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PubMed2006

[The law of March 4, 2002: how to implement it with regards to informed consent in radiology].

The duty of providing information to patients makes it possible to obtain an informed consent. Information must be complete and relate to the health of the patient and not only to the risks of a medical procedure. From jurisprudence initially, and then from the law of March 4, 2002, it is a right for patients. It is the physician's burden to prove that he or she informed his patient well. This provision raises difficulties in radiology because of the particular nature of this practice. The radiologist intervenes after a fellow-physician has prescribed the examination. This relation involves three individuals: the requesting physician, the radiologist and the patient. Both physicians have a duty to provide information. As such, should consultations with radiologists prior to specific invasive procedures be obtained? This article aims at clarifying the concept of informed consent in radiology, based on the law of March 4, 2002, examples of jurisprudence, and the recent regulation specific to radiology in the decrees of March 2003.

France↗
PubMed2005

[A modified informed-consent procedure in which the complete information is given retrospectively: no objection from participating patients].

OBJECTIVE: To determine whether a modified informed-consent procedure, in which permission is requested to send a questionnaire and to provide all the information about the study only after it is completed, would raise objections from patients who were asked to participate in a study on satisfaction with the follow-up care after a cerebrovascular accident. DESIGN: Descriptive cohort study. METHOD: 123 patients were approached for the randomised study. The patients who were included were interviewed by telephone two weeks after they had been sent the postponed information. RESULTS: During recruitment, 5 patients refused to participate but this was not because of the modified procedure. Of the 112 survivors, 102 (91%) could be interviewed and 79 had read the letter. Nobody (0%; 95% CI: 0-5) said that their trust in doctors had decreased; one patient (1%; 95% CI: 0-7) indicated decreased willingness to participate in future studies; two patients (3%; 95% CI: 0-9) were dissatisfied about the procedure followed. CONCLUSION: The participants in the trial had no major objections to the modified informed-consent procedure in which full information was given only after their participation had ended. Furthermore, patients did not refuse participation because of the modified procedure.

Cohort Studies↗
PubMed1978

Videotape aids informed consent decision.

Obtaining informed consent for clinical investigations represents a major legal, ethical, and moral consideration in human experimentation. Mechanisms for informing the patient vary widely, and usually no system exists to confirm the degree of information retained by the patient. A Veterans Administration Cooperative Study, begun in 1975, has used a videotape information package in addition to a standard written consent form to ensure uniformity. Each presentation was followed by a questionnaire to assess the amount of material learned before attempting randomization. Repeated showings were occasionally necessary and did not affect the rate of randomization. A videotape presentation, especially in cooperative studies, ensures uniformity, makes allowance for varying educational levels of patients, and provides documentation of the degree of informed consent.

Audiovisual Aids↗
PubMed1998

Medicolegal aspects of informed consent.

This article discusses informed consent and emphasizes four critical features of ethically and legally appropriate informed consent. The article also highlights some exceptions to informed consent requirements. The authors outline practical advice for avoiding litigation resulting from consent issues.

Ethics, Medical↗
PubMed2001

Towards better informed consent in endoscopy: a study of information and consent processes in gastroscopy and flexible sigmoidoscopy.

OBJECTIVE: To determine the level of knowledge achieved by patients who have read a simple information sheet on gastroscopy and flexible sigmoidoscopy, and to determine the levels of information required by patients and solicitors specializing in clinical negligence. DESIGN: Self-administered questionnaires were sent to 516 patients in Leicester and 79 solicitors specializing in clinical negligence in England and Wales. The main objective outcome measures were the correct scores measured in a simple test of the content of information sheets about gastroscopy and flexible sigmoidoscopy. Other scores were based on the opinions of patients and solicitors on the type of information patients should receive and the levels of risk about which they should be informed. RESULTS: Of the clinical negligence specialists, 75%, compared with 44% of patients, felt that consent to procedures should be obtained 2 weeks before the test. In addition, 86% of solicitors felt that patients needed to be told about tests on at least two occasions and favoured booklets and videos. Both 48% of solicitors and 38% of patients felt that patients should be told of very uncommon risks, with 16% of clinical negligence specialists expecting patients to be told of risks of 1 in 1,000,000. The majority of patients (98%) and solicitors (95%) felt that patients should be formally tested as to whether they understand what they are told in the consent process. In an initial study of an information leaflet, South Asian patients had significantly poorer scores than English patients on formal testing of their knowledge of the leaflet's content. The poorest response (61% correct) was to a question including the word 'indigestion', which had been omitted from the information leaflet. Its inclusion led to a significant increase in the number answering the question correctly (96%). The positioning of a word in the list of reasons for doing the test was also important. In the flexible sigmoidoscopy leaflet, the word 'anaemia' was placed in the middle of a list of reasons for doing the test; only 85% answered the question correctly. In the sample of patients who received the modified gastroscopy leaflet, recall at 6 months was significantly impaired with most loss of memory being related to the purpose of the test. CONCLUSIONS: Consent needs to be supported by easy-to-read information and the patients' understanding needs to be formally tested. Important concepts must be included in this information as well as any uncommon risks of the procedure. In order to ensure that the information can be understood, the text should be reviewed by an experienced educationalist. If the text is to be used in a multicultural setting, it is important to ensure that patients for whom English is not their first language can easily understand it. The movement away from 'informed consent' towards an 'informed decision' process should facilitate these improvements.

