Dataset Information

E-Consent: The design and implementation of consumer consent mechanisms in an electronic environment.

ABSTRACT: The effective coordination of health care relies on communication of confidential information about consumers between different health and community care services. However, consumers must be able to give or withhold "e-Consent" to those who wish to access their electronic health information. There are several possible forms for e-Consent. In the general consent model, a patient provides blanket consent for access to his or her information by an organization for all future information requests. Conversely, general denial explicitly denies consent for information to be used in future circumstances, and in each new episode of care, a new consent would be needed to obtain information. In the general consent with specific denial model, a patient attaches specific exclusion conditions to his or her general approval to future accesses. In contrast, in the general denial with explicit consent model, a patient issues a blanket block on all future accesses but allows the inclusion of future use under specified conditions. There also are several alternative functions for an e-Consent system. Consent could be captured as a matter of legal record. E-Consent systems could be more active by prompting clinicians to indicate that they have noted consent conditions before they access a record. Finally, the record of patient consent could be fully active and used as a gatekeeper in a distributed information environment. There probably will need to be some form of data object that is associated with patient information. This e-Consent object (or e-Co) will contain the specific conditions under which the data to which it is attached can be retrieved. Given the complexity of clinical work and the substantial variation we can expect in an individual's desire to make his or her personal medical details available, it is unlikely a "one size fits all" approach to e-Consent will work. Consequently, with a well-chosen consent design, it should be possible to balance the specific need for privacy of some of the population against the desire by others to err on the side of clinical safety, and clinicians desire to minimize the burden that an electronic consent mechanism would impose.

SUBMITTER: Coiera E

PROVIDER: S-EPMC353020 | biostudies-literature | 2004 Mar-Apr

REPOSITORIES: biostudies-literature

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e-Consent: The design and implementation of consumer consent mechanisms in an electronic environment.

Coiera Enrico E Clarke Roger R Clarke Roger R

Journal of the American Medical Informatics Association : JAMIA 20031207 2

The effective coordination of health care relies on communication of confidential information about consumers between different health and community care services. However, consumers must be able to give or withhold "e-Consent" to those who wish to access their electronic health information. There are several possible forms for e-Consent. In the general consent model, a patient provides blanket consent for access to his or her information by an organization for all future information requests. C ...[more]

PMID: 14662803

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Project description:BackgroundInformed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.ObjectiveWe aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.MethodsWe conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.ResultsA total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.ConclusionsElectronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.

Project description:IntroductionCommunicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients' decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.Methods and analysisFirst, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form.Control groupParticipants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology.AnalysisFor the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.Ethics and disseminationHuman Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ACTRN12622001354774).

Project description:BackgroundFor decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers' views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers' views on the optimal content and layout of the layered consent materials for a large and complex Bayesian adaptive platform trial (the SNAP trial).MethodsWe conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their carers (2). Interview transcripts were examined using inductive thematic analysis.ResultsConsumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form is signed. Three other themes emerged; the need to prioritise participants' information needs; the importance of health literacy; the importance of information about a trial's benefits (over its risks) for decision-making and the interplay between the two.ConclusionsOur findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial. A 3-page PICF was considered sufficient for decision-making for the SNAP trial, provided that further information was available and accessible.

Project description:BackgroundWhen we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador.ObjectiveThis paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs.MethodsWe developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage.ResultsConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection).ConclusionsConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

Project description:BackgroundSocial media can be used to engage consumers in hospital service design and quality improvement (QI) activities, however its uptake may be limited by a lack of guidance to support implementation. This article presents the perceived barriers and enablers in using social media for consumer engagement derived from an interview study with public hospital stakeholders.MethodsSemi-structured interviews with 26 Australian hospital service providers and consumer representatives. Data were analysed using a deductive content analysis method.ResultsData were collected between October 2019 and April 2020. Facebook was the platform most commonly used for consumer engagement activities. Barriers and enablers to social media-based consumer engagement were identified. The barrier themes were (1) fears and concerns; (2) lack of skills and resources for social media engagement; (3) lack of organisational processes and support; and (4) problems with social media platforms and the changing social media landscape. The enabler themes were: (1) hospitals facilitating access and use; (2) making discussions safe; (3) cultivating a social media community; and (4) building on success.ConclusionUsing social media to facilitate consumer engagement in hospital service design and QI activities is feasible and acceptable to service providers and consumers. Hospitals and their executives can create a supportive environment for social media-based engagement activities through developing clear governance systems and providing training and support to all users. Consumers need to be involved in co-designing social media-based activities and determining which forms of engagement are accessible and acceptable. For some consumers and service providers, barriers such as a lack of resources and distrust of social media companies might mean that social media-based engagement will be less acceptable for them. Because of this it is important that hospitals provide complementary methods of engagement (eg, face-to-face) alongside social media-based methods.

Dataset Information

E-Consent: The design and implementation of consumer consent mechanisms in an electronic environment.

Publications

e-Consent: The design and implementation of consumer consent mechanisms in an electronic environment.

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