Consent to Medical Procedures of Patients with Neurodegenerative Diseases: A Comparative Study of Legal Regulations in Selected European Countries and in the United States

Abstract

According to the projections of the statistical office of the European Union, Eurostat, nearly one third of EU citizens will be at least 65 in 2060. The U.S. population age 65 and older continues to increase and is projected to nearly double from 48 million to 88 million by 2050. Elderly people are especially exposed to neurodegenerative diseases (NDs). The most common ND is Alzheimer’s disease (AD), a chronic and progressive disorder with a variety of pathological changes within neuronal tissue, which begin even 10–15 years before the onset of cognitive impairment symptoms. AD is perceived as a disease continuum and considered to include three basic phases: preclinical (asymptomatic) stage, mild cognitive impairment (MCI), and dementia due to AD. A very important issue, from medical and legal perspectives, is the NDs patient’s consent to medical procedures, including diagnostic procedures, such as lumber puncture. NDs patients are not always able to express their consent and do not always understand the information provided by a physician. This applies to a group of patients in the final stages of NDs. This paper presents legal regulations of selected European countries and signalizes the U.S. legal solutions on the issue of NDs patients’ informed consent to medical procedures.

Keywords

Alzheimer’s disease consent to treatment legal regulations neurodegenerative diseases

EPIDEMOLOGY OF NEURODEGENERATIVE DISEASES

Senescence of communities in industrialized countries leads to a significant increase of the population of people affected by neurodegenerative diseases (NDs)—a group of complex disorders linked by the chronic and progressive neurodegeneration [1]. This neurodegenerative process is characterized as a gradual damage of structure and function of neurons, leading to a decreased signal transduction, loss of synapses, and, finally, neuronal death [2]. Therefore, NDs can seriously disable functioning of patients affected, especially in more advanced stages.

Although the causes underlying NDs are extremely variable and complicated by environmental and/or genetic factors, there are some common features among them. Many neurodegenerative diseases are characterized by the intracellular aggregation of misfolded toxic proteins, which are the hallmarks of NDs [3]. These protein aggregates cause cellular toxicity and contribute to death of neurons.

Neurodegeneration may occur either in the central (CNS) or peripheral nervous systems (PNS). NDs of the central nervous system, such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and PD-related disorders, or Huntington’s disease (HD), can affect the brain and/or spinal cord. On the other hand, PNS diseases may be classified further depending on the type of neurons (sensory or motor) involved. NDs of motor neurons, including amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA), can cause an impairment in voluntary muscle control, such as constriction and relaxation [4].

The most common neurodegenerative disorder is AD, a chronic and progressive ND with a variety of pathological changes within neuronal tissue, which begin even 10–15 years before the onset of cognitive impairment symptoms [5]. AD is characterized by loss of neurons and synapses in CNS, especially in the cerebral cortex and certain subcortical regions responsible for memory formation. This disease is also the most frequent cause of dementia, which constitutes 60–70% of all dementia cases worldwide [6]. According to the World Alzheimer Report 2016, currently AD affects around 47 million people worldwide, and there are nearly 10 million new cases every year [6]. It is also the sixth-leading cause of death in the United States [7]. In aging population, AD is one of main health NDs problems, but also the most important socio-economic issue. AD patients, especially at later stages of the disease, require permanent healthcare from related and unrelated caregivers.

AD is perceived as a disease continuum [8] and considered to include three basic phases: preclinical (asymptomatic) stage, mild cognitive impairment (MCI), and dementia due to AD [8 –10]. MCI is a significant risk factor for the development of dementia representing, in some circumstances, the prodromal phase of AD or other NDs. It is estimated that approximately up to 35% of MCI patients progress to AD dementia within a 3-year follow-up with an annual conversion rate of 5%–10% [11].

Clinical staging of AD may be also assessed using more differentiated scale of Reisberg et al. [12], which divides the progression steps of AD into seven stages, from no impairment, through very mild, mild, moderate, moderately severe, severe to the final stage of very severe decline. Behavioral and psychological symptoms of dementia (BPSD) and associated disturbances in individuals with AD are also increasing burden and a source of growing distress for patients’ spouses and families, requiring employment of professional caregivers. Moreover, an increase of BPSD according to the stage of disease is also associated with more rapid institutionalization and higher morbidity and mortality in persons with AD, as well as with the necessity of legal incapacitation due to severity of dementia.

PD is the second most common ND in the world, after AD [13]. Similarly to AD, PD is also a multifactorial disorder that affects mainly older people. Currently, PD prevalence is increasing with age and PD affects 1% of the population over 60. The core symptoms of PD include: resting tremor with progressive muscle weakening, muscle stiffness, bradykinesia, as well as impaired postural balance and coordination [14]. Additionally, PD is also characterized by certain vegetative, emotional and cognitive symptoms, with dementia at later stages of this disease. Cognitive impairment in PD ranges from Parkinson’s disease mild cognitive impairment (PD-MCI) to Parkinson’s disease dementia (PDD) [15].

Presence of certain specific proteins in CSF is a characteristic feature in the course of some NDs. Lumbar puncture (LP) and analysis of cerebrospinal fluid (CSF) is a useful tool in the diagnosis of AD. Decreased concentrations of amyloid-β 1–42 and elevated levels of tau and P-tau proteins in CSF are observed in patients with AD [16]. CSF examination, together with neuropsychological examination and neuroimaging, is useful for estimation of probability of AD in the patient. Certain diagnosis of AD is possible only in postmortem histopathological examination of patient’s brain tissue.

LP, similarly to other medical procedures (both diagnostic and therapeutic), requires obtaining an informed consent from patients. This is regulated by law, which might result from historical reasons, personal experience of physicians or their attitude to certain medical procedures like LP.

The present paper discusses law regulations binding in selected European countries (Poland, Germany, England, and Wales), as well as in the United States. The authors have chosen these countries, as they represent different types of legal orders. In the world, there are three types of legal systems according to the sources of law: civil law, common law and case law, with their specific features. All of them are referred to in this paper, represented by respective countries (Table 1).

Table 1

Legal systems according to the sources of law

System	Civil Law	Common Law	Case Law
Country	Poland Germany	England Wales	United States
Sources of law	Legal norms passed by the legislature	Case law rules of common law and equity	Judicial precedent Federal and state law systems
Examples of legal acts	Penal Code (Poland and Germany); Civil Code (Poland and Germany); Act on professions of doctor and dentist (Poland)	Mental Capacity Act	National Alzheimer’s Project Act; Nursing Home Reform Law; 45 C.F.R. part 46; state laws

It should be noted that the paper does not aim at discussing ethical issues (bioethics, medical ethics, etc.), but presenting and comparing legal regulations binding in the aforementioned countries.

LEGAL REGULATION IN POLAND

According to the latest Demographic Yearbook of 2017, prepared by the Central Statistical Office of Poland, around 38,433,000 people lived in Poland at the end of 2016, including 6,303,400 over 65 years of age, representing 16.4% of the total population. This means that every sixth resident of Poland is at least 65 [17].

