Struggling With Extensive Informed Consent Procedures for Cancer Trails – Is There Even a Benefit for the Patients?
Tilch M, Moringlane A, Schranz M, Theobald M, Hess G
Research Square, 3 January 2022
Abstract
Purpose
Informed consent procedures in clinical trials often differ in length and complexity to those in clinical routine care. Little is known about the benefit of extensive procedures as intended in clinical trials compared to procedures in routine cancer treatment.
Methods
In two different clinical studies performed at a comprehensive cancer center, we compared patients’ comprehension and satisfaction of current informed consent procedures in routine clinical care with the level of comprehension and satisfaction of patients treated within clinical trials. Patients with a new cancer diagnosis and recent informed consent received a questionnaire about satisfaction, comprehension, time management and physician-patient relationship of the informed consent process. Patients in cohort 1 consented to cancer treatment within a clinical trial and were additionally interviewed in a structured way; patients in cohort 2 consented to “standard” chemotherapy and received a follow-up questionnaire after 6 months.
Results
In cohort 1, 82 patients completed the questionnaire and had an additional structured interview. They were treated in 41 different trials, receiving up to 40 pages of educational material. In cohort 2, 89 patients completed the first and 52 completed the follow-up questionnaire after receiving a standard informed consent form of 6 pages. Subjective understanding and satisfaction with the information provided was equally very high. However, deficits in objective understanding were observed in both cohorts.
Conclusion
Extensive informed consent procedures for clinical cancer trials have not been associated with a higher level of satisfaction or measurable objective understanding, therefore the benefit seems to be limited.
Year: 2022
“Informed Consent in the Refugees and Immigrants Mental Health Researches – A Qualitative Systematic Review and Recommendations”
“Informed Consent in the Refugees and Immigrants Mental Health Researches – A Qualitative Systematic Review and Recommendations”
Fatemah Samir Alghamdi
Arab Journal for Scientific Publishing, January 2022
Open Access
Abstract
The refugee and migration crisis is at its most critical consideration in history. Millions of people fled their countries to save their lives from armed conflicts or natural disasters that impacted their mental and physical health. This article aimed to map out the body of published articles in the refugees’ and immigrants’ researches to highlight the method of informed consent process that is crucial for the Institutional Review Boards. This research systematically reviewed published literature between 2010 and 2020 on acquiring informed consent among refugees and immigrants. This systematic review was conducted in the Association of Computing Machinery (ACM), PschInfo, EBSCO, and PubMed using Preferred Reporting Items of Systematic Review and Meta-Analyses (PRISMA) framework to identify the process of informed consent in researches that addressed mental health and related issues among refugees and immigrants. A total of 32 qualitative and quantitative research genres were reviewed to highlight the informed consent procedure in refugees and immigrants researches between 2010 to 2020. The current research found out three themes: a third party involvement, participants’ educational level, and ethical violation in the informed consent process. Also, this research suggested the multifaceted informed consent to maximize their search outcomes and elude ethical violations.
Consent for rapid genomic sequencing for critically ill children: legal and ethical issues
Consent for rapid genomic sequencing for critically ill children: legal and ethical issues
Original Article
Christopher Gyngell, Fiona Lynch, Zornitza Stark, Danya Vears
Monash Bioethics Review, 31 December 2021; 39 pp 117–129
Abstract
Although rapid genomic sequencing (RGS) is improving care for critically ill children with rare disease, it also raises important ethical questions that need to be explored as its use becomes more widespread. Two such questions relate to the degree of consent that should be required for RGS to proceed and whether it might ever be appropriate to override parents’ decisions not to allow RGS to be performed in their critically ill child. To explore these questions, we first examine the legal frameworks on securing consent for genomic sequencing and how they apply to the specific context of RGS for critically ill children. We then use a tool from clinical ethics, the Zone of Parental Discretion, to explore two case studies and identify under which circumstances it might be appropriate for parental refusal of RGS to be overridden. We argue that RGS may be a context where, in addition to assessing the complexity of the test offered, it is ethically appropriate to consider an effect on patient outcomes when deciding the degree of consent required. We also suggest that there are some contexts where it may be ethically justified to perform RGS, even when it is actively against the wishes of the parents. More work is needed to examine exactly how ‘time-sensitive’ exceptions to current guidance on consent for genomic sequencing could be formulated and operationalised for RGS for critically ill-children.
