Dynamic governance: A new era for consent for stem cell research
Perspective
Rosario Isasi, Heidi B. Bentzen, Morris Fabbri, Antonie Fuhr, Joel C. Glover, Nancy Mah, Deborah Mascalzoni, Sabine Mueller, Stefanie Seltmann, Andreas Kurtz
Stem Cell Reports, 15 August 2024
Open Access
Summary
Governance infrastructures streamline scientific and ethical provenance verification of human pluripotent stem cell (SC) lines. Yet, scientific developments (e.g., SC-derived embryo models, organoids) challenge research governance approaches to stored biospecimens, questioning the validity of informed consent (IC) models. Likewise, e-health platforms are driving major transformations in data processing, prompting a reappraisal of IC. Given these developments, participatory research platforms are identified as effective tools to promote longitudinal engagement, interactive decision-making, and dynamic governance. Learning from European initiatives piloting dynamic IC for biobanking and SC research, this Perspective explores the benefits and challenges of implementing dynamic IC and governance for SC.
Year: 2024
Consent to Data Processing in Biobanking: Regulatory Challenges of Data Processing in Biobanking, Using the Estonian Example
Consent to Data Processing in Biobanking: Regulatory Challenges of Data Processing in Biobanking, Using the Estonian Example
Book Chapter
Kärt Pormeister
Privacy, Data Protection and Data-driven Technologies, 2024 [Taylor&Francis]
Abstract
Under European Union (EU) data protection law, consent can generally only be relied upon as a legal basis for processing personal data if the consent has been given for one or more specified purposes. The fact is that in the world of scientific research, this is not always possible or feasible, is recognized in the recitals of the General Data Protection Regulation. Unfortunately, the European Data Protection Board has rendered this recognition in the recitals effectively moot by maintaining that even in research, a broader consent to data processing could only go as far as to cover multiple pre-defined projects, but not undefined future projects. This ‘one-size-fits-all’ stance on consent to data processing is a problem for biobanks, the existence and data processing purposes of which cannot be confined to pre-defined research projects. In the first part of this chapter, the author explores the evolution of consent to data processing for research purposes in EU data protection law and the interpretations given to it by a number of data protection institutions, and contrasts these to other emerging regulatory regimes within the EU concerning the (secondary) research use of personal data. In the second half of the chapter, the author exemplifies the previously explored theoretical problems using the Estonian Biobank as a practical example.
Genomic sequencing in newborn screening: balancing consent with the right of the asymptomatic at-risk child to be found
Genomic sequencing in newborn screening: balancing consent with the right of the asymptomatic at-risk child to be found
Bartha Maria Knoppers, Ana Eliza Bonilha, Anne-Marie Laberge, Arzoo Ahmed, Ainsley J. Newson
European Journal of Human Genetics, 12 August 2024
Open Access
Abstract
In this paper, we explore key aspects of the complex ethical and legal landscape surrounding consent in the context of incorporating genomic sequencing into existing newborn bloodspot screening programs. In particular, we consider the potential impact of genomic sequencing on the health rights of the child in relation to existing consent practices in newborn screening. We begin with an introduction to newborn screening programs and their population health goals. We then discuss public health ethics as a rationale underpinning newborn screening before turning to consent. We go on to describe seven current research projects on genomic sequencing in newborn screening and then introduce the ‘right of the asymptomatic at-risk child to be found’ as a useful concept to draw on when considering consent to newborn screening. We draw on this novel right to argue for the adoption of “appropriate consent” when it comes to certain uses of genomics in newborn screening. We contend that, for ‘virtual panels’ at least, appropriate consent proportionately balances the ongoing universality of newborn screening for important health conditions with an acknowledgement of the complex outcomes that bringing a complicated diagnostic technology into the screening domain will generate.
Editor’s Note: After assessing the observations and arguments made in this paper, we are reaching out to the corresponding author for clarification.
Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing
Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing
Lyndsay Newett, Rebekah McWhirter, Lisa Eckstein, Vanessa Warren, Dianne Nicol
Journal Of Empirical Research on Human Research Ethics, 2 August 2024; 19(3) pp 113–123
Abstract
This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data – without express consent – and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results (N = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia.
