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

Tag: research ethics (Page 7 of 8)

Research ethics as moral assurance system

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogModern society seems to be driven by skepticism. As philosophers systematically doubted the senses by enumerating optical and other illusions, our human ability to think for ourselves and take responsibility for our professional activities is doubted by enumerating scandals and cases of misconduct in the past.

The logic is simple: Since human practices have a notorious tendency to slide into the ditch – just think of scandals x, y and z! – we must introduce assurance systems that guarantee that the practices remain safely on the road.

In such a spirit of systematic doubt, research ethics developed into what resembles a moral assurance system for research. With reference to past scandals and atrocities, an extra-legal regulatory system emerged with detailed steering documents (ethical guidelines), overseeing bodies (research ethics committees), and formal procedures (informed consent).

The system is meant to secure ethical trustworthiness.

The trustwortiness of the assurance system is questioned in a new article in Research Ethics, written by Linus Johansson together with Stefan Eriksson, Gert Helgesson and Mats G. Hansson.

Guidelines, review and consent aren’t questioned as such, however. (There are those who want to abolish the system altogether.) The problem is rather the institutionalized distrust that makes the system more and more formalized, like following a checklist in a mindless bureaucracy.

The logic of distrust demands a system that does not rely on the human abilities that are doubted. That would be self-contradictory. But thereby the system does not support human abilities to think for ourselves and take responsibility.

The logic demands a system where humans become what they are feared being.

The cold logic of distrust is what needs to be overcome. Can we abstain from demanding more detailed guidelines and more thorough control, next time we hear about a scandal?

The logic of skepticism is not easily overcome.

Pär Segerdahl

We challenge habits of thought : the Ethics Blog

Overview of the regulatory framework of European biobanking

Unless you have an education in law, it is almost impossible to find your way through the regulatory landscape of European biobanking, or to understand the motives behind the proposed new general data protection regulation.

However, a helpful overview and discussion can be found in this article by Evert-Ben van Veen:

The article also contains some interesting thinking on a number of important issues, like the concept of personal data, the need for a third category of data between personal data and anonymous data, and the role of trust in institutions.

Pär Segerdahl

We recommend readings - the Ethics Blog

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

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

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

Two PhD positions at the Centre for Research Ethics and Bioethics

We are recruiting two new PhD students:

1. PhD position in the field of Research Ethics/Bioethics. This position has two possible research focuses:

2. PhD position in the field of bioethics/philosophy of mind. This position has the following possible research focuses:

  • (a) Conceptual and empirical analyses of the nature and function of consciousness in the light of modern neuroscience and philosophy of mind.
  • (b) How consciousness can be accessed neurotechnologically.
  • (c) Clinical studies of consciousness of patients with disorders of consciousness and ethical analyses of the results.

Read more about the PhD projects and the application in the links above. If you are interested we look forward to receiving your application no later than April 22, 2013.

Pär Segerdahl

We transgress disciplinary borders - the Ethics Blog

Is there a need for a retractions database?

I wrote a while ago about drug companies as whistle blowers. Evidently, the pharmaceutical industry wastes more and more resources unsuccessfully trying to replicate published research studies.

The amount of irreproducible published research surprised me. If there is such a trend, questions accumulate. Are researchers becoming increasingly careless, or even fraudulent? Are researchers acting under too heavy pressure to publish positive results? Do many researchers lack sufficient skills in statistics?

Or has research in the life sciences entered such complex terrain that it has become virtually inhuman to survey all factors that may influence the results?

I’m not competent to answer these questions and welcome helpful comments.

A way to handle at least part of the problem has been suggested: set up a centralized retractions database. Such a resource would help scientists and the industry to exclude at least some of the most unsuitable candidates for replication.

An ambitious study of retractions used secondary sources when the journals’ own reasons for the retractions seemed incomplete or vague. According to this study, fraud or suspected fraud caused 43% of the retractions. Duplication accounted for 14% of the retractions, and plagiarism for 10%; only 21% of the retractions had to do with error.

If you want to read more about the study on retractions, it is summarized in this recent Nature News article.

Pär Segerdahl

Following the news - the ethics blog

Drug companies as whistleblowers

Some years ago, John Ioannidis warned that most published research findings probably are false.

More recently, the drug companies Bayer and Amgen reported that their attempts to replicate scientifically published studies that could be a basis for new drug development most often fail. Amgen, for example, failed to replicate 47 of 53 oncology and hematology results that they initially deemed interesting for their purposes.

We are used to seeing drug companies under attack by right-minded critics. Now they are in the position of delivering the critique. They invalidate most scientifically published findings in the field of medicine. By going public about this embarrassing fact, they act as whistleblowers revealing emptiness in current scientific practices and ways of supporting and awarding high quality research.

A solution to the problem is now being proposed, though not by the research community, but by a company: Science Exchange. They offer researchers a new service. For a fee, they attempt to reproduce the researchers’ studies. If the studies can be successfully replicated, the company issues a certificate of reproducibility.

Can such a proposal contribute to a transformation of current scientific practices, towards an order where peers not merely read and assess papers, but practically try to validate results?

But shouldn’t validation be internal to the research work, rather than outsourced?

If I interpret Karl Popper right, a scientist should actively try to achieve negative results. Only by failing to produce negative results can she tentatively claim positive results.

Do current ways of measuring and awarding scientific quality undermine the self-critical spirit of scientific work?

Pär Segerdahl

Following the news - the ethics blog

Ethics before the event

It is easy to be wise after the event. This easily accessible form of wisdom is also a painful accusation: you should have been wise before the event.

If you are extremely sensitive to the pain of these attacks, you might want to become someone who always is “wise before the event.” If you let your life be governed by such an ideal, you’ll become an ethical perfectionist.

Ethical perfectionism may seem like the most demanding form of ethical attitude. If it derives from oversensitivity to the pain of being wise after the event, however, which is ridiculously easy, I’m more doubtful about the value of this attitude.

The ethical perfectionist runs the risk of avoiding life altogether, until even the slightest chance of moral complexity has been eliminated. “Postpone life; I’ve discovered another possible ethical problem!”

My reason for bringing up this subject is that research ethics seems to be in continual danger of succumbing to problematic forms of ethical perfectionism. The dependence on research scandals in the past and the demand to avoid them in the future makes it especially vulnerable to this strange ideal.

Don’t for a moment believe that I recommend living without reflection. But ethical problems must be confronted while we live and develop our activities: “as we go along.” We cannot postpone life until all ethical complexity has been eliminated.

The risk is that we fancy ethical problems without reality and postpone urgent research initiatives on the basis of derailed demands, while we fail to face the real ethical challenges.

Pär Segerdahl

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

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