What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research
Article
Kara Berwanger, Jon F. Merz
Ethics & Human Research, 17 April 2024
Abstract
We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.
Year: 2024
Translating “medicalese”: The case of informed consent forms
Translating “medicalese”: The case of informed consent forms
Raluca Chereji
Medical Writing, March 2024; 33(1) pp 44–47
Abstract
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their linguistic and textual features exceed the comprehensibility needs of their non-expert target audience. These issues also impact medical translators who translate ICFs for prospective participants of international trials. This article discusses some of the main challenges of translating ICFs, such as specialised terminology and jargon, lexico-syntactic complexity, and text length, and argues for increased training and collaboration to mitigate these difficulties in medical translation.
Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework
Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework
Research
Godwin Pancras, Mangi Ezekiel, Erasto Mbugi, Jon F. Merz
BMC Medical Ethics, 14 May 2024
Open access
Abstract
Background
A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case.
Methods
The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software.
Results
The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research.
Conclusion
In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.
Upholding Informed Consent: Experiences of Note –Taking without Audio Recording of in-Depth Individual Interviews in a Qualitative Study on the Implementation of the Pregnancy ReEntry Policy in Zambia
Upholding Informed Consent: Experiences of Note –Taking without Audio Recording of in-Depth Individual Interviews in a Qualitative Study on the Implementation of the Pregnancy ReEntry Policy in Zambia
Namakau Kakanda-Sinkala
International Journal Of Multidisciplinary Research And Analysis, 5 May 2024
Abstract
The context of the research study needs to determine the data recording method to be used in order to ensure that no harm is done to the participants. In-depth individual Interviews (IDIs) is one of the main data collecting strategy used in qualitative research on sensitive topics such as teenage pregnancy. Audio recording in capturing data during IDIs is a common practice. However, audio recording of IDIs should be done in the context of informed consent. The objective of this paper is to elaborate on how note-taking was used to capture data within the context of informed consent. The research design was multiplecohort Case studies involving Chongwe district plus national stakeholders of the Pregnancy Re-entry policy in Zambia. Semistructured interviews were conducted with hundred (100) participants from different cohorts of stakeholders using note-taking to capture the data. Ninety percent (90%) of the interviews involved physical note-taking with 10 % being electronic notes. The results are that note-taking increased the interview time but it afforded the interviewer the opportunity to probe further as the data was being collected. The major disadvantage with note –taking is that it reduces the pace of data collection as time has to be dedicated to consolidating the notes and memory recall of information shared. The conclusion drawn is that upholding informed consent in research is key, therefore the capturing of data during IDIs should be guided by what best upholds the rights of the participants. Therefore, note-taking offers an alternative to audio recording.
The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines
The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines
Research Article
Nadine S. J. Stirling, Melanie K. T. Takarangi
Ethics & Behavior, 28 April 2024
Abstract
The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, participant views for consent were similar irrespective of trauma-exposure. Our study has implications for IRBs and psychological researchers.
Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study
Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study
Xengie Doan, Arianna Rossi, Marietjie Botes, Annika Selzer
JMIR Human Factors, 30 April 2024
Abstract
Background
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. The addition of graphics, video, and other mediums to use can vary widely in effectiveness; and improper use can be detrimental to users.
Objective
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 understand the appropriateness of different mediums and identify elements of each medium that most affect engagement with the content.
Methods
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 consent and were then shown each consent medium and asked about engaging elements across mediums, preferences for consent mediums, and the value of document quality criteria. We transcribed and qualitatively co-coded to identify themes and perform analyses.
Results
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 decisions. The infographic was ranked first for enhancing understanding, prioritizing information, and maintaining the proper audience fit for serious consent in health data sharing scenarios. In addition, specific elements such as structure, step-by-step organization, and readability were preferred engaging elements.
Conclusions
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 the future. Overall, preferences for mediums are highly contextual, and more research should be done.
Video-Assisted informed consent in endoscopic urology: a randomized trial on ureterorenoscopy
Video-Assisted informed consent in endoscopic urology: a randomized trial on ureterorenoscopy
Research Article
Dr. Guglielmo Mantica, Dr. Francesco Esperto, Dr. Rafaela Malinaric, Dr. Francesca Ambrosini, Dr. Loris Cacciatore, Prof. Rocco Papalia, Dr. Daniele Panarello, Prof. Roberto Mario Scarpa, Prof. Carlo Terron
Journal of Endourology, 17 May 2024
Abstract
Purpose
The aim of this study is to evaluate the possible beneficial effect of using the video – consent in the preoperative URS consent giving process.
Material and Methods
Prospective randomized trial took place at two Italian tertiary-care centers from March 2022 to September 2022. Patients were randomly assigned to two groups: Group A (standard verbal/written informed consent) and Group B (informed consent supported by video). We investigated the impact of both types of the informed consent on the level of patients’ anxiety assessed with the STAI questionnaire pre- and postoperatively. Additionally, we evaluated the effect of informed consents on the postoperative pain, measured with the VAS scale, and the number of assistances calls during hospitalization as secondary outcomes. To assess the satisfaction level related to the whole process, we asked patients to rate their experience on a scale of 1-10, with 1 indicating “not satisfied” and 10 indicating “completely satisfied.”
