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.
Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation
Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation
Sarah L. Mayer, Michelle R. Brajcich, Lionola Juste, Jesse Y. Hsu, Nadir Yehya
Original Investigation Pediatrics
JAMA Network Open, 15 May 2024
Key Points
Question
Are sociodemographic factors associated with rates of approach and consent for pediatric intensive care unit (PICU) research?
Findings
This cohort study of 3154 children found disparities in approach and consent according to race and ethnicity, language, religion, and degree of social deprivation. Lower consent rates were partly mediated by lower approach rates, with reduced approach mediating approximately half of the lower rates of consent for Black children.
Meaning
In this study, multiple sociodemographic variables were associated with disparate consent rates for PICU research, and strategies to increase approaches could contribute to equitable enrollment in PICU studies.
Abstract
Importance
While disparities in consent rates for research have been reported in multiple adult and pediatric settings, limited data informing enrollment in pediatric intensive care unit (PICU) research are available. Acute care settings such as the PICU present unique challenges for study enrollment, given the highly stressful and emotional environment for caregivers and the time-sensitive nature of the studies.
Objective
To determine whether race and ethnicity, language, religion, and Social Deprivation Index (SDI) were associated with disparate approach and consent rates in PICU research.
Design, Setting, and Participants
This retrospective cohort study was performed at the Children’s Hospital of Philadelphia PICU between July 1, 2011, and December 31, 2021. Participants included patients eligible for studies requiring prospective consent. Data were analyzed from February 2 to July 26, 2022.
Exposure
Exposures included race and ethnicity (Black, Hispanic, White, and other), language (Arabic, English, Spanish, and other), religion (Christian, Jewish, Muslim, none, and other), and SDI (composite of multiple socioeconomic indicators).
Main Outcomes and Measures
Multivariable regressions separately tested associations between the 4 exposures (race and ethnicity, language, religion, and SDI) and 3 outcomes (rates of approach among eligible patients, consent among eligible patients, and consent among those approached). The degree to which reduced rates of approach mediated the association between lower consent in Black children was also assessed.
Results
Of 3154 children included in the study (median age, 6 [IQR, 1.9-12.5] years; 1691 [53.6%] male), rates of approach and consent were lower for Black and Hispanic families and those of other races, speakers of Arabic and other languages, Muslim families, and those with worse SDI. Among children approached for research, lower consent odds persisted for those of Black race (unadjusted odds ratio [OR], 0.73 [95% CI, 0.55-0.97]; adjusted OR, 0.68 [95% CI, 0.49-0.93]) relative to White race. Mediation analysis revealed that 51.0% (95% CI, 11.8%-90.2%) of the reduced odds of consent for Black individuals was mediated by lower probability of approach.
Conclusions and Relevance
In this cohort study of consent rates for PICU research, multiple sociodemographic factors were associated with lower rates of consent, partly attributable to disparate rates of approach. These findings suggest opportunities for reducing disparities in PICU research participation.
Ethical Frameworks of Informed Consent in the Age of Pediatric Precision Medicine
Ethical Frameworks of Informed Consent in the Age of Pediatric Precision Medicine
David Chen
Precision Medicine, 6 May 2024
Abstract
Precision medicine is an emergent medical paradigm that uses information technology to inform the use of targeted therapies and treatments. One of the first steps of precision medicine involves acquiring the patient’s informed consent to protect their rights to autonomous medical decision making. In pediatrics, there exists mixed recommendations and guidelines of consent related practices designed to safeguard pediatric patient interests while protecting their autonomy. Here, we provide a high-level, clinical primer of 1) ethical informed consent frameworks widely used in clinical practice and 2) promising modern adaptations to improve informed consent practices in pediatric precision medicine. Given the rapid scientific advances and adoption of precision medicine, we highlight the dual need to both consider the clinical implementation of consent in pediatric precision medicine workflows as well as build rapport with pediatric patients and their substitute decision-makers working alongside interdisciplinary health teams.
Editor’s note: The modern adaptions mentioned by the authors include having a two-step consent process, providing options for pediatric patients to exercise their right to re-consent for continued use of genomic data at the age of majority, and using broad consent strategies.
The Role of Parental Consent in Counseling for Minors: Requirement or Necessity?
The Role of Parental Consent in Counseling for Minors: Requirement or Necessity?
Novianti Novianti, Nandang Budiman, Nadia Aulia Nadhirah
Indonesian Journal of Guidance and Counseling Research, 27 April 2024
Abstract
The purpose of this study is to determine the Role of Parental Consent in Counseling Minors. This research uses the systematic literature review (SLR) method. Based on the results of the synthesis, the urgency of parental consent before the implementation of counseling for minors is as a condition, not a necessity, which means that it must only be fulfilled administratively so that counseling can be carried out but does not have a significant impact on the implementation of counseling. The conclusion of the study reveals that counselors must continue to prioritize the rights and trust of children in conducting counseling, the limits of decisions that can be taken by minors without intervention from parents need to be studied more deeply in further research. The contribution of this research can be used as one of the ethical references for school counselors both theoretically and practically, especially when dealing with minors.
Center for Informed Consent Integrity 