Use of tissue: opt-out system for patients is optimal and endorsed in many countries
Wendler has given a valuable contribution to the discussion on the
use of residual tissue (left-over tissue) for research with his overview
of some empirical studies of patients’ preferences on this subject.
However, his overview is not complete. The discussion has already been
settled by legislation in many countries. In 2004 the Danish act on
patient rights was amended with an opt-out system for the use of residual
tissue for research. In 2004 the US Office for Human Research Protections
(OHRP) issued a guidance in which it was stated that research on residual
tissue which is anonymous at the level of the researcher is not human
subject research and therefore can be used without consent 1. Earlier the
Dutch Federation of Medical Research Societies drafted, together with
patient organisations, a Code of Conduct on research with residual tissue
with an opt out system for research on samples which are anonymous on the
level of the researcher 2. In the recent UK Human Tissue Act no form of
consent is needed for the use of fully anonymous or coded (or linked)
residual tissue that is anonymous at the level of the researcher, provided
that an ethical review board has permitted the study. The more restrictive
provisions on this subject in the original Bill were amended, also due to
pressure from patient groups who were afraid that research to their
benefit would be hampered by the proposed consent system.
Wendler stresses autonomy and argues that a one–time consent protects both
the autonomy of individuals and protects them from serious risks. There
are two major arguments against this. First, autonomy should be balanced
against other values like the interests of patients who might benefit from
this research. 3, 4 Second, autonomy as such cannot protect individuals
from risks, but only from risks they do want to carry. Research on
residual tissue, whether anonymous or anonymously used and being coded,
does not carry any risks to individuals. Ethical review boards should
oversee that sufficient measures have been taken so that the samples used
in research will remain anonymously used. It should be possible to enrich
data from tissue research with patient data e.g. on his response to
treatment, long term survival, etc. Fully anonymising samples as suggested
by Wendler is a waste of valuable information.5
Rapid Response:
Use of tissue: opt-out system for patients is optimal and endorsed in many countries
Wendler has given a valuable contribution to the discussion on the
use of residual tissue (left-over tissue) for research with his overview
of some empirical studies of patients’ preferences on this subject.
However, his overview is not complete. The discussion has already been
settled by legislation in many countries. In 2004 the Danish act on
patient rights was amended with an opt-out system for the use of residual
tissue for research. In 2004 the US Office for Human Research Protections
(OHRP) issued a guidance in which it was stated that research on residual
tissue which is anonymous at the level of the researcher is not human
subject research and therefore can be used without consent 1. Earlier the
Dutch Federation of Medical Research Societies drafted, together with
patient organisations, a Code of Conduct on research with residual tissue
with an opt out system for research on samples which are anonymous on the
level of the researcher 2. In the recent UK Human Tissue Act no form of
consent is needed for the use of fully anonymous or coded (or linked)
residual tissue that is anonymous at the level of the researcher, provided
that an ethical review board has permitted the study. The more restrictive
provisions on this subject in the original Bill were amended, also due to
pressure from patient groups who were afraid that research to their
benefit would be hampered by the proposed consent system.
Wendler stresses autonomy and argues that a one–time consent protects both
the autonomy of individuals and protects them from serious risks. There
are two major arguments against this. First, autonomy should be balanced
against other values like the interests of patients who might benefit from
this research. 3, 4 Second, autonomy as such cannot protect individuals
from risks, but only from risks they do want to carry. Research on
residual tissue, whether anonymous or anonymously used and being coded,
does not carry any risks to individuals. Ethical review boards should
oversee that sufficient measures have been taken so that the samples used
in research will remain anonymously used. It should be possible to enrich
data from tissue research with patient data e.g. on his response to
treatment, long term survival, etc. Fully anonymising samples as suggested
by Wendler is a waste of valuable information.5
References:
1. http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
2. English language version: www.fmwv.nl under “Codes of Conduct”
3. Harris J. Scientific research is a moral duty, J.Med. Ethics
2005;31:242-8.
4. Oosterhuis J.W., Coebergh J.W., van Veen E.B. Tumour banks: well
guarded treasures in the interests of patients. Nat. Rev. Cancer 2003:3:73
-7.
5. Knoppers B.M., Chadwick R. Human genetic research: emerging trends
in ethics. Nat. Rev. Genetics 2005; 6:75-9.
Competing interests:
None declared
Competing interests: No competing interests