Postoperative Vision Loss Elements of Research Proposal

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More times than not, a patient will argue that he did not understand what the physician stated to him; even amidst documented proof the medical professional and the patient did engage in an informed conversation. "The fact that a meeting took place does not necessarily mean that there was a meeting of the minds" (Informed consent…, 2010, ¶ 5). This issue leads some health care providers to assert that informed consent forms possess little value, particularly when a legal battle ensues and the professional cannot prove the patient did, in fact, understand the informed consent process.

Currently, lawyers routinely challenge informed consent forms in courtrooms throughout the United States (U.S.). "The model consent forms incorporate substantial details of anesthesia techniques, risks and other elements of 'informed consent', so that a strong presumption is established on its face" (Informed consent…, 2010, ¶ 7). During the informed consent process, to help inoculate the physician against lawsuits, healthcare providers must follow strict guidelines. They need to early explain and communicate properly each aspect of the consent form to the patient.

Two different and distinct philosophies of liability exist regarding informed consent. One: The common law battery may be defined as unauthorized touching of a patient without confirmed valid written consent, even if the action did not ham the patient. The second philosophy involves negligent failure to warn. This may occur when a healthcare provider does not inform the patient of the risks of a procedure or offer alternative attainable procedures. In 1914, a legal dispute between Scholendorff vs. Society of New York Hospitals began the foundation for informed consent laws by Justice Cardozo, noted at start of this chapter (Informed consent…, 2010).

Justice Cardozo stated the principle of the right of self-determination when he wrote: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained." (Informed consent…, 2010, ¶ 8)

Figure 1 depicts elements that should be clear in standard informed consent forms.

Figure 1: Elements of an Informed Consent Form (adapted from Informed consent…, 2010, ¶ 9).

As the Courts have defined what must be discussed with a patient for a patient to decide whether or not his right of self-determination has been fulfilled and understood, an informed consent form should contain both well communicated information about the procedure and documented proof of the risks.

The process of informing a patient about a medical procedure, particularly a surgical procedure, generally begins at their first healthcare appointment. The article, "Informed consent in the operating room" (1998), explains that "in contrast, the informed consent for anesthesia is often obtained in the minutes before surgery in which the anesthesiologist and patient meet for the first time" (¶ 1). A number of other considerations exist that medical professionals need to ponder when informing a patient about a medical procedure. Some circumstances may lessen or hinder a patient's ability to understand informed consent. Figure 2 illustrates examples of some situations where a patient may not be able to make health care decisions.

Figure 2: Patients Who May be Unable to Make Healthcare Decisions (adapted from Informed consent…, 1998, ¶ 2).

Healthcare providers may at times encounter a problem with a patient who has been sedated or received pain medication immediately before his procedure is to take place. Sometimes, for healthcare providers to obtain the necessary informed consent forms, the patient may be denied particular pain medications before their procedure. "When pain medications are withheld, patients may feel pressured to consent in order to obtain medication to relieve their suffering (Informed consent…, 1998, ¶ 3). On the other hand, some healthcare providers feel that premedication may help a patient decide to undergo a medical procedure, because he, as a result is able to concentrate on the healthcare decisions, instead of his pain. Most healthcare providers agree that medical personnel should never withhold pain medication from a patient suffering and in pain to obtain informed consent.

Regardless of how insignificant the risks of anesthesia may appear, healthcare providers must discuss all the details. Some physicians cite statistics, such as approximately one in 50,000 patients risk death while under anesthesia.

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During general anesthesia, the approximately one in 50,000 risk of death for a healthy patient may be compared "to that of the risk of death in an automobile accident (about twice that), as a way of putting perspective on the information being provided" (Informed consent…, What information…section, 1998, ¶ 2). This may or may not influence whether or not a person chooses to undergo a medical procedure.

A.M. Chen, D.R. Leff, J. Simpson, S.J.D. Chadwick and P.J. Mcdonald (2006), all with the Departments of Gastroenterology and General Surgery, North West London Hospitals NHS Trust, London, United Kingdom, conducted the study, "Variations in consenting practice for laparoscopic cholecystectomy." This study was designed "to compare the difference in consenting practice amongst trainees and consultant surgeons for laparoscopic cholecystectomy with specific reference to the documentation of significant risks of surgery" (Chen, Leff, Simpson, Chadwick & Mcdonald, p. 482). Ultimately, the authors found that a significant variation existed between the three grades of participating clinicians involved when acquiring the patient's consent.

As no consensus mandates what complication must be discussed with the patient, the professional soliciting the consent and implementing the provision of information, vital to the consent process, determines what is related. The legal position regarding the provision of information, Chen, Leff, Simpson, Chadwick and Mcdonald (2006) explain, proves identical to that judging whether the physician had been negligent in his care.

In the past, a doctor would not be held negligent if it was found that he acted in accordance with a reasonable body of medical opinion. …Current case law, therefore, places the burden on the clinician obtaining the consent to make a balanced judgment regarding what information needs to be disclosed to the patient. The only guide it offers is that all "material" and "significant" complications should be disclosed (Chen, Leff, Simpson, Chadwick & Mcdonald, 2006, p.485).

From their study, Chen, Leff, Simpson, Chadwick and Mcdonald (2006) assert that as trainees mention complications more than consultants do, they may be a better choice for taking consent. The authors also found that more often than not, conclude, physicians do not provide patients are with adequate information they may need to make an informed choice. Consequently, even though a standardized consent form may possibly overwhelm some patients with pointless information, Chen, Leff, Simpson, Chadwick and Mcdonald recommend that if each surgeon would adapt a consent form for his particular practice, this would complement legal and ethical concerns.

Few, limited circumstances occur when a medical care provider may intervene without consent. When a patient under the age of 18, a minor, requires medical treatment, complicated informed consent issues may arise. In some circumstances, such as abortions, access to contraceptives, or treating sexually transmitted diseases, legal council may be brought in to clarify general rules of informed consent.

Anesthesiologists who encounter minors or patients, unable to comprehend informed consent, must attain consent from a person who can legally provide it for the patient. Some states have specific statutes that contain a list of people who may give and sign consent forms for that patient. A few examples of individuals who may substitute and give consent for a minor or patient unable to comprehend consent include:

A parent (usually only one is necessary) for a minor child.

A husband or wife for their spouse.

A guardian for their ward.

Any adult standing in loco parentis (place of the parent) for a minor. (Often defined in state statutes or case law; example, the principal of a boarding school.) (Informed consent…, 2010, ¶ 14).

In extreme circumstances strictly defined by the law, other parties may be solicited or permitted to sign consent forms.

A common exception to the rule of obtaining informed consent occurs when an emergency situation arises. In general, as the consent would be implied, consent is not required during an actual emergency. In such instance, albeit, the physicians must be certain the patient is in fact, experiencing a real emergency. In Canterbury vs. Spence, the federal court states: "An emergency exists when the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent and outweighs any harm threatened by the proposed treatment" (Informed consent…, 2010, ¶ 15). It is generally assumed, for instance, that a person will choose to permit a physician to perform necessary medical procedures in to save his life or extremities. In a.....

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