Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad (...) consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material. (shrink)

In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta-consent framework, participants can choose the type (...) of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process. (shrink)

The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of specific consent, broad consent, blanket consent (...) or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years. Most users indicate 1) that they find the choices they are asked to make easy to understand, 2) that the application is easy to use, and 3) that this kind of choice should be offered to people. It is possible to collect meta consent preferences in the general, adult population using a smartphone app. (shrink)