1410 Ethical dilemmas: Informed consent

1410 Ethical dilemmas: Informed consent

Wednesday 1 November 1995 S297 Round table 1405 ETHICAL DILEMMAS IN CANCER CARE DISCONTINUING TREATMENT 1408 ETHICAL DILEMMAS IN CANCER CARE: INFOR...

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Wednesday 1 November 1995

S297

Round table 1405 ETHICAL DILEMMAS IN CANCER CARE DISCONTINUING TREATMENT

1408 ETHICAL DILEMMAS IN CANCER CARE: INFORMED CONSENT

F. Guillet

C. Arrigo Soclite Beige des Infirmieres en Oncologie (SIO), Brussels

What is the meaning of discontinuing and treatment? Who decides to stop and when? What is the impact on the family, the patient and medical team? When we could speak about "overtreatment". How to keep clearness: the limit of the medical team's power. In conclusion: how could we keep an agreement that offers comfort and respect for the patient's decision?

1406 ETHICAL DILEMMAS IN CANCER CARE-EUTHANASIA JJA. van den Berg The Dutch Association oj Voluntary Euthanasia

Euthanasia is often requested, but it is hardly ever carried into effect. If it is realized at all, it must be seen as the conclusion of a rather intensive decision making process sustained by a caring doctor-patient, nurse-patient relation. Such a process ought to be executed with the utmost prudence. As long as euthanasia remains a controversial issue, nurses will be confronted with its practical implications. One major implication for nursing practice is patient advocacy. How do nurses react when a patient requests euthanasia? It is important to examine one's feelings about euthanasia and discuss them with colleagues. In order to provide guidelines governing the process of euthanasia, recommendations of the Dutch National Health Council together with the established jurisprudence resulted in a list of criteria to be adhered to by medical practitioners. A doctor, strictly complying with these requirements, may be held inculpable under the law, and not liable to prosecution. The role of the nurse is very important and begins when a patient requests euthanasia. Because nurses are the intermediary of the patient, it is expected that they can give adequate support to the patient and his relatives during the whole process of decision-making, carry into effect and after-care. How far can nurses go as the patients intermediary in the discussion about euthanasia and how far can they go in actions? . Nurses are allowed to give nursing care based on observations, or can perform duties at the request of the physician. Liability for malpractice is judged by civil law. This makes nurses very vulnerable in the eyes of the law, especially in the role of advocate during euthanasia.

1407 EUTHANASIA: AN ETHICAL DILEMMA IN CANCER PATIENTS E. Markiewicz Medical intensive care unit, Institut Jules Bordet, Brussels, Belgium

The recent technological and therapeutic developments in medicine, especially in critical care, might allow us to maintain artificially alive patients with incurable diseases like cancer. These progresses have lead to discussions about quality of life and euthanasia. Euthanasia is a painless death by applying appropriate care to relieve agony. Euthanasia is called active when euthanasia consists to provide care shortening survival, and passive when treatment is no longer used to prolong survival. It is practically easier in patients with incurable disease not to start a therapeutic procedure than to stop it and thus to perform active euthanasia. Active euthanasia can be direct or indirect: it is indirect when provided care can reduce survival without intention to give death and it is direct when care is given with the intention to reduce survival to abbreviate pain. In Europe, direct active euthanasia is only performed in Holland by some physicians in well defined cases, a law allowing this practice since 1993. Examples of various situations, as any nurse working in an oncological department may have to face, will be discussed during the round-table session in order to allow the nurses to give their opinion on cases where a medical decision on some type of euthanasia has to been taken.

The objective of this round table session is to discuss in depth an important ethical dilemma: the Informed Consent. "Informed Consent is a voluntary, uncoerced decision, made by a competent or autonomous person, on the basis of adequate information and deliberation, to accept a specific treatment when fully cognizant of the nature of the treatment, its consequences and risks" 1. Overview Informed Consent is based on the ethical principle of autonomy. Patients have the right to make their own decisions regarding treatment, based on information received from medical doctors. Nationallaws and regulations on the basic principle of autonomy are now enforced in several European countries while still in development in others. This session will focus on ethical dilemmas related to Informed Consent in clinical research and more specifically in randomized phase III clinical trials. Items proposedJor discussion ( I) Current situation in randomized phase III multicentric studies:

how are patients informed, which is the role of the consent document, how are nurses involved? (2) Information to be included in consent forms: how to determine the amount, the readability, etc. What is the role of the nurse in the preparation of the content? (3) Importance of cultural aspects. 1 Consent, Gillon R., Philosophical Medical Ethics, Chichester, Wiley, 1985, pp 113-118. 1409 INFORMED CONSENT, CANCER CARE ETHICAL DILEMMA IN FRANCE

