A blog from the Centre for Research Ethics & Bioethics (CRB)

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Broad and deep consent for biobanks

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)

This post in Swedish

We challenge habits of thought : the Ethics Blog

Online course in research ethics, spring 2016

Pär SegerdahlAnyone who manages research also needs to be able to reflect on research. Not only the researchers themselves, but also funding bodies, journal editors, members of research ethics committees, administrators, journalists, organizations, politicians, and others.

How do you act if you suspect research misconduct, and what is it? What are the ethical and legal regulations governing data management or research on humans and animals?

If you want to learn more about these issues, or perhaps about publication ethics and authorship rules, conflicts of interest, mentor/trainee responsibilities, biosecurity and more – then we can help you. We give an online course in research ethics for medicine and the life sciences.

The course runs for ten weeks, from April 4 to June 10, every week with its own theme (the last week is devoted to sharing what you learned with your home institution). The course includes video lectures and texts to read, but also interactive exercises and regular e-meetings with other students and with the teacher.

The course is given in English and is open to students from all over the world. If you want to know what some of the former students have to say about the course, you can read more here. And if you want to know who the course is aimed at, read more here.

Research ethical responsibility is vital and it is important that ethics education reaches out. The course fee is € 1.125 (including tax), and to students who cannot receive financial support from their home institution we offer a limited number of scholarships for which application deadline is February 15.

If you don’t need a scholarship you can apply for the course until course start.

Pär Segerdahl

This post in Swedish

We care about education

Dynamic consent in biobank research: better than broad consent?

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.

Pär Segerdahl

The temptation of rhetoric - the ethics blog

An ape genius, or just an ordinary talking ape?

In 2001 I travelled to Atlanta, where Sue Savage-Rumbaugh then worked with the language-competent bonobos Kanzi and Panbanisha. A question I travelled with concerned the linguistic tests that I had seen in a TV-documentary, Kanzi, an ape of genius.

In these tests, the ape responds to requests in spoken English, uttered by an experimenter who – to avoid cueing Kanzi through extra-linguistic assists like gestures and gazes – stands behind his back, or sits in an adjacent room speaking through a microphone, or covers her face with a welder’s mask. The aim of this experimental design is to distill Kanzi’s comprehension of vocabulary and syntax, the essence of language.

What I wondered was this: how did the experimenters get the ape into the test situation?

In the documentary, Kanzi appears miraculously as if he were nothing but a brilliant subject of scientific experimentation, an ape genius. Sitting on a chair wearing headphones, he picks up photos of grapes, keys, potatoes, people… He responds perfectly reliably, hearing the verbal requests, “Kanzi, give Sue the picture of grapes,” and so on.

How did Kanzi become that brilliant research subject? What happened before the camera was turned on? Does Kanzi spend his days on a chair wearing headphones, just waiting for an experimenter? Probably not, but then what is the relation between his ordinary life and the test situation? Is it irrelevant, since the conditioning anyhow took place in the same kind of scientific situation?

My first question to William M. Fields, who invited me to Atlanta, was: How do you get Kanzi into the experiment? The simplicity of his answer stunned me:

  • “We ask Kanzi if he wants to work.”

In contrast to his half-sister, Panbanisha, who typically refused to play the research subject role, Kanzi usually is willing to work. Then follows negotiations about the food he will have access to during work and which activities and meetings he’ll be granted later because he admits to work.

The filmed tests have a context, but the context isn’t more science. It is Kanzi’s life with other bonobos and with the speaking humans who co-reared young bonobos together with their bonobo mothers. Kanzi is an adult, but a point can be made by comparing him with children who participate in controlled psychological experiments. These children are not raised in a lab. They have a home. Only occasionally are they taken into the lab to participate in science. This often requires quite a bit of negotiation and instruction.

Child participation in psychological experimentation exhibits home/lab duality. The child’s language develops at home and is only tested in the lab. The science that charts the child’s linguistic development doesn’t reflect the more significant context outside of the lab, where the child becomes the speaking being that is being tested.

The child’s life at home is primal. Science plays the second fiddle and doesn’t recreate the vitality that made what is scientifically tested possible.