Genetic Data Privacy and ‘Legitimate Interest’ in Genetic Research: Is consent still a relevant narrative within the realm of big data research under the European data protection regime?
Genetic Data Privacy and ‘Legitimate Interest’ in Genetic Research: Is consent still a relevant narrative within the realm of big data research under the European data protection regime?
B Bak
PhD Thesis, University of Reading, 2024
Abstract/Summary
The processing of genetic data in scientific research delivers substantial benefits, striving for better well-being and healthcare for the public. The collection of genetic data stored in research repositories or biobanks for future research use, where researchers and research subjects do not engage, has become commonplace. However, the research use of genetic data also raises controversial questions regarding data protection. Genetic data uniquely distinguishes individuals from others and provides sensitive information about them and their relatives, concerning their current and future health status. Hence, its commercial misuse, leading to unethical discriminatory practices, and the reidentification of individuals must be prevented. This study aims to strike a balance between the public’s interest in genetic research and the protection of genetic privacy, by focusing on the General Data Protection Regulation (GDPR). Specifically, it assesses the degree to which individual consent, one of the GDPR bases for justifying research and the traditional research method, can effectively establish this delicate balance. It argues that the legitimate interest ground, an alternative GDPR basis, offers certain advantages over consent and the public interest ground—another GDPR basis. Contrary to the dominant opinion, the legitimate interest basis may effectively establish an equilibrium between this public/private divergence for certain genetic research activities. This is a consequence of the shift towards big data research and contemporary dynamics in the biomedical field, and it occurs without necessarily compromising data protection principles and research ethics. The study introduces a novel perspective on genetic research, aiming to catalyse transformative changes in both legal frameworks and societal norms from a standpoint of solidarity. This unconventional approach is offered as a topic for further research.
Editor’s Note: After assessing the observations and arguments made in this paper, we are reaching out to the corresponding author for clarification.
Use of E-Consent in Healthcare Settings: A Scoping Review
Use of E-Consent in Healthcare Settings: A Scoping Review
Haris Obaidi, Youssef Elkhyatt, Mahmood Alzubaidi, Mowafa Househ
Studies In Health Technology and Informatics, 22 August 2024
Abstract
Electronic consent is a technology-driven approach that remains challenging in various healthcare settings. Transitioning from paper-based to electronic consent (e-consent) has streamlined the consent process. This scoping review explores patients’ electronic consent in different healthcare settings. We searched four databases and selected 14 studies that met our inclusion criteria. Our results show that E-consent is associated with key measures such as sufficient information, accuracy, enhanced shared decision-making, and efficiency. The majority of studies used a comparative design model to contrast paper-based consent with E-consent. Our findings provide an overview of the current state of E-consent use in healthcare settings.
Examining Introduction of E-consent in The Neurosurgical Caseload: Understanding The Barriers to Implementation
Examining Introduction of E-consent in The Neurosurgical Caseload: Understanding The Barriers to Implementation
Original Article
Daniele S.C. Ramsay, Virensinh Rathod, Sami Rashed, Sohani Dassanayake, Santhosh Thavarajasingam, Nigel Mendoza, Ali R. Haddad
World Neurosurgery, 12 August 2024
Open Access
Abstract
Objective
To evaluate current usage and barriers of e-consent implementation in neurosurgical practice. Electronic consent (e-consent) forms provide an alternative method for conducting the informed consent (IC) procedure. IC requires an ability to understand, retain, weigh up and communicate decisions regarding the proposed procedure. Currently, e-consent has shown promise as a method of improving IC, yet barriers to implementation exist.
Methods
A comparative analysis regarding procedural and consent data was collected over six months in two neurosurgical centres with elective and emergency caseloads. These were evaluated for changes over time following e-consent introduction. Clinicians were surveyed for their experience using of e-consenting to understand the barriers to implementation.
Results
Over half (55.6%) of neurosurgical procedures made use of e-consent for IC. Lower rates of e-consent were used in trauma related procedures (38.38%) as compared to elective procedures. This did not increase significantly over the study period. Positive clinician survey feedback indicated e-consenting reduces the time required to perform IC, with 50% of respondents strongly agreeing. Barriers to implementation were reported on free-text entry pertaining largely to difficulties in emergency situations due to form complexity. The inability to create and edit templates for personalised e-consent delivery was a further limitation.
