Broad and deep consent for biobanks

November 18, 2019

Pär SegerdahlA new article on consent for biobanks manages to surprise me. How? By pointing out what ought to be obvious! If we want to judge what kind of consent works best for biobanks, then we should look at today’s biobanks and not look back at more traditional medical research.

The risks in traditional medical research are mainly physical. Testing new substances and interventions on human subjects can harm them. Potential research participants must therefore be informed about these physical risks, which are unique to each specific project. For this reason, study-specific informed consent is essential in traditional medical research.

In biobank research, however, the risks are primarily informational. Personal data may end up in the wrong hands. The risks here are not so much linked to the specific projects that use material from the biobank. The risks are rather linked to the biobank itself, to how it is governed and controlled. If we want to give biobank participants ethical protection through informed consent, it is information about the biobank they need, not about specific projects.

In the debate on consent for biobanks, study-specific consent figured as a constant requirement for what informed consent must be. However, in the context of biobanks, that requirement risks placing an irrelevant demand on biobanks. Participants will receive the wrong protection! What to do?

Instead of looking back, as if study-specific consent were an absolute norm for medical research, the authors formulate three requirements that are relevant to today’s biobanks. First, potential participants should be informed about relevant risks and benefits. Second, they should be given an opportunity to assess whether research on the biobank material is in line with their own values. Finally, they should be given ethical protection as long as they participate, as well as opportunities to regularly reconsider their participation.

In their comparison of the various forms of consent that have figured in the debate, the authors conclude that broad consent particularly well satisfies the first criterion. Since the risks are not physical but concern the personal data that the biobank stores, information to participants about the biobank itself is more relevant than information about the specific projects that use the services of the biobank. That is what broad consent delivers.

However, the authors argue that broad consent fails to meet the latter two criteria. If potential participants are not informed about specific projects, it becomes difficult to judge whether the biobank material is used according to their values. In addition, over time (biobank material can be saved for decades) participants may even forget that they have provided samples and data to the biobank. This undermines the value of their right to withdraw consent.

Again, what to do? The authors propose a deepened form of broad consent, meant to satisfy all three requirements. First, the information provided to participants should include a clear scope of the research that is allowed to use the biobank material, so that participants can judge whether it is consistent with their own values, and so that future ethical review can assess whether specific projects fall within the scope. Secondly, participants should be regularly informed about the activities of the biobank, as well as reminded of the fact that they still participate and still have a right to withdraw consent.

Ethical reasoning is difficult to summarize. If you want to judge for yourself the authors’ conclusion that broad and deep consent is best when it comes to biobanks, I must refer you to the article.

In this post, I mainly wanted to highlight the originality of the authors’ way of discussing consent: they formulate new relevant criteria to free us from old habits of thought. The obvious is often the most surprising.

Pär Segerdahl

Rasmus Bjerregaard Mikkelsen, Mickey Gjerris, Gunhild Waldemar & Peter Sandøe. Broad consent for biobanks is best – provided it is also deep. BMC Medical Ethics volume 20, Article number: 71 (2019)

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An extended concept of consciousness and an ethics of the whole brain

November 4, 2019

Pär SegerdahlWhen we visit a newly operated patient, we probably wonder: Has she regained consciousness? The question is important to us. If the answer is yes then she is among us, we can socialize. If the answer is negative then she is absent, it is not possible to socialize. We can only wait and hope that she returns to us.

Michele Farisco at CRB proposes in a new dissertation a more extensive concept of consciousness. According to this concept, we are conscious without interruption, basically, as long as the brain lives. This sounds controversial. It appears insensitive to the enormous importance it has for us in everyday life whether someone is conscious or not.

Maybe I should explain right away that it is not about changing our usual ways of speaking of consciousness. Rather, Michele Farisco suggests a new neuroscientific concept of consciousness. Science sometimes needs to use familiar words in unfamiliar ways. For example, biology cannot speak of humans and animals as an opposition, as we usually do. For biology, the human is one of the animals. Just as biology extends the concept of an animal to us humans, Michele Farisco extends the concept of consciousness to the entire living brain.

Why can an extended concept of consciousness be reasonable in neuroscience? A simple answer is that the brain continues to be active, even when in the ordinary sense we lose consciousness and the ability to socialize. The brain continues to interact with the signals from the body and from the environment. Neural processes that keep us alive continue, albeit in modified forms. The seemingly lifeless body in the hospital bed is a poor picture of the unconscious brain. It may be very active. In fact, some types of brain processes are extra prominent at rest, when the brain does not respond to external stimuli.

Additional factors support an extended neuroscientific concept of consciousness. One is that even when we are conscious in the usual sense, many brain processes happen unconsciously. These processes often do the same work that conscious processes do, or support conscious processes, or are shaped by conscious processes. When we look neuroscientifically at the brain, our black and white opposition between conscious and unconscious becomes difficult to discern. It may be more reasonable to speak of continuities, of levels of the same consciousness, which always is inherent in the living brain.

In short, neuroscience may gain from not adopting our ordinary concept of consciousness, which makes such an opposition between conscious and unconscious. The difference that is absolute when we visit a newly operated patient – is she conscious or not? – is not as black and white when we study the brain.

Does Michele Farisco propose that neuroscience should make no difference whatsoever between what we commonly call conscious and unconscious, between being present and absent? No, of course not. Neuroscience must continue to explore that difference. However, we can understand the difference as a modification of the same basic consciousness, of the same basic brain activity. Neuroscience needs to study differences without falling victim to a black and white opposition. Much like biology needs to study differences between humans and other animals, even when it extends the concept of an animal to the human.

The point, then, is that neuroscience needs to be open to both difference and continuity. Michele Farisco proposes a neuroscientific distinction between aware and unaware consciousness. It captures both aspects, the difference and the continuity.

Michele Farisco’s extended concept of consciousness also has ethical consequences. It can motivate an ethics of the whole brain, not just of the conscious brain, in the usual sense. The question is no longer, merely, whether the patient is conscious or not. The question is at what level the patient is conscious. We may need to consider ethically even unconscious brains and brain processes, in the ordinary sense. For example, by talking calmly near the patient, even though she does not seem to hear, or by playing music that the patient usually appreciates.

Perhaps we should not settle for waiting and hoping that the patient will return to us. The brain is already here. At several levels, this brain may continue to socialize, even though the patient does not seem to respond.

If you want to know more about Michele Farisco’s extended concept of consciousness and his ethics of the whole brain, read the dissertation that he recently defended. You can also read about new technological opportunities to communicate with patients suffering from severe disorders of consciousness, and about new opportunities to diagnose such disorders.

Pär Segerdahl

Farisco, Michele. 2019. Brain, consciousness and disorders of consciousness at the intersection of neuroscience and philosophy. (Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine 1597.) Uppsala: Acta Universitatis Upsaliensis.

This post in Swedish

We challenge habits of thought : the Ethics Blog


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