biobank and issues

2. What are the ethical concerns in biobank research?
• Biobank research involves many stakeholders with different interests.
• - Individuals have an interest in being protected from harm and in medical
advances.
• - Researchers have an interest in easy access to samples and data and may
have personal or economic interests.
• - Doctors and hospitals may receive monetary compensation for
conducting clinical trials.
• - The research community relies on public trust and society has an interest
in healthcare advancement and protection of citizens.
• - Commercial interests may be involved, with pharmaceutical companies
seeking profits but also necessary for drug development.
• - Balancing the benefits and risks for individuals is an ethical concern.
• - Other ethical issues include commercialization, returning results, and
maintaining public trust.

3. Benefits of biobank research
• - Biobank research offers the potential to advance healthcare with minimal
individual cost or risk.
• - Risks in biobank research are known in advance and can be minimized.
• - Biobanks are used for basic research, clinical research, and Genome Wide
Association Studies (GWAS) to identify genetic risk factors for common diseases.
• - Progress in identifying factors associated with common diseases has been slow,
but discoveries from GWAS have led to new biological insights.
• - Biobank research has contributed to clinical benefits, such as the HPV vaccine
and research on predictors of rheumatoid arthritis.
• - Post-marketing surveillance studies using biobank samples can provide long-term
data on drug efficacy and adverse events.
• - Research on stored tissue samples has led to the identification of gene expression
signatures for poor prognosis in breast cancer patients.
• - Collaboration between researchers nationally and internationally is necessary to
maximize the benefits of biobank research.
• - Standardization of sample processing, data collection, and ethical and legal
standards is crucial in biobank research.

4. Risks involved in biobank research
• - The risks involved in biobank research are mainly informational, such as breaches
of confidentiality leading to social, economic, or psychological harm.
• - There is a risk of indirect physical harm if clinical samples are used to the extent
that there is not enough left for the patient's own future use.
• - Individuals may be harmed if research results lead to stigmatization or
discrimination.
• - Individuals may feel "wronged" if their samples are used for purposes they did
not consent to.
• - Genetic research can have direct consequences for family members, raising
concerns about the right to know and the right not to know.
• - Risks for groups of people include potential stigma or discrimination based on
study results.
• - The future use and potential misuse of stored samples and data is a concern.
• - Risks can be minimized through coding mechanisms, secrecy legislation, ethics
review, and weighing the risks and benefits of research projects.
• - Ethical and legal means are necessary to balance the risks and benefits of
biobank research.

5. A legal perspective: The Swedish legislation pertaining to biobank
research
• - Balancing the risks and benefits of biobank research
requires weighing the risks of biobank research against
the risks of not conducting research or conducting
poorer research.
• - Obtaining informed consent for biobank research is
important for respecting the autonomy of individuals,
but it can be difficult and costly, and may introduce
selection bias.
• - Broad consent is the emerging solution for consent in
biobank research, as surveys have shown that
individuals may prefer simple choices of whether or
not to donate their samples for research, subject to
ethics review.

6. • - The issue of confidentiality in biobank research has also been
debated, with the use of complete anonymization making it
impossible for individuals to withdraw samples or link them to
other data. Coding or double-coding samples creates the possibility
of breaches of confidentiality, but increases the usability of samples
and data.
• - The lack of consensus and clarity regarding the terminology of
different levels of identifiability of samples and data creates
uncertainty and has negative impacts on research collaborations.
• - Different strategies have been adopted in Europe and the United
States to balance the risks and benefits, with broad consent and
ethics review required in Europe, and samples that are coded and
whose researchers do not have access to the code key being
considered non-identifiable and not requiring consent or approval
by an ethics review board in the U.S.