Cultural Characteristics↗
PubMed1999

Patient recall and appropriate timing for obtaining informed consent for endoscopic procedures.

OBJECTIVES: Although informed consent is an issue in many medical malpractice claims, there is no standardized time or method to obtain informed consent for endoscopic procedures. The objectives of this study were to determine whether sedation for endoscopic procedures interfered with pre-endoscopic informed consent and to determine the appropriate time to obtain informed consent. METHODS: Patients undergoing a sedated esophagogastroduodenoscopy had informed consent obtained either 48-72 h before the procedure (group 1A, n = 50) or 10-60 min before the procedure (group 1B, n = 50). Patients undergoing an unsedated flexible sigmoidoscopy had informed consent obtained either 48-72 h before (group 2A, n = 47) or 10-60 min before the procedure (group 2B, n = 49). Methods of informed consent consisted of an oral and a written explanation about the procedure. Patients were sedated with midazolam and meperidine. A Trieger test evaluated recovery from sedation. Recall was assessed by asking six questions about the procedure before discharge and again 2-3 days later. RESULTS: Standard t tests and Mann-Whitney U nonparametric rank tests were used to compare the 1) 1-h recall scores, 2) 2-3-day recall scores, and 3) recall difference scores for groups 1A and 1B, 1A and 2A, 2A and 2B, and 1B and 2B. There were no differences in recall for the different groups. CONCLUSIONS: This study shows that sedation for endoscopic procedures does not interfere with pre-endoscopic informed consent. Informed consent for endoscopic procedures can be obtained at any time before sedation with similar recall.

Adult↗
PubMed1999

National efforts to improve the informed consent process.

OBJECTIVES: To inform oncology nurses about several national efforts to improve the informed consent document and process. DATA SOURCES: A federally funded grant program to stimulate research of informed consent, an initiative from the National Cancer Institute to improve informed consent documents in cancer clinical trials, and a model consent document developed by the National Action Plan on Breast Cancer. CONCLUSIONS: These initiatives assist investigators and institutional review boards in presenting relevant and understandable information to potential clinical trial participants. IMPLICATIONS FOR NURSING PRACTICE: These national efforts will raise awareness of providing potential research participants with clear information to assist them in making an educated, informed decision.

Breast Neoplasms↗
PubMed1989

Informed consent for lumbar puncture.

Informed consent procedures are commonly employed prior to lumbar puncture. An understanding of the legal and ethical basis of informed consent is important in developing an acceptable approach to consent and in dealing with problems confronted when consent cannot be obtained. I review the current legal concepts in informed consent and their ethical foundation, and make recommendations to clinicians for obtaining consent for this common procedure in the ambulatory pediatric population.

Child↗
PubMed1976

An evaluation of "informed consent" with volunteer prisoner subjects.

"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.

Aggression↗
PubMed1997

Legal and ethical considerations of informed consent.

