Ashley Clayton, MS | Sage Bionetworks | https://orcid.org/0000-0002-4570-2706
Christine Suver, PhD, PMP | Sage Bionetworks | https://orcid.org/0000-0002-2986-385X
Anita Walden, PhD| University of Colorado | https://orcid.org/0000-0002-3327-7423
Chunlei Wu, PhD | The Scripps Research Institute | https://orcid.org/0000-0002-2629-6124
Marie Rape, RN, BSN | University of North Carolina at Chapel Hill | https://orcid.org/0000-0002-0608-7093
Individuals interested in the selection, implementation, and use of electronic informed consent (eConsent) platforms in clinical research settings. The framework presented here may also be adapted to help select other platforms and tools.
eConsent; informed consent; electronic consent; Technology Assessment Tools; Technology Evaluation
Chapter version: 1.0
Date: 21 Oct 2022
V1.0 Qualtrics implementation: eConsent Needs Assessment Tool (Qualtrics)
V1.0 PDF rendition: eConsent Needs Assessment Tool (PDF)
V1.0 Qualtric implementation: eConsent Evaluation Tool (Qualtrics)
V1.0 PDF rendition: eConsent Evaluation Tool (PDF)
Selecting or developing a suitable eConsent platform can be challenging and may be informed by a variety of factors at both the study and organizational level. Furthermore, there is a spectrum of eConsent features, from the simple rendition of an informed consent form in an electronic format to a multimedia interactive eConsent experience in different languages. Prior to selecting an eConsent platform, researchers must:
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assess their eConsent needs from research, administrative, technical, and financial standpoints, as well as the needs of consenting individuals.
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evaluate platforms to determine which ones meet their needs.
This may require input from consenting individuals, study teams, information technology (IT) experts, regulatory personnel, institutional decision makers, and other relevant stakeholders. This chapter describes several considerations for the selection of an eConsent platform for clinical research studies, using a novel assessment framework to evaluate needs and eConsent platform features. It should also be noted that while this chapter focuses on eConsent platforms, the considerations and related tools for eConsent selection may be transferable to the assessment of other platform types and research tools (e.g., electronic data capture tools).
Choosing any tool or product requires balancing needs, wants, finances, and constraints with the technology tool or product specification. Similarly, when selecting an eConsent platform to implement in biomedical research, one must understand what the platform is meant to achieve, how it will be used, and by whom. In collaboration with partners at the National Center for Data to Health (CD2H), representatives of the North Carolina Translational and Clinical Sciences (NC TraCS) Institute at the University of North Carolina (UNC) surveyed Clinical and Translational Science Awards (CTSA) program hubs about their eConsent needs, experiences, and satisfaction. The information was used by Sage Bionetworks to develop and pilot an eConsent Assessment Framework composed of two related tools:
- eConsent Needs Assessment Tool (i.e. "what do I need in an eConsent platform?")
- eConsent Evaluation Tool (i.e. "what features does eConsent platform 'x' have?")
Several factors may inform the decision to select or build an eConsent platform for clinical research use. Ultimately, the selected platform should meet as many anticipated requirements as possible, based on an assessment of eConsent needs, wants, and constraints at the user, study, and organizational levels. Answering the following questions using the eConsent Needs Assessment Tool can help recognize what matters most in selecting an eConsent platform:
Consider which study team member(s) and organizational role(s) are best suited to determine the eConsent needs for a specific study, a group of related studies, and/or the enterprise level. Those individuals assessing needs must be able to differentiate essential features that are ‘required’ from those that are ‘preferred’ and ‘not important’. The selection of these individuals may be informed by their familiarity with informed consent, eConsent practices and regulatory practices, prior experience with clinical research studies, technical expertise, and organizational structure, among other factors.
| Research Stakeholders | Types of Requirements |
|---|---|
| Study Coordinators | Administration of eConsent and use of the information, target population |
| Investigators | Administration of eConsent and use of the information, target population |
| Data Managers/Informaticists | Data collection, quality, cleaning, integration and reporting |
| Programmers/Developers | Determine requirements for tool integration, configuration, development |
| Regulatory Personnel | Compliance with institution, local, regional and national regulations. |
| Security/Privacy Officers | Security and Privacy technical and policy requirements |
| Enterprise IT | Integration with other systems level of support |
Consider whether the eConsent platform would be used only for a specific study or for multiple studies organization-wide. At the study-specific level, eConsent platform needs may be informed by factors such as:
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regulatory and ethical compliance (e.g., domestic vs. international studies),
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study population (e.g. familiarity with technology),
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study type (e.g., pediatric studies), or
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budgetary considerations (e.g., free-to-use vs. license-based platforms), among other factors.