Results
Overall, 166 patients were randomized 1:1 in each group. According to the multivariable regression model, the video-assisted informed consent significantly increased the difference between postoperative and preoperative STAI, reducing the level of anxiety. The video-assisted informed consent significantly predicted the number of assistance calls during the hospitalization.
Conclusions
Video-consent for ureteroscopies are a valid tool to improve patients’ satisfaction and awareness of the procedure. Video-consent is able to reduce patients’ anxiety related to the procedure and assistance calls during the postoperative period, resulting in a useful tool to administer a better-informed consent for endourological procedures.
The Impact of a Computer-Based Interactive Informed Consent for Surgery on Decision Conflict
The Impact of a Computer-Based Interactive Informed Consent for Surgery on Decision Conflict
Scientific Article
Sina Ramtin, Floor Davids, Amir Reza Farhoud, Raul Tejada, David Ring
The Journal of Hand Surgery, 12 May 2024
Abstract
Purpose
Informed consent for surgery can address the legal aspects of care while also being simple, informative, and empathic. We developed interactive informed consents and compared them with standard printed informed consents asking: (1) are there any factors associated with lower decision conflict or greater patient-rated clinician empathy including consent format? (2) Are there any factors associated with rating the consent process as informative, comfortable, and satisfying including consent format?
Methods
Ninety-four adult patients accepted an offer of surgery from one of three hand surgeons to address one of six common hand surgery diagnoses: carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign mass, including a ganglion cyst, and Dupuytren contracture release. Fifty-three patients were randomized to complete an interactive consent, and 41, a standard written consent. Symptoms of anxiety, depression, and unhelpful thoughts were measured. Patients completed the Decision Conflict Scale and the Jefferson Scale of Patient’s Perceptions of Physician Empathy and rated the consent as informative, comfortable, and satisfactory on a scale of 0–10.
Results
Greater decisional conflict was slightly associated with greater patient unhelpful thoughts about symptoms and was not associated with consent format. A higher rating of comfort with the consent process was slightly associated with patient choice to proceed with surgical treatment, but not with consent format. Accounting for potential confounding in multivariable analysis, a higher rating of the consent process as informative was slightly associated with patient preference for surgical over nonsurgical treatment,
Conclusions
The observation that an interactive consent form was not related to decision conflict or other aspects of patient experience suggests that such tools may not have much weight relative to the interaction between patient and clinician.
Clinical relevance
Efforts to improve informed consent may need to focus on the dialog between patient and surgeon rather than how information is presented.
Power to the people? Time to improve and implement patient decision aids to strengthen shared decision-making
Power to the people? Time to improve and implement patient decision aids to strengthen shared decision-making
Invited Commentary
Sandra B Lauck, Krystina B Lewis, Michelle Carter, Catriona Jennings
European Journal of Cardiovascular Nursing, 26 April 2024
Excerpt
For many people living with heart disease, the journey from their diagnosis to their consent for treatment and beyond is rarely a straight path. Barriers along the way include the maze of diagnostic testing and consultations, the steep learning curve to grasp what options might be appropriate and feasible, the evolving emotions accompanying the diagnosis and the need for treatment, and the diverse power dynamics that might be at play with health care providers. These challenges are often compounded by the need to manage their increasing burden of symptoms. In this complex context of care, patients must make decisions about their treatment, decisions that can have implications for their current and future health and quality of life.
Recognizing the importance of engaging and supporting patients to achieve a high-quality treatment decision in partnership with their providers, multiple cardiovascular guidelines have endorsed shared decision-making (SDM) as a core principle of patient-centred communication in multidisciplinary team best practices. This bi-directional exchange of information is a mechanism to promote patient empowerment, consideration of patients’ preferences, values and priorities, and ultimately, the provision of true informed consent. Patient decision aids (PtDAs) are evidence-based, patient-facing interventions developed according to international standards and designed to facilitate SDM. Patient decision aids explicitly state the decision to be made, provide information about options (inclusive of the option of not actively intervening and choosing watchful waiting/active surveillance) and outcomes associated with each option, while helping patients clarify their values and preferences…
Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review
Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review
Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau
Journal Of Empirical Research On Human Research Ethics, 15 May 2024
Open Access
Abstract
This scoping review explores current practices for obtaining consent in research on risky behaviours among adolescents in Canada. The JBI methodology for scoping reviews was used. The database search was conducted in August 2021 and updated in November 2022. Papers published in 2010 or later were included. Extracted data included study characteristics, sample characteristics, and consent procedures. The review included 83 reports covering 57 studies. Nearly 60% of studies relied on adolescent self-consent for participation. Adolescent self-consent was more common than parental/guardian consent for studies using in-person research methods, older adolescent groups, and particularly vulnerable populations. Parental/guardian consent was more common for studies using younger age groups and general population samples. Adolescent self-consent was more common than parental/guardian consent for most risky behaviours covered by this review. These results provide insight into current consent practices in this area and offer guidance to researchers and institutional review boards in Canada.
Center for Informed Consent Integrity 