The increasing number of elderly people in nursing homes with failing competence to give consent represents a great challenge to healthcare staff’s protection of patient autonomy in the issues of life-prolonging treatment, hydration, nutrition and hospitalisation. The lack of national guidelines and internal routines can threaten the protection of patient autonomy.
To place focus on protecting patient autonomy in the decision-making process by studying how relatives experience their role as substitute decision-makers.
A qualitative descriptive design with analysis of the contents of transcribed in-depth interviews with relatives.
Fifteen relatives of 20 patients in 10 nursing homes in Norway.
The main findings reveal deficient procedures for including relatives in decision-making processes. Relatives have poor knowledge about the end of life, and there is little discussion about their role as substitute decision-makers for patients who are not competent to give consent. Few relatives understand the concept of patient autonomy. In Norway the treating physician is responsible for patient treatment. When relatives are included in discussions on treatment, they perceive themselves as responsible for the decision, which is a burden for them afterwards. This qualitative study describes relatives’ experiences, thus providing important information on the improvement potential with the main objective of safeguarding patient autonomy and caring for relatives.
The study reveals failing procedures and thus a great potential for improvement. Both ethical and legal aspects must be addressed when considering patient autonomy.
The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive’s principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the "single opinion" process in each country. This led to a situation in which two models of research ethics committees organisation systems exist, being the model in which the "single opinion" is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload.
A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded.
There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees’ membership based in common curricula is recommended by the majority of countries.
Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing.
Lay persons’ judgements of the acceptability of the not uncommon practice of ending the life of a damaged neonate have not been studied.
A convenience sample of 1635 lay people in France rated how acceptable it would be for a physician to end a neonate’s life—by withholding care, withdrawing care, or active euthanasia—in 54 scenarios in which the neonate was diagnosed either with perinatal asphyxia or a genetic abnormality. The scenarios were all combinations of four factors: three levels of maturity or immaturity, three levels of severity of the health problem, three levels of parents’ preference concerning prolonging care and two levels of decision-making (with or without consulting the other caregivers).
Analyses of variance of the participants’ responses were performed to determine the importance of each factor; the interactions among factors, with methods of ending life and with other patient characteristics; and the differences between asphyxia and genetic abnormality. A cluster analysis was performed to look for groups with different patterns of responses.
Lay people assigned most importance to the parents’ request and to the severity of the problem. Except for a small group (12%) always opposed to ending life, they used a simple additive-type rule in integrating the information.
Most of this sample of French lay people are not categorically for or against ending the life of a damaged neonate, but judge its degree of acceptability by adding up those factors that seem most salient to them.
Research in intensive care is necessary for the continuing advancement of patient care. In research, informed consent is considered essential for patient protection. In intensive care, the modalities of informed consent are currently being debated by both lawyers and the medical community. The preferences of patients and their relatives regarding informed consent for research in intensive care have never been assessed. The aim of this study was to investigate these preferences.
A pilot study conducted via a questionnaire mailed to patients and relatives who had experienced intensive care.
52/400 patient–relative pairs completed the questionnaire fully. If the patient was imagined to be conscious, 75% of patients and 77% of relatives believed the patient should be the person who should consent. If the patient was imagined to be unconscious, 72% of patients and 67% of relatives thought that a relative should be asked to consent. The majority of responders thought that at least two persons should consent. Their answers were concordant in 61–80% of cases, depending on the question. Patients (25%) and relatives (30%) did not feel free in their decision to participate in a study. The majority of patients and relatives wanted to consent by writing, indifferently with or without a witness.
Patients are willing to decide on their own participation in a study. If they lose their capacity to decide for themselves, in the great majority of cases, they would agree to delegate the decision to a relative.