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

Tag: data sharing (Page 2 of 3)

Fourth issue of our newsletter about biobanks

Now you can read the fourth newsletter this year from CRB and BBMRI.se about ethical and legal issues in biobanking:

The newsletter contains three news items:

  1. Moa Kindström Dahlin describes the work on ethical and legal issues in the European platform for biobanking, BBMRI-ERIC, and reflects on what law is.
  2. Josepine Fernow features two PhD projects on research participants’ and patients’ preferences and perceptions of risk information.
  3. Anna-Sara Lind discusses the ruling of the European Court of Justice against the Safe Harbour agreement with the United States.

(Link to PDF version of the newsletter)

And finally, a link to the December issue of the newsletter from BBMRI.se:

Merry Christmas and a Happy New Year!

Pär Segerdahl

We recommend readings - the Ethics Blog

Open data access is regulated access

Pär SegerdahlWe usually associate open access with the publication of scientific articles that anyone with internet access can read, without price barrier.

The concept “open access” is now being used also for research data. I have written about this trend towards open data earlier on the Ethics Blog: Openness as a norm.

In many cases, research data are made as freely available as the open access articles that anyone can read; often in connection with the publication of results based on the data. This occurs, for example, in physics.

There is a strong trend towards open data also in medical research; but here the analogy with articles that anyone can read is no longer valid. Biobank and register-based research work with sensitive personal data, to which a number of laws regulating data access apply.

Yet one could speak of a trend towards open data also in this domain. But it then means something different. It’s about making data as accessible as possible for research, within the regulations that apply to this type of data.

Since the relevant laws and ethical frameworks are not only opaque but also differ between countries, the work is largely about developing common models for researchers to work within. One such attempt is made in an article by, among others, Deborah Mascalzoni and Mats G. Hansson at CRB:

The article formulates 15 principles for sharing of biological samples and personal data between researchers. It also includes a template of the written agreements that scientists can make when one research group transfers data or materials to another research group.

Take a look at these principles, and the template of the agreements, and you’ll soon get an idea of how many strict conditions that must be met when biological samples and personal data are shared for research purposes.

Given how open access often is associated with the possibility for anyone at any time to read articles without price barrier, one should perhaps avoid using the term in this context. It may mislead, since this form of data access is heavily regulated, although the aim is to support researchers to share their data and samples.

Pär Segerdahl

This post in Swedish

Minding our language - the Ethics Blog

Interesting Big Data-symposium on video

Pär SegerdahlMany posts on the Ethics Blog are about how new possibilities to collect and process large amounts of data change the horizon for medical research.

But “Big Data” makes its entry also in the humanities and social sciences. How does the horizon change there? How is the understanding of humans and of society affected when processing large amounts of data opens up a new field of vision for humanists and social scientists?

A symposium in Gothenburg last summer took up the issues, I saw at Christian Munthe’s blog (“Philosophical Comment”). He links to a video recording from the symposium and I link to Christian’s blog post; that way you’ll find both the blog and the video:

When you have time, take a look – the presentations are exciting!

Pär Segerdahl

We like challenging questions - the ethics blog

Laboratories interpret genetic test results differently

Pär SegerdahlA new study suggests that the results of genetic tests are not always as reliable as we want to believe. A comparison between laboratories providing these tests shows that the same genetic variant can be interpreted differently.

A single gene variant can thus be interpreted as an increased risk of breast cancer by one laboratory, but as no increased risk by another.

Given that the results of genetic tests can motivate a person to undergo, or not undergo, preventive surgery, this is quite alarming.

Genetic risks are not literally written in our genes. They require interpreting the significance of different genetic variants. The interpretation requires research that can show whether the variant is associated with increased risk of disease or not.

Most variants cannot be interpreted at all. Many are so rare that there is no data to even begin interpreting their meaning.

If I understand correctly, interpretations differ partly because laboratories do not always share their data. Their interpretations are based on limited studies using their own data. Such studies may point in different directions.

In addition to emphasizing the importance of open data, all this shows that we cannot take genetic tests or effective healthcare for granted. They require ongoing research work with large amounts of data.

We easily neglect this: how research continuously underpins healthcare.

