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

Idling normativity

August 17, 2015

Pär SegerdahlI recently wrote about the tendency of ethical practices to lose their vital functions and degenerate into empty rituals. Why is there such a tendency?

The tendency is not unique to ethics: it is everywhere.

Suddenly, patients and students are to be called “customers” and be treated “as” customers. This can be perceived as an imposed language, as empty rituals that demean all concerned.

Since the edict to treat a variety of relationships “as” customer relationships can be experienced as demeaning, expanding customer normativity has become a problem even where it has its rightful place: in our stores, where we really are customers.

A retail chain – I will not say which – is now instructing their employees to call their customers “guests” and to treat them “as” guests!

The retail chain “solves” the problem of expanding customer normativity by decreeing guest normativity at precisely the place where customer normativity should work authentically.

I don’t know why we so easily go astray in our own forms of normativity, but I have a name for the phenomenon: idling normativity.

Pär Segerdahl

Minding our language - the Ethics Blog

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 :

When writing becomes investigating

July 13, 2015

Pär SegerdahlWe write for many reasons. To remember, to instruct, to tell, to amuse…

Sometimes we write to investigate. Investigate what? Of course, something that we don’t really understand and therefore wonder about.

Writing is also a prestigious linguistic medium. Printed products (books and articles) often express the opposite of incomprehension and wonder. This is not surprising, since the printed product is the end result of long work.

This creates problems for the investigating beginner. One of the difficulties of writing about difficult things is to dare express your lack of understanding. You have to put your finger (or pen tip, or keys) precisely on your incomprehension.

Instead, one tends to quickly write up an impressive facade that hides one’s incomprehension. One mimics the style of the finished printed matter. One then starts at the wrong end. One starts at the end.

If you just slow down and ask yourself: What do I really understand here? What don’t I understand? And then honestly write it down – in the form of questions – you soon begin to write in a way that explores what needs to be clarified.

The moment your writing makes contact with your incomprehension, the writing becomes explorative. It will also come alive, because you don’t write as if you already were finished with everything. You make discoveries and you change during the work.

I would liken it to daring to ski down the slopes for the first time and dare to trust that you can turn back and forth so as to maintain a speed that you yourself can keep up with.

The equivalent of “turning back and forth” are the questions you regularly ask based on your incomprehension. Without the questions, you soon rush downhill and risk breaking your neck.

To write in an explorative way is to think. Therefore, philosophy doesn’t resemble a profession, because here it is your lack of competence that drives the work.

Pär Segerdahl

The Ethics Blog - Thinking about thinking

Our publications on neuroethics and philosophy of the brain

June 30, 2015

Pär SegerdahlAt CRB, an international, multidisciplinary research group works with ethical and philosophical questions that are associated with the neuroscientific exploration of the human mind and brain.

As part of the European Human Brain Project, they approach not only ethical questions that arise, or may arise, with the development and practical application of neuroscience. They also more fundamentally explore philosophical questions about, for example, the concepts of consciousness, human identity, and the self.

In order to give an overview of their extensive work, we recently compiled a report of their articles, books and book chapters. It is available online:

The report also contains abstracts of all the publications. – Have a look at the compilation; I’m sure you will find it fascinating!

I might add that we recently updated similar reports on our work in biobank ethics and in nursing ethics:

Here too you’ll find abstracts of our interesting publications in these fields.

Pär Segerdahl

Approaching future issues - the Ethics Blog

Laboratories interpret genetic test results differently

June 15, 2015

Pär SegerdahlA new study suggests that the results of genetic tests are not always as reliable as we want to believe. A comparison between laboratories providing these tests shows that the same genetic variant can be interpreted differently.

A single gene variant can thus be interpreted as an increased risk of breast cancer by one laboratory, but as no increased risk by another.

Given that the results of genetic tests can motivate a person to undergo, or not undergo, preventive surgery, this is quite alarming.

Genetic risks are not literally written in our genes. They require interpreting the significance of different genetic variants. The interpretation requires research that can show whether the variant is associated with increased risk of disease or not.

Most variants cannot be interpreted at all. Many are so rare that there is no data to even begin interpreting their meaning.

If I understand correctly, interpretations differ partly because laboratories do not always share their data. Their interpretations are based on limited studies using their own data. Such studies may point in different directions.

In addition to emphasizing the importance of open data, all this shows that we cannot take genetic tests or effective healthcare for granted. They require ongoing research work with large amounts of data.

We easily neglect this: how research continuously underpins healthcare.

But even with better interpretations of genetic tests, it will be difficult to interpret what the results mean for the individual.

Genetic risk continues to be a complex concept.

Pär Segerdahl

Following the news - the ethics blog


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