Abbreviations: CIOMS, Council for International Organizations of Medical Sciences; NBAC, National Bioethics Advisory Commission; UNAIDS, United Nations Programme on HIV/AIDS; WMA, World Medical Association
The Council of Europe Protocol would seem to adopt the most restrictive interpretation, as it deals only with research which entails “interventions” on human beings. However, the question is how broad this should be interpreted. The position of the CDBI is that any form of contact with a research subject would constitute an intervention; therefore, also questionnaires, interviews and observational research come within the scope of the Protocol. The revised Declaration of Helsinki is rather wide in its scope,
as according to Art.1 “medical research involving human subjects includes research on identifiable human material or identifiable data”. On the other hand, it does not elaborate this, so it remains unclear to what extent for instance research with already available human tissue needs prior approval by an ethics committee. The most comprehensive approach is adopted in the CIOMS guidelines. They do not define “biomedical research involving human subjects”, but as a matter of fact they also cover secondary use of
research records and specimens as well as research on patient records and on blood or tissue samples taken in the course of clinical care. These issues, however, are dealt with only briefly and without much regard to the specific
nature of the different kinds of research scope is substance. Also in this respect variation exists, be it on some points more than on others.9 A conspicuous example – which is also relevant in a human rights perspective – is the rotection
afforded to persons who are not able to give consent to their participation in medical research, in particular non-therapeutic research. Separate set of standards on non-therapeutic medical research. In case a research subject is incapable of giving consent, consent must be obtained
from the legally authorized representative. Incompetent persons should not be included in research, unless the research is necessary to promote the health of
the population represented and this research cannot instead be performed on legally competent persons (Art.24). Although this provision sets limits to the inclusion of incompetent persons, it does not exclude non-therapeutic
research with them. The same holds for Art.26 which further specifies the necessity and subsidiarity principles expressed in Art.24.10 The proposed CIOMS guidelines include (in Art.14 and 15) similar safeguards as the Helsinki Declaration.11 Furthermore, there is an additional
guideline dealing with (research) interventions that do not hold out the prospect of direct benefit to an (incompetent) individual (Guideline 5); it requires that the risk of such interventions should be no more likely and not
greater than the risk attached to routine medical or psychological examination of such persons. However, “slight or minor increases above such risk may be permitted when an ethical review committee is persuaded that the object of
the research is sufficiently important”. According to the explanatory text “the meaning of this standard is inferred from what various research ethics committees have reported as having met that standard”, including “the performance of additional lumbar punctures or bone-marrow aspirations in
children having conditions for which such examinations are regularly indicated in clinical practice”. Unfortunately, this would seem to set hardly any limits to the interventions that can take place in non-therapeutic research with incompetent persons. In this respect, the draft Council of Europe Protocol provides much more protection to persons not capable of giving consent. Research that has not the
potential to produce results of direct benefit may only be carried on them by way of exception and under additional conditions, including among others that the research entails only minimal risk and minimal burden for the
individual concerned and that any consideration of additional potential benefit of the research shall not be used to justify an increased level of risk of burden (Art.18). According to Art.20, research bears minimal risk if it is to be EDITORIAL 297 expected that it would result, at the most, in a very slight and temporary negative impact on the health of the person concerned; for the burden to be minimal, it is required that it is to be expected that the symptoms or
unpleasantness will be, at the most, temporary and very slight. These strict provisions do more justice to the human rights of this vulnerable group of persons than (in particular) the draft CIOMS guidelines.