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Results for “informed consent”

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PubMed1998

Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary?

OBJECTIVE: The purpose of this study was to assess informed consent to human immunodeficiency virus (HIV) testing in a perinatal HIV transmission study in a major referral hospital serving a largely Black population in South Africa. METHODS: First-time antenatal clinic attenders who were randomly selected from those enrolled in the perinatal HIV study (n = 56) answered questionnaires before and after counseling. RESULTS: Knowledge of HIV transmission and prevention, high at the outset, was little improved after counseling. The acceptance rate for HIV testing was high. Despite assurances that participation was voluntary, 88% of the women said they felt compelled to participate in the study. CONCLUSIONS: Informed consent in this setting was truly informed but not truly voluntary.

AIDS Serodiagnosis↗
PubMed2000

[Mental competence and informed consent. Clinical practice and ethical analysis].

The doctrine of informed consent has become a legal and ethical standard in psychiatry today. However, ethical problems arise if patients lose the capacity to give informed consent due to their psychiatric disorders. Particularly in the field of psychiatry, the assessment of competence of informed consent to medical treatment and participation in clinical trials is a controversial issue. New empirical data suggest that a high percentage of psychiatric patients are incompetent according to defined standards for assessing their capacity to make treatment decisions. Assessing competence according to a sliding scale integrates the ethical principles of autonomy and beneficence and provides help in assessing competence in clinical practice.

Ethics, Medical↗
PubMedDate not supplied

Informed consent and the geriatric dental patient.

Dental professionals are increasingly aware of their ethical responsibility to permit patients to participate in treatment decisions through the informed consent process. At the same time, growing numbers of geriatric patients present special challenges that can jeopardize the use of informed consent. Consequently, the use of informed consent with geriatric patients warrants special analysis due to complicating factors such as patient passivity and questionable competency. This article establishes the relationship between the ethical principle of autonomy and informed consent while examining factors that must be present in order for a valid informed consent to be obtained. Additionally, the article addresses informed consent issues regarding competent patients, geriatric patients with fluctuating or uncertain competency, and patients who are clearly incompetent.

Aged↗
PubMed1989

Teaching the informed consent process to residents.

We believe the focus and emphasis of this committee on informed consent is unique, and that the development of an informed consent teaching process for residents will focus on the moral and ethical issues regarding informed consent. Even more important, we believe we will emphasize the patient care aspects of informed consent and also teach residents their responsibilities for long-term patient care with regard to patients' satisfaction and understanding of their disease process.

Informed Consent↗
PubMed1998

Informed consent: what do patients want to know?

AIM: To determine which aspects of informed consent are important to patients and surgeons and to determine where there is disparity and similarity. METHOD: A questionnaire was developed from the Disability Commissioner's Regulations (1996) and was administered to 256 patients and 37 doctors at Christchurch Hospital. RESULTS: According to patients the five most important aspects of informed consent were: (1) the major risks, (2) quality of life, (3) outcome, (4) consequences of not undergoing the procedure and (5) quantity of life. The five most important aspects to the doctors were (1) the general nature of the procedure, (2) major risks, (3) consequences of not undergoing the procedure, (4) alternative options and (5) consequences of the procedure in regard to management. The aspects of informed consent of greatest divergence (power of divergence, p < 0.05) between patient and doctor were (1) the importance of technical details of the procedure, (2) cost to the country, (3) qualifications of the doctor, (4) experimental and non-conventional treatment options and (5) whether the doctor would have the procedure if they were in the position of the patient. CONCLUSIONS: This study has identified aspects of informed consent that patients and doctors consider important, as well as aspects where there are significant differences. Both patients and doctors consider the explanations of risks and complications important, especially if the complication is serious and risk is greater than 1 in 1000. Patients consider aspects of outcome (quantity and quality of life) important, while doctors are concerned about "process" including the general nature of the procedure and consequences of the procedure for the patient's management. This study gives direction to medical practitioners concerning what it is that patient's are wanting to know during informed consent about a procedure.

Adult↗
PubMed1996

[Informed consent of the esophageal cancer].

