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PubMed2006

Informed consent in clinical research at a general hospital in Mexico: opinions of the investigators.

In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,(1) 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work.

Attitude↗
PubMed1995

Informed consent: an essential element of safe anesthesia practice.

Generally, health care providers have viewed safety in terms of prevention of patient accidents. However, with the growth of patient consumerism and stress on quality improvement, the concept of "safety" has been expanded. This article examines the legal concept of informed consent and offers practical suggestions on increasing both patient and provider safety and improving quality of care. For reasons dictated by statute, case law, and professional ethics, informed consent should be part of the practice of every CRNA. With proper informed consent, misinformation, dissatisfaction, and subsequent legal action can be diminished. Information should be offered to the patient and family and reinforced with written educational materials and instructions. These procedures should be documented in the medical record to provide verification that the patient was informed of the risks and benefits and agreed to the procedure contemplated. Failure to do so could expose the CRNA to legal actions under legal theories that include not only negligence, but battery, and contract as well.

Contract Services↗
PubMed2001

[Autonomy, privacy and the implementation of the principle of "informed consent" with regard to nursing intervention from the view point of the aged].

The aim of this study was to describe patient autonomy, privacy and the implementation of the principle of informed consent in the care of elderly patients in facilities experienced by themselves. This study is part of the BIOMED 2 project "Patients' autonomy and privacy in nursing interventions" supported by the European Commission. Interview data (n = 95) were collected among elderly people in German facilities for geriatrics and in nursing homes. The results showed there was a lack of opportunity by the elderly people to make self-determined decisions. The principle of "informed consent" was hardly realised. The participants felt their privacy was not respected in multi-bedded rooms and in situations of dressing and eliminating. One can proceed on the assumption that the lack of information, the need of help and the fixed organizing structures of the facilities are the reasons why elderly people play a rather passive role as patients. It might be possible to improve the autonomy of elderly people if the nurses as an advocate supported them to make self-determined decisions. The implementation of the principle of informed consent with regard to nursing interventions would promote both autonomy and respect of privacy. Furthermore, one can assume that the autonomy and quality of life of elderly people could be promoted if the organizing structures of the facilities were more flexible.

Aged↗
PubMed1994

CMHC practices related to tardive dyskinesia screening and informed consent for neuroleptic drugs.

OBJECTIVE: The authors conducted a national survey of community mental health centers to determine their policies and practices about screening patients for tardive dyskinesia and obtaining informed consent for use of neuroleptic drugs. METHODS: Clinical directors of 235 centers in the United States, selected by geographic region and population, were surveyed through a nine-item questionnaire. RESULTS: Although nearly all the 160 respondents reported that they screened patients for tardive dyskinesia, only about two-fifths had formal screening policies, and about two-fifths had screening programs. The Abnormal Involuntary Movement Scale examination was used by almost two-thirds of respondents who screened patients, and about one-fifth relied on unstructured observation. Slightly more than half of respondents specified a frequency for screening examinations, at a modal interval of six months. Seventy percent used nonpsychiatric clinicians for screening. Almost three-quarters of the respondents had informed consent policies for use of neuroleptics. Urban centers tended to be more aware than rural centers of the American Psychiatric Association's tardive dyskinesia screening guidelines. They also used fewer nonmedical practitioners for screening and were more likely to obtain informed consent for neuroleptics. CONCLUSIONS: Despite the existence of APA guidelines and state policies and regulations about tardive dyskinesia screening, a national effort to educate clinicians about prevention of tardive dyskinesia is still needed.

Antipsychotic Agents↗
PubMed2003

'No-suicide contracts' and informed consent: an analysis of ethical issues.

