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At least 469 records · Page 26Linked to original sources
PubMed2007

Acupuncture trials and informed consent.

Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture, consistent with the practice of placebo-controlled drug trials.

Acupuncture Therapy↗
PubMed1993

[Free and informed consent in dental practice].

The right to give or withhold free and informed consent to care is basic, but has been eroded. Lack of consent to treatment could result in a charge of the crime of battery. The parameters of free and informed consent include autonomy, veracity, beneficence, nonmaleficence and justice. Consent may be implied, expressed or written; consent may be withdrawn, exceeded or limited. Informed consent is considered in detail and guidelines are suggested for the dentist. The problems of implantology are presented including the question of prepared consent forms for this treatment. Capacity to consent is described with particular reference to children, the aged and the mentally impaired.

Adolescent↗
PubMed2005

General aspects and specific issues of informed consent on breast cancer treatments.

Informed consent (IC) is the process by which a patient can make choices about his/her health care; therefore it is considered to be a voluntary authorization given by the patient to the physician. To ensure the patient's right to self-determination, what can the physicians do? When treating breast cancer, there are several specific issues that must be clarified by the IC. We have selected and evaluated the basic elements of IC and mentioned the basic concepts of IC in details. First of all, complete information must be disclosed to the patient (physician's responsibility for medical accountability). The information to be disclosed is summarized in the following three elements: 1) The nature of the treatment/procedure, 2) The relevant risks/benefits, and 3) Reasonable alternatives to the proposed intervention (alternative treatments/procedures). However, the physician is not obliged to persuade the patient to accept the proposed intervention. IC information should be documented in detail on the patient's chart without delay. These issues include IC regarding surgical procedures (mastectomy or breast conservation treatment), IC regarding clinical studies (description of randomized controlled trials), IC regarding genetic diagnosis (ethical issues), and the like. IC means informed decision-making, close relationships between physicians and patients are needed.

Breast Neoplasms↗
PubMed2006

Informed consent: an international researchers' perspective.

We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

Africa↗
PubMedDate not supplied

'What have I done?': the issue of informed consent.

Patients are presented with informed consent forms at a time of stress and indecision. The patient should be treated with respect and not encouraged to sign a form that is not fully understood. Rehabilitation nurses whose patients face surgery are in a unique position to explore the implications of surgery with the patient. The nurse's role in assessing whether the patient is alert, knowledgeable of, and agreeable to all aspects regarding the surgery is vital.

Humans↗
PubMed2002

The requirement for informed consent prior to nursing care procedures.

AIM OF THE PAPER: The aim of this paper is to examine the extent to which there is a requirement to obtain informed consent prior to nursing care procedures. RATIONALE: The requirement for nurses to obtain consent prior to nursing care procedures is addressed in various nursing policy documents. It is important that nurses understand the legal and ethical rationale behind the principles of informed consent so that the principles are applied appropriately to the particular context of nursing care. ARGUMENT: The ethical and legal rationale behind the concept of informed consent and its relevance to nursing practice are examined. In this paper, it is argued that the function of informed consent is to protect patient autonomy and to promote meaningful decision-making. Given the potential for nursing care procedures to infringe patient autonomy, consent is clearly a relevant concept in nursing. Furthermore, in law, any touching without consent is a potential battery. Informed consent is often associated as a rigid procedure, only relevant to surgical or research procedures. Consent should be obtained prior to nursing care procedures whenever patient autonomy is at stake. However, information-giving should be determined by the needs of the patient and approached in such a way as to facilitate meaningful decision-making. Given the individual nature of infringements to patient autonomy, it is difficult to predetermine all those care procedures that require consent; any list of procedures would fail to be comprehensive. CONCLUSIONS: The principles of informed consent should underpin our approach to nursing care procedures, which should not be mechanistic but determined by the needs of individual patients.

Ethics, Nursing↗
PubMed2006

Informed consent for research in ICU obtained before ICU admission.

OBJECTIVE: To analyze the procedure of the informed consent for ICU research obtained before ICU admission. DESIGN: Prospective, open, observational study. SETTING: 20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU. PATIENTS: Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study. INTERVENTIONS: Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward. MEASUREMENTS AND RESULTS: Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure. CONCLUSIONS: Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.

