scholarly journals Written Informed Consent—Translating into Plain Language. A Pilot Study

Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 232
Author(s):  
Agnieszka Zimmermann ◽  
Anna Pilarska ◽  
Aleksandra Gaworska-Krzemińska ◽  
Jerzy Jankau ◽  
Marsha N. Cohen
Keyword(s):  
Informed Consent ◽  
Plain Language ◽  
Consent Forms ◽  
Software Analysis ◽  
Informed Consent Form ◽  
Education Levels ◽  
Polish Language ◽  
University Degree ◽  
Study Participants ◽  
Written Informed Consent

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.

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

Therapies ◽  
2009 ◽  
Vol 64 (3) ◽  
pp. 179-186 ◽  
Author(s):  
Olivier Chassany ◽  
Micheline Bernard-Harlaut ◽  
Gilles Guy ◽  
Nathalie Billon ◽  
Bernard Alberola ◽  
...  
Keyword(s):  
Clinical Study ◽  
Informed Consent ◽  
Consent Forms ◽  
Study Participants

Factors Influencing a Persons Reaction to Informed Consent

1984 ◽  
Vol 54 (1) ◽  
pp. 112-114 ◽  
Author(s):  
Linda L. Gertson ◽  
J. Regis McNamara
Keyword(s):  
Informed Consent ◽  
School Setting ◽  
Demand Characteristics ◽  
Research And Practice ◽  
Initial Decision ◽  
Informed Consent Form ◽  
Study Participants ◽  
Relationship Of ◽  
Oral Presentations ◽  
The Relationship

The present study examined how social and physical demand characteristics influenced the willingness of 128 volunteer undergraduates to participate in a drug experiment. Subjects read an informed consent form about an experiment and then received different amounts of supplemental information about the study presented orally by a physician-confederate in a medical school setting. After making an initial decision about participation in the study, participants were tested for their comprehension about the experiment. All subjects who indicated an interest in the project were asked to attend a second meeting in the Psychology Department when they were asked if they wished to change their original decisions. Because high trust was placed in the physician-confederate, there were no differences, no effect for the differing oral presentations was found. However, a significant number of subjects changed their decisions to participate at the second session. The relationship of these and other findings to clinical research and practice were discussed.

Use, content, and readability of written informed consent forms for treatment.

1986 ◽  
Vol 17 (6) ◽  
pp. 514-518 ◽  
Author(s):  
Mitchell M. Handelsman ◽  
Melinda B. Kemper ◽  
Pamela Kesson-Craig ◽  
Joanne McLain ◽  
Cynthia Johnsrud
Keyword(s):  
Informed Consent ◽  
Consent Forms ◽  
Written Informed Consent

Personality, Sex of Participant, and Face-to-Face Interaction Affect Reading of Informed Consent Forms

2014 ◽  
Vol 114 (1) ◽  
pp. 297-313 ◽  
Author(s):  
Michael M. Knepp
Keyword(s):  
Informed Consent ◽  
Information Seeking ◽  
Consent Form ◽  
Research Support ◽  
Consent Forms ◽  
Face To Face ◽  
Informed Consent Form

Students ( N = 183) participated in a study designed to determine if each student read the informed consent form. Approximately 12% of students in the online condition followed the procedure compared with 38% in the laboratory phase. Participants with higher trait worry and those with lower emotion reappraisal were more likely to follow the procedure, while women were more likely to read the form than men. Across conditions, most students do not read informed consent documents, particularly in online formats. These findings of this research support the idea that women tend to be more information-seeking than men in health and research settings and those with higher trait worry tend to read the consent forms to alleviate uncertainty and trust concerns.

scholarly journals Improving readability of informed consents for research at an academic medical institution

2017 ◽  
Vol 1 (6) ◽  
pp. 361-365 ◽  
Author(s):  
Kristie B. Hadden ◽  
Latrina Y. Prince ◽  
Tina D. Moore ◽  
Laura P. James ◽  
Jennifer R. Holland ◽  
...  
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Plain Language ◽  
Post Intervention ◽  
Consent Forms ◽  
Institutional Review ◽  
Final Rule ◽  
The Mean ◽  
Protection Of Human Subjects

IntroductionThe final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

How well informed is the informed consent for cancer clinical trials?

