Dynamic Consent: An Evaluation and Reporting Framework

Abstract

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher–participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.

Reflections on dynamic consent in biomedical research: the story so far

“…Coincident to the development of DC has been a growth in electronic consenting tools, which allow PDF copies of consent forms to be shared via email or electronic signatures to be recorded. These approaches tend to provide an electronic version of a paper form, maintaining a static single point consent, and an electronic receipt, rather than allowing participants to change their mind over time, and thus do not support the fundamental behaviour change that DC espouses [7]. Electronic or 'eConsent' methods have been touted as having advantages over, or at least being comparable with, paper-based consent, yet uptake has remained slow.…”

“…While these findings demonstrate the potential opportunity for DC to support patients and participants to interact with their data, there is still limited evidence surrounding how DC affects the patient experience. To this end, an evaluation approach has been proposed to allow projects using DC to better understand its impact on key outcomes, such as knowledge and understanding, decisional conflict, satisfaction with the research, and trust in the researchers [7]. This will be a crucial step in moving beyond the promissory discourse around DC, to measure empirically the benefits and drawbacks of the tool, allowing researchers themselves to make an informed decision whether to adopt it as a viable consenting approach.…”

Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting

“…There are a variety of custom-built platforms for entirely virtual consenting [ [11] , [12] , [13] , [14] ], as well as commercial software programs such as REDCap [ 8 ], ResearchKit [ 15 ] and Consent2Share [ 16 ]. E-consenting platforms have also been modified by researchers to enable participants to record their consenting preferences across multiple studies [ 17 , 18 ].…”

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40

“…From the bioethics perspective, personal data protection is primarily related to respecting the rule of confidentiality and non-malfeasance. In the bioethics literature, attention is often paid to the scope of informed consent, access policies, biosharing, commercial use of samples and data, ownership issues, children involving, returning results or incidental findings ( Pawlikowski et al, 2010 ; De Clercq et al, 2017 ; Klingstrom et al, 2018 ; Boonen et al, 2019 ; Mikkelsen et al, 2019 ; Prictor et al, 2019 ). The respective guidance is included in the Declaration of Taipei of the World Medical Association ( Taipei, 2016 ), providing details for the biobanking area to the general ethical principles for medical research included in the Declaration of Helsinki ( World Medical Association, 2013 ).…”