Centre for Research Ethics & Bioethics (CRB)

Research : Biobank Ethics

BBMRI.se - Biobanking and Molecular Resource Infrastructure of Sweden : Ethical and legal aspects (WP7)

 

Interactive conference on biobanking

Welcome to an interactive conference on biobanks! Meet biobank researchers and industry, listen to interesting talks and participate in idea labs and workshops. Topics range from the latest technology through ethical challenges and legislation to outcome in clinical praxis and drug development.

Welcome to Uppsala 20-21 September 2012!

HandsOn: Biobanks, interactive conference Uppsala 20-21 September 2012

BBMRI.se

Format

Work package (WP7) of BBMRI.se

Funding

Swedish Research Council (Vetenskapsrådet)

About BBMRI.se

BBMRI.se is a national effort for efficient and automated collection of biological material.

About WP 7

WP7 works with pressing ethical and legal questions rising from biobank related research.  There are a number of ethical and legal aspects of research conducted on human tissue samples that need to be addressed in a professional and constructive manner. The proposed new act on biobanks, existing laws on personal data and public access to information and secrecy, exert an influence on what can and can’t be done with biobanks and data. A major obstacle for researchers is that laws in part overlap, but provide slightly different answers to some questions and fail to address certain aspects of research activities. This poses major challenges for the scientific community in their strife to produce knowledge that can benefit patients.

To meet these challenges, WP7 was expanded in the autumn 2011 to examine the legal aspects. Some questions have also been raised in the media on the ethics of biobank research, especially in connection to the large population studies. WP7 will examine these questions and also provide answers to frequently asked questions (FAQ). WP7, together with the other work packages, plans to host a national biboank fair in Uppsala, Hands on biobanks.

 Within the framework of BBMRI.se WP7 will:

  • Assist the management of BBMRI.se and researchers  with qualified legal and ethical advise and training.
  • Be a knowledge centre for ethical management of biobank related research.
  • Contribute to a constructive weighing of ethical interests in the field of biobanking.
  • Constitute a competitive and attractive node for international co-operation on ethical and legal aspects of biobank research.
  • Contribute to an initiated discussion on biobank related issues in society.
  • Investigate how biobank research that protects integrity can be conducted.
  • Investigate how biobanks can collaborate with national quality registries in an efficient and legal manner.
  • Investigate the legal requirements for updating collections of samples thorough single mass-withdrawals from health-data registries.
  • Investigate the legal prerequisites for using databases and biobanks for future unspecified purposes.
  • Investigate the legal requirements for supplementing quality registries within the health care sector with blood and tissue samples. 

What we have achieved

WP7 continuously assists the management of BBMRI.se and researchers with advise and training. The group has also prepared and disseminated information for the preparation of comments on suggested legislations for biobanks and national quality registries respectively.

In November 2010, WP7 delivered an inventory of convergences and divergences in different international regulations and guidelines on biobank related research.

BBMRI.se and CRB helped organize the Nordic committee on bioethics conference ”Nordic biobank research – Opportunities and obstacles” that was held in Uppsala on 3-4 May 2011 with 180 participants. Both Joanna Forsberg and Mats G. Hansson were speakers. 

Mats G. Hansson also lectured on biobank ethics at the conference “Is medical ethics really in the best interest of the patient?” held in Uppsala on 14-16 June 2010 with 200 participants and on “The need for a wider view of autonomy” at the Bari Eso-Oeci course  ‘‘Biobanking for Cancer Research: Rules and Roles’’ on 12–13 November 2010.

Researchers at the Centre for Research Ethics & Bioethics (CRB) have worked with biboank related ethical issues for ten years and are involved in several international research collaborations on related issues. Work packages on ethical and legal aspects of biobank research is led by Mats G. Hansson in both AutoCure, supported by the EU sixth framework programme, and in BT-Cure, supported by the Innovative Medicines Initiative (IMI).

What happens next?

The new legal competence in WP7 adds legal advise and counsel to researchers to the ethical advise and teaching already conducted.

WP7 will also contribute to finding solutions to the ethical and legal questions brought to the fore when both biobanks and registry data are used for research.

In collaboration with the Medical Products Agency, WP7 will evaluate factors of success and problems encountered by international clinical registries and clinical networks. We also continue our international participation in BBMRI.eu.

In 2013, we are planning a conference on commercialisation of biomedical research in collaboration with Cardiff University.

During the autumn 2011, Pär Segerdahl will set up a research blog, focusing on ethical issues related to biobank research.

WP7 will continue publishing research in international peer-reviewed journals on:

  • Legal issues on accessibility of data, data protection and integrity
  • Secondary use of previously collected samples.
  • The return of information on incidental findings and research results.
  • Childrens participation in biobank studies.
  • Guidance for ethical committees and researchers.
  • Questions brougt to the fore in contact with biobank researchers. 

Publications

The WP7 – research group has published extensively during many years within the domain of ethical aspects of biobank-related research. Abstracts of these publications are available in a report for download. The arguments provide an excellent and by many scientists used basis for preparation of ethics applications and discussions with ethical review boards. One interesting example is the recent law on biomedical research in Spain that was designed regarding ethical aspects with inspiration from our publications.

Recent publications include

Researchers

WP7 is led by Mats G. Hansson at the Centre for Research Ethics and Bioethics  (CRB) at Uppsala University. In March 2010 two collaborators were recruited to work with the ethical issues at hand:  Kathinka Evers,  Associate professor of theoretical philosophy and  Joanna Forsberg, PhD student and MD, both from CRB.

In September 2011, legal competence was added to the group: Jane Reichel, Associate  professor of  administrative law, and Anna-Sara Lind, Associate professor of public law, both from the Department of Law at Uppsala university and now tied part-time  to CRB to work with WP7.

In October 2011 Pär Segerdahl, Associate professor of theoretical philosophy was added to the team to work with research communication. 

More information


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