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Results for “informed consent”

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PubMedDate not supplied

[Obtaining informed consent and resorting to ethical committee in clinical and epidemiological research in Italy. A survey].

OBJECTIVES: To describe how informed consent (CIn) and ethical review (CEt) are obtained in the Italian clinical and health research. DESIGN: survey SETTING: 6 Italian and 7 foreigner journals in the years 2001 and 2002. SAMPLE: 157 original or short articles, letters and case reports for which a member of an Italian institution was the corresponding author. MAIN OUTCOME: Mention in the text of CIn and CEt procedures. RESULTS: In 42% of such studies (95% CI: 35-50%), informed consent was obtained; in 30% (95% CI: 23-37%), ethical committee approval was obtained, in 27% (95% CI: 21-35%) both had been obtained. The probability of informed consent and ethical review varied with type of data used (primary or secondary source). No significant differences, however, were noted based on the type of study population (vulnerable or non-vulnerable), the year, or the country in which the article was published (Italy or elsewhere). Keywords search in the articles text showed that ethical aspects of the study were not debated. Ethical procedures were synthetically reported as a rule, yet there were differences in their formulation. CONCLUSIONS: The limited resorting to CIn and CEt procedures and the concision and variability of their description might depend on the plethora of the ethical, legal, editorial guidelines available for Italian researchers that partially overlap and partially present specific aspects whose interpretation is not free of niceties.

Epidemiology↗
PubMed1991

Role of ultrasound and informed consent in the evaluation of elevated maternal serum alpha-fetoprotein.

Informed consent of medical procedures should include a discussion of both the risk of the procedure and the probability of the malady in question. Many centers in the United States currently recommend amniocentesis for all women with elevated levels of maternal serum alpha-fetoprotein (MSAFP) unexplained by targeted ultrasound examination. Prospective clinical data from our unit support the use of an algorithm that provides for a 90% reduction of the predicted risk of neural tube defect from MSAFP alone. The predicted risk is revised only if the ultrasound shows normal fetal cranial size and shape, normal ventricular size, normal posterior fossa anatomy, and normal spinal anatomy. Preliminary results supported this approach with no reduction in sensitivity, while substantially reducing the need for invasive testing. The additional experience reported here of 20,211 patients resulted in 451 ultrasound examinations for an elevated MSAFP, but only 54 amniocenteses. During this period, nine open neural tube defects were detected among patients with elevated MSAFP using ultrasound; none was missed. All fetuses with defects had ultrasound findings of cranial and intracranial changes first reported by Campbell. These data support the premise that, prior to amniocentesis, informed consent should include discussion of the ultrasound evaluation.

Amniocentesis↗
PubMed2006

Informed consent for facial transplantation.

Now that partial face transplantation has been performed, attention is focused on likely functional, aesthetic and immunological outcomes, and full facial transplantation is the likely next step. Facial transplantation has been the source of ethical debate, a key part of which focuses on valid informed consent. We review the process of informed consent in health settings, assessing how applicable the current standards are for facial transplantation. The factors which need to be assessed during the screening programme are outlined. We conclude that both individual and process factors are important in obtaining consent for radical new procedures, and outline our own gold standard for ensuring informed consent in facial transplantation.

Consent Forms↗
PubMedDate not supplied

Interpreter accuracy and informed consent among Spanish-speaking families with cancer.

Language interpreters mediate a growing number of health care communication events, including the informed consent process, which underlies the ethical conduct of clinical research. This article explores a key interpretive outcome, accuracy, in 21 Spanish/English informed consent consultations. Discussions were transcribed, translated, and coded according to established techniques. Most (74%) discussion was accurately interpreted (range: 47%-98%; std. deviation: .137). Accuracy was lower in the more technical portions of the discussion when compared with nontechnical portions such as discussion of coping and quality-of-life issues (p = .024). The concept of "randomization" often was poorly communicated and interpreted. These differences may be due in part to the use of long, uninterrupted, and jargon-filled sentences by clinicians explaining research, among other factors. The article concludes that accuracy may be promoted if clinicians used less technical language and shorter sentences, and are more "process driven." Interpreters may need to be better informed about research-related concepts such as randomization. Further research is needed to determine the effects of interpretive accuracy on the informed consent process, the decision to participate in research, and other outcomes.

Adolescent↗
PubMed1998

The ethics of informed consent among storyteller cultures.

