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1. Iceland's Health Sector Database
2. What Are Some Of The Ethical Issues?
3. Some Concluding Comments (Feb. 4, 1999)
* Draft WHO guidelines (links added Apr. 1, 1999)
* Opposition to Icelandic gene database (links added on May 21, 1999)
* "The assent of a nation" (modified Nov. 3, 2002)
* Iceland Review (plus links added on Mar. 21, 2000)
* "Sale of the century" (added June 15, 2000)
* "What's in it for me?" (added August 5, 2000, updated Jul. 18, 2002)
* deCODE has successful initial public offering (updated Jan. 26, 2010)
* Database in Estonia (modified Nov. 3, 2002)
* Financial data about deCode Genetics (updated Jan. 1, 2007)
* "Informed consent" and "assumed consent" (added Aug. 16, 2001)
* Tonga gene pool (updated Dec. 20, 2002)
* Newfound Genomics (modified Jul. 28, 2002)
* Human Genome Diversity Project (modified Jul. 28, 2002)
* UK Biobank (updated Nov. 14, 2003)
* Website for the Ministry of Health and Social Security (added Jul. 28, 2002)
* Questions of bioethics raised in Sweden (updated Sep. 27, 2003)
* Website for Mannvernd (modified Nov. 3, 2002)
* Quebec Founder Population (updated Nov. 16, 2003)
* Genomics Collaborative Inc. (added Sep. 13, 2002)
* DNA Bank for Clinical Trials (added Nov. 3, 2002)
* WMA declaration (modified Dec. 20, 2002)
* Access and Benefit Sharing (modified Dec. 23, 2002)
* The Quebec-based CARTaGENE project (added Jan. 2, 2003)
* The Alberta-based Tomorrow Project (modified Jul. 16, 2003)
* DNA databanks and consent (opdated Sep. 27, 2003)
* Negotiations with National-University Hospital (added Mar. 29, 2003)
* Genetic heterogeneity of Icelanders(?) (updated Nov. 16, 2003)
* Comparison of Genebanks (updated Nov. 28, 2003)
* Race cannot be defined by genes (added Aug. 13, 2003)
* Japan guidelines under fire (added Aug. 23, 2003)
* Population health differs from public health (added Nov. 14, 2003)
* The charitable trust model for biobanks (added Dec. 28, 2003)
* A 500,000-person study? [in the USA] (added May 4, 2004)
* Newfoundland seeks control of its genes (added Nov. 16, 2004)
* Cancer in Families in Iceland (added Jan. 3, 2005)
* Investments in biobanks (added Apr. 13, 2005)
* The Genographic Project (added Apr. 14, 2005)
* Conference in Iceland, August 2004 (added Apr. 14, 2005)
* Analysis of the Icelandic Supreme Court judgement (added Oct. 22, 2005)
* Example of a 2006 publication from deCODE Genetics (added Jul. 26, 2006)
* deCODE sues former employees (modified Jun. 22, 2007)
* Icelandic fire (added Jan. 29, 2007)
* Iceland family tree (added Mar. 6, 2007)
* Connotea bookmarks matching tag biobanks (added Apr. 14, 2007)
* Genetic Test for Type 2 Diabetes (added Apr. 25, 2007)
* Consent for Genomic Epidemiology (modifed Jun. 27, 2007)
* American Cancer Society cohort study (modified Jul. 4, 2007)
* Genetic variations and increased heart attack risk (added May 5, 2007)
* Public Population Project in Genomics: P3G (added Jun. 15, 2007)
* Genome Quebec unveils biobank (added 28 Aug. 28, 2007)
* Wikipedia entry for deCODE Genetics (modified Sep. 26, 2008)
* Recent articles by David Winickoff (added Sep. 26, 2008)
* Canadian Partnership for Tomorrow Project (added Nov. 19, 2008)
* Ontario Health Study (updated Apr. 6, 2010)
* deCODE files for bankruptcy protection (updated May 11, 2010)
* Articles in Newsweek about deCODE (added Apr. 6, 2010)
* Amgem buys deCODE (added Dec. 11, 2012)
* Amgen claimed Big Data software prize in $415M deCODE buyout (added Apr. 1, 2013)
* Nordic Gene Study Requires Consent (added Jun. 25, 2013)
* Privacy on Ice:This company wants to collect DNA from one-third of Iceland’s population (added May 23, 2014)
* Iceland's genomes offer glimpse into mutations' varied effects (modified Apr. 7, 2015)
* In Iceland, Debate Simmers Over Imputed Genotypes, Preventive Medicine, and Public Health (added Jan. 15, 2016)
* Iceland's genetic goldmine, and the man behind it (added Apr 20, 2017)
* Another Iceland Experiment, on a "hydrogen economy" (modified Jul. 26, 2006)

Jim Till, Ph.D.
