Biobanking - Ethical legal aspects of biobanking
9 important questions on Biobanking - Ethical legal aspects of biobanking
Is there already a steady framework for medical research on human tissue? Is ethical approval required by law?
No ethical approval not required by law.
What are the international guidelines available?
• HUGO statements (human genome) (1998/2002)
• Council of Europe Recommendation (2006) on research on biological materials of human origin
• OECD-guidelines (2009) on Human Biobanks and Genetic Research Databases (HBGRDs)
What are the general stakeholders for biobanking?
• Management biobank
• Researchers and other users
• Sponsor of biobank
• General public
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Summarize what is important when you work for biobank? (2)
- Self regulation on national level is important!
What are the underlying principles of international regulations?
- human rights (e.g. autonomy, privacy, non- discrimination)
- general ethical principles (e.g. not paying participants, reporting important findings to participants, benefit sharing)
- general governance principles (e.g. transparency, accountability, involvement of stakeholders, for how long do you store the materials)
What are ethical concerns about biobanking?
- Privacy issues with DNA => historical abuses and mistrust, inequities in health outcomes.
- Do you really give informed consent when the future use is unknown? => commercialization => broad consent
- How are you able to withdrawal consent?
- How to deal with the burden/risks of obtaining the tissue (biopsie)
- How do you show results to the patient/family, and which results? => incidental findings
What are pros and cons of broad consent and is it allowed?
- less patient needed
- scientific progress
- cost effective
Con
- less autonomy
- difficult to have oversight that only ethical research is done with it
- potential misuse
- less trust
Yes it is allowed
What are issues with incidental findings?
- Finding something in research setting does not mean that is it clinically relevant
- Some patients want to know genetic findings while others don't
- Researchers do not have the capacity to report everything to the subject
What are the recommendations for incidental findings?
- Only findings with clinical utility
- Limit the possibilities to find incidental findings
- Patients should be able to opt-out on incidental findings.
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