The protection of the rights of people from research risks is a primary reason for obtaining informed consent from a potential volunteer. The procedure followed in the United States utilizes a standardized ethical code. Its basic principles are set forth in the Belmont Report, which serves as the basis for the regulations regarding informed consent contained in 45 CFR 46, The Protection of Human Subjects. However, this standardized approach may be inappropriate for use with peoples who have a different ethical perspective or moral outlook on life. This paper presents an alternative approach to the issue of informed consent of people to be participants in research. The ethic is examined as a narrative consisting of a dialogue between the inquirer and the participant in the research process. A story evolves that is the ethic, and this involves a dynamic, ongoing process that continues for the duration of the inquiry. These issues are addressed from a philosophical and an applied perspective. The applicability of this approach to research and interventions among indigenous northern peoples is discussed.

Alaska↗
PubMedDate not supplied

Informed consent: do we achieve it? What are the elements that help create it?

Informed consent is a complex concept, it raises issues which involve ethical, moral and legal debates. This paper is intended to explore the elements of informed consent and to give guidance to those in the process of gaining consent from patients. The process should be seen as a partnership between the multidisciplinary team and the patient.

Ethics, Medical↗
PubMed2006

Is informed consent a "yes or no" response? Enhancing the shared decision-making process for persons with aphasia.

Respect for patient autonomy and the need to have a comprehensive discussion of the risks and benefits of a medical intervention are two important issues involved in the process of obtaining informed consent. In dealing with individuals with aphasia, there may be particular challenges in balancing these two ethical imperatives. Although decision-making capacity may be preserved with aphasia, the patients' ability to fully participate in a dialogue regarding a proposed medical intervention is frequently impaired. We propose a process of enhancing informed consent for persons with aphasia while continuing to respect and enhance patient autonomy and the exercise of decision making for these patients. The use of a patient-selected "helper" during the informed consent process can improve the quality of the informed consent, while reserving final decision-making authority for the patient.

Aphasia↗
PubMedDate not supplied

Radiotherapy under informed consent report of a long-term survivor of advanced esophageal cancer.

This paper reports a patient with advanced esophageal cancer who has survived asymptomatically for five years after radiotherapy given under informed consent. Previously, we had not practiced radiotherapy under informed consent for patients with esophageal cancers. His excellent clinical course encouraged us to promote this form of treatment. This report presents his excellent clinical course in detail and discusses the significance of informed consent in radiotherapy for malignancies.

Aged↗
PubMed2001

The adequacy of informed consent for placement of gastrostomy tubes.

BACKGROUND: Gastrostomy tubes are placed commonly in patients with limited life expectancy. However, it is unclear whether the process of informed consent is adequate in these patients. This study examined the quality of informed consent in hospitalized patients undergoing placement of gastrostomy tubes. METHODS: Retrospective review of the medical records of a cohort of 154 consecutive hospitalized adults undergoing placement of gastrostomy tubes in the context of chronic progressive illness, in the setting of a large community-teaching hospital. RESULTS: The medical record documented a procedure-specific discussion of benefits and burdens of and alternatives to tube feeding in only 1 of 154 patients. Only 12 of 33 definitely or probably competent patients signed the hospital consent form; in the remaining 21, a surrogate decision-maker signed the form. The cumulative 1-year mortality for this cohort was 50%. CONCLUSIONS: The quality of informed consent for placement of gastrostomy tubes was inadequate in a large community-teaching hospital. Indirect evidence from the literature suggests that these results are not unique to this institution. Physicians should become more familiar with the medical and ethical issues relevant to medically administered nutrition near the end of life, and institutions should develop procedures to improve the quality of decision-making for patients considering this intervention.

Adult↗
PubMed2006

Motivating donors to genetic research? Anthropological reasons to rethink the role of informed consent.

In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors' motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research.

Anthropology, Cultural↗
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↗
PubMed2004

Informed consent for screening sigmoidoscopy in a Veterans Administration population.