An informed consent (IC) is composed of sufficient explanation from medical providers about illness and proposed treatment and its acceptance by a patient with a principal intention to protect patients. Esophageal cancer has some characteristic features in contrast to other malignancy that is (1) high prevalence in elderly with advanced stage (2) significant malignant potential in nature (3) high surgical risk with mortality of 3% and morbidity of over 50% (4) availability of diverse treatment modality such as resection, irradiation and chemotherapy. Therefore it is highly advised for medical providers to inform patients of their diagnosis and explain anticipated surgical risks to help them understand the negative features mentioned above although extent of revelation of illness should be highly individualized according to the judgment of medical providers. It is also mandatory for medical providers to inform patients of available treatment modalities applicable according to the stage of disease and evaluated surgical risk before obtaining a consent to a proposed treatment. Illustrated figures advocate patients to further understand the stage of disease, the necessity of proposed treatment, surgical risk with anticipated complication etc, and explanatory forms if accompanied are even more helpful in this respect. An informed consent is to be signed to verify the acceptance of a proposed treatment by a patients who has been fully aware of illness. An informed consent should be utilized to establish ensured patient, doctor relationship through its make-up process instead of being considered as an exclusive legal document of agreement.

Esophageal Neoplasms↗
PubMed2005

[Readability of informed consent forms for subjects participating in biomedical research: updating is required].

OBJECTIVE: We compared informed consent forms of subjects participating in biomedical research with those of references texts in order to determine the factors that influence readability. METHODS: We assessed the readability of 73 informed consent forms of research protocols conducted in the clinical investigation centres in the Rhone-Alpes area, and then compared them with 33 reference texts corresponding to 5 French school grades (first year infant, primary school, GCS level, high school, and classics aggregation), using the Flesch test and Cordial" analyser. RESULTS: Median Flesch scores were 66 for the first year infant level, 62 for the primary school level, 58 for the GCS level, 42 for the high school level, and 43 for the aggregation level. It was 22 for the informed consent forms. Median Cordial scores were 86 for the first year infant level, 77 for the second, 74 for the third, 49 for the fourth, 43 for the fifth. It was 1 for the informed consent forms. No methodological factor correlated with Flesch and Cordial" results. CONCLUSION: The quantitative readability scores for informed consent forms for subjects participating in biomedical research are low, lower than those proposed to aggregation candidates, whatever the type of protocol. Some thought must be given to the impact of the reduced readability on patients' understanding, and steps should be taken to improve the readability of the forms.

Adolescent↗
PubMed2006

Informed consent.

Disclosure of information prior to consent is a very complex area of medical ethics. On the surface it would seem to be quite clear cut, but on closer inspection the scope for 'grey areas' is vast. In practice, however, it could be argued that the number of cases that result in complaint or litigation is comparatively small. However, this does not mean that wrong decisions or unethical scenarios do not occur. It would seem that in clinical practice these ethical grey areas concerning patients' full knowledge of their condition or treatment are quite common. One of the barometers for how much disclosure should be given prior to consent could be the feedback obtained from the patients. Are they asking relevant questions pertinent to their condition and do they show a good understanding of the options available? This should be seen as a positive trait and should be welcomed by the healthcare professionals. Ultimately it gives patients greater autonomy and the healthcare professional can expand and build on the patient's knowledge as well as allay fears perhaps based on wrongly held information. Greater communication with the patient would help the healthcare professional pitch their explanations at the right level. Every case and scenario is different and unique and deserves to be treated as such. Studies have shown that most patients can understand their medical condition and treatment provided communication has been thorough (Gillon 1996). It is in the patients' best interests to feel comfortable with the level of disclosure offered to them. It can only foster greater trust and respect between them and the healthcare profession which has to be mutually beneficial to both parties.

Confidentiality↗
PubMed1986

Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital.

To examine whether written informed consent might influence the results of clinical trials the effect of placebo when given with or without informed consent to patients suffering from insomnia was studied. The study was a single blind observer blinded trial, and patients were paired according to sex, age, and hospital environment. Randomisation assigned the first patient of each pair to the control group (without informed consent) or the group to give informed consent. Of the 56 patients, 26 refused to give informed consent, and the age and sex distribution of these differed significantly (p less than 0.02) from the 30 pairs of patients ultimately enrolled into the study. In this "biased" sample, the hypnotic activity of placebo was significantly higher in the control group (p less than 0.05). It is concluded that the informed consent procedure biases the results of clinical trials and might affect their general applicability.

Age Factors↗
PubMed1991

[Informed consent in cardiac surgery].

Recently, it has been recognized in Japan that informed consent is indispensable to make decisions for medical treatment, although it had been already confirmed in western countries for several decades of years. However, there may be some differences in the content of informed consent between Japan and western countries. We discussed the problems of informed consent in Japan concerning the choice of prosthetic valve, mechanical prosthesis or bioprosthesis, in patients to be undergone valve replacement. We conclude that informed consent should be the humane relationship between therapists and a patient.

