Informed consent is an important element of healthcare, which is used as a way to inform, educate, and involve the patient in his own healthcare solutions. There are two major aspects that influence informed consent application in medicine – the first one is ethical, and the second one is legal. Both of them were derived from patient’s right to take control over each medication course that is used in order to cure patient’s body. Although this paper concentrates on the legal aspect of informed consent in American healthcare, it touches upon ethical issues associated with it as well.
Every state in the US has its own legal definition of what informed consent means. However, in every state it goes beyond mere patient’s signature on the medical course agreement. The most important part here is giving patient an opportunity to participate in his or her treatment by communicating with the therapist or any other doctor and to choose the necessary option of medical treatment (US Department of Health and Human Services, 2012).
According to basic human rights outlined in the US, the patient can refuse healthcare and treatment without explaining the reasons behind this decision. In some cases, it may be related to religious beliefs and personal reasons. The physician or any other healthcare practitioner cannot consider those grounds as unworthy or unfair. However, the physician’s job is to make sure that the patient has enough information to make the right decision. That is why informed consent is so important. Any medical treatment forced upon the patient without getting his informed consent is perceived as a tort by the law. Not everyone can obtain informed consent from the patient. This is only a responsibility of those specialists, who are responsible for the patient’s treatment. The legal requirement is that informed consent must be obtained by the current physician. Although authority delegation is possible, the responsibility for any consequences still lies upon the attending physician.
It is important to ensure that even the smallest interventions such as touching the patient are allowed by the informed consent. Finally, the patient can refuse any treatment at any stage for any reason at his/her own will (Beauchamp & Childress, 1994).
History of the Informed Consent Law
The right of the patient to become an ‘expert’ on choosing the right medical treatment for him was granted after the case Schloendorff v. Society of N.Y. Hospital in 1914. This decision was made by the New York Court of Appeals, which developed basic principles of informed consent including the assessment itself, the legal substitutes, and the treatment of specific cases. A malignant tumor was found in the body of Mary Schloendorff, and though she withheld her informed consent for the removal surgery, the attending physician did not listen to her wish and still removed it. After this case, the court decided that each adult person who is capable of evaluating information and making decisions should be recognized as a primary expert in selecting the best medical interventions that should be done to his or her body. Exceptions can be made in cases such as emergency situations, life-threatening cases, and when the patient is unconscious. However, since Mary Schloendorff sued the non-profit organization instead of the responsible physician no charges were passed.
It was the first legal acceptance of the informed consent principles in the US, but actually this right was outlined as early as the Hippocratic Oath was composed. The laws regarding informed consent made their last steps on their way to legal completion in 1947, when the American Medical Association was established.
Elements of Qualitative Informed Consent
Despite of the variety of legal definitions in different American states, informed consent still has some basic uniform elements that make it complete (US Department of Health and Human Services, 2012). Basic informed consent form should:
- Explain the patient’s diagnosis if it is known;
- Explain the nature of the recommended procedure(s) or medical decisions. The connection to patient’s diagnosis should be clear;
- Offer several options to choose from. Offered intervention should not puzzle the patient. He or she should always know about the alternatives if they are available;
- Make up the list of anticipated health benefits, risk factors, and uncertainties and present them to the patient in a clear form. This will certainly help the patient to make the right decision and be informed about features of the procedure;
- Provide the patient with risk and benefit details of the alternative solutions including costs;
- Make sure that the patient understands everything correctly. Question/answer section should be included;
- Provide all necessary documents for the patient to review and sign in case of agreement;
- Make sure that the patient knows about possible dangers of not taking any treatment at all.
Obviously, the person who should talk to the patient about all of the above is the physician, but in case it is not possible, a nurse or other representative can take this responsibility, though sometimes it does influence the quality of the process of obtaining an informed consent. The attending physician is legally responsible for obtaining informed consent, and though the delegated healthcare specialist may replace him, the consequences of malpractice will lie upon the attending specialist. The patient who is dissatisfied with the process of obtaining his/her informed consent has a right to sue the medical specialist or institution.
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There are several criteria that the patient’s consent has to meet in order to be legal. It should be obtained on a voluntary basis, and the patient should be eligible to make the decision by himself. In some cases, for example, before breast surgeries in Virginia, the patient is obliged to sign a special form confirming her consent. All surgical interventions require patient’s written informed consent, and institutions to perform surgeries should have JCAHO accreditation (American Hospital Association, 1992). If it is necessary, the patient can confirm his consent by telephone or e-mail. In case of telephone confirmation, the third arty can be used to prove the credibility of this consent in court if it is necessary. Most of American state laws make informed consent reasonable for a limited time. JCAHO determines this period to equal 30 days. In cases when the patient and the healthcare provider have to plan medical treatment or intervention long before it actually starts (for instance, in chemotherapy) the legal validity period is extended up to 6 months.