Joint Centre for Bioethics, University of Toronto
c/o The Ontario Cancer Institute
610 University Avenue, Room 9-416
Toronto, Ontario, Canada  M5G 2M9
Legislation in Iceland, passed on December 17. 1998, has given a
private company permission to build a central database of health
records for the entire nation.  The legislation, which has been very
controversial, poses some important ethical and legal issues that
are not unique to Iceland.
Return to Contents
1. Iceland's Health Sector Database
On January 22, 1999, I posted a message on the subject:
OT: Decoding Iceland to the Breast-Cancer discussion Group.
The text of the message was:                                      
There's a fascinating (to me) article in the January 18, 1999 issue of
the New Yorker (pages 40-51). The author is Michael Specter. The title
is: "Decoding Iceland", and the subtitle is: "The next big medical
breakthrough may result from one scientist's battle to map the Viking
gene pool". It's about Dr. Kari Stefansson, the founder of the
biotechnology company Decode Genetics in Iceland, and his plans to
create a giant electronic database in Iceland, which will allow his
firm to hunt for genes associated with many common diseases.
Three excerpts:
"... researchers discovered only one BRCA2 mutation in Iceland:
Einar's" [Einar was a sixteenth-century Icelandic cleric, who
transmitted a mutation in his BRCA2 gene to many descendants in
"Most genetic researchers agree that such a database could become a
scientific instrument of unparalleled power, but the proposal also set
off one of the most rancorous debates in the long history of Iceland".
"The legislation" [to enable the creation of the database, passed by
the Icelandic legislature on December 17, 1998, was, according to one
of its critics] "a totalitarian act which casts a dark shadow over
Iceland in the international scientific community".
The article illustrates vividly how the field of "genomics" is
presenting extraordinary scientific opportunities, and also
extraordinary social and ethical challenges.
For more information about the legislation in Iceland, please try the
website at: Act on a Health Sector Database no. 139/1998.  
There are also some notes I've assembled, that include material
about deCODE Genetics, at another webpage of mine, at:
At the end of this webpage (Part 1 of this set of notes on Research
Ethics and Genetics Research), the following links were attached:
[Note added Nov. 4, 2002: the original links are no longer
appropriate. Alternative links have been substituted]:
1) See: The Controversy:
An excerpt:
   "On December 17, 1999, the 123rd session of Althing, the Icelandic
   parliamentary house, passed the Act on Health Sector Database 139/1998
   by 37 votes to 20 (6 members abstained)". 
The company website for deCODE Genetics Inc. in Reykjavik was: 
[Note added Nov. 4, 2002: this website is no longer available.
The currnt website for deCODE Genetics is at:]
An excerpt from the "Questions & Answers" section of [the
earlier] website:
"What is the relationship between deCODE genetics and Hoffmann La Roche
and does it involve the centralized healthcare database?"
   "DeCode genetics is majority owned by Icelandic employees and investors
   and carries out research on many diseases in collaboration with
   Icelandic physicians and scientists. DeCODE genetics has sought and is
   still seeking to enter into corporate partnerships, and has a
   non-exclusive corporate deal with Hoffmann La Roche. This deal covers
   positional cloning projects for 12 common diseases. This deal does not
   cover any aspect of the proposed healthcare database".
2) For a version, in English, of the bill, "Act on a Health Sector Database":
[Note added Nov. 4, 2002: see Act on a Health Sector Database no. 139/1998]
Some selected excerpts:
From article 5:
   "The licence shall be temporary, and it shall not be granted
   more than 12 years at a time".
