Evaluating models of consent in changing health research environments

Abstract

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss.

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review

“…Data on consent models were extracted and categorized based on the seminal eConsent model framework by Coeira and Clarke [38]. The framework was then expanded to include contemporary models [26,[39][40][41][42]. The types of consent models include broad open, broad controlled, broad tiered/menu/meta, dynamic, and general denial consent.…”

“…With the growing use of eConsent, new consent models have emerged, each providing individuals with varying control and autonomy over the collection, use, and sharing of their PHI. Broad consent models [ 26 ] (ie, consenting to the use of PHI for broad purposes) have commonly been used by digital health service providers; however, newer consent models such as dynamic consent [ 26 ] (ie, providing consent through a web-based platform, with the ability to set or change consent preferences) are being adopted to better support meaningful and informed consent practices. The Office of the Privacy Commissioner (OPC) of Canada has deemed meaningful consent a vital component of Canadian privacy legislation, citing the importance of meaningful consent and choice in establishing and sustaining public trust in digital health [ 27 , 28 ].…”

Dateninfrastrukturen für die Gesundheitsforschung

“…Gesetzliche und ethische Grundlage der Verarbeitung von personenbezogenen Daten ist ganz überwiegend die (breite) Einwilligung seitens der betroffenen Personen [5,6]. 3 Gerade zur Ermöglichung der Kernfunktion der Infrastrukturen, dass Daten für verschiedene Forschungsprojekte entdeckbar, nutzbar oder zur Verfügung gestellt werden (können), ist die breite Einwilligung (Broad Consent) das zur Zeit einzige auch in der Praxis umsetzbare Aufklärungs-und Einwilligungsmodell, während Alternativen wie Dynamischer Consent oder Meta Consent bisher eher theoretisch diskutiert werden und erhebliche praktisch-technische, datensicherheitsrelevante und ethische Herausforderungen implizieren [7,8]. 4 Auf Grundlage einer breiten Einwilligung wird bestimmt, welche Arten der Datennutzung und Datenweitergabe durch die betroffene Person autorisiert werden.…”

“…Über die Verpflichtung zur rechtmäßigen Datenverarbeitung hinaus kön- 4 Zu einem Überblick über verschiedene Einwilligungsmodelle s. [7]. Zu den technischen, datenschutzrechtlichen und ethischen Herausforderungen (bei der Umsetzung) der sogenannten dynamischen Einwilligung (Dynamic Consent) s. [8].…”

“…Diese vornehmlich ethischen Anforderungen sind u. a. auch unabdingbar, um das Vertrauen der Öffentlichkeit und aller anderen Stakeholder in die Infrastrukturen und in die angestrebten Verwendungsweisen der Daten zu Forschungszwecken zu etablieren und aufrechtzuerhalten. 7 Schon bei der Entwicklung von Werkzeugen, Prozessen und normativer Governance durch Infrastrukturen sollten die jeweils besonders betroffenen Stakeholder partizipieren können. Ebenso sollten sich im Rahmen von Infrastrukturen für personenbezogene Daten (Vertreter:innen von) Patient:innen und Bürger:innen an den etablierten Strukturen und Entscheidungsgremien wirksam, dauerhaft und nachhaltig beteiligen können.…”