But even with better interpretations of genetic tests, it will be difficult to interpret what the results mean for the individual.

Genetic risk continues to be a complex concept.

Pär Segerdahl

Following the news - the ethics blog

Openness as a norm

Pär SegerdahlWhy should scientists save their code keys as long as 20 years after they conducted their study, the Swedish Data Inspection Board apparently wonders. In its opinion to a proposed new Swedish law on research databases, it states that this seems too long a period of time.

Yet, researchers judge that code keys need to be saved to connect old samples to new registry data. The discovery of a link between HPV infection and cervical cancer, for example, could not have been made with newly collected samples but presupposed access to identifiable samples collected in the 1960s. The cancer doesn’t develop until decades after infection.

New generations of researchers are beginning to perceive it as an ethical duty to make data usable for other scientists, today and in the future. Platforms for long-term data sharing are being built up not only in biobank research, but also in physics, in neuroscience, in linguistics, in archeology…

It started in physics, but has now reached the humanities and the social sciences where it is experienced as a paradigm shift.

A recent US report suggests that sharing data should become the norm:

Research is obviously changing shape. New opportunities to manage data mean that research is moving up an IT-gear. The change also means a norm shift. Data are no longer expected to be tied to specific projects and research groups. Data are expected to be openly available for a long time – Open Access.

The norm shift raises, of course, issues of privacy. But when we discuss those issues, public bodies can hardly judge for researchers what, in the current vibrant situation, is reasonable and unreasonable, important and unimportant.

Perhaps it is profoundly logical, in today’s circumstances, to give data a longer and more open life than in the previous way of organizing research. Perhaps such long-term transparency really means moving up a gear.

We need to be humbly open to that possibility and not repeat an old norm that research itself is leaving behind.

Pär Segerdahl

Approaching future issues - the Ethics Blog

Rare diseases need international research infrastructure

Pär SegerdahlThere are a few thousand diseases that you never heard the name of. They affect so few people and have no names in the common language.

These diseases are usually called rare diseases (or orphan diseases). They often (but not always) have genetic origin. They often affect children, are disabling and can even be life-threatening, and in many cases organ systems in the body degenerate.

Because the diseases are rare, they are difficult for doctors to diagnose. Even if one manages to make a diagnosis, treatments are often lacking. It’s hard to do research and develop treatments when the patient groups are small and scattered across the world.

In recent years one has begun to prioritize research on rare diseases, not least in the EU. A background to this trend is the development of biobank research. It starts to make it possible to do research on rare diseases, even though the patient groups are small and scattered across the world.

How? Since one can collect samples and data from such patient groups in biobanks that are linked with each other in international networks. Biobank networks thus give researchers access to large enough material to identify genetic and other origins of rare diseases. In this way, one can begin to develop diagnoses and treatments for small patient groups spread across the world.

In an article in the Journal of Biorepository Science for Applied Medicine,

twenty researchers, among them Mats G. Hansson, describe trends in research on rare diseases. They mention several international biobank networks developed to make such research possible, and describe the challenges that they have to deal with.

One challenge is to develop a common standard for how to, for example, document and code samples for rare diseases. Otherwise it is difficult to locate relevant samples in biobanks in different parts of the world and use them in research. One also needs to link the samples to electronic health records. Otherwise, the patterns behind the diseases will not be visible to the research.

Another challenge is that ethical review and governance operate at a national level, and often in different ways in different countries. In one case, mentioned in the article, where the researchers needed to use data from 130 patients from 30 different countries (and collaborate with 103 clinical centers), it took two years to get ethical approval of the project.

The project was not ethically controversial: 97% of the ethical review committees approved the project without requiring changes or further information. The time delay was due to problems of coordination between the governance systems in the different countries.

Another challenge mentioned in the article is to make researchers, doctors and patients aware of the existence of biobanks for research on rare diseases, and the importance of contributing to these biobank networks by collecting samples and updating databases.

The trend to link biobanks in networks has been clear for a while, even independently of the research on rare diseases. But this research really highlights a key feature in today’s biobanking: its infrastructural nature. Research on rare diseases, needing data from patients spread across the world, can therefore also likely accelerate the development of biobanks as infrastructures for future research.

