Practical approaches for supporting informed consent in neonatal clinical trials

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Practical approaches for supporting informed consent in neonatal clinical trials
Mini Review
Susan H. Wootton, Matthew Rysavy, Peter Davis, Marta Thio, Mar Romero-Lopez, Lindsay F. Holzapfel, Tamara Thrasher, Jaleesa D. Wade, Louise Owen
Acta Paediatrica, 22 February 2024
Abstract
The survival and health of preterm and critically ill infants have markedly improved over the past 50 years, supported by well-conducted neonatal research. However, newborn research is difficult to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials.
Conclusion
The authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.

Editor’s note: Acta Paediatrica is a peer-reviewed monthly journal published on behalf of the Foundation Acta Paediatrica based at the Karolinska Institute in Sweden.

The Donation of Human Biological Material for Brain Organoid Research: The Problems of Consciousness and Consent

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The Donation of Human Biological Material for Brain Organoid Research: The Problems of Consciousness and Consent
Masanori Kataoka, Christopher Gyngell, Julian Savulescu, Tsutomu Sawa
Science and Engineering Ethics, 5 February 2024
Abstract
Human brain organoids are three-dimensional masses of tissues derived from human stem cells that partially recapitulate the characteristics of the human brain. They have promising applications in many fields, from basic research to applied medicine. However, ethical concerns have been raised regarding the use of human brain organoids. These concerns primarily relate to the possibility that brain organoids may become conscious in the future. This possibility is associated with uncertainties about whether and in what sense brain organoids could have consciousness and what the moral significance of that would be. These uncertainties raise further concerns regarding consent from stem cell donors who may not be sufficiently informed to provide valid consent to the use of their donated cells in human brain organoid research. Furthermore, the possibility of harm to the brain organoids raises question about the scope of the donor’s autonomy in consenting to research involving these entities. Donor consent does not establish the reasonableness of the risk and harms to the organoids, which ethical oversight must ensure by establishing some measures to mitigate them. To address these concerns, we provide three proposals for the consent procedure for human brain organoid research. First, it is vital to obtain project-specific consent rather than broad consent. Second, donors should be assured that appropriate measures will be taken to protect human brain organoids during research. Lastly, these assurances should be fulfilled through the implementation of precautionary measures. These proposals aim to enhance the ethical framework surrounding human brain organoid research.

Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review

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Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review
Wendy M Charles, Mark B van der Waal, Joost Flach, Arno Bisschop, Raymond X van der Waal, Hadil Es-Sbai, Christopher J McLeod
JMIR Research Protocols, 5 February 2024
Abstract
Background
Blockchain has been proposed as a critical technology to facilitate more patient-centric research and health information sharing. For instance, it can be applied to coordinate and document dynamic informed consent, a procedure that allows individuals to continuously review and renew their consent to the collection, use, or sharing of their private health information. Such has been suggested to facilitate ethical, compliant longitudinal research, and patient engagement. However, blockchain-based dynamic consent is a relatively new concept, and it is not yet clear how well the suggested implementations will work in practice. Efforts to critically evaluate implementations in health research contexts are limited.
Objective
The objective of this protocol is to guide the identification and critical appraisal of implementations of blockchain-based dynamic consent in health research contexts, thereby facilitating the development of best practices for future research, innovation, and implementation.
Methods
The protocol describes methods for an integrative review to allow evaluation of a broad range of quantitative and qualitative research designs. The PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) framework guided the review’s structure and nature of reporting findings. We developed search strategies and syntax with the help of an academic librarian. Multiple databases were selected to identify pertinent academic literature (CINAHL, Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science) and gray literature (Electronic Theses Online Service, ProQuest Dissertations and Theses, Open Access Theses and Dissertations, and Google Scholar) for a comprehensive picture of the field’s progress. Eligibility criteria were defined based on PROSPERO (International Prospective Register of Systematic Reviews) requirements and a criteria framework for technology readiness. A total of 2 reviewers will independently review and extract data, while a third reviewer will adjudicate discrepancies. Quality appraisal of articles and discussed implementations will proceed based on the validated Mixed Method Appraisal Tool, and themes will be identified through thematic data synthesis.
Results
Literature searches were conducted, and after duplicates were removed, 492 articles were eligible for screening. Title and abstract screening allowed the removal of 312 articles, leaving 180 eligible articles for full-text review against inclusion criteria and confirming a sufficient body of literature for project feasibility. Results will synthesize the quality of evidence on blockchain-based dynamic consent for patient-centric research and health information sharing, covering effectiveness, efficiency, satisfaction, regulatory compliance, and methods of managing identity.
Conclusions
The review will provide a comprehensive picture of the progress of emerging blockchain-based dynamic consent technologies and the rigor with which implementations are approached. Resulting insights are expected to inform best practices for future research, innovation, and implementation to benefit patient-centric research and health information sharing.

Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit

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Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit
Emily Sangillo, Neena Jube-Desai, Dina El-Metwally, Colleen Hughes Driscoll
Pediatric Quality and Safety, January-February 2024; 9(1)
Abstract
Background
Informed consent is necessary to preserve patient autonomy and shared decision-making, yet compliant consent documentation is suboptimal in the intensive care unit (ICU). We aimed to increase compliance with bundled consent documentation, which provides consent for a predefined set of common procedures in the neonatal ICU from 0% to 50% over 1 year.
Methods
We used the Plan-Do-Study-Act model for quality improvement. Interventions included education and performance awareness, delineation of the preferred consenting process, consent form revision, overlay tool creation, and clinical decision support (CDS) alert use within the electronic health record. Monthly audits categorized consent forms as missing, present but noncompliant, or compliant. We analyzed consent compliance on a run chart using standard run chart interpretation rules and obtained feedback on the CDS as a countermeasure.
Results
We conducted 564 audits over 37 months. Overall, median consent compliance increased from 0% to 86.6%. Upon initiating the CDS alert, we observed the highest monthly compliance of 93.3%, followed by a decrease to 33.3% with an inadvertent discontinuation of the CDS. Compliance subsequently increased to 73.3% after the restoration of the alert. We created a consultant opt-out selection to address negative feedback associated with CDS. There were no missing consent forms within the last 7 months of monitoring.
Conclusions
A multi-faceted approach led to sustained improvement in bundled consent documentation compliance in our neonatal intensive care unit, with the direct contribution of the CDS observed. A CDS intervention directed at the informed consenting process may similarly benefit other ICUs.

Assessment of the current status of real-world pharmacogenomic testing: informed consent, patient education, and related practices

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Assessment of the current status of real-world pharmacogenomic testing: informed consent, patient education, and related practices
Original Research
Lucas Pereira, Cyrine-Eliana Haidar, Susanne B. Haga, Anna G. Cisler, April Hall, Sanjay K. Shukla, Scott J. Hebbring,
Emili J. W. Leary
Frontiers in Pharmacology, 8 February 2024
Abstract
Introduction
The practice of informed consent (IC) for pharmacogenomic testing in clinical settings varies, and there is currently no consensus on which elements of IC to provide to patients. This study aims to assess current IC practices for pharmacogenomic testing.
Methods
An online survey was developed and sent to health providers at institutions that offer clinical germline pharmacogenomic testing to assess current IC practices.
Results
Forty-six completed surveys representing 43 clinical institutions offering pharmacogenomic testing were received. Thirty-two (74%) respondents obtain IC from patients with variability in elements incorporated. Results revealed that twenty-nine (67%) institutions discuss the benefits, description, and purpose of pharmacogenomic testing with patients. Less commonly discussed elements included methodology and accuracy of testing, and laboratory storage of samples.
Discussion
IC practices varied widely among survey respondents. Most respondents desire the establishment of consensus IC recommendations from a trusted pharmacogenomics organization to help address these disparities.

The Effects of Placement and Order on Consent to Data Linkage in a Web survey

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The Effects of Placement and Order on Consent to Data Linkage in a Web survey
Jonathan Burton, Mick P Couper, Annette Jäckle
Journal of Survey Statistics and Methodology, 24 February 2024
Abstract
We report on an experiment in a supplemental web survey as part of a longitudinal study in the United Kingdom where we ask survey respondents to consent to two forms of data linkage to health records and to consent to be mailed a serology kit. We varied the placement (early, early in context, or late in the survey) and order (linkage first or serology first) of the consent requests. We also examine reasons for consent or non-consent. We find that order of the requests does not make much difference, but making the requests early in the survey significantly increases consent rates over asking them after a series of content-related questions (by 3.4 percentage points) or later in the survey (by 7.2 percentage points). This is consistent with previous research showing that early requests for consent in a survey have a positive effect. The main reason chosen for not consenting related to the personal nature of the information requested.