Polish regulation of a patient’s consent to a medical procedure is provided for in the Act of December 5, 1996 on professions of doctor and dentist [18]. Specific provisions concerning the subject issue can be found in Chapter 5 thereof, containing rules for pursuing the profession. Article 30 provides for the general, basic duty of every physician, namely: “A physician is obliged to provide medical assistance in all cases when the delay in doing so could cause the risk of death, heavy bodily injuries or severe health disorders, as well as in other cases of urgency” [18]. This provision is related to Article 162 of the Penal Code, which obliges every person to provide assistance to a person in need, if providing such assistance is possible “without exposing him or herself or another person to the risk of death or severe health disorders”. Anyone who does not provide such assistance is liable to imprisonment for up to three years [19]. Ł. Caban and M. Urbańska draw attention to two important aspects of this provision. First, it applies to a physician regardless of whether in a given, particular moment she or he provides medical assistance or by a pure coincidence, not related to conducting by her or him professional activities, she or he has found herself or himself in a situation where another person requires a physician’s intervention. Second, it does not apply merely to the moment of a direct risk of death, heavy body injuries or severe health disorders, but also to a situation where such danger can occur, as a result of delay in providing assistance by a physician [20]. If a physician does not follow the said provision, she or he can bear disciplinary, civil or criminal liability [21].

Moving on to more detailed solutions on the problem of consent of AD patients, regulation provided for in the next provision of the Act on professions of doctor and dentist should be examined. Article 31 Paragraph 1 introduces the following solution: “A physician is obliged to provide the patient or his statutory representative with straightforward information about his health condition, examination, suggested and possible diagnostic and treatment methods, the foreseeable consequences of their application or omission, results of treatment and prognoses” [18]. This provision clearly represents the principle of a patient’s participation in a medical process, possible to implement only when a patient is aware of her or his health condition and particular possibilities of treatment [20].

A key provision on informing AD patients about treatment is provided for in Article 31 Paragraph 6: “If a patient is under 16 years of age or is unconscious or unable to understand the meaning of information, a physician provides information to a close person within the meaning of Article 3 Paragraph 1 pt 2 of the Act of November 6, 2008 on patients’ rights and the Commissioner for Patients’ Rights” [18]. The close person, according to the Act mentioned in the quoted provision, is: “a spouse, a relative by consanguinity or a relative by affinity up to the second degree in a straight line, a statutory representative, a cohabitant or a person indicated by the patient” [22]. Thus, there is a closed catalogue of persons who can be informed instead of the patient, when AD makes her or him unable to understand the meaning of information provided by a physician.

When discussing a patient’s consent to medical procedures, Article 32 of the Act on professions of doctor and dentist should be kept in mind. Its Paragraph 1 introduces the general principle: “A physician may conduct examination or provide other healthcare services subject to exceptions provided for in the Act, after consent has been expressed by the patient” [18]. It is the right of every patient to self-determination. It is expressed in the right to make specific decisions in the course of treatment [23].

An exception to this rule is provided for in Article 33 of the subject Act, according to which: “An examination or providing of different healthcare services to a patient without his consent is permissible, if he requires immediate medical assistance, and due to his health condition or age, cannot express consent and there is no possibility to communicate with his statutory representative or actual caregiver” [18].

There are several important features of the patient’s consent to a medical procedure, that make it valid. First, a patient’s decision must be made before a physician conducts a given activity [23]. Therefore, it is not possible for the decision to be made post-factum. It is also important that a person expressing consent is entitled to make the decision [24]. This entitlement results from legal provisions. Generally, it is the patient her- or himself; there are some exceptions however. Another feature of the consent is the fact that it cannot apply to the actions taken by a physician, which are contrary to the law or to the principles of social coexistence [24].

The key attribute of a patient’s decision, from the point of view of AD patients, is its consciousness. Two features of such consciousness are raised in the literature. The first feature is a requirement that a physician explains a patient her or his health situation and actions the physician proposes in order to improve the patient’s health. The second feature concerns mental health of a patient, who has to be capable of making decisions [23]. The mental condition preventing informed decision-making can result from a late stage of AD. In the assumed simplified, three-stage scale of the AD development, it corresponds to the third, last one, phase.

Article 32 Paragraph 2 of the Act on professions of doctor and dentist is, in a way, an introduction to a situation where a patient is unable to independently express consent to a procedure. It reads as follows: “If a patient is a minor or unable to give informed consent, a consent from his statutory representative is required, and when the patient has no statutory representative or communication with such representative is impossible – a guardianship court’s authorization” [18]. This regulation applies to patients who reached the final stage of Alzheimer (the third phase), and are therefore unable to make conscious decisions. Article 32 Paragraph 3 introduces great facilitation to a situation of these people, as it enables an actual caregiver of a person unable to make decisions to express consent [18].

In certain situations, a person for whom AD seriously limits ability to function independently, is granted a status of a full interdict. In such situation, there is an explicit solution – according to Article 32 Paragraph 4, a decision is made by a statutory representative of a patient. It is so-called the substitute consent. As the provision further reads: “If such person is able to express informed opinion on the examination, obtaining consent of this person is also necessary” [18]. Thus, the double consent, i.e., cumulative, is required [23].

Regulation of Article 32 Paragraph 6 is also of a great importance. It introduces, for a person with inter alia AD, who has sufficient knowledge on her or his situation, a possibility to oppose a decision made or lack of decision by a patient’s statutory representative or actual caregiver. In such an event, a guardianship court gives authorization to conduct a medical procedure [18]. The same court makes decision in a situation where a person with inter alia AD, who is unable to make informed decision concerning further healthcare, has neither an actual caregiver nor a statutory representative or, at a given time, when it is necessary to obtain consent to further medical actions, contacting such persons is not possible [18].

Legal regulation of medical actions with a higher risk for a patient is different. In such a situation, a written patient’s consent is required [18]. If an AD patient is unable to give informed consent, consent of the patient’s statutory representative is required. As in the case of usual medical actions, if a patient has no statutory representative or, at a given time, contacting the statutory representative is impossible, a decision is made by a guardianship court [23].

In the case of medical actions with a higher risk for a patient, the guardianship court has a second competence. If a statutory representative of an AD patient unable to make informed decision, does not consent to take actions related to “the risk of death of a patient or heavy bodily injuries or severe health disorder”, a physician may conduct such actions if a court authorizes her or him to do so [18].

In exceptional situations, “when delay caused by a procedure for obtaining consent could cause the risk of death for a patient, of heavy bodily injuries or severe health disorder”, a physician may conduct medical actions without statutory representative’s consent, or even without consent of a guardianship court. She or he should, however, if it is possible, consult another physician, preferably of the same specialization. In such a situation, a statutory representative, actual caregiver or guardianship court shall be immediately notified of these actions [18].

LEGAL REGULATION IN THE FEDERAL REPUBLIC OF GERMANY

A patient with AD is an adult (pursuant to Section 2 of the Civil Code, majority begins at the age of eighteen) [25], capable or incapable of expressing consent. A physician is obliged to comprehensively inform a patient on treatment’s purposes. This reflects treatment of a patient as a person aware of self-responsibility, as a subject and partner in conversation. Such treatment is based on conviction that a physician cannot undertake any medical actions without voluntary consent of a patient. And the only way for her or him to obtain such consent is to provide the patient with the necessary information, making it easier for the patient to make decision. A physician’s obligation to explain covers important stages of treatment and planned methods, consequences and possible risk, as well as diagnosis. If there is a possibility to choose a treatment method, a patient has to be familiar with the alternatives. Providing information is especially important, when experimental treatment is considered. Information should be provided in such a manner that it is understandable for a patient, preferably in a form of detailed conversation [26].