The Assessment Procedure
Obtaining informed consent from a patient can be complicated because differences in words, implications, and intentions of patients and their attending specialists may create numerous misunderstandings. In some cases, even the clear expression of consent does not mean that the informed consent is obtained, and obtaining a legally verified informed consent does not mean that all risks and alternatives are fully understood by the patient. There is no perfect instrument for obtaining informed consent, although verbal communication, writing, special forms, and other alternatives are available.
In some cases, for example, when dealing with sexual problems, patient’s consent should be assumed from his actions, health condition, or observations. Contradictory situations when the validity of informed consent is not clear include (Beauchamp & Childress, 1994):
- Situations when the patient signed the form because of fear, panic, psychological pressure, or the need for social approval;
- Situations when the patient was unable to evaluate and digest all the risks and benefits at the time the consent was given;
- Situations when the patient the consent was obtained based on the body language signs;
- Situations when the patient changed his decision in spite of the written consent provided (only in case of misinformation on behalf of the doctor);
- Emergency medical situations.
Special Cases of Obtaining Informed Consent
Expressed informed consent is the common proof of patient’s awareness and agreement. It can be either oral or it can be written if the proposed treatment implies a serious intervention into patient’s body. If medical specialist wants to secure himself from being sued in case some negative consequences are expected, he can offer the patient to sign the written informed consent form, which is an undoubted proof of doctor’s legitimate actions.
Implied informed consent is obtained in cases when patient’s agreement and awareness can be understood from his actions, for example, if he comes and asks for the certain kind of medication, which was offered to him before (US Department of Health and Human Services, 2012).
In some cases, after the informed consent was obtained and the patient has already received part of the planned treatment, unforeseen circumstances make medical specialist take emergency measures or choose another alternative treatment. If the patient is not able to give the consent to adjust treatment to the new conditions by himself, the attending physician or other responsible doctor can do it under the Extension Doctrine, which will cover the new changed ways of treatment. This is only acceptable if the newly offered measures are medically appropriate and do not threaten the reproductive abilities of the patient. Evidently, if the option offered by the healthcare provider was rejected by the patient before, it cannot be forced on him one more time, and, therefore, the Extension Doctrine will not cover it. If the healthcare provider is aware about future procedures and measures needed to support the treatment, he must undoubtedly inform the patient about them. Any actions that can damage reproductive organs and abilities of the patient should be covered in another independent informed consent form (Beauchamp & Childress, 1994).
In emergency cases, when death or serious health impairment needs to be prevented urgently, necessary treatments are allowed to be provided without the informed consent. Nevertheless, if the patient or some authorized individual is able to provide it, the healthcare provider needs to make sure he gets the informed consent to ensure additional legal support of his actions. For example, if the patient is unconscious and no family members are available, the doctor can make the assumption that emergency measures can be taken without any agreement. However, if the attending physician knows that offered measures would definitely be rejected by the patient, he should never take them. In case the police representatives force certain procedures on a patient, for example, urine or blood tests, the responsible physician should never perform those, unless he gets court’s order or patient’s agreement.
Informed consent is required to be obtained before any intervention into patient’s body is done, and the patient has a right to reject the recommended procedures. The rejection may be due to lack of belief in success, religious reasons, or some other personal ideas. However, there is an exception to this rule. If the patient has a young child and there is no one else to adopt and take care of that young child, then the offered measures need to be taken regardless of the patient’s decision. However, this is not applicable in some American states. Some states issue a court order in this situation, which empowers the attending physician to do whatever is required to save patient’s life regardless of his objections. In this case, the most important interests of the child are protected and the right of the adult to reject unwanted interventions is outweighed.
