Hoping when there is no hope

November 27, 2017

Pär SegerdahlPatients participating in phase I oncology trials have terminal cancer and are near the end of life. Participating in research cannot cure them or even extend their lives. Not only because they have terminal cancer, but also because in phase I trials one tests the safety profile of the treatment, not effectiveness against cancer.

Nevertheless, many patients state that hope is an important reason for them to participate in phase I oncology trials. This is worrying from an ethical perspective. Do they understand what they agree to when they enroll as research participants? Have they been properly informed?

In an article in the Journal of Oncology Practice, Tove Godskesen discusses the issue, together with Ulrik Kihlbom. They argue that it is a norm in cancer care to provide hope to patients, and that this norm may support a tendency in personnel who recruit research participants to not always discourage hope, but rather reinforce it.

Since supporting hope in cancer patients is humanly important, it is not entirely easy to find a solution to the problem. Godskesen and Kihlbom proceed cautiously by distinguishing three kinds of hope that cancer patients may have concerning their participation in phase I trials.

The first is independent hope: patients hope for something that is independent of cure, such as receiving more attention by participating in research. The second kind of hope is realistic hope: patients understand that there is really no hope of cure or prolonged life, but they still hope against hope. The third kind is unrealistic hope: patients misunderstand the situation and think they are offered a treatment that doctors/researchers believe can help.

It is reasonable to support independent and realistic hope in phase I trials, according to Godskesen and Kihlbom. However, unrealistic hope is ethically worrying. It should be discouraged when patients enroll as research participants.

Discouraging unrealistic hope requires awareness of the norm to provide hope to cancer patients. The authors describe how a hopeful attitude is activated simultaneously with the cancer diagnosis. Words like treatment, hope and cure are immediately emphasized in the conversations with patients. The risk is that these words are used in the same hopeful spirit also when participation in a phase I trial is discussed.

Another problem in this context is that patients participating in phase I trials rarely receive palliative care, which would be reasonable given their terminal cancer. This may create the false appearance that research participation means being offered a new treatment. Perhaps the norm to provide hope creates this reluctance to mention palliative care. Staff is afraid that they may discourage hope. That fear is problematic, the authors claim.

What measures do Godskesen and Kihlbom propose? First of all, we need to put extra high demands on the information to participants in phase I oncology trials so that this vulnerable patient group is not exploited. Secondly, the information should contain palliative options. Thirdly, patients should receive palliative counseling throughout the trial.

Integrating research participation with palliative care reduces the risk of encouraging unrealistic hope in this patient group. The fact that trial participation is research and not treatment becomes clearer.

Pär Segerdahl

Godskesen T. and Kihlbom, U. (2017), “I have a lot of pills in my bag, you know”: institutional norms in the provision of hope in phase I clinical cancer trials. Journal of Oncology Practice 13(10): 679-682. DOI: 10.1200/JOP.2017.021832

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Communicating risk in human terms

October 4, 2017

Pär SegerdahlThe concept of risk used in genetics is a technical term. For the specialist, risk is the probability of an undesired event, for example, that an individual develops some form of cancer. Risk is usually stated as a percentage.

It is well known that patients have difficulties to access the probability notion of risk. What do their difficulties mean?

Technical notions, which experts use in their specialist fields, usually have high status. The attitude is: this is what risk really is. Based on such an attitude, people’s difficulties mean: they have difficulties to understand risk. Therefore, we have to help them understand, by using educational tools that explain to them what we mean (we who know what risk is).

We could speak of communicating risk in the experts’ terms (and on their terms). Of course, one tries to communicate risk as simply and accessibly as possible. However, the notion of ​​what to communicate is fixed. Anything else would disturb the attitude that the expert knows what risk really is.

In an article in Patient Education and Counseling, Jennifer Viberg Johansson (along with Pär Segerdahl, Ulrika Hösterey Ugander, Mats G. Hansson and Sophie Langenskiöld) makes an inquiry that departs from this pattern. She explores how people themselves make sense of genetic risk.

