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Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action
BackgroundInformed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of...
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Consent for Medical Treatment: What is ‘Reasonable’?
The General Medical Council (GMC) instructs doctors to act ‘reasonably’ in obtaining consent from patients. However, the GMC does not explain what it...
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Informed consent: a shared decision-making process that creates a new professional obligation for care
This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This...
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e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence
BackgroundDuring the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote...
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Informed Consent for Surgery During COVID-19
Informed consent has become a challenging issue when surgery at the time of novel corona virus disease 2019 (COVID-19) is to be performed, in view of...
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Randomized study of two different consent procedures on recall: a study within a digital alcohol intervention trial
IntroductionIndividuals’ comprehension of the information provided in consent forms should fundamentally influence whether to participate initially...
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Participant characteristics and reasons for non-consent to health information linkage for research: experiences from the ATHENA COVID-19 study
BackgroundThe linkage of primary care, hospital and other health registry data is a global goal, and a consent-based approach is often used....
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Early experiences of deemed consent legislation for organ donation in Nova Scotia: a qualitative study
PurposeIn 2021, Nova Scotia, Canada, became the first jurisdiction in North America to adopt a deemed consent organ donation system under its revised...
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Consent models in Canadian critical care randomized controlled trials: a sco** review
PurposeOur primary objective was to describe consent models used in Canadian-led adult and pediatric intensive care unit (ICU/PICU) randomized...
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A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
BackgroundThe consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of...
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Informed Consent for Emergency Obstetric Care During COVID-19 Pandemic
Informed consent process has become a challenging issue before surgery for any emergency obstetric care during this COVID pandemic. There is an...
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Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework
BackgroundFor the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the...
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Secondary use of health care data and left-over biosamples within the ‘Medical Informatics Initiative’ (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process
BackgroundData collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the...
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E-Consent—a guide to maintain recruitment in clinical trials during the COVID-19 pandemic
BackgroundThe COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic...
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Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes
BackgroundPatients with acute conditions often lack the capacity to provide informed consent, and narrow therapeutic windows mean there is no time to...
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Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial
BackgroundRandomised trials play a vital role in underpinning evidence-based care. However, trials involving adults with impaired capacity to consent...
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How do dementia researchers view support tools for informed consent procedures of persons with dementia?
The study aimed to assess how dementia researchers view eight support tools that have been defined to enhance informed consent (IC) procedures for...