Bioprosthesis↗
PubMed1980

Legal and ethical issues in clinical pharmacy research--informed consent, Part II.

Preparation of an effective informed consent document presents significant problems to those investigators not familiar with federal and institutional requirements. This article examines a detailed format for preparation of an informed consent instrument. Prepared by the authors and supplied to potential clinical investigators by a university institutional review committee, the guidelines incorporate Department of Health, Education, and Welfare regulations. An example consent form is provided.

Clinical Trials as Topic↗
PubMed1998

Informed consent: an Australian case study.

OBJECTIVE: Informed consent, as practiced in Australian chiropractic practice, was explored by means of a collective case study. DESIGN: Twenty-one chiropractic practices were visited and 25 chiropractor-patient units explored. Purposive sampling of practitioners was undertaken using a maximum variation strategy. Convenience sampling of patients was performed within each participating practice. Data was gathered from each chiropractor-patient unit, consisting of one practitioner and usually five patients, by means of practitioner interview, patient questionnaire and interview and, in certain cases, practice observation. Thematic analysis of the interviews were correlated with information derived from the patient questionnaires and validated by selective practice observation. Data was compared within and across chiropractor-patient units. RESULTS: Consent for chiropractic care was usually implied. Chiropractors in this study seldom obtained formal verbal, and never written, informed consent. New chiropractic patients were nonetheless informed about the procedures that the chiropractor intended to perform, and their acquiescence was taken as consent. Participants seldom discussed the potentially serious consequences of chiropractic adjustment but did actively attempt to identify and avoid exposing at-risk patients. Patients were often counseled about potential muscle soreness after the chiropractic adjustment. The behavior of chiropractors in this study was consistent with their patients' expectations. CONCLUSION: This study suggests that chiropractic behavior in Australian clinical practice meets the moral, but not all of the legal, requirements for informed consent.

Adult↗
PubMedDate not supplied

[Survey of informed consent in a gastrointestinal endoscopy unit].

OBJECTIVES: Gastrointestinal endoscopy, like all diagnostic and therapeutic techniques, must be preceded by written informed consent. The aim of this study was to evaluate the patients' acceptance and understanding of the aim of informed consent as well as to determine their perception of the investigation. METHODS: For 2 months, informed consent forms were given together with a questionnaire to 221 consecutive patients who underwent diagnostic gastrointestinal endoscopy. RESULTS: Distribution of the patients according to level of education was: university graduated (6.5%), high-school graduate (21.1%) those who had completed primary school (48.6%) and those with no schooling (23.9%). The document was read by 144 patients (65.1%) and the attending physician had previously explained it to 69.6%. Informed consent was understood by 90.7% of the patients who read the document. Understanding was related to education (university and high-school graduates (83.3%) vs. those who had completed primary school or who had no schooling (60%); p < 0.005) and was not related to the information given by the attending physician. Patients' opinion on the aim of informed consent was: absolve the doctor of responsibility (42%), provide information in the patients' interests (51.1%) and senseless document (42%). Signing the document provoked fear in 20% of those surveyed. This fear was greater in patients who had not been informed by the attending physician (31.2% vs. 14.5%; p > 0.01). CONCLUSIONS: Informed consent is understood by most patients who read the form but a significant proportion perceive it as designed to defend the physician. When the technique is explained by the attending physician and the doctor performing the procedure, acceptance is increased and fear is reduced.

Adolescent↗
PubMed1999

Observing communication skills for informed consent: an examiner's experience.

OBJECTIVE: To examine medical students' communication skills and competence regarding informed consent during an objective structured clinical examination (OSCE). METHOD: At the University of Toronto, 22 candidates wrote MCCQE part II as a prerequisite for medical licensure. The candidates' performance at one station involving informed consent was assessed using binary checklists and global ratings. Candidates were assessed for their clinical skills in approaching the problem, knowledge of subject matter, attitude towards the situation, and communication ability with the patient. RESULTS: Of the candidates, 90 per cent performed well and demonstrated their ability to effectively deal with the patient's physical concerns. Only 50 per cent performed relevant mental-status examinations; and 50 per cent of the candidates seemed to be biased and physician-centered. They were unable to acknowledge the associated psychological issues that might influence the patient's decision in the process of informed consent. Only a few expressed their concern and empathy, and were able to guide the patient in making an autonomous decision about surgical procedures. CONCLUSION: The OSCE seems to be an appropriate and effective means to evaluate clinical competence in psychiatry. The variation in candidates' performance, however, suggests a greater need to improve clinical skills, particularly those that are relevant to psychological considerations in obtaining informed consent and providing required information to patients. Thus, emphasis should be given in undergraduate teaching programs to addressing effective means of assessing patients' competency and their ability to give informed consent.