How does Viberg’s study depart from the pattern? She does not use the technical notion of risk as the norm for understanding risk.

Viberg interviewed healthy participants in a large research project. She found that they avoided the technical, probability notion of genetic risk. Instead, they used a binary concept of risk. Genetic risk (e.g., for breast cancer) is something that you have or do not have.

Furthermore, they interpreted risk in three ways in terms of time. Past: The risk has been in my genome for a long time. When symptoms arise, the genetic risk is the cause of the disease. Present: The risk is in my genome now, making me a person who is at risk. Future: The risk will be in my genome my entire life, but maybe I can control it through preventive measures.

These temporal dimensions are not surprising. People try to understand risk in the midst of their lives, which evolve in time.

It is not the case, then, that people “fail” to understand. They do understand, but in their own terms. They think of genetic risk as something that one has or does not have. They understand genetic risk in terms of how life evolves in time. A practical conclusion that Viberg draws is that we should try to adapt genetic risk communication to these “lay” conceptions of risk, which probably help people make difficult decisions.

We could speak of communicating risk in human terms (and on human terms). What does genetic risk mean in terms of someone’s past, present and future life?

When you talk with people with lives to live, that is probably what the risk really is.

Pär Segerdahl

J. Viberg Johansson, et al., Making sense of genetic risk: A qualitative focus-group study of healthy participants in genomic research, Patient Educ Couns (2017), http://dx.doi.org/10.1016/j.pec.2017.09.009

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Internal investigation of research misconduct often fails

May 30, 2017

Pär SegerdahlWhat characterizes a research scandal? In a short article in Hastings Center Report, Carl Elliott uses as an example the case of Paolo Macchiarini at the Swedish Karolinska Institutet.

Macchiarini’s deadly experiments with stem cell-covered artificial trachea, transplanted to patients who did not have life-threatening diseases, have unique features linked to the personality and charisma of the researcher. However, the scandal resembles other scandals on one point, Elliott says. Whistle-blowers who use internal channels at the home university to handle research misconduct often fail. Justice is not done until the press reveals the scandal. In this case, a Swedish documentary film, The Experiments, exposed the scandal.

If Elliott is right, I personally draw two conclusions. The first is that investigative journalism is important. It reveals misconduct that would otherwise not be exposed. My second conclusion is that we cannot be satisfied with this.

Angry customers who want to force the shop assistant to correct what they think went wrong can threaten: “If you don’t fix this, I’ll contact the local newspaper.” A responsible person who suspects research misconduct should not have to act in a way that others can interpret as partial exercise of power. It poisons the situation and increases the risk for the whistle-blower.

If internal channels often fail to handle research misconduct, as Elliott claims, a system of external management is required. Therefore, it is good that a Swedish public inquiry recently suggested that an independent agency should investigate suspected research misconduct.

Contacting the media should not have to be “the way” of effectively exposing research misconduct; it is a way out if the standard way fails. If the way out often is required, something is wrong with the way.

Pär Segerdahl

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Consent based on trust rather than information?

March 21, 2017

Pär SegerdahlConsent to research participation has two dimensions. On the one hand, the researcher wants to do something with the participant: we don’t know what until the researcher tells. To obtain consent, the researcher must provide information about what will be done, what the purpose is, what the risks and benefits are – so that potential participants can decide whether to consent or not.

On the other hand, potential participants would hardly believe the information and consider consenting, if they didn’t trust the researcher or the research institution. If trust is strong, they might consent even without considering the information. Presumably, this occurs often.

The fact that consent can be given based on trust has led to a discussion of trust-based consent as more or less a separate form of consent, next to informed consent. An article in the journal Bioethics, for example, argues that consent based on trust is not morally inferior to consent based on information. Consent based on trust supports autonomy, voluntariness, non-manipulation and non-exploitation as much as consent based on information does, the authors argue.

