Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “informed consent”

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 235 records · Page 13Linked to original sources
PubMed1999

Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period.

BACKGROUND: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. METHODS: After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. RESULTS: The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). CONCLUSIONS: No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.

Adolescent↗
PubMedDate not supplied

Patient satisfaction with an informed consent process.

PURPOSE: This study evaluates patient and family member level of satisfaction with alternative approaches in obtaining informed consent before colonoscopy or upper gastrointestinal endoscopy. DESCRIPTION: A convenience sample of 204 endoscopy patients at Memorial Sloan-Kettering cancer Center in new York and 102 of their family members were approached to participate in the study. All patients were 19 years of age or older, able to speak and read English, and mentally competent. After proceeding through the informed consent process using both videotape and physician discussion, participants completed a ten-question survey on their previous informed consent experience and their preferences regarding receiving consent information. RESULTS: Overall, participants reported that a combination of videotape and physician explanation was preferred for receiving consent information over either method alone. The participants found that the videotape helped to make the information easier to understand and provided the appropriate amount of information about risks, benefits, and alternatives to the prospective endoscopic procedure. CLINICAL IMPLICATIONS: Patient satisfaction should be a factor in determining the best method of providing informed consent information. Because this study indicates that participants are most satisfied with the method of videotape followed by physician discussion, the addition of the videotape to the informed consent process may be beneficial in preparing the participant for a meaningful dialogue with the physician. The use of the videotape also may eliminate the problem of readability of the written document and ensure that all patients receive the same information. With a concerted effort on the part of oncology healthcare providers, including oncologists, nurses, and patient education professionals, this method may hold promise for ensuring the achievement of informed consent in oncology patients.

Adult↗
PubMed1998

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

OBJECTIVES: To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. DESIGN: Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. MEASUREMENTS: Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. RESULTS: A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). CONCLUSIONS: A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.

Adult↗
PubMed1997

Genetic testing for susceptibility to adult-onset cancer. The process and content of informed consent.

OBJECTIVE: To provide guidance on informed consent to clinicians offering cancer susceptibility testing. PARTICIPANTS: The Task Force on Informed Consent is part of the Cancer Genetics Studies Consortium (CGSC), whose members were recipients of National Institutes of Health grants to assess the implications of cancer susceptibility testing. The 10 task force members represent a range of relevant backgrounds, including various medical specialties, social science, genetic counseling, and consumer advocacy. EVIDENCE: The CGSC held 3 public meetings from 1994 to 1996. At its first meeting, the task force jointly established a list of topics. The cochairs (G.G. and J.R.B) then developed an outline and assigned each topic to an appropriate writer and reviewer. Writers summarized the literature on their topics and drafted recommendations, which were then revised by the reviewers. The cochairs compiled and edited the entire manuscript. All members were involved in writing this report. CONSENSUS PROCESS: The first draft was distributed to task force members, after which a meeting was held to discuss its content and organization. Consensus was reached by voting. A subsequent draft was presented to the entire CGSC at its third meeting, and comments were incorporated. CONCLUSIONS: The task force recommends that informed consent for cancer susceptibility testing be an ongoing process of education and counseling in which (1) providers elicit participant, family, and community values and disclose their own, (2) decision making is shared, (3) the style of information disclosure is individualized, and (4) specific content areas are discussed.

Adaptation, Psychological↗
PubMed2003

Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community.

STUDY OBJECTIVES: The US Food and Drug Administration (FDA) and Department of Health and Human Services created a method for obtaining a waiver of informed consent to permit research in emergency settings when patients are not competent. One of the requirements to obtain a waiver is public disclosure about the research. We describe approaches used to meet the public disclosure requirement. METHODS: We performed a qualitative content analysis of the FDA's repository for mandatory documentation of public disclosure efforts as of November 1999. Data from 4 studies were analyzed: 2 multi-institutional trials involving trauma and 2 smaller trials involving cardiac arrest. These efforts included both 1-way communications, such as announcements, and 2-way communications, such as focus groups and public meetings. Participation in and common concerns expressed during 2-way communications were noted, as was evidence of mechanisms of advance refusal and the collection of quantitative data on public opinion. RESULTS: One-way communications were the predominant method of disclosure. Many 2-way communications were not directed toward lay persons. Those that were often involved fewer than 15 participants. Concerns regarding inability to refuse study participation, racial biases affecting study design and execution, and ambiguity with regard to how community input would be used in study decision making were raised in several 2-way communications. A minority of participating hospitals announced mechanisms of advance refusal or collected quantitative data on public opinion concerning proposed research. CONCLUSION: Initial experience with obtaining a waiver of informed consent for emergency research suggests that community involvement and specific public concerns should be carefully considered in future applications for such a waiver.

Cardiopulmonary Resuscitation↗
PubMed2001

Enhancing informed consent for research and treatment.

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

Clinical Trials as Topic↗
PubMedDate not supplied

Sociocultural limits in informed consent in dementia research.

