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Penn-developed online informed consent tool could boost number of patients in cancer clinical trials

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...

Informed consent processes need local adaptation

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.

SourcePLOS·JournalPLOS Medicine·DateSep 13, 2011

People want to be asked before sharing genetic data

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.

SourceGroup Health Research Institute·JournalJournal of Empirical Research on Human Research Ethics·DateSep 1, 2010

Study finds patients benefit from thorough discussion of recommended operations

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.

SourceWeber Shandwick Worldwide·JournalJournal of the American College of Surgeons·DateJul 7, 2010

Doctors should disclose off-label prescribing to their patients

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.

SourcePLOS·JournalPLOS Medicine·DateNov 10, 2008

Debate over safety of gene therapy trials focuses on issue of informed consent

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.

Ways to improve informed consent are testable, study says

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...

SourceJohns Hopkins Medicine·JournalClinical Trials·DateJan 11, 2008

JGIM: studies show importance of language services on disparities, quality of care

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 ...

SourceThe Reis Group·JournalJournal of General Internal Medicine·DateNov 1, 2007

UI examines issues related to research involving prisoners

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.

SourceUniversity of Iowa·JournalComprehensive Psychiatry·DateJan 2, 2004

Consent form language too complex for many

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.

SourceJohns Hopkins Medicine·JournalNew England Journal of Medicine·DateFeb 19, 2003