20 Development of an application for digital capture of informed consent in research [POSTER]

20 Development of an application for digital capture of informed consent in research [POSTER]
Azariah Kusi-Yeboah, Dan Ward, Ross Murray, Daiana Bassi, Sue Conner, Yun Fu, Dean Mohamedally, Gemma Molyneux, Graham Roberts, Neil Sebire
Archives of Disease in Childhood, 22 November 2019; 104(supplement 4)
Abstract
Introduction 
Clinical trials and research studies are vital for treatment innovations. In order to give informed consent, participants are provided with information sheets that describe the study in detail. The current system is paper based and documents must be retained and archived. The aim of this project was to create a system to digitalise the process.
Method 
As part of a joint collaboration between GOSH and UCL computer science (CS) through the industry exchange network programme, we developed a mobile application for digital capture and management of consent. The application was based on a standard 3-tier (presentation, logic and data), software architecture pattern. The presentation tier consists of mobile and web applications. The mobile app was developed in Ionic4, while the web app makes use of Bootstrap to create fully responsive web pages. The logic tier, which contains the application’s functional business logic, was written in Node.js and consists of the RESTful APIs the mobile and web app use to access data. The data tier comprises of a MySQL database.
Results 
A web application was developed to create study documentation that can be viewed and completed on a mobile app. The system allows for the management of study documents to ensure version control. User profiles for staff can be created to control access to studies, therefore only staff with permission can access documentation and consent participants to a research study. The application allows information sheets to be sent to by email to participants, and for signatures to be taken digitally. All completed paperwork can be stored on a cloud database.
Conclusion 
A proof of principle system for capturing consent electronically has been developed. This system could be further enhanced to provide a screen reader function and could incorporate animations or films to enhance the description of research studies to children.

Editor’s note: GOSH refers to the Great Ormond Street Hospital and UCL to the University College London.

Privacy Nudges: An Alternative Regulatory Mechanism to Informed Consent for Online Data Protection Behaviour

Privacy Nudges: An Alternative Regulatory Mechanism to Informed Consent for Online Data Protection Behaviour
Sheng Yin Soh
European Data Protection Law Review, 1 October 2019; 65
Abstract
The informed consent paradigm of data protection law in the EU has failed to foster privacy-protective behaviour online, due to findings from behavioural science such as bounded rationality and asymmetric information. Hence, this article proposes a soft partnership approach through the use of “privacy nudges” as an alternative regulatory tool to informed consent to nudge users towards more optimal privacy protection decisions. This article also discussed the potential benefits of privacy nudges, some of the main critiques of nudging and future direction for improvement.

Dynamic Consent: An Evaluation and Reporting Framework

Dynamic Consent: An Evaluation and Reporting Framework
Research Article
Megan Prictor, Megan A. Lewis, Ainsley J. Newson, Matilda Haas, Sachiko Baba, Hannah Kim, Minori Kokado, Jusaku Minari, Fruzsina Molnár-Gábor, Beverley Yamamoto, Jane Kaye, Harriet J. A. Teare
Journal of Empirical Research of Human Research Ethics, 15 November 2019
Abstract
Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher–participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.

 

Informed Consent in Clinical Trials for Persons with Dementia

Informed Consent in Clinical Trials for Persons with Dementia
Joan G Carpenter
Innovation in Aging, 8 November 2019; 3(Supplement 1)
Abstract
Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

 

What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study

What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study
Jennifer NW Lim, Rosa Almeida, Vjera Holthoff-Detto, Geke DS Ludden, Tina Smith, Kristina Niedderer
International Mind Conference, 19-20 September 2019; Dresden Germany
Open Access
Abstract
Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.