   "The licensee shall hand over to the committee cp. art. 6 a copy of
   the database, which shall be updated regularly, to be further
   specified in the licence. A copy of the database shall always be
   stored in a bank safety deposit box, or in some other secure manner,
   to be further specified in the licence".
   "The licensee shall ensure that after the expiry of the period of
   the licence, the Minister of Health and Social Security, or the party
   assigned by the Minister to operate the database, shall receive
   indefinite use of all software and right required for the maintenance
   and operation of the database".
From article 10:
   "The licensee is authorised during the period of the licence to use the
   data on the database for purposes of financial profit, under the
   conditions laid down in this legislation and the licence.
   The health service database may not be transported out of Iceland, and
   processing of it may only be carried out here in Iceland".
Return to Contents
2. What Are Some Of The Ethical Issues?
Martin Enserink, in an article published in SCIENCE (283: 13, Jan 1,
1999), identified three of the ethical issues raised by critics of
the bill:
1. Are the informed consent procedures appropriate?  Information will
be sent to the database unless the patient specifically requests that
this not be done.  (According to Enserink, some general practitioners
and specialists in Iceland have already pledged not to send information
to the database unless a patient specifically requests them to do so). 
2. Are the current safeguards enough to ensure privacy?  In a country
of less than 300,000 people, it's possible that just a few pieces of
data may be enough to reveal a person's identity (see another
article by Martin Enserink in SCIENCE 282: 859, Oct 30, 1998).
3. Should one company have commercial rights to information about a
whole nation's gene pool?  (For example, did, as some critics claim, 
deCODE Genetics have too much influence in drafting the bill?).
In a response to criticisms of the bill, also published in SCIENCE
(283: 487, Jan 22, 1999), Ragnheidur Haraldsdottir, Deputy Permanent
Secretary of the Ministry of Health and Social Security in Reykjavik,
"The bill has been harshly criticized, but it has also received
substantial praise for its progressive stance and its promise to
preserve human rights while facilitating scientific endeavors for
the benefit of health".
"Iceland has outstanding health statistics, a high quality of health
care, thorough patient and genealogy records, and a well-educated
public in favor of participating in an experience such as the one
proposed in the bill.  This situation imposes on us an ethical
obligation and gives us a unique opportunity to promote medical
"The ethical and legal issues under consideration are not unique to
Return to Contents
3. Some Concluding Comments (Feb. 4, 1999)
On the one hand, one should not try to impose the values of another
society on the population of an independent, democratic nation.
On the other hand, the issues under consideration are not unique to
Iceland (although Iceland, as a nation, may be unique in relation to
some of its characteristics ... especially those that led to the
establishment of deCODE Genetics, and to the formulation of the bill).
Suppose, for example, that some entrepreneurial company decided to try
to develop an analogous database that extended beyond any existing
national boundaries?  Suppose further that the focus of the database
was on the genetic and health records of a population that's not 
only relatively homogeneous from a genetic viewpoint (as in Iceland),
but also has been vulnerable in the past to exploitation,
discrimination, or prejudice?
These examples may illustrate some reasons why the "Iceland Experiment"
seems likely to continue to attract interest abroad. 
Return to Contents
Copyright 1999 by Jim Till
The text above was prepared on 4 February, 1999 [and last
modified on 4 November, 2002].
* Draft WHO guidelines (links added Apr. 1, 1999)
From: Nature, Volume 398, page 179, March 18, 1999
Re: Draft WHO bioethics guidelines:
   The draft guidelines are due to be presented to the general
   assembly of the WHO in May. They are likely to prove controversial.
   For example, they strongly support the rights of populations that are
   the subject of genetic research to have an "equitable share in the
   fruits of research, and a financial stake in any profits on resulting
   They demand that genetic research on populations should respect "group
   consent, confidentiality, and the protection of the group's identity,
   culture, reputation and traditional beliefs". And they call for all
   research results from human genome projects to be made public.
