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

Author(s):  
Miraida Morales ◽  
Sarah Barriage

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.

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
N Darwish ◽  
M Iqbal ◽  
Adeel A Dhahri ◽  
N Jacob ◽  
J Jebamani ◽  
...  

Abstract Aim The Royal College of Surgeons of England published guidance on consent during COVID-19. Through this study, we aimed to assess our local consent adherence to these guidelines on the resumption of elective activity after the first wave of COVID-19. Method This prospective review of consecutive elective surgical consent forms was conducted from 20 July 2020 to 16 August 2020 at the Princess Alexandra Hospital NHS Trust, England. The primary outcome was evidence of COVID-19 risk documentation on the consent forms. Results A total of 116 patients’ consent forms were reviewed. Most patients were American Society of Anaesthesiologists (ASA) grade 2 (n = 70; 60.34%). Only 25 consent forms (21.55%) had COVID -19 and its associated risks documented, with registrars being the most compliant (19/46; 41.3%) followed by consultants (6/51; 11.7%). With regards to the surgical sub-specialities, general surgery, orthopaedics and ENT had the highest compliance with the guidance. Conclusions As the elective activity resumes, peri-operative risks of COVID-19 should be weighted in during the informed consent process, as mentioned in the latest international guidelines on consent to avoid litigation and negligence claims.


SAGE Open ◽  
2016 ◽  
Vol 6 (3) ◽  
pp. 215824401666588 ◽  
Author(s):  
Emma Aguila ◽  
Beverly A. Weidmer ◽  
Alfonso Rivera Illingworth ◽  
Homero Martinez

2017 ◽  
Vol 13 (1) ◽  
pp. 50-60 ◽  
Author(s):  
Evan K. Perrault ◽  
David M. Keating

Participants often do not read consent forms in social science research. This is not surprising, especially for online studies, given they do not typically offer greater risk than what is encountered in daily life. However, if no one is reading, are participants really informed? This study used previous research to craft experimentally manipulated consent forms utilizing different visual presentations (e.g., greater use of line spacing, bullets, bolding, diagrams). Participants ( n = 547) were randomly exposed to one of seven form variations. Results found no significant differences between forms in reading or comprehension. Open-ended questions asked participants why they do not read consent forms and what would influence them to read the forms. Participants most frequently stated forms need to be shorter, and important information needs to be highlighted. We suggest improvements to informed consent forms, including removing much of the information that is constant across forms, and only including unique aspects of studies.


2017 ◽  
Vol 52 (5) ◽  
pp. 859-863 ◽  
Author(s):  
Mohammed Firdouse ◽  
Amy Wajchendler ◽  
Martin Koyle ◽  
Annie Fecteau

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Boluwatife Ayantunde ◽  
Danielle Clyde ◽  
Gregory Ekatah

Abstract Aims Due to the current COVID-19 pandemic, The Royal College of Surgeons of England released guidelines advising on additional considerations which should be discussed with patients as part of the informed consent process prior to surgery. We conducted a prospective audit on whether COVID-19 infection was mentioned as a possible complication during the consenting process for patients undergoing emergency and elective general surgical procedures at a District General Hospital. Methodology We prospectively collected data on the patients admitted for surgical procedures over a 2-week period. Consent forms were reviewed noting whether COVID-19 infection was listed as a possible complication. Results 35 patients were audited with a median age of 54 (12-94) years including 17 males and 18 females. Patients presented with varying surgical diagnoses, with 16 and 19 undergoing emergency and elective operations, respectively. 77.1% (27) of patients had COVID-19 infection mentioned as a possible complication on their consent forms. Five out of six consent forms completed by Clinical Fellows or CT trainees, 10 out of 13 by Registrars, 12 out of 16 by Consultants mentioned COVID-19 infection. We found no significant correlation between the grade of the consent taker and COVID-19 infection being mentioned as a possible complication. Conclusion Most of the consent takers were aware of the guidelines and mentioned COVID-19 infection as a possible complication during consenting. However, this awareness could be expanded. The results will be presented to the department before a plan to re-audit and close the loop in a few weeks.


2019 ◽  
Author(s):  
Shu Yu Chen ◽  
Shu-Chen Susan Chang ◽  
Chiu-Chu Lin ◽  
Qingqing Lou ◽  
Robert M. Anderson

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