Health data: when children reach the age of consent
Health data: when children reach the age of consen
World View
Jillian Hastings Ward
Nature Medicine, 6 January 2022
Open Access
Excerpt
Parents give consent for their children’s health data to be used in research, but what happens when the children reach adulthood, and how can researchers keep families involved in the meantime? COVID-19 vaccinations for teenagers have been in the news, which raises questions about parental influence over the decision of children to get vaccinated — or not. In some countries, including the UK, children under the age of 16 can give consent for medical treatment once they are deemed able to fully appreciate what is involved (sometimes known as ‘Gillick competence’). This is of growing importance for children whose parents have signed them up for genetic research and other studies that use their health data. When and how do children get a say in what happens to their health data?..
CrowdMed-II: a blockchain-based framework for efficient consent management in health data sharing
CrowdMed-II: a blockchain-based framework for efficient consent management in health data sharing
Chaochen Hu, Chao Li, Guigang Zhang, Zhiwei Lei, Mira Shah, Yong Zhang, Chunxiao Xing, Jinpeng Jiang, Renyi Bao
World Wide Web, 1 January 2022
Open Access
Abstract
The healthcare industry faces serious problems with health data. Firstly, health data is fragmented and its quality needs to be improved. Data fragmentation means that it is difficult to integrate the patient data stored by multiple health service providers. The quality of these heterogeneous data also needs to be improved for better utilization. Secondly, data sharing among patients, healthcare service providers and medical researchers is inadequate. Thirdly, while sharing health data, patients’ right to privacy must be protected, and patients should have authority over who can access their data. In traditional health data sharing system, because of centralized management, data can easily be stolen, manipulated. These systems also ignore patient’s authority and privacy. Researchers have proposed some blockchain-based health data sharing solutions where blockchain is used for consensus management. Blockchain enables multiple parties who do not fully trust each other to exchange their data. However, the practice of smart contracts supporting these solutions has not been studied in detail. We propose CrowdMed-II, a health data management framework based on blockchain, which could address the above-mentioned problems of health data. We study the design of major smart contracts in our framework and propose two smart contract structures. We also introduce a novel search contract for searching patients in the framework. We evaluate their efficiency based on the execution costs on Ethereum. Our design improves on those previously proposed, lowering the computational costs of the framework. This allows the framework to operate at scale and is more feasible for widespread adoption.
Informed Consent in Digital Data Management [BOOK CHAPTER]
Informed Consent in Digital Data Management [BOOK CHAPTER]
Elisabeth Hildt, Kelly Laas
Codes of Ethics and Ethical Guidelines, 1 January 2022; pp 55-81 [Springer]
Abstract
This article discusses the role of informed consent, a well-known concept and standard established in the field of medicine, in ethics codes relating to digital data management. It analyzes the significance allotted to informed consent and informed consent-related principles in ethics codes, policies, and guidelines by presenting the results of a study focused on 31 ethics codes, policies, and guidelines held as part of the Ethics Codes Collection. The analysis reveals that up to now, there is a limited number of codes of ethics, policies, and guidelines on digital data management. Informed consent often is a central component in these codes and guidelines. While there undoubtedly are significant similarities between informed consent in medicine and digital data management, in ethics codes and guidelines, informed consent-related standards in some fields such as marketing are weaker and less strict. The article concludes that informed consent is an essential standard in digital data management that can help effectively shape future practices in the field. However, a more detailed reflection on the specific content and role of informed consent and informed consent-related standards in the various areas of digital data management is needed to avoid the weakening and dilution of standards in contexts where there are no clear legal regulations.
An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
Study Protocol
Lydia O’Sullivan, Stefano Savinelli, Stephen O’Hare, Sinéad Holden, Ciara McHugh, Patrick Mallon, Peter Doran
Trials, 17 January 2022; 23(50)
Open Access
Abstract
Background
It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants’ understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This protocol describes a study to evaluate whether an enhanced PIL/ICF and website help research participants to understand important information about a human immunodeficiency virus (HIV) randomised clinical trial.
Methods
This Study Within A Trial (SWAT) is a prospective, multi-centre, randomised, controlled, parallel-group study embedded in a host clinical trial. The host trial (the SWIFT trial; EudraCT: 2019-002314-39) is a prospective, multi-centre, randomised, open-label, controlled trial investigating if semaglutide along with dietary advice assists individuals with HIV and obesity to lose weight, compared to dietary advice alone. For the SWAT, participants will be randomised in a 1:1 ratio to either the control (standard PIL/ICF) or the intervention (an enhanced PIL/ICF and a website which includes animations). The enhanced PIL/ICF and website were developed in line with the guidance from organisations which promote plain English and accessible public-facing materials in conjunction with HIV Ireland, a HIV advocacy organisation, and our previous work on consent documents. The primary outcome of the SWAT is the quality of informed consent, assessed by a validated comprehension test—the modified Deaconess Informed Consent Comprehension Test (DICCT). The DICCT will be administered within 48 h of consent to the host trial. The secondary is recall, measured by the modified DICCT questionnaire scores 2 weeks post-consent to the host trial.