Consent Management System on Patient-Generated Health Data

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Consent Management System on Patient-Generated Health Data
Randine P, Salant E, Muzny M, Pape-Haugaard L
Studies in Health Technology and Informatics, 1 January 2024
Abstract
We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.

Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities

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Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities
Pillay N, Ncube N, Moopelo K, Mothoagae G, Welte O, Shogole M, Gwiji N, Scott L, Moshani N, Tiffin N, Boulle A, Griffiths F, Fairlie L, Mehta U, LeFevre A, Scott K
Sexual and Reproductive Health Matters, 1 December 2023
Abstract
The increasing digitisation of personal health data has led to an increase in the demand for onward health data. This study sought to develop local language scripts for use in public sector maternity clinics to capture informed consent for onward health data use. The script considered five possible health data uses: 1. Sending of general health information content via mobile phones; 2. Delivery of personalised health information via mobile phones; 3. Use of women’s anonymised health data; 4. Use of child’s anonymised health data; and 5. Use of data for recontact. Qualitative interviews (n = 54) were conducted among women attending maternity services in three public health facilities in Gauteng and Western Cape, South Africa. Using cognitive interviewing techniques, interviews sought to:(1) explore understanding of the consent script in five South African languages, (2) assess women’s understanding of what they were consenting to, and (3) improve the consent script. Multiple rounds of interviews were conducted, each followed by revisions to the consent script, until saturation was reached, and no additional cognitive failures identified. Cognitive failures were a result of: (1) words and phrases that did not translate easily in some languages, (2) cognitive mismatches that arose as a result of different world views and contexts, (3) linguistic gaps, and (4) asymmetrical power relations that influence how consent is understood and interpreted. Study activities resulted in the development of an informed consent script for onward health data use in five South African languages for use in maternity clinics.

Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures

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Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures
Original Article
Winnie Kavulani Luseno, Bonita J. Iritani, Shane Hartman, Fredrick S. Odongo, Florence Anyango Otieno, Barrack Otieno Ongili, Stuart Rennie
Journal of Adolescent Health, March 2024
Abstract
Purpose
Youth aged 15–19 years and parents of minors aged 15–17 years in sub-Saharan Africa are under-represented in empirical consent research. Thus, knowledge is limited concerning the adequacy of consent procedures and need for strategies to improve consent comprehension among these groups. We assessed comprehension following standard consent procedures and evaluated an enhanced procedure among Kenyan youth and parents.
Methods
Participants were adolescents aged 15–17 years (n = 273), their parents (n = 196), and young adults aged 18–19 years (n = 196). We used a quasi-experimental cohort design to implement standard and enhanced (single condition: extended discussion, test/feedback) consent procedures. Participants completed a 21-item informed consent comprehension assessment instrument.
Results
After standard consent procedures, mean comprehension scores were 11.36, 13.64, and 13.43 (score range: 0–21) among adolescents, young adults, and parents, respectively. About 6.2% of adolescents, 19.6% of young adults, and 21.4% of parents answered ≥ 80% of the questions correctly. After the enhanced procedures, comprehension scores (15.87 adolescents, 17.81 young adults, and 16.77 parents) and proportions answering ≥ 80% of the questions correctly (44.9% adolescents, 76.8% young adults, and 64.3% parents) increased significantly. Regression analysis indicated statistically significant differences (p < .001) in comprehension scores between the enhanced and standard groups (β = 3.87 adolescents, β = 4.03 young adults, and β = 3.60 parents) after controlling for sociodemographic factors.
Discussion
Enhancing consent procedures with extended discussions, quizzes, and additional explanation where understanding is inadequate is a promising approach for improving comprehension. However, poorer comprehension among adolescents compared to young adults and parents underscores the need for research to identify additional approaches to improve understanding.