The 2 paragraphs above are excerpts from a news report at:
  • The draft guidelines are at:
  • Editorial comment is at:
  • Return to Contents ----------------------------------------------------------- * Opposition to Icelandic gene database (links added on May 21, 1999) World Medical Association opposes Icelandic gene database:
  • BMJ 1999; 318: 1096
  • Responses in BMJ
  • Another letter in BMJ Return to Contents ----------------------------------------------------------- * "The assent of a nation" (modified Nov. 3, 2002)
  • Article by J Gulcher & K Stefansson: "An Icelandic saga on a centralized healthcare database and democratic decision making", Nature Biotechnology 1999; 17(7):620 (July) [PubMed Abstract] An excerpt: "Since the company is majority-owned by Icelanders, most of the value that accrues to the company directly benefits Icelanders. The database will be a powerful instrument to use in the running of the Icelandic health care system. The database law stipulates that the Ministry of Health should negotiate for a share in any profit that may result from the database".
  • Article by JR Gulcher & K Stefansson: "Ethics of population genomics research", Nature 1999; 400(6742):307-308 (22 July) [PubMed Abstract] An excerpt: "Comprehensive genealogy is an essential tool for population genomics research".
  • Move to market gene pool angers Iceland's MDs: Article by Patrick Sullivan, in CMAJ 1999;161(3):305 (10 August) An excerpt: "... perhaps something like this could happen gradually without Canadians really taking notice of the small steps along the way".
  • The Icelandic database - do modern times need modern sagas?: Article by Ruth Chadwick in BMJ 1999;319(7207):441 (14 August) An excerpt: "The Icelandic database is considered to constitute a measure in the interest of public health --- but is it "necessary" for public health? This question needs to be answered, but if one of the justifications of the database is to test the extent to which the new genetics can deliver, it is not clear how it can be answered in the affirmative beforehand and thus provide a clear public health justification for overriding considerations of informed consent". Chadwick identified 5 relevant ethical issues, of which benefit was one. The others were informed consent, privacy, scientific freedom and commercial monopoly.
  • Article by MG McInnis: "The assent of a nation: genethics and Iceland", Clin. Genet. 1999;55(4):234-239 [PubMed Abstract] An excerpt (from page 237): "The Icelandic law provides for protection of the rights of privacy regarding disclosure of information, and they presume this obviates the need for informed consent. This is the basic flaw in the legislation. It is therefore certain the Icelandic legislation will be appealed to the European courts where it will be determined if it is both within the context and spirit of the law. The outcome will have a major impact on the future of the collection and maintenance of medical research data". The article by MG McInnis provides some relevant links. Two examples:
  • Ref. 11: Mannvernd (via menu page): [was:]: Association of Icelanders for Ethics in Science and Medicine [see: Mannvernd home page]
  • Ref. 15: Ross Anderson The DeCODE Proposal for an Icelandic Health Database
  • Bibliography/self-help kit for studying the HSD deCODE controversy: Compiled by Skúli Sigurdsson (primarily until May 2001, less systematically thereafter). Return to Contents ----------------------------------------------------------- * Iceland Review (plus links added on Mar. 21, 2000)
  • Note added August 22, 2003: The web address for the Icelandic Review is now
  • Iceland Review: See the Back Issues of the Daily News section for updates about deCODE Genetics, and about the Iceland Genomics Corporation and its subsiduary in Iceland named UVS.
  • Start-Up Claims Piece of Iceland's Gene Pie Article by Martin Enserink in Science 2000 (11 Feb); 287 (5455): 951 Excerpts: "Now, a small biotech start-up is providing an alternative for those critics who want to mine Iceland's genetic riches but dislike the arrangement with deCODE." "Says Stefansson: "For me, it's a relief to have another company, so I'm not accused of monopolizing" Iceland's gene pool."
  • U.K. Plans Major Medical DNA Database Article by Michael Hagmann in Science 2000 (18 Feb); 287 (5456): 1184 Excerpts: "Following the examples of Iceland, Sweden, and Estonia, the United Kingdom is drawing up plans to create a national database linking the DNA of 500,000 of its citizens to their medical records and lifestyle details." "It's basically a very large-scale epidemiological study" Return to Contents ----------------------------------------------------------- * "Sale of the century" (added Jun. 15, 2000)
  • Sale of the century: New Scientist 2000 (19 February); 165 (2226): 3 Excerpts: "In return for the nation's DNA, deCODE will supply Iceland with any drugs developed from the database free of charge. In a similar deal, Gemini has agreed to pay royalties on any commercial developments from its database to a foundation for the benefit of the people of Newfoundland and Labrador. Are these reasonable returns for the wealth the databases will generate? Britain's database will initially be operated by the MRC and the Wellcome Trust, two organisations that plough profits back into biomedical research. What happens, though, if they decide to sell off this lucrative product?"
