A risk-specific anesthesia consent form may hinder the informed consent process

1991 ◽  
Vol 3 (6) ◽  
pp. 481 ◽  
Author(s):  
Scott K. Clark ◽  
Barbara L. Leighton ◽  
Joseph L. Seltzer
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process

A risk-specific anesthesia consent form may hinder the informed consent process

1991 ◽  
Vol 3 (1) ◽  
pp. 11-13 ◽  
Author(s):  
Scott K. Clark ◽  
Barbara L. Leighton ◽  
Joseph L. Seltzer
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

2021 ◽  
pp. 174077452110095
Author(s):  
Holly A Taylor ◽  
Daphne Washington ◽  
Nae-Yuh Wang ◽  
Hiten Patel ◽  
Daniel Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process ◽  
P Value ◽  
Fact Sheet ◽  
Significant Difference ◽  
Participant Understanding

Background/Aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). Methods: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. Results: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. Conclusion: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

Design and Implementation of an Informed Consent Process before Liver Transplantation

2008 ◽  
Vol 18 (4) ◽  
pp. 273-283 ◽  
Author(s):  
Lori Rosenthal
Keyword(s):  
Informed Consent ◽  
Medical Center ◽  
Informed Consent Process ◽  
Educational Process ◽  
Consent Form ◽  
Consent Process ◽  
Columbia University ◽  
Department Of Health ◽  
Informed Consent Form ◽  
National Model

In the past, the content of patient education was designed at the discretion of each individual transplant center and could vary greatly from center to center. Since the 2007 implementation of the guidelines from the Department of Health and Human Services, Centers for Medicare and Medicaid Services, transplant centers have had to standardize the educational material they give to patients while generating an informed consent form to incorporate this required information. This article describes the development and use of an informed consent form and the educational process for potential liver transplant recipients at Columbia University Medical Center in adherence with the new regulations. This informed consent process can be used as a national model.

Informed Consent Process Scale--Chinese Version

2019 ◽  
Author(s):  
Shu Yu Chen ◽  
Shu-Chen Susan Chang ◽  
Chiu-Chu Lin ◽  
Qingqing Lou ◽  
Robert M. Anderson
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Chinese Version ◽  
Consent Process ◽  
Process Scale

Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Communities with Limited or Low Literacy

2016 ◽  
Author(s):  
Miraida Morales ◽  
Sarah Barriage
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Measurement Tool ◽  
Low Literacy ◽  
Consent Forms ◽  
Early Readers ◽  
Research With Children ◽  
Consentement Éclairé

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

Sign in / Sign up

Export Citation Format

Share Document