Patient Autonomy and Informed Consent in Critically Ill A

Introduction: Patient autonomy has been a cornerstone of contemporary clinical ethics since the Nuremberg trial, especially in American school of bioethics. Topic: Patient autonomy has been defi ned in the Nuremberg Code, and re-defi ned in the Declaration of Helsinki, Belmont Report and Barcelona Declaration. Founders and followers of the rights-oriented bioethics (for example, Hellegers, Beauchamp and Childers) have established and promoted the patient autonomy as the main principle of bio(medical) ethics since 1970s. However, there is a lot of controversy surrounding such a principle, especially in vulnerable patients. We aimed at evaluating the real meaning and value of patient autonomy in critical care settings regarding the communication between health workers and their patients and families. Conclusion: Protection of patients autonomy in critically ill is a complex issue. Careful benefi t-risk assessment is needed in order to fi nd the most appropriate way of obtaining the informed consent, proxy consent or to omit or delay it.


INTRODUCTION
Patient autonomy is the main principle of contemporary rights-oriented bioethics [1][2][3][4][5][6].Andre Hellegers, a physician and professor of obstetrics, physiology and biophysics developed a concept of biomedical ethics focused strictly on medical issues, ie.human medicine.Autonomy is inherent to the American culture and liberal individualism.Th e patient's right to decide is rooted in American tradition of personal liberties and privacy rights [7].Of note, there is completely diff erent, responsibilityoriented approach to bioethics, established and developed by Fritz Jahr and Van Rensse-laer Potter.In contrast to the previous concept, Potter's vision is holistic.It involves all living creatures in the interaction with the environment.Basic principles of the responsibilityoriented bioethics are benefi cence/nonmaleficence and justice.Ultimately, rights-oriented approach fi ts better into the individual ethics, while responsibility-oriented approach is closer to the collective ethics [8].
Autonomy involves two important steps: (1) patient with decision-making capacity makes autonomous decision about his health and treatment, and (2) health workers give the advice and conduct the treatment according to the patient's choice.It seems rea-sonable to consider that patient autonomy has instrumental value in promoting wellbeing [9].However, certain philosophers argue that health care providers are sometimes in good position to decide what is better for their patients, and informed consent is neither necessary nor suffi cient for ethical clinical research in some cases [10][11][12].Additionally, there are patients without decision-making capacity (for example, vulnerable subjects and groups), and autonomy is restricted in certain cases (for example, weakness of will, external infl uences -coercion/manipulation, and lack of information).In cases where individual participant is not capable of providing valid informed consent, a substitute decision-maker (SDM) is allowed to legally confi rm the acceptance for participation in the study.SDMs do not oft en accurately represent participants' wishes [13][14][15] A notorious example of disrespect for patients' autonomy is the Tuskegee study (syphilis experiment).Th ere are, however, more subtle cases of such a disrespect in medical practice.One could argue that patient autonomy is not restricted just to the promotion of wellbeing (instrumental value) but has an intrinsic value as well.In medical practice, there is also false autonomy, that could be best described as 'Brave New World' model of manipulation with patients attitudes in order to make them happy in an artifi cial way.
Th e aim of our study is to evaluate the real meaning and value of patient autonomy in critical care settings regarding the communication between health workers and their patients and families.Pros and cons of the current model of autonomy in critically ill will be discussed according to the fi ndings from the literature, and authors' personal opinion.Google was searched for publications on the patients' autonomy in critical care settings.Th e following keywords were used: "informed consent" AND "critical care".Retrieved citations were limited to those published between 2007 and 2017 in English.

Informed consent in vulnerable subjects
Vulnerable persons are relatively (or absolutely) incapable of protecting their own interests.Th ey could be particularly susceptible to undue infl uence (coercion, manipulation, persuasion) [16][17][18][19][20][21][22].Protection of their autonomy is not just restricted to the informed consent (given usually by their legally-authorized representative), but it is an ongoing process.Table 1 shows basic bioethical principles.
Full protection of the autonomy of vulnerable subjects obviously depends on the interplay between all presented bioethical principles.Such an issue is even more complex if we discuss the autonomy of critically ill.
Informed consent is a voluntary agreement of individual or his/her legally authorized representative to participate in the study.It is "a process by which a subject voluntarily confi rms his or her willingness to participate in a particular trial, aft er having been informed of all aspects of the trial that are relevant to the subject's decision to participate.Informed consent is documented by means of a written, signed and dated informed consent form." (ICH GSP Glossary).Informed consent should fulfi ll the following mandatory conditions stated in the Belmont report: adequate information about the study (risks and benefi ts explained), the patients' comprehension, and the voluntariness [23].
According to the CIOMS International Ethics Guidelines for Health-related Research Involving Humans, "adults who are not capable of giving informed consent must be included in health-related research unless a good scientifi c reason justifi es their exclusion." Valid informed consent from the legally authorized representative and the assent from the subject must be obtained.If there is no obvious benefi t for such participants, the intervention should be conducted fi rst in persons who are capable of giving informed consent, and the risks of the intervention must be minimized, and no more than minimal [6].
Th e assent of the incapacitated subject should be respected even if the legally authorized representative signed the consent.However, the assent could be also overruled (a) if the study off ered the only available treatment, (b) which has been previously confi rmed to be benefi cial for the vulnerable subject, and (c) the agreement to conduct the study was reached both by treating physician and legally authorized representative.