  • Rules for Research on Human Genetic Variation -- Lessons from Iceland: 'Sounding Board' article by the U.S. bioethicist George J. Annas, in The New England Journal of Medicine 2000; 342 (24, June 15): 1830-1833 An excerpt: "Iceland's experience with deCODE provides a useful catalyst for formulating fair and ethical rules for research on genetic variation. The Icelandic experience demonstrates that people are concerned about how genetic research is done, that medical-records research and DNA-based research are not the same, that community consultation is necessary but not sufficient to justify DNA-based research ethically, that the probable benefits of such research should be spelled out as clearly as possible, and that international standards for consent to and withdrawal from research should apply directly to research on human genetic variation".
  • The Icelandic Healthcare Database and Informed Consent: 'Sounding Board' article by Jeffrey R. Gulcher & Kari Stefansson of deCODE genetics, in The New England Journal of Medicine 2000; 342 (24, June 15): 1827-1830 An excerpt: "The question of the distribution of knowledge and the need for a free flow of information is important. We should all do our best to make certain that scientific discoveries in medicine are quickly and widely distributed. The primary goal is to use medical discoveries to develop better methods to diagnose, prevent, and cure diseases. Today, this often requires that an intellectual property be secured, which may delay publication of a discovery. The choice between early publication and the development of a product for the benefit of patients with a particular disease is, in our minds, an easy one. More often, however, these two goals go hand in hand, and no choice has to be made". Return to Contents ----------------------------------------------------------- * "What's in it for me?" (added Aug. 5, 2000, updated July 18, 2002)
  • The Gene Trust Project A database project of DNA Sciences An excerpt from the Gene Trust FAQ (accessed August 5, 2000): "What's in it for me? The excitement and satisfaction that you played a part in medical history. We are looking for volunteers that want to be a part of something that is very big and very important: understanding what all of our genes do. We also want people who want to help others. Because of the tremendous cost of doing this research, DNA Sciences is not paying people to participate. However, if you contribute information to one of The Gene Trust studies, and that study leads to a diagnostic test that might help you, you will be notified and have access to that test - free of charge. You will also receive updates on the status of our studies. You will receive all published material that comes from The Gene Trust". Return to Contents ----------------------------------------------------------- * deCODE has successful initial public offering (updated Jan. 26, 2010)
  • Human resource: Article by Sarah Staples in Report on Business Magazine 2000; 17(3) September: 117. Subtitle: "Newfoundland's 300-year-old genetic legacy has triggered a gold rush" An excerpt: "...deCODE Genetics Inc., a company that is studying the highly homogeneous population of Iceland - some 270,000 descendants of ninth-century Norse and Celtic settlers - raised $172.8 million (U.S.) in July with an initial public offering on the Nasdaq Stock Market. Shares of the four-year-old firm shot up by 41% from their issue price of $18 on the first day of trading". See also:
  • deCODE offered on the Nasdaq: From: Daily News from Iceland, July 19, 2000: the stock opened at USD 29.5 per share, jumping to a high of 31.5 before it closed at 25.4
  • deCODE Launches Initial Public Offering of Common Stock: Via the deCODE Genetics website, about the IPO on July 17, 2000. deCODE Genetics (DCGN) stock price on NASDAQ: Close on Sep. 1, 2000 was USD 27 1/2 [Close at the end of 2000 was USD 10 1/2 (high 31 1/2, low 8 15/16)] [Close at the end of 2001 was USD 9.80 (high 31.00, low 5.28)] [Close at the end of 2002 was USD 1.85 (high 10.30, low 1.55)] [Close at the end of 2003 was USD 8.19 (high 9.74, low 1.70)] [Close at the end of 2004 was USD 7.81 (high 13.80, low 5.10)] [Close at the end of 2005 was USD 8.26 (high 10.67, low 5.09)] [Close at the end of 2006 was USD 4.53 (high 10.77, low 4.08)] [Close at the end of 2007 was USD 3.68 (high and low not noted)] [Close at the end of 2008 was USD 0.185 (high 3.96, low 0.15)] [Close at the end of 2009 was USD 0.140 (high and low not noted)] On November 16, 2009, DGI Resolution, Inc. (formerly known as deCODE genetics, Inc.) filed a voluntary petition for relief under chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware. [Added Nov. 4, 2002]:
  • deCODE Investigation: From: Daily News from Iceland, Oct. 31, 2002: [Iceland Review_Online is at: (free registration is available)] Daily News, 2002.10.31 - An excerpt: "Sverrir Hermannsson, the leader of Iceland’s Libertarian party, has suggested that a nine member panel, appointed by parliament, look into the relationship between deCODE and the government, which both encouraged state-owned companies, along with individuals, to purchase large amounts of deCODE stock". Return to Contents ----------------------------------------------------------- * Database in Estonia (modified Nov. 3, 2002)
  • Estonian Genome Project.
