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Long-awaited international ethical guidelines for biobank researchers

Many sets of guidelines and regulations, and great differences among countries. This is what medical researchers encounter if they want to use previously collected samples from biobanks in their research. For one thing, this makes it extremely complicated to carry out major international studies. In the latest issue of Nature Biotechnology, Swedish ethics researchers at the Center for Bioethics (CBE), together with leading biobank researchers, put forward a pioneering solution: a set of practical ethical guidelines for biobank research.

Biobanks consist of systematically gathered biological samples and are valuable for both research and medical treatments. When tissues samples are linked to good clinical data, they become indispensable to medical science. At the same time a number of ethical issues are raised regarding the use of these samples. For instance, can we be certain that information about an individual will not reach the wrong people, such as employers and insurance companies"

It is crucial to be able to weigh the conflicting interests, so that the regulation of biobank research doesnt become a patient security problem in diagnosis, care, and treatment, says Mats G. Hansson, professor of biomedical ethics and director of the Center for Bioethics at the Karolinska Institute and Uppsala University in Sweden.

Today there is a plethora of extremely comprehensive guidelines and regulations in different countries, which entails major complications for biobank scientists, especially in international collaborative projects. In other words, there is a crying need for a simple model providing a comprehensive ethical balancing of medical needs and personal integrity concerns.

The article in Nature Biotechnology presents for the first time an ethical framework for research using previously collected tissue samples, guidelines that can be used as a practical and direct instrument for researchers. Together with an article by the same researchers in the journal The Lancet Oncology from 2006, which provides guidance for the collection of new samples, and an article by Mats G. Hansson published in the latest issue of Pathobiology presenting a manual for biobank research, central issues involving biobank research have now been given a comprehensive solution. Hansson feels that it is important that ethical questions surrounding medical research be discussed and examined in the same forum as the scientific discussion is carried on.

Its also important that proposals regarding the ethical balancing of various interests be put through the same type of independent scrutiny by being peer-reviewed in established scientific journals, just like medical research, he avers.

The framework is not only an instrument for researchers, but can also serve as a guide for ethics committees throughout Europe.


Contact: Mats G. Hansson
Uppsala University

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