At the organization level, eConsent platform needs may be informed by:
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the projected number of studies over a period of time,
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the need for integration with existing infrastructure (e.g., Clinical Trials Management System (CTMS), Clinical Data Management System (CDMS), current organization-wide licenses and subscriptions), and
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implementation requirements (e.g., security review and validation for new platforms), among other factors.
eConsent platform needs may be informed by the intended user audience and anticipated user setting. Consider what elements (e.g., features) of an eConsent platform are important and/or required to support ease of use and cultural competency among study team members and organizational personnel that will be using or interacting with the platform. The level of existing training materials, anticipated user support, and available resources to support both implementation and maintenance of the platform should also be considered in the assessment of platform needs. Additionally, requirements related to ease of use and engagement from the perspective of consenting individuals should be considered. eConsent platform requirements may also be informed by the setting(s) under which the consent is anticipated to be performed (e.g., in-person vs. remote), or use of specific equipment (e.g., laptops vs. tablets), among other factors.
Existing free-to-use and license-based platforms offer a range of features and levels of customization. Some features may be required (i.e., essential) while others may be preferred (i.e., “nice-to-have”) but not required for a given study, or “not important.” General categories of platform features and customization include, but are not limited to:
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Language
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Accessibility
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Automation
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Reporting and metrics
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Security
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Integration
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Understanding eConsent Platform Needs:
* eConsent Needs Assessment Tool: Developed by Sage Bionetworks in collaboration with CD2H and North Carolina Translational and Clinical Sciences (NC TraCS) Institute at the University of North Carolina (UNC). One of two tools within the eConsent Assessment Framework, this tool can be used by research teams and organization stakeholders to assess their eConsent platform needs and requirements, exploring each of the needs-based considerations described in this chapter.
* Readings:
* Doerr M, Moore S, Suver C. Elements of Informed Consent. In: Sage Bionetworks [Internet]. [cited 30 June 2022]. Available `here <https://sagebionetworks.org/wp-content/uploads/2020/01/SageBio_EIC-Toolkit_V3_21Jan20_final.pdf>`_.
* Cobb NL, Edwards DF, Chin EM, Lah JJ, Goldstein FC, Manzanares CM, Suver CM. From paper to screen: regulatory and operational considerations for modernizing the informed consent process. J Clin Transl Sci. 2022 Mar 28;6(1):e71. doi: 10.1017/cts.2022.379. PMID: `35836789 <https://pubmed.ncbi.nlm.nih.gov/35836789/>`_; PMCID: PMC9257776.
* Moore S, Tassé AM, Thorogood A, Winship I, Zawati M, Doerr M. Consent Processes for Mobile App Mediated Research: Systematic Review. JMIR Mhealth Uhealth. 2017 Aug 30;5(8):e126. doi: 10.2196/mhealth.7014. PMID: `28855147 <https://pubmed.ncbi.nlm.nih.gov/28855147/>`_; PMCID: PMC5597795.
eConsent platforms available today offer a range of features and levels of customization,with varying cost, regulatory compliance, implementation ease, and security measures). This can make it challenging for prospective users to assess which platform(s) may be best suited for implementation based on their particular needs and requirements. Additionally, the expertise to adequately evaluate eConsent platforms against user-level, study-level, and organizational-level requirements may reside across multiple individuals and roles.
The eConsent Evaluation Tool provides a set of harmonized criteria for objective evaluation of eConsent platform characteristics and feature availability. This approach facilitates the comparison and potential selection of eConsent platforms. The tool is structured to evaluate a range of feature categories by representatives across different roles and areas of expertise within an organization (e.g., study team members, regulatory experts, IT professionals), allowing for consolidated, multi-user evaluation of a particular eConsent platform.
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Evaluating eConsent platforms
* `eConsent Evaluation Tool <https://sagebionetworks.qualtrics.com/jfe/form/SV_6u5qGT5HDmzcxds>`_: Developed by Sage Bionetworks in collaboration with CD2H and North Carolina Translational and Clinical Sciences (NC TraCS) Institute at the University of North Carolina (UNC). One of two tools within the eConsent Assessment Framework, this tool provides a set of criteria for research teams to harmonize their evaluation of eConsent platform characteristics and feature availability, facilitating ease of comparison and potential selection of eConsent platforms.