Essentially, according to the settled case law, every medical action involving violation of physical integrity of a patient has the attributes of a prohibited act – bodily injury, regardless of whether it is effective, unsuccessful, lege artis or mistaken [27, 28]. For a medical procedure to take place under the allowed justification, it has to satisfy specific premises excluding its criminality. Otherwise, behavior of a physician conducting medical actions will fulfill attributes of offences, set forth in Chapter XVII of the German Penal Code – StGB [28] (Offences against physical integrity), namely: intentional bodily injury (§ 223); aggravated (§ 224) or grievous bodily injury (§ 226); bodily injury resulting in death (§ 227) or unintentional bodily injury (§ 229), depending on subjective and objective sides of an offence, subject to the physician’s awareness.

Undoubtedly, a patient’s consent is the root of justification for allowed medical procedures, which allows for conducting medical actions. The key provision in this regard is provided for in § 228 of StGB, which reads as follows: “Anyone who commits bodily injury with the consent of the given person, acts unlawfully only when the act, despite the given consent, goes beyond good morals”. Thus, the consent is the main attribute of the lack of liability, but not the only one. Violation of good morals (gute Sitten), even when the condition of consent to a medical procedure is met, causes criminal liability of a physician conducting the procedure [30, 31].

The expressed consent must be preceded by explanation of the essence of the procedure, typical risk associated with it and possible side effects and consequences. The obligation to explain these circumstances lies with a physician conducting the procedure who, if possible, should explain them to the patient ex ante, and not ex post.

The necessity to conduct a procedure should be dictated by medical reasons, and the medical action itself must be conducted in accordance with the principles of medical practice lege artis, regardless of whether the procedure will be eventually successful [34]. It should be emphasized that, in this particular context, it is not important whether a medical treatment is successful or not, because a physician is obliged to conduct a medical procedure lege artis, regardless of whether the treatment turned out to be successful, and the liability for medical malpractice does not depend on the success of the treatment. When the aforementioned premises are met, a successful medical procedure will not fulfil attributes of bodily injury [35, 36], whereas if unsuccessful, there might be liability for potential medical malpractice and, as a consequence, unintentional bodily injury.

According to Ch. Knauer, every medical procedure should be treated in a diversified manner. He offers the following triad of possible solutions:

Prescribing medicines, using medical methods, which do not involve violating physical integrity of a patient, also diagnostic actions, which do not deteriorate health condition and do not cause further side effects, do not fulfil attributes of bodily injury. As an example, he mentions recommendation to use painkillers or diagnostics using X-ray machines, unless they cause damage to a patient’s health;

Medical procedures involving minimum invasiveness, and therefore, in certain way, injuring a patient, but consequently improving the patient’s health, do not fulfil attributes of a prohibited act, e.g., minimally invasive endoscopy procedures;

All medical procedures involving significant injuring effect, as, e.g., amputation, organ procurement, all actions that, due to their difficulty, have to be conducted under full anesthesia, as well as using medicines, which cause side effects hard to reverse, e.g. chemotherapy – shall be qualified as fulfilling attributes of bodily injury.

Methods of treatment mentioned in points 1 and 2 would constitute bodily injury if, due to malpractice, patient’s condition deteriorated or new disorders occurred [28].

The proposed systematics seems to be rational and assuming that premises of consent, at source of which lies informing a patient about risk and consequences of undertaken actions, will be fulfilled, the proposal of Ch. Knauer should be shared. This correlates even with the assessment of the degree of risk and significance of medical actions, which are differentiated according to their scope and consequences. The third group distinguished by the Author is characterized by increased risk, whereas two first groups are characterized by greater routine and lower likelihood of error.

The said Author also proposes a minimum standard for a physician’s information, using quite reach judicature to support the proposal:

The aim of explaining a procedure is to acquaint a patient with a type, significance, scope and risk of the planned procedure, to enable the patient to assess all arguments “for” and “against”;

Information concerning a diagnosis is essential from legal point of view, only to the extent that it relates to a medical procedure; exceptionally, a patient should be informed about diagnosis, if in relation to it there is a need to undergo necessary actions other than the medical procedure, in order to avoid deterioration of health condition;

Information concerning a therapy should be provided to a patient generally when the therapy is connected to the planned medical procedure and always, when due to the treatment, a change of the patient’s lifestyle or diet are necessary;

The scope of information about the planned medical procedure each and every time depends on the degree of its invasiveness. The point of gravity should lie, most of all, in warning a patient about the risk associated with the procedure, what is the most important from the legal point of view, but also the least liked by medical environment in practice;

When the risk is concerned, a patient should be informed about all typical, possible results of the undertaken procedure, but also consequences that can happen in the given case (e.g. change of voice tone in case of singers, academic teachers);

The degree of accuracy and intensity of provided information increases with decreasing necessity of the procedure, meaning that, in practice, when there is no time due to necessity of the procedure in order to save life, providing only essential information is enough;

In a close relation remains the obligation to provide information on alternative treatment methods, which occurs only when a patient can be treated with the use of many methods, differing in intensity of medical interference and diverse perioperative risk;

Medical information not always should be provided ad ultimum to every patient. The degree of patient’s sensitivity should be taken into account and attention paid to the way of providing information, so it doesn’t cause harming results;

A patient, who already has necessary diagnostic information provided by another consulting physician, usually does not require additional explanation. This does not apply to a physician conducting the procedure, as she or he is the main perpetrator of eventual violations. Thus, she or he is obliged to inform the patient reliably and factually, even if the patient has already received information from lower healthcare personnel;

A recipient of this information is basically the patient her- or himself, provided that she or he is capable of expressing consent (what is excluded e.g. in the case of AD patients in the last – third phase of the disease). When procedures have to be conducted immediately, without a possibility of being postponed, the lack of providing information can be justified by acting in the state of necessity (Article 34 of StGB) and the principle of supposed presumed patient’s consent;

Information should be provided sufficiently in advance, so the patient can comfortably consider all arguments for and against the procedure. The less necessary the procedure or more severe its consequences, the longer time lag should be given between providing information and the planned procedure. And contrarily, the more necessary the procedure or less severe consequences, the shorter can be the time lag between medical information and the procedure itself;

The form of providing information is irrelevant from the point of view of the penal law, meaning that there is no need to fill out forms documenting that the obligation of providing information has been fulfilled. It is proposed, however, that an annotation on providing information was placed in a patient card, what could make physician’s defense easier in the eventual criminal proceeding. It is worth to mention also the so-called gradual concept, according to which a patient receives written information prepared beforehand, and then a personal conversation takes place, when a physician provides more detailed explanation.

The exception from the said minimum standard of conduct can apply only to prescribing medicines to a person fully aware, as a patient is obliged her- or himself to familiarize with possible side effects, according to the rule that a patient should know that a medicine can cause some side effects. However, at a patient’s clear request, a physician is obliged to provide her or him with requested information concerning a prescribing medicine [28].

The abundant case-law and the literature invoked by Ch. Knauer when developing the aforementioned minimum standard, deserve wide recognition. It is difficult to formulate any allegation against such model and the only things that should be emphasized are differences between eventual procedural positions of a physician as the accused in a criminal proceeding or a defendant in a civil proceeding. While in a criminal proceeding the burden of proof lies with law enforcement, in a civil proceeding it lies with a person who derives legal effects from it. It would be more desirable then that a physician, even because of so-called litigation prudence, documented the fact of providing information to a patient, not only on the basis of a routine note in the patient card. It is of a great importance when possible line of defense in a criminal proceeding is planned; a physician, hypothetically taking care of hundreds of patients, is not always able to accurately remind her- or himself how and to what extent she or he provided specific information to the patient.