2014 ◽  
Vol 11 (6) ◽  
pp. 686-688 ◽  
Author(s):  
Laeeq Malik ◽  
James Kuo ◽  
Desmond Yip ◽  
Alex Mejia
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Tertiary Care ◽  
Reading Level ◽  
Consent Form ◽  
Consent Forms ◽  
Investigational Agent ◽  
Informed Consent Form ◽  
Grade Reading Level

Aims: The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Methods: Informed consent forms for Phase I–III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch–Kincaid and Gunning-Fog index readability tests. Results: All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8–28). A detailed estimation of the frequency or intensity of risks (range: 3–8 pages) was provided. The average reading level of the informed consent forms was high (Flesch–Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. Conclusion: Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length.

scholarly journals Prosocial and antisocial behaviors in Turkish female and male football players

2021 ◽  
Keyword(s):  
Informed Consent ◽  
Data Collection ◽  
Antisocial Behavior ◽  
Female Athletes ◽  
Football Players ◽  
Antisocial Behaviors ◽  
Male And Female ◽  
Informed Consent Form ◽  
Football Match ◽  
Study Participants

Background and objective: Women have increasingly taken more part in a rather male-dominated sport in recent years: football, so our study's main focus is exploring the acts and behaviors of the female athletes during a football match. The study analyzes the sex-related differences in prosocial and antisocial behaviors between male and female athletes. Materials and methods: A total of 837 players, recruited from various leagues in Turkey, participated in the study. Participants were active female (n = 432) and male (n = 405) football players. The informed consent form and Prosocial and Antisocial Behavior in Sport Scale (PABSS) were utilized as data collection tools. Results: Female football players displayed less prosocial and more antisocial behaviors compared to male football players. Among all the league statuses, both female and male players exhibited the highest prosocial and the lowest antisocial behaviors in the top league status. Additionally, there were statistically significant differences concerning the age variable (p < 0.05). Conclusions: Our study findings indicate that male football players engaged in more prosocial behaviors toward both their teammates and opponents than female football players; moreover, male players engaged in less antisocial behaviors in general. Players reported higher prosocial and lower antisocial behavior scores as league status increased. Lastly, higher prosocial behavior scores were obtained with increasing age.

Assesment of a written informed consent form in clinical trials

2012 ◽  
Vol 19 (2) ◽  
pp. 223.3-224
Author(s):  
P. Marrero Álvarez ◽  
J. Ruiz Ramos ◽  
J.E. Megías Vericat ◽  
S. Rodríguez Capellán ◽  
M. Tordera Baviera ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Form ◽  
Informed Consent Form ◽  
Written Informed Consent

Quality of written informed consent forms for electroconvulsive therapy in Australia: a comparative analysis

2021 ◽  
pp. 103985622110092
Author(s):  
Karuppiah Jagadheesan ◽  
Frances Walker ◽  
Vinay Lakra
Keyword(s):  
Informed Consent ◽  
Electroconvulsive Therapy ◽  
Health Department ◽  
Consent Form ◽  
Missing Information ◽  
Consent Forms ◽  
The Right ◽  
Comparative Audit ◽  
Written Informed Consent

Objectives: We compared the quality of the written informed consent forms for electroconvulsive therapy (ECT) in Australian jurisdictions. Method: For this comparative audit-type study, a checklist was developed to compare informed consent forms from different jurisdictions. The main information sources for consent forms were government health department websites and Google. The directors of clinical services were contacted if a consent form was not available through a web source. Results: Majority of the informed consent forms covered information about ECT, general anaesthesia and alternative treatments, supports available for decision making, and a reference to the right to withdraw consent. Missing information affected information areas such as likely outcome if no ECT, lack of guaranteed response and cultural and linguistic supports. Conclusions: A standardised consent form that can be used across all jurisdictions can help improve the ECT practice.

Readability of Pediatric Biomedical Research Informed Consent Forms

PEDIATRICS ◽  
1990 ◽  
Vol 85 (1) ◽  
pp. 58-62 ◽  
Author(s):  
Kenneth J. Tarnowski ◽  
Denise M. Allen ◽  
Christine Mayhall ◽  
Patricia A. Kelly
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Human Subjects ◽  
Linear Increase ◽  
Willingness To Participate ◽  
Consent Forms ◽  
Flesch Reading Ease ◽  
Informed Consent Form ◽  
Consent Document ◽  
Protection Of Human Subjects

Informed consent forms are used in biomedical research as a mechanism to convey study information to potential subjects so that they may arrive at a decision concerning their willingness to participate. Although the Department of Health and Human Services Regulations for the Protection of Human Subjects require the presentation of specific study information at a level that is easily understood, according to research concerning adult biomedical consent forms, the typical form is not readily comprehensible. Unfortunately, no data exist concerning the readability of informed consent forms that are used in the context of pediatric biomedical research. In the present study, readability analyses were conducted on a large sample (N = 238) of pediatric biomedical informed consent forms obtained during a 10-year period from a large midwestern children's hospital. For the entire sample, results derived from two readability estimates (Fry grade equivalent and Flesch Reading Ease methods) indicated that the consent forms were written at the college graduate level. Although there was a linear increase in the length of the consent document during the 10-year period evaluated, expanded length was not associated with improved readability. According to analyses, a differential pattern of reading difficulty was associated with specific sections of the informed consent document. Findings are highly consistent with those from studies of adult biomedical consent forms and document that the purpose of the informed consent form is being compromised, in part, by a readability factor. Suggestions for solving this critical problem are advanced.

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