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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 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.”[1] Our first step will be to define informed consent and look briefly at the history, and then attempt to struggle with this issue and what it means for Orthodox Christians, and hopefully come to some conclusion.  == Definition & History == What is informed consent? According to the Merriam-Webster’s Medical Dictionary, informed consent is a noun which means “consent to surgery by a patient or to participation in a medical experiment by a subject after achieving an understanding of what is involved.”[2] Vital to this understanding is that the patient is supplied with the necessary facts but also fully capable to understand these facts - in other words, the patient needs to be mentally competent. This brings about legal ramifications which, of course, cloud the issue. When there is an absence of informed consent, ethical issues arise. Legally, certain procedures cannot be allowed to happen. If the patient is unable to give informed consent him or herself, for example in the case of a mentally incompetent patient or a child, then someone else is usually in a position to give consent. [3]  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 and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.”[4] 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.”[5] 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.[6]  The National Cancer Institute describes two key elements for informed consent in the case of a clinical trial: the document and the process. The document is what the participant actually signs and lists a summary of the clinical trial – “including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.”[7] – and also the rights of the participant. The National Cancer Institute says that the process of informed consent is ongoing and begins long before the trial begins and ends long after the trial is over. “Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.”[8] I think that this definition of informed consent is vital also to doctor-patient relationships as well and should not be limited to clinical trials.  The question of mental competency plays a major factor in this discussion. When is it ok for a doctor to question the mental competency of a patient and 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?[9]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.[10] 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.[11] 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.   To summarize a definition of informed consent let us look to a listing of the following elements which are necessary for a complete definition of informed consent:# the nature of the decision/procedure; # reasonable alternatives to the proposed intervention; # the relevant risks, benefits, and uncertainties related to each alternative; # assessment of patient understanding; and # the acceptance of the intervention by the patient.[12] This list provides a thorough and complete understanding for the patient and also for the doctor which will in turn provide for the best possible care. Informed consent is not needed in every situation. Generally, when surgery, anesthesia and other invasive procedures are involved, informed consent is needed. In situations where informed consent is not needed, it is still important for the lines of communication to be open and working between the patient and the doctor.[13] The patient should not be afraid to ask questions and the doctor should not be annoyed with having to answer them. == Orthodoxy and Informed Consent == For Orthodox Christians, what does all this mean? The issue seems to be clear cut, why all the fuss? According to Fr. Breck, “Some Christian ethicists today are suggesting that our unity in the Body of Christ implies a mutual commitment that 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.”[14] 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 to the doctor’s care in love because, ultimately, we are giving ourselves over to God because the 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.”[15] Personally, I see this as being the ultimate goal, what we need to strive for in this world, but I do not think that this is our current reality or something that we can feasibly expect at this point. If this is the ultimate goal of Orthodox Christians, how do we continually work towards this goal within the world we live in? What is our response to informed consent within the secular framework as followers of Christ?  Unfortunately, not a lot has been written on this topic from an Orthodox standpoint.[16] I would venture a guess that this is 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 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.”[17] 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.   As followers of [[Jesus Christ]], this means that our prayer becomes “Thy will be done.” When we pray that way, our acceptance of that will is our submission to God as His creation. Within the world as we now know it, this is not always easy. We need to seek out for our physicians people that understand and accept that we will be responding in this manner. A good relationship with our primary doctor will ensure this, as they will, ideally, suggest specialists that will also understand this and not try and force anything on us. == Conclusion == Ultimately, 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. Unfortunately, this has become very common and, in my humble opinion, has caused for physicians to fear patients and also provided for a lot of extra paperwork. Ideally, we would all work within the framework provided by Fr. Breck of “the ultimate relationship of love, trust and mutual devotion shared by the three Persons of the Holy Trinity,”[18] but within our current reality our calling as Orthodox Christians is to at least work towards these goals in ourselves first and by our example bring others to this understanding. Issues surrounding informed consent at the end of life further complicate things, but within 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 will in all situations and, by putting our trust in Him, we will be able to make proper decisions. I suppose 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 will.  == Notes ==[1] Breck, John. ''Sacred Gift of Life: Orthodox Christianity and Bioethics''.<br>[2] Informed Consent.Merriam-Webster's Medical Dictionary.<br>[3] Informed Consent.Wikipedia, Inc.<br>[4] Informed Consent. American Medical Association.<br>[5] ''Ibid.''<br>[6] ''Ibid.''<br>[7] Informed Consent. National Cancer Institute.<br>[8] ''Ibid.''<br>[9] Informed Consent.University of Washington School of Medicine.<br>[10] ''Ibid.''<br>[11] ''Ibid.''<br>[12] ''Ibid.''<br>[13] ''Ibid.''<br>[14] Breck, p. 17<br>[15] ''Ibid.''<br>[16] Of my three textbooks for a course on Bioethics at Holy Cross Seminary, only one listed informed consent in the index. Within that book, it was only discussed in one paragraph.<br>[17] Breck, p. 17<br>[18] ''Ibid.''<br> == Bibliography == Breck, John. ''Sacred Gift of Life: Orthodox Christianity and Bioethics''. (Crestwood: SVS Press. 1998) p. 17 Informed Consent. American Medical Association. (Accessed: April 26, 2007). Informed Consent. Merriam-Webster's Medical Dictionary. Merriam-Webster, Inc. Consent (Accessed: April 30, 2007). Informed Consent. National Cancer Institute. (Accessed: April 27, 2007) Informed Consent. University of Washington School of Medicine. (Accessed: April 26, 2007) Informed Consent. Wikipedia, Inc. (Accessed: April 26, 2007).[[Category:bioethics]]fag

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