scholarly journals The biobank consent debate: why ‘meta-consent’ is still the solution!

2019 ◽  
Vol 45 (5) ◽  
pp. 295-297 ◽  
Author(s):  
Thomas Ploug ◽  
Soren Holm
Keyword(s):  
Informed Consent ◽  
Medical Ethics ◽  
Recent Article ◽  
Broad Consent ◽  
Autonomous Choice ◽  
Biobank Research ◽  
Meta Consent

In a recent article in the Journal of Medical Ethics, Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that (i) Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; (ii) his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy that misconstrues how biobank research is actually conducted and (iii) a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice.

The case against meta-consent: not only do Ploug and Holm not answer it, they make it even stronger

2019 ◽  
Vol 46 (9) ◽  
pp. 627-628 ◽  
Author(s):  
Neil C Manson
Keyword(s):  
Recent Article ◽  
Broad Consent ◽  
Ethical Reason ◽  
Dynamic Consent ◽  
Additional Costs ◽  
Meta Consent ◽  
Biobank Governance

In a recent article, I argued that Ploug and Holm’s ‘meta-consent’ proposal should be rejected for biobank governance. This was because, although meta-consent is permissible, it is both burdensome and ethically omissible. There is no ethical reason why funders should undertake the additional costs. Ploug and Holm have sought to respond to these arguments. Here, it is noted that not only do they fail to adequately refuse the case against meta-consent, they fail to even engage with the arguments, either misunderstanding them or ignoring them. In their response, Ploug and Holm unwittingly provide the basis of an even stronger case against meta-consent. They argue that broad consent has a built in tendency to expire, while also holding that broad consent should be one of the options available in meta-consent. Meta-consent thus ends up being more like dynamic consent, but, arguably, even more burdensome and costly.

scholarly journals Broad consent for biobanks is best – provided it is also deep

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rasmus Bjerregaard Mikkelsen ◽  
Mickey Gjerris ◽  
Gunhild Waldemar ◽  
Peter Sandøe
Keyword(s):  
Human Subjects ◽  
Ethical Review ◽  
Future Research ◽  
Broad Consent ◽  
Research Subjects ◽  
Ongoing Debate ◽  
Biobank Research ◽  
Ethical Acceptability ◽  
Meta Consent

Abstract Background As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. Main text In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. Conclusion We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

scholarly journals The ‘Expiry Problem’ of broad consent for biobank research - And why a meta consent model solves it

2020 ◽  
Vol 46 (9) ◽  
pp. 629-631 ◽  
Author(s):  
Thomas Ploug ◽  
Søren Holm
Keyword(s):  
Significant Problem ◽  
Governance Structures ◽  
Broad Consent ◽  
Biobank Research ◽  
The Cost ◽  
Changes Over Time ◽  
Meta Consent ◽  
Over Time

In this response to Neil Manson’s latest intervention in our debate about the best consent model for biobank research we show, contra Manson that the ‘expiry problem’ that affects broad consent models because of changes over time in methods, purposes, types of data used and governance structures is a real and significant problem. We further show that our preferred implementation of meta consent as a national consent platform solves this problem and is not subject to the cost and burden objections that Manson raises.

scholarly journals The biobank consent debate: Why ‘meta-consent’ is not the solution?

2018 ◽  
Vol 45 (5) ◽  
pp. 291-294 ◽  
Author(s):  
Neil C Manson
Keyword(s):  
Informed Consent ◽  
Central Element ◽  
Consent Process ◽  
Practical Reasons ◽  
Broad Consent ◽  
Ethical Considerations ◽  
Ethical Argument ◽  
The Past ◽  
Different Types ◽  
Meta Consent

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.

scholarly journals Healthcare Interpreting and Informed Consent: What is the Interpreter’s Role in Treatment Decision-Making?

2007 ◽  
Vol 18 (2) ◽  
pp. 225-247 ◽  
Author(s):  
Andrew Clifford
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Medical Ethics ◽  
Treatment Decision ◽  
Cross Cultural ◽  
Professional Relationships ◽  
Case Scenario ◽  
Treatment Decision Making ◽  
General Communication

This article examines the part that healthcare interpreters play in cross-cultural medical ethics, and it argues that there are instances when the interpreter needs to assume an interventionist role. However, the interpreter cannot take on this role without developing expertise in the tendencies that distinguish general communication from culture to culture, in the ethical principles that govern medical communication in different communities, and in the development of professional relationships in healthcare. The article describes each of these three variables with reference to a case scenario, and it outlines a number of interventionist strategies that could be potentially open to the interpreter. It concludes with a note about the importance of the three variables for community interpreter training. Keywords: community interpreting, informed consent, role of the interpreter, healthcare.

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

2013 ◽  
Vol 21 (9) ◽  
pp. 897-902 ◽  
Author(s):  
Kristin Solum Steinsbekk ◽  
Bjørn Kåre Myskja ◽  
Berge Solberg
Keyword(s):  
Ethical Problem ◽  
Broad Consent ◽  
Biobank Research ◽  
Dynamic Consent

Broad consent is informed consent

BMJ ◽  
2011 ◽  
Vol 343 (nov01 3) ◽  
pp. d6900-d6900 ◽  
Author(s):  
M. Sheehan
Keyword(s):  
Informed Consent ◽  
Broad Consent
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