Human Genome Organisation; Ethical, Legal, and Social
Issues Committee; Statement on the Principled Conduct of Genetics Research
HUGO Ethical, Legal, and Social Issues Committee Report to HUGO Council
Based on the Discussion Paper, "Ethical Issues in International Collaborative
Research on the Human Genome: The HGP and the HGDP,"
The Human Genome Project (HGP), proposed in the 1980s and formally initiated in
1990, has as its specific goals identification of all human genes and sequencing
of the entire genome. Completion of the HGP in the projected 15 years will provide
a source book for biology and medicine. Yet, in this time frame, the function
of all genes, singly and in concert, will not be known, nor will the worldwide
variation in the genes have been defined.
Bartha Maria Knoppers, LL.D., Member HUGO-ELSI Committee; Marie Hirtle, LL.M.
and Sébastien Lormeau, B.Sc., 1995.
The Human Genome Diversity Project (HGDP) is an international scientific endeavor
that complements the HGP by examining the genomic variation of the human species,
through analysis of DNA from populations, families, and individuals worldwide.
The HGDP promises to help us understand the fundamental unity of humankind,
human biological history, population movements, and susceptibility or resistance
to various human diseases.
The HGP, the HGDP, and other genetic research have given rise to a number of
The Council of the Human Genome Organisation (HUGO) asked its Ethical, Legal and
Social Issues Committee (HUGO-ELSI), comprising experts from a number of countries
and disciplines, to provide guidance and procedures which would address these
concerns and ensure that ethical standards are met as the HGP and the HGDP proceed.
- Fear that genome research could lead to discrimination against and stigmatization
of individuals and populations and be misused to promote racism;
- Loss of access to discoveries for research purposes, especially through
patenting and commercialization;
- Reduction of human beings to their DNA sequences and attribution of social
and other human problems to genetic causes;
- Lack of respect for the values, traditions, and integrity of populations,
families, and individuals; and;
- Inadequate engagement of the scientific community with the public in the
planning and conduct of genetic research.
The HUGO-ELSI Committee has based its recommendations on the following four
The HUGO-ELSI Committee recommends:
- Recognition that the human genome is part of the common heritage of humanity;
- Adherence to international norms of human rights;
- Respect for the values, traditions, culture, and integrity of participants;
- Acceptance and upholding of human dignity and freedom.
- That scientific competence is an essential prerequisite for ethical
research. It includes appropriate training, planning, pilot and field testing,
and quality control through continual review.
- That communication not only be scientifically accurate, but understandable
to the populations, families, and individuals concerned and sensitive to their
social and cultural context. Communication is a reciprocal process; researchers
must strive to understand as well as to be understood.
- That consultation should precede recruitment of possible participants
and should continue throughout the research. Cultural norms vary, as do perceptions
of health, disease, and disability; of family; and of the place and importance
of the individual.
- That informed decisions to consent to participate can be individual,
familial, or at the level of communities and populations. An understanding
of the nature of the research, the risks and benefits, and any alternatives
is crucial. Such consent should be free from coercion by scientific, medical,
or other authorities. Under certain conditions and with proper authority,
anonymous testing for epidemiological purposes and surveillance could be an
exception to consent requirements.
- That any choices made by participants with regard to storage or
other uses of materials or information taken or derived therefrom be respected.
Choices to be informed or not with regard to results or incidental findings
should also be respected. Such choices bind other researchers and laboratories.
In this way, personal, cultural, and community values can be respected.
- That recognition of privacy and protection against unauthorized access
be ensured by the confidentiality of genetic information. Coding of
such information, procedures for controlled access, and policies for the transfer
and conservation of samples and information should be developed and put into
place before sampling. Special consideration should be given to the actual
or potential interests of family members.
- That collaboration between individuals, populations, and researchers
and between programs in the free flow, access, and exchange of information
is essential not only to scientific progress but also for the present or future
benefit of all participants. Co-operation and co-ordination between industrialized
and developing countries should be facilitated. An integrated approach and
standardization of conditions and consents is essential to ensure viable collaboration
and comparison of results.
- That any actual or potential conflict of interest be revealed at
the time information is communicated and before agreement is reached. Such
actual or potential conflicts should also be reviewed by an ethical review
committee before any research begins. Honesty and impartiality are cornerstones
of ethical research.
- That undue inducement through compensation for individual participants,
families, and populations should be prohibited. This prohibition, however,
does not include agreements with individuals, families, groups, communities
or populations that foresee technology transfer, local training, joint ventures,
provision of health care or of information infrastructures, reimbursement
of costs, or the possible use of a percentage of any royalties for humanitarian
- That continual review, oversight, and monitoring are essential for
the implementation of these recommendations. Such review should include, where
possible, representatives of participants in this research. Indeed, without
continuing evaluation, the potential for exploitation, for duplicity, for
abandonment, and for abuse by all cannot be ignored. Like competence, continual
review is imperative to respecting human dignity in international collaborative
HUGO-ELSI Committee Members (March 1996)
Professor Kåre Berg
Professor Alex Capron
Professor Ruth F. Chadwick
The Honorable Justice Michael Kirby
Professor Bartha Maria Knoppers, Chairperson
Dr. Darryl R.J. Macer
Dr. Victor A. McKusick
Professor Benno Müller-Hill
Dr. Thomas H. Murray
Professor M.F. Niermeijer, Cochairperson
Professor Alain Pompidou
Professor Stefano Rodotà
Dr. Hiraku Takebe, Cochairperson
Dr. Nancy S. Wexler