If harm was done to a patient, civil law provisions are of importance, especially § 823 pt I of the Civil Code (BGB), providing for the restitutive obligation to redress damage, reading as follows: “A person who intentionally or negligently, unlawfully injures the life, body, health, freedom, property or another right of another person is liable to make compensation to the other party for the damage arising from this” [37]. From the civil law perspective, a physician should obtain a patient’s consent to a medical procedure. The consent is effective and excludes unlawfulness of a physician’s act only if a patient has been informed about the essence, significance and scope of the procedure. According to the leading commentators of the Civil Code, informing a patient in especially comprehensive manner is necessary, when new methods of treatment are used, when invasive operations are to be conducted and when there is a high probability of an unsuccessful procedure. This allows avoiding tortious liability, however the burden of proof lies with a physician. In the case of gross negligent or medical malpractice, the burden of proof in civil law cases lies with a physician. The procedure conducted without the patient’s consent is permissible only when there is no possibility to obtain the consent (e.g. due to the lack of consciousness, that can occur in the last – third stage of AD), and the patient’s life is threatened [38].

Of a great importance, with respect to AD, is regulation stipulated in § 104 pt II of BGB (“A person is incapable of contracting if [...] he is in a state of pathological mental disturbance, which prevents the free exercise of will, unless the state by its nature is a temporary one”) and § 105 of BGB (“(1) The declaration of intent of a person incapable of contracting is void. (2) Also void is a declaration of intent that is made in a state of unconsciousness or temporary mental disturbance”), according to which a declaration of intent made by a person without capacity to make acts in the law is invalid. This means that a patient at the advance stage of AD is incapable of deciding for her- or himself.

Additionally, the German Civil Code, in provisions of § 630a - §630 h provides for duties typical in the treatment contract. According to these provisions, “the treatment contract obliges the party agreeing to provide medical treatment for a patient (treating party) to provide the promised treatment, and the other party (patient) to pay the agreed remuneration unless a third party is obliged to effect payment. Unless agreed otherwise, the treatment must take place according to the medical standards that are generally recognized at the time of the treatment” [39].

Pursuant to § 630c of BGB: “The treating party and the patient should work together to implement the treatment. The treating party is obliged to explain to the patient in a comprehensible manner at the beginning of the treatment, and where necessary during the same, all and any circumstances that are relevant to the treatment, in particular the diagnosis, the anticipated health development, the therapy and the measures to be taken on the occasion of and subsequent to the therapy. If circumstances are recognizable for the treating party which give rise to the presumption of malpractice, he/she shall inform the patient thereof on request or in order to avert health risks. (...)”. Whereas § 630d of BGB, when it comes to the consent, reads as follows: “Prior to implementing medical treatment, in particular a procedure affecting the body or health, the treating party is obliged to acquire the consent of the patient. If the patient is unable to consent, the consent of a party entitled to do so is to be acquired unless a living will in accordance with section 1901a (1) sentence 1 permits or prohibits the measure. Further requirements with regard to consent ensuing from other provisions remain unaffected. If consent to a measure which cannot be delayed cannot be acquired in good time, it may be implemented without consent if this is in line with the implicit will of the patient. (...) Consent may be revoked at any time, without complying with a specific format, and without stating reasons”.

Pursuant to § 630e of BGB: “The treating party is obliged to inform the patient of all and any circumstances which are relevant to consent. This includes in particular the nature, extent, implementation, anticipated consequences and risks involved in the measure, as well as its necessity, urgency, suitability and prospects for success with regard to the diagnosis or the therapy. Alternatives to the measure must also be referred to in the information if several equally medically indicated, customary methods may lead to significantly different strains, risks or chances of recovery.

The information must:

be provided orally by the treating party or by a person who has the requisite training to carry out the measure; additionally, documents may also be referred to which the patient receives in text form;

be provided in good time so that the patient can take his/her decision on consent in a well-considered manner;

be understandable for the patient.

The patient shall be provided with duplicates of documents which he/she has signed in connection with the information or consent.

The patient does not need to be provided with information where this can be exceptionally dispensed with because of particular circumstances, in particular if the measure cannot be delayed or the patient has explicitly waived being provided with the information. If, in accordance with section 630d (1) sentence 2, the consent of a party entitled to do so is to be obtained, the latter shall be informed in accordance with subsections (1) to (3).

In cases coming under section 630d (1) sentence 2, the major circumstances in accordance with subsection (1) shall also be explained to the patient in a manner that he/she is able to understand, where the latter is capable of absorbing the explanation on the basis of his/her state of development and ability to understand and unless it is inconsistent with his/her well-being. (...)”

Patients incapable of expressing consent, thus patients with and advanced AD in the third phase, who cannot recognize and assess the significance of the consent, act through other entitled persons.

LEGAL REGULATION IN ENGLAND AND WALES

In England and Wales, the problem of deciding on treatment by patients, who are incapable of making decisions for themselves, thus inter alia patients in the third phase of AD, is regulated by the Mental Capacity Act of 2005. This act sets out the rules of making decisions for such persons [40]. The Mental Capacity Act introduces five principles that apply for the purposes thereof. First, it shall be assumed that a given person has capacity to decide, unless it is established otherwise. Second, a person shall not be treated as unable to make a decision concerning treatment for her- or himself, unless all practicable and rational steps have been taken to help her or him to do so. Further, the fact that a given person makes unwise and objectively unreasonable decisions shall not be a reason for treating such person as unable to make a decision concerning treatment. Additionally, all acts done under the act for or on behalf of patients, shall serve their best interest. Finally, according to the last principle, before the provisions of the act are applied, it shall be considered whether the purposes for which they need to be applied can be achieved without restricting the given person’s right to choose freely [41].

For the purposes of the Mental Capacity Act, regarding a patient as incapable of making a decision on a specific issue concerning treatment, has two important features. First, this incapacity must be at the material time. Whereas, it is irrelevant whether this incapacity is temporary and passing, or permanent. Second, the incapacity should result from impairment or disturbance in the functioning of the mind or brain [41]. Therefore, it applies to inter alia patients with AD, especially in its third (last) phase.

A patient is considered as unable to make a decision for her- or himself in four cases, namely: 1. When she or he is unable to understand the information relevant to the decision; 2. When she or he is unable to retain the information and data on the treatment; 3. When she or he is unable to use the received information in the process of making the decision; 4. When she or he is unable to communicate her or his decision [42].

Mental Capacity Act provides for various solutions to the situation when a patient is unable to make informed decisions on her or his treatment. Section 9 describes the institution of the lasting power of attorney. According to pt 1, “A lasting power of attorney is a power of attorney under which the donor (“P”) confers on the donee (or donees) authority to make decisions about all or any of the following: (a) P’s personal welfare or specified matters concerning P’s personal welfare, and (b) P’s property and affairs or specified matters concerning P’s property and affairs, and which includes authority to make such decisions in circumstances where P no longer has capacity” [42].