The law of informed consent remains ineffective at resolving patient comprehension issues primarily because differing interpretations exist regarding who is responsible for the duty to inform. Court cases continue to set precedents for practicing physicians and other health care providers; however, other measures can be applied for effectual patient advocacy. Health care personnel should rewrite typical consent forms in simpler terms, use larger print, and create duplicate copies. If patients are given copies of the permits they sign, the can reread the forms at home when they are more comfortable. For true autonomy to exist in informed consent for surgical procedures, consent forms should contain patients' primary languages whenever possible, or an adequate interpreter should be made available. Surgeons, nurses, and other health care providers must become aware of their responsibilities related to informed consent for treatment. It is necessary for health care personnel to develop and use effective communication techniques and remember that although some patients are more visually attuned to new information, other patients may benefit more from listening or reading. The cases in this article show that a patient's autonomy is part of the informed consent process and the duty to inform the patient lies with the person performing the procedure. A more important issue, however, involves the patient's comprehension of the information given, because without it, the patient cannot achieve true autonomy in making decisions. Ensuring that all elements of informed consent are met to obtain informed consent will result in fewer malpractice claims, greater patient satisfaction, and an improved professional image. Nevertheless, nurses should make themselves aware of the state laws in which they practice, including their nurse practice acts. They then should advocate for patient rights by encompassing all elements of informed consent.

Ethics, Medical↗
PubMed2004

Informed consent in sports medicine.

Informed consent acknowledges the autonomy of a person to make choices consistent with personal goals and values. The virtuous physician will understand that the athlete's autonomy is severely diminished by internal and external forces beyond the control of medical personnel. Because of this, a truly informed consent in sports medicine is even more difficult to achieve than in other medical specialties. Awareness of these problems does not assure a genuine informed consent, but being unaware of them isa guarantee of its impossibility.

Athletic Injuries↗
PubMed1988

Two models of implementing informed consent.

The doctrine of informed consent has been controversial since its inception. In spite of the professed ideal of improving physician-patient communication, many commentators have argued that it interferes with the relationship. However, the problem may not be the doctrine itself but rather the manner in which it is usually implemented. This article describes two different ways in which informed consent can be implemented. The event model treats informed consent as a procedure to be performed once in each treatment course, which must cover all legal elements at that time. The process model, in contrast, tries to integrate informing the patient into the continuing dialogue between physician and patient that is a routine part of diagnosis and treatment. We suggest that the process model has many benefits.

Disclosure↗
PubMed1998

Understanding informed consent.

Understanding and facilitating the informed consent process is our duty as perioperative nurses. Acting as patient advocates, we must determine if our patients have given "informed consent" prior to surgical treatment. When we witness our patients signing consent forms, we must be sure they are competent to sign; that they have spoken with the physician and have discussed the proposed procedure (including the risks, benefits and alternative treatments) and have had their questions answered; and have read the consent form they are being asked to sign. As nurses, we must become aware of our responsibilities related to informed consent. By understanding the concept of informed consent and its legal implications, we will be able not only to the facilitate informed consent process but also to fulfill our legal responsibilities.

Documentation↗
PubMed1997

The significance and applications of informed consent.

Bringing well-informed patients to the OR is a challenge for all who participate in surgical patients' care. Although the issue of informed consent has been around for a long time, it was not until the latter half of the twentieth century that health care professionals and patients began to focus on informed consent as a central concern in health care. This article explains the roots of informed consent, the path it has traveled, and the importance that health care professionals, especially perioperative nurses, play in ensuring that patients are fully informed about their impending procedures.

Comprehension↗
PubMed1992

Effects of readability on the impact and recall of written informed consent material.

Participants (49 women, 23 men) rated a hypothetical psychologist after (a) receiving either no informed consent information, a highly readable consent form, or a less readable form; and (b) reading a transcript of a therapy session containing either positive or negative self-involving statements. Informed consent forms had no effect on ratings; there was a trend for participants to recall less of the less readable form. Participants rated the therapist more favorably when he used positive self-involving statements. In a second study, participants (62 women, 28 men) received 1 of the 3 levels of informed consent information and a transcript with either no mention of informed consent or a brief mention at the end. Men who received the less readable consent form had poorer first impressions of the therapist and recalled less of the form. The mention of informed consent in the transcript had no effect.

Comprehension↗
PubMed2006

Neuroscience of decision making and informed consent: an investigation in neuroethics.

Progress in neuroscience will allow us to reveal the neuronal correlates of psychological processes involved in ethically relevant notions such as informed consent. Informed consent involves decision making, the psychological and neural processes of which have been investigated extensively in neuroscience. The neuroscience of decision making may be able to contribute to an ethics of informed consent by providing empirical and thus descriptive criteria. Since, however, descriptive criteria must be distinguished from normative criteria, the neuroscience of decision making cannot replace the ethics of informed consent. Instead, the neuroscience of decision making could complement the current ethics, resulting in what can be called neuroethics of informed consent. It is concluded that current progress in the neurosciences could complement and change the way in which we approach ethical problems in neuropsychiatry.

Bioethical Issues↗