Information, consent and coding - Keys to an ethical praxis in biobanking
Format
Completed research project
Key words
Biobanks, information, consent, coding, ethical praxis
Time table
The project began in April 2002. Consent forms were ready in the fall 2002. Coding-model proposal and instruction to took place in 2003. Consultancy was offerend throughout the project.
Financial support
The National Biobanking Platform within the Wallenberg foundation Functional Genomics programmes Swegene and Wallenberg Consortium North.
Aims
A new law on biobanking came into effect January 1, 2003. In this project, we will suggest an ethical praxis for county councils, scientists and research ethics committees within the framework of this law. The praxis will concentrate on information and consent procedures, infrastructure for coding, and the distinction between different kinds of research projects with regard to what values are at stake for actual and future patients.
It is not reasonable that rules for obtaining informed consent should be the same in all situations, spanning from ordinary treatment to clinical trials and protocols for epidemiological research, where no personal identification is desired. The quality of consent has to be balanced against the different values at stake in different situations. Consent forms for research protocols should include separate sections for subjects that are requested to provide consent for the use of biological material for research. Subjects should be informed of the purpose and procedures of the research, and whether or not their material will be stored for future research. However, the scope of the information should be adjusted to the values at stake. Donors should be given information about the storage and they should receive information on how their integrity will be preserved.
A coding system needs to be developed, where biological material, relevant medical information, personal information and personal identifiers can be coded separately, then linked back together in order to optimize the research potential and protect personal integrity.
Within the project, information and consent procedures for larger groups of research protocols will be developed. These procedures aim, when appropriate, to include both primary and secondary use. The project will formulate a set of standard consent forms and investigate different models for achieving a comprehensive coding system, and suggest a model that is acceptable to researchers, university hospitals and health-care providers. The project will also offer ethical and legal advice to researchers regarding the use of human biological material for research.
Publications
Eriksson S, Helgesson G, Potential harms, anonymization, and the right to withdraw consent to biobank research, European Journal of Human Genetics, 2005;13:1071–1076.
Eriksson S, Helgesson G, Keep people informed or leave them alone? A suggested tool for identifying research participants who rightly want only limited information, Journal of Medical Ethics, 2005;31:674-678.
von Essen U, Etikprövning av biobanks- och registerforskning, Förvaltningsrättslig tidskrift 2002;5-6:351-380.
von Essen U, Biobanksforskning - forskares möjligheter att få tillgång till vävnadsmaterial och personuppgifter, Förvaltningsrättslig tidskrift, 2003;2:197-214.
von Essen U, Focusing on Personal Integrity Violation - Legal guidelines for ethical practice, in: Hansson, M.G. & Levin, M. (eds.), Biobanks as Resources for Health, Uppsala University, 2003, pp. 129-148.
Helgesson G, A Swedish Standard for Information and Consent Procedures in Biobank Research, in: Hansson, M.G. & Levin, M. (eds.), Biobanks as Resources for Health, Uppsala University, 2003, pp. 149-164.
Helgesson G, Johnssonn L, The right to withdraw consent to research on biobank samples, Medicine, Health Care and Philosophy 2005;8:315-321
Helgesson G, Ludvigsson J, and Gustafsson Stolt U, How to handle informed consent in longitudinal studies when participants have a limited understanding of the study, Journal of Medical Ethics, 2005;31 670-673.
Helgesson G, Children, longitudinal studies, and informed consent, Medicine, Helalth Care and Philosophy, 2005; 8:301-313.
Kaijser M, Examples from Swedish Biobank Research, in: Hansson, M.G. & Levin, M. (eds.), Biobanks as Resources for Health, Uppsala University, 2003, pp. 33-50.
Other activities
von Essen U, Den nya biobankslagen, lagens innehåll och användning. Lecture on the course entitled "Biobankslagen", March 20-21, 2003, Uppsala, Kurssekretariatet, Uppsala University.
Hansson MG, Seminar on biobanking, SweGene & Wallenberg Consortium North, Sigtuna, May 29, 2001.
Hansson MG, Seminar for the Parliamentary Standing Committee on Social Affairs concerning the Government's Biobanks Bill, the Riksdag (Swedish Parliament), January 29, 2002.
Hansson MG, Seminar on biobanking, SweGene & Wallenberg Consortium North, Såstaholm, October 1, 2002.
Hansson MG, Seminar on the ethical and legal issues of biobanking, Stockholm County Council, October 8, 2002.
Hansson MG, Seminar on ethical and legal issues related to biobank research, AstraZeneca, Södertälje, January 17, 2003.
Biobank user service - website with information and FAQ
Helgesson G, Biobanker i Sverige: nätverk, juridik, etik. Föredrag vid "Seminar om etiske, juridiske og samfunnsmessige aspekter ved bruk av humane biobanker", Arranged by GUGE and the Norwegian Research Council, Bergen, May 7, 2003
Participation in the conference "Biobanks as Health Resources", Uppsala Castle, March 10-11, 2003.
More information
- Mats G. Hansson, Professor of Biomedical Ethics
Collaborators
Professor Mats G. Hansson (project leader)
Dr. Gert Helgesson
Department of Learning, Management and Ethics, Karolinska Institutet
Dr. Richard Wessman
Department of Law, Stockholm University
Dr. Ulrik von Essen
Department of Law, Stockholm University
Dr. Magnus Kaijser
Medical Epidemiology, Karolinska institutet
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