Article

European Journal of Human Genetics (2013) 21, 897–902; doi:10.1038/ejhg.2012.282; published online 9 January 2013

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

Kristin Solum Steinsbekk1, Bjørn Kåre Myskja2 and Berge Solberg1

  1. 1Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway
  2. 2Department of Philosophy, Norwegian University of Science and Technology, Trondheim, Norway

Correspondence: Dr KS Steinsbekk, Department of Public Health and General Practice, Norwegian University of Science and Technology, NTNU, Trondheim 7491, Norway. Tel: +47 95 27 01 97; E-mail: kristin.steinsbekk@samfunn.ntnu.no

Received 10 September 2012; Revised 24 October 2012; Accepted 15 November 2012
Advance online publication 9 January 2013

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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.

Keywords:

broad consent; dynamic consent; biobank; research participation; ethics

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Background

The standing of the ‘biobank donor’ as to what type of involvement and control donors of biological samples should have has been one of the major issues in the ethical debate surrounding the use of biobanks as resources for research. This has been embodied in an extensive discourse on consent and consent processes in biobank research (see for example, Shickle,1 Caulfield and Kaye,2 Otlowski,3 Elger and Caplan4 and Caulfield and Knoppers5). No consensus seems to exist on a theoretical level whether ‘blanket consents’, ‘specific consents’, ‘no consents’ or ‘broad consents’ fit best as a consent model for balancing the interest of donors and research in the best possible way. In practice, however, the model termed ‘broad consent’ has been adapted by many current biobank projects, like UK Biobank, CARTaGENE (Montreal, QC, Canada) and the Norwegian HUNT study.6

Broad consents are not open nor are blanket consents. To give a broad consent means consenting to a framework for future research of certain types.7, 8, 9, 10 Included in this framework is ethical review of each specific research project by an independent ethics committee as well as strategies to update regularly the biobank donor and ongoing withdrawal opportunities. If anything in the framework changes, the participant should re-consent.8 In that sense, broad consents still claim to be informed consents.

However, this is opposed by some scholars. They reject labelling broad consents to biobank research ‘informed’, as aspects of future research projects are today often unspecified and to some extent unforeseen. The promoters of this view render ‘informed broad consent’ to biobank research a contradiction in terms.11, 12, 13, 14 Taken even further, some claim that broad consents ‘ hinder donors from exercising fundamental rights and freedoms’.15 Based on arguments like these and technological developments enabling easy, two-way, cost-efficient, real-time contact with individuals, it is not surprising that the use of broad consent processes in biobank research is revisited.

‘Dynamic consent’ has recently been proposed as a model to resolve the alleged consent problem within biobanking.16, 17 These are Internet-based, 2.0 type and interactive consents. Herein lies hope of solving the problem of participants not being appropriately informed. In addition, an essential shift in the standing of the donor is envisioned by being a ‘participant-centred initiative’, which locates ‘the research patient in the centre of decision-making as equal partners in the research process’.18

Dynamic consent intuitively sounds like a beautiful idea. It is a strategy that first of all involves a more active and potentially more interactive follow-up process of biobank contributors (compared with today’s broad consent). Obtaining specific consent from individual biobank participants for each subsequent research proposal after the initial broad consent has, up until now, in general been deemed unachievable.1, 16, 17, 19 Dynamic consent employs features of web-based technology to solve the perceived problem of lack of ‘real-time’ specific information about individual research projects seen in the broad consent procedure used in many research biobanks today.20

A dynamic longitudinal consent strategy for biobank research is promoted by some leading ethical and legal scholars. Kanellopoulou et al16 anticipate ‘that ‘dynamic consent’ will become an essential and sustainable component of research infrastructure’.16 As this proposal immediately seems appealing, it is, from an ethical perspective, important to investigate that there are no hidden challenges related to the model. As a matter of fact, we will argue that there are.