Aged↗
PubMed1985

Comprehension of information for informed consent by spouses of surgical patients.

The adequacy of comprehension of the information needed for informed consent to participate in research on spouse responses to a husband's or wife's general surgery was assessed. Comprehension of information about the research study by 75 spouses was measured by the Informed Consent Questionnaire containing questions on study purpose, time involvement, nature of participation, risks, benefits, voluntariness, confidentiality, and anonymity. The result showed that 72 of the 75 spouses had adequate comprehension of the information for informed consent. Because adequate comprehension is atypical of most studies, possible reasons for this unexpected result are discussed and then explained within a self-determination theory of informed consent.

Comprehension↗
PubMed1997

Cognitive functions in the informed consent evaluation process: a pilot study.

Assessment of capacity to give informed consent in the general hospital setting usually rests on a clinical judgment made of a patient's understanding and appreciation of his or her illness, a process limited by its subjective nature, interexaminer variability, and relative deficiency of quantitative instruments available to provide collateral information. Inasmuch as identification of associated variables could strengthen this process, this study examines the association of cognitive functions to the capacity to give informed consent. Over a one-year period, 65 patients were evaluated independent of medical or psychiatric diagnoses. The study population consisted of medical and neurology inpatients seen for neuropsychiatric evaluation. All evaluations included assessment of capacity to give informed consent as it related to the reason for the admission to the hospital, followed by administration of the Hopkins Competency Assessment Test, the Mini-Mental Status Examination, the Trail-Making Test, Parts A and B, and the Executive Interview. Of 65 patients, 34 were excluded based on preset criteria. The remaining patients were assigned to either a "competent" or "noncompetent" group based on clinical evaluation. Number of patients, gender, and handedness distributions between groups were similar. The groups did not differ significantly in terms of age or education. Significant between-group differences were found on an empirical measure of competency, a general mental state measure, and on measures of attentional and executive cognitive functions. An analysis of classification rates indicated that a measure of executive cognitive functioning (Executive Interview) had the best sensitivity and specificity in correctly classifying competent and noncompetent patients. The results of this study support the association between the capacity to give informed consent in the hospital setting and measures of cognitive functioning, suggesting that utilization of cognitive function measures may strengthen the competency assessment process.

Adult↗
PubMed1983

Mental health aspects of the informed consent process.

Recent social, political, legal, and technical developments have led to increasing consideration of informed consent practices. Many physicians have reservations about possible harm, especially to the more "vulnerable" individual which might be done by truth telling. Observations made by a psychiatrist in a government research hospital, where informed consent is mandatory, are reported in this paper. There was no evidence that the informed consent process was harmful or not desired by patients and/or families of either "normal" or "vulnerable" populations. Concern about possible harm from truth telling came mainly from physicians and is based on physicians' personal anxiety in a situation involving close emotional contact with another person, the patient. There was some evidence that the informed consent process, when adequately supported by appropriate behavioral-science services, may be a factor in enhancing the mental health of both patients and members of the health team. Mental health implications of the style of openness and honesty as seen in the informed consent process are discussed.

Adult↗
PubMed1999

A commentary on 'Informed consent to septoplasty: an anecdote from the field'.

This paper is an analysis of the events recounted in 'Informed consent to septoplasty: An anecdote from the field.' As a commentary, it assesses the behavior of many agents who are parties to the story - physicians, nurses, friends of the patient, the patient's wife and the patient himself. This story is interesting for being mundane. The medical condition involved and the failures of care are not momentous. The patient's role as a medical ethicist led him to see things in particular perspective and motivated or influenced his conduct sometimes not in the smartest of ways. Several accounts of informed consent are reviewed and used as measures of what happened. The moral vision behind informed consent, the rights and duties it implies and the elements of its contents are identified. No account was fulfilled. Some of the reasons and causes for this are discussed. Many sources of information and forces acting on the situation are explored. Post-operative experiences include severe irritation and discomfort as well as severe frustration and a sense of alienation and abandonment. The case communicates a hint about what physicians do not know in order to have informed consent occur. Physicians' lack of awareness about, e.g., post-operative experience means that they will not provide what the informed aspect of informed consent requires. Patients can feel abandoned and perhaps are abandoned in a variety of ways, subtle and not so subtle. A few issues besides informed consent are discussed (the roles of wives in working at their physician-husband's front desk, the language of reassurance).

Disclosure↗