The 'no-suicide contract' is a frequently utilized tool in both the assessment and dispersal of suicidal patients. However, little attention has been given to questioning whether suicidal persons are able to give informed consent to enter such a contract. This article utilizes both the existing literature on no-suicide contracts and the results of recent research into the effects of this tool, to examine whether its use is consistent with the legal and ethical doctrine of informed consent. Particular attention is given to issues of competence, fullness of information, voluntariness and paternalistic intervention when no-suicide contracts are used. This analysis finds the tool to be problematic and suggests that individual patients' ability to give informed consent about a no-suicide contract needs to be carefully considered by clinicians.

Adolescent↗
PubMed2003

Informed consent in trials for neurological emergencies: the example of subarachnoid haemorrhage.

BACKGROUND: In patients with acute life threatening diseases, and in their relatives, the ability to make a balanced decision on participation in a clinical trial may be impaired. OBJECTIVES: To assess what relevant information could be recalled by patients who were living independently after a subarachnoid haemorrhage, and by their relatives; and to determine how these patients and relatives had reacted to the informed consent encounter. METHODS: Twenty months (range 7 to 31) after treatment for subarachnoid haemorrhage, 49 patients and 47 relatives who had participated in one of two randomised trials on medical management were interviewed. The interview consisted of items on: spontaneous recall and knowledge of trial design; understanding of the trial design and the informed consent procedure; the amount and clarity of the information given; and reasons for participating. Finally patients and relatives were asked whether they would participate again in similar circumstances. RESULTS: One third of the patients recalled having participated in a clinical trial. Thirteen per cent of the patients and 20% of the relatives felt that the information supplied had not been sufficient. Nine per cent of the patients and half the relatives had read the written information. None of the patients and one relative thought that participation had been obligatory. Twenty eight per cent of the patients and 94% of the relatives felt in retrospect that they had been capable of making an adequate decision. Virtually all patients and relatives would participate again in similar circumstances. CONCLUSIONS: Many patients and their relatives have little recall of the informed consent procedure and the essentials of acute subarachnoid haemorrhage trials. However, most were satisfied with the overall procedure and would participate again.

Decision Making↗
PubMed2005

Informed consent for vascular intervention.

AIM: To audit documentation of the process of informed consent in patients undergoing vascular surgical and radiological procedures. METHOD: A retrospective audit of randomly selected elective vascular radiological and surgical admissions was undertaken at Christchurch Hospital (Christchurch, New Zealand) to assess documented evidence of the consent process. Clinic letters, handwritten entries in patient notes, and consent forms were scrutinised and data collated on which medical practitioners took consent, what details of the consent process were documented, and what additional information was made available to patients. RESULTS: 100 sets of notes were reviewed (surgical n=51, radiological n=49). For patients undergoing vascular surgery, the consent form was signed by a consultant in 2 (4%) sets of notes compared to 46 (94%) for patients undergoing vascular radiological intervention (p<0.001). All radiology consent forms were signed on the day of the procedure whereas 43 (84%) of surgical consent forms were signed before the day of surgery (p<0.01). Documentation that risks had been discussed with the patient was present in 44 (86%) sets of surgical notes compared to 20 (41%) radiology notes (p<0.001). Additional information (e.g. College of Surgeons' information leaflets) was supplied to 6 (12%) surgical patients and none of the patients undergoing radiological intervention (p<0.05). CONCLUSIONS: In our centre, documentation of the process of informed consent compares favourably with the published literature. This study demonstrates significant differences in documentation between surgery and radiology.

Adult↗
PubMed1996

[Problems in informed consent in psychiatry].

In this work the author is trying to show some problems related to informed consent in psychiatry. It deals especially with problems of medical research, sterilisation, involuntary therapy, treatment of drug addition etc. In each of these areas there can come to a clash of interests between the society and the patient. The informed consent turns our attention to the patient.

Humans↗
PubMedDate not supplied

The effect of standardized patient feedback in teaching surgical residents informed consent: results of a pilot study.