The eConsent Assessment Framework was designed to facilitate the selection of eConsent platforms in clinical research settings. Although various sources of information on informed consent and eConsent practices exist, this framework, consisting of an eConsent Needs Assessment Tool and an eConsent Evaluation Tool, may be helpful to reconcile specific eConsent needs against the availability of eConsent platform features. Existing familiarity with both general study participant consent and eConsent practices may be helpful for adoption of these tools.
Similarly to first identifying the eConsent needs, acknowledging the involvement and expertise to adequately evaluate eConsent platform features may be distributed across a range of study team personnel and organizational roles, it should be noted that the eConsent Evaluation Tool can be completed by several personnel in different roles within an organization (e.g., study team members, regulatory experts, IT professionals), to provide a consolidated, multi-user evaluation of a given eConsent platform. While the framework was developed to facilitate the selection of eConsent platforms, a similar assessment framework structure developed with relevant stakeholder and community input could be utilized to assess other platforms and research tools for potential implementation (e.g., electronic data capture tools).
Several limitations were identified and acknowledged throughout the refinement and launch of the eConsent Assessment Framework, and have been described below. These limitations may also be applicable in the evaluation of other research-related platforms and applications.
- Language: The language of both tools is quite technical in nature. Future iterations of these tools should adjust for a wider range of technical literacy to improve accessibility, user experience, and potential generalizability to other applications.
- Roles: The questions included in both tools have been prioritized and organized based on the following themes and categories of anticipated user roles: Study Team (e.g., investigator), IT (e.g., information security officer), and Regulatory / Compliance (e.g., data privacy officer). However, the scope of users across the research community, domains of expertise, and areas for evaluation with respect to eConsent platforms may extend beyond these three roles. Future iterations of this tool should accommodate an expanded set of user roles accordingly.
- Barriers to platform evaluation: The assessment of certain platform features using this framework may be limited and/or prohibited by proprietary software or confidential information protections, thus preventing a comprehensive evaluation of some eConsent platforms. Some evaluation questions may be more appropriately directed to the vendor of an eConsent platform, as some information may not be accessible to the general research community to adequately evaluate certain features.
- Access to evaluation data: At this time, completed assessments of eConsent needs and platforms are accessible only to study teams performing these assessments. However, the evaluation and potential comparison of eConsent needs across larger, unrelated study portfolios, at the broader organizational level, and across organizations may be of interest to the research community. Access to a comparison matrix of eConsent platform evaluation data across multiple users - similar to a consumer report - may be helpful to facilitate the comparison of different eConsent platforms. Additionally, with the ongoing development and evolution of eConsent platforms, access to updated and/or versioned evaluations of a particular platform will need to be considered.
- Different requirements will inform the selection of an eConsent platform for use in a single/small group of studies versus in multiple studies across anorganization or enterprise.
- First, identify the stakeholder needs for an eConsent platform (eConsent Needs Assessment Tool)
- Determine the current and long term future needs, such as if the eConsent platform will be used for FDA-regulated studies, or the number and types of studies.
- Identify multiple eConsent platforms of interest to evaluate.
- Evaluate multiple platforms using an eConsent evaluation list of required and desired features (eConsent Evaluation Tool).
- Involve a variety of stakeholders consisting of different roles, including potential study participants, study team and regulatory administrators, and IT/security officers in the eConsent needs assessment process and platform evaluation.
- The eConsent Assessment Framework can be adapted and applied to other applications
The National Center for Data to Health (CD2H) is committed to the development of tools for assessing and comparing best practice approaches in research across the Clinical and Translational Science Awards (CTSA) program hubs and broader scientific community (see also https://cd2h.org/maturity). The CD2H tasked Sage Bionetworks with the development and iterative refinement of an eConsent Assessment Framework for use by research teams to help them evaluate, select, or build an eConsent tool or platform. This process informed several of the considerations described in this chapter regarding the evaluation and selection of eConsent platforms.
The authors would like to thank Xindi Guo and Emily Lang at Sage Bionetworks and representatives at NC TraCS Institute (University of North Carolina) for their contributions to the development of the assessment questions and piloting the eConsent Assessment Framework. Thank you also to representatives at the following institutions for piloting the assessment framework: Sage Bionetworks, University of Colorado, The Scripps Research Institute, Emory University, University of Wisconsin, and West Virginia University.
This work was supported by the National Center for Data to Health (CD2H) of the National Institutes of Health (NIH) under award number U24TR002306 and by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through award number UL1TR002489. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.