Informed consent in clinical practice and medical research

The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats). However, it is important to recognize the limitations of these formats when used outside the context of a continuous communication process with the patient. For this reason, ultimate instrumentation is through continuous dialogue between patient and physician. Finally, Informed Consent might help improve the patient-physician relationship which, in the end, might be the best way to counteract the influence of the establishment of health management services.     

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.     

Informed consent for clinical photography

The question of (informed) consent to medical photography has long been a vexed one. This paper briefly considers key landmarks in the debate, and examines in detail the evolution of the Addenbrooke's NHS Trust policy Photography and Video Recordings of Patients: Confidentiality and Consent, Copyright and Storage . The impact of the 1998 Data Protection Act, the Department of Health's Model Policy on Consent , and the implications of wider access to digital photography are discussed together with their integration into the Addenbrooke's policy.     

Informed consent and the history of inclusion of women in clinical research

The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.     

Informed consent and assent in human subject research.

Informed consent is an important aspect of human subject research, designed to uphold individual autonomy and the moral principle of respect for persons. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research articulates three distinct elements of informed consent as "information, comprehension, and voluntariness." These elements are discussed as they apply to informed consent. This article then discusses the concept of child assent. Finally, informed consent as it applies to public health research is discussed.     

Informed consent in clinical training--patient experiences and motives for participating

The purpose of this study was to assess patients' attitudes to and experiences of participating in the clinical training of medical students. Samples of patients (n = 582) selected at random from six different departments (gynaecology, psychiatry, internal medicine, paediatrics, urology and a health care centre with general practitioners) were interviewed by means of a questionnaire. The patients were selected from those who had consulted the actual departments in the last six months of 1995. Four hundred and forty-one patients (76%) answered the questionnaire. Seventy-one per cent of all patients had experience of participating; of these 41% had estimated that they had once or several times participated without being informed. Eighty per cent felt aggrieved if they were not informed. On average 88% were, in principle, positive to participating. Of those who were, in principle, negative a majority had negative experiences of participating. Elderly patients tended to accept participating more often without being informed. Almost all patients seemed to be positive to participating in the education of medical students, although a silent precondition might be that patients should be informed and given the opportunity to abstain.     

Informed consent in epidemiologic research before the implementation of ethical guidelines

On June 17, 2002, the Ministry of Education, Culture, Sports, Science and Technology, together with the Ministry of Health, Labour and Welfare, introduced the Ethical Guidelines for Epidemiological Research. Although studies begun before the adoption of the Guidelines are not necessarily required to conform to them, some studies have been reviewed anew by ethics review committees. In this article for the Young Investigator Award of the Japan Epidemiological Association, therefore, the author would like to offer an overview of informed consent in epidemiologic researches conducted before the introduction of the Guidelines. It is hoped that this may serve as a reference as to the contents and status of ethical considerations in these studies, for use in examinations of research that was already in progress when the Guidelines were introduced.     

Informed consent for screening

Mauad et al. found that simple, understandable information wasvital in successfully encouraging the uptake of cervical screeningin a poor population in Brazil.¹ We decided to assess Britishwomen’s understanding and opinions of two patient informationleaflets about nuchal translucency scans and mammograms used