Bioethicists suggest broad consent for biobank research

September 2, 2015

Pär SegerdahlIt is still unclear what kind of consent should be used when collecting biological samples for future research. Different forms of consent are practiced, which creates another uncertainty: which research is actually permitted with the collected samples?

This haphazard situation leads to unintended constraints on research. But it also leads to research sometimes being carried out without consent.

Against this background, the US National Institutes of Health (NIH) organized a workshop to discuss whether it is ethically reasonable to manage these uncertainties by using broad consent for future research when collecting biological samples.

The group of bioethicists who attended the workshop, including Mats G. Hansson, recently published their thoughts and conclusions in the American Journal of Bioethics:

The group’s proposal is that broad consent is ethically reasonable and often the best option, if it has three components:

  1. Consent is conducted initially, in connection with sample collection.
  2. There is a system for oversight and approval of future research.
  3. As far as possible, there should be ongoing communication with, and information to, donors.

Biological samples are collected in a variety of contexts. It is here that the haphazard situation arises, if different forms of consent are used, or perhaps no consent at all. By initially informing potential donors of the wide range of research that can be carried out, they can take a position on risks and benefits of donation (given the oversight and the general conditions of the future research that they are informed about).

The group emphasizes that broad consent gives donors control over the use of samples, while minimizing costs and burdens for both donors and researchers.

They also point out that empirical studies show that most people want to decide if their samples may be used for research. Most respondents also say that the decision is not influenced by the specific details of the future research (e.g. what diseases are studied, what techniques are used, or which parts of the sample are studied).

Of course there are examples of research that can be perceived as controversial, such as human cloning. But broad consent can be combined with specific restrictions. Oversight moreover considers whether research proposals can be said to comply with the donors’ values.

If donors still hesitate, they are free to choose not to donate the sample.

Pär Segerdahl

Approaching future issues - the Ethics Blog

Ethics research keeps ethical practices alive (new dissertation)

August 25, 2015

Pär SegerdahlI have in two posts complained about a tendency of ethical practices to begin to idle, as if they were ends in themselves.

A risk with the tendency is that bioethics is discredited and attacked as no more than an unhappy hindrance to novel research.

Like when Steven Pinker recently wrote that the primary moral goal for bioethics today should be:

But there is a way to go: self-scrutinizing ethics research.

Bioethics is often misunderstood as merely a fixed and finished framework of ethical rules, principles and review systems: as a cumbersome bureaucracy. I guess that is how Pinker understands it.

But first, the “framework” is the result of novel ethical thinking at a time when we had reason to rethink the position of science. Doing research is important, but it does not justify exploiting research participants. There are other values ​​than Science, which scientists should take seriously.

Secondly, this ethical thinking will never be finished. There are always new problems to subject to self-scrutinizing ethics research.

Not infrequently these problems are occasioned by the bioethical framework. Pregnant women and children are routinely excluded from research, on ethical grounds. But does not the protection of these groups as research participants mean that they are exposed to risks as patients? If new drugs are tested only on adult males, we don’t know what doses a pregnant woman or an infant should receive.

We need self-critical ethics research, to keep ethics alive and to avoid idling.

Therefore, I formulate a different imperative than the one Steven Pinker suggests. Bioethics main goal should be: Think anew, reflect critically, do ethics research!

We follow that imperative at CRB. An example is Tove Godskesen’s thesis,

which will be defended on Friday, August 28, at 09:15, in room A1:107a at BMC (Biomedical Centre, Husargatan 3, Uppsala, Sweden).

This thesis is not about standing in the way of cancer research, but about doing empirical-ethical research to examine how well the ethical practices work when cancer patients are recruited as participants in such forms of research.

Do the patients understand the information they receive about the research? Do they understand that the possibility that they will be cured through research participation is extremely low? Do they understand that cancer research involves certain risks? Do they understand what a randomized study is?

And why do they volunteer as research participants? Because they hope for a new miracle drug? Because they want to help future patients? As thanks for the help they received? Because they feel a duty towards relatives, or because of (perceived) expectations from the doctor?

All these questions are empirically studied in the thesis.

Godskesen’s dissertation also contains reflections on the concept of hope. Her empirical studies show that it is precisely the patients with the least chance to be cured – those who don’t have much time left, and who usually are asked to participate in Phase 1 clinical studies – who primarily are motivated by the hope of a cure, at the last moment.

How should we view this fact? Does it mean that these participants misunderstand the study they have chosen to participate in, and thus participate on false premises? Or is it a hope which gives meaning at the end of life, a hope which might be nourished even if you understand the study design?

These are questions we cannot “step out of the way” of. Tove Godskesen does not step out of their way. Come and listen on Friday (but observe that the examination will be conducted in Swedish)!

Pär Segerdahl

In dialogue with patients

Openness as an ethical ritual

August 3, 2015

Pär SegerdahlBarbara A. Koenig wrote last year about how informed consent has acquired a “liturgical feel” in biomedical research ethics. Each time the protection of research participants is challenged by new forms of research, the answer is: more consent!

The procedure of informing and asking for consent may feel like assuming a priestly guise and performing an ethical ritual with the research participant.

