Under-age girl as a patient of pediatric and adolescent ginecology outpatient clinic

The research carried out in Poland reflected that sexual initiation before 18 years of age is a common phenomenon and refers to roughly 80% of teenagers. In Poland there is no uniform standing of medical and legal environments with regard to dealing with a juvenile patient who has become sexually active and expects the advice of a gynaecologist, gynaecologic examination and often asks for prescribing contraceptives. The procedures must take into account the fact that in Poland, until 18 years of age, a juvenile functions under the parental or tutelary authority, while a consent for medical service requires beside of the consent of legal guardian also the consent of a juvenile who is 16 years of age and becomes a full-right patient. According to the Act on Health Care Institutions, a patient has the right to self-decisions, the respect of physical and mental integrity and the respect of privacy, while the participation of a statutory representative post 16th year of age refers practically to co-deciding on a medical service provision. Therefore, the information received from such juvenile patient in subjective and objective examination does not have to be passed to the statutory representative, if the juvenile patient requires confidentiality and if this does not affect the patient's health and the planned medical procedures (e.g. the necessity of making an operation). The knowledge of conduct procedures with regard to a juvenile patient as a carrier of rights shall enable doctors to make aware choices of conduct and provide services or, in most cases, only advice, without the necessity to breach the laws of Poland.     

Medical malpractice: a case study in medical and legal decision making

The conference was organized in part to dispel some of the misinformation that interferes with cooperative efforts of attorneys and physicians to redress the malpractice situation. During discussion of the hypothetical case, participants identified how medical decision-making responsibilities were allocated among health care providers caring for the patient. Panel members suggested ways in which medical decision making might be affected by non-medical factors such as third-party reimbursement (e.g., selection of inpatient or outpatient setting, the opportunity to discuss issues related to informed consent prior to the day of a procedure) and potential malpractice litigation (e.g., documentation in charts, use of diagnostic procedures). The characterization of decision-making roles and responsibilities differed somewhat for purposes of malpractice litigation; that is, which caregivers might be named as defendants. Panel members reconstructed the development of the medical incident into a legal case. Plaintiff's attorney commented that it is often a hospital employee who advises the family to consult an attorney and described some of the constraints on information gathering (e.g., the rule of "discovery" requiring that suit be filed before defendants can be forced to give statements about what happened, insurance contract provisions prohibiting physicians from talking without legal counsel present to persons who indicate that they plan to file suit). He also briefly explained the rationale for the contingency fee arrangement in these cases. Describing the role of the medical expert witness and the need to review the medical record, he outlined the process of deciding whether to pursue a malpractice case. In making this decision, plaintiff's attorney evaluates the facts to identify issues in the case, to determine if there are deviations from the standard of care, and to try to predict jury reaction. If a suit is filed, defense attorneys employed by the hospital, insurance company, or individual defendants will decide, based on facts including coverage limits, possible publicity, and likelihood of successful prosecution, whether the case should be settled and for what amount. Interests represented by the defense attorneys differ and may affect settlement strategies. Physician feelings of concern for the patient/family or desire for vindication will, to varying degrees, be factors in the decision to try or settle a case. Panel members explored several important policy issues. Among these were the effect of malpractice cases on doctor-patient communications and ethical issues concerning expert witnesses.(ABSTRACT TRUNCATED AT 400 WORDS)     

What is a medical experiment?

Innovative therapy may appear to coincide with medical experimentation, raising ethical and legal issues, for instance on informed consent and institutional review. Medical treatments may be classified, however, to distinquish novel procedures from experimentation.     

Can children withhold consent to treatment?

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child''s refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children''s consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.     

Best Practice Guidelines on Informed Consent for Weight Loss Surgery Patients

Objective: To provide evidence‐based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. Research Methods and Procedures: We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence‐based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. Results: This Task Group found that the informed consent process contributes to long‐term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Discussion: Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.     

Informed Consent — A Reappraisal of Patients' Reactions

In response to the November 1972 ruling of the California Supreme Court requiring complete, detailed disclosure of risks for procedures and treatments, a survey was made of the reactions of one hundred patients to this decision. A fictional man was described with a clinical diagnosis of brain tumor, and then the procedure for cerebral angiography and all of that procedure''s potential complications were described. The majority of the patients surveyed responded that this complete disclosure of risks helped them in making an intelligent decision about giving consent for the procedure. However, 50 percent of these patients would have withheld consent for the procedure on learning of the complications. Although physicians would have reacted differently, it is certainly the patients'' right to make the choices they did.     