Pär Segerdahl

Part of international collaborations - the Ethics Blog

Building European infrastructures for research

PÄR SEGERDAHL Associate Professor of Philosophy and editor of The Ethics BlogThe European Union is traditionally about creating an internal market, where goods, services, labor and capital can move freely between member states.

Lately there have been efforts to create also European infrastructures for research, where researchers in the different member states can collaborate more efficiently, and compete on a global “research market.” A new tool for such European governance of research is the European Research Infrastructure Consortium, abbreviated ERIC.

If at least three member states hand in a joint application, the Commission can establish an ERIC – an international organization where the involved member states jointly fund and manage a European infrastructure for research in some area. In November 2013, an ERIC was established for biobank research: BBMRI-ERIC, placed in Graz, Austria.

Understanding what an ERIC is and whether BBMRI-ERIC has tools to make the diverse regulations for biobanking in different EU member states more uniform, is not easy. However, a “Letter” in the European Journal of Human Genetics addresses both issues:

The letter is written by Jane Reichel, Anna-Sara Lind, Mats G. Hansson, and Jan-Eric Litton who is the Director General of BBMRI-ERIC.

The authors write that although the ERIC lacks substantial tools to make the regulative framework for biobanking more uniform, it provides a platform where researchers and member states can collaborate developing better ways of navigating the complex legal and ethical landscape. The ERIC also facilitates administration, owning and running of equipment and employment of staff on a long-term basis, thus enabling a time perspective proper to research infrastructures (rather than individual research projects). It also provides opportunities to develop common standards for biobanking activities (e.g., handling of samples) that make biobanks function better together.

Finally, because of the required regular contacts with the Commission and representatives of all EU member states, channels are opened up through which the interests of research can be communicated and influence policy areas like data protection.

Read the letter if you are interested to know more about this new way of building European infrastructures for research.

Pär Segerdahl

Part of international collaborations - 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

“The Route” is taking shape

Our plans for the interactive part of the conference program for HandsOn: Biobanks, in Uppsala 20-21 September 2012, are taking shape. This part of the program is called “the Route.”

During coffee and lunch breaks, participants can walk through an interactive exhibition illustrating the process of informed consent, data and sample sharing, and new legislation.

Within the Route, participants can also meet law scholars, ethicists, biobank researchers and journalists. They can listen to and participate in conversations on a broad range of issues, such as the role or trust in biobank research, handling of incidental findings, patents, and regulatory processes.

Finally, the LifeGene debate will be discussed with representatives from LifeGene, EpiHealth, the Swedish Data Inspection Board, and the Central Ethical Review Board.

Curious? Do you want to partake in the Route?

Registration is open until September 11.

Pär Segerdahl

I want to contribute to research, not subscribe to genetic information

What do researchers owe participants in biobank research?

One answer is that researchers should share relevant incidental findings about participants with these helpful individuals. Returning such information could support a sense of partnership and acknowledge participants’ extremely valuable contribution to research.

I’m doubtful about this answer, however. I’m inclined to think that return of information might estrange participants from the research to which they want to contribute.

Certainly, if researchers discover a tumor but don’t identify and contact the participant, that would be problematic. But incidental findings in biobank research typically concern difficult to interpret genetic risk factors. Should these elusive figures be communicated to participants?

Samples may moreover be reused many times in different biobank projects. A relevant incidental finding about me may not be made until a decade after I gave the sample. By then I may have forgotten that I gave it.

Do I want to be seen as a biobank partner that long after I gave the sample? Do I want my contribution to research to be acknowledged years afterwards in the form of percentages concerning increased disease risks? Wasn’t it sufficient with the attention and the health information that I received when I gave the sample: when I actually MADE my contribution?

Personally, I’m willing to contribute to research by giving blood samples, answering questions, and undergoing health examinations. But if that means also getting a lifelong subscription to genetic information about me, I’m beginning to hesitate.

That’s not what I wanted, when I wanted to contribute to research.

Realizing that my blood sample rendered a lifelong subscription to genetic information would estrange me from what I thought I was doing. Can’t one simply contribute to research?

But other participants might want the information. Should biobank research then offer them subscription services?

Pär Segerdahl

We like challenging questions - the ethics blog

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