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

Category: In the research debate (Page 32 of 37)

Making the Helsinki Declaration coherent?

The Helsinki Declaration is under revision. One suggested change concerns a paragraph about biobank and register-based research, which states:

  • “For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse.”

The paragraph currently continues with the following exceptions:

  • “There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee.” (My emphasis.)

The proposed revision is to delete the exception I emphasized. – Why? I speculate that the deletion is proposed to avoid perceived conflict with an earlier paragraph, stating that

  • “the well-being of the individual research participant must take precedence over all other interests.”

In particular, the interests of research must not take precedence over the interests of the participant. But it might appear as if “…or would pose a threat to the validity of the research” does just that. The phrase seems to emphasize the interests of research.

In the latest issue of Science, CRB researchers Joanna Forsberg and Yusuke Inoue question the proposal to delete the exception. In a letter, “Beware Side Effects of Research Ethics Revision,” they point out that in biobank and register-based research, risks of participation are only minimal.

Human beings are “participants” in a markedly different sense when the research is done on their data or samples, rather than on themselves or their bodies.

The authors argue that “when the risks are minimal, it is not clear that the individual’s interests in having a say should automatically outweigh the good that can result from robust research.”

I think their views should be taken seriously. There is a risk that the effort to achieve verbal consistency neglects actual distinctions between forms of medical research. If the paragraphs that seem to conflict concern markedly different forms of research and markedly different forms of participation with markedly different risks – then an important exception might be sacrificed for the sake of an only apparent conflict.

Pär Segerdahl

We participate in debates - the Ethics Blog

Human existence and biological life: what is most fundamental?

My post last week tried to highlight a tension between human existence and biological life, using Henrietta Lacks as an example. She was a unique human being, existing in a human world; but the HeLa cells obtained from her cancer tumor function in laboratories all over the world as “bio-objects” representing biological life more generally.

This tension between a human world and a laboratory world, between human existence and biological life, could be questioned (as in a comment to the Swedish version of the post): There is no tension, for humans owe their “existence” to the biological processes of life. If cells didn’t organize human brains, there simply would be no “human existence.”

Biological life is fundamental: human existence should bow and scrape to its biological origins.

The tension could be questioned also from a humanistic perspective, however. On this view, the biological perspective is formed by humans. Human existence is the unnoticed condition for the biological notion of life. Once again there is no tension, for the biological notions of “cells” and “brains” owe whatever meaning and function they have to human existence.

Human existence is fundamental: the biological perspective should bow and scrape to its human origins.

Both attempts to reject the tension by determining who should bow humbly backfire. The tension is rejected by each party, but in opposed ways, making the tension surface instead as total intellectual war.

So let’s face the tension instead, and perhaps that’s what the article mentioned last week tried to do.

Pär Segerdahl

The Ethics Blog - Thinking about thinking

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

HandsOn: Biobanks 2013

The interactive conference, HandsOn: Biobanks, organized for the first time in Uppsala last year, attracted participants from 27 countries. The “movie version” of the event can be viewed on BBMRI.se.

This stimulating interactive concept will be repeated on 21-22 November 2013, in The Hague.

HandsOn: Biobanks focuses this year on the interaction between disciplines, and on questions like (quoting from the website):

  • “How to deal with issues that evolve from the connections with other disciplines? How do we strengthen and optimize these connections, so all communities will benefit?”

For information about the program and registration, visit HandsOn: Biobanks 2013.

Early bird registration is open!

Pär Segerdahl

We recommend conferences - the ethics blog

Vaccine prioritization and the new Japanese pandemic law (by Yusuke Inoue)

Yusuke InoueFor many years, balancing individual human rights against social benefits has been the standard theme for public health ethics. Here I would like to update you on a recent discussion in Japan.

Last month a new law was introduced in Japan. Originally the enactment was planned later, but it was speeded up because of the recent series of death cases from emerging bird flu in neighboring Asian countries. This new law is entitled,

  • Act in response to new flu strains and other diseases

Unlike existing laws, such as the Immunization Act and the Act on Infectious Diseases, this new law is clearly intended to empower national and areal authorities to take substantial action. For example, in order to,

  • “prevent the spread of a disease,”
  • “protect a citizen’s rights or health,” or
  • “avoid social and economic confusion,”

these authorities can close public spaces or meetings, take special actions to sustain infrastructures, and direct medical staff to treat patients. This law was mainly drafted by bureaucrats and passed lacking sufficient explanation and public debate on the draft.

Based on the act, a national plan for prioritizing vaccine has become a matter of discussion. There are more than one hundred million people living in Japan, and securing vaccine for them quickly has been regarded as difficult. Therefore, this topic can be understood as a matter of distributive justice, and various methods for achieving justice have been discussed.

