Articles tagged with Informed Consent
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...
A University of Melbourne study found that doctors failed to properly explain complications risks in over 70% of medical negligence cases. The study analyzed nearly 2000 claims and found that surgical procedures were the primary source of complaints.
A survey of patients in a teaching hospital found that they prefer to be informed about trainee participation in their care and have varying levels of willingness to consent. Consent rates differ based on scenarios describing increased resident involvement, with higher rates for minor procedures and private facility preferences.
Researchers from KEMRI-Wellcome Trust Programme in Kenya modified informed consent processes to consider local social, cultural, and economic contexts. Locally adapted communication processes strengthened informed consent, particularly in international research.
Most study participants preferred an opt-in consent process, while 41% supported a broad description of how samples and health information might be used. The study suggests that public support and trust for biobanks can be built by implementing an informed consent process that meets formal requirements and standards.
Experts warn that disclosing quantitative data to patients can backfire due to numeracy problems and biases in interpreting data. Studies show that decision aids increase patient knowledge but may not always lead to informed decisions. Researchers advocate for further research on presenting risk information to aid decision-making.
Researchers argue that current rules requiring written consent in emergency situations are causing unnecessary delays, resulting in patients missing out on life-saving treatments. The study found that up to one sixth of patients in a major clinical trial were denied treatment due to these regulations.
A recent study by Group Health Research Institute and the University of Washington found that 86% of patients agreed to share their de-identified genetic information in a federal database. The study suggests that researchers should ask for consent before sharing data, even if participants initially agree to it.
Researchers found that extending the time spent on informed consent discussions leads to greater patient comprehension, with a stronger impact seen in patients who had 'repeat back' discussions. Additionally, factors such as race, ethnicity, age, and type of surgical procedure were associated with improved comprehension.
A study analyzing two popular medical dramas found that they often depict bioethical issues and actions that run afoul of professional codes of conduct. Informed consent was the most frequently observed issue, with exemplary discussions being more common than inadequate ones.
A study found that parents of children who underwent tonsillectomy or ear tube placement recalled an average of 57% of surgical risks immediately after counseling and 57% after surgery. Despite detailed data sheets and counseling, no parent was able to recall all nine intended surgical risks.
A study found that kidney transplant consent forms are written at a 12th-grade reading level, but should be prepared at a 5th-8th grade reading level to ensure all patients can provide informed consent. This disparity may lead to unequal access to treatment and health outcomes among different patient populations.
Jessica Ridpath's PRISM Toolkit helps researchers communicate clearly in written materials, improving informed decision-making and reducing risks. The toolkit has been downloaded 2,000 times and has led to revisions of patient letters, brochures, and consent forms across healthcare institutions.
A new study in PLoS Medicine argues that doctors should disclose off-label prescribing to patients to ensure informed consent and shared decision-making. Off-label prescriptions, which account for half of all US prescriptions, are often not supported by sound scientific evidence and can pose serious risks to patients.
A series of commentaries in Human Gene Therapy explores key controversies surrounding patient recruitment and trial management in gene therapy trials. The authors discuss the challenges of patients comprehending lengthy and technical study descriptions and consent forms, and propose innovative strategies for improving informed consent.
A new questionnaire tool was developed to assess the informed consent process in clinical trials. The tool aimed to educate potential participants on the risks and benefits of taking part in research. However, the results showed that the tool did not improve informed consent in this experiment. Despite this, the study's findings provid...
A new study is expanding to include patients with severe strokes who cannot give informed consent, aiming to determine if early administration of magnesium sulfate improves patient outcomes. The trial has already enrolled over 250 patients and aims to answer a crucial question about the best approach to stroke treatment.
The use of RFID devices in patients raises benefits such as improved patient safety and expediting access to medical records. However, risks include potential unintended consequences, including loss of privacy and accessibility issues, as well as misuse by law enforcement or other malicious actors.
New studies published in JGIM examine the consequences of language barriers for patients with limited English proficiency, finding measurable disparities in quality of care. Hospitals are often unable to obtain full informed consent from patients due to lack of professional interpreter services, while Hispanic patients are less likely ...
A study found that two-thirds of ICU patients who gave informed consent to clinical trials did not remember the purpose and risks. Most patients remembered participating in the trial, but lacked recall of specific details.
A new procedure-based consent form developed by surgeons at the University of Pittsburgh Medical Center significantly improves patient recall of diagnoses, procedures, and treatment alternatives. The study found that 98% of patients recalled treatment alternatives and 97% recalled risks after using the specialized form.
A new 12-point plan provides guidance on conducting email-based health research, emphasizing the need for informed consent, identity protection, and confidentiality safeguards. The plan aims to maximize technical knowledge and secure the research process.
Disagreements over treatment decisions between healthcare professionals, patients, and families are the top ethical challenge in Canada. Key findings include emotional end-of-life critical care cases and clashes of value systems due to cultural diversity.
A study published in BMC Medicine found that using visual aids significantly improved pregnant women's understanding of HIV study information. The researchers suggest that the current informed consent process is inadequate and should be revised to effectively communicate information.
Patients undergoing cosmetic surgery showed improved risk recall when informed of potential complications through both verbal and written means. A study found that patients who received a pamphlet outlining their procedure's risks retained more information than those who only discussed it verbally.
A study of 70 patients found that informed consent before cataract surgery had no significant impact on their decisions. Cognitive dissonance also played a role in shaping their choices. The results suggest that ophthalmologists should consider the limited influence of informed consent in surgical decision-making.
A study examined the ability of prisoners with mental illness to give informed consent and found that nearly all were competent but scored lower than healthy controls. The researchers suggest that extra time and effort should be spent during the consent process to ensure these individuals understand the risks and benefits.
A universal consent form improved the consent rate for invasive procedures in ICU patients from 53% to 90.5%. This allowed patients and families to make more decisions and enabled healthcare providers to be more responsive to their wishes.
A study found that less than 20% of patients read the information sheet before giving consent, highlighting the need for verbal communication supported by written information. Patients with limited educational background had difficulty understanding the information sheet.
A recent study found that medical consent forms are typically written at a 10th-grade reading level, despite an estimated one in two American adults struggling with eighth-grade level literacy. To improve readability, researchers suggest using simpler language and alternative methods like multimedia presentations.
A study found that conventional explanations of consent forms were insufficient to ensure understanding among research participants in Haiti. In contrast, in-depth explanations with visual material resulted in high pass rates on an oral test, highlighting the need for new techniques to improve informed consent processes.
Researchers developed a standardized procedure to obtain oral consent from illiterate populations through audiovisual recording. The method allowed more than half of potential participants to exercise their freedom of refusal, paving the way for increased participation in clinical research.