Section 11 of the Mental Capacity Act introduces restrictions to the said institution. The lasting power of attorney does not authorize the donee to undertake any act that is intended to restrain the donor, unless the following three conditions are cumulatively satisfied: 1. the donor lacks capacity to make decision in a given situation, or the donee reasonably believes so; 2. the donee reasonably believes that it is necessary to undertake the act in order to prevent harm to the donor; 3. the act is proportionate to the likelihood of the donor’s suffering harm on the seriousness thereof. Section 11 pt 5, which is of importance with regard to this matter, reads as follows: “For the purposes of this section, the donee restrains P if he (a) uses, or threatens to use, force to secure the doing of an act which P resists, or (b) restricts P’s liberty of movement, whether or not P resists, or if he authorises another person to do any of those things” [42].

The competence of the court relating to making decisions for a patient who lost such capability are set forth in Section 16 pt 2 of the Mental Capacity Act, which reads as follows: “The court may (a) by making an order, make the decision or decisions on P’s behalf in relation to the matter or matters, or (b) appoint a person (a “deputy”) to make decisions on P’s behalf in relation to the matter or matters”. ”P” refers to a patient who lost capacity to make informed decisions about her or his treatment. Thus, the court may both directly make decisions for the patient, and appoint a person to make decisions. When deciding whether it is in the patient’s best interests to appoint a deputy or make the decision by making order, the court takes into consideration two matters described in pt 4, namely: “(a) a decision by the court is to be preferred to the appointment of a deputy to make a decision, and (b) the powers conferred on a deputy should be as limited in scope and duration as is reasonably practicable in the circumstances” [42].

The court of a higher instance hearing cases of patients who are unable to make decisions on the treatment for themselves is the Court of Protection. It has a position equal to the Supreme Court. It has also a number of additional competences concerning situation of persons who are unable to make decisions on the treatment by themselves. One of these competences is making interim orders and giving directions, regulated in Section 48 of the Mental Capacity Act, which reads as follows: “The court may, pending the determination of an application to it in relation to a person (“P”), make an order or give directions in respect of any matter if – (a) there is reason to believe that P lacks capacity in relation to the matter, (b) the matter is one to which its powers under this Act extend, and (c) it is in P’s best interests to make the order, or give the directions, without delay”. The Court has also a power to call specific institutions for reports [42].

The Mental Capacity Act establishes an institution of the Public Guardian. He has a number of competences with regard to persons unable to make informed decisions on the treatment for themselves. These are, inter alia, functions stipulated in Section 58, such as: “(a) establishing and maintaining a register of lasting powers of attorney, (b) establishing and maintaining a register of orders appointing deputies, (c) supervising deputies appointed by the court”, as well as “(f) receiving reports from donees of lasting powers of attorney and deputies appointed by the court, (g) reporting to the court on such matters relating to proceedings under this Act as the court requires, (h) dealing with representations (including complaints) about the way in which a donee of a lasting power of attorney or a deputy appointed by the court is exercising his powers” [42].

U.S. REGULATIONS

The number of Americans with AD or other dementias is expected to grow, as the U.S. population age 65 and older continues to increase [43] and is projected to nearly double from 48 million to 88 million by 2050 [44]. The so-called baby boom generation has begun to reach age 65 and beyond, the age range of greatest risk of AD. In 2010, there were an estimated 454,000 new cases of AD; by 2030, that number is projected to reach 615,000, and by 2050, 959,000 (increase of 35% and 110% respectively) [45]. It is estimated that 5.5 million Americans of all ages are living with AD, including 5.3 million people age 65 and older [43]. One in ten people age 65 and older has AD [43]. It is estimated that, by 2050, the number of people age 65 and older with AD may nearly triple, to projected 13.8 million [45]. AD is the sixth-leading cause of death in the United States [46], and the fifth-leading cause of death for people age 65 and older [47]. Still, the number of deaths caused by AD may be even higher than recognized by official sources; and it is the only top 10 cause of death that cannot be prevented, cured or even slowed [43]. The costs of health care and long-term care for individuals with AD are substantial; estimated at USD 259 billion in 2017 [43]. AD is seen as a major public health issue.

On January 4, 2011, the National Alzheimer’s Project Act (NAPA) was signed into law [48]. The Act defines “Alzheimer’s” and requires the Secretary of the U.S. Department of Health and Human Services to establish the National Alzheimer’s Project to inter alia create and maintain an integrated national plan to overcome AD; provide information and coordination of AD research and services; accelerate the development of treatments that would prevent, halt, or reverse the course of AD; improve early diagnosis of AD and coordination of the care and treatment of people with AD etc. Additionally, the Act establishes the Advisory Council on Alzheimer’s Research, Care and Services (Advisory Council).

The enactment of NAPA allowed for focusing the country’s attention on the challenges of AD. The National Plan is guided by three following principles: 1) Optimize existing resources, and improve and coordinate ongoing activities; 2) Support public-private partnerships, 3) Transform the way people approach AD and related dementias. The following five goals form the foundation of the National Plan: 1) Prevent and effectively treat AD and related dementias by 2025; 2) Enhance care quality and efficiency; 3) Expand supports for people with AD and related dementias and their families; 4) Enhance public awareness and engagement; 5) Track progress and drive improvement [49].

The Alzheimer’s Association, the leading voluntary health organization in Alzheimer’s care, support and research, encourages persons with AD to plan for the future, with particular focus given to legal plans [50]. Legal planning includes inter alia planning for long-term care and health care. The person with AD should take part in legal planning as long as she or he has legal capacity—the level of judgment and decision-making ability needed to sign official documents, to make medical or financial decisions. As the required level of legal capacity can vary from one document to another, a lawyer can help determine what level of legal capacity is required for a person to sign a particular document.

A person with AD has the legal right to limit, refuse or stop medical treatments and can express these wishes through advance directives—legal documents specifying, e.g., the type of medical care the person wants to receive once she or he can no longer make such decisions due to incapacity, but also who should make those decisions on her or his behalf [51]. The advance directives include a living will, where a person with AD can express how she or he wishes to be treated in certain medical situations, or what her or his wishes are regarding artificial life support; a durable power of attorney for health care, where a person with AD can name an agent to make health care-related decisions on her or his behalf, when she or he is no longer capable of doing so. Such health care-related decisions can include choosing physicians and health care providers, types of treatments and care facilities; or making end-of-life decisions [50].

Ideally, the advance directives have been put in place to specify the AD patient wishes. When there are no such directives or certain issues have not been addressed, the family must make decisions based on what they believe the person would want, facing such issues as: honoring the person’s wishes, understanding levels of care, making informed decisions, or resolving family conflicts [51]. When making choices about a family member’s end-of-life care decisions, a person should inter alia focus on the person’s wishes, stay true to the person’s values and beliefs, weigh pros and cons of treatments, consider where care will be given, as well as understand the difference between withholding treatment and assisted suicide. Laws and processes related to advance directives vary from state to state and can greatly differ.

When a person with AD is no longer able to provide for hers or his own care, and there is no family or the family is unable to agree upon the type of care, a court can appoint a guardian or conservator to make decisions about that person’s care [50]. Acquiring guardianship is a time-consuming process, involving testifying in the court. Guardians are responsible to and supervised by the court. However, here again, the rules surrounding guardianship vary by state. Therefore, it is necessary to check local laws.