The medical decision-making process and the family: the case of breast cancer patients and their husbands

Objectives:  The objectives of the study were (1) to assess similarities and differences between breast cancer patients and their husbands in terms of doctor-patient/spouse relationships and shared decision making; and (2) to investigate the association between breast cancer patients and husbands in terms of preference of type of doctor, doctor-patient relationship, and shared decision making regarding medical treatment.
Method:  Fifty-seven women with breast cancer, and their husbands, completed questionnaires measuring doctor-patient/spouse relationships (paternalism, autonomy), and decision making regarding medical treatment.
Results:  Patients believe they have a key role in the medical decision-making process (93%) and that the participation of their husbands, and their agreement with the decision, is important (84% and 89%, respectively). Both breast cancer patients and their husbands prefer a shared decision-making process to paternalistic or autonomy-based approaches.
Conclusion:  In contrast to legal and bioethical approaches, which focus on the patient as the primary decision maker, this study reflects a practical recognition of the role of the breast cancer patient's husband in the decision-making process. It also reflects a relational rather than an individualistic perception of patient autonomy.     

‘VAGUE OVIEDO’: AUTONOMY,CULTURE AND THE CASE OF PREVIOUSLY COMPETENT PATIENTS

The paper examines the ethical and legal challenges of making decisions for previously competent patients and the role of advance directives and legal representatives in light of the Oviedo Convention. The paper identifies gaps in the Convention that result in conflicting instructions in cases of a disagreement between the expressed prior wishes of a patient, and the legal representative. The authors also examine the legal and moral status of informally expressed prior wishes of patients unable to consent. The authors argue that positivist legal reasoning is insufficient for a consistent interpretation of the relevant provisions of the Convention and argue that ethical argumentation is needed to provide guidance in such cases. Based on the ethical arguments, the authors propose a way of reconciling the apparent inconsistencies in the Oviedo Convention. They advance a culturally sensitive approach to the application of the Convention at the national level. This approach understands autonomy as a broader, relational consent and emphasizes the social and cultural embeddedness of the individual. Based on their approach, the authors argue that there exists a moral obligation to respect the prior wishes of the patient even in countries without advance directives. Yet it should be left to the national legislations to determine the extent of this obligation and its concrete forms.     

Informed consent procedures: responsibilities of researchers in developing countries

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision-making process enhances women's ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process.     

Informed Consent in Direct‐to‐Consumer Personal Genome Testing: The Outline of A Model between Specific and Generic Consent

Broad genome‐wide testing is increasingly finding its way to the public through the online direct‐to‐consumer marketing of so‐called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision‐making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings.     

Withholding or Withdrawing Extraordinary Life Support—Optimizing Rights and Limiting Liability

For many years physicians, ethicists and members of the legal community have attempted to minimize ambiguity and unpredictability in making decisions to withhold or withdraw extraordinary life support. Recent developments in national and California law now afford medical care providers unparalleled protection from criminal and civil liability in surrogate decision-making situations. They also reinforce the concept of patient''s rights by providing medical care consumers with new and effective mechanisms for enforcing their “right to decide,” even after they have lost decision-making capacity. A case in point is California''s new Durable Power of Attorney for Health Care, which serves as a model for other jurisdictions that do not have such legislation. Thus, the medical and legal professions, working together, can contribute immeasurably to respectful medical decision making by educating the public about these developments and by adopting policies that reinforce these rights.     

Ethical obligation and legal requirements: On informed consent practices in Bangladesh

Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care.     

End‐of‐life decision‐making and advance care directives in Italy. A report and moral appraisal of recent legal provisions

The present article reviews the state of public debate and legal provisions concerning end‐of‐life decision‐making in Italy and offers an evaluation of the moral and legal issues involved. The article further examines the content of a recent law concerning informed consent and advance treatment directives, the main court pronouncements that formed the basis for the law, and developments in the public debate and important jurisprudential acts subsequent to its approval. The moral and legal grounds for a positive evaluation of this law, which attests that the patient may withhold or withdraw from life‐prolonging treatment, will be offered with reference to liberal approaches and particularly to the frameworks of care and virtue ethics; but reasons will also be offered in order to consider not only the latter but also broader range of end‐of‐life treatment decisions as morally apt options. In this light, we argue in favour of a further development of the Italian legislation to encompass forms of assisted suicide and active euthanasia.     

