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In the past, many of our ancestor’s actions have created an uncertainty about our human rights. As recently as the 1960’s, the Tuskeegee study, which infected three generations of African American males with syphilis and withheld treatment, has shown the American people that human experimentation exists. More importantly, human experimentation exists without the permission of the participants. America prides itself as a “free” country. As defined by Webster’s Dictionary, freedom is the “enjoyment of personal liberty, of not being a slave nor a prisoner, the enjoyment of civil rights (freedom of speech, freedom of assembly, etc.) generally associated with constitutional government, and the state of not being subject to determining forces.” Any person who is participates in a research study or has a procedure performed on them for any reason and has not been informed of certain information is in a state of being subject to determining forces.
Informed consent is the critical component of medicine that assures that patients have adequate information for deciding whether to participate in treatment or research. In order for a physician to obtain true informed consent, the physician must meet the following three criteria: provide information to the patient, make certain that the patient comprehends the information and that the patient’s actions are voluntary. What kind of information should a person expect before participating in a research study or before allowing a procedure to be performed on his/her body for treatment? A physician should request from the patient: a thorough medical history, state the purpose of the study, invite the patient to participate in the study, describe the selection criteria for the study, provide a full disclosure of all material risks and benefits, state any alternatives to the proposed treatment or study, provide assurances for confidentiality, provide an opportunity for the patient to deny treatment or participation, disclose all financial aspects of the proposed treatment or study, and offer time for questions. If a patient has ample knowledge and understanding of treatment options, alternatives, material risks and benefits, then that patient can make informed decisions about his/her healthcare. However, knowledge is not enough to justify “informed consent.” In order for a patient to give informed consent to any procedure or treatment option, the patients must be able to comprehend all information that a physician provides. Current research indicates that there is a connection between the quality of doctor-patient communication and the rising malpractice lawsuits.
In order to avoid malpractice lawsuits, how does a physician document whether a patient comprehends any information? Consent forms document that the patient understands the treatment options or the research study and that they may cause harm or death. Recent studies have shown that patients have limited comprehension of consent forms. Consequently, efforts are under way to improve the readability of consent forms. These efforts include making consent forms brief, 6th grade reading level, few to no technical words, add diagrams or pictures when helpful to patient comprehension and that the form includes all the criteria previously mentioned for informed consent. Ideally, the patient should have been well informed before signing a consent form. Unfortunately in some cases, the standard practice has been to substitute the physician’s verbal explanation with a consent form. Frequently, consent forms are written are at a Ph.D. reading level, very lengthy, and mostly technical, don’t include pictures or diagrams and don’t include all the elements of informed consent.
Currently, legal requirements have upheld patients’ claims against physicians who failed to verbally inform patients and depended on consent forms for documentation of patient comprehension. Informed consent is the only manner in which patients can express their desires for treatment options. In order for any patient to be truly informed, physicians must disclose all information to the patient. Physicians should never take it upon themselves to treat patients or perform experiments using human without their “informed consent.” Unfortunately, many cases in our world’s history have forced us to create global guidelines like the Belmont Report that expressly forbids any person from committing a crime against humanity. I find it a shame that such guidelines have to be spelled out.
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