Several important requirements relating directly to the concept of informed consent are stipulated in the 1987 federal Nursing Home Reform Law, providing for a numerous nursing home resident rights [52]. When a resident has not been adjudged incompetent by the state court, she or he has the right to designate a representative, in accordance with state law and any legal surrogate so designed may exercise the resident’s rights to the extent provided by state law (§ 483.10(b)(3)). The facility must treat the decisions of a resident representative as the decisions of the resident to the extent required by the court or delegated by the resident, in accordance with applicable law (4). However, if the facility has reason to believe that a resident representative is making decisions or taking actions not in the best interest of a resident, the facility shall report such concerns in the manner required under state law (6). If a resident is adjudged incompetent under the state law by a court of competent jurisdiction, the rights of the resident are exercised by the resident representative appointed under state law to act on the resident’s behalf (7).

According to the said Law, the resident has the right to be informed of, and participate in, her or his treatment (§ 483.10(c)). In particular, the resident has: the right to be fully informed in language that she or he can understand of her or his total health status; the right to participate in the development and implementation of her or his person-centered plan of care; the right to be informed, in advance, of the care to be furnished and the type of care giver or professional that will furnish care; the right to be informed in advance of the risks and benefits of proposed care, of treatment and treatment alternatives or treatment options and to choose the alternative or option she or he prefers; the right to request, refuse, and/or discontinue treatment, to participate in or refuse to participate in experimental research, and to formulate an advance directive. The facility shall not only inform the resident of the right to participate in his or her treatment, but also shall support the resident in this right.

These requirements are not always interpreted as mandating informed consent to treatment [53]. In 2012, The Improving Dementia Care Treatment in Older Americans Act [54] was introduced, providing specific protocols for physicians and health care providers to follow for obtaining informed consent from and older adult with dementia prior to prescribing an antipsychotic. The bill did not pass in the 112th Congress however. The need for clarity regarding residents’ rights to provide informed consent to (or rejection of) medication and other treatment, as well as the potential for federal legislative action to explicitly provide for a right to informed consent are noted [53].

In the U.S., a lot of attention is paid to the matter of informed consent to research of an AD patient. Regulations of the U.S. Department of Health and Human Services, at 45 C.F.R. part 46 for the protection of human subjects in research [54], require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative. When informed consent is required, it must be sought prospectively, and documented to the extent required under the U.S. Department of Health and Human Services regulations at 45 C.F.R. 46.117 (Documentation of informed consent).

The requirement to obtain the legally effective informed consent of individuals before involving them in research is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report [56].

When considering whether a legally authorized representative may provide consent on behalf of an adult diminished decision-making capacity, the U.S. Department of Health and Human Services regulations at 45 C.F.R. part 46 should be consulted along with the laws of the jurisdiction in which the research is conducted. Generally, if an adult lacks capacity to consent, as a result of dementia, only a legally authorized representative for that adult can give consent for participation in the research, unless the requirement to obtain informed consent is waived by the IRB in accordance with the requirements at 45 C.F.R. 46.116(c)(d), or in accordance with the provisions for emergency waiver, which are permitted under the authority of the Health and Human Services Secretary at 45 C.F.R. 46.101(i) [57].

Consent capacity is discussed also on the National Institutes of Health Grants & Funding website on Research Involving Individuals with Questionable Capacity to Consent [58].

State laws on informed consent differ in many aspects. E.g. all states specify an “age of majority”, by which legal decisions can be made. Usually it is 18 years of age. However, in Alabama and Nebraska a person must be 19. Many states outline the minimum age for healthcare consent, but they do not specify a minimum age for clinical research consent [59]. Usually, the age for healthcare consent is 18, but in several states the required age is different, e.g. 15 in Oregon, 16 in Rhode Island, 16 in Texas. Many states allow minors to make healthcare decisions for themselves, if they are married, emancipated, they live independently, they are pregnant or they are parents.

Currently, all states have legislation that requires some level of informed consent. And although the details of these regulations vary from state to state, failure to obtain informed consent renders any U.S. physician liable for negligence or battery and constitutes medical malpractice [60]. However, exceptions are made for emergencies and legally adjudicated mental incompetency.

CONCLUSIONS

The issue undertaken in this article lies in the borderland of medicine and law. From ancient times, there has been a problem of salus aegroti suprema lex or voluntas aegroti suprema lex. Nowadays it is recognized that a patient’s will is decisive. Autonomy of a patient is of a great importance. Consent to medical procedures, including both diagnostic and therapeutic procedures, is a prerequisite for the legality of conducting such procedures. Otherwise, a physician conducting the procedure without the patient’s consent is subject to criminal liability for violating physical integrity or health disorder.

The most important category is informed consent, required by all legal systems. There are similarities and differences between legal regulations of the analyzed countries concerning medical procedures of AD patients. Patients with NDs, in the last phases of their development, are unable to express legally valid consent, therefore the so-called substitute consent is provided for in such cases. It is expressed on behalf of the patient by persons authorized, meaning close persons defined in the implemented regulation. There is also a possibility of the family and guardianship court’s intervention. Courts can play an important role in treatment of AD patients. In Poland, the substitute consent may be given by the District Court (Sąd Rejonowy); in Germany, by the Local Court (Amtsgericht), which may be compared to the Magistrates’ Courts in England and Wales, where, in turn, such consent may be given by the Court of Protection; whereas in the USA, each state has its own judicial system. The essential difference results from the countries’ belonging to the certain legal systems—civil law, common law, or case law. In every system, informed consent and physicians’ liability are regulated by different legal instruments, right for the given system. It is worth noting that there are no acts of international law regulating informed consent of patients.

DISCLOSURE STATEMENT

Authors’ disclosures available online (https://www.j-alz.com/manuscript-disclosures/17-1176r1).

References

Rubinsztein

(2006) The roles of intracellular protein degradation pathways in neurodegeneration. Nature 443, 780–786.

Bredesen

, Rao

, Mehlen

(2006) Cell death in the nervous system. Nature 443, 796–802.

Sweeney

, Park

, Baumann

, Dunlop

, Frydman

, Kopito

, McCampbell

, Leblanc

, Venkateswaran

, Nurmi

, Hodgson

(2017) Protein misfolding in neurodegenerative diseases: Implications and strategies. Transl Neurodegener 6, 6.

What is neurodegenerative disease? http://www.neurodegenerationresearch.eu/about/what/, Accessed on December 18, 2017.

Beason-Held

, Goh

, An

, Kraut

, O’Brien

, Ferrucci

, Resnick

(2013) Changes in brain function occur years before the onset of cognitive impairment. J Neurosci 33, 18008–18014.

Dementia, http://www.who.int/mediacentre/factsheets/fs362/en/, Last updated on December 2016, Accessed on December 18, 2017.

World Alzheimer Report 2016, https://www.alz.co.uk/research/worldalzheimerreport2016sheet.pdf, Accessed on December 18, 2017.

Sperling

, Aisen

, Beckett

, Bennett

, Craft

, Fagan

, Iwatsubo

, Jack

Jr , Kaye

, Montine

, Park

, Reiman

, Rowe

, Siemers

, Stern

, Yaffe

, Carrillo

, Thies

, Morrison-Bogorad

, Wagster

, Phelps

(2011) Toward defining the preclinical stages of Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement 7, 280–292.

Albert

, DeKosky

, Dickson

, Dubois

, Feldman

, Fox

, Gamst

, Holtzman

, Jagust

, Petersen

, Snyder

, Carrillo

, Thies

, Phelps

(2011) The diagnosis of mild cognitive impairment due to Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement 7, 270–279.

10.

