. The National Cancer Institute says that the process When there is an absence of informed consent is ongoing and begins long before , ethical issues arise. Legally, certain procedures cannot be allowed to happen. If the trial begins and end after the trial patient is over. “Thus, unable to give informed consent is an ongoinghim- or herself, interactive processfor example, rather than in the case of a one-time information session.” I think that this definition of informed consent mentally incompetent patient or a child, then someone else is vital also usually in a position to doctor-patient relationships as well and should not be limited to clinical trialsgive consent.{{ref|3}}
The question of mental competency plays American Medical Association (AMA) defines informed consent slightly differently on their website, which has a major factor in this discussionbanner saying "Helping Doctors Help Patients. When " They say, "Informed consent is ok for more than simply getting a doctor patient to question the mental competency sign a written consent form. It is a process of communication between a patient and at what point does the family of physician that results in the patient begin 's authorization or agreement to question their mental competency? undergo a specific medical intervention."{{ref|4}} The University AMA implores doctors on its website to focus on the communication process and also to document it as well. The AMA provides steps for proper communication with a patient, saying at the end of Washington School of Medicine advises that this list, "this communications process, or a patient’s mental competency variation thereof, is generally clearboth an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states. "{{ref|4}} In According to the cases when competency is unclearAMA, they provide the following suggestions for assessment legal ramifications of informed consent are recent, although the situationethical guidelines have been understood for a long time. Is Informed consent as such only began appearing on the patient able to: *understand his or her situation, *understand the risks associated with legal scene in the decision at hand1950s, and*communicate a decision based on before that understanding? If it was lumped into the tort law category of battery. The emphasis placed on informed consent by the AMA is hard not only to assess protect the patient’s competencydoctor legally, it is possible that the doctor will bring in a psychological consult. Often making the discernment of mental competency difficult is that some patients move in and out of competency based on medication and but also disease. Doctors are encouraged, in these situations, to try and include protect the patient in rights of the decision making process when the patient is lucidpatients. {{ref|4}}
It is important The National Cancer Institute describes two key elements for informed consent in the both case of a clinical trial: the patient document and the doctor to realize that if the patient refuses treatment, this is not necessarily an indication that the patient is mentally incompetentprocess. The patient has document is what the right to say no. I think that many legal struggles over mental competency stem from a differing opinion between the patient participant actually signs and the family as to the course of treatment. To summarize a definition of informed consent let us look to lists a listing summary of the following elements which are necessary for a complete definition of informed consent: 1) the nature of the decision/procedureclinical trial— 2) reasonable alternatives to "including its purpose, the proposed intervention; 3) the relevant treatment procedures and schedule, potential risks, and benefits, and uncertainties related alternatives to each alternative; 4) assessment of patient understandingparticipation, etc."{{ref|5}}— and 5) also the acceptance rights of the intervention by participant. The National Cancer Institute says that the patient. This list provides a thorough process of informed consent is ongoing and complete understanding for begins long before the patient trial begins and also for ends long after the doctor which will in turn provide for the best possible care. Informed consent trial is not needed in every situationover. Generally, when surgery, anesthesia and other invasive procedures are involved"Thus, informed consent is neededan ongoing, interactive process, rather than a one-time information session. "{{ref|5}} In situations where This definition of informed consent is not needed, it is still important for the lines of communication vital also to be open and working between the patient and the doctor. The -patient should not be afraid to ask questions relationships as well and the doctor should not be annoyed with having limited to answer themclinical trials.
== Orthodoxy The question of mental competency plays a major factor in this discussion. When is it okay for a doctor to question the mental competency of a patient and Informed Consent ==at what point does the family of the patient begin to question their mental competency? The University of Washington School of Medicine advises that a patient's mental competency is generally clear. In the cases when competency is unclear, they provide the following suggestions for assessment of the situation. Is the patient able to:* understand his or her situation, * understand the risks associated with the decision at hand, and* communicate a decision based on that understanding?{{ref|6}}If it is hard to assess the patient's competency, it is possible that the doctor will bring in a psychological consult. Often making the discernment of mental competency difficult is that some patients move in and out of competency based on medication and also disease. Doctors are encouraged, in these situations, to try and include the patient in the decision making process when the patient is lucid.{{ref|6}} It is important for the both the patient and the doctor to realize that if the patient refuses treatment, this is not necessarily an indication that the patient is mentally incompetent.{{ref|6}} The patient has the right to say no. I think that many legal struggles over mental competency stem from a differing opinion between the patient and the family as to the course of treatment.
