Context is key: ethical considerations related to consent and study design in acute cardiac care research
Journal Article
Neal W Dickert, Madeline Meer
European Heart Journal Acute Cardiovascular Care, 28 November 2024
Excerpt
    …There is also an important set of ethical issues that arise in cardiac critical care research. By their very nature, acute care studies involve ‘high stakes’ outcomes such as mortality, organ failure, and other major morbidities. Communicating about study enrolment with patients and family members in the context of life-or-death situations is difficult, and research itself is complex and unfamiliar. To make matters worse, decisions often must be made very quickly, because acute care must be delivered rapidly. These issues make consent processes difficult and, in some cases, impossible. Many patients with severe acute cardiac illness lack capacity to engage in decision-making, and surrogate decision makers are often unavailable and may struggle with having to make research enrolment decisions for someone else. The urgency of these situations only compounds baseline challenges related to deciphering patients’ preferences for participating in research.
In this piece, we focus on these ethical challenges and integrate them with practical considerations outlined above. We articulate paths forward for major types of acute cardiac care research, emphasising throughout the importance of attention to critical contextual factors…

On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup and collecting consent data
Research Article
Katharina Danhauser, Larissa Dorothea Lina Mantoan, Jule Marie Dittmer, Simon Leutner, Stephan Endres, Karla Strniscak, Jenny Pfropfreis, Martin Bialke, Dana Stahl, Bernadette Anna Frey, Selina Sophie Gläser, Laura Aurica Ritter, Felix Linhardt, Bärbel Maag, Georgia Donata Emily Miebach, Mirjam Schäfer, Christoph Klein, Ludwig Christian Hinske
PLOS Digital Health, 25 November 2024
Open Access
Abstract
Enrolling in a clinical trial or study requires informed consent. Furthermore, it is crucial to ensure proper consent when storing samples in biobanks for future research, as these samples may be used in studies beyond their initial purpose. For pediatric studies, consent must be obtained from both the child and their legal guardians, requiring the recording of multiple consents at once. Electronic consent has become more popular recently due to its ability to prevent errors and simplify the documentation of multiple consents. However, integrating consent capture into existing study software structures remains a challenge. This report evaluates the usability of the generic Informed Consent Service (gICS) of the University Medicine Greifswald (UMG) for obtaining electronic consent in pediatric studies. The setup was designed to integrate seamlessly with the current infrastructure and meet the specific needs of a multi-user, multi-study environment. The study was conducted in a pediatric research setting, where additional informed consent was obtained separately for the biobank. Over a period of 54 weeks, 1061 children and adolescents aged 3 to 17 years participated in the study. Out of these, 348 agreed also to participate in the biobank. The analysis included a total of 2066 consents and assents, with 945 paper-based and 1121 electronic consents. The study assessed the error susceptibility of electronic versus paper-based consents and found a significant reduction rate of errors of 94.7%. These findings provide valuable insights into the use of gICS in various studies and the practical implementation of electronic consent software in pediatric medicine.

Consent-Related Outcomes in the Alteplase Compared to Tenecteplase Trial
Michel C. Shamy, Brian Dewar, Yan Deschaintre, Nishita Singh, Carol Kenney, Mohammed A. Almekhlafi, Ayoola Ademola, Brian H. Buck, Tolulope T. Sajobi, Luciana Catanese, Kayla D. Sage, Dar Dowlatshahi, Laura C. Gioia, Aleksander Tkach, Richard H. Swartz, Bijoy K. Menon
Neurology, 26 November 2024
Abstract
Background and Objectives
In recent years, researchers have sought to address the challenges of obtaining informed consent for participation in acute stroke trials. We studied outcomes related to the use of deferral of consent in the phase 3 Alteplase Compared to Tenecteplase (AcT) trial.
Methods
As part of our protocol, we captured methods of consent, participant withdrawals, door-to-randomization times, and door-to-needle times. Participants at 3 sites were invited to complete a survey of attitudes regarding consent for AcT and for acute stroke trials generally.
Results
The AcT trial enrolled 1,600 participants from 22 centers across Canada of whom 1,537 were enrolled through deferral of consent (96.0%) and 63 (4.0%) were enrolled by prospective verbal consent followed by written informed consent. Of those enrolled by deferral of consent, 95% (1,454/1,537) consented to ongoing participation. Door-to-randomization times were similar regardless of method of consent, with an overall median of 30 minutes (interquartile range [IQR] 22–42): 29 minutes (IQR 22–42) in the deferral of consent group vs 32 minutes (IQR 25–44) in the prospective consent group (p = 0.1602). Survey respondents overwhelming agreed or strongly agreed with the use of deferral of consent in AcT (86%) and in any acute stroke trial (76%).
Discussion
Deferral of consent was broadly acceptable to participants in the AcT trial as demonstrated by low rates of withdrawal and by survey results. Door-to-randomization times using deferral of consent in AcT were short, although a system of prospective verbal consent used at 1 center took only slightly longer. These results support the importance of innovation around consent for acute stroke trials.

Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study
Eddy Xiong, Carissa Bonner, Amanda King, Zoltan Maxwell Bourne, Mark Morgan, Ximena Tolosa, Tony Stanton, Kim Greaves
JMIR Formative Research, 6 November 2024
Abstract
Background
Dynamic consent has the potential to address many of the issues facing traditional paper-based or electronic consent, including enrolling informed and engaged participants in the decision-making process. The Australians Together Health Initiative (ATHENA) program aims to connect participants across Queensland, Australia, with new research opportunities. At its core is dynamic consent, an interactive and participant-centric digital platform that enables users to view ongoing research activities, update consent preferences, and have ongoing engagement with researchers.
Objective
This study aimed to describe the development of the ATHENA dynamic consent platform within the framework of the ATHENA program, including how the platform was designed, its utilization by participants, and the insights gained.
Methods
One-on-one interviews were undertaken with consumers, followed by a workshop with health care staff to gain insights into the dynamic consent concept. Five problem statements were developed, and solutions were posed, from which a dynamic consent platform was constructed, tested, and used for implementation in a clinical trial. Potential users were randomly recruited from a pre-existing pool of 615 participants in the ATHENA program. Feedback on user platform experience was gained from a survey hosted on the platform.
Results
In the 13 consumer interviews undertaken, participants were positive about dynamic consent, valuing privacy, ease of use, and adequate communication. Motivators for registration were feedback on data usage and its broader community benefits. Problem statements were security, trust and governance, ease of use, communication, control, and need for a scalable platform. Using the newly constructed dynamic consent platform, 99 potential participants were selected, of whom 67 (68%) were successfully recontacted. Of these, 59 (88%) agreed to be sent the platform, 44 (74%) logged on (indicating use), and 22 (57%) registered for the clinical trial. Survey feedback was favorable, with an average positive rating of 78% across all questions, reflecting satisfaction with the clarity, brevity, and flexibility of the platform. Barriers to implementation included technological and health literacy.
Conclusions
This study describes the successful development and testing of a dynamic consent platform that was well-accepted, with users recognizing its advantages over traditional methods of consent regarding flexibility, ease of communication, and participant satisfaction. This information may be useful to other researchers who plan to use dynamic consent in health care research.

Maximising the opportunities in lung cancer screening: uptake of consent to contact for research
T Patrick, SB Naidu, L Anandan, K Desai, V Marshman, P Robinson, S Patel, A Nair, R Thakrar, N Navani, JR Hurst, SM Janes, A Bhamani
BMJ Thorax, 3 November 2024
Abstract
Introduction
Low-Dose CT (LDCT) screening reduces lung cancer mortality. However, the benefits of Lung Cancer Screening (LCS) can be extended, for example, by offering individuals the opportunity to participate in research. We investigated the proportion and characteristics of individuals willing to be approached about research participation in our Targeted Lung Health Check programme.
Methods
In our programme, eligible individuals as assessed in an initial telephone questionnaire proceed to a face-to-face lung health check and LDCT. An additional question for eligible individuals (‘Are you happy to be approached by a member of our research team about participating in research?’) was introduced on 4th December 2023. All individuals subsequently completing a telephone questionnaire up to 20th May 2024 were included in this analysis.
Results
1708/3095 (55.2%) individuals consented to being approached about participating in research. Of these, 1068 (62.5%) were male, 746 (43.7%) were current smokers and 1380 (80.8%) were of white ethnicity. Multivariable binary logistic regression analysis (table 1) showed that the factors associated with an increased likelihood of agreeing to research contact were: personal cancer history (aOR 1.39 (95% confidence interval (CI) 1.15–1.69)) and exposure to asbestos (aOR 1.63 (95%CI 1.34–1.99)). Being Asian (aOR 0.56 (95%CI 0.44–0.72)), having fewer years of formal education (finished education aged 15 or less aOR 0.44 (95%CI 0.33–0.60)) and a self-reported medical history of COPD (aOR 0.83 (95%CI 0.69–0.99) were associated with a reduced likelihood of consenting to research contact.
Discussion
Increasing public participation in research is important and part of the current NHS Long Term Plan.1 The majority of individuals undergoing LCS consented to be approached about research. However, groups already underrepresented in research were less likely to consent. Future studies should focus on increased diversity in research, potential benefits of which include increased public trust, promotion of fairness and improved generalisability of research findings.

Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic
Research article
Tom Gugel, Karen Adams, Madelon Baranoski, N David Yanez, Michael Kampp, Tesheia Johnson, Ani Aydin, Elaine C Fajardo, Emily Sharp, Aartee Potnis, Chanel Johnson, Miriam M Treggiari
Clinical Trials, 27 April 2024
Abstract
Introduction
Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research.
Methods
The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings.
Results
During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public.
Conclusion
The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

Advance Consent for Participation in Acute Stroke Trials: A Focus Group Study with People with Lived Experience of Stroke
Brief Communication
Ubong Udoh, Rena Seeger, Emma Cummings, Brian Dewar, Stuart Nicholls, Mark Fedyk, Sophia Gocan, Victoria Shepherd, Dar Dowlatshahi, Michel Shamy
The Canadian Journal of Neurological Sciences, 15 October 2024
Abstract
Advance consent could address many of the limitations traditional consenting methods pose to participation in acute stroke trials. We conducted a series of five focus groups with people with lived experience of stroke. Using an inductive thematic approach, two themes were developed: factors in favour of, and against, advance consent. Participants supported the idea of advance consent and highlighted trust, transparent communication and sufficient time as major factors that would positively affect their decision to provide advance consent. The results will be used to finalise a model of advance consent suitable for testing the feasibility in stroke prevention clinics.

Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study
Ubong Udoh, Rena Seeger, Brian Dewar, Emma Cummings, Sophia Gocan, Stuart Nicholls, Mark Fedyk, Victoria Shepherd, Jeff Perry, Robert Fahed, Tim Ramsay, Jamie Brehaut, Michael D Hill, Alexandre Y Poppe, Bijoy K Menon, Richard H Swartz, Dar Dowlatshahi, Michel Shamy
Stroke and Vascular Neurology, 2 October 2024
Abstract
Introduction
Obtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the hospital in a state of incapacitation. Adaptations to standard consenting approaches-such as the use of surrogate consent or deferral of consent-have significant limitations. This feasibility study aims to test a new consenting approach in acute stroke care that we call advance consent. Advance consent has the potential to render emergency trial enrolment faster, fairer and more transparent, leading to more generalisable results.
Methods and design
We will conduct a five-part study at The Ottawa Hospital, a quaternary care stroke centre: (1) administering questionnaires in the Ottawa Hospital Stroke Prevention Clinic that will examine patients’ perspectives on research participation and advance consent; (2) inviting participants to consent in advance to any or both currently enrolling acute stroke trials; (3) tracking patient enrolment into these trials over 1 year; (4) administering a follow up questionnaire to participants at 1 year and (5) administering a questionnaire to participating hospital staff in order to interrogate their experiences with advance consent. Outcomes include but are not limited to eligibility rate, recruitment rate, withdrawal rate and the proportion of patients whose advance consent results in trial enrolment.
Conclusion
This study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.

The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial
Case Commentaries
Meredith A. Atkinson, Erika Ezumba, Jena L. Miller
The American Journal of Bioethics, 16 September 2024
Excerpt
… In the face of uncertainty about the longer-term burden of morbidity and mortality in surviving neonates, the study team had to consider what level of detail regarding neonatal outcomes observed in infants born to trial participants to share with potential participants during the study screening process, while the study continued active recruitment. In addition, they had to determine if and how such information should be modified over the course of the trial as additional neonates were born to trial participants, and an increasing amount of data on the clinical course and outcomes of the neonates became available. Given the high potential burden in neonatal survivors and their families, including the need for intensive caregiver-provided, at-home care for infants who survive to hospital discharge and a need for life-long renal replacement therapy, the consent discussion takes place over days and in collaboration with multiple specialists… More

information is required to deeply characterize long-term outcomes among survivors and the psychosocial impact on the family, whether the amnioinfusion intervention is offered through a research protocol or as clinical care. This will require systematic collection of prospective data beyond the primary outcome defined in the RAFT trial, including observational data from institutions where the intervention is offered as clinical care.

Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective
Kun Li, Mingtao Huang, Xiaomei Zhai, Chen Wang
Developing World Bioethics, 13 September 2024
Abstract
In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long-term, large-scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust-based informed consent and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants’ autonomy. Informed consent in long-term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants’ rights despite the complexity of modern biomedical research.