I think it is important to highlight trust as a dimension of consent to research participation. Consent based on trust need not be morally inferior to consent based on careful study of information.

However, I get puzzled over the tendency to speak of trust-based consent as almost a separate form of consent, next to informed consent. That researchers consider ethical aspects of planned research and tell about them seems to be a concrete way of manifesting responsibility, respect and trustworthiness.

Carefully planning and going through the consent procedure is an ethical practice that can make us better humans: we change through what we do. It also opens up for respondents to say, “Thank you, I trust you, I don’t need to know more, I will participate.” Information and trust go hand in hand. There is dynamic interplay between them.

I guess that a background to talk of trust-based consent as almost a separate form of consent is another tendency: the tendency to purify “information” as cognitive and to idealize humans as rational decision makers. In addition, there is a tendency to regiment the information that “must” be provided.

This tendency to abstract and regulate “information” has made informed consent into what sometimes is perceived as an empty, bureaucratic procedure. Nothing that makes us better humans, in other words!

It would be unfortunate if we established two one-dimensional forms of consent instead of seeing information and trust as two dimensions of consent to research.

Another article in Bioethics presents a concrete model of trust-based consent to biobank research. Happily, the model includes willingly telling participants about biobank research. Among other things, one explains why one cannot specify which research projects will use the donated biological samples, as this lies in the future. Instead, one gives broad information about what kind of research the biobank supports, and one informs participants that they can limit the use of the material they donate if they want to. And one tells about much more.

Information and trust seem here to go hand in hand.

Pär Segerdahl

Halmsted Kongsholm, N. C., Kappel, K. 2017. Is consent based on trust morally inferior to consent based on information? Bioethics. doi: 10.1111/bioe.12342

Sanchini, V. et al. 2016. A trust-based pact in research biobanks. From theory to practice. Bioethics 4: 260-271. doi: 10.1111/bioe.12184

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Stem cells: unique biobank material?

March 7, 2017

Pär SegerdahlStem cells are perhaps not what first springs to mind as biobank material. Yet, even stem cells can be biobank material and there are biobanks that focus on stem cells. The use of this biobank material, however, has some unique features.

Stem cell researchers process not only data from human material. The material itself is “processed” and sometimes transplanted to research participants. Commercializing stem cell research moreover implies that cells derived from donated human tissue appear in products on a market. This gives rise to ethical and legal questions.

Does the law allow patenting cell lines derived from human donated material? Is buying and selling such material lawful? Another issue concerns research participants’ right to withdraw their consent at any time. Human embryonic stem cell research uses stem cells from donated spare embryos from IVF treatment. How far does embryo donors’ right to withdraw consent stretch? Must transplanted devices with matured cells be removed from research participants, if the embryo donor withdraws consent? Moreover, assuming that researchers share stem cell lines with companies, are these companies willing to invest in the development of stem cell products if embryo donors may withdraw their consent at any time?

Another difficulty is the purpose to which embryo donors are asked to consent. According to the law, human embryos can be donated only for research purposes (or to other IVF patients). Yet, medical research loses its meaning if results cannot be commercialized. It cannot then reach patients. It is important to inform donors about this broader context of embryo donation. Does that information imply that the consent becomes broader than has support in the law? Or is there support since embryos are not used in product development, only derived material?

The answers to these questions probably depend on whether one can distinguish between donated embryos and cell material derived from embryos (using various inventions). This raises also more philosophical questions about how to view embryos, stem cell lines, matured cells, and human tissue.

Pär Segerdahl

An earlier version of this text was published in Biobank perspectives.

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Identifying individuals while protecting privacy

August 24, 2016

Pär SegerdahlResearch ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

But everyday life hasn’t collapsed yet. Perhaps we should keep a cool head and ask: Why are personal data and biological samples not fully anonymized, but coded so that researchers can identify individual patients/research participants? The answer is that it’s necessary to achieve scientific results (and to provide individual patients the right care). Discovering relationships between genetics, lifestyle and disease requires running several registries together. Genetic data from the biobank may need to be linked to patient records in healthcare. The link is the individual, who therefore must be identifiable to the research, through the use of advanced code keys.

