Level of Patients’ Education and Knowledge About Informed Consent of Cesarean Section in Females Undergoing Planned Cesarean Section

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Level of Patients’ Education and Knowledge About Informed Consent of Cesarean Section in Females Undergoing Planned Cesarean Section
Robina Zahoor, Rabia, Adila Ashraf, Hania Zafar, Shazia Abid
Journal of Akhtar Saeed Medical & Dental College, July-September 2022; 4(3)
Open Access
Abstract
Background
The consent-providing individual must not only have the appropriate mental ability but also have all of the required knowledge to give consent correctly. The patient must provide consent to accept or decline any treatment or examination. The study aimed to find the level of patients’ education and knowledge about informed consent of cesarean section in females undergoing planned cesarean section
Material and Methods
This study was cross-sectional and carried out at Unit I, Department of Obstetrics and Gynecology, Sir Gangs Ram Hospital, Lahore for a duration of six months after approval of synopsis from January 2022 to June 2022. All the enrolled patients were asked about the informed consent of cesarean section before undergoing cesarean section and their knowledge about informed consent was noted. The Female education about informed consent was obtained as per operational definition by the researcher herself after the procedure. Data analysis was done through SPSS version 21 software.
Results
A total of 100 cases were enrolled in the current study. Level of adequate knowledge about informed consent of cesarean section was recorded in 74 (74%) of the cases whereas adequate knowledge was not recorded in 26 (26%) cases. Level of adequate education about informed consent of cesarean section was recorded in 9 (9%) of the cases whereas adequate education was not recorded in 91 (91%) cases.
Conclusion
Our study concluded that a high number of patients have an adequate level of knowledge about informed consent for cesarean section in females undergoing planned cesarean section while the level of adequate education was very low.

Editor’s note: The Journal of Akhtar Saeed Medical & Dental College is in Lahore.

Dignity and Respect: Why Therapeutic Assent Matters

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Dignity and Respect: Why Therapeutic Assent Matters
Discussion and Review Paper
Jaime Flowers, Jillian Dawes
Behavior Analysis in Practice, 19 January 2023
Abstract
During therapeutic treatment and research in psychology and related fields, informed consent by the client or participant is required when they are over the age of 18; assent is required when a client or participant is under the age of 18 or a conserved adult. During both research and treatment, behavior analysts often work with neurodiverse individuals who have language deficits, and these clients may require unique assent procedures. This article will outline reasons behavior-analytic research and therapy require field-specific assent procedures. Furthermore, the goals of research and therapy are different and therefore assent may need to differ as well. This article will also argue that therapeutic assent during behavior-analytic treatment requires a unique set of guidelines and procedures that may differ from the behavior-analytic research.

Evaluation of consent to link Twitter data to survey data

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Evaluation of consent to link Twitter data to survey data
Zeina Mneimneh
Journal of the Royal Statistical Society, December 2022; 185(S2) pp 364-386
Abstract
This study presents an initial framework describing factors that could affect respondents’ decisions to link their survey data with their public Twitter data. It also investigates two types of factors, those related to the individual and to the design of the consent request. Individual‐level factors include respondents’ attitudes towards helpful behaviours, privacy concerns and social media engagement patterns. The design factor focuses on the position of the consent request within the interview. These investigations were conducted using data that was collected from a web survey on a sample of Twitter users selected from an adult online probability panel in the United States. The sample was randomly divided into two groups, those who received the consent to link request at the beginning of the survey, and others who received the request towards the end of the survey. Privacy concerns, measures of social media engagement and consent request placement were all found to be related to consent to link. The findings have important implications for designing future studies that aim at linking social media data with survey data.

Metadiscourse in Informed Consent: Reflections for Improving Writing and Translation

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Metadiscourse in Informed Consent: Reflections for Improving Writing and Translation
Isabel García-Izquierdo
GEMA Online Journal of Language Studies, November 2022, 22(4) pp 161-185
Abstract
Metadiscourse has been one of the most prolific areas of research in the field of applied linguistics in recent years. It is understood as the way we use language to connect with our audience, which is the result of integrating propositional content and interpersonal factors (Hyland, 2017). In this paper we will analyse Metadiscourse in one of the most complex medical-legal genres: informed consent (IC). Drawing on a small comparable bilingual corpus of texts belonging to this genre for surgery in Spanish and English, the paper aims to analyse (by using Sketch Engine tools) how metadiscursive elements are evident in written IC documents, and to reflect on what aspects need to be taken into account in order to improve the way these documents are written and translated in the future. The Key findings are a low frequency of Interactive resources and a more significant presence of Interactional resources in both corpora. However, boosters are almost non-existent, because a large part of the texts belonging to this genre incorporate pre-established formulaic text. Most of the content is related to the procedures requiring consent and their possible consequences, so the sender almost always tends to avoid universal statements and to display a certain reserve in case predictions are not fulfilled. The conclusion is threefold: some metadiscursive elements in the IC manifest themselves in a different way from other medical genres; a more frequent use of some of the interactive and interactional resources could lead to a better understanding; and finally, it would be important to include the analysis of these metadiscursive elements in the training of future medical writers and translators.