Discussion
The results of this SWAT will add to the methodological evidence base on the use of multimedia to improve the quality of informed consent to randomised clinical trials.
Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Daniel Robins, Rachel Brody, Irena Parvanova, Joseph Finkelsein
Nurses and Midwives in the Digital Age, December 2021
Open Access
Abstract
This study focuses on feedback from domain experts to assess usability and acceptance of the E-Consent electronic consent platform. Quantitative and qualitative data were captured throughout the usability inspection, which was structured around a cognitive walkthrough with heuristics evaluation. Additional surveys measured biobanking knowledge and attitudes and familiarity with informed consent. A semi-structured qualitative interview captured open-ended feedback. 23 researchers of various ages and job titles were included for analysis. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction, and the mean result of 86.7 corresponds with an ‘above average’ usability rating in the >90th percentile. Overall, participants believe that electronic consenting using this platform will be faster than previous workflows while enhancing patient understanding, and human rapport is still a key component of the consent process. Expert review has provided valuable insight and actionable information that will be used to further enhance this maturing platform.
Developing an e-consent system
Developing an e-consent system
K. Burke, N. Grover, L. Zhang, N. Amdeeb, E. Liu, A. Sapozhnikova
Clinical Trials, 2021; 18(supplement 5) pp 87-88
Abstract
With the COVID-19 pandemic, the ability to coordinate and manage research studies remotely has become increasingly important. Most systems offer a variation of a mobile interface for study participants to complete self-administered questionnaires outside of the clinical setting. However, there was a need for functionality to allow a potential participant to virtually and electronically complete a screening questionnaire and provide consent. The web development team and research staff at the George Washington University Biostatistics Center collaborated to create a web-based public form and electronic informed consent system. This system allows potential participants to be screened and join studies without the need to be physically present to sign regulatory documents. The e-consent system is based on the Biostatistics Center’s existing electronic patient report outcome system. Users are able to access the system on a variety of devices, as the display is tailored to the size of the screen. To assure data quality and security, the system incorporates reCAPTCHA verification, email verification, tailored in-system messaging, personal links and codes, link expiration, electronic signature, and encryption. Existing features from the electronically patient report outcome system-such as skip patterns, range checks, lookup tables, and partial saving-were utilized to minimize data quality issues. In describing the design, implementation, successes, and challenges of this system, the Biostatistics Center team hopes to inform other coordinating centers and research studies interested in utilizing virtual enrollment systems for remote research.
Empowering patients with dementia to make legally effective decisions: a randomized controlled trial on enhancing capacity to consent to treatment
Empowering patients with dementia to make legally effective decisions: a randomized controlled trial on enhancing capacity to consent to treatment
Research Article
Aoife Poth, Susanne Penger, Maren Knebel, Tanja Müller, Johannes Pantel, Frank Oswald, Julia Haberstroh
Aging & Mental Health, 6 January 2022
Abstract
Objectives
As our society ages, the incidence of age-related diseases increases and with it the number of medical treatments that require informed consent. Capacity to consent is often categorically questioned in persons with dementia (PwD) without appropriate assessment, depriving them of their right to autonomous decision-making. Supportive structures for PwD that comply with legal requirements are lacking. The EmMa project tried to overcome this shortcoming by developing and testing possible supportive measures to enhance the informed consent process for PwD.
Method
These enhanced consent procedures (ECPs) were tested in a randomized controlled trial with 40 PwD. It was hypothesized that strengths-based ECPs could improve capacity to consent to a drug treatment in PwD as measured with a semi-structured interview.
Results
Against the expectations, no effect of the ECPs on capacity to consent could be found, but the ECPs improved understanding of information in PwD.
Conclusion
To empower PwD in clinical settings, however, all aspects of capacity to consent should be targeted with specific aids that are implemented carefully and selectively. More research on possible aids for ECPs is urgently needed in order to enable ethically and legally robust informed consent. In particular, effective ways to improve both reasoning and appreciation are yet to be found.
Center for Informed Consent Integrity 