Animal science rarely exhibits home/lab duality. The animals are conditioned in the same type of controlled situations as those in which they are tested. If an animal picks up laminated photos of keys, it is because it was trained to pick up laminated photos of keys. It doesn’t have a life with doors, cabinets and keys, independently of its scientific disciplining. But Kanzi does.

Like a child whose parents decided to contribute to psychological science, Kanzi is not disciplined as a pure research subject. He became a speaking being at home, in ordinary ape-human ways of life (in an ape-human culture). Only occasionally is he talked and instructed into the lab, to participate in activities that don’t reflect the vibrant home situations in which he became who he is.

Kanzi is no aberrant ape genius. He is just an ordinary talking ape. Home/lab duality enabled him to become one.

(Want to read more? Here are some books.)

Pär Segerdahl

Understanding enculturated apes - the ethics blog

Project Nim: a tragedy that was interpreted as science?

Last week I wrote about the significance of negative results in science. This week I saw one of the saddest documentaries I’ve ever seen, featuring the tragic context of an often cited negative result in science.

The documentary, Project Nim (2011), was about the psychologist Herb Terrace’s attempt in the 1970:s to teach American sign language to a young chimpanzee, in a specially designed classroom at Columbia University in New York City. “Specially designed” here meant bare and small in order to avoid suggesting activities that are more exciting for a young ape than reproducing the teacher’s hand movements.

Terrace’s personal stance to the language project struck me as odd. Scientifically, he wanted to test the hypothesis that an ape can be taught to construct sentences. This would disprove Chomsky’s view that language is an innate and uniquely human trait. From a more “personal” point of view, what excited Terrace most was the prospect of experiencing a nonhuman animal communicate ape thoughts.

It would be like meeting an alien from outer space who miraculously communicated foreign thoughts to humankind. Treating young Nim as such an alien research subject strikes me opposed to the very idea of human language and communication.

The whole project was a mess, ill-planned and dysfunctional from the start. And yet there were happy moments where good relationships developed between Nim and responsible caretakers/teachers/surrogate parents outside the classroom.

In these more “distractive” real-life situations, where the point wasn’t about reproducing the teacher’s signs but about doing meaningful things together and communicating about them while doing them, it seemed Nim used signs to talk. The caretakers were optimistic, as was Terrace.

However, as Nim got bigger and stronger and approached adolescence, new problems appeared. He began to attack and bite his teachers, and Terrace feared being sued. These troublesome behaviors developed more rapidly than Nim’s signing abilities, and Terrace was worried.

One day, Terrace called his staff to a meeting and declared that the project was over. They had collected suffient data, and Nim could be sent back to the primate research center in Oklahoma where he was born.

The rest of Nim’s life was was awful, terrifying (although responsible caretakers did try to make a difference).

Simultaneously, Terrace started reporting the project; in a book as well as in an article published in Science. He sat down, watched videotaped interactions between Nim and his teachers, and came to the conclusion that Nim had not acquired the ability to use signs linguistically in genuine communication with humans. He was merely mirroring the teacher’s signs (or begging for things).

The negative result that Terrace published perhaps received more attention than any other scientifically published negative result. In spite of the fact that the project was dysfunctional from the start, Terrace’s publications were welcomed as presenting hard scientific evidence that apes cannot learn to communicate in language.

I’m not so sure what conclusions can be drawn from a research project that could just as well be described as a dysfunctional family history ending in tragedy. Moreover, as Peter Singer observed when he watched the documentary, Terrace could hardly end the project and send Nim away without reporting negative results.

Can we trust Terrace’s judgment when we watched the videotapes and decided that the ape he sent away did not speak with the fellow humans with whom he interacted?

Anyway, the book that Terrace wrote, Nim: a Chimpanzee Who Learned Sign Language (1979), is fascinating and well worth reading. It contains vivid descriptions of Nim’s life with humans; recollections that often seem to contradict the conclusions that Terrace finally reached.

Pär Segerdahl

Understanding enculturated apes - the ethics blog

How unspecific is broad consent?

