Announcements on the First Analysis of Genome Sequence
February 12, 2001
DATA RELEASE AND ACCESS
PRINCIPLES AND POLICY
- The human genome, the common heritage of all humanity, is arguably the most
valuable dataset the biomedical research community has ever known. It holds
long-sought secrets of human development, physiology, and medicine.
- The highest priority of the International Human Genome Sequencing Consortium
is ensuring that sequencing data from the human genome are available to the
world's scientists rapidly, freely, and without restriction.
Since the sequencing phase of the Human Genome Project began five years ago,
all of the data generated by participants has been deposited in publicly available
databases every 24 hours.
- Translating the text of the human genome into practical applications that
will alleviate suffering is one of the greatest challenges facing humankind.
This mission will require the work of tens of thousands of scientists throughout
the world. No scientist wanting to advance this cause should be denied the
opportunity to do so for lack of access to raw genomic data.
- Delaying the release of either unfinished or finished genomic DNA sequence
data serves no scientific or societal purpose.
- Free and unfettered access to raw sequence data has sparked an explosion
of scientific discovery in both academia and industry - even before the sequence's
final assembly and completion.
- Identification of Disease Genes: Already, public access to genome
data has enabled researchers to identify at least 30 novel disease genes,
including those for susceptibility to some forms of breast cancer, epilepsy,
muscular dystrophy, and deafness. Hundreds more are certain to follow in the
next few years.
- Identification of Drug Targets: Access to the entire complement
of genes and proteins embedded in the human genome will greatly expand the
search for suitable drug targets. A systematic search of the human genome
database has already identified many regions with DNA sequences that closely
resemble known disease genes. These regions are likely to represent promising
new drug targets.
POLICY STATEMENTS RELEVANT TO THE RELEASE OF
AND ACCESS TO GENOMIC SEQUENCE DATA
- Policy on Availability and Patenting of Human Genomic DNA Sequence, Produced
by NHGRI Pilot Projects(April 1996)
- NHGRI Policy on Release of Human Genomic Sequence Data (March 1997)
- NIH-DOE Guidelines for Access to Mapping and Sequencing Data and Material
- For additional information regarding data release for large-scale sequencing
of model organism genomes, see Guyer, M. "Statement on the Rapid Release
of Genomic DNA Sequence." Genome Research. 8(5): 413 (May 1998)
- NHGRI Policy on Availability of Human Genomic Sequence Data (July 1999)
- Update of NHGRI policy for release and database deposition of sequence data
- Determination of Exceptional Circumstances (DEC) under 35 USC 202(a)(ii)
and 37 CFR 401.3(a)(2) and (e) for the NIH Full-Length cDNA Initiative Contract
and its Subcontracts, Harold Varmus, M.D., as NIH Director, (16 November 1999)
- Full text available upon request
- Excerpt: "The success of this initiative depends on the timely
availability of all the clones and sequences generated by this initiative
to ensure a publicly accessible gold standard set of reagents for biomedical
research. The cDNA libraries, clones, and sequences generated as part
of the NIH Full-Length cDNA Initiative will most effectively contribute
to a resource for the research community if they are made publicly available
without restriction and in a timely manner. The sharing of materials and
data in a timely manner has been an essential element in the rapid progress
that has been made in biomedical research."
- NIH Principles and Guidelines for Sharing of Biomedical Research Resources
- Excerpt: "Progress in science depends upon prompt access to the
unique research resources that arise from biomedical research laboratories
throughout government, academia, and industry. Ideally, these new resources
flow to others who advance science by conducting further research... The
goal is widespread, timely distribution of tools for further discovery.
When research tools are used only within one or a small number of institutions,
there is a great risk that fruitful avenues of research will be neglected."
International Strategy Meetings on Human Genome Sequencing:
- Summary of Principles Agreed at the First International Strategy Meeting
on Human Genome Sequencing as distributed by The Wellcome Trust, Bermuda,
25th - 28th February 1996.
- Human Genome News, April-June 1996; 7(6): International Large-Scale Sequencing
- Summary of the Report of the Second International Strategy Meeting on Human
Genome Sequencing, sponsored by the Wellcome Trust, Bermuda, 27th February
- 2nd March 1997.
- A summary of the Third International Strategy Meeting on Human Genome Sequencing
is described in Guyer, M. "Statement on the Rapid Release of Genomic
DNA Sequence." Genome Research. 8(5): 413, May 1998
National Research Council
- Mapping and Sequencing the Human Genome (1988)
- Excerpt 1 (p. 7): "Considerable data will be generated from the
mapping and sequencing project. Unless this information is effectively
collected, stored, analyzed, and provided in an accessible form to the
general research community worldwide, it will be of little value... Because
access to all sequences and materials generated by these publicly funded
projects should and even must be made freely available, two different
types of centralized facilities will be needed: (1) information centers
to collect and distribute mapping and sequencing data and (2) centers
to collects and distribute materials such as DNA clones and human cell
- Excerpt 2 (p. 91): "Absolutely essential to the success of the
project will be cooperation between laboratories and centers - within
the United States and internationally - and the ready availability of
data and materials to all participants. This committee believes that human
genome sequences should be a public trust and therefore should not be
subject to copyright."
Office of Technology Assessment
- Mapping Our Genes - Genome Projects: How Big? How Fast? (April 1988)
- Excerpt: " ...genome projects raise no new questions of patent
or copyright law. Genome projects would be subject to the same statutes
and executive orders as other scientific efforts. There is a clear role
for congressional oversight, however, in ensuring that data are shared
promptly and fully.... If private corporations do form to develop map
and sequence data and research materials, they will operate at private
expense. If they are successful, scientists will have new information,
services, and materials available for a price. . . . Corporate efforts
need not entail restricted access to information. . . . The essential
point is not whether a grantee or a contractor is a university or corporation,
but whether the research results will be widely shared."
Human Genome Organization (HUGO)
- HUGO Statement on Patenting Issues Related to Early Release of Raw Sequence
Data (May 1997)
- The Wellcome Trust, Statement on Genome Data Release
- Bentley, David R. "Genomic Sequence Information Should Be Released
Immediately and Freely in the Public Domain." Science. 274(5287):533-4,
25 October 1996
Clinton/Blair Joint Statement on Access to Human Genome Sequence Data
- Joint Statement by President Clinton and Prime Minister Tony Blair of the
UK (14 March 2000)
- President Clinton and Prime Minister Tony Blair Applaud Scientists Who Make
Human Genome Sequence Freely Available