The Ethics Blog

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

Tag: ethical review (Page 2 of 2)

Stress turns ordinary cells into pluripotent stem cells

19 February, 2014 / / 0 Comments

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogTissues of the body originally form when “naïve” undifferentiated embryonic stem cells differentiate to form the “mature” cells of specific tissues: liver cells, brain cells, skin cells, and so on.

The mature cells are then locked in their differentiated forms, as if they met their fate.

I recently mentioned that Yamanaka and Gurdon were awarded the Nobel Prize in Medicine in 2012 for their surprising findings about dedifferentiation. Through direct genetic modification of nuclear function, mature cells can be reprogrammed to return to naïve stem-cell states. These dedifferentiated cells are pluripotent and can differentiate again and form a variety of mature cell types.

The rejuvenated cells regain the naïve properties of embryonic stem cells!

In January this year, an article published in Nature reported that the genetic reprogramming can be achieved more easily, without direct nuclear manipulation.

All you need to do to dedifferentiate mature cells, according to this article, is to subject them to stress: like an acid environment. Not all but some of the mature cells will be freed from their fate as liver or skin cells and return to naïve pluripotent states.

An easy to read summary can be found in BioEdge, and here is a link to the article:

Using mature cells to create stem cells with properties of embryonic stem cells might thus be easier than expected. In fact, the new findings weren’t even made in a stem-cell laboratory.

The ethical responses to the findings are not as thrilling as the findings. Some welcome the possibility of creating “ethical stem cells” that avoid the controversy about embryonic stem cells. Others see “new ethical issues” on the horizon.

These responses are characteristic of a routine view of ethical assessment as a static one-way process: ethicists assess others. But these findings indicate that processes in the opposite direction are possible as well, since they seem to challenge ethical assumptions about the unique function of the embryo.

I’m tempted to extend Thomas Kuhn’s notion of scientific revolutions to ethics. The new findings could function as anomalies for ethically paradigmatic ways of thinking about the embryo.

As stress turns mature cells into naïve pluripotent stem cells, these findings could stress some ethicists to return to more open-minded states that in the future can differentiate in new and unexpected directions.

Pär Segerdahl

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Dynamic consent in biobank research: better than broad consent?

2 October, 2013 / / 0 Comments

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

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

2 April, 2013 / / 0 Comments

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

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Life scientists’ responsibility when their research has dual use

13 March, 2013 / / 0 Comments

Do life scientists have moral responsibility when their research can be used not only to do good (like preventing pandemics) but also to harm others (like developing biological weapons)?

It could be tempting to think that researchers’ only responsibility is the advancement of scientific knowledge. The use and practical application of that knowledge is the responsibility of others.

The September 11 attacks made that idea much less tenable. Since then, the security sector has pushed the scientific community to take more extensive responsibility for research that could be used to develop, for example, biological weapons.

Do scientists have such a responsibility for how others might use their findings? If they do have responsibility, how is it most appropriately approached in practice? These questions are investigated by Frida Kuhlau at CRB in a dissertation that she defends on March 23:

Kuhlau argues that researchers do have a moral responsibility for research with dual use and she tries to specify the content of that responsibility. It includes, for example, always considering possible negative implications of one’s research; reporting activities of concern; being prepared to occasionally delimit the dissemination of results.

How is such responsibility best approached in practice? The traditional way of taking ethical responsibility for research is by imposing ethical regulatory systems (guidelines, codes, ethical review).

Like Linus Johnsson who defended his dissertation last Saturday, Frida Kuhlau doubts such bureaucratic attempts to ethically regulate research. Researchers need to shoulder the responsibility themselves, learning how to deliberate and take action concerning research with dual use.

Shouldering responsibility does not mean, however, doing it alone. Individual researchers normally don’t have all the competencies needed to reasonably assess possible risks of research. The scientific community and the security sector are dependent on each other. What is required to take proper responsibility, Frida Kuhlau suggests, is therefore an ethic of conversation and deliberation.

