Statement On The
Principled Conduct Of Genetics Research
Approved by HUGO Council, March 21, 1996.
- Based on the discussion paper, "Ethical issues in International
Collaborative Research on the Human Genome: The HGP and the HGDP", BM.
Knoppers, M. Hirtle, S. Lormeau, 1995.
Eubios Journal of Asian and International Bioethics 6 (1995), 59-60.
The Human Genome Project (HGP), proposed in the 1980 s 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.
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
concerns:
- Fear genome research could lead to discrimination against and stigmatization
of individuals and groups 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 Council of the Human Genome Organization (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
HGDP proceed.
The HUGO-ELSI Committee bases its recommendations on the following four
principles:
- 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;
and
- Acceptance and upholding of human dignity and freedom.
The HUGO-ELSI Committee recommends:
That scientific competence is the
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 senstive 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 or 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. Cooperation
and coordination between industrialized and developing countries should be
facilitated. As 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 committee before any research begins. Honesty and
impartiality are the 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 forsee
technology transfer, local training, joint ventures, provision of health care
or on information infrastructures, reimbursement of costs, or the possible use
of a percentage of any royalties for humanitarian purposes.
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 genetic research.
HUGO-ELSI Committee Members
Prof. Kare Berg, Prof. Alex Capron, Prof. Ruth F. Chadwick, Hon. Justice
Michael Kirby, Prof. Barth Maria Knoppers (Chair), Dr. Darryl R.J. Macer, Dr.
Victo A. McKusick, Prof. Benno Muller-Hill, Dr. Thomas H. Murray, Prof. M.F.
Niermeijer (Co-chair), Prof. Alain Pompidou, Prof. Stefano Rodota, Dr. Hikaru
Takebe (Co-chair), Dr. Nancy Wexler.
Comments for
publication in EJAIB to: Dr Darryl Macer,
Institute of Biological Sciences, University of Tsukuba,
Tsukuba Science City 305, Japan;
Email < D.macer@unescobkk.org
>.
The text of this Declaration on the Human Genome is in EJAIB 6 (May 1996).
HUGO Ethics Committee Statement on DNA Sampling: Control
and Access (March 1998)
HUGO Ethics Committee Statement on Cloning (March 1999)
HUGO Ethics Committee Statement on Benefit Sharing
(April 2000)
Go to EJAIB May 1996
Go to EJAIB
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