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.

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 Role of the consent form in UK veterinary practice

2020 ◽  
Vol 187 (8) ◽  
pp. 318-318
Author(s):  
Carol Gray
Keyword(s):  
Informed Consent ◽  
Thematic Analysis ◽  
Potential Role ◽  
Consent Form ◽  
Consent Process ◽  
Consent Forms ◽  
The Status ◽  
The Uk ◽  
Sufficient Space

BackgroundInformed consent from the client is required before veterinary professionals may administer treatment or perform surgery on an animal patient, except in an emergency. This study investigates the potential role(s) of the consent form in the consent process in the UK.MethodsThematic analysis was carried out on the text contained in 39 blank consent forms sourced from veterinary practices in the UK. Analysis was conducted at the levels of topical survey and thematic summary.ResultsConsent forms were used to authorise procedures, to define proposed treatment, to offer or recommend additional procedures, to convey the risks of treatment and to document the client’s financial obligations. None of the forms analysed provided sufficient space to document the accompanying conversation. Notable omissions from the submitted forms included options for treatment and benefits of treatment.ConclusionsThe consent form acts as a record of the procedure to be performed, the associated costs and the status of the person giving consent. However, from this analysis, it often fails to record the detail of the consent discussion, an essential part of the consent process. A proposal for an improved version of a veterinary consent form is provided.

scholarly journals Informed consent of human subjects: a review

2014 ◽  
Vol 5 (1) ◽  
pp. 20-35
Author(s):  
Mohammad Rashedul Islam
Keyword(s):  
Developing Countries ◽  
Informed Consent ◽  
Human Subjects ◽  
Research Process ◽  
Informed Decision ◽  
Consent Form ◽  
Clear Understanding ◽  
Human Research ◽  
Vital Part

Informed consent is a vital part of the research process, and as such entails more than obtaining a signature on the consent form. Researchers or investigators must educate potential subjects to ensure that they can reach a truly informed decision about whether or not to participate in the research. Their consent must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Only then it can be regarded as ‘informed consent’. Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18444 Bangladesh Journal of Bioethics 2014 Vol.5(1): 20-35

Effectiveness of consenting in Otorhinolaryngology

Open Medicine ◽  
2012 ◽  
Vol 7 (2) ◽  
pp. 198-202
Author(s):  
Nnaemeka Okpala ◽  
Amala Okpala ◽  
Gareth John ◽  
Hugh Cox
Keyword(s):  
Informed Consent ◽  
Therapeutic Alliance ◽  
Medical Practice ◽  
Consent Form ◽  
Consent Process ◽  
Pharyngeal Pouch ◽  
Consent Forms ◽  
Ethical Component ◽  
At Home

AbstractInformed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.

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 Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form

2012 ◽  
Vol 46 (3) ◽  
pp. 122-125
Author(s):  
Nusrat Shafiq ◽  
Samir Malhotra
Keyword(s):  
Developing Countries ◽  
Informed Consent ◽  
Clinical Research ◽  
Patient Information ◽  
Research Process ◽  
Informed Consent Process ◽  
Patient Information Leaflet ◽  
Consent Form ◽  
Information Leaflet ◽  
Informed Consent Form

ABSTRACT Informed consent process is an integral component of conducting clinical research ethically. Prior to giving an informed consent to participate in clinical research, it is important that the participant has fully understood all the components of a patient information leaflet and the consent form. The issue of comprehension of informed consent form and patient information leaflet has acquired particular importance in view of research being carried out in developing countries and in vulnerable population. The present review addresss this issue by discussing the need for addressing comprehension of research process by the participant, the tools for assessing the same and various ways in which these tools have been used. How to cite this article Shafiq N, Malhotra S. Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form. J Postgrad Med Edu Res 2012;46(3):122-125.

scholarly journals Are patients truly informed? A retrospective chart review of the documentation of informed consent in laparoscopic cholecystectomy

2021 ◽  
Vol 64 (4) ◽  
pp. E435-E441
Author(s):  
Erin Williams ◽  
Raj Selvam ◽  
Wilma Hopman ◽  
Sulaiman Nanji
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Informed Consent ◽  
Operating Room ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Consent Form ◽  
Consent Forms ◽  
Future Studies ◽  
Attending Physicians ◽  
Better Than

Background: Research on informed consent (IC) has traditionally focused on the documentation of the discussion with patients of potential complications. We sought to examine the completeness of documentation for all elements of IC for laparoscopic cholecystectomy (LC): potential complications, alternatives to LC and details of the procedure. Differences in the documentation of IC for elective and emergent LC were examined. Methods: A retrospective chart review of patients undergoing LC at our institution between 2015 and 2017 was performed. Completeness of documentation was defined as documentation of all 3 elements of IC in the clinic note, the operating room note or the consent form itself. Data were analyzed descriptively. We compared documention for emergent and elective cases as well as documentation by residents and attending physicians using t tests. Results: A total of 270 patients were included in the analysis. Only 5 (2%) had complete documentation of all elements of IC. Documentation of potential complications was noted in 232 cases (86%), of which 58 (25%) were elective and 174 (75%) were emergent. Details were noted in 28 (10%) cases, of which 21 (75%) were elective and 7 (25%) were emergent. Alternatives were documented the least frequently: they were documented in 23 cases (9%), of which 20 (87%) were elective and 3 (13%) were emergent. Residents performed better than attending physicians in documenting IC discussions in clinic notes and on consent forms, but not in operating room notes. Conclusion: Documentation of the elements of IC for LC was poor. Potential complications were the most frequently documented element of IC; alternatives and details were often omitted. Future studies comparing audiotaped IC conversations with the documentation of IC are warranted. The use of procedure-specific consent forms for LC may facilitate documentation.

scholarly journals Informed consent and the readability of the written consent form

2017 ◽  
Vol 99 (8) ◽  
pp. 645-649 ◽  
Author(s):  
N Sivanadarajah ◽  
I El-Daly ◽  
G Mamarelis ◽  
MZ Sohail ◽  
P Bates
Keyword(s):  
Informed Consent ◽  
Significant Proportion ◽  
Consent Form ◽  
Online Tool ◽  
Consent Forms ◽  
Flesch Reading Ease ◽  
Written Information ◽  
Ease Score ◽  
The Mean ◽  
British Orthopaedic Association

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2–66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7–70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13–15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

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.

Informed consent: a patients’ perspective

2005 ◽  
Vol 119 (1) ◽  
pp. 19-22 ◽  
Author(s):  
Paul Burns ◽  
Ivan Keogh ◽  
Conrad Timon
Keyword(s):  
Informed Consent ◽  
Medical Practice ◽  
Surgical Procedure ◽  
Legal Issues ◽  
Consent Form ◽  
Consent Forms ◽  
Good Medical Practice ◽  
Standard Questionnaire ◽  
High Level ◽  
Patients Perspective

The medico-legal issues surrounding informed consent are highly topical and contentious. Current attitudes to consent emphasize the high level of ’good medical practice’ expected by a ’reasonable patient/parent’. The authors’ objectives were to assess the levels of knowledge and information expected by patients and parents, prior to signing consent forms for a surgical procedure. Each patient or parent was asked a series of questions prior to signing a consent form. Answers were recorded on a standard questionnaire. More than 80 per cent of respondents were happy with the information provided in out-patients, however, over half of these could not list even one complication of their operation. Two-thirds of those surveyed sought information elsewhere, while over half expected to be informed of all known complications, even if the rate of complications was less than one per cent. In conclusion, the information provided by surgeons might not meet the expectations of today’s informed patients.

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