The need to identify participants is particularly evident in research on rare diseases. Obviously, there is only scant data on these diseases. The data needs to be shared between research groups, often in different countries, in order to collect enough data for patterns to appear, which can lead to diagnoses and treatments.

An overly dramatic heroic effort to protect privacy would have its own victims.

In an article in the European Journal of Human Genetics, Mats G. Hansson and co-authors develop a different, more sustainable ethical response to the risk of re-identification.

Respecting and protecting participants’ privacy is, of course, a central concern in the article. But protection isn’t the only perspective, since science and health care are ethical values too. And here you need to be able to identify participants. The task the authors assume, then, is that of discussing the risks of re-identification, while simultaneously considering the needs for identifiable data.

The authors are, in other words, looking for a balance between different values: simply because identifiable data are associated with both risks and benefits.

You can read a summary of the article on the CRB website. What I focus on in this post is the authors’ overall approach to research ethics, which doesn’t emphasize the hero/villain/victim opposition of certain dramatic situations.

The public image of research ethics is very much shaped by its function in response to research scandals. But research ethics is usually, and less dramatically, about making everyday life function ethically in a society which contains research. Making everyday life run smoothly is a more complex and important task than playing the hero when everyday life breaks down. In this work, more values and challenges need to be taken into account simultaneously than in emergency scenarios where ethicists, very naturally, focus on protection.

Everyday life may not be as exciting as a research scandal, but if we don’t first and foremost take responsibility for making everyday life work smoothly, as a complex whole, then we can expect more drama.

Keep a cool head and consider the issues from a variety of perspectives!

Pär Segerdahl

Hansson, M. G. et al. The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics, advance online publication, 25 May 2016; doi: 10.1038/ejhg.2016.52

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Research ethics is not only protection ethics

June 6, 2016

Pär SegerdahlSystems for ethical review of research would never have been developed if it were not for the need to protect research participants from being exploited, exposed to excessive risks, or injured.

Considering how several research scandals strengthened this protection motive, it is easy to believe that protection is the sole aim of research ethics. This is not the case.

The starting point has always been that research is something worthwhile; something ethically important. Medical research provides knowledge that can lead to better diagnoses and more effective treatments. The humanities and social sciences can provide knowledge that supports more informed debates and more thoughtful political decisions.

Ethics review is about striking a balance between ethical values. Are the risks in proportion to the value of the research? Are the risks minimized, or can the research questions be examined more safely? Are research participants properly informed about the research purpose and the risks that participation might entail? Do they get the opportunity to freely decide whether to participate or not?

The “novelty” of research ethics is thus the balancing of ethical values. It’s not that ethical values are turned against research, for research itself is regarded as an ethical value. Also researchers are learning to balance values when they plan their research. The balancing is done not only in the review system, then, but pervades research itself more and more.

Doing the balancing is rarely easy. Moreover, as already mentioned, it is easy to overlook the starting point: that research is regarded as a value. This invites interpreting research ethics as pure protection ethics, which threatens to make ethics review one-sided.

For these reasons, well-written manuals are needed for members of ethical review boards, and for researchers. Manuals that not only inform about regulations and legislation, but also discuss the difficulties of balancing ethical values, and highlight how research ethics is “balance ethics” and not just protection ethics (except when protection law applies).

A new book, Balanced Ethics Review (Springer 2016), by Simon N. Whitney, is such a manual. It is written from within the American review system. But by openly discussing the difficulties of balancing ethical values, and by bringing to the fore how research ethics functions as “balance ethics,” the book has greater universality. – Perhaps precisely where the need for guidance is greatest.

Pär Segerdahl

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