Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Consent Forms”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,027 records · Page 57Linked to original sources
PubMedDate not supplied

[The performance and perception of informed consent in a health-care section of Catalonia].

BACKGROUND: Informed consent entails a process which involves more than signing a form to give one's consent. This process involves the mutual exchange of information, understanding, trust and consent between physician and patient. The purpose of this study is that of ascertaining the degree to which those consumers who have gone through the informed consent process in a health care district in Catalonia have filled out and fully understood this form. METHODS: Telephone survey conducted among 314 former surgery patients at hospitals in a given district, ages 18-75, who had undergone surgery within the three months immediately prior to the date on which the survey was conducted for the purpose of ascertaining the opinion of these consumers regarding the consent process. A review of the clinical records of 30% of these individuals was conducted for the purpose of ascertaining the degree of compliance with the consent form process. RESULTS: Sixty-one percent (61%) of the patients surveyed remembered having signed the consent form, 59.2% recalling explanations regarding risks or complications of the surgery they were to undergo. Nine percent (9%) did not understand well enough what was going to be done to them during the surgery, and 36% were of the understanding that the consent form released the health care professionals from liability. A statistically significant relationship was found to exist among the age group, educational level and admissions channel. Seventy-eight percent (78%) of the clinical records reviewed included informed consent forms. The diagnosis was stated on 14.9% of these forms, and 48.9% had been signed by the attending physician. A statistically significant relationship was found between the channels through which patients were admitted to the hospital. CONCLUSIONS: The informed consent process is not being implemented correctly at the two hospitals analyzed. Physicians are not totally involved in the process.

Adolescent↗
PubMed1981

Effect of informed consent and educational background on patient knowledge, anxiety, and subjective responses to cardiac catheterization.

Thirty-four patients undergoing elective cardiac catheterization were followed linearly with three questionnaires during their hospitalization to study some of the effects of informed consent. Patients learn about catheterization from the informed consent session conducted by a cardiology fellow. Several areas of knowledge deficiency were found. The emotional experience of hospitalization and the amount of knowledge about catheterization determined at the end of hospital stay is shown to be dependent on the educational level of the patient. Several recommendations are made for the conduct of the informed consent sessions to improve the knowledge of the less educated.

Adult↗
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↗
PubMed2005

Informed consent for anesthesia: survey of current practices in Japan.

Anesthesia requires informed consent because it is an invasive procedure with certain risks. However, the state of informed consent for anesthesia in Japan remains unclear. The purpose of this survey was to examine the state of informed consent for anesthesia in Japan. A questionnaire was sent to all hospitals certified by the Japanese Society of Anesthesiologists (n = 854). The questionnaire consisted of four sections: explanation of the anesthesia, method of documentation, consent for anesthesia, and other information such as the hospital's size. A total of 504 (59.0%) questionnaires were completed and returned. At 96.7% of hospitals, an anesthesiologist would explain the scheduled anesthesia. Most departments provide an explanation of dental damage, malignant hyperthermia, and nausea/vomiting. Explanation of anesthesia was standardized at 59.0% of hospitals. A written description was handed out to patients routinely at 61.3% of hospitals. Although consent for anesthesia was obtained at more than 90% of departments, only 59.9% of departments would keep records of having obtained consent. This survey found that the explanation of anesthesia varied among hospitals and was not standardized in Japan. Further attention is needed on how to improve the documentation of informed consent.

Anesthesia↗
PubMed1984

Factors influencing comprehension of information for informed consent: ethical implications for nursing research.

Empirical studies on comprehension of information for informed consent show that research subjects often do not understand major portions of that to which they have consented. This raises the ethical question of whether or not the consent process has accomplished its purpose--the protection of the individual's right to self-determination. This article focuses on the following factors derived from the research literature that influence comprehension of information for informed consent: the nature of information, method of presentation of information, demographic factors, and personal factors. From these factors and methodological considerations, ethical implications for nursing research are addressed.

Comprehension↗
PubMed1998

Consent to clinical trials in anaesthesia.