  • Estonia Prepares for National DNA Database Article by Lone Frank in Science 2000; 290(5489) Oct 6: 31. An excerpt: "If a nation's most valuable resource is its people, then how precious are its people's genes? For this tiny Baltic state, the opening bid lies somewhere between $100 million and $150 million. That's how much money Estonia expects to raise for a project, set to begin next year, that would compile DNA profiles and health information on 75% of the country's 1.4 million citizens. Officials hope that the database will not only allow researchers to track down disease genes and improve health care but also boost Estonia's budding biotechnology sector".
  • Gene Pool Expeditions: Estonians or subjects of the crown of Tonga: Whose gene pool hides gold? Article by Tom Hollon in The Scientist 2001(19 Feb); 15(4): 1. An excerpt: "Tonga and Estonia laid final plans last November and December [2000], respectively, for national gene pool exploration programs aimed at discovering disease-associated genes and developing therapies based on the discoveries". Return to Contents ----------------------------------------------------------- * Financial data about deCode Genetics (updated Jan. 1, 2007)
  • Financial data about DeCode Genetics (DCGN): Via Yahoo Financial.
  • Financial data about DeCode Genetics (DCGN): Via Google.
  • Chart for DeCode Genetics (DCGN): Via Return to Contents ----------------------------------------------------------- * "Informed consent" and "assumed consent" (added Aug. 16, 2001)
  • Consent in genetic research in Iceland: Article by Pétur Hauksson, Chair, Mannvernd, the Association of Icelanders for Ethics in Science and Medicine, in Language Perils™. Return to Contents ----------------------------------------------------------- * Tonga gene pool (updated Dec. 20, 2002)
  • Australian company buys rights to Tonga gene pool Article by Megan Howe in The Lancet Oncology, 2001(January); 2(1). Some excerpts (the article is freely available, but registration is required): "An Australian genomic biotechnology company has signed a deal which gives it the right to access the entire gene pool of the small South Pacific Kingdom of Tonga, in its bid to uncover the genes which predispose people to diseases including cancer, diabetes and obesity. Autogen Ltd announced in November that it had struck the deal with Tonga's Ministry of Health, giving it access to DNA samples volunteered by the island's 108,000 population of mainly Polynesian descent". "The agreement states that any serum or DNA samples collected in Tonga will remain the property of Tonga and Autogen will establish a health database and a major research facility on the island". "In return for access to the samples and data, the company will provide annual research funding to Tonga's Ministry of Health and will pay royalties on revenue generated from any discoveries that are commercialised. Autogen director of research and development Greg Collier, who described the deal as a 'win-win situation' for Tonga and the company, said there was no 'exclusivity' clause in the deal, despite media reports to the contrary". "[Grant] Sutherland, Director of the Cytogenetics and Molecular Genetics at The Women's and Children's Hospital, Adelaide, said there did not appear to be any major ethical concerns about the Autogen project, because it would rely on Tongan citizens volunteering to provide DNA samples".
  • Opposition Stalls Genetic Profiling Plan for Tonga: Article by Bob Burton in Common Dreams News Center, February 18, 2002.
