Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

2021 ◽  
pp. 155626462110201
Author(s):  
Caitlin Geier ◽  
Robyn B. Adams ◽  
Katharine M. Mitchell ◽  
Bree E. Holtz
Keyword(s):  
Individual Differences ◽  
Informed Consent ◽  
Research Process ◽  
The Other ◽  
Consent Form ◽  
Online Research ◽  
Consent Forms ◽  
Potential Benefits

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

scholarly journals 396 Dermatology consent form readability: A barrier to comprehension and inclusivity

2021 ◽  
Vol 141 (5) ◽  
pp. S69
Author(s):  
A. Faletsky ◽  
J.J. Han ◽  
S.J. Li ◽  
K. Lee ◽  
Y. Soliman ◽  
...  
Keyword(s):  
Consent Form

scholarly journals 515 How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
A M Hussein ◽  
C J Callaghan
Keyword(s):  
Gold Standard ◽  
Deceased Donor ◽  
Consent Form ◽  
Donor Kidney ◽  
Consent Forms ◽  
Legal Case ◽  
Deceased Donor Kidney ◽  
Single Kidney ◽  
Donor Kidney Transplantation ◽  
Deceased Donor Kidney Transplantation

Abstract Introduction The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake. Method Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used. Results Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form. Discussion This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.

Informed consent in interventional radiology – are we doing enough?

2021 ◽  
pp. 20201368
Author(s):  
Akash Prashar ◽  
Saqib Butt ◽  
Davide Giuseppe Castiglione ◽  
Nadeem Shaida
Keyword(s):  
Interventional Radiology ◽  
Clinical Practice ◽  
Informed Consent ◽  
Blood Transfusion ◽  
Retrospective Analysis ◽  
Patient Information ◽  
Potential Risk ◽  
Current Model ◽  
Consent Form ◽  
Consent Process

Objectives: Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure. Methods: A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined. Results: 39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this. Conclusion: The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential. Advances in knowledge: The paper highlights the inadequacies of the current model in gaining consent for IR procedures. A more comprehensive consent process making use of all available resources is essential.

Improving consent forms for first-in-human trials through participant feedback.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13563-e13563
Author(s):  
Hannah Claire Sibold ◽  
Gavin Paul Campbell ◽  
John Bourgeois ◽  
Margie D. Dixon ◽  
R Donald Harvey ◽  
...  
Keyword(s):  
Patient Preferences ◽  
Clinical Trial Design ◽  
Study Drug ◽  
Clinic Visit ◽  
Consent Form ◽  
Consent Forms ◽  
Investigational Agents ◽  
Study Participants ◽  
Background Risks ◽  
Published Research

e13563 Background: Risks and benefits of investigational agents that have not been tested in humans are, at best, incompletely characterized in nonclinical investigations. Despite the growing emphasis to include patient voices in clinical trial design, no published research has explored patient preferences on how best to convey the information that the agent has not been tested in humans. This study established that First in Human (FIH) consent forms present this information in different locations and queried participants for their input on the preferable FIH consent form structure. Methods: Consent forms for FIH oncology trials open to accrual at Winship Cancer Institute in 2019-2020 were analyzed for (1) the location of the mention that the study drug has not been used in humans before (FIH information), (2) the location of animal and other nonclinical data, and (3) placement of the risks section. Patients offered enrollment in a FIH trial were eligible for this study. Participants were interviewed during a clinic visit after consent was obtained. An ethics researcher asked questions about the participant’s opinions on the wording and placement of the FIH, nonclinical, and risk information in the specific trial consent form. All interviews were audio-recorded and double coded by two independent coders. The location of FIH and nonclinical data in the consent forms was compared to the patient’s suggested location for this information. Results: Saturation of themes was reached after interviewing 17 (17/19, 89% accrual) participants who were enrolled in 9 different FIH trials. Twenty FIH consents were qualitatively analyzed. Preferred placement compared to actual consent placement is listed in the table. 82% (14/17) of participants thought that nonclinical data on risks and efficacy was important to mention. 95% (19/20) of consents listed nonclinical data and most participants thought the placement in the consent was appropriate but 18% (3/17) of participants wanted the information earlier in the consent. No consent forms that were analyzed had the risks section before the study schedule; however, 47% (8/17) of participants wanted to move the risks sections before the study schedule. Conclusions: There is considerable variation in the layout of FIH consent forms that does not align with patient preferences. Standardization of FIH consent forms to better reflect patient input is essential in order to promote understandability of these important yet sometimes misunderstood clinical trials and to ensure ethical informed consent.[Table: see text]

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