In order to evaluate satisfaction with, and recollection of, the consent process, we sent a postal questionnaire to 204 patients who had taken part in one of six clinical trials. Three trials were multicentre commercial studies and three were 'in house'. The readability of the different patient information sheets was compared. Seventy-seven per cent of patients responded, of whom 82% remembered having an information sheet. Most (99%) thought this was easy to read and understand. Five patients claimed that they had felt pressurised to take part in the trials. Nearly all patients (97%) realised that participation was voluntary and that other treatment would not be affected; 83% knew they could have changed their minds. There were no differences in the response patterns between the patients taking part in the different trials although the patient information sheets produced by pharmaceutical companies were longer and more complex than the 'in hospital' variety. We conclude that increasing the amount and complexity of information does not alter patient satisfaction. Taken overall, patients were content with the way they were approached when asked for consent for clinical trials.

Adult↗
PubMed1992

Elements of informed consent in clinical research with drugs: a survey of Spanish clinical investigators.

An anonymous survey was conducted on 302 Spanish clinical investigators in order to determine whether a patient's information sheet should be prepared for each clinical trial, and what items of information should be included. The survey, using close-response type questions, included 23 proposed items of information. A total of 275 (91%) investigators considered it necessary that a patient's information sheet be prepared for each clinical trial. At least 83% of those investigators considered that seven items of information should always be included: an invitation to participate in a clinical trial, the aim of the study, a description of the predictable benefits and risks, a declaration that participation is voluntary, and a statement that refusal to participate does not imply loss of normal medical care and that the trial has been approved by a Clinical Trials Committee. Only 29% and 53% considered that the patient should always be informed about clinical trial design and data confidentiality, respectively. Overall, the responses obtained are in line with most of the elements of informed consent regarded as 'basic' in US regulations and included in the European Community and Nordic Good Clinical Practice guidelines.

Adult↗
PubMed1986

Informed consent for research. Effects of readability, patient age, and education.

Comprehension of informed consent materials from a study of psychological variables associated with chest pain was evaluated as a function of age (27 to 69 years), education (5 to 20 years), and readability of information [low (college level) versus high (7th grade)]. The potentially confounding effect of memory was eliminated by allowing patients to use the written information sheets to find answers to the multiple choice test. Feedback and a repeat test were provided if any answers were incorrect. The findings indicated that comprehension varied inversely with age and directly with education. It is suggested that while ensuring informed consent may be difficult for all volunteers, it may be a critical problem for elderly patients with low education. The effects of readability were not consistent, suggesting that simplifying informed consent materials by shortening words and sentences may not, by itself, be sufficient to improve comprehension.

Adult↗
PubMed2003

Understanding of informed consent by demented individuals.

BACKGROUND: The informed consent process is central to the conduct of research but may be difficult for cognitively impaired participants to understand. The authors developed a brief test addressing the elements of informed consent for a specific minimum-risk nontreatment research protocol. OBJECTIVE: To evaluate and document understanding of informed consent by elderly research participants across a range of dementia severity. METHODS: The elements of informed consent regarding participation in a longitudinal study of healthy aging and dementia were reviewed with both demented (n = 250) and nondemented (n = 165) participants who then completed a short test requiring yes-no responses to assess understanding of these elements. Demented participants had very mild, mild, or moderate dementia as staged by the Clinical Dementia Rating. RESULTS: After adjusting for education, performance on the test varied with dementia severity in mean differences and by correlation. All nondemented and very mildly demented participants and 92% of mildly demented participants provided correct answers for at least 8 of 10 true-false items, whereas only 67% of the moderately demented participants achieved this level of accuracy. CONCLUSIONS: Demented individuals, very mild and mild, understood informed consent information for this nontreatment research study. Understanding notably declined in the moderate stage of dementia. Brief tests may be useful as one method to assess understanding of the consent process for specific studies.

Aged↗
PubMed2006

Procedural misconceptions and informed consent: insights from empirical research on the clinical trials industry.

This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function as root causes of therapeutic misconceptions.

Behavioral Research↗