Advanced directives. Legal and practical aspects of negative instructions concerning medical treatment

The right of a competent patient to stipulate in advance of possible non-competence, medical treatment he does not want, is based on the fundamental legal principle that a person cannot be medically treated without his informed consent. It is in Dutch law a strong and almost unqualified right. There are indications in the international literature, however, that advance directives in many cases may not have much influence on medical treatment at the end of life. Very little is known about the social practice of advance directives in the Netherlands.     

Informed Consent in California: Latent Liability Without `Negligence'

Informed consent is a legal obligation due from a physician to his patient, an obligation which may not be met by the physician''s skillful treatment of his patient. It may only be met by the treating physician obtaining from his patient knowing authorization for carrying out the intended medical procedure. The physician is required to disclose whatever would be material to his patient''s decision, including the nature and purpose of the procedure, and the risks and alternatives. The disclosures should be made by the physician to his patient, and not through use of consent forms which are not particular to individual patients. To minimize any subsequent claim by the patient that there was a lack of adequate disclosures, the physician should record in the patient''s chart the circumstances of the patient''s consent, and should not rely on the patient''s unreliable ability to recall those circumstances.     

Medical management of canine and feline dystocia

When dystocia is diagnosed in the bitch or queen, two forms of treatment exist: medical or surgical therapy. Medical management of dystocia has the advantage of aiding completion of the parturition process without surgery or anesthesia. However, since not all cases of dystocia can be managed medically, educated and careful decision making is required prior to instituting medical management in cases of dystocia. Improper medical treatment, especially when surgical management is clinically indicated, can result in compromise and even death of the dam and fetuses. This paper focuses on the decision making necessary prior to instituting medical management for cases of dystocia in both bitches and queens, and describes available therapeutics.     

WHEN CONCRETIZED EMOTION‐BELIEF COMPLEXES DERAIL DECISION‐MAKING CAPACITY

There is an important gap in philosophical, clinical and bioethical conceptions of decision‐making capacity. These fields recognize that when traumatic life circumstances occur, people not only feel afraid and demoralized, but may develop catastrophic thinking and other beliefs that can lead to poor judgment. Yet there has been no articulation of the ways in which such beliefs may actually derail decision‐making capacity. In particular, certain emotionally grounded beliefs are systematically unresponsive to evidence, and this can block the ability to deliberate about alternatives. People who meet medico‐legal criteria for decision‐making capacity can react to health and personal crises with such capacity‐derailing reactions. One aspect of this is that a person who is otherwise cognitively intact may be unable to appreciate her own future quality of life while in this complex state of mind. This raises troubling ethical challenges. We cannot rely on the current standard assessment of cognition to determine decisional rights in medical and other settings. We need to understand better how emotionally grounded beliefs interfere with decision‐making capacity, in order to identify when caregivers have an obligation to intervene.     

论知情同意制度的不足以及术中改变术式的法律责任

知情同意制度贯穿于医疗活动的整个过程，尊重患者的知情同意权是医务人员的法定义务，国内诸多法律法规均对医疗活动中的知情同意做了原则性的规定。但是由于缺乏针对具体医疗行为如何适用知情同意制度的指引或者规范，导致医务人员常常不知如何正确地履行知情同意程序。而且，当前的知情同意制度存在诸多不足，司法实践也对知情同意缺乏深入的研究，这为医务人员的执业活动带来了潜在的法律风险。     

Informed consent,and an ethico- legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study

Birth cohort studies are important tools for life-course epidemiology, given the spectrum of the environmental, behavioural, and genetic factors that should be considered when making judgements on human health. Biobanks are valuable components of studies designed to investigate the genetic variability of diseases and improve phenotypic characterisation. In studies involving vulnerable populations and biobanks, it is essential to provide ethical reasoning and analyse the legal requirements. We describe the processes and the tools used in the iterative design of an appropriate informed consent model and the ethico-legal framework of the Piccolipiù study. The Piccolipiù study is a prospective population-based study funded by the Italian Ministry of Health that intends to enrol 3,000 newborns and their mothers in five Italian cities, and to store biological samples for future use. To realise these objectives, we performed a thorough evaluation of the literature, of national and international guidelines, and of the impact of the Italian legal requirements for research biobanking. Discussions among stakeholders facilitated the design of the informed consent and the ethico-legal framework. Several topics are addressed, including the suitability of a broad informed consent for paediatric biobanks, infant vulnerability, access to and sharing of data, and the disclosure of individual’s genetic results. Discussion of the ethical and legal procedures adopted in epidemiological biobanking might be a fruitful ground for comparison both at the national level, where standardization and homogeneity are lacking, and at the international level, where different regulatory issues are often in the background and might hamper research biobanks networking.