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
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
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.

Co-creation of information materials within the assent process: From theory to practice
Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Health expectations : an international journal of public participation in health care and health policy, 23 November 2022
Open Access
Abstract
Introduction
The informed consent process is key to safeguarding the autonomy of the participant in medical research. For this process to be valid, the information presented to the potential participant should meet their needs and be understood by them. The i-CONSENT project has developed ‘Guidelines for adapting the informed consent process in clinical trials’ which aim to improve informed consent so that they are easier to understand and better adapted to the needs and preferences of the target population. The best way to tailor information to the characteristics and preferences of the target population is to involve the community itself.
Methods
Following guidelines developed by i-CONSENT, assent materials were co-created for a mock clinical trial of the human papillomavirus vaccine in adolescents. During the process, two design thinking sessions were conducted involving a total of 10 children and 5 parents. The objectives of the sessions were to find out the children’s opinion of the informed consent (assent in their case) process in clinical trials, identify the parts that were most difficult to understand and alternatives for their presentation and wording, identify the preferred formats for receiving the information and the main characteristics of these formats, design a video explaining the clinical trial and evaluate a tool for assessing comprehension.
Results
Assent materials were co-created in three formats: a web-based material following a layered approach; a video in story format; a pdf document with an innovative way of presenting information compared to traditional assent documents. In addition, the Comprehension of Assent Questionnaire was co-designed, based on the Quality of Informed Consent questionnaire.
Conclusion
The design thinking methodology has proven to be an easy and useful tool for involving children in designing information tailored to their needs and preferences.
Patient or public contribution
A sample of the target population participated in the design and piloting of the materials created using design thinking methodology. In addition, patient representatives participated in the design and evaluation of the guidelines developed by the i-CONSENT project that were followed for the development of the materials in this study.

Using provocative design to foster electronic informed consent innovation
Research
Evelien De Sutter, Stef Verreydt, Koen Yskout, David Geerts, Pascal Borry, An Outtier, Marc Ferrante, Corinne Vandermeulen, Nele Vanmechelen, Bart Van der Schueren, Isabelle Huys
BMC Medical Informatics and Decision Making, 17 November 2022; 22(296)
Open Access
Abstract
Background
The development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.
Methods
Using a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants’ views and concerns were solicited. Thematic analysis was undertaken using NVivo.
Results
The majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders’ access to an eIC system, and thus, to participants’ personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants’ understanding before providing their eIC.
Conclusions
Following a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants’ motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.

Overcoming barriers to informed consent in neurological research: Perspectives from a national survey
Research Article
Lauren R Sankary, Megan E Zelinsky, Paul J Ford, Eric C Blackstone, Robert J Fox
Research Ethics, 30 October 2022
Open Access
Abstract
The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

Misconduct and Consent: The Importance of Informed Consent in Medical Research
Book Chapter
Marton Gergely, Fida K. Dankar, Saed Alrabaee
Integrity of Scientific Research, 14 October 2022; pp 81-91 [Springer]
Abstract
Human subject research in the medical arena offers an indisputable contribution to society. However, all medical research needs to be conducted through maintaining strict levels of research standards and by complying with applicable regulations and guidelines. Despite this, medical research misconduct has been around for centuries, with countless examples of gross ethical oversights and morally flawed decisions made by both medical practitioners and researchers. One area of such misconduct is within that of informed consent. Despite the continually evolving rules and regulations surrounding informed consent in medical research, countless breaches are present surrounding the topic. In this paper, we discuss the origins of informed consent, the regulations and guidelines surrounding it, the common types of informed consent necessary to be gathered, and the potential pitfalls therein. We conclude with an overview of a selection of breaches in informed consent in the area of medical research and their likely reasons.

Informed consent in clinical trials
G P Kovane, V C Nikoderm, O Khondowe
South African Journal of Bioethics and Law, 12 October 2022; 15(2)
Abstract
Background
Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding.
Objectives
To assess participants’ understanding of IC of the research trial that they agreed to participate in.
Methods
A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.
Results
Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.
Conclusion
Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation.

Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial
Leonie Gerke, Sönke Ladwig, Franz Pauls, Manuel Trachsel, Martin Härter, Yvonne Nestoriuc
JMIR Research Protocols, 30 September 2022; 11(9)
Abstract
Background
Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects, the latter posing a moral dilemma between patient autonomy and nonmaleficence.
Objective
This protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation.
Methods
The optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations.
Results
This trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023.
Conclusions
If effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making.

Informed consent in clinical trials: Implementing methods to improve patient understanding in cancer research—A quality improvement initiative in a sarcoma trials unit
Meeting Abstract
Caitriona Goggin, Bader Al-Badri, Anna Stansfeld, Elizabeth Barquin, Benjamin Durand, Thuy-Giang Nguyen, Preethika Mahalingam, Eniola Ayeni, Andrea Napolitano, Shane Zaidi, Aisha Miah, Robin Lewis Jones, Charlotte Benson
American Society of Clinical Oncology Journal, Quality Care Symposium, 2022
Abstract
Background
Clinical trials are considered the cornerstone of improving outcomes for cancer patients. The understanding of an individual patient of the trial on which they are enrolled can vary significantly, with some studies demonstrating poor patient understanding of their involvement in trials. This exploratory study aimed to improve patient understanding of clinical trials and patient experience of the informed consent process by implementing measures to present complex trial information in alternative formats.
Methods
The project was undertaken in a sarcoma trials unit in a specialist cancer treatment centre. Baseline knowledge was assessed using an adapted version of the Quality of Informed Consent (QuIC) questionnaire. A decision-aid was created following focus group discussions with stakeholders, focusing on key trial questions for patients, such as consent, the research description, risks, benefits, and alternatives to the trial. A patient education video was produced by the research team, explaining general aspects of clinical trials in patient-friendly language. The decision-aids and videos were distributed during the informed consent process of trial recruitment over a 12-week period. The patient group was assessed with post-intervention questionnaires. Statistical analysis was descriptive due to the small numbers.
Results
Thirty sarcoma patients participated in the project, including baseline assessment of 15 patients previously enrolled on study, and 15 patients considering participation in a trial who underwent the intervention. 100% (n = 15) of the interventional group found the video and decision-aid useful. 60% (n = 18) of patients had a university level education, indicating a well-educated population. A pre- and post-intervention comparison demonstrated an improved understanding of 10 key elements of clinical trial information as shown in Table.
Conclusions
Our exploratory study has shown that patient education tools including decision-aids and patient videos can be successfully implemented to help improve patient understanding of clinical trial information and may be of benefit in other trials units. Further larger studies are required to confirm these findings.