PURPOSE: The purpose of this pilot study was to determine the effectiveness of using feedback from a standardized patient (SP) to teach a surgical resident (SR) informed consent (IC) protocol. METHODS: Four general case types of increasing difficulty were tested in a longitudinal experimental design format. The four types of cases were appendectomy, cholecystectomy, colorectal cancer, and breast cancer. Eight SRs of varying years of completion in medical school served as subjects-four in the experimental group (received performance feedback from an SP) and four in the control group (received no SP feedback). Both the control and experimental groups participated in two patient encounters per case type. The first patient encounter served as the pretest, and the second patient encounter was the posttest. In each encounter, an SP rated the resident on 14 measures using an open-ended seven-point rating scale adopted and modified from the Brown University Interpersonal Skill Evaluation (BUISE). Each resident also reviewed a videotape of an expert giving IC between pretest and the posttest for basic instructional protocol. Random stratified sampling was used to equally distribute the residents by postgraduate years. A total of 16 SPs were used in this study. All patient/SR encounters were videotaped. RESULTS: There was a statistically significant overall change--pretest to posttest and across cases (p = 0.001). The group effect was statistically significant (p = 0.000), with the experimental group averaging about 10 points greater than the control group. CONCLUSIONS: Standardized patient feedback is an effective modality in teaching surgical residents informed consent protocol. This conclusion is tentative, due to the limitations of sample size. The results of this study support continued research on the effects of standardized patient feedback to teach informed consent to surgical residents.

General Surgery↗
PubMed2004

Informed consent for blood transfusion: should the possibility of prion risk be included?

The emergence of bovine spongiform encephalopathy (BSE) in British cattle has received significant media attention since its discovery in 1986. Transmission of this prion from cattle to humans has been documented, and the BSE prion is believed to be the causative agent for variant Creutzfeldt-Jakob disease (vCJD). Evidence of this spread is a significant threat to public health, and, although there has never been a proven case, there is a theoretical risk of transmission between humans by blood transfusions. In addition, recent animal studies have documented spread in this fashion, raising the question of whether vCJD should be included as part of informed consent for blood transfusions. The process of informed consent requires disclosure of material risks, defined as the risks that a reasonable person, under such circumstances, would want to know. Consent should, therefore, include the risks of a transfusion reaction, as well as the known infectious risks of blood. It should also include the unknown or theoretical risks of blood transfusions because full disclosure of even remote risks preserves the patient/physician trust relationship, which if breached, is very difficult to mend. Given the high level of public awareness, the potential lethality of the infection, and the theoretical risk of transmission by blood, vCJD can be considered a material risk, and consequently, it is reasonable to include it in the informed consent process.

Animals↗
PubMed2006

Patient-centered informed consent in surgical practice.

OBJECTIVES: To review the medical, ethical, and legal basis of the doctrine of informed consent for surgery and its complications, particularly for an incapacitated patient who requires a surrogate decision maker; to discuss the elasticity of the consent doctrine, whether surgical consent encompasses consent for surgical complications, and emphasize the importance of communication and shared decision making in the context of the patient-surgeon relationship; and to discuss patient and surrogate refusal of treatment, standards of surrogate decision making, barriers to effective communication, the role of the hospital ethics committee in resolving disputes over treatment, and how to reconceptualize surgical consent in the context of patient-centered medicine. DATA SOURCES: We reviewed PubMed citations for informed consent in surgery, patient-physician communication, shared decision making, patient-centered medicine, and consent guidelines published by specialty societies, particularly the American College of Surgeons and the Society for Critical Care Medicine. STUDY SELECTION: We selected articles in which issues of consent for surgical treatment were discussed or measured. DATA EXTRACTION: We extracted data relevant to questions of consent in surgical practice. DATA SYNTHESIS: We studied qualitative aspects of the consent doctrine. CONCLUSIONS: Surgical consent is not an event or a signature on a form but is an ongoing process of communication that continues throughout preoperative, perioperative, and postoperative care. In the context of patient-centered medicine, consent is best conceptualized as shared decision making with patients or their surrogates.