The ritual is moreover sometimes practically impossible to implement. For example, if one is to inform participants in genetic research about incidental findings that might be made about them, so that they can decide whether they want to be re-contacted if researchers happen to discover “something” about them.

If it takes one hour to inform a patient about his or her actual genetic disease, how long would it take to inform a research participant of all possible kinds of genetic disease risks that might be discovered? Sorry, not just one participant, but hundreds of thousands.

How then can research participants be respected as humans, if informed consent has become like an empty ritual with the poor participant? (A ritual that in genetic research sometimes is impracticable.)

In the August issue of Nature, Misha Angrist suggests a solution: we treat participants as partners in the research process, by being open to them. How are we open to them? By offering them the researchers’ genetic raw data, which can be handed over to them as an electronic file.

Here we are not talking about interpreted genetic disease risks, but of heaps of genetic raw data that are utterly meaningless for research participants.

Openness often has important functions. Making scientific articles openly accessible so that everyone can read them has a function. Making researchers’ data available to other researchers so that they can critically review research, or use already collected data in new research, has a function.

But offering files with genetic raw data to research participants, what is its function? Is it really the beginning of a beautiful partnership?

Openness and partnership seem here to become yet another ethical ritual; yet another universal solution to ethical difficulties.

Pär Segerdahl

We think about bioethics :

Second issue of our newsletter about biobanks

June 2, 2015

Pär SegerdahlNow you can read the second newsletter this year from CRB and

The newsletter contains four news items:

1. Anna-Sara Lind presents a new book, Information and Law in Transition, and the contributions to the book by CRB researchers.

2. Anna-Sara Lind describes the situation for the temporary Swedish law on research registries.

3. Mats G. Hansson reports on a modified version of broad consent for future research.

4. Josepine Fernow presents a new article by Jennifer Viberg on the proposal to give research participants freedom of choice about incidental findings.

(Link to PDF version of the newsletter)

Pär Segerdahl

We recommend readings - the Ethics Blog

Where is consciousness?

May 26, 2015


Michele FariscoWould it be possible to use brain imaging techniques to detect consciousness and then “read” directly in people’s brains what they want or do not want? Could one, for example, ask a severely brain injured patient for consent to some treatment, and then obtain an answer through a brain scan?

Together with the philosopher Kathinka Evers and the neuroscientist Steven Laureys, I recently investigated ethical and clinical issues arising from this prospective “cerebral communication.”

Our brains are so astonishingly complex! The challenge is how to handle this complexity. To do that we need to develop our conceptual apparatus and create what we would like to call a “fundamental” neuroethics. Sound research needs solid theory, and in line with this I would like to comment upon the conceptual underpinnings of this ongoing endeavor of developing a “fundamental” neuroethics.

The assumption that visualizing activity in a certain brain area can mean reading the conscious intention of the scanned subject presupposes that consciousness can be identified with particular brain areas. While both science and philosophy widely accept that consciousness is a feature of the brain, recent developments in neuroscience problematize relating consciousness to specific areas of the brain.

Tricky logical puzzles arise here. The so called “mereological fallacy” is the error of attributing properties of the whole (the living human person) to its parts (the brain). In our case a special kind of mereological fallacy risks to be embraced: attributing features of the whole (the brain) to its parts (those visualized as more active in the scan). Consciousness is a feature of the whole brain: the sole fact that a particular area is more active than others does not imply conscious activity.

The reverse inference is another nice logical pitfall: the fact that a study reveals that a particular cerebral area, say A, is more active during a specific task, say T, does not imply that A always results in T, nor that T always presupposes A.

In short, we should avoid the conceptual temptation to view consciousness according to the so called “homunculus theory”: like an entity placed in a particular cerebral area. This is unlikely: consciousness does not reside in specific brain regions, but is rather equivalent to the activity of the brain as a whole.

But where is consciousness? To put it roughly, it is nowhere and everywhere in the brain. Consciousness is a feature of the brain and the brain is more than the sum of its parts: it is an open system, where external factors can influence its structure and function, which in turn affects our consciousness. Brain and consciousness are continually changing in deep relationships with the external environment.

We address these issues in more detail in a forthcoming book that I and Kathinka Evers are editing, involving leading researchers both in neuroscience and in philosophy:

Michele Farisco

We want solid foundations - the Ethics Blog


Letting people choose isn’t always the same as respecting them

May 5, 2015

Jennifer Viberg, PhD Student, Centre for Research Ethics & Bioethics (CRB)Sequencing the entire genome is cheaper and faster than ever. But when researchers look at people’s genetic code, they also find unexpected information in the process. Shouldn’t research participants have access to this incidental information? Especially if it is important information that could save a life if there is treatment to offer?

The personal benefits of knowing genetic information can vary from individual to individual. For one person, knowledge might just cause anxiety. For another, genetic risk information could create a sense of control in life. Since different people have different experiences, it could seem tempting to leave it for them to decide for themselves whether they want the information or not.

Offering participants in genetic research a choice to know or not to know is becoming more common. Another reason for giving a “freedom of choice” has to do with respecting people by allowing them to make choices in matters that concern them. By letting the participant choose, you acknowledge that he or she is a person with an ability to make his or her own choices.