McKhann

, Knopman

, Chertkow

, Hyman

, Jack

Jr , Kawas

, Klunk

, Koroshetz

, Manly

, Mayeux

, Mohs

, Morris

, Rossor

, Scheltens

, Carrillo

, Thies

, Weintraub

, Phelps

(2011) The diagnosis of dementia due to Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement 7, 263–269.

11.

Mitchell

, Shiri-Feshki

(2009) Rate of progression of mild cognitive impairment to dementia–meta-analysis of 41 robust inception cohort studies. Acta Psychiatr Scand 119, 252–265.

12.

Reisberg

, Monteiro

, Torossian

, Auer

, Shulman

, Ghimire

, Boksay

, Guillo BenArous

, Osorio

, Vengassery

, Imran

, Shaker

, Noor

, Naqvi

, Kenowsky

, Xu

(2014) The BEHAVE-AD assessment system: A perspective, a commentary on new findings, and a historical review. Dement Geriatr Cogn Disord 38, 89–146.

13.

Elbaz

, Carcaillon

, Kab

, Moisan

(2016) Epidemiology of Parkinson’s disease. Rev Neurol (Paris) 172, 14–26.

14.

What research is being done? https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-Disease-Information-Page, Accessed on December 18, 2017.

15.

Yang

, Tang

, Guo

(2016) Parkinson’s disease and cognitive impairment. Parkinsons Dis 2016, 6734678.

16.

Lewczuk

, Riederer

, O’Bryant

, Verbeek

, Dubois

, Visser

, Jellinger

, Engelborghs

, Ramirez

, Parnetti

, Jack

Jr , Teunissen

, Hampel

, Lleó

, Jessen

, Glodzik

, de Leon

, Fagan

, Molinuevo

, Jansen

, Winblad

, Shaw

, Andreasson

, Otto

, Mollenhauer

, Wiltfang

, Turner

, Zerr

, Handels

, Thompson

, Johansson

, Ermann

, Trojanowski

, Karaca

, Wagner

, Oeckl

, van Waalwijk van Doorn

, Bjerke

, Kapogiannis

, Kuiperij

, Farotti

, Li

, Gordon

, Epelbaum

, Vos

SJB

, Klijn

CJM

, Van Nostrand

, Minguillon

, Schmitz

, Gallo

, Lopez Mato

, Thibaut

, Lista

, Alcolea

, Zetterberg

, Blennow

, Kornhuber

, Members of the WFSBP Task Force Working on this Topic: Peter Riederer, Carla

Gallo

, Dimitrios

Kapogiannis

, Andrea Lopez

Mato

, Florence

Thibaut

(2017) Cerebrospinal fluid and blood biomarkers for neurodegenerative dementias: An update of the Consensus of the Task Force on Biological Markers in Psychiatry of the World Federation of Societies of Biological Psychiatry. World J Biol Psychiatry 27, 1–85.

17.

Rocznik Demograficzny 2017, GUS [Demographic Yearbook 2017, Polish Central Statistical Office] http://stat.gov.pl/obszary-tematyczne/roczniki-statystyczne/roczniki-statystyczne/rocznik-demograficzny-2017,3,11.html, Last updated on October 13, 2016, Accessed on December 18, 2017.

18.

Ustawa z dnia 5 grudnia 1996 roku o zawodach lekarza i lekarza dentysty, Dz. U. 1997 nr 28 poz. 152 [Act of December 5, 1996 on professions of doctor and dentist. Journal of Laws of the Republic of Poland of 1996, No. 28, item 152].

19.

Ustawa z dnia 6 czerwca 1997 roku - Kodeks karny, Dz. U. 1997 nr 88 poz. 553 [Act of June 6, 1997 – Penal Code, Journal of Laws of the Republic of Poland of 1997, No. 88, item 553].

20.

Caban

, Urbańska

, Komentarz do art. 30 ustawy o zawodach lekarza i lekarza dentysty. In Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, Kopeć M, ed. [Caban Ł, Urbańska M. Commentary to the Article 30 of the Act on professions of doctor and dentist. In The Act on profession of doctor and dentist. Commentary, Kopeć M, ed.].

21.

Zielińska

, Komentarz do art. 30 ustawy o zawodach lekarza i lekarza dentysty. In Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, Zielińska E., ed. [Zielińska E., Commentary to the Article 30 of the Act on professions of doctor and dentist. In The Act on professions of doctor and dentist. Commentary, Zielińska E, ed.].

22.

Ustawa z dnia 6 listopada 2008 r. o prawach pacjenta i Rzeczniku Praw Pacjenta, Dz.U. z 2009, nr 52, poz. 417 [Act of November 6, 2008 on patients’ rights and the Commissioner for Patients’ Rights, Journal of Laws of the Republic of Poland of 2009, No. 52, item 417].

23.

Caban

, Urbańska

, Komentarz do art. 32 ustawy o zawodach lekarza i lekarza dentysty. In Ustawa o zawodach lekarza i lekarza dentysty, Kopeć M, ed. [Caban Ł, Urbańska M., Commentary to the Article 32 of the Act on professions of doctor and dentist. In The Act on professions of doctor and dentist. Commentary, Kopeć M, ed.].

24.

Malczewska

, Komentarz do art. 32 ustawy o zawodach lekarza i lekarza dentysty. In Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, Zielińska E, ed. [Malczewska M, Zielińska E, Commentary to the Article 32 of the Act on professions of doctor and dentist. In The Act on professions of doctor and dentist. Commentary, Zielińska E, ed.].

25.

Bürgerliches Gesetzbuch vom 18. August 1896, RGBl. 1896, 195. [The Civil Code of August 18, 1896].

26.

Uświadamianie należy do zadań lekarza. In Michalik MB, ed., Kronika medycyny, Warszawa 1994, s. 550 [Rasing awareness belongs to the tasks of a doctor. In Annal of medicine, Michalik MB, ed., Warsaw 1994, p. 550].

27.

von Gerlach

, Ärztliche Aufklärungspflicht und eigenmächtige Heilbehandlung. In Moderne Medizin und Strafrecht. Ein Vademecum für Ärzte und Juristen über strafrechtliche Grundfragen ärztlicher Tätigbereiche, Kaufmann A, ed., Heidelberg 1989, p. 15 [von Gerlach A, A doctor’s obligation to explain and unauthorized treatment (without consent of a patient). In Modern medicine and criminal law. Handbook for doctors and lawyers on the basic legal and criminal questions concerning medical acts, Kaufmann A, ed., Heidelberg 1989, p. 15].

28.

Knauer

, Ärztlicher Heileingriff, Einwilligung und Aufklärung - überzogene Anforderungen an den Arzt? In Medizinstrafrecht. Im Spannungsfeld von Medizin, Ethik und Strafrecht, Roxin C, Schroth U, eds., Stuttgart-München-Hannover–Weimar-Dresden-Boorberg 2001, pp. 20-29 [Knauer Ch, Medical intervention, consent and explanation – excessive requirements imposed upon a doctor? In Medical criminal law. At the interface between medicine, ethics and criminal law, Roxin C, Schroth U, eds., Stuttgart-München-Hannover-Berlin-Weimar-Dresden-Boorberg 2001, pp. 20-29].

29.

Strafgesetzbuch vom 15. Mai 1871, RGBl 1871, 127, BGBl I 1998, 3322 [The Penal Code of May 15, 1871].

30.