Taking moral responsibility for research with dual use presupposes ongoing communicational processes. These processes need organizational support, platforms. A novel suggestion in the dissertation is that ethical review boards could function as such platforms.

Rather than only reviewing, as ethical review boards normally do, these boards would support an ethical culture of conversation and deliberation about dual-use research.

For more information about this important dissertation, see News from Uppsala University. If you are in Sweden and want to visit the public examination, it takes place in Auditorium Minus, Museum Gustavianum, Uppsala, Saturday, March 23, 2013, at 09:15.

Pär Segerdahl

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Dissertation on trust in biobank research

6 March, 2013 / / 0 Comments

On Saturday, March 9, Linus Johnsson at CRB defends his dissertation:

The dissertation is based on four studies. The first two scrutinize empirical evidence concerning public trust in biobank research. They indicate that people do trust biobank researchers, at least in Sweden.

Such findings might give rise to complacency. The ethical regulatory system obviously works and promotes trust. Biobankers can relax.

The third study, however, is a conceptual investigation showing such a reaction to be mistaken. Trust creates obligations in the person who is being trusted. If a doctor collects samples from patients and suspects that their trust is mistaken in one way or another, the doctor has an obligation to handle that mistaken trust appropriately. (I’ve written about this study on The Ethics Blog.)

Public trust doesn’t merely indicate trustworthiness. It creates a moral demand. The proper response to public trust in biobank researchers, then, is taking increased moral responsibility.

The fourth study strives in the same direction. It critiques prevalent faith that trustworthiness is best quaranteed by an extensive ethical regulatory system (ethical review, guidelines, etc.). The opposite may very well be the case. Such a system may foster moral complacency and failure among researchers to deal with ethical issues that are not addressed by the system.

If I interpret Linus Johnsson right, the current widespread trust in ethical regulatory systems is mistaken, and his dissertation is an attempt to take responsibility for that mistaken trust by intellectually highlighting and critiquing it.

As this brief summary shows, the dissertation is original and presents some very thought-provoking results, empirically and above all conceptually. For more information about the dissertation, see News from Uppsala University.

If you are in Sweden and want to visit the public examination, it takes place in Auditorium Minus, Museum Gustavianum, Uppsala, Saturday, March 9, 2013, at 09:15.

Pär Segerdahl

We recommend readings - the Ethics Blog

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Interactive conference seeks the value of biobanking

20 April, 2012 / / 0 Comments

I have the privilege of belonging to a group of ethicists and law scholars that currently discuss how to visualize ethical and legal dimensions of biobanking.

We organize an interactive part of the scientific conference program for HandsOn: Biobanks in September. The conference invites participants to Uppsala to explore the values of biobanking and to take part in its interactive exhibition.

Biobanking is hot in medicine. There are hopes that it will substantially improve diagnosis, treatment and prevention of widespread as well as rare diseases. At the same time, however, the route to such values is difficult to survey, and the goals of large biobank investments are not always entirely transparent.

HandsOn: Biobanks is an ambitious attempt to explore and visualize the values of biobanking and the path towards them.

The conference asks: What are the values sought after? How can they be achieved in practice? There are the ethical, legal, scientific and commercial challenges, but there are also challenges for the industry. How can biobanking affect public trust in medical research and industry?

The conference combines keynote presentations with idea labs and educational sessions. The interactive part of the conference where I participate is called “the Route.” It follows the research process from ethical review, consent, sampling, storage and analysis, to end results that hopefully add value in ethics and trust, in clinical practice, in health economy, and in drug development.

If you want to participate in this interactive conference and help us better understand the values of biobanking, or simply are curious to see how we manage to solve the tricky problem of visualizing ethical and legal aspects – keep these dates in mind:

We are in the midst of brainstorming “the Route.” I hope that future blog posts can share with you some of the ethical and legal issues that we want to visualize and make accessible to participant interaction.

Registration is open – hope to see you in September!

Pär Segerdahl

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Should ethical review boards begin to act like business accountants?

16 December, 2011 / / 0 Comments

The company Geron recently decided to stop its unique clinical trial concerning treatment of spinal cord injury with neural cells derived from human embryonic stem cells.