Minors and Informed Consent Guidelines
In case the intervention or treatment is required for a child under 18, the consent cannot be obtained from the child directly. The consent is obtained from the parents or other individuals responsible for the child. There are several exceptions from this rule. If minors serve in the military, are married, have children themselves, are totally independent and mature, or have special status that allows the physician to treat them as adults, then the consent should be obtained from them directly. There are special requirements relating to minors’ consent: all sexual, venereal, and pregnancy-related health issues should be treated with the consent of minors, not their parents. This does not include sterilization. In some states like Virginia any treatments that arre related to drug or alcohol usage and mental diseases are allowed to be provided with the consent of the minor himself. However, this does not apply to many other American states. The emancipation process is different in American states: some of the states require a minor to have the court order to be treated as an adult, while in other states general background is be enough to judge about the degree of minor’s maturity. Some states set a line at 14-15 years as a maturity age but others do not (like Virginia). If a minor is married, he or she is automatically treated as an adult in terms of obtaining consent. The only exception is the sterilization case, where additional information (health condition, age, etc.) is taken into account. Sometimes, a separate court order needs to be issued for such an operation (American Hospital Association, 1992).
Minor’s parents have the right to sign the informed consent form for their child. The only exception is the case when the custody of a child has been granted to someone else. It is interesting that minor’s parent cannot complete the informed consent form if he does not fit into any of the exceptions listed above. In most American states parenthood is not enough to be considered as adult, and other information is taken into account. Current marriage or military service, however, will work as a proper ground.
In most cases parents have the right to refuse medical intervention into their child’s body. Such decisions are generally respected by the law since parents are perceived as the best judges of what is appropriate for their child. If the attending physician or any other responsible healthcare provider doubts that parents’ decision is based on the interests of the child, or wants to prove that his judgment is more reasonable, he may request a court order if he has considerable grounds for such assumptions. Court representatives have the authority to decide whether parents are acting in the best interests of the child, and if they do not, intervention is ordered to be provided. If minor gets into emergency condition after parent’s rejection of medical treatment, and the attending specialist does not have enough time to request a court order and prove he is right, he may perform the intervention. However, he may as well be sued for doing it without informed consent from the parents. The doctor will be found innocent if the court decides that the child’s parents did not act according to the child’s best interests. In this case, the court will accept the medical condition of the minor as emergency. The court should also agree that this specific treatment would have been ordered to be provided in case more time was available. If all these conditions are relevant to the situation, the parents cannot accuse the attending doctor of anything.
If a minor is currently under the care of temporary supervisor, the healthcare provider still needs parents’ consent, except for the emergency cases. If Social Services Organization takes care of a minor, the consent-related responsibilities lie on representatives of this organization, and parents are no longer authorized to give their consent. A parent who is no longer a legal custodian does not have any vote in the consent. In all other cases a healthcare provider cannot ignore the right of legal custodians to give informed consent, except for emergency situations (American Hospital Association, 1992). If one of the parents approves and the other rejects medical intervention, consent of one parent is enough. If time allows, it is recommended to support this decision with a corresponding court order.
Informed Consent of Incompetent Patients
An issued court order about legal incompetence applies to all life spheres and is not influenced by the right to give informed consent. In some cases the patient is not able to comprehend all necessary information relating to the benefits and the risks of recommended medical interventions with enough reason and make a wise decision. It may happen for many reasons, but speech or communication disabilities alone do not present the ground to treat the patient as incompetent. Mental competence is the foremost requirement for giving informed consent. Incompetent patients are defined by the court because of their inability to perform information analysis and take care about themselves and their dependents. Generally, these roles are assigned to legal guardians. These appointed individuals are also responsible for making informed consent decisions. If the recommended medical intervention is a serious one and is going to affect the functionality of the incompetent patient’s entire body, a court order is issued to support the decision of the legal guardian. Sometimes, even incompetent patient’s vote has some weight in court’s decision-making process.
Institutionalized patients have a different legal status than the ordinary incompetents, even if their institutionalization was conducted involuntary. The decision about each healthcare intervention is made by them individually. Temporary incompetence is also possible in some cases. When the patient is proven to lack the ability to evaluate and understand all risks of each option, his informed consent may be substituted by the consent of an authorized individual. Every American state has its own procedures and rules regarding who can provide substituted consent (family members, close relatives, etc.). Anyway, the patient can grant these responsibilities to someone based on his own choice (US Department of Health and Human Services, 2012). In this case, a special form needs to be completed and signed by the patient. If this is not possible, the court needs to decide about each individual medical intervention. If there are several authorized individuals, the decision needs to be made on the majority of their votes and their importance should be taken into consideration. For instance, out of 4 adult children of the patient at least 3 need to give their consent about the proposed intervention. In case the votes are split as 2 vs 2, the court should make the final decision.
Court decisions are made after all relevant factors are taken into account. For example, the court can conclude that the patient may become competent to make the decision in the nearest future. If the court concludes that the treatment option contradicts religious beliefs of the patient, the court will forbid this specific practice, unless it is an emergency condition and patient’s life is at risk.