Rudolphi

, Horn

, Günther

, eds., Systematischer Kommentar zum Strafgesetzbuch, 7th ed., Neuwied, Kriftel, 2003, Commentary to § 228, s. 86, 87 [Rudolphi HJ, Horn E, Günther HL, eds., The systemic commentary to the Penal Code, 7th ed., Neuwied, Kriftel, Berlin 2003, Commentary to § 228, pp. 86, 87];.

31.

Neumann

, Puppe

, Schild

, eds., Nomos Kommentar zum Strafgesetzbuch, 8. Lieferung, Baden-Baden 2000, Commentary to 228, p. 43 [Neumann U, Puppe I, Schild W, eds., Nomos Commentary to the Penal Code, 8. Lieferung, Baden-Baden 2000, Commentary to § 228, p. 43].

32.

Arzt G, Weber U, Strafrecht. Besonderer Teil. Lehrbuch, Bielefeld 2000, p. 166-171 [Arzt G, Weber U, Penal law. The special part. Textbook, Bielefeld 2000, p. 166-171]; Küpper G, Strafrecht. Besonderer Teil I. Delikte gegen Rechtsgüter der Person und Gemeinschaft, Heidelberg 1996, pp. 39-40 [Küpper G, Penal law. The special part I Offences against legal goods of persons, Berlin, Heidelberg 1996, pp. 39-40].

33.

Wessels

, Hettinger

, Strafrecht. Besonderer Teil 1. Straftaten gegen Persönlichkeits- und Gemeinschaftswerte, Heidelberg 2003, pp. 89-92 [Wessels J, Hettinger M, Penal law. The special part. Part 1. Offences against legal goods or persons, Heidelberg 2003, pp. 89-92].

34.

Krey

(1998) Strafrecht. Besonderer Teil. Band 1. Besonderer Teil ohne Vermögensdelikte, Stuttgart, Köln, pp. 111-114 [Krey V (1998), Penal law. The special part. Part 1. The special part without offences against material values, Stuttgart, Berlin, Köln, pp. 111-114].

35.

Hirsch HJ In Jescheck HH, Ruß W, Willms G, eds., Strafgesetzbuch. Leipziger Kommentar. Großkommentar, 10th ed., New York 1989, 223, No 17; [Hirsch HJ In Jescheck HH, Ruß W, Willms G, eds., The Penal Code. Leipzig’s Commentary. Large commentary, 10th ed., Berlin New York 1989, § 223, No 17].

36.

Lilie H In Jähnke B, Laufhütte HW, Odersky W, eds., Strafgesetzbuch. Leipziger Kommentar. Großkommentar, 11th ed., New York 2001, 223, No 18 [Lilie H In Jähnke B, Laufhütte HW, Odersky W, eds., The Penal Code. Leipzig’s Commentary. Large commentary, 11th ed., Berlin New York 2001, § 223, No 18].

37.

Bürgerliches Gesetzbuch vom 18. August 1896, RGBl. 1896, 195 [The Civil Code of August 18, 1896, RGBI of 1896, item 195].

38.

Bassenge

, Diederichsen

, Edenhofer

, et al., Bürgerliches Gesetzbuch, München 1998, 57th ed., pp. 946, 948 [Bassenge P, Diederichsen U, hofer W, et al., the Civil Code, München 1998, 57th ed., pp. 946, 948].

39.

§ 630a BGB [§ 630a of the Civil Code].

40.

General medical council – Good medical practice: The explanatory guidance – Consent guidance: Legal framework: https://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_legal_framework.asp, Accessed on December 19, 2017.

41.

General medical council – Good medical practice: The explanatory guidance – Consent guidance: Legal Annex – Legislation: https://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_legislation.asp, Accessed on December 18, 2017.

42.

Mental Capacity Act, 2005, Chapter 9. https://www.legislation.gov.uk/ukpga/2005/9, Last updated on April 7, 2005, Accessed on December 19, 2017.

43.

Alzheimer’s Association. 2017 Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2017:13:325-373, https://www.alz.org/documents_custom/2017-facts-and-figures.pdf, Accessed on December 19, 2017.

44.

He W, Goodkind D, Kowal P. U.S. Census Bureau, International Population Reports, P95/16-1, An Aging World: 2015, U.S. Government Publishing Office, Washington, DC, 2016, https://census.gov/content/dam/Census/library/publications/2016/demo/p95-16-1.pdf, Accessed on December 20, 2017.

45.

Hebert

, Beckett

, Scherr

, Evans

(2001) Annual incidence of Alzheimer disease in the United States projected to the years 2000 through 2050. Alzheimer Dis Assoc Disord 15, 169–173.

46.

Kochanek

, Murphy

, Xu

, Tejada-Vera

(2016) Deaths: Final Data for 2014. National Vital Statistics Reports; vol 65, no 4. Hyattsville, Md.: National Center for Health Statistics: 2016.

47.

Doblhammer

, Fink

, Zylla

, Fritze

, Willekens

(2014) Short-term trends in German dementia prevalence, incidence, and mortality. Presentation at the Alzheimer’s Association International Conference; July 16, 2014.

48.

National Alzheimer’s Project Act, Public Law 111-375-JAN.4, 2011.

49.

National Plan to Address Alzheimer’s Disease: 2017 Update, U.S. Department of Health and Human Services, https://aspe.hhs.gov/report/national-plan-address-alzheimers-disease-2017-update, Accessed on December 20, 2017.

50.

Legal Plans, Assisting a Person with Dementia in Planning for the Future, Alzheimer’s Association, https://www.alz.org/national/documents/brochure_legalplans.pdf, Accessed on December 20, 2017.

51.

End-of-life decisions. Honoring the wishes of the person with Alzheimer’s disease, Alzheimer’s Association, https://www.alz.org/national/documents/brochure_endoflifedecisions.pdf, Accessed on December 21, 2017.

52.

C.F.R. § 483.10.

53.

Mollot

, Butler

, Baratt

, Symkowski

. Informed Consent Rights in U.S. Nursing Homes: An Overview of State & Federal Requirements, 2013 The Long Term Care Community Coalition, http://theconsumervoice.org/uploads/files/issues/ltccc-rpt-informed.pdf, Accessed on December 22, 2017.

54.

S. 3604 (112th): Improving Dementia Care Treatment for Older Adults Act of 2012, https://www.gpo.gov/fdsys/pkg/BILLS-112s3604is/pdf/BILLS-112s3604is.pdf, Accessed on December 22, 2017.

55.

C.F.R. part 46, https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html, Accessed on December 22, 2017.

56.

The Belmont Report, Office of the Secretary, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979, https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html, Accessed on December 22, 2017.

57.

The U.S. Department of Health and Human Services, Office for Human Research Protections, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html, Accessed on December 22, 2017.

58.

Research Involving Individuals with Questionable Capacity to Consent: Points to Consider, November 2009, https://grants.nih.gov/grants/policy/questionablecapacity.htm, Accessed on December 22, 2017.

59.

State laws and informed consent 2015, https://www.slideshare.net/PaulBelow/state-laws-and-informed-consent-2015, Las updated on May 18, 2015, Accessed on December 24, 2017.

60.

Pizzi

, Goldfarb

, Nash

. Procedures For Obtaining Informed Consent in Shojania

, Duncan

, McDonald

, Wachter

, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Rockville, MD: Agency for Healthcare Research and Quality. Evidence Report/Technology Assessment No. 43; AHRQ publication 01-E058. 2001: 546–554.