Aged↗
PubMed1995

Obtaining "informed" consent from the elderly.

Regardless of the age of the potential subjects, three conditions constitute informed consent: freedom to decide, clear information, and decision-making capacity. Numerous factors associated with the aging process affect elders' abilities to fulfill all of these conditions; however, as research involving the elderly increases, researchers must act responsibly to ensure that the rights and privileges of elderly research subjects are protected. There are numerous techniques researchers can use to increase the likelihood that truly informed consent is being obtained from elderly potential subjects; this article has described a few of these techniques. Many of the techniques mentioned require additional investigator time. Extra time to ensure this is a small price to pay for setting the stage for greater cooperation and increased quality of research. The development and dissemination of informed consent process guidelines geared toward the needs of the elderly would facilitate an individual researcher's efforts to protect elderly subjects.

Clinical Nursing Research↗
PubMed2003

The challenges of informed consent for rapid HIV testing in labor.

BACKGROUND: Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor. METHODS: To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study. RESULTS: In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study. CONCLUSIONS: We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions.

AIDS Serodiagnosis↗
PubMed2004

Informed consent and the use of placebo in Poland: ethical and legal aspects.

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials.

Controlled Clinical Trials as Topic↗
PubMed2003

Informed consent for septal surgery: the evidence-base.

Informed consent is becoming an increasingly important issue in patient care. Inherent in this is the ability to accurately inform patients of the risks and complications involved in surgery. Nasal septal surgery is commonly performed by otolaryngologists and although often considered routine has a number of recognized complications that can have a significant effect on life quality. We carried out a review of the literature over the last 25 years and reviewed studies quoting rates of complications after septoplasty and submucous resection (SMR) using strictly applied criteria for study inclusion. There was a paucity of prospective data, especially for the cosmetic effects of septal surgery. Rates of septal perforation were two to eight per cent for SMR and 1.6-5.4 per cent for septoplasty. The incidence of cosmetic deformity was low for both procedures zero to one per cent. More well-designed studies are required to augment the current evidence base. While this does not replace the need for surgeons to audit their own results it provides evidence-based information to assist in the process of informed consent.

Evidence-Based Medicine↗
PubMed2001

[Evaluation of thoroughness and legibility of informed consent documents in pediatric surgery].

BACKGROUND: The written information that is provided to the patient must gather a series of characteristics, quantitative and qualitative, so that fulfill the ethical criteria that govern the theory of the Informed Consent. AIMS: To evaluated the degree of exhaustivity and readability of a series of Informed Consents forms in Pediatric Surgery units. MATERIAL AND METHODS: 1. Forms: We evaluated 118 consent forms submitted by 17 pediatric surgery units. 2. Exhaustivity: The studied variables have been: name of the hospital, name of the patient, name of the physician, date, description of the procedure, objectives, risks mention, personalized risks, possibility of recovery, benefits of the procedure, alternatives, possibility from withdrawing the assent, arrangement to widen the information, comprehension of the document, express assent and signatures. All the variables are dichotomics, being collected your presence or absence. 3. Readability: Each document has been introduced in the program "Corel Word Perfect". It was applied to the usefulness "Grammatik" and were collected: number of words, number of phrases, Flesch/Kincaid index, Orational Complexity index and LEGIN index. RESULTS: 1. Exhaustivity: The paragraphs presence in the different forms by order of frequency were: physician signature (100%), express assent (100%), signatures (100%), date (98%), name of the patient (97%), comprehension of the forms (97%), name of the physician (94%), risks mention (92%), name of the hospital (85%), description of the procedure (78%), possibility from withdrawing the assent (70%), personalized risks (67%), arrangement to widen information (43%), to explain alternatives (41%), objectives of the procedure (36%), benefits (36%), and possibility of the recovery (16%). 2. Readability: 11.1% of the forms fulfills the Flesch index, 27.9% the Orational Complexity index, and 22.1% LEGIN index. CONCLUSIONS: Most of the documents offer sufficient quantity of information with respect to the formal aspect and the risks an less with respect to the benefits. This seems to indicate your defensive character. Equally, they are difficult to reading and by difficult to understanding.

