Articles tagged with Informed Consent
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A new Canadian guideline sets out 75 core elements for participant consent forms to ensure transparency and understanding. The guidance aims to simplify the approval process for all involved in clinical research across Canada.
A new study from Uppsala University found that 75% of women aged 24 wanted to have children, significantly lower than the 91% in 2014. The survey also revealed that 40 women stated they didn't want children due to various reasons, including uncertainty about the future and health concerns.
The Texas Tech University Health Sciences Center is conducting a randomized controlled trial to investigate the effectiveness of calcium and vasopressin in treating severely injured patients who experience significant blood loss. The study, known as CAVALIER, will enroll approximately 1,050 participants aged 18-90.
Researchers at the University of Cincinnati presented studies on intracerebral hemorrhage treatment eligibility, finding only 3% of patients are eligible for a minimally invasive procedure. Additionally, a study found racial disparities in stroke recovery, with Black individuals experiencing worse functional outcomes after ischemic str...
A new law in Utah allows minors to revoke their informed consent for gender-affirming care, casting a cloud over the trusted process between doctors and patients. This legislation puts clinicians at risk of litigation and may limit access to necessary medical treatments.
A new report outlines best practices and standards for human body donation programs in the US, emphasizing the importance of informed consent and oversight. The guidelines aim to uphold donor dignity and maintain highest ethical standards.
A panel of bioethicists and experts emphasize that human accountability is crucial for healthcare decisions made by AI. The importance of diverse data sets was also stressed to avoid biases in AI-enabled medical technologies. Experts stress the need for collective liability among developers, programmers, and data scientists.
A longitudinal study found no significant difference in deceased donor rates between opt-in and opt-out countries, but fewer living donors in opt-out countries. The results suggest that switching to an opt-out system does not automatically lead to more organ donations without accompanying measures.
University of Cincinnati researchers highlight the importance of emergency consent in acute stroke trials due to time-sensitive nature and high mortality rate. They argue for more efficient alternatives to traditional informed consent, emphasizing patient autonomy and beneficence.
A new study calls for the adoption of new research ethics policies to foster learning and discussion of ethical issues. The guidelines aim to shift from compliance-based ethics to promoting ethical norms and practices.
A survey found that spiritual beliefs and distrust of clinical research contribute to Black patients' hesitation to enroll in cancer trials. Despite trusting their medical teams, some patients express concerns about the purpose of research and its potential impact on their health and community.
A study found that ketamine clinics have inconsistent policies on pregnancy-related safeguards, including inadequate warning systems and contraception prescription. This is concerning given the potential harm of ketamine to developing fetuses.
After three decades, perioperative mortality rates for living kidney donors have decreased substantially, from fewer than 1 event per 10,000 donations in the past decade to even lower numbers. Donor demographics, such as male donors and those with a history of hypertension, are identified as high-risk groups.
A new study emphasizes the importance of strict legal rules governing fertility treatment in the UK, warning that recent court cases could create a common law exception to informed consent. The research highlights the need for rigorous consent regimes to protect vulnerable patients from exploitation and misuse of genetic material.
A joint study by Medical University of South Carolina and Clemson University found that teleconsent, a remote consenting method, is the preferred approach for clinical trial participation. This method eliminates travel costs and improves real-time communication between researchers and participants, increasing trust and understanding.
A new study suggests that more women should be aware of the potential for revision surgery after cosmetic breast augmentation. The researchers found that those who consider themselves healthier and have higher levels of education are less likely to undergo or recommend the procedure.
A chatbot-based system improved the informed consent process for genomics research studies, leading to faster completion, higher understanding, and increased accessibility. The study involved 72 families and found that 96% of participants passed a quiz assessing their knowledge, with 86% reporting a positive experience.
A new study explores how teenage boys are taught about consent in schools and how they interpret educational messages. The research highlights the need for a more nuanced approach to consent education, addressing ambivalence, ambiguity, and uncertainty.
Researchers at North Carolina State University developed a blueprint for incorporating ethical guidelines into AI decision-making programs. The new mathematical formula, based on the Agent, Deed, and Consequence (ADC) Model, considers intent, character, and consequences of actions to make more informed decisions.
A prospective study found that patient decision aids improve patients' self-perceived understanding of image-guided procedures and satisfaction with the consent conversation. Patients who received a PDA before their visit reported significantly greater understanding and felt more listened to by their clinician.