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Dynamic consents respect participants’ autonomy far more than broad consents!

Dynamic consent is argued by its proponents to better meet the specifications of autonomy embedded in informed consent requirements compared with broad consent. Kanellopoulou et al16 explicitly express this as they write, ‘The benefit of [Dynamic consent]... is that it enables individuals to exercise their autonomy by giving informed consent for new types of research in real time rather than being asked to give a broad consent at the beginning of the research process when they are recruited into a biobank’.

However, both consent models can be said to respect autonomy as they both provide information about biobank endeavours and leave it up to the individual to decide if he or she would like to take part or not. The fundamental difference between the two is disagreement on whether consent to ‘unknown’ future activities, can be labelled ‘informed consent’ and be viewed as an expression of an autonomous will. As Sheehan26 and Steinsbekk and Solberg8 have argued, we regard many ordinary decisions people make as properly informed without having all the specifics – thus they are still ‘perfectly acceptable autonomous decisions’ in most people’s minds. The model of broad consent follows such decision patterns.8, 27

In the dynamic consent model, participants should always make an informed consent to both primary and secondary use of their data. It does not matter whether a new project Y is only slightly different from an initial project X. And it does not matter whether it is possible or impossible to find any kind of ‘rational’ justification for taking part in X and saying no to Y. As such, dynamic consent takes people’s preferences as the point of departure.

In the broad consent model, on the other hand, people are asked to re-consent only when there may exist an ethically relevant difference between X and Y.8 Participants in such situations are asked to re-consent, because a research ethics committee or the biobank institution believes there is something to ask them about, something that matters.

The difference between dynamic consent and broad consent is then made clearer: In a dynamic consent model, participants will be asked for consent continuously, simply because each new project is a new project. Thus, they will be asked to re-consent both for trivial and essential reasons, and often the former. In a broad consent model, participants will seldom be asked to re-consent, but when they are asked, they are asked for a non-trivial reason. When described like this, it is not obvious that the dynamic consent model respects the autonomy of participants in a better way than the broad consent model.

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Conclusion

Proposals of dynamic consent, especially its focus on new possibilities for communication with research participants embedded in Internet and social media, definitely have the potential to sharpen and broaden consent strategies. We concur with the importance of information and that improvement of information strategies should be addressed repeatedly. However, based on the reflections above where we argue that the broad consent model is consistent with the value of autonomy and informed consent, we are not ‘forced’ to accept all aspects of dynamic consent. The dynamic consent strategy with repeatedly opt-in options holds the risk of participants not opting in or opting in with a bad conscience for not making an informed choice, risk of weaker ethical review of research projects, risk of disillusionment based on unfulfilled expectations, as well as the risk of inviting participants into therapeutic misconception. Therefore, we hold that the relatively passive participation implied by broad consent has ethical strengths that outweigh the potential problems suggested by dynamic consent proponents, as long as well-functioning systems for ethical review and information strategies with opt-out arrangements are in place.

Assuming that biobank research carries the potential for important medical breakthroughs, it is morally problematic if consent procedures unnecessarily reduce or prevent these opportunities. As the overall goal of biobank research is beneficial medical inventions, the choice between broad and dynamic consents is not merely a matter of their respective internal merits in protecting the interests of participants. We have a prima facie duty to promote this kind of research. This means that if broad and dynamic consent are considered morally equivalent in protecting participant interests, we should use the one that is least likely to reduce the value of this research.

As we hold that the proponents of dynamic consent have not made a convincing case that their proposal will be better in this respect, under the current circumstances we claim that broad consent combined with competent ethics review and an active information strategy is a more sustainable solution.

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Conflict of interest

The authors declare no conflict of interest.

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Acknowledgements

This work is part of our project ‘In Genes We Trust? Biobanks, commercialization and everyday life’ funded by the Research Council of Norway. We thank three anonymous reviewers for constructive feedback helping us develop the final version of this paper.

This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/.

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