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

Tag: samples (Page 2 of 4)

Idling biobank policy?

If you allow researchers to do brain imaging on you for some research purpose, and they incidentally discover a tumor, or a blood vessel with thin walls, you probably want them to inform you about this finding. There are no doubts about the finding; the risks are well-known; it is actionable.

Suppose instead that you donate a blood sample to a biobank. Suppose that researchers studying the sample discover a genetic variant that, depending on a number of interacting factors, might result in disease in three years’ time, or in thirty years, or not at all. It is difficult to predict! Do you still want to know?

How should these incidental findings be handled that increasingly often will be made in genetic biobank research? We are all different, so finding variants with some statistical relation to disease is more or less expected.

A common approach to this question within attempts to develop a policy for incidental biobank findings is to formulate general conditions for when researchers should inform participants. Like: if the finding is analytically valid; if it has clinical significance; if it is actionable – then participants should be informed.

The problem is: we already knew that. We know what these conditions mean in imaging studies when a tumor or a damaged blood vessel is discovered. In these cases, the conditions can be assessed and they make it reasonable to inform. But what about genetic risk information, which often is more multidimensional and has unclear predictive value?

This question is discussed in a recent article in the European Journal of Human Genetics, written by Jennifer Viberg together with Mats G. Hansson, Sophie Langenskiöld, and me:

Viberg argues when we enter this new and more complex domain, we cannot rely on analogies to what is already known in a simpler domain. Nor can we rely on surveys of participants’ preferences, if these surveys employ the same analogies and describe the findings in terms of the same general conditions.

Time is not yet ripe for a policy for incidental genetic findings, Viberg and colleagues conclude. Formulating a policy through analogies to what is already known is to cover up what we do not know. The issue requires a different form of elucidation.

That form of elucidation remains to be developed.

Pär Segerdahl

We participate in debates - the Ethics Blog

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

Being human; representing life

A new article reconsiders Henrietta Lacks and the immortal HeLa cells that were obtained from her rare cancer tumor in the 1950s; cells that still replicate and are used in biomedical laboratories all over the world:

The article is written by Anna Lydia Svalastog and Lucia Martinelli, both members of the Culture, Health and Bioethics network at CRB.

There is a lot going on in the article, making it difficult to summarize. As I understand it, though, the article focuses on two fields of tension when biological samples from humans are used in biomedical research – tensions between:

  1. being human; and representing biological life,
  2. the value of the one; and the value of the many.

Both fields of tension intersect in the case of Henrietta Lacks:

  1. Henrietta Lacks was a human being, existing in a human world; but HeLa cells function as “bio-objects” representing biological life.
  2. Henrietta Lacks was one unique individual; but HeLa cells have come to represent humanity.

These tensions highlight the interchange between research and society. We exist as human beings; but by donating samples to research, we also contribute to representing biological life. We are unique individuals; but through our samples, we also contribute to representing what is general.

The authors cite the European biobank infrastructure, BBMRI, as an approach to governance and ownership of knowledge and property that begins to address these tensions in interesting, new ways. The article also speaks in favour of interdisciplinary collaboration between the life sciences, the social sciences, and the humanities, to understand the fields of tension that arise when individual human beings contribute to medical research.

Pär Segerdahl

Part of international collaborations - the Ethics Blog

The diversified uses of biological samples

As a reminder of how diversified the collection and use of biological samples is, I recommend a paper by Takako Tsujimura-Ito, Yusuke Inoue (currently a guest researcher at CRB), and Ken-ichi Yoshida:

Departments of forensic medicine obtain samples from autopsies in order to secure evidence that can be used in court. These samples, often whole organs, typically need to be stored for long periods, since cases sometimes require re-examination of the evidence. The samples are stored also for secondary use in research advancing both clinical and forensic medicine.

The problem addressed in the paper concerns the communication with bereaved families. Families are often not contacted by the forensic departments in Japan, since such contacts can be seen to threaten the neutrality of the evaluation of the evidence.

Emphasizing that stored samples from autopsies benefit bereaved families, patients and society as a whole, the paper recommends more effective ways of communicating with families, to avoid damage to public confidence when families inadvertently get to know that samples from deceased family members are stored or used in research.

