A blog from the Centre for Research Ethics & Bioethics (CRB)
The second issue of the newsletter from CRB and BBMRI.se is now available:
This April issue contains four interesting news items about:
You’ll also find a link to a two-page PDF-version of the newsletter.
Today I recommend three short and instructive readings on biobanking:
The European Parliament voted in October 2013 on an amended proposal for a new European Data Protection Regulation. In a newsletter from CBR and BBMRI.se, the legal scholars Jane Reichel and Anna-Sara Lind explain implications for biobank research:
A new law on biobanks entered into force in Finland in September 2013. The law allows broad consent for future research and enables use of already collected samples. It also gives donors a stronger position and better protection of their integrity, Joanna Forsberg and Sirpa Soini write in Nature:
International guidelines on biobank research diverge, not least concerning the specificity of the consent and the use of already collected samples and waiver of consent. These ambiguities are discussed in the European Journal of Epidemiology, in an article by Joanna Forsberg, Mats G. Hansson and Kathinka Evers:
These texts help clarifying the complicated regulatory framework.
At the Centre for Research Ethics and Bioethics in Uppsala, we have since the 1990s been studying the ethics of biobank and registry-based research.
If you are interested to see what we have done in this field, you can find a recently updated list of our publications by clicking the link below:
The compilation also contains abstracts of the publications.
Unless you have an education in law, it is almost impossible to find your way through the regulatory landscape of European biobanking, or to understand the motives behind the proposed new general data protection regulation.
However, a helpful overview and discussion can be found in this article by Evert-Ben van Veen:
The article also contains some interesting thinking on a number of important issues, like the concept of personal data, the need for a third category of data between personal data and anonymous data, and the role of trust in institutions.
If you allow researchers to do brain imaging on you for some research purpose, and they incidentally discover a tumor, or a blood vessel with thin walls, you probably want them to inform you about this finding. There are no doubts about the finding; the risks are well-known; it is actionable.
Suppose instead that you donate a blood sample to a biobank. Suppose that researchers studying the sample discover a genetic variant that, depending on a number of interacting factors, might result in disease in three years’ time, or in thirty years, or not at all. It is difficult to predict! Do you still want to know?
How should these incidental findings be handled that increasingly often will be made in genetic biobank research? We are all different, so finding variants with some statistical relation to disease is more or less expected.
A common approach to this question within attempts to develop a policy for incidental biobank findings is to formulate general conditions for when researchers should inform participants. Like: if the finding is analytically valid; if it has clinical significance; if it is actionable – then participants should be informed.
The problem is: we already knew that. We know what these conditions mean in imaging studies when a tumor or a damaged blood vessel is discovered. In these cases, the conditions can be assessed and they make it reasonable to inform. But what about genetic risk information, which often is more multidimensional and has unclear predictive value?
This question is discussed in a recent article in the European Journal of Human Genetics, written by Jennifer Viberg together with Mats G. Hansson, Sophie Langenskiöld, and me:
Viberg argues when we enter this new and more complex domain, we cannot rely on analogies to what is already known in a simpler domain. Nor can we rely on surveys of participants’ preferences, if these surveys employ the same analogies and describe the findings in terms of the same general conditions.
Time is not yet ripe for a policy for incidental genetic findings, Viberg and colleagues conclude. Formulating a policy through analogies to what is already known is to cover up what we do not know. The issue requires a different form of elucidation.
That form of elucidation remains to be developed.
Biobanks make contributing to medical research easy: easier than when the research is performed on living human bodies.
I simply donate my sample and consent to storage for certain kinds of future research, under specified conditions like that the research is ethically reviewed and the sample is coded so that it cannot be traced to me without keys. I consent to a specific biobank framework.
Thereafter, the research is done on the sample and data in registers. What an easy way of contributing to research!
Too easy, it is sometimes objected. Broad consent to future research implies ethically problematic passivity among biobank participants, the objection goes. Participants are precluded from exercising fundamental rights and freedoms. Power is transferred from participants to researchers.
What’s the solution, then? An often proposed solution is familiar to all who make choices on the internet. Passive biobank participants can be activated by keeping themselves updated via a website. On this website, they give dynamic consent in real time, as researchers continually inform about proposed research with donated samples.
Dynamic consent would empower biobank participants, make them engaged in the decision-making process and equal partners in the research.
It sounds brilliant! What an easy solution! In the case of large population-based biobanks, however, it would mean that hundreds of thousands would spend the rest of their lives keeping themselves updated about planned research with samples donated perhaps decades ago, and for each new project make active choices: yes or no?
Researchers would be free to come and leave the biobank, while participants are fettered to a life-long commission as ethical gate-keepers, with their own login information.
Seduced by sugary phrases? In an article last month – Broad versus dynamic consent in biobank research – Norwegian research ethicists identify six often cited reasons in favor of a dynamic consent model for biobanks. For each cited claim, they are able to adduce reminders and considerations that make the claim notably less appetizing, at least to me.
This post would become long-winded if I informed about all objections to the claims in favor of dynamic consent: who reads long texts on the internet? Two central objections, however, are that a dynamic consent model would invite people into the therapeutic misconception and that it would individualize the ethical review of public health research.
Still, it is vital that biobanks continually inform about ongoing and planned biobank activities, making the research transparent, and giving those who might want to opt-out opportunity to do so.