Ethical considerations in obtaining informed consent for dementia research have remained a largely neglected issue with respect to recruiting members of ethnic minorities and low-income groups. After briefly sketching the development of informed consent guidelines in the United States, this article focuses on the complex interactions between minority culture and low socioeconomic status as inhibiting factors in the informed consent process. We note that, at a minimum, freely given informed consent rests on the potential participant's belief that he or she is totally free to say "no." Suggestions are presented for making the informed consent more ethically constructive for members of socially underpowered populations.

Cultural Characteristics↗
PubMed1996

Informed consent: process and clinical issues.

PURPOSE/OBJECTIVES: To review the issues related to informed consent in a clinical cancer care setting and suggest strategies to improve the informed consent process. DATA SOURCES: Published books, journal articles, and clinical research experience. DATA SYNTHESIS: Clinicians and researchers are ethically obligated to maintain the informed consent process when treating participants in clinical cancer research. Nurse clinicians, clinical trial nurses, and nurse researchers often encounter dilemmas while ensuring proper informed consent. Nurses involved in pediatric cancer care must address specific consent issues relevant to children and youth. CONCLUSIONS: Informed consent does not end with a patient's signature on a form. Establishing and maintaining informed consent is a multidisciplinary effort in cancer clinical trials. Nurses can improve the informed consent process by ensuring adequate time for patient consideration and understanding and by reassessing consent during the study. IMPLICATIONS FOR NURSING PRACTICE: Clinical trial nurses and nurse investigators in both adult and pediatric oncology have a duty and obligation to maintain continued informed consent throughout a study and to be involved in all aspects of study planning and implementation.

Adolescent↗
PubMed2005

Informed consent and ethical issues in military medical research.

Informed consent in military research shares many of the same fundamental principles and regulations that govern civilian biomedical research. In fact, much of modern research ethics is grounded in events that occurred in the context of war or government-sponsored research. Despite these similarities and common origins, research in the military has additional requirements designed to preserve service members' informed consent rights. The special nature of the superior-subordinate relationship in the military necessitates careful protections to avoid perceptions of coercion or undue influence on a military subject. Additionally, current legal and regulatory requirements for advanced informed consent significantly restrict the flexibility of the military to conduct research using waiver of consent. This has implications on the ability of the nation to develop effective medical treatments for the global war on terrorism. Nevertheless, work is under way to realign defense research policy with the norms of civilian biomedical practice. Future directions include the adoption of waivers for military emergency research, and the cautious introduction of human subject studies on the battlefield. This paper discusses historical background, regulatory differences, and concerns and challenges of some of these regulatory differences for research personnel that apply to informed consent and waiver of said informed consent for emergency research conducted by the U.S. military.

Government Regulation↗
PubMed2002

Informed consent for the neurosurgeon.

Obtaining informed consent from patients contemplating neurosurgical procedures is an important process in preoperative care. A surgeon's failure to fulfill his or her legally prescribed duty to inform the patient and obtain consent can result in unnecessary exposure to liability. This paper describes the legal background, doctrine, and elements of informed consent. It also outlines the dialog that should legally take place between physician and patient before a planned procedure and discusses special circumstances that may affect the informed consent process.

Humans↗
PubMed2005

Quality of informed consent: measuring understanding among participants in oncology clinical trials.

PURPOSE/OBJECTIVES: To describe newly enrolled clinical trial subjects' knowledge and understanding of the oncology clinical trials in which they were participating. DESIGN: Descriptive, correlational. SETTING: The oncology center of a small community hospital in New England. SAMPLE: 8 patients who consented to enroll in oncology clinical trials. METHODS: The Quality of Informed Consent questionnaire was sent to 17 potential participants who recently had consented to participate in oncology clinical trials. MAIN RESEARCH VARIABLES: Knowledge of the basic elements of informed consent and participants' understanding of the clinical trials in which they were enrolled. FINDINGS: Scores on the Quality of Informed Consent questionnaire indicated that participants had a good overall understanding of the basic elements of informed consent as well as the clinical trials in which they were enrolled. However, half of the sample failed to understand that clinical trial treatment is not standard treatment and may involve additional risk when compared with standard treatment. CONCLUSIONS: The results of this investigation provide valuable feedback regarding participants' understanding of the informed consent process. The Quality of Informed Consent questionnaire may be a useful tool for monitoring the quality of the informed consent process and contributing to patients' understanding of clinical trials and the research process. IMPLICATIONS FOR NURSING: The Quality of Informed Consent questionnaire may provide valuable feedback regarding clinical trial participants' understanding of clinical trials and the research process. Individual responses to questions on the questionnaire may be used to aid personalized patient education and validation of the informed consent throughout trial enrollment. Future research efforts need to focus on the development of reliable tools to measure participants' understanding of informed consent and nursing interventions that improve the informed consent process as well as enhance patients' understanding of the research process.

Adult↗
PubMed2004

Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study.

