Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service

2020 ◽  
Vol 27 (10) ◽  
pp. 1825-1831
Author(s):  
A. G. Jaramillo Vélez ◽  
M. Aguas Compaired ◽  
M. Granados Plaza ◽  
E. L. Mariño ◽  
P. Modamio
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Information ◽  
Consent Forms

The quality of informed consent forms for oncology clinical trials

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 6544-6544
Author(s):  
W. Y. Cheung ◽  
G. R. Pond ◽  
R. J. Heslegrave ◽  
L. Potanina ◽  
L. L. Siu
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Forms ◽  
Oncology Clinical Trials

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

Quality of informed consent in cancer clinical trials in India: A cross-sectional survey.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e17652-e17652 ◽  
Author(s):  
Vikram Gota ◽  
Manjunath Nookala ◽  
Akanksha Yadav ◽  
Sadhna Kannan ◽  
Raghib Ali
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Clinical Trials ◽  
Cross Sectional Survey ◽  
Cross Sectional

Quality of informed consent in cancer clinical trials: a cross-sectional survey

The Lancet ◽  
2001 ◽  
Vol 358 (9295) ◽  
pp. 1772-1777 ◽  
Author(s):  
Steven Joffe ◽  
E Francis Cook ◽  
Paul D Cleary ◽  
Jeffrey W Clark ◽  
Jane C Weeks
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Clinical Trials ◽  
Cross Sectional Survey ◽  
Cross Sectional

scholarly journals Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

2012 ◽  
Vol 18 (2) ◽  
pp. 183-189 ◽  
Author(s):  
Ellen M. Denzen ◽  
Martha E. Burton Santibáñez ◽  
Heather Moore ◽  
Amy Foley ◽  
Iris D. Gersten ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Consent Forms

scholarly journals Rescuing Informed Consent: How the new “Key Information” and “Reasonable Person” Provisions in the Revised U.S. Common Rule open the door to long Overdue Informed Consent Disclosure Improvements and why we need to walk Through that door

2019 ◽  
Vol 26 (3) ◽  
pp. 1423-1443 ◽  
Author(s):  
Mark Yarborough
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Social Value ◽  
Nuremberg Code ◽  
Reasonable Person ◽  
Common Rule ◽  
Published Evidence ◽  
Extensive Body ◽  
Shed Light

AbstractThere is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that would alert research candidates to the ethically problematic nature of the trials. The “reasonable person” and “key information” provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the “key information” is that should be disclosed to a “reasonable person”: the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials.

scholarly journals Quality of informed consent in clinical trials patients

2019 ◽  
Vol 30 ◽  
pp. v827
Author(s):  
G. Catania ◽  
A. Dal Molin ◽  
N. Diaz ◽  
A. Bagnasco ◽  
M. Zanini ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent
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