Colledge

Flora Colledge
Bernice Elger
Heidi C Howard
Overview
1. Changes
2. Implications and benefits
3. 3 key issues
4. Conclusion
Previous versions 1964 – 2000
“22. In ANY research on human beings, each potential subject must be
adequately informed of the aims, methods … the anticipated benefits and
potential risks of the study and the discomfort it may entail… the
physician or another appropriately qualified individual must then seek
the potential subject’s freely-given informed consent…”
“1. The World Medical Association has developed the Declaration of
Helsinki as a statement of ethical principles to provide guidance to
physicians and other participants in medical research involving human
subjects. Medical research involving human subjects INCLUDES research
on identifiable human material or identifiable data.”
A new paragraph – 2008
“25. For medical research using identifiable human
material or data, physicians must normally seek consent
for the collection, analysis, storage and/or reuse. There
may be situations where consent would be impossible or
impractical to obtain for such research or would pose a
threat to the validity of the research. In such situations
the research may be done only after consideration and
approval of a research ethics committee.”
Why discuss human material and
data separately?
Obtainment – research and clinical
Samples stored, sometimes indefinitely
Possible uses far into the future – unknowable
Possible use of archived samples
No risk of physical harm
Potential for harms through identifiability
Ambiguous terms
“25. For medical research using identifiable human
material or data, physicians must normally seek consent
for the collection, analysis, storage and/or reuse. There
may be situations where consent would be impossible
or impractical to obtain for such research or would pose
a threat to the validity of the research. In such
situations the research may be done only after
consideration and approval of a research ethics
committee.”
Implications
In certain cases…
Not mandatory to obtain fresh consent every time a new
study is proposed
Not mandatory to obtain consent when samples are
included in biobank
Ethics committees will determine the permissibility of
the study without accompanying consent
Benefits
May widen sample pools
Old samples could be useable
Research may be quicker/cheaper/less biased
Rare samples could be useable
Samples of the deceased could be useable
Three emerging issues
1. The importance of seeking consent
2. Public engagement and trust
3. Confusion over applicability and standards
1. Seeking consent
Safeguard for patients and physicians
Respect- recognition of autonomy
Dependent on meaning of impossible or impractical
Who decides? Puri et al.
2. Public trust
Public perception of biobank research: Kaufman et al.
Public views on consent/ re-consent: Eurobarometer,
Hoeyer et al., Johnsson et al.
Future projects – place for broad consent?
3. Applicability
Primacy of Declaration and national/institutional rules
Use of the paragraph is not widely evidenced
Increased burden for ethics committees
Concluding comments
1. Clarification of the scope of «impractical» and
«threat to validity» needed
2. Different implications for existing and new samples
(collection) require clarification
3. Better understanding of the risks of biobank
research needed
Thank You
Thank you to our sponsors: the University of Basel, the
Marie Curie FP7 Initiative, and the Kathe Zingg-
Schwichtenberg Foundation
flora.colledge@unibas.ch