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.