Pär Segerdahl

We recommend readings - the Ethics Blog

The specific study misconception of biobank infrastructure

It is comprehensible that a patient who agrees to participate in a clinical trial expects to get access to a new effective therapy that will restore health. It is comprehensible that it is difficult to convey objective, dispassionate information that such an expectation is unrealistic, given randomization and other features of clinical trials.

Participation in biobank research ought to be simpler to understand. How can you expect to get healthy by giving a blood sample and allowing future research to combine the genetic data that can be obtained from the sample with data accumulating over time in health registries? The therapeutic misconception ought to be less tempting in biobank research, making the relationship between researchers and participants more straightforward.

For this reason, I was surprised to read on the Science Codex Blog about a study indicating difficulties to understand participation in biobank research; difficulties similar to those that more comprehensibly arise for participation in clinical trials.

What surprised me even more, however, was the discussion about this finding that was quoted on the blog. The fact that participants in biobank studies cannot expect a new and better therapy was presented as a shortcoming vis-à-vis clinical trials, as if such an expectation was not a misconception. Moreover, hopes were expressed that a change is underway:

  • “Some new models for biobank studies are more inclusive of the research subject, offering on-going contact and return of results that may impact their health, says Dr. McBride.”

I do not exclude that such models might work for some restricted biobank studies about specific diseases, which might require on-going contact with a particular patient group to get the research done.

But biobanking is more and more about building infrastructures where samples are stored indefinitely for future research that cannot be specified in advance. Making participation in such infrastructures more like participation in specific clinical trials – supporting the therapeutic misconception where it ought to be most distant! – appears fundamentally misguided.

The infrastructural nature of modern biobanking remains to be understood. It needs to be freed from what might be termed the specific study misconception.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

Don’t shoot at the patient (or at the messenger)

The newly proposed European Data Protection Directive overprotects research participants and exposes patients to greater risks of contracting illness and dying.

Thus dramatically a recent article in The Lancet Oncology can be summarized, written by Mats G. Hansson at CRB together with Gert Jan van Ommen, Ruth Chadwick and Joakim Dillner.

People who provide data to research registers are not exposed to physical risks, like participants in interventional research. The risks associated with register-based research are informational: unauthorized release of information about participants. One might ask if it even makes sense to say that people “participate in research” when researchers process large data sets.

Patients (and people in general) have significant protection from disease thanks to register-based research. For example, it is estimated that the HPV vaccine will save about 200 women from dying in cervical cancer each year, in Sweden alone. This cancer-preventive treatment became possible because researchers had access to samples dating back to the 1960s providing evidence for a causal connection between a certain virus infection and cervical cancer later in life.

  • Despite this vital value in biobanks and registers,
  • despite the fact that risks are only informational,
  • despite rigorous safety routines to prevent unauthorized spread of information,
  • despite the fact that researchers don’t study individuals but statistical patterns, and
  • despite the question if people really are “participants” in register-based research,

the EU committee proposing the new directive treats the integrity of “research participants” as so pivotal that researchers who process data not only must be subjected to the same ethical review process as for invasive research, but also must obtain informed consent from each and every one who once gave their data to the register, whenever the researchers want to study a new disease pattern.

Data protection efforts easily lose their sense of proportions, it seems, at least concerning register-based research. Not only is one prepared to expose patients to greater physical risks in order to protect research participants from (already rigorously controlled) informational risks.

One also is prepared to disturb data providers who hardly can be described as “participating” in research, by forcing researchers to recontact them about informed consent. Not only on one occasion, but time and again, year after year, each time a new disease pattern is explored in the registers. That’s what I call privacy intrusion!

Pär Segerdahl

We participate in debates - the Ethics Blog

Public ethics and human morality

Is ethics universally valid or can we act differently as moral individuals than as ethical representatives of public institutions?

I just read a well-argued article in Science Policy Forum, discussing whether patients should be paid for their tissue. As their point of departure, the authors cite the (by now) famous case of Henrietta Lacks.

Contrary to the many readers and reviewers of the bestseller who thought that Henrietta Lacks was exploited by the medical establishment, the authors arrive at the following conclusion. In cases similar to that of Henrietta Lacks, patients (or their families) are NOT entitled to payment for their tissue. – Why not?

First of all, there are no property rights for human bodies, people don’t own the tissue they leave: no one has the right to demand payment for their tissue.

People should, however, be compensated for the effort of giving the tissue. But there is no such effort associated with patient samples, since the samples were taken for the sake of caring for the patients. There is no effort to compensate for.