In a previous post on this blog, I used the company’s decision to illustrate a possible consequence of the European ban on stem cell patents requiring the destruction of human embryos. The same day I posted my consideration, Francoise Baylis published a wholly different perspective on Geron’s decision…

Geron claims that the decision to stop the trial was made for business reasons. They wanted to concentrate their limited resources to their oncology drugs. However, the decision left the four research participants that had been enrolled in the trial in a vacuum.

Geron says it will continue to study these participants and report findings. But the trial was originally meant to include ten participants. Will results with only four participants be scientifically valid, Baylis asks. If the results are valid, then using ten participants, as originally planned, would have meant using more patients than required for producing valid results. If results with four participants are not valid, four patients are exposed to risk without any prospects of countervailing new knowledge.

– Which conclusions can be drawn from this example? Should the practices of ethical review be changed for applications from the private sector? Should financial resources and business strategies be included in the issues to consider? That seems to be Baylis’ response to Geron’s decision to quit stem cell research.

For my own part, I think we need more than one example before we consider making ethical review practices even more complex. A more time-consuming process of ethical review has a cost that we need to acknowledge…

As Simon Whitney summarized his views on the expansion of ethical regulation of medical research, “since biomedical research saves lives, it is unsurprising that the regulation of research costs lives.” – It may be unethical to make the process of ethical review even more cumbersome. Patients die when life-saving research is delayed. That cost must be brought into the equation when we consider single examples of ethically problematic conduct that we may wish to regulate against.

Pär Segerdahl

We think about bioethics : www.ethicsblog.crb.uu.se

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Research ethics in a new situation

15 November, 2011 / / 0 Comments

Let me introduce a topic that will be recurrent on this blog! It is the question whether research ethics and the practices of ethical review can give rise to their own ethical problems. Do we create new ethical problems while we handle old ones?

Research ethics developed in a different situation than our present one. The starting-point was inhuman: terrible experiments with prisoners in concentration camps during World War II. Thereafter, a series of research scandals where research subjects were harmed in different parts of the world. Simplifying somewhat, research ethics developed to protect people from being forced into harmful research. One such ethical protection was the demand that people cannot be used as research subjects if they haven’t been properly informed about the project, about its possible risks, and have given their consent. Another protection was a legislated ethical review apparatus that can reject ethically problematic research proposals.

Ethical review and information and consent procedures are integral parts of contemporary medical research. Thereby, however, they change the situation for the research ethics of today. As a result of its success, research ethics may create its own ethical problems! If the previous threat primarily was injustices and acts of cruelty towards research subjects, new threats appear on the ethically regulated horizon. In a number of cases, one can ask if research subjects are overprotected against their own interest.

Pregnant women and children can be vulnerable and are therefore regularly excluded from clinical research. It may seem comforting to know that these groups are safe from possibly harmful research. The result of the well-intentioned protection, however, is that these groups are subjected to possibly harmful medical treatments as patients. We don’t know how treatments that are effective on non-pregnant adults work on children and pregnant women, nor the dosage. Vulnerable groups are protected as research subjects, but as a result of that protection they are put to risk as patients. Clearly, new ethical problems arise here because of the way we handle the old ones!

I’m not claiming that the old problems have disappeared. Just read The Independent (Monday, 14 November 2011): “Without consent: how drug companies exploit Indian guinea pigs.” But perhaps we have become a little too habituated to the rhetoric of victimizing research, if we fail to see and address the questions that arise as a result of the present ethical regulation and practice. If research ethics is not open to unforeseen ethical problems related to its own role in contemporary research, I believe it risks becoming self-sufficient and ideological.

We discussed these self-critical ethical questions last year at the conference, “Is Medical Ethics Really in the Best Interest of the Patient?” Conference articles were published in the April issue of JIM, 2011. I can inform you that several related articles from CRB are in the pipeline. I’ll reflect on them as they are published.

Pär Segerdahl

We think about bioethics : www.ethicsblog.crb.uu.se

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