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F C van Wijmen

Publications and source records attributed to F C van Wijmen.

11 recordsLinked to original sources
PubMed1997

Myth and reality of informed consent in clinical trials.

Informed consent is a prerequisite for any medical intervention or for participation in scientific research. Legal requirements in health care towards informed consent provide qualifications of information disclosure and focus on procedures to obtain a valid consent. The premise of informed consent as a rational decision making process implies an informed consideration, assessment and patient choice and may be perceived as an ideal in the nature of a myth. These principles and assumptions will be discussed to obtain more insight into informed consent in clinical trials. A cogent model of informed consent is presented, which could be useful in clinical trials. We suggest a gradual distinction between informed consent in regular treatment vs. clinical trials, based on concepts like achievable benefits and risk disclosure. Suggestions are made for further empirical research, to obtain more insight into the myth and reality of informed consent in clinical trials.

Clinical Trials as Topic↗
PubMed1996

Informed consent in clinical trials.

A review is provided in this paper on the empirical literature on informed consent from 1979 to 1995 referring to information disclosure and trial participation in clinical trials. Articles being reviewed focus upon information disclosure, reactions to disclosure and recall, features of consent and perceptions of informed consent, both in hypothetical and in real life situations. It is concluded that further research is needed to study the process of informed consent in clinical trials, to obtain a better insight into the myth and reality of informed consent in daily practice. Future studies should come forward on the limitations of previous empirical research on informed consent. Additional research should focus on the perspectives of patients who accept or decline trial participation.

Attitude of Health Personnel↗
PubMed1991

Patients' rights and the admission and discharge process.

This study examines what patients' admission to and discharge from hospital means for nurses in their relations with patients. The study focuses on the rights of patients and the rights and duties of nurses working in a general hospital and in the community. The 'information standard' is introduced, consisting of three conceptions: informed consent, informed referral and informed discharge. In-depth interviews have been conducted with patients (n = 11) and nurses (n = 22) to elucidate views on and personal experience of the admission and discharge process, in relation to the information standard. The interviews have been analysed by means of qualitative research methods. The results show that patients did not complain about the admission and discharge process, and that they were not informed about the information exchange between nurses working in hospital and in the community. In addition, community nurses were often not informed about a patient's admission to hospital. Nursing programmes for home care were arranged by community nurses and hospital nurses without co-ordination, resulting in unsuitable nursing care.

Attitude of Health Personnel↗
PubMed1989

[Legal regulations for the testing of animal experiments].

In 1987, the Dutch Secretary of State for Public Health stated before Parliament that in the near future a legal basis will be given to the review-organisation of (intended) experimental studies on animals. The Department of Health Law of the State University of the province of Limburg recently carried out investigations to test the desirability and framework of such a review-organisation. Standards and criteria are laid down in Dutch as well as in international laws, regulations and codes of conduct. In the United States, Canada and several European countries, systems of regulation and review are operative. In the Netherlands, governmental and private initiatives have led to the establishment of experimental-study review committees. However, the functioning and effectiveness of these committees varies markedly. On the basis of the literature and opinions of experts, a concept of a modification of the existing Experimental Studies in Animals Act was formulated, in which experimental study review committees can find a legal basis.

Animal Welfare↗
PubMed1987

Quality improvement of patient care: some preliminary results of a hospital-wide quality-assurance project at the University Hospital of Maastricht.

Dutch hospitals have to design their quality-assessment programmes within the boundaries set by "indirect government legislation". At the University hospital of Maastricht a five-stage project was started in 1985 to construct a hospital-wide quality-assurance organisation that includes regular review of the quality of professional performance. This paper will describe intermediate results of the first stage and will discuss the results of different subsurveys undertaken to assess the current level of quality of care and several key-issues conditional to the implementation of such a hospital-wide structure in the existing organisation of a University hospital. Finally the results of the first stage will be contrasted with external legislative standards and internal needs of the University hospital recognised during assessment of the current situation.

Attitude of Health Personnel↗