According to the recent draft plan, medical and caring staff, public officers, and manpower to sustain infrastructure are included in the prioritized class. It is not surprising that the longer the discussion goes on, the more people insist that they should be included in this class. For example, food industry workers are also suggested to be added to the class. Until now the targeted population has already reached more than 20 million! There was a similar discussion during the A/H1N1 swine flu “pandemic” in 2009, and many groups argued that they should have priority getting immunized.

Discussion on vaccine allocation is not unique to Japan. Until now, various ways of rationing, such as utility-based or justice-based allocation, have been suggested, as recently summarized by Buccieri and Gaetz in Public Health Ethics.

The nature of virus complicates the problem. It is difficult to know the nature of each flu virus just after outbreak of the pandemic. At least we can say that the scientific validity of a vaccine rationing plan should be continually tested, and flexible and practical interpretation will be needed. Furthermore, whichever principle for rationing we chose, the principle has to be shared and understood by the society in order to be effective in a real situation. On this point, today’s planning concerning the “prioritized class” in Japan needs further transparency about the evidence of setting the class – for rational policy making.

I also consider that cooperation between northern and southern countries should be more in focus. We remember concerns shown by some southern countries that pandemic vaccine was mainly occupied by the developed countries, and it was difficult for them to secure vaccine for their own citizens. Some emerging flu viruses lead to fatal conditions in developing countries, but do not have so serious consequences in developed countries. Nevertheless, vaccine allocation has been independently coped with by many countries.

Considering the global context of pandemic flu, I think that rationing vaccine as a domestic matter cannot be morally justified from the “justice” or “utility” point of view.

We are not sure that a pandemic will come or what will it be like. Fickle viruses haunt our thinking and test core value of our civilized society and the way of justice.

Yusuke Inoue

We want to be just - the Ethics Blog

Conference on global aspects of reproductive technology and surrogacy

Reproductive technology and surrogacy often is a cross-border practice that raises several ethical issues concerning the rights not only of adult participants but also of the children involved.

Do the children have a right to know about their genetic parents and do they have a right to be recognized by the countries of their contractual parents? What are the rights of surrogate mothers?

These and related questions will be discussed at an upcoming conference,

organized by The Nordic Committee on Bioethics.

Participation is free of charge. Young researchers (mainly PhD students) are invited to submit an abstract no later than May 20.

More information about abstracts, programme and registration can be found on the website of the Nordic Committee on Bioethics.

If you want to participate, register no later than August 15.

Pär Segerdahl

We recommend conferences - the ethics blog

The debate about after-birth abortion continues

Last year the Journal of Medical Ethics published an article by two philosophers claiming that the same arguments that support abortion also support abortion of newborns.

The article provoked strong reactions and I too felt I had to comment on the article here on The Ethics Blog.

What’s so provocative? I’m not so sure it is the conclusion that if we allow abortion we also should allow abortion of newborns. The two philosophers actually never concluded with any practical recommendations. They only wanted to theoretically explore the logic in the arguments for abortion.

And maybe this is what’s so provocative, or rather tragi-comical: the spirit in which one approaches questions of life and death as an entrepreneur might use the annual report to consider his reasons for terminating a project that can become a burden for the company.

Recently, the same journal reissued the article; this time with two editorials and a number of comments by ethicists (here).

The reissuing of the article reaffirms the attitude that the burning hot questions of life and death should be discussed as a rational entrepreneur manages his firm.

Should we allow infanticide? We’ll have to postpone decision until we’ve received the annual report from the neuroscientists on neonates’ capacity for thought.

Pär Segerdahl

We follow debates : The Ethics Blog

Revised European data protection will make data about rare diseases even rarer

EU is currently discussing changes to the European privacy laws. The intention is to strengthen the protection of privacy and to give people more control over their data.

The problem, which I highlighted on The Ethics Blog, is that the new proposal applies also to research. Presently there is an exception for scientific research about health and disease. The proposed revision of the privacy regulation, however, allows no exceptions.

Every person who has given data to a register must according to the new proposal be asked for consent each time researchers want to study some new disease pattern. Patient data can never be used in research without specific consent, and not even historical registers and data from diseased persons are given exception in the new proposal.

A recent article in Nature Reviews Genetics by Deborah Mascalzoni et al. highlights a patient group that is especially vulnerable to the proposed revision: patients suffering from rare diseases. In Sweden a disease is defined as rare if it affects less than a hundred persons in a million.

Data on rare diseases are, as a matter of course, rare. We therefore know little about these diseases and it is difficult to develop effective medical treatments. To achieve statistically significant analyses, researchers must typically share data over national borders. Every lost piece of data about rare diseases can mean dramatically impaired prospects of new drugs and treatments for these patient groups.

Rare diseases are thus a further strong reason for maintaining the current exception for scientific research in the data protection legislation. Read more on the CRB website.

Pär Segerdahl

Approaching future issues - the Ethics Blog

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