As consent for data sharing evolves with the digital age, plain-text consent is not the only format in which information can be presented. However, designing a good consent form is highly challenging....
This study aims to explore the expectations and experiences of adults toward consent given in infographic, video, text, newsletter, and comic forms in a health data sharing scenario to better understa...
We designed mock consent forms in infographic, video, text, newsletter, and comic versions. Semistructured interviews were conducted with adults who were interviewed about their expectations for conse...
We interviewed 24 users and identified different thematic archetypes based on participant goals, such as the Trust Seeker, who considered their own understanding and trust in organizations when making...
We identified archetypes to better understand user needs and elements that can be targeted to enhance user engagement with consent forms; this can help inform the design of more effective consent in t...
Informed consent empowers patients to exercise their autonomy and actively participate in their medical care. Guidance published by the British Association of Spine Surgeons (BASS) lists three compone...
Retrospective review of clinic letters and consent forms was performed for 100 consecutive cases of elective, non-instrumented spinal decompression surgeries performed in 2019. Documentation was grade...
Documentation of indications and risks of elective spinal surgery, specifically risk of recurrence (62%) and sphincter disturbance (85%), was suboptimal on the consent forms. Documentation of these ri...
Lack of informed consent plays a major role in medical malpractice claims in spinal surgery. Poor documentation puts the surgeon in a liable position. BASS guidance could be implemented to create a mo...
Postoperative pulmonary complications occur in half of patients with perioperative COVID-19 and are associated with high mortality. The Royal College of Surgeons of England published guidance on recov...
Over an 8-week period in October and November 2020, consent forms for patients under the general surgery department were audited four times against the Royal College of Surgeons of England's standards...
Baseline measurement showed that fewer than 37% of patients were consented for the risk of contracting COVID-19; this rose to almost 61%, 71% and 85% in the second, third and fourth parts of the proje...
Errors or omission of important elements in documentation of patient consent can delay operations, expose hospital trusts to medicolegal risk and ultimately may represent a failure to fully respect pa...
Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed ...
In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 7...
The median age (IQR and range) of participants was 35.5 (28 - 49 and 13 - 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The ...
This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the qualit...
For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting informa...
We conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their ca...
Consumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form...
Our findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to co...
Use of electronic methods to support informed consent ('eConsent') is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and ...
We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standa...
We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be pre...
Design Single-blind randomised controlled trial.Intervention Patient and parent pairs were randomly assigned via a random number generator to Group A or B. Both groups were given ten minutes to read a...
The purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee ...
Consecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12-month period in a single-centre were retrospectively identified. All medical records...
A total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequent...
This study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritize impr...
Few studies are available on informed consent (IC) among detained persons, even with ethics being a critical aspect of prison research. In IC research, audiovisual material seems to improve understand...
To compare audiovisual and paper-based materials for 1-time general IC for research in prisons....
This cross-sectional randomized clinical trial was conducted in 2 corrections facilities in Switzerland (an adult prison and a juvenile detention center). The study was conducted from December 14, 201...
Participants were randomized to receive paper-based conventional material or to watch a 4-minute video. Materials included the same legal information, as required by the Swiss Federal Act on Research ...
The main outcome was acceptance to sign the IC form. Secondary outcomes included understanding, evaluation, and time to read or watch the IC material....
The study included 190 adults (mean [SD] age, 35.0 [11.8] years; 190 [100%] male) and 100 adolescents (mean [SD] age, 16.0 [1.1] years; 83 [83.0%] male). In the adult prison, no significant difference...
Given the small benefit of audiovisual material, these findings suggest that giving detained adults and prison health care staff a choice regarding IC material is best. For adolescents, audiovisual ma...
ClinicalTrials.gov Identifier: NCT05505058....
Literature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC docum...
From November 2021 to January 2022, we conducted a literature search using a PRISMA tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We th...
Out of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each...
Our review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest tha...