  • Proposed genetic database on Tongans opposed: Commentary by Bob Burton in BMJ 2002(23 Feb); 324(7335):443. Some excerpts: "While the company's board boasts some political heavy hitters, it failed to anticipate that the secretly negotiated agreement would encounter opposition from those advocating a more accountable government in the Pacific's only remaining monarchy." "Autogen's statement on ethics emphasised prior informed consent of individual volunteers but remained mute on the traditional Tongan role of the extended family in decision making." [There have also been objections] "to the conversion of God-created "life-forms, their molecules or parts into corporate property through patent monopolies." "The chief scientific officer of Autogen ... insisted that the company had no immediate plans for research work in Tonga and was concentrating its resources in the Australian state of Tasmania: "In Tasmania it is easier for us to find families and work with them more easily."
  • Whose DNA? Tonga & Iceland, biotech, ownership and consent: Co-presented by Lopeti Senituli and Margaret Boyes, at the Australasian Bioethics Association Annual Conference, Adelaide, February 14-16 2002. The final two sentences of the presentation by Lopeti Senituli are: "We really cannot afford to go back to the frontier days when it was open season on all things indigenous to the Pacific Islands including Australia. Instead we must build on the new foundations found in the Mabo and Wik decisions which the Australian High Court handed down in the early 1990s. That is the way forward."
  • Autogen: Home page of Autogen Ltd. Return to Contents ----------------------------------------------------------- * Newfound Genomics (modified Jul. 28, 2002)
  • Newfound Genomics: The home page of Newfound Genomics: "Newfound Genomics is a genomics research company based in Newfoundland and Labrador working to gain a better understanding of the relationship between genes, human health and disease". See also: Newfound Genomics: About Us: Two excerpts: "Research conducted by Newfound Genomics could eventually contribute to medical breakthroughs that benefit Newfoundlanders and Labradorians, their children, and their children's children. In fact, people all over the world could benefit from this research". "Newfound Genomics is performing this research through the collection of DNA samples, and supporting medical information from donor volunteers". And: Newfound Genomics: Partnerships: Newfound Genomics is affiliated with Sequenom [of San Diego], see: Sequenom, [also accessible via:].
  • About Us [Sequenom]: An excerpt: "By focusing on disease genes with a broad population impact, SEQUENOM expects to play a critical role in bringing new therapeutic products to the market while maximizing the return on drug development". Return to Contents ----------------------------------------------------------- * Human Genome Diversity Project (modified Jul. 28, 2002)
  • The genetic saga of Icelanders: Palsson G, GeneLetter 2(17), August 15, 2001. An excerpt: "Failing to recognize the historically-embedded debates in which the project was set, including debates on collective rights and identities, the Human Genome Diversity Project stumbled when confronted by indigenous groups". "As long as bio-political issues are not seriously addressed, such embarrassments will remain routine. Perhaps, the problems encountered by the recent attempt to trace the saga of Icelanders similarly illustrate the consequences of the failure to address social context".
  • Human Genome Diversity Project: Model Ethical Protocol for Collecting DNA Samples: These guidelines were published in the Houston Law Review 33(5): 1431-1473 (1997, with the addition of the first title word "Proposed").
  • Iceland's Blond Ambition: An article by by Eliot Marshall in Mother Jones magazine, May/June 1998. An excerpt: "While gene collection is moving along at a rapid pace in Europe and the United States, some attempts to collect genes from less developed countries have backfired". Return to Contents ----------------------------------------------------------- * UK Biobank (updated Nov. 14, 2003)
  • Welcome to the UK Biobank: Website of the UK Biobank.
  • House of Lords supports first UK genetic database: Article by Annabel Ferriman in BMJ 2001(31 Mar); 322(7289): 755 Some excerpts: "The database, to be known as the UK Population Biomedical Collection, will hold details of 500000 men and women volunteers, aged 45-64, including basic measurements, such as height, weight, and blood pressure, together with details of medical history and lifestyle from questionnaires". "Follow up data on the participants' health and lifestyle would be collected over succeeding years, and genetic analyses would be carried out on the volunteers by separate research groups, although the results would be held centrally to increase the value of the resource". See also:
  • UK gene bank a step closer: Article in The Scientist (21 February 2001). An excerpt: "But anybody considering volunteering for the study in the hope that they would be tipped off if they were found to be at risk of developing a serious health problem will have to think again. Direct feedback of results to individual members of the study population is not a possibility".