The Hastings Center introduces five ethical criteria to improve human subject protections in phase I healthy volunteer trials and research biopsies. These guidelines focus on translational science value, fair opportunity and burden sharing, fair compensation for service, experiential welfare, and enhanced voice and recourse.
A study by Kyoto University Professor Misao Fujita found that Japan's Act on the Safety of Regenerative Medicine lacks key provisions to prevent unproven treatments from being administered to patients. The lack of scientific verification and clear definitions for medical innovations and interventions are major concerns.
A study by LUNGevity Foundation found that informed consent forms for lung cancer clinical trials are often too complex, leading to patient overwhelm. The researchers proposed a tri-fold template addendum to provide patients with key information relevant to their participation.
A new blockchain model proposes to give Indigenous governments control over how genomic data are used, prioritizing community priorities and respecting Indigenous Nations' rules and regulations. This framework aims to prevent the misuse of genomic data and reinforce stereotypes.
Researchers from Osaka University proposed a comprehensive ethical framework and practical guidance for communicating with research participants through the Internet. The framework addresses issues such as participant recruitment, informed consent, and data protection, aiming to improve future practice in medical research.
A recent study by Edith Cowan University highlights the lack of information available to women with a breech presenting baby. Women often feel pressured into having a caesarean section without being fully informed of all options, including vaginal birth and alternative techniques such as moxibustion.
A new project will provide scientific evidence on the outcomes of gender-affirming hormone therapy (GAHT) for transgender people. The AFFIRM Relationships project seeks to identify causal links between GAHT and psychosocial functioning, empowering individuals to make informed decisions about their care.
The American Academy of Neurology issues a position statement on how to navigate consent issues for people with stroke, emphasizing the importance of advance health care directives and surrogate decision makers. Neurologists may need to guide patients' wishes and make decisions based on their best interests when time is of the essence.
A new study reveals how design bias can affect medical data used in artificial intelligence tools and personalized healthcare. The research highlights the need for more inclusive recruitment strategies to ensure diverse patient populations are represented.
Experts debate whether newborn genome sequencing should be routine, with some arguing it can save lives and be cost-effective. A phased rollout is advocated, with genomic information disclosed sequentially at appropriate ages. The rollout requires data quality improvement and informed consent.
Researchers argue that companies must provide explanations for algorithmic decision-making processes, as this is an ethical obligation apart from performance impact. They propose that companies can achieve transparency while maintaining trade secrets by hiring data interpreters or implementing explainable AI.
This study validates the significance of two critical thresholds in pancreatitis, one for damage to acinar cells and another for clinical symptoms. It highlights the importance of cost transparency, preoperative informed financial consent, and price regulation to reduce financial hardship faced by patients and their families.
A three-arm randomized controlled trial showed that participants had the most satisfaction and subjective understanding with the trust-enhanced e-consent after six months. Interactive consent forms beyond federal regulations can enhance patient-informed consent and trust in research.
A study estimates that accounting for recent population aging reduced non-COVID-19 excess deaths in the US by 65%. The number of COVID-19 deaths remained unchanged. These findings can guide clinical and public health interventions to prevent future unnecessary deaths.
Researchers at NHGRI conducted a study to better understand the needs of patients with sickle cell disease regarding genome editing clinical trials. Participants showed higher genetic literacy levels than expected, but emphasized the need for accessible information about risks and benefits.
A team of bioethicists from Johns Hopkins University emphasizes the need for informed consent in public health activities, including those related to COVID-19. The authors suggest that good governance of public health surveillance infrastructure is crucial to maintain public trust and prevent research abuses.
To minimize risks, interventional radiologists propose a tiered approach for delaying cross-sectional procedures during the pandemic. Procedures should be categorized into urgent, within 2 weeks, or delayed for 2-6 months based on clinical circumstances.
A large-scale malaria vaccine study by the World Health Organization has been criticized for failing to obtain informed consent from parents whose children are taking part in the study. The WHO claims that a 'pilot introduction' and not a research activity, but experts argue that this violates international ethical standards.
A study by the European Society of Cardiology found that most patients do not understand or recall information given to them before heart procedures. Patients often believe that opening blocked arteries can cure their heart disease, despite this being a misconception.
Researchers found that comic-style information improves patient comprehension and reduces anxiety before cardiac catheterization. The comic booklet was shown to be effective in explaining procedural details and postoperative advice, with patients reporting feeling better prepared for surgery.