For Orthodox Christians, what does all this mean? The issue seems To summarize a definition of informed consent let us look to be clear cut, why all a listing of the fuss? According to Fr. Breck, “Some Christian ethicists today following elements which are suggesting that our unity in the Body necessary for a complete definition of Christ implies a mutual commitment that in certain cases transcends the need for informed consent and transforms :# the self-centered notion nature of personal ‘rights’ into the self-giving gesture of care offered to others in love.” My understanding of what Fr. Breck is saying here is that there should not be a need for informed consent because we should totally give ourselves over decision/procedure; # reasonable alternatives to the doctor’s care in love becauseproposed intervention; # the relevant risks, ultimatelybenefits, we are giving ourselves over and uncertainties related to God because each alternative; # assessment of patient understanding; and # the acceptance of the intervention by the doctor is working within patient.{{ref|6}}This list provides a Christian framework of caring through love, “ground[ing] personal relationships – between doctor thorough and complete understanding for the patient as between the medical team and also for the patient’s family – doctor which will in turn provide for the ultimate relationship of love, trust and mutual devotionbest possible care. Informed consent is not needed in every situation.” PersonallyGenerally, I see this as being the ultimate goalwhen surgery, what we need to strive for in this worldanesthesia and other invasive procedures are involved, but I do not think that this informed consent is our current reality or something that we can feasibly expect at this pointneeded. If this In situations where informed consent is not needed, it is still important for the ultimate goal lines of Orthodox Christians, how do we continually work towards this goal within communication to be open and working between the patient and the world we live in? What is our response doctor.{{ref|6}} The patient should not be afraid to informed consent within ask questions and the secular framework as followers of Christ?doctor should not be annoyed with having to answer them.
Unfortunately, not a lot has been written on this topic from an Orthodox standpoint. I would venture a guess that this is because there is not a lot to say. The issue appears to be pretty cut == Orthodoxy and dry. Informed informed consent is necessary for a proper understanding of a procedure being done and it is the responsibility of doctors to provide the needed information so that patients can understand what is happening. Following the guidelines listed above and others in the cited websites should ensure that the patient is informed. The real issues appear to be revolving around the question of the patient’s mental competency. For Orthodox Christians, the answer to that question appears simple. The patient, the patient’s family and the doctor all need to open themselves up to hear what God is saying in the situation. The patient’s family needs to be sensitive to the needs of the patient and listen to what they are actually saying, not only what the family thinks they are saying. The doctor needs to also be sensitive to the needs of the patient and recognize their concerns and fears. In addition, the doctor must be vigilant in providing the patient with all the possible options in an unbiased manner allowing the patient to make the decision that they feel fit. The patient needs to be open to listening to others, whether the doctor or their family. Inasmuch as they all need to listen to the patient, the patient also needs to listen to them. The patient, patient’s family and the medical team needs to work within a framework of “the ultimate relationship of love, trust and mutual devotion shared by the three Persons of the Holy Trinity.” This may mean the patient or their family needs to “let go,” or that the doctor needs to accept a difficult decision from the family. ==
As followers of ChristFor Orthodox Christians, what does all this means that our prayer becomes “Thy will mean? The issue seems to be doneclear cut, why all the fuss? According to Fr.” When we pray Breck, "Some Christian ethicists today are suggesting that way, our acceptance unity in the Body of [[Christ]] implies a mutual commitment that will in certain cases transcends the need for informed consent and transforms the self-centered notion of personal 'rights' into the self-giving gesture of care offered to others in love.{{ref|1}} It seems that Fr. Breck is our submission saying that there should not be a need for informed consent because the patients should totally give themselves over to the doctor's care in love because, ultimately, the patients are giving themselves over to God as His creationthe doctor is working within a Christian framework of caring through love, "ground[ing] personal relationships—between doctor and patient as between the medical team and the patient's family—in the ultimate relationship of love, trust and mutual devotion. "{{ref|1}} Within This seems as being the world as we now know itultimate goal, this that is not always easy. We need needed to seek out strive for our physicians people in this world, but that understand and accept is not a current reality or something that we will be responding in is feasibly expected at this mannerpoint. A good relationship with our primary doctor will ensure If thisis the ultimate goal of Orthodox Christians, how does one continually work towards this goal within the world of today? What should be the response to informed consent within the secular framework as they will, ideally, suggest specialists that will also understand this and not try and force anything on us.followers of Christ?
== Conclusion ==Unfortunately, not a lot has been written on this topic from an Orthodox standpoint.{{ref|7}} This may be because there is not a lot to say. The issue appears to be pretty cut and dry. Informed consent is necessary for a proper understanding of a procedure being done and it is the responsibility of doctors to provide the needed information so that patients can understand what is happening. Following the guidelines listed above and others in the cited websites should ensure that the patient is informed. The real issues appear to be revolving around the question of the patient's mental competency. For Orthodox Christians, the answer to that question appears simple. The patient, the patient's family and the doctor all need to open themselves up to hear what God is saying in the situation. The patient's family needs to be sensitive to the needs of the patient and listen to what they are actually saying, not only what the family thinks they are saying. The doctor needs to also be sensitive to the needs of the patient and recognize the patient's concerns and fears. In addition, the doctor must be vigilant in providing the patient with all the possible options in an unbiased manner allowing the patient to make the decision. The patient needs to be open to listening to others, whether the doctor or the family. Inasmuch as they all need to listen to the patient, the patient also needs to listen to them. The patient, patient's family, and the medical team need to work within a framework of "the ultimate relationship of love, trust and mutual devotion shared by the three Persons of the Holy Trinity.{{ref|1}} This may mean the patient or their family needs to "let go," that the doctor needs to accept a difficult decision from the family, or the patient needs to trust the suggestions of the doctor even if this means a difficult surgery.