But what about the revenue generated by the tissue? Can people make millions of dollars on patients’ cells, as in the Henrietta Lacks case, without sharing the profits with the patients (or with their families)?

Once again, the authors argue convincingly that patients have no right to demand payment or part of revenue streams. The tissues are only raw material for developing cell lines. It is the intellectual work of the investigators that creates value. Moreover, since so few donors have tissue that can be used to generate profitable medical products, the end result of trying to be fair by sharing profits with these few lucky donors would be injustice vis-à-vis the majority of donors.

What interests me here is that although I consider the ethical policy proposed in the article as well-argued and right, I can still understand if a morally concerned individual saw injustice in a case like that of Henrietta Lacks and decided to donate money to her family.

Consider this passage from the article:

  • “Christoph Lengauer, a cancer drug developer and former Hopkins faculty member, articulated this sense of inequity when he reportedly told Lacks’s daughter that he thought Hopkins had ‘screwed up’ by not sharing some of the proceeds from the HeLa cell line with the Lacks family.”

The Science Policy Forum article demonstrates that this accusation is not as reasonable as it might seem.

Still, if a concerned individual (like Lengauer) saw injustice in a destiny like that of Henrietta Lacks and personally donated money to the family, I think I could see that as a perfect moral action and not necessarily as deluded.

Can one appreciate the ethical arguments for a policy not to pay patients for their tissue, and still, as an individual, experience injustice and personally donate money?

Unless we demand that human beings should be like representatives of public institutions through and through, I think we can admit such a possibility. It would even make me uncomfortable if we didn’t acknowledge such freedom.

Pär Segerdahl

We like challenging questions - the ethics blog

Commercial gene tests and incidental findings

I read Arthur Caplan’s criticism of the personalized gene tests that some companies insist we must buy to gain control over our future health. I could not help wondering if his criticism is applicable also to the idea that biobanks should inform research participants about incidental findings about their genes.

Caplan rejects the crystal ball view of genetic information that is utilized in the marketing for commercial gene tests: the image that genetic information is uniquely predictive about YOUR future health.

The crystal ball image is a prejudice. It is a gene myth that makes people believe they MUST get genetic information to control their future health. It is a myth that makes people think they have a RIGHT to look into the crystal ball, now that this uniquely powerful instrument is available.

But disease risk is the result of complex interactions between genes and environment, and “no one knows how a single person’s lifestyle, upbringing and environment interacts with their particular genes to create risks,” Caplan writes.

If this is true and genetic information in abstraction is far from predictive, then I cannot avoid worrying about how the crystal ball image shapes also the ethical discussion about incidental findings in genomic biobank research.

In this discussion, accidentally discovered individual genetic variation is sometimes described as a good that participants have a right to be informed about, in return for the biological material they donate to the biobank.

If Caplan is right and such information typically is not worth the money, how can it be a good that participants have a right to receive such information from the biobank in return for their sample?

Do well-meant ethical arguments sometimes resemble unethical marketing campaigns?

Pär Segerdahl

Approaching future issues - the Ethics Blog

No consent for maintaining high-quality health care?

Collecting biological samples and health information from healthy donors in the construction of biobanks and research registers obviously requires the donors’ informed consent.

But is a similar demand for consent reasonable when patients provide their doctor with samples for diagnosis, undergo medical examination and treatment, and answer the doctor’s questions? Or can patients be expected to accept that their traces in the health care system – for example, data about experienced side effects – are monitored to optimize the quality of medical diagnosis and treatment?

A recent article by Mats G. Hansson at CRB discusses the issue. The article in Theoretical Medicine and Bioethics is well-argued and challenges common assumptions.

The basic argument is that quality registers and biobanks within the health care system play such a decisive role in optimizing the quality of the care that we expect as patients, that no consent should be required for collecting and studying our traces as patients (provided that the purpose is maintenance of high-quality health care, and nothing else).

Consent is associated with costs, in the form of drop-out of data. This impairs the value of the information in quality registers and biobanks, and thereby also the conditions for optimizing medical diagnosis and treatment.

Privacy is not the only ethical concern. Quality of care carries moral weight too.

Perhaps we are prepared to accept certain access to our patient histories, if such access is a precondition to maintaining and developing high standards of health care?

Pär Segerdahl

We recommend readings - 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

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