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"Informed consent"
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Dynamic consent: a patient interface for twenty-first century research networks
Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes.
Journal Article
Mental capacity in relationship : decision-making, dialogue, and autonomy
Recent legal developments challenge how valid the concept of mental capacity is in determining whether individuals with impairments can make decisions about their care and treatment. Kong defends a concept of mental capacity, but argues that such assessments must consider how relationships and dialogue can enable or disable the decision-making abilities of these individuals. This is thoroughly investigated using an interdisciplinary approach that combines philosophy and legal analysis of the law in England and Wales, the European Court of Human Rights, and the United Nations Convention on the Rights of Persons with Disabilities. By exploring key concepts underlying mental capacity, the investigation concludes that both primary relationships, as well as capacity assessments themselves, must display key competencies in order to ensure that autonomy skills are promoted and encouraged. This ultimately provides scope for justifiable interventions into disabling relationships and articulates the dialogical practices that help better situate, interpret, and understand the choices and actions of individuals with impairments.
Book
Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials
Background
Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
Purpose
To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods.
Methods
The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique.
Results
Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats.
Conclusions
Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.
Journal Article
A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions
Background
Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process.
Methods
Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed.
Results
The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose.
Conclusions
IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.
Journal Article
Interactive Informed Consent: Randomized Comparison with Paper Consents
Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p = .07) in the direction of iPad subjects testing better on the online test (mean correct = 77%) compared with paper subjects (mean correct = 57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.
Journal Article
Enduring and Emerging Challenges of Informed Consent
The author summarizes emerging standards for informed consent as the underpinning of ethical research in humans.
Informed consent is a widely accepted legal, ethical, and regulatory requirement for most research and health care transactions. Nonetheless, the practice of informed consent varies by context, and the reality often falls short of the theoretical ideal. Contemporary developments in health care and clinical research call for renewed efforts to address the enduring and emerging challenges of informed consent, such as what information should be disclosed, how it should be disclosed, how much the persons providing consent should understand, and how explicit consent should be.
The moral force of consent is not unique to health care or research. Integral to . . .
Journal Article
Four ethical priorities for neurotechnologies and AI
Current BCI technology is mainly focused on therapeutic outcomes, such as helping people with spinal-cord injuries. It might take years or even decades until BCI and other neurotechnologies are part of our daily lives. Such advances could revolutionize the treatment of many conditions, from brain injury and paralysis to epilepsy and schizophrenia, and transform human experience for the better. But the technology could also exacerbate social inequalities and offer corporations, hackers, governments or anyone else new ways to exploit and manipulate people.
Journal Article
Informed consent—It's more than a signature on a piece of paper
Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought respect for autonomy and with it--informed consent. This article briefly reviews the basics of informed consent, when is it required, how did informed consent evolve into what it is today and what can the surgeon do to truly achieve informed consent.
•The basics of clinical informed consent.•The ethical and historical foundations of clinical informed consent.•The legal foundation of clinical informed consent.•Discussion of barriers to informed consent.
Journal Article
Core elements of consent documentation for clinical research in Canada: guidance for policy
Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research institutions. Under the auspices of the Canadian Institutes of Health Research and the Canadian Critical Care Trials Group, we identified a core set of elements for participant consent documents to be used in clinical research and present these as a template consent form.
Our guideline core team comprised experts in the legal and ethical aspects of research, and a clinical trialist–scientist. We conducted a directed review to compile a list of applicable regulatory, policy, and guidance requirements for the documentation of informed consent for research conducted with human participants in Canada. We used a gap analysis to identify the elements required in a research consent form, based on these documents and in comparison with 10 existing research ethics board (REB) informed-consent form templates. The guideline, as well as a fillable template for the form, was created with input from a pan-Canadian advisory group, interested parties, and broad public input. We tested the template with a small group of studies across several research domains. Our process for managing competing interests adhered to Guidelines International Network principles.
From our gap analysis, we identified 75 core elements for participant consent forms in clinical research, which we have grouped under 6 main categories (i.e., information for potential participants about participating in research in general and in the particular study; harms and benefits of participation; protection of participant data; points of contact; and giving consent) in a fillable consent template. Because studies vary, specific elements should be included in a study consent form only if relevant to the type of research being conducted and the corresponding compliance requirements, as identified in our gap analysis.
The template with the core set of required elements is intended to be used by any researcher applying for REB approval to document participant consent and, when applied with consideration of our associated guidance, is sufficient to meet regulatory requirements for research in Canada. Identifying the required elements for consent forms is intended to streamline consent documents across the country, facilitate multi-site projects, and simplify the approval process for all those involved.
Journal Article