UltimatelyAs followers of [[Jesus Christ]], the issue this means that prayers becomes "Thy will be done." Praying that way, acceptance of informed consent that will is one of submission to God as his creation. Within the fewpresent world, if this is not the only, doctor-related issues within Bioethicsalways easy. The onus appears to be placed primarily on the physician to completely inform the patient and continue in dialogue with the patient. When this burden need is not upheld by the physician, there are boundaries within secular law that can allow for the patient to seek remuneration from the physician. Unfortunately, this has become very common and, in my humble opinion, has caused out for physicians to fear patients people who understand and also provided for a lot of extra paperwork. Ideally, we would all work within accept that the framework provided by Fr. Breck of “the ultimate relationship of love, trust patient and mutual devotion shared by the three Persons of the Holy Trinity,” but within our current reality our calling as Orthodox Christians is to at least work towards these goals patient's family will be responding in ourselves first and by our example bring others to this understandingmanner. Issues surrounding informed consent at the end of life further complicate things, but within A good relationship with a primary doctor will ensure this framework are seemingly easier to understand and cope with. As Orthodox Christians, within issues of Bioethics, we will continually be searching for God’s as they will in all situations and, by putting our trust in Himideally, we will be able to make proper decisions. I suppose suggest specialists that for Orthodox Christians, a definition of informed consent or a list of what is considered complete informed consent would then have to include information regarding God’s willalso understand this and not try and force anything on us.
== Bibliography Conclusion == Breck, John. Sacred Gift of Life: Orthodox Christianity and Bioethics. (Crestwood: SVS Press. 1998) p. 17 Informed Consent. AMA.org. American Medical Association. http://www.ama-assn.org/ama/pub/category/4608.html (Accessed: April 26, 2007). Informed Consent. Dictionary.com. Merriam-Webster's Medical Dictionary. Merriam-Webster, Inc. http://dictionary.reference.com/browse/Informed Consent (Accessed: April 30, 2007).
Informed ConsentUltimately, the issue of informed consent is one of the few, if not the only, doctor-related issues within bioethics. The onus appears to be placed primarily on the physician to completely inform the patient and continue in dialogue with the patient. When this burden is not upheld by the physician, there are boundaries within secular law that can allow for the patient to seek remuneration from the physician. CancerUnfortunately, this has become very common and may have caused for physicians to fear patients and also provided for a lot of extra paperwork.govIdeally, we would all work within the framework provided by Fr. National Cancer InstituteBreck of "the ultimate relationship of love, trust and mutual devotion shared by the three Persons of the [[Holy Trinity]],"{{ref|1}} but within the current reality as Orthodox Christians one is to at least work towards these goals first and by example bring others to this understanding. http://wwwIssues surrounding informed consent at the end of life further complicate things, but within this framework are seemingly easier to understand and cope with.cancerWithin the issues of Bioethics, Orthodox Christians will continually be searching for God's will in all situations and, by trust in him, Orthodox Christians will be able to make proper decisions.gov/ClinicalTrials/AGuidetoUnderstandingInformedConsent/page2 (Accessed: April 27Thus, for Orthodox Christians, 2007)a definition of informed consent or a list of what is considered complete informed consent would then have to include information regarding God's will.
== References ==*{{note|1}} [[John Breck|Breck, John]]. ''Sacred Gift of Life: Orthodox Christianity and Bioethics''. (Crestwood: SVS Press. 1998) ISBN 0881411833*{{note|2}} [http://dictionary.reference.com/search?r=2&q=Informed%20consent Informed consent]. Merriam-Webster's Medical Dictionary.*{{note|3}} [[w:Informed Consent|Informed consent]]. Wikipedia.*{{note|4}} [http://www.ama-assn.org/ama/pub/category/4608.html Informed consent]. American Medical Association. Washington*{{note|5}} [http://www.cancer.edugov/ClinicalTrials/AGuidetoUnderstandingInformedConsent/page2 A Guide to Understanding Informed Consent]. University of Washington School of MedicineNational Cancer Institute. *{{note|6}} [http://depts.washington.edu/bioethx/topics/consent.html Informed Consent]. University of Washington School of Medicine.*{{note|7}} Of three textbooks for a course on Bioethics at [[Holy Cross Greek Orthodox School of Theology (Accessed: April 26Brookline, 2007Massachusetts)|Holy Cross Seminary]], only one listed informed consent in the index. Within that book, it was only discussed in one paragraph.
Informed Consent. Wikipedia.com. Wikipedia, Inc. [[Category:Bioethics]]http://en.wikipedia.org/wiki/Informed_consent (Accessed[[Category: April 26, 2007).Ethics]]
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