In response to an informative article on personalized medicine and biobanking in Nature Biotechnology, a recent letter to the Editor defends broad consent for biobanking.

The three letter writers emphasize the patient and donor perspective:

  • “…patient donors actually express concern that study-specific consent can be burdensome and impede research.”

Given these donors’ desire to give so-called broad consent, I want to highlight two problematic aspects of the distinction between specific and broad consent.

The first is that the word “broad” consent may give rise to the impression that the consent is so general and vague that it cannot be seen as informed consent to anything specific at all. But broad consent is not “broad” in such an absolute sense, akin to vagueness. It is “broad” only in a relative sense: in relation to the historically more prevalent case of consenting to individual research projects.

The distinction between specific and broad consent is a distinction between two ways of being specific. One of these ways of being specific dominated the scene first. It therefore functioned as a linguistic standard. The other way of being specific had to put up with being called “broad.”

Specific consent, then, is specific only in a specific sense: one that is historically conditioned and changeable. It is not the golden standard of exactitude. Consent can therefore be “broad” without being vague.

The second problematic aspect is that when people donate samples to biobanks, the exact nature of the individual research projects that might use their samples is less relevant to them than when they consent to invasive procedures in clinical trials.

The risks are minimal in biobank research. Donors therefore look more to the practical utility of the research than to the research itself. Forcing them to consider the purposes and questions and procedures of individual research projects is forcing them to attend to a level of medical research that is less relevant to them as donors.

In short, a historically and linguistically insensitive demand for “specific consent” in biobanking may hinder donors from giving the kind of specific consent they authentically want to give in this new but more and more prevalent context.

Pär Segerdahl

Minding our language - the Ethics Blog

Henrietta Lacks and the power of rhetoric

Paradoxically, the victim can have the most powerful position, namely, as a “rhetorical figure.”

I sense this rhetorical power in Rebecca Skloot’s bestselling book, The Immortal Life of Henrietta Lacks. I think less freely under the spell of this rhetoric. My thoughts are not allowed to discover new aspects of things. Questions are being silenced and the direction of my “reasoning” is predestined.

Who dares to be scrutinizing in the confrontation with the tear-jerking language that occurs on the author’s website for the book? This could be the lyrics of a whole genre of sad songs.

We read and write about Henrietta Lacks as if we were spellbound.

The most spellbound of all seem to be the reviewers of the book. Many excel in morbid presentations of a both dead and living body abducted by science; of a poor black woman who anonymously “paid the price” for a whole series of profitable medical discoveries and innovations.

Who wouldn’t yield to the temptation?

As a result, however, obvious questions are silenced. For example: Is it not wonderful that she was anonymous (until the publication of the bestseller)? Is it not splendid that scientists speak of “HeLa cells” and not about “Henrietta Lacks’ cells”? Wasn’t her integrity protected that way (until the publication of the bestseller)?

We don’t know how Henrietta Lacks would have described her destiny. Would she describe herself as a victim of science (rather than as a victim of cancer, for example)? Or has she become one of the most recent victims of the enchanting rhetoric of the victim?

(I wish to thank Joanna Forsberg for inspiration. A comment of hers on our Swedish Etikbloggen helped break the spell for me and gave birth to this post.)

Pär Segerdahl

The temptation of rhetoric - the ethics blog

Protecting children: through research or from research?

Children pose a dizzyingly difficult problem for research ethics.

One of the most important tasks of research ethics is the protection of human research participants. This significant aim is realized above all through the requirement of proper information and consent procedures.

But children often cannot be protected though these means. They are too young to understand information about research and to give their own autonomous consent.

Children often are excluded from medical research. Since they cannot be protected by the standard ethical precautions, they can be protected only by being excluded from research, so to speak.

The result, however, is that “experimentation” on children in practice moves elsewhere. It moves to the prescription of medical substances to sick children in health care.

We often don’t know the side-effects of medical substances in children; at least not as well as we know them in adults. We often don’t know what dosages are required in children to gain the sought-after effect. We often don’t know when the dosages become toxic.