Researchers at Nemours Children's Health System developed a novel video-based informed consent process to improve participants' understanding and retention of trial information. The study found that caregivers of children who watched the video presentation retained more information about the study design five months later.
A population-based study of patients with hip fracture surgery and elective total hip replacement found that overlapping surgery was associated with an increased risk for complications, especially in nonelective procedures. The duration of the surgical overlap appeared to increase the risk.
A study found that a non-burdensome scientific reframing intervention improved patients' understanding of clinical research and its differences from clinical care. The 12-minute slideshow had no significant effect on participants' desire to enroll, but reduced therapeutic misconception scores by about 6 points.
The Hastings Center recommends adopting reimbursement policies and guidelines to support clinicians in providing informed consent for prenatal genetic testing. The authors also suggest funding education and counseling approaches to help patients make decisions about testing.
A study published in PLOS ONE found that shortening standard consent documents did not affect comprehension, but early delivery and in-person explanations improved it. Concise forms showed promise in streamlining ethics committee reviews, but further testing is needed.
Researchers compared informed consent quality in clinical trials of a hookworm vaccine conducted in Brazil and the US. Despite differences in education and healthcare access, there were few statistically significant differences in consent quality between participants in urban and rural locations.
A new study by the American Academy of Orthopaedic Surgeons found that incorporating multiple senses in physician-patient conversations improves patient comprehension of orthopaedic conditions. The study showed significant differences in understanding between groups using verbal, video, and model-based discussions.
Researchers at Carnegie Mellon University developed simplified patient-centered consent forms that were equally effective but more engaging than traditional lengthy forms. Video formats also improved comprehension, with participants reporting feeling more engaged in the consenting process.
A study by Australian doctors found that using iPads to present surgical information improves patient understanding, with 71% preferring video delivery. The use of portable media devices can help enhance informed consent, allowing patients to better cope with procedures and make informed decisions.
Researchers found that when participants understand the implications of data sharing, they are willing to consent. The study's findings could inform revisions to the Common Rule, requiring researchers to obtain consent from patients for using their biological samples and personal data through public online databases.
A study found that 76.2% of older adults prefer administration of clot-dissolving medications in case of a stroke, supporting the use of this treatment when surrogate consent is not available. Lower education and poorer health were associated with refusal of thrombolysis.
A study found that educating the public about medical information access and bio tissue research improves attitudes, with participants supporting safeguards and anonymity. The study's results suggest that once the general public understands the risks and options, they are more willing to contribute to research.
A recent analysis of hospital trust policies found significant shortcomings in post mortem exam procedures, with many failing to explain the law behind consent or outline clear processes for obtaining consent. The study highlights the need for adequate guidance to ensure that patients are treated with dignity and respect after death.
A study found that more than half of parents misunderstood key concepts of genetic biobanking consent, highlighting the need for clearer explanations and inclusive consent models. Researchers are exploring alternative methods of consent delivery to improve understanding and empower families as partners in genetic research.
Researchers propose reforms to increase transparency and engagement of patients in clinical trials. A study found that obtaining consent on the same day as surgery does not compromise understanding, challenging existing practices. Experts argue for a broader focus on patient values and voices in research.
Bioethicists argue that traditional informed consent models do not translate well to online health research, requiring a more collaborative approach to build trust with individuals whose information is collected. Transparent disclosure of research uses is also crucial.
A study analyzing malpractice claims in Australia found that doctors often fail to disclose significant risks to patients before treatment. The authors argue that this can lead to factual disagreements and disputes over informed consent, highlighting the need for improved communication between healthcare providers and patients.
The Johns Hopkins Berman Institute of Bioethics has received a $653,344 PCORI pilot project award to study stakeholder views on streamlined informed consent options. The project aims to identify ethically acceptable strategies for patient-centered outcomes research, capturing the views of diverse stakeholders.
Canadian provinces should adopt patient charters with independent enforcement to help patients resolve concerns and complaints easily and cost-effectively. A well-designed charter can improve the quality and timeliness of care, increase accountability and reduce costly litigation.
Researchers developed an internet-based multimedia informed consent resource to make it easier for cancer patients to understand and feel comfortable enrolling in clinical trials. The tool, accessed via the Internet, contains a video version of the traditional informed consent process and a PDF of the written materials, allowing patien...