P. Dielenseger Phase I Unit, Institut Gustave-Roussy, Villejui], France

Patients (pts) included in a Cancer Clinical Trial in France receive oral and written information about it, and must sign an Informed Consent Form (ICF) according to the French law (Loi Ruriet 88-1 138 of December 22th 1988). Nurses take an active part during those trials and must define their position face to different ethical dilemmas during research protocols. During our workshop, it would be interesting to share ideas about some of the ethical questions: - Is the nurse a pts's advocate? 'What does this mean for us? - Is the ICF only a step of a law, because of coming after oral information? - What are the nurse's role face to the signing ofICF? Are they different during Phases I, II or III trials? - Does the nurse's speech influence the pts's decision face to ICF? - Is a nurse allowed to influence pts's decision making according to her own ideas? - Is the nurse dependant of the ward or only of her own ethics? - Can relationship confidence between pts and nurse survive if, afterwards, pts feel manipulated? And we will also debate other questions coming during the workshop if necessary. 1410 ETHICAL DILEMMAS: INFORMED CONSENT A. C. Dubhelman The Netherlands Cancer Institute/Antont van Leeuwenhoek Hospital Amsterdam, The Netherlands

The Informed Consent Doctrine is based on a statement made by an American judge (1914): "Every human being who is capable of reasoning, has the right to decide what is being done with his body". The unethical experiments performed during World War II caused world concern with regard to the future of human research. As a result of the Niirnberg trial recommendations were made (the Niirnberg Code 1947) which safeguard the integrity of the research subject and the concept of Informed Consent was introduced. Since then many national,

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international and professional guidelines have been developed which describe the procedures for ensuring the patients right to an Informed Consent. Since the introduction of Good Clinical Practice, the conduct of clinical research has changed drastically in Europe and is now under regulatory control. An Informed Consent means that the subject of an experiment is competent, has given his consent freely, is fully informed and has understood the information. Although the conditions are clear, there is much discussion about the Informed Consent concept and procedure. The following questions need to be addressed: - Do all patients want to be informed and is Informed Consent harmful to some patients? - How freely is consent given when the choice is between therapy or no therapy especially in the case of terminal disease? - Who and how many people should inform the patient? and - Is there a "best way" of informing the patient? Remarkably, very little attention has been paid to the potential contribution of nurses to the Informed Consent process. There remain many questions with not so many answers. In the round table session we will address and discuss these issues because the Informed Consent procedure requires a continuous critical contemplation.

Nurses are confused about the process of achieving the Informed Consent. Cooperation between nurses and doctors can be achieved on the basis of a common philosophy which determines a policy of providing information by the doctor, clarification by the nurse, who will get the feedback from the patient, and then obtaining the signature. The "Informed Consent" then will be a decision making tool and not only a protective defensive tool for the doctor.

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ETIDCAL ISSUE: PATIENT CHOICE Agnes Delogne Institur Jean-Godinor, Reims, France

To make a choice you need, at least, two possibilities, but it can be much more. To make a choice you need information and time to make up your mind. - Choice: is it a right of the patient? Who is informing, and what has the patient to be told? Is there any written information? What did the patient understand? - As nurses do we have a role to play in this choice, and if so what can we do? Wbat kind of information do nurses receive? ... it can be also as patient to come ...

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ETIDCAL DILEMMAS IN THE PROVISION OF EXPERIMENTAL TREATMENT: PATIENTS, DOCTORS AND NURSES N. Tabak Tel Aviv University, Nursing Division, Faculty of Medicine Ramat Aviv, Israel

The difficulties involved in obtaining Informed Consent raise a conflict between the Ethical requirements and the professional ones. Doctors and nurses tendency to provide information, consult the patients and involve them in the decision making process is often met with the inability of the patients to accept and process such information due to anxiety and feelings of psychological stress or coercion. The main conclusions of a recent research conducted among 66 patients, 23 of them suffering from cancer were that (I) in spite of the patients will to be autonomic and free there are medical constraints (2) the information they had received was relatively scarce and (3) most of the patients did not remember having signed the form.

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ETIDCAL DILEMMAS IN CANCER CARE PATIENT CHOICE V Speechley Patient Information Officer, The Royal MarsdenNHS Trust, Fulham Road, London SW3 6]], u.K.

In the past decade or so patients have asserted their right to be involved in decision-making concerning their treatment and care. This has presented challenges to health care professionals, requiring attitude changes and acceptance of the responsibility to inform and involve patients so that they can make a real choice. This presentation will consider some of the issues generated by patients' choices, including the genuineness of a choice, refusal of treatment and patients who do not wish to be involved in decision-making. Participants will be encouraged to discuss dilemmas related to their own practice.