But when researchers hand over the decision to participants they also transfer responsibility: A responsibility that could have consequences that we cannot determine today. I recently wrote an article together with colleagues at CRB about this in Bioethics. We argue that this freedom of choice could be problematic.

Looking at previous psychological research on how people respond to probabilities, it becomes clear that what they choose depends on how the choice situation is presented. People choose the “safe” outcome before taking a risk in cases where the outcome is phrased in a positive way. But they are more prone to taking a risk when the result is phrased in a negative way, despite the fact that the outcome is identical. If a participant is asked if he or she wants information that could save their life, there is a risk that they could be steered to answering “yes” without considering other important aspects, such as having to live with anxiety or subjecting themselves to medical procedures that might be unnecessary.

The benefit of incidental findings for individual participants is hard to estimate. Even for experienced and knowledgeable genetic researchers. If we know how difficult the choice situations are, even for them, and if we know how psychological processes probably will steer the participants’ choices, then it seems that it is hardly respectful to give the participants this choice.

There are good intentions behind giving participants freedom to choose, but it isn’t respectful if we can predict that the choices won’t be free and well grounded.

If you want to learn more, you find further reading on CRB’s web, and here is a link to our article: Freedom of choice about incidental findings can frustrate participants’ true preferences

Jennifer Viberg

We like real-life ethics :

Conversations with seemingly unconscious patients

September 23, 2014

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogResearch and technology changes us: changes the way we live, speak and think. One area of ​​research that will change us in the future is brain research. Here are some remarkable discoveries about some seemingly unconscious patients; discoveries that we still don’t know how to make intelligible or relate to.

A young woman survived a car accident but got such serious injuries that she was judged to be in a vegetative state, without consciousness. When sentences were spoken to her and her neural responses were measured through fMRI, however, it was discovered that her brain responded equivalently to conscious control subjects’ brains. Was she conscious although she appeared to be in a coma?

To get more clarity the research team asked the woman to perform two different mental tasks. The first task was to imagine that she was playing tennis; the other that she visited her house. Once again the measured brain activation was equivalent to that of the conscious control subjects.

She is not the only case. Similar responses have been measured in other patients who according to international guidelines were unconscious. Some have learned to respond appropriately to yes/no questions, such as, “Is your mother’s name Yolande?” They respond by mentally performing different tasks – let’s say, imagine squeezing their right hand for “yes” and moving all their toes for “no.” Their neural responses are then measured.

There is already technology that connects brain and computer. People learn to use these “neuro-prosthetics” without muscle use. This raises the question if in the future one may be able to communicate with some patients who today would be diagnosed as unconscious.

– Should one then begin to ask these patients about informed consent for different treatments?

Here at the CRB researchers are working with such neuro-ethical issues within a big European research effort: the Human Brain Project. Within this project, Kathinka Evers leads the work on ethical and societal implications of brain research, and Michele Farisco writes his (second) thesis in the project, supervised by Kathinka.

Michele Farisco’s thesis deals with disorders of consciousness. I just read an exciting book chapter that Michele authored with Kathinka and Steven Laureys (one of neuro-scientists in the field):

They present developments in the field and discuss the possibility of informed consent from some seemingly unconscious patients. They point out that informed consent has meaning only if there is a relationship between doctor/researcher and patient, which requires communication. This condition may be met if the technology evolves and people learn to use it.

But it is still unclear, they argue, whether all requirements for informed consent are satisfied. In order to give informed consent, patients must understand what they agree to. This is usually checked by asking patients to describe with their own words what the doctor/researcher communicated. This cannot be done through yes/no-communication via neuroimaging. Furthermore, the patient must understand that the information applies to him or her at a certain time, and it is unclear if these patients, who are detached from the course of everyday life and have suffered serious brain injury, have that understanding. Finally, the patient must be emotionally able to evaluate different alternatives. Also this condition is unclear.

It may seem early to discuss ethical issues related to discoveries that we don’t even know how to make intelligible. I think on the contrary that it can pave the way for emerging intelligibility. A personal reflection explains what I mean.

It is tempting to think that neuroscience must first determine whether the patients above are unconscious or not, by answering “the big question” how consciousness arises and becomes disturbed or inhibited in the brain. Only then can we understand these remarkable discoveries, and only then can practical applications and ethical implications be developed.

My guess is that practical technological applications, and human responses to their use, rather are venues for the intelligibility that is required for further scientific development. A brain does not give consent, but perhaps a seemingly unconscious patient with neuro-prosthesis. How future technology supported communication with such patients takes shape – how it works in practice and changes what we meaningfully can do, say and think – will guide future research. It is on this science-and-technology supported playing field that we might be able to ask and determine what we thought neuroscience had to determine beforehand, and on its own, by answering a “big question.”

After all, isn’t it on this playing field that we now begin to ask if some seemingly unconscious patients are conscious?

Ethics does not always run behind research, developing its “implications.” Perhaps neuro-ethics and neuroscience walk hand in hand. Perhaps neuroscience needs neuro-ethics.

Pär Segerdahl

In dialogue with patients

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