The Helsinki Declaration is under revision. One suggested change concerns a paragraph about biobank and register-based research, which states:
The paragraph currently continues with the following exceptions:
The proposed revision is to delete the exception I emphasized. – Why? I speculate that the deletion is proposed to avoid perceived conflict with an earlier paragraph, stating that
In particular, the interests of research must not take precedence over the interests of the participant. But it might appear as if “…or would pose a threat to the validity of the research” does just that. The phrase seems to emphasize the interests of research.
In the latest issue of Science, CRB researchers Joanna Forsberg and Yusuke Inoue question the proposal to delete the exception. In a letter, “Beware Side Effects of Research Ethics Revision,” they point out that in biobank and register-based research, risks of participation are only minimal.
Human beings are “participants” in a markedly different sense when the research is done on their data or samples, rather than on themselves or their bodies.
The authors argue that “when the risks are minimal, it is not clear that the individual’s interests in having a say should automatically outweigh the good that can result from robust research.”
I think their views should be taken seriously. There is a risk that the effort to achieve verbal consistency neglects actual distinctions between forms of medical research. If the paragraphs that seem to conflict concern markedly different forms of research and markedly different forms of participation with markedly different risks – then an important exception might be sacrificed for the sake of an only apparent conflict.
It is comprehensible that a patient who agrees to participate in a clinical trial expects to get access to a new effective therapy that will restore health. It is comprehensible that it is difficult to convey objective, dispassionate information that such an expectation is unrealistic, given randomization and other features of clinical trials.
Participation in biobank research ought to be simpler to understand. How can you expect to get healthy by giving a blood sample and allowing future research to combine the genetic data that can be obtained from the sample with data accumulating over time in health registries? The therapeutic misconception ought to be less tempting in biobank research, making the relationship between researchers and participants more straightforward.
For this reason, I was surprised to read on the Science Codex Blog about a study indicating difficulties to understand participation in biobank research; difficulties similar to those that more comprehensibly arise for participation in clinical trials.
What surprised me even more, however, was the discussion about this finding that was quoted on the blog. The fact that participants in biobank studies cannot expect a new and better therapy was presented as a shortcoming vis-à-vis clinical trials, as if such an expectation was not a misconception. Moreover, hopes were expressed that a change is underway:
I do not exclude that such models might work for some restricted biobank studies about specific diseases, which might require on-going contact with a particular patient group to get the research done.
But biobanking is more and more about building infrastructures where samples are stored indefinitely for future research that cannot be specified in advance. Making participation in such infrastructures more like participation in specific clinical trials – supporting the therapeutic misconception where it ought to be most distant! – appears fundamentally misguided.
The infrastructural nature of modern biobanking remains to be understood. It needs to be freed from what might be termed the specific study misconception.
EU is currently discussing changes to the European privacy laws. The intention is to strengthen the protection of privacy and to give people more control over their data.
The problem, which I highlighted on The Ethics Blog, is that the new proposal applies also to research. Presently there is an exception for scientific research about health and disease. The proposed revision of the privacy regulation, however, allows no exceptions.
Every person who has given data to a register must according to the new proposal be asked for consent each time researchers want to study some new disease pattern. Patient data can never be used in research without specific consent, and not even historical registers and data from diseased persons are given exception in the new proposal.
A recent article in Nature Reviews Genetics by Deborah Mascalzoni et al. highlights a patient group that is especially vulnerable to the proposed revision: patients suffering from rare diseases. In Sweden a disease is defined as rare if it affects less than a hundred persons in a million.
Data on rare diseases are, as a matter of course, rare. We therefore know little about these diseases and it is difficult to develop effective medical treatments. To achieve statistically significant analyses, researchers must typically share data over national borders. Every lost piece of data about rare diseases can mean dramatically impaired prospects of new drugs and treatments for these patient groups.
Rare diseases are thus a further strong reason for maintaining the current exception for scientific research in the data protection legislation. Read more on the CRB website.
The newly proposed European Data Protection Directive overprotects research participants and exposes patients to greater risks of contracting illness and dying.
Thus dramatically a recent article in The Lancet Oncology can be summarized, written by Mats G. Hansson at CRB together with Gert Jan van Ommen, Ruth Chadwick and Joakim Dillner.
People who provide data to research registers are not exposed to physical risks, like participants in interventional research. The risks associated with register-based research are informational: unauthorized release of information about participants. One might ask if it even makes sense to say that people “participate in research” when researchers process large data sets.
Patients (and people in general) have significant protection from disease thanks to register-based research. For example, it is estimated that the HPV vaccine will save about 200 women from dying in cervical cancer each year, in Sweden alone. This cancer-preventive treatment became possible because researchers had access to samples dating back to the 1960s providing evidence for a causal connection between a certain virus infection and cervical cancer later in life.
the EU committee proposing the new directive treats the integrity of “research participants” as so pivotal that researchers who process data not only must be subjected to the same ethical review process as for invasive research, but also must obtain informed consent from each and every one who once gave their data to the register, whenever the researchers want to study a new disease pattern.
Data protection efforts easily lose their sense of proportions, it seems, at least concerning register-based research. Not only is one prepared to expose patients to greater physical risks in order to protect research participants from (already rigorously controlled) informational risks.
One also is prepared to disturb data providers who hardly can be described as “participating” in research, by forcing researchers to recontact them about informed consent. Not only on one occasion, but time and again, year after year, each time a new disease pattern is explored in the registers. That’s what I call privacy intrusion!
Pär Segerdahl is the editor of the Ethics Blog and Associate Professor of Philosophy at the Centre for Research Ethics & Bioethics (CRB)
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