Seeking informed consent from patients in the acute phase of acute myocardial infarction (AMI) poses an ethical challenge due to the fact that these patients are under stress and require urgent medical attention. The very procedure of informed consent, which is supposed to protect eligible patients, may in fact cause harm due to a potential delay in the provision of therapy. Whether or not informed consent can and should be obtained under these particular circumstances is far from evident. Patients participating in various large-scale AMI trials have been enrolled with, as well as without, informed consent in recent years. Little is known, however, about how patients experience the informed consent process in the emergency situation of an AMI. This paper reports the results from qualitative interviews with 32 patients, who had to decide whether or not to participate in a large multi-centre clinical trial in Denmark. We analyse to what extent patients found the informed consent process acceptable as well as how various factors influenced their experience of the consent process. We argue that it is morally sound to involve those patients in a brief and concise informed consent process and that consent should be sought in such trials. Finally, we discuss how future AMI trials may nonetheless be improved by accommodating some of the concerns of the patients.

Aged↗
PubMedDate not supplied

The role of risk and benefit perception in informed consent for surgery.

BACKGROUND: Informed consent relies on patients' ability to understand risk information. Evidence suggests that people may extract the gist of any risk information to make medical decisions. Existing evidence also suggests that there is an inverse relationship between the perception of risk and the perception of benefit. METHOD: Seventy-one patients on the waiting list for carotid endarterectomy (CEA) were surveyed regarding their understanding and recall of the risk and benefit to health of undergoing CEA. Patients were surveyed 1 month after their initial consultation, and a subgroup was surveyed again on the day before their operation. RESULTS: Patients' estimates of their baseline risk of stroke without surgery were significantly different from what they had been told by the surgeon. Patients' estimates of stroke risk due to surgery ranged from 0% to 65% (actual local risk 2%). Patients also had unreasonable expectations about the benefit of the operation for their health. Estimates of stroke risk correlated positively with the degree of expected benefit from the operation (r = 0.29, P = 0.05). When resurveyed the day before the operation, patients' perceptions of both risk and benefit had increased significantly. The risk perception data from some patients appeared to contradict some of the predictions of the fuzzy-trace theory. CONCLUSIONS: Most patients failed to understand the risks and benefits associated with CEA. Some patients' estimates of stroke risk were actually greater than the perceived potential benefit of surgery in terms of risk reduction. The data also suggested a positive correlation between the degree of perceived benefit and the degree of perceived risk.

Cognitive Dissonance↗
PubMed1997

Informed consent from whom?

To obtain legally safe informed consent requires that the patient has a 'substantial understanding' of the proposed procedure and that the doctor obtaining the informed consent has sufficient knowledge to explain the nature of the procedure to the patient. In this paper we have shown that significant misunderstanding exists among non-specialist junior doctors of certain common orthopaedic procedures and conditions. Junior doctors often lack sufficient technical training to fully inform their patients and thus meet legal requirements. The implications of this are that the onus falls even more on specialists to ensure that their patients receive a more detailed explanation of the proposed intervention.

Arthroscopy↗
PubMedDate not supplied

Informed consent for fertility control services.

Informed consent has special relevance for patients seeking fertility control services who are not ill in the usual sense. Genuine informed consent requirements should not be confused with spurious ones induced by political pressure.

Abortion, Legal↗
PubMed2000

Decisional capacity for informed consent in schizophrenia research.

BACKGROUND: The adequacy of subjects' informed consent to research is the focus of an important public and professional debate. The potential impairment of decisional capacity in persons with schizophrenia is central to the discussions. This study ascertains the decisional capacity for informed consent in schizophrenic research subjects, to determine if reduced capacity relates to specific aspects of psychopathologic features and to test the hypothesis that reduced capacity can be remediated with an educational informed consent process. METHODS: Decisional capacity was assessed for 30 research subjects with schizophrenia and 24 nonill (normal) comparison subjects. Measures of psychopathologic features and cognition were obtained for the subjects with schizophrenia. Subjects who performed poorly on the decisional capacity measure received an educational intervention designed to improve their ability to provide informed consent and were then retested. RESULTS: The patient group did not perform as well as the controls on initial decisional capacity assessment. Poor performance was modestly related to the extent of symptoms but robustly related to cognitive impairments. Following the educational intervention, the performance of subjects with schizophrenia was equal to that of the nonill comparison group. CONCLUSIONS: Many persons with schizophrenia may be challenged by the cognitive demands of an informed consent process for research participation. In many cases, their reduced capacity can be compensated by a more intensive educational intervention as part of the informed consent process.

Adult↗
PubMed2005

Informed consent.

In the last half century, informed consent has become a central tenet of all research involving human subjects. However, even after the worldwide adoption of regulations aimed at ensuring the protection of subjects, some abuses continue. The installation of oversight bodies, such as institutional review boards, has prevented the bulk of deliberate mistreatment; however, unintentional coercion is still a problem. Informed consent is not limited to obtaining a signature on a consent form, but a process of decision making designed to protect the rights of patients and subjects. It is a constant, ongoing exchange of information between researcher and subject. Although research is invaluable to the advancement of medicine and transplantation, researchers have the responsibility to protect their subjects' rights and autonomy. This paper provides an overview of informed consent, principles behind the process, and implications of current regulations to assist readers in their endeavor for sound and ethical research.

Documentation↗