OPINION OF THE NATIONAL BIOETHICS COMMITTEE ON THE
EUROPEAN PROTOCOL ON BIOMEDICAL RESEARCH
19 November 1999
The NBC, as its meeting on 19 November 1999, examined the
document prepared by the Steering Committee on Bioethics (the
Council of Europe's CDBI) dated 29 July 1999 (Doc.
CDBI-CO-GT2/99/10). This is the latest version of the work
carried out on the drafting of a 'Protocol on biomedical
research' in implementation of the 'European Convention for the
protection of human rights and dignity of the human being with
regard to the application of biology and medicine' (the Oviedo
Convention, 1997).
FOREWORD
While the NBC appreciates the results achieved by by the CDBI it
notes that, in general terms, there has been a gradual distancing
from the ethical positions elaborated to fully guarantee
individuals undergoing trials, and from the overall philosophy
which inspired the Helsinki Declaration on biomedical research
involving human subjects. These diverging positions relate in
particular to several very important issues that may be
summarized as follows:
- the guarantees of good practice for trials and for the
protection of the individuals taking part in them refer
excessively to the laws of each individual state; this is a
source of concern because most European countries have very
little legislation dealing with this matter;
- unlike the position adopted in
the Helsinki Declaration research may also be carried out on individuals
who are unable to give their consent (albeit in compliance with specific
indications to protect them).
Lastly, one particularly important feature of the draft Protocol
is the lack of consistency between the positions taken up in the
draft on biomedical research and the points previously
established in the European Community framework by the
'guidelines for good clinical practice' adopted by the European
Agency for the evaluation of drugs (CPMP/ICH/1995). This
inconsistency betrays a lack of cooperation between the European
agencies and an inadequate harmonization of the rules and
regulations they produce.
RESERVATIONS
The NBC therefore considers it appropriate to make the
following observations:
1) It is necessary to apply the safety guarantees established
in the Protocol in their entirety (and not only the fundamental
guarantees) to research carried out on human beings in countries
which are not party to the Protocol (see art.10). A more
effective form of legal protection should be provided for
individuals from non-signatory states, particularly if they are
less developed. For the purposes of applying the principle of
individual self-determination, for example, it would appear
appropriate to introduce a 'cultural mediator' from the local
population, whenever required on account of the different
cultural, economic and social environments in the country
proposing the trial and the country in which the trials are to be
performed. A 'cultural mediator' would guarantee that full
information and a full understanding of the risks of the
research, and in more general terms the risk/benefit ratio, is
are made public. The results of the research should also be to
the benefit of the population of the countries in which it is
carried out.
2) We are opposed to persist with placebo treatment when it is
necessary to ascertain the greater effectiveness of new drugs on
persons requiring treatment with traditional drugs (arts.12 and
19). The objection made to the previous draft of the document was
that if a treatment is active, by definition the fact of not
using it cannot be a matter of arbitrary choice. The following
wording was therefore proposed 'placebo treatment may only be
used in cases where there is no treatment of proven
effectiveness'. The new version has accepted the emphasis made by
the word 'only', but it still accepts the use of placebo
treatment even when active treatment exists, even though it does
specify that withdrawing or withholding active treatment must not
present significant/considerable risks or burden. It should be
quite clear that the use of placebo treatment when alternative
treatment of proven effectiveness exists is a violation of the
ethical code and is not in the interests of the patient. This
cannot even be justified by reference to the interests of science
and society. For whenever it is discovered that a particular
treatment has a positive effect on changing the natural course of
a particular condition or disease, the essential issue as far as
science and society are concerned is to see whether the new
treatments can produce a further improvement still. With regard
to the treatment to be reserved to control groups, it would be
preferable to speak of assuring them of the best treatment of
proven effectiveness, using the wording of the Helsinki
Declaration.
3) We would use the definition of 'minimal risk': this provides
better guarantees for the patient than the other two wordings
proposed, namely 'significant risk' or 'considerable risk'. The
term 'integrity' should also be considered to comprise both
mental and physical integrity. Consequently, consent must be
requested both for physical and for psychological
treatments.
4) No obligation is envisaged about giving clear information,
when carrying out research projects, regarding the possible use
of the findings and the documentation collected for industrial
application and for patenting procedures and products.
5) Despite the improvements made to the text, some ambiguity
still remains in the wording regarding experiments during
pregnancy, whether this is designed to collect data regarding the
mother's organism or data relating to the foetal organism, or
whether they are trials being conducted for the health of the
mother or of the foetus, which should guarantee mutual negative
non-interference. It should also be clearly stated that
non-therapeutic trials on pregnant and nursing women must exclude
the maximum level of risk for the individuals involved.
6) The possibility of carrying out research on dependent
persons (see art.24) or on persons deprived of liberty (art.25).
In these cases, even though they are subject to different
conditions, it may always be possible for unjustified influence
to be brought to bear on them to secure their consent. As a
secondary point, the Committee notes that research on dependent
persons or persons deprived of liberty must be strictly limited
to instances in which the individuals concerned can themselves
benefit from the research.
ENDORSEMENT
As far as the amendments proposed by the Secretariat are
concerned, the NBC endorses the changes made, and particularly
the introduction of the following points into the text:
1) further specification regarding the complex relations between
researchers and the persons undergoing research with regard to
the information required to be able to validly give consent
(arts.11 and 12) and - in the case of persons unable to consent -
further provisions taking account of any objections which that
person may have expressed previously regarding participation in
the research (art.20);
2) the clearer wording adopted regarding the restrictions on
research on pregnant or nursing women (art.23) coupled with the
remarks made above;
3) the clearer wording regarding the requirements for research
on personal data (arts. 26 and 27);
4) the clearer wording regarding the protection of the
confidentiality of personal data (art.29) and damages due in the
case of breach of confidentiality (art.30);
5) the introduction in the new version of the requirements for
research on biological materials which we have frequently
advocated in the past (arts. 31, 32, 33, 34, 35);
6) the general statement that no research can be undertaken on
human beings except when there is no alternative of comparable
effectiveness (arts. 11 and 26).
CONCLUSIONS
In conclusion, the NBC notes the lack of any clear reference
in the text to the need to spell out the purposes of the
research, both from the point of view of the scientific analysis
of the results and an ethical appraisal of the research, in the
protocol submitted for approval to the authorizing authorities.
We believe that it is a matter of absolute priority to indicate
this, to establish the real relevance to human health and welfare
of the objectives set for the research project, independently of
the need to adopt sound procedures and guarantee the scientific
validation of the research protocols.
The NBC has noted that the protocol does not cover experiments
on embryos, and will return later to this subject with a reasoned
opinion regarding the specific protocol currently being prepared
for this purpose.
The NBC also notes that the draft protocol provides a much
broader definition of research than previous versions, and also
includes psychological, sociological research (relating to the
Convention) and population studies. These are all issues that
require further detailed discussion.
Lastly, the NBC believes that the role of Ethics Committee,
which is given recognition in the protocol, must be more
forcefully emphasized. The Ethics Committee must be entrusted
with such fundamentally important tasks as examining and
approving research projects, expressing a binding decision
regarding their implementation. The Committee must also guarantee
that no unjustified influence is brought to bear to obtain
consent to experimentation and that patients are kept fully
informed of all the possible unexpected adverse effects (which,
if they materialize, are conditions for halting the research,
and, if the trials are to be continued, the patient-s consent
must once again be sought, and the Ethics Committee requested to
issue an opinion on the amended protocols).
The NBC hopes that the final drafting of the 'Protocol' will
take account of the reservations expressed above regarding the
present wording.