PURPOSE: This study was performed to test the hypotheses that current consent methods may not convey the data that we imagine that they do, and that many patients may not want the data that we believe that we ought to provide. We also argue that excessive and unthinking emphasis on informed consent documentation may ignore real and important issues. METHODS: Fifty-nine male patients consecutively scheduled for screening sigmoidoscopy were interviewed before and after the procedure in a tertiary care academic health center. Chi-squared analysis was used to determine if the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience were able to discriminate various components of the informed consent process. RESULTS: Thirty-nine percent of patients could describe no indication other than doctor recommendation for the procedure. Although 86 percent of patients had heard of the word "polyp," 16 percent could not define it. Fifteen percent of patients could not pick out from a list subsequent steps to be taken in case of an abnormal examination. Although most patients could describe discomforts associated with the procedure, only 19 percent of patients mentioned bleeding and perforation as possible complications. Only 5 percent of patients knew any alternatives to sigmoidoscopy. No patient could explain risks and benefits of alternatives. Eighty-eight percent of patients could not identify their endoscopist, but this only bothered 13 percent. Ninety-three percent of patients were given an opportunity to ask questions, but only 22 percent actually did so. All patients signed the consent form, but only 14 percent of patients actually read all of it. Most patients, 97 percent, thought that they had enough information to proceed with the endoscopy. CONCLUSIONS: By traditional and classic standards, the patients in this study did not give informed consent. Yet, surprisingly, despite this lack of informed consent, most of the patients failed to ask further questions of their physicians and claimed that they had sufficient information to proceed with the procedure. This was the case across the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience.

Aged↗
PubMed2002

Informed consent and the history of inclusion of women in clinical research.

The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.

Clinical Trials as Topic↗
PubMed2002

Informed consent in complementary and alternative medicine: current status and future needs.

"Informed consent" is an action. It is a process that fulfills the pretreatment ethical obligations of provider to patient. Through the process, the provider discloses meaningful and realistic facts about positive and negative expectations concerning the proposed intervention and addresses concerns that are pertinent to the patient. Disclosure is of facts that are known or realistically expected to be known by a qualified provider regardless of background or product genus. The disclosure obligation does not vary with the background of the provider or the label given to the therapy. MD, nurse, naturapath, chiropractor, and licensed and unlicensed practitioner have the responsibility to provide quality information about the therapeutic worth of the intervention based on reliable data. This obligation pertains whether the intervention is standard, experimental, investigational, natural, alternative, complementary, or unproven. Misrepresentation of material facts voids consent and triggers legal liability. Today, the oncology community meets the informed consent obligation through a stepwise process that produces standards of care and builds studies and data collection to produce reliable outcome information on patient benefit. These data enrich the ability of a patient to consider and provide informed consent to treatment. In contrast, although there are some ongoing studies of complementary and alternative (CAM) therapies, there does not appear to be a groundswell of support for these activities within the CAM community. The development of standards of care and reliable information about CAM therapies appears to be seriously lagging and a disservice to obligations toward informed participation and consent by the patients seeking CAM interventions.

Anecdotes as Topic↗
PubMed2003

Perceptions of informed consent in the care of elderly people in five European countries.

The focus of this article is on elderly patients' and nursing staff perceptions of informed consent in the care of elderly patients/residents in five European countries. The results suggest that patients and nurses differ in their views on how informed consent is implemented. Among elderly patients the highest frequency for securing informed consent was reported in Finland; the lowest was in Germany. In contrast, among nurses, the highest frequency was reported in the UK (Scotland) and the lowest in Finland. In a comparison of patients' and nurses' perceptions, nurses had more positive views than patients in all countries except Finland. Patients with less need for nursing interventions in Greece and Spain gave their consent less often. The German and Greek patients were older, and the results also point to an association between this and their lower frequency of giving consent. In Spain, patients who were married or who had a family member or friend to look after their personal affairs were more likely to be included in the group whose consent was sought less often. This is the fourth of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented.

Activities of Daily Living↗
PubMed1996

Routine HIV testing of hospital patients and pregnant women: informed consent in the real world.

The Centers for Disease Control and Prevention (CDC) has recommended that HIV testing be routinely offered to certain patients in hospitals with a high prevalence of HIV infection and on all pregnant women. The CDC does not, however, offer implementation level guidelines for obtaining informed consent. We provide a moral justification for requiring informed consent for HIV testing and propose guidelines for securing such consent. In particular we argue that genuine informed consent can be secured without elaborate counseling, such as that currently used at Counseling and Testing Sites, provided that sufficient written notice is given to the patients before testing and that they are specifically asked for permission.

Centers for Disease Control and Prevention, U.S.↗
PubMed2005

A model designed to enhance informed consent: experiences from the HIV prevention trials network.

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.

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