Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?

Abstract

In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach.

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

“…9,34,35 On the other hand, it is suggested that obtaining specific consent for every linkage or re-use may be overly burdensome or impossible, because this could result in costly and time-consuming procedures, poor recruitment, consent bias, or unwarranted intrusion into the private lives of individuals. [36][37][38] As a response to the difficulties in obtaining specific consent, adapted models of consent have been put into practice and discussed in the literature. The most common adaptations of consent are models that shift away from specific consent, such as 'broad consent', covering a broad range of future data uses.…”

“…41 Others argue that broad consent is an ethically sound alternative for specific consent, although individuals are not given specific information about future research projects. 36,44 In the draft GDPR texts, the current conflicting positions of the Parliament and Council on this topic appear to be reflected. Some indicate that broad consent may not meet the conditions on consent as defined in the Parliament's draft GDPR, regarding the information that must be given to the individual.…”

“…46,47 Critics, however, argue that dynamic consent could for example lead to an information overload for the individual. 36 As a response to this critique, it is emphasised that dynamic consent is not a replacement for existing consent models, but rather a tool that could better facilitate the process of obtaining any form of consent. 47,48 Adapting anonymisation mechanisms A conventional method to protect data and avoid consent or other legal requirements is anonymisation.…”

The Concept of Biobanking in Terms of Ethics: Review

“…Genel onam, açık ya da sınırsız bir onam (blanket consent (açık onam); herhangi bir kısıtlama söz konusu olmadan, örneklerin ve verilerin sınırsız bir biçimde her türlü araştırma için kullanılması) türü değil; katı-lımcılar tarafından, gelecekte yapılması muhtemel, farklı amaçlardaki tıbbi araştırmalar için belirli bir çerçevede örneklerin ve verilerin kullanımına izin verildiği bir onam türüdür. 11,22 Söz konusu çerçe-vede, herhangi bir değişim meydana geldiğinde, katılımcılardan yeniden onam alınmalıdır. 22 Genel onam, araştırmacıların biyolojik örnek-ler ile bunlarla ilişkili verileri geniş bir yelpazedeki araştırma faaliyetlerinde kullanmak amacıyla katı-lımcılardan izin alınması sürecini tanımlamakta-dır.…”

“…11,22 Söz konusu çerçe-vede, herhangi bir değişim meydana geldiğinde, katılımcılardan yeniden onam alınmalıdır. 22 Genel onam, araştırmacıların biyolojik örnek-ler ile bunlarla ilişkili verileri geniş bir yelpazedeki araştırma faaliyetlerinde kullanmak amacıyla katı-lımcılardan izin alınması sürecini tanımlamakta-dır. 23 Pek çok ülkenin kılavuz ilkesine göre, projenin etik kurul tarafından onaylanması ve verilen onamın araştırmanın herhangi bir zamanında katılımcı tarafından geri alınabilir olması koşulları-nın yerine getirildiği durumlarda, gelecekte yapılması muhtemel araştırmalar için, genel onam alınması kabul edilebilir bir görüştür.…”