DoH_Cape_Town_Enhancement_-_Wiesing

Research on Enhancement –
an Issue for the Declaration of
Helsinki?
Urban Wiesing, Tübingen
Institut für Ethik und
Geschichte der Medizin
Enhancement – an issue?
• The practice of enhancement is growing.
• Neuroenhancement, aesthetic surgery,
fitness…
• The debate on enhancement is growing.
• The efforts in enhancement will increase!
• Enhancement is an issue of the future!
Institut für Ethik und
Geschichte der Medizin
Research on enhancement – an issue?
• Mainly off-label use
• Currently no evidence for all of the alleged
enhancement technologies about efficacy,
effectiveness, safety, unwanted effects.
(Except drugs with unacceptable side-
effects).
“The claimed and assumed benefits are often
exaggerated.” (Saskia Nagel)
Institut für Ethik und
Geschichte der Medizin
Research on enhancement – an issue?
• Research on enhancement is necessary.
• Current use is not based on valid information.
• Scientific evidence is also needed for a social
and political debate!
Institut für Ethik und
Geschichte der Medizin
Norms in research on enhancement?
• All norms for research involving human beings
are valid in research on enhancement.
• In addition: There is no health benefit in case of
successful research on enhancement.
 Risk/benefit assessment is different
• The patient must be informed about the nature
of the research: no health benefit!
 Informed consent is different
Institut für Ethik und
Geschichte der Medizin
Research on enhancement is not
explicitly mentioned in the DoH
Art. 7 : “The primary purpose of medical research
involving human subjects is to understand the causes,
development and effects of diseases and improve
preventive, diagnostic and therapeutic interventions
(methods, procedures and treatments).”
Research on enhancement: research with medical
technologies for non-medical purposes
Institut für Ethik und
Geschichte der Medizin
Are the norms for research on
enhancement covered by the DoH?
Yes, implicitly:
Part B: PRINCIPLES FOR ALL MEDICAL RESEARCH
Institut für Ethik und
Geschichte der Medizin
Are the norms for research on
enhancement covered by the DoH?
risk/benefit assessment:
Art. 18: “Every medical research study involving human subjects
must be preceded by careful assessment of predictable risks and
burdens to the individuals and communities involved in the
research in comparison with foreseeable benefits to them and to
other individuals or communities affected by the condition under
investigation.”
Art. 21: “Medical research involving human subjects may only be
conducted if the importance of the objective outweighs the
inherent risks and burdens to the research subjects.”
Institut für Ethik und
Geschichte der Medizin
Are the norms for research on
enhancement covered by the DoH?
Informed consent:
Art 24: “In medical research involving competent human
subjects, each potential subject must be adequately
informed of the aims, methods, sources of funding, any
possible conflicts of interest, institutional affiliations of
the researcher, the anticipated benefits and potential
risks of the study and the discomfort it may entail, and
any other relevant aspects of the study.”
Institut für Ethik und
Geschichte der Medizin
A proposal for a new paragraph:
The norms of the Declaration are also valid for
medical research on enhancement. The
risk/benefit assessment must be extremely
careful, if no medical benefit can be gained by
the research. The participants must be
informed about the non-medical purposes of
the research.
Institut für Ethik und
Geschichte der Medizin
Final remarks
• The final decision whether to implement a paragraph
on research on enhancement is a political decision.
• There are other issues that could be regulated explicitly
in the DoH as well.
• Other considerations have to be taken into account
(length of the DoH, importance of the issue, are
explicitly mentioned norms necessary?…)
Institut für Ethik und
Geschichte der Medizin
Research on Enhancement –
an Issue for the Declaration
of Helsinki?
Urban Wiesing, Tübingen
Institut für Ethik und
Geschichte der Medizin