Advance Directive Adherence↗
PubMed1995

Decision-making capacity for informed consent in the older population.

We discuss key concepts and review 12 published research studies relevant to informed consent and decision-making capacity in the older population. The literature suggests that aging is associated with impaired decision-making capacity; the following additional factors amplify the detrimental effect of aging: lower vocabulary level, lower educational level, chronic medical illness (as in nursing home residents), and acute medical illness. Aging may be associated particularly with impaired comprehension of consent forms. We discuss guidelines for clinicians and researchers for improving the process of obtaining a truly informed consent.

Aged↗
PubMed1995

Informed consent for the prosthodontic patient with temporomandibular disorders. Report of the Committee on Temporomandibular Disorders of the American College of Prosthodontists.

The prosthodontic treatment of patients with a history of temporomandibular disorders presents unique risk-management problems because of the varied nature, uncertain prognosis, and frequent recurrence of these disorders. Patients with temporomandibular disorders frequently require managed treatment over extended periods of time and may complicate the delivery and outcome of prosthodontic treatment. Informed consent is needed to protect both the patient and the prosthodontist because it facilitates proper communication, goal setting, and cooperation. The purpose of this article is to discuss the essential elements of informed consent and to present an informed consent program useful in the prosthodontic treatment of patients with temporomandibular disorders.

Dental Care for Chronically Ill↗
PubMed2003

Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

BACKGROUND: Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. METHODS: We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. FINDINGS: The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. INTERPRETATION: Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

Aged↗
PubMed1996

The impact of disease severity on the informed consent process in clinical research.

PURPOSE: To assess the efficacy of informed consent in subjects differing in disease severity, ranging from those with immediately life-threatening disease to healthy volunteers. SUBJECTS AND METHODS: A total of 127 subjects, enrolled in four types of clinical research protocols, were tested. Subjects completed questionnaires before entry into the protocol, within 24 hours of signing the primary protocol's consent document, and 4 to 6 weeks after entry. RESULTS: Healthy volunteers retained the most information about risks and side effects, and severely ill Phase I subjects retained the least (P <0.0001). Phase I and II subjects had the best long-term retention of information about procedures, whereas Phase III subjects and healthy volunteers retained the least (P <0.001). Information about the scientific purpose and confidentiality of data were retained best by symptom-free, Phase III subjects (P <0.05). Phase I subjects entered the study primarily for treatment purposes, and the consent document was rated less useful by subjects with more advanced disease (P <0.05). CONCLUSIONS: Subjects with differing disease processes and illness severities focused on and retained different aspects of experimental protocols for dissimilar reasons. During the informed consent process, research staff should inquire of potential subjects' personal goals for participating in experimental protocols and develop means for ensuring subjects' understanding of the inherent risks and alternative interventions available.

Adult↗
PubMedDate not supplied

Informed consent and advance directives.

Contrary to popular belief, a patient's signature on a piece of paper does not constitute informed consent. This article describes the ethical framework of consent in the context of the larger process of informed decision making. The elements of informed consent are examined in practical terms. Common pitfalls are addressed, with strategies to help anticipate and resolve possible dilemmas. These important tools are integral to all levels of medical decision making, including those at the end of life.

Advance Directives↗
PubMed1993

Informed consent and living wills.

The text of this paper was originally presented to the RCN Cancer Nursing Society Conference which was held in June 1993. It was written in response to a request to cover the topics of informed consent, ethics and the multidisciplinary team and living wills. Clearly, this is an extremely broad range of topics so, in order to introduce some coherence into the paper, the 'Tuma' case is used to connect the themes of cancer nursing, informed consent and working in a multidisciplinary team. The topic of living wills and its parent concept, that of advance directives, constitute a particular aspect of informed consent. These ideas are introduced via two recent legal judgements concerning 'T' and Tony Bland. The focus then moves from legal to moral concerns, ending with a brief critique of the whole idea of living wills.

Advance Directives↗