As a consequence of this, medical prescriptions to children lack the scientific evidence that we have for adult patients. Moreover, when children become sick, they may be “protected” as patients by being denied what could be the most effective medical treatment. Doctors cannot prescribe potent medical substances to children if they don’t know their effects in the body of a child.

The dizzying difficulty can perhaps be simplified thus:

  1. Adults can be ethically protected as research participants. Therefore, scientific knowledge is gained that protects them as patients too.
  2. We cannot protect children as research participants. Therefore, we cannot protect them as patients either (at least not as well as we protect adult patients)

There is growing concern among ethicists about this situation. More knowledge is needed about children’s responses to various medical treatments. Otherwise they cannot be given the best possible treatments when they are patients. That, however, requires more clinical research with children. – But how can we ethically justify such research?

The problem is discussed in the current issue of The American Journal of Bioethics. A target article by David Wendler is followed by seven open peer commentaries.

If you are interested in the problematic, I strongly recommend reading this discussion and considering whether the attempted justifications get to the root of the dizzying problem.  One thing is clear, though:

Protecting children ethically by excluding them from research participation is not the unambiguously good deed it may appear to be.

Pär Segerdahl

We like challenging questions - the ethics blog

Can infrastructure for biobank research make ethical notions obsolete?

In a comment to what I posted earlier about the decision of the Swedish Data Inspection Board to stop LifeGene, Åke Thörn asks what I mean by saying that

  • “LifeGene represents a new reality in the making.”

Since the question has deep interest, I want to answer it here, in a new post. I will use a simile to explain my intended meaning.

Suppose that rather than discussing biobank ethics, we were playing a form of chess with the strange feature that the chessboard sometimes changes. Squares turn into circles. Or the entire chessboard turns into a rhomb.

These changes of the chessboard make the old rules obsolete. What is “straight” and what is “diagonal” on a chessboard with the shape of a rhomb? The rules need to be reconsidered!

Research ethics and ethical review can be compared to games played on chessboards that sometimes change and require that rules and basic notions are reconsidered. What I meant in my previous post was that LifeGene represents such a basic change of the research ethical chessboard.

How should the “aim” of biobank infrastructure be described, given that infrastructure is not a research project with the aims of individual biobank projects? Do people turn into “research participants” when their ten-year old blood samples are used in new studies?

We cannot always cherish old ethical notions – as if there were no such things as TIME and CHANGE. We sometimes need to rethink rules and basic notions.

I hope these considerations explain my understanding of ethics as sensitive to changing times, and my notion of LifeGene as a “new reality.”

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

The Swedish Data Inspection Board stops large biobank

Swedish biobank research suffered serious defeat last week. The Swedish Data Inspection Board decided that the ongoing collection of biological samples and health data to the large biobank LifeGene is against the law.

Karolinska Institutet (that runs LifeGene) must now stop collecting further data and is not allowed use already collected data. The reason for the decision is said to be the loosely formulated purpose of LifeGene: “future research.” Participants cannot give consent to anything that vague, the Data Inspection Board argues.

Well, that openness happens to be the point of this new type of biobank!

LifeGene is not a research project, nor is it part of a research project. LifeGene is intended as infrastructure of future biobank projects. Researchers are invited to apply for access to the biobank within specific studies of, for example, genetic and environmental risk factors for widespread diseases.

The more specifically formulated research purposes enter later in the process!

Collecting hundreds of thousands of biological samples and health data anew, each time researchers want to ambitiously study widespread diseases, is unfeasible. Therefore, LifeGene was developed as standing infrastructure of such biobank research in the future.

… And now it has been decided that developing such infrastructure is illegal. Because the purpose cannot be specified as in the research projects that later use the biobank!

This is a category mistake, as philosophers say when what is fundamentally distinct is conflated. In this case, research infrastructure is conflated with research projects.

Other posts about biobanks on this blog are directly related to the risk of the decision that the Swedish Data Inspection Board made:

My views can be summarized in two simple points:

  1. Infrastructure for biobank research must not be treated as if it were one of the projects meant to use it.
  2. My given blood sample does not make me a research participant (who must give consent each time the sample is used).

LifeGene represents a new reality in the making. It remains for the authorities, for legislators, and for all of us to better understand it!

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

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