Informed consent in critically ill patients
Critically ill patients belong to vulnerable subjects [24].Accordingly, the achievement of a valid informed consent is a challenging issue.Clinical trials in such a cohort could be ethically acceptable if additional protecting mechanisms are in place to minimize risks.Such a research is needed in order to develop new drugs for their own good.Also, clinical trials in critically ill fulfi ll the social value requirement [25].However, there are no specifi c guidelines on the research involving critically ill patients [26][27][28][29].
Making decisions is a hard work even in the mature, autonomous person [30].It is even worse and more complex issue in critically ill and their relatives.Majority of literature on the autonomy of critically ill deals with extreme situations (for example, end-of-life cases), but routine medical care is usually more important for the assessment of real meaning and value of the informed consent and patientphysician interaction.Assent is even more common in such a routine care than the appropriate autonomy-based consent.Critically ill patients rather agree with the procedure than make their own choice.
Decision-making capacities of patients with acute illnesses could be dimished [31].Th ere are two types of errors in obtaining informed consent from critically ill.First, surrogate consent is obtained from the legallyauthorized representative despite the patient's capability to provide valid consent.Second, informed consent is required from critically ill who lacks the decisional capacity.Another problem is "therapeutic misconception" ie.participants misconstrue that clinical trial (research) is therapeutic process [32].In other words, critically ill may misunderstand that a research procedure (for example, randomization) is tailored to their personal needs, or they may hold unreasonable appraisal of the likelyhood of personal medical benefi t from the study participation.
Careful reading of the informed consent form is of a vital importance for understanding the benefi ts and risks properly.Simplifi ed forms of informed consent might improve understanding [33].Informed consent training of physicians might be of a great value as well [34].
Capacity assessments methods are not standardized.Some of them are timeconsuming and not appropriate for use as a screening measure.However, University of California, San Diego, developed a shorter form, Brief Assessment of Capacity to Consent (UBACC) [35].Th ere are less formal methods for the capacity assessment.
Proxy consent requres legal guardian (legally-authorized representative).Such a representative might be appointed in advance, or "naturally chosen" (for example, family member or friend).Proxies are supposed to know patients preferences in making a decision, but is does not seem to be realistic.Instead, they should consider what would be in the best interest of the patient.
Silverman [24] proposed diff erent safeguard levels depending on the risk of the procedure with critically ill.For example, when the risk is minimal, safeguards involve a written plan on the methods to assess decision making capacity, and methods to obtain proxy consent, assent and dissent, and re-consent if possible.
Chenaud et al. have shown that patients in the intensive care units suff er from poor recall of participation in a clinical trial, as well as purpose and the risks, which may preclude obtaining of valid informed consent [36].
Waiver of informed consent is allowed when the research has an important social value, poses no more than minimal risk to participants, and would not be feasible without the waiver.Th at is the the case in emergency research (for example, unconscious patients with septic shock) [37].
Finaly, we may agree that true autonomy of the critically ill should be strengthened and enhanced.Residence education should be adjusted and clinical ethics should be incorporated into ward rounds.All other medical staff (for example, nurses, technicians and social workers) should be instructed and trained to improve their communication skills.Institutional paternalism, even in its subtlle form, should not replace the true communication between critically ill and their physicians regarding major health-related decisions.

CONCLUSION
Protection of patients autonomy in critically ill is a complex issue.Careful benefi t-risk assess-ment is needed in order to fi nd the most appropriate way of obtaining the informed consent, proxy consent or to omit or delay it.A set of safeguards could be applied depending on the risk of the procedure and the expected befi t of the trial.Ultimately, there is a shift from rights-to responsibility-oriented bioethics regarding the respect to autonomy in critically ill, as well as the shift from American to the European principles of bioethics defi ned in the Barcelona Declaration with vulnerability as a cornersone.

Volume 4 • 1 .
Number 1 • January 2017 • HOPH Table Basic bioethical principles: American vs.European school of bioetics Belmont Report (American school of bioethics) Barcelona Declaration (European school of bioethics) Respect for Persons • respect for autonomy and • protection of people with diminished autonomy (immature and incapacitated) Autonomy • the capacity of creation of ideas and goals for life • the capacity of moral insight, etc. • the capacity of rational decision and action without coercion • the capacity of political involvement and personal responsibility • the capacity of informed consent Benefi cence • respect for individual's decisions, in order to • protect them from harm, and • to secure their well-being Dignity • intrinsic value of the individual • inter-subjective value of every human being in its encounter with the other Justice • fairness in distribution of benefi ts and burdens of research • equal distribution to each person -an equal share -according to individual needs -according to individual eff ort -according to societal distribution -according to merit Integrity • inviolability of the human being • quality of the person as such • coherence of life in time and space (in memory and corporeal life) that should not be touched and destroyed • respect for integrity = respect for privacy and personal environment, in particular for patient's understanding of his/her own life and illness in body and soul Vulnerability • concerns integrity • all life could be hurt, wounded and killed • respect for vulnerability = recognition of the fi nitude of life