Child↗
PubMed1980

The nurse's role in informed consent.

Only by having complete information about health problems and treatment can the patient exercise the right to free choice in determining what care is acceptable. The nurse, whether in the role of care giver or acting as patient advocate, can help to ensure that patients receive quality care by explaining medical and nursing procedures. Problem areas in informed consent may exist for both patients and staff, and these issues can be identified and corrected through quality assurance activities. When patients are properly informed about the medical and nursing treatments planned for them and when the continuance of adequate procedures for imparting information is assured through quality assurance mechanisms, then it can be said that true consent, rather than mere compliance, is being obtained.

Communication↗
PubMed1978

A simple technique for increasing cancer patients knowledge of informed consent to treatment.

Seventy-seven sequential patients referred to a radiation oncology clinic for treatment of malignant neoplasms were tested for their immediate recall of information presented, recorded, and signed on informed consent documents. An experimental group of 40 patients were given the intervention of taking the completed form home before signing. Results support the usefulness of the intervention. The experimental patients were found to possess greater information than the 37 patients who signed the form after the usual clinic procedure in virtually every area required of informed consent. The most significant gains were made in patients' understanding of proposed treatment procedures and appropriate treatment alternatives. Women recalled more information relevant to informed consent than did men. Results also indicated a tendency for younger patients to recall more informed consent information than older patients.

Adolescent↗
PubMed2005

Informed consent for medical treatment and research: a review.

The practice of informed consent has historical roots in various disciplines, including medicine, moral philosophy, and the law. It is closely tied to philosophical notions of respect for persons and respect for individual autonomy. Consent to treatment is rooted in case law. Consent to research, in contrast, has its basis in ethical codes, statutes, and administrative regulations, with the courts playing a lesser role. In this article, we define the elements of informed consent in the treatment setting, outline its ethical and legal foundations, and explore some of its limitations. We contend that informed consent plays a critical role in clinical medicine but that other models of decision making deserve consideration under particular circumstances. We also delineate the current federal regulatory schemes guiding human subject research in the U.S., highlight how consent to research differs from consent to treatment, and explore the difficulties that arise in research involving cancer patients and certain vulnerable populations.

Humans↗
PubMed2002

[Ethics committees bear a responsibility for patient information. Informed consent implies that the patient understands what he has consented to].

A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Directives defining informed consent in relation to clinical trials have been issued by The EU Commission. The Department of Health and Social Security in England has also published several documents governing patient consent. Even if information is given to the patient it is not always comprehended. In one study of cancer treatment about one third of the patients had misunderstood the information in certain respects.

Clinical Trials as Topic↗
PubMed2003

Reviving informed consent: using risk perception in clinical trials.

The current doctrine of informed consent falls far short of its potential to serve as a valuable safeguard for human research subjects. Instead of providing a channel of communication between physician and subject, informed consent is a lifeless entity responsible for a large portion of the misunderstanding existing between these parties. Acknowledging risk perception principles may help transform the informed consent process into an effective communication of health risks.

Choice Behavior↗
PubMedDate not supplied

Informed consent: court viewpoints and medical decision making.

Twenty-five years of appellate court decisions about informed consent in three influential states were examined to address four issues: the criteria used to define adequate informed consent; trends in court decisions; parallels between court decision making and decision analysis; the contribution of decision analytic concepts to defining "reasonable" medical informed consent. Court standards have evolved in three phases: the "medical community" standard before 1972, the "reasonable person" standard since 1972, and recent inroads toward developing an "individual preference" standard. The latter two standards form the current basis for deciding whether a patient has been adequately informed. Decision analysis offers a framework for communication about medical outcomes and probabilities, and methods for assessing preferences. Jurists and physicians should consider whether the legal system should adopt a decision analytic perspective in the doctrine of informed consent. Researchers should address issues raised by use of decision analysis for communication between the physician and the patient.

California↗