Prepared by the Council for International Organizations of Medical Sciences
(CIOMS) in collaboration with the World Health Organization (WHO), Geneva 2002

  >>> International Ethical Guidelines for Biomedical Research (CIOM) (0.16 MB )

INTRODUCTION

This is the third in the series of international ethical guidelines for biomedical research
involving human subjects issued by the Council for International Organizations of
Medical Sciences since 1982. Its scope and preparation reflect well the transformation
that has occurred in the field of research ethics in the almost quarter century since
CIOMS first undertook to make this contribution to medical sciences and the ethics of
research. The CIOMS Guidelines, with their stated concern for the application of the
Declaration of Helsinki in developing countries, necessarily reflect the conditions and the
needs of biomedical research in those countries, and the implications for multinational or
transnational research in which they may be partners.

An issue, mainly for those countries and perhaps less pertinent now than in the past, has
been the extent to which ethical principles are considered universal or as culturally
relative – the universalist versus the pluralist view. The challenge to international
research ethics is to apply universal ethical principles to biomedical research in a
multicultural world with a multiplicity of health-care systems and considerable variation
in standards of health care. The Guidelines take the position that research involving
human subjects must not violate any universally applicable ethical standards, but
acknowledge that, in superficial aspects, the application of the ethical principles, e.g., in
relation to individual autonomy and informed consent, needs to take account of cultural
values, while respecting absolutely the ethical standards.

Related to this issue is that of the human rights of research subjects, as well as of health
professionals as researchers in a variety of sociocultural contexts, and the contribution
that international human rights instruments can make in the application of the general
principles of ethics to research involving human subjects. The issue concerns largely,
though not exclusively, two principles: respect for autonomy and protection of dependent
or vulnerable persons and populations. In the preparation of the Guidelines the potential
contribution in these respects of human rights instruments and norms was discussed, and
the Guideline drafters have represented the views of commentators on safeguarding the
corresponding rights of subjects.

Certain areas of research are not represented by specific guidelines. One such is human
genetics. It is, however, considered in Guideline 18 Commentary under Issues of
confidentiality in genetics research. The ethics of genetics research was the subject of a
commissioned paper and commentary.

Another unrepresented area is research with products of conception (embryo and fetal
research, and fetal tissue research). An attempt to craft a guideline on the topic proved
unfeasible. At issue was the moral status of embryos and fetuses and the degree to which
risks to the life or well-being of these entities are ethically permissible.

In relation to the use of comparators in controls, commentators have raised the the
question of standard of care to be provided to a control group. They emphasize that
standard of care refers to more than the comparator drug or other intervention, and that
research subjects in the poorer countries do not usually enjoy the same standard of allround
care enjoyed by subjects in richer countries. This issue is not addressed specifically
in the Guidelines.

In one respect the Guidelines depart from the terminology of the Declaration of Helsinki.
‘Best current intervention’ is the term most commonly used to describe the active
comparator that is ethically preferred in controlled clinical trials. For many indications,
however, there is more than one established ‘current’ intervention and expert clinicians
do not agree on which is superior. In other circumstances in which there are several
established ‘current’ interventions, some expert clinicians recognize one as superior to
the rest; some commonly prescribe another because the superior intervention may be
locally unavailable, for example, or prohibitively expensive or unsuited to the capability
of particular patients to adhere to a complex and rigorous regimen. ‘Established effective
intervention’ is the term used in Guideline 11 to refer to all such interventions, including
the best and the various alternatives to the best. In some cases an ethical review
committee may determine that it is ethically acceptable to use an established effective
intervention as a comparator, even in cases where such an intervention is not considered
the best current

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