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Informed Consent: A Monthly Review
_________________

January 2023 :: Issue 49

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_January 2023

Informed Consent: Research Staff’s Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication

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Informed Consent: Research Staff’s Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication
Delphine Eeckhout, Karolien Aelbrecht, Catherine Van Der Straeten
Journal of Empirical Research on Human Research Ethics, 23 December 2022
Abstract
Informed consent (IC) is the process of communication between research staff and potential research participants. However, ensuring that participants clearly understand what research participation entails, raises significant challenges. The aim of this study is to provide insight into some communication barriers that research staff are confronted with and make practical recommendations to improve communication between research staff and participants. A qualitative research study using semi-structured interviews (n = 13) with research staff from Ghent University Hospital was conducted. Data were transcribed verbatim and coded thematically. Our results indicate that communication- and process-related factors affect the IC process. Emergent recommendations include communication training, more interactive information materials and the use of digital alternatives, increasing general knowledge about research participation and patient- and public involvement.

The Informed Consent Form Navigator: A Tool for Producing Readable and Compliant Consent Documents

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The Informed Consent Form Navigator: A Tool for Producing Readable and Compliant Consent Documents
Jonathan P. Bona, Joseph Utecht, Aaron S. Kemp, Jennifer M. Gan, Alison Caballero, Christopher R. Trudeau, Mathias Brochhausen, Laura James
Journal of Clinical and Translational Science, December 2022 [preprint]
Open Access
Abstract
Background/Objective
Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements.
Methods
Our team first developed requirements for the ICF navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool.
Results
The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.
Conclusion
The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa

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A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa
Dorothy Maxwell Kazembe, Tigist Mesfin, Abigiya Abebe, Saba Mehari Embaye, Esther Nthenya Muthoka, Kedir Usmael, Mediha Ahmedin, Tsegahun Manyazewal
Medical Research Archives, November 2022; 10(11)
Abstract
Background
Informed consent provides detailed information to the participants to make informed voluntary and rational decision to participate in a study. It is a communication tool between investigator and the subject to ensure that high research ethical standards are followed. This review paper assessed the level of participants’ understanding of the information given to them by researchers during the clinical research.
Methods
A review approach was used to achieve the study objective.
Results
The findings showed that the level of comprehension varied from study to study. There was a good comprehension in four domains; purpose, voluntariness, benefits and right to withdraw. Poor comprehensions were mostly in risks, side effects, and blinding. Higher level of education, repeated assessments of comprehension, time spent by the researcher explaining and clarifying the information influenced the comprehension.
Conclusion
The study findings point out that comprehension to informed consent is still a challenge that needs to be addressed during the field study. Once the consent is given it becomes a distant memory for most of the participants. This implies that proper tools and cut off points to determine participants’ comprehension need to be developed for standard assessment of such.

Consent Codes: Maintaining Consent in an Ever-expanding Open Science Ecosystem

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Consent Codes: Maintaining Consent in an Ever-expanding Open Science Ecosystem
Stephanie O. M. Dyke, Kathleen Connor, Victoria Nembaware, Nchangwi S. Munung, Kathy Reinold, Giselle Kerry, Mamana Mbiyavanga, Lyndon Zass, Mauricio Moldes, Samir Das, John M. Davis, Jordi Rambla De Argila, J. Dylan Spalding, Alan C. Evans, Nicola Mulder, Jason Karamchandani
Neuroinformatics, 15 December 2022
Open Access
Abstract
We previously proposed a structure for recording consent-based data use ‘categories’ and ‘requirements’ – Consent Codes – with a view to supporting maximum use and integration of genomic research datasets, and reducing uncertainty about permissible re-use of shared data. Here we discuss clarifications and subsequent updates to the Consent Codes (v4) based on new areas of application (e.g., the neurosciences, biobanking, H3Africa), policy developments (e.g., return of research results), and further practical considerations, including developments in automated approaches to consent management.

Attitudes of the Public Toward Consent for Biobank Research in Japan

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Attitudes of the Public Toward Consent for Biobank Research in Japan
Masanori Oikawa, Yoshiyuki Takimoto, Akira Akabayashi
Biopreservation & Biobanking, 19 December 2022
Abstract
Background
Parallel to the rapid advancement of biological and information technologies, the role and forms of biobank research have been constantly changing. The ethical, legal, and social implications of consent in biobank research are in a state of flux. This study aimed to clarify current Japanese public preferences regarding the consent model and explore how public attitudes are determined.
Methods
We conducted an online, population-based quantitative survey among Japanese residents aged between 20 and 69 years. Statistical analyses consisted of univariate and multivariate logistic regression.
Results
Of the 1580 respondents, 60.9% preferred autonomy-based consent (specific or dynamic consent) and 23.9% preferred broad-type consent (opt-out or broad consent). Marital status, gender, and privacy concerns were significantly associated with the preference for a consent model.
Conclusions
Our results demonstrated the public’s current preference for autonomy-based consent, including dynamic consent. However, our findings also revealed that approximately half of the respondents considered broad consent as somewhat preferable.