Conclusion
Despite the advantages conferred by e-consent for the administration of IC in neurosurgical procedures, reflected in our survey data, there remains limited use of the technology. Limitations remain relating to ease of access and complexity of use in trauma scenarios.
Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital
Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital
Research
Alexandra Schulz, Sabine Bohnet-Joschko
BMC Health Services Research, 2 August 2024
Open Access
Abstract
Background
This study aims to investigate the integration of modern sources of patient information, such as videos, internet-based resources, and scientific abstracts, into the traditional patient informed consent process in outpatient elective surgeries. The goal is to optimize the informed consent experience, enhance patient satisfaction, and promote shared decision making (SDM) between patients and surgeons. By exploring different patient informed consent formats and their impact on patient satisfaction, this research seeks to improve healthcare practices and ultimately enhance patient outcomes. The findings of this study will contribute to the ongoing efforts to improve the informed consent process in public hospitals and advance patient-centred care.
Methods
Data collection occurred at the day care clinic of a prominent German public hospital, forming an integral component of a prospective clinical investigation. The study exclusively focused on individuals who had undergone surgical intervention for skin cancer. For the purpose of meticulous data examination, the statistical software SPSS version 21 was harnessed. In the course of this study, a chi-square test was aptly employed. Its purpose was to scrutinize the nuances in patient experiences pertaining to informed consent across four distinct categories, viz., oral informed consent discussion (Oral ICD), written informed consent discussion (Written ICD), video-assisted informed consent discussion (video-assisted ICD), and digitally assisted informed consent discussion (digital-assisted ICD). The primary dataset of this inquiry was diligently gathered via a structured questionnaire administered to a targeted cohort of 160 patients. Within this sample, a balanced representation of genders was observed, encompassing 82 males and 78 females. Their collective age span ranged from 18 to 92 years, with an average age of 71 years. A randomized selection methodology was employed to include participants in this study during the period spanning from July 2017 to August 2018.
Results
Significant differences were observed across the groups for all research questions, highlighting variations in patient responses. Video-assisted and digital-assisted IC were rated as superior in patient satisfaction with information compared to written and oral IC. Demographic profiles of the four study groups were found to be comparable.
Conclusion
The findings of this study indicate that the incorporation of digital technologies in the informed consent process can enhance patient understanding during outpatient elective skin cancer surgeries. These results have important implications for increasing patient satisfaction and improving the SDM process within the hospital environment.
Compromised informed consent due to functional health literacy challenges in Chinese hospitals
Compromised informed consent due to functional health literacy challenges in Chinese hospitals
Research
Dangui Zhang, Zhilin Hu, Zhuojia Wu, Ting Huang, Tingting Huang, Junhao Liu, Hongkun Sun, William Ba-Thein
BMC Medical Ethics, 23 August 2024
Open access
Abstract
Background
Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study’s aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent.
Methods
In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs —teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05.
Results
The median age (IQR and range) of participants was 35.5 (28 – 49 and 13 – 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments—teach-back, perception, and cognizance—was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent.
Conclusions
This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.
CLARA-MeD Tool – A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish
CLARA-MeD Tool – A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish
Leonardo Campillos-Llanos, Federico Ortega-Riba, Ana R Terroba, Ana Valverde-Mateos, Adrián Capllonch-Carrión
Studies In Health Technology and Informatics, 22 August 2024
Abstract
We present an NLP web-based tool to help users understand consent forms (CFs) and clinical trial announcements (CTAs) in Spanish. For complex word identification, we collected: 1) a lexicon of technical terms and simplified synonyms (14 465 entries); and 2) a glossary (70 547 terms) with explanations from sources such as UMLS, the NCI dictionary, Orphadata or the FDA. For development, we extracted entities from 60 CTAs, 60 CFs and 60 patient information documents (PIDs). To prepare definitions for new terms, we used ChatGPT and experts validated them (28.99% needed to be fixed). We tested the system on 15 new CTAs, 15 CFs, and 15 PIDs, and we achieved an average F1 score of 82.91% (strict match) and of 94.65% (relaxed). The tool is available at: http://claramed.csic.es/demo.
Center for Informed Consent Integrity 