Informed consent as a situated research process in an ethnography of incarcerated youth in Denmark [BOOK CHAPTER]

Informed consent as a situated research process in an ethnography of incarcerated youth in Denmark [BOOK CHAPTER]
Tea Terbenfeldt Bengtsson
Complexities of Researching with Young People, December 2019; chapter 10
Excerpt
In this chapter I reflect on the complexities of obtaining informed consent when doing ethnography with incarcerated youth. Through concrete examples, it is demonstrated that it is often impossible to obtaining informed consent through standardized research practice. Thus, informed consent cannot be standardized if we are to conduct ethically grounded ethnographies with vulnerable youth but must be developed as a situated research practice throughout the research process…

A framework for tiered informed consent for health genomic research in Africa

A framework for tiered informed consent for health genomic research in Africa
Victoria Nembaware, Katherine Johnston, Alpha A. Diallo, Maritha J. Kotze, Alice Matimba, Keymanthri Moodley, Godfrey B. Tangwa, Rispah Torrorey-Sawe, Nicki Tiffin
Nature Genetics, 28 October 2019; 51 pp 1566–1571
Abstract
A generic framework for providing participant information and implementing a tiered consent process for health genomic research in Africa can help to harness global health benefits from sharing and meta-analysis of African genomic data while simultaneously respecting and upholding the autonomy and individual choices of African research participants.

 

Patients’ decision-making in the informed consent process in a hierarchical and communal culture

Patients’ decision-making in the informed consent process in a hierarchical and communal culture
Original Article
Astrid Pratidina Susilo, Brahmaputra Marjadi, Jan van Dalen, Albert Scherpbier
The Asia Pacific Scholar, 3 September 2019; 4(3) pp 57-66
Open Access
Abstract
Objective
To investigate patients’ decision-making in the informed consent process in a hierarchical and communal culture.
Methods
This qualitative study took place in an Indonesian hospital and was conducted in line with the Grounded Theory approach. Fifteen patients and twelve family members were interviewed to understand the patients’ decision-making process and factors that contributed to this process. Interview transcripts were analysed using the constant comparison method.
Results
Patients used information to develop an explanation of their illness and treatment. They consented to a medical procedure if information from their physicians matched their own explanation. An increasing severity of the disease urged patients to decide, even when a satisfying explanation had not been developed. A hierarchical relationship between physicians and patients hampered patients’ discussing concerns or sharing emotions with their physicians. To maintain a harmonious relation with their physicians, patients accepted that some questions remained unanswered even after a decision had been made.
Conclusion
The strong hierarchical and communal context added to the complexity in the physician-patient relationship and consequently influenced patients’ decision-making. In addition to strengthening physicians’ communication skills, involving other health professionals as patient advocates or mediators is recommended to ensure patients make voluntary and informed decisions.

Informed Consent as Fulfillment of Rights and Obligations in Therapeutic Transactions Indonesian Medical Services

Informed Consent as Fulfillment of Rights and Obligations in Therapeutic Transactions Indonesian Medical Services
Teguh Anindito
Advances in Social Science, Education and Humanities Research, 2019; 358
Abstract
The informed consent principle functions to protect the autonomy and integrity of individuals who have the right to make their own choices freely for treatment to be carried out by doctors/medical personnel. According to MKDKI 80% of the 135 cases reported were caused by poor communication between doctors and patients. This study aims to analyze informed consent in therapeutic transactions as a fulfillment of rights and obligations for doctors and patients. The research was conducted in a normative juridical method, emphasizing the norms in legislation, theories, and doctrines related to health law, especially the study of informed consent. The data obtained is analyzed by the logic of deduction, taking into account the legal concept in the system of legislation. The results of the study find that urgency of informed consent is to protect and increase patient autonomy, protect patients and prevent manipulative and coercive actions and increase the attitude of self-awareness of the medical team. Therefore, medical personnel must be rational as both medics and moralists. Medical personnel needs to pay attention to the implementation of informed consent and standard professional practice in accordance with applicable regulations.

Acting In Good Faith: Operating Without Truly Informed Consent

Acting In Good Faith: Operating Without Truly Informed Consent
Jeffrey G. Gaca
The Annals of Thoracic Surgery, December 2019; 108(6) pp 1613-1614
Abstract
Patients who undergo cardiac surgical procedures represent the full spectrum of society, from those who obsessively research, investigate, and query the treating physicians prior to an operation to those who want to hear nothing at all about an upcoming procedure. This latter group of patients often will say, “Doc, I trust you, just do what you think is right.” The key question in this scenario1 is should the surgeon proceed with mitral valve repair without truly informed consent? Informed consent comprises several important fundamental elements, including (1) competence, (2) disclosure, and (3) voluntariness.