Information Sheets and Informed Consent Forms for Clinical Study Participants: Towards Standardised Recommendations?

Background: Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability. Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

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Experience at Informed Consent Forms (ICF) Procedures in an Endoscopic Unit in Greece

Endoscopy ◽

10.1055/s-2006-954743 ◽

2006 ◽

Vol 38 (10) ◽

Author(s):

V Koussoulas ◽

S Vassiliou ◽

G Tassias ◽

A Spyridaki ◽

V Karagianni ◽

...

Keyword(s):

Informed Consent ◽

Consent Forms

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

Proceedings of the Annual Conference of CAIS / Actes du congrès annuel de l'ACSI ◽

10.29173/cais945 ◽

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.

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Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00843-x ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Alina Weise ◽

Julia Lühnen ◽

Stefanie Bühn ◽

Felicia Steffen ◽

Sandro Zacher ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Informed Consent ◽

Adverse Events ◽

Knee Arthroplasty ◽

Evidence Based ◽

Nocebo Effect ◽

Legal Requirements ◽

Consent Forms ◽

Link Type ◽

Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/15562646211020160 ◽

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.

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Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms

JAMA Network Open ◽

10.1001/jamanetworkopen.2020.9296 ◽

2020 ◽

Vol 3 (7) ◽

pp. e209296

Author(s):

Stephanie A. Kraft ◽

Kathryn M. Porter ◽

Devan M. Duenas ◽

Erin Sullivan ◽

Maya Rowland ◽

...

Keyword(s):

Informed Consent ◽

Behavioral Health ◽

Intervention Study ◽

Health Intervention ◽

Child Participation ◽

Consent Forms ◽

Behavioral Health Intervention ◽

Parent Decisions

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

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e13563 ◽

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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