  • The UK Biobank study gets funding go-ahead: Joint news release (29 April 2002). An excerpt: "The Wellcome Trust, the Medical Research Council and the Department of Health are providing an initial £45 million for the UK biobank project - a study of genes, environment and health".
  • UK Biobank: A study of genes, environment and health: Via the website of The Wellcome Trust.
  • Public Attitudes to Participating in BioBank UK: Abstract by D. Shickle and colleagues, for the 3rd International DNA Sampling Conference, Montreal, September 5-8, 2002. An excerpt: "Most people were happy to be only asked once for consent for access to their medical records, however, there was a preference for permission to be sought annually".
  • BioBank UK: "The Wellcome Trust (WT) and the Medical Research Council (MRC) commissioned People Science & Policy Ltd to conduct a public consultation about the ethical and management issues surrounding the proposed BioBank UK project". Two excerpts: "...there remained concern that companies should address major healthcare issues and not just focus on "profitable diseases". "Some were also keen that their descendants should have access to the samples in case it could help with future family diseases that are found to be genetic".
  • Doctors warned to press for safeguards before collecting patients’ genes: Press release from GeneWatch, January 14, 2002. An excerpt: "There are clear dangers as well as potential benefits from this type of research. The Government must first ensure that people’s genetic information cannot be abused".
  • Ethical Concerns at the DNA Bank: An article in Wired News by Dermot McGrath, May 6, 2002. An excerpt: "GeneWatch’s Wallace said that aside from concern about how genetic information might be used as the basis for patent applications by commercial interests -- as happened recently in Iceland -- there were also very real doubts about any benefits to public health that might result from the research". For the reference for the comment "as happened recently in Iceland", see: Iceland's Genes Frozen in Time. An excerpt: "...Stefansson is confident DeCode will secure patents since his discoveries include information highlighting pathways that link genes to disease".
  • Gene-environment interactions--the BioBank UK study: An article by Wright AF, Carothers AD, Campbell H, in Pharmacogenomics J. 2002;2(2):75-82 [PubMed citation] This article is of particular interest from epidemiological and statistical perspectives. Two excerpts: "The goal is not gene discovery but the identification of interactions between identified genes and environmental factors of public health significance". "The situation with pharmacogenetic responses may be considerably more favourable, since the complexity of genetic effects influencing drug responses is likely to be less than with susceptibility to complex disorders such as coronary artery disease or hypertension".
  • UK launches tumor bank to match maligned Biobank. Spinney L., Nat Med. 2003 May;9(5):491. [PubMed Abstract]. An excerpt from the text: "A report from the House of Commons' Science and Technology Select Committee, published 25 March, slammed the MRC's allocation of funds and raised ethical concerns about Biobank, such as police access to the database. Critics of the project have recommended that legal safeguards be put in place to protect volunteers before recruitment begins, and that volunteers be made aware of the risks. They also recommend that the government invest in research into encryption techniques to ensure the data is secure". Return to Contents ----------------------------------------------------------- * Website for the Ministry of Health and Social Security (added Jul. 28, 2002)
  • Icelandic Health Sector Database: Links to information about the Health Sector Database, via a webpage of the Ministry of Health and Social Security, Reykjavik, Iceland. Return to Contents ----------------------------------------------------------- * Questions of bioethics raised in Sweden (updated Sep. 27, 2003)
  • News item on the Mannvernd webpage (dated 20 Sep. 2002): "Controversy and questions of bioethics raised in Sweden: Sweden's Uman Genomics and Umea University strike an agreement over biomaterial": "Latest update: The agreement allows non-commercial research on the condition that Uman Genomics in each case is guaranteed that no competing commercial interests utilize the biobank. Independent basic research, both in Umeå and the rest of Sweden (this is vague), can after applying and the bioethics committee’s authorization, obtain access to the specimens, but problems can ensue in cases where the free scientist and Uman Genomics compete for the same specimens, where resources are limited".
  • An ethical dilemma. Hilary Rose, Nature 2003(11 Sep); 425: 123-4. A well-informed commentary on "The rise and fall of UmanGenomics - the model biotech company?". [Unfortunately, not openly accessible]. Two excerpts from the end of the commentary: "Less glitzy than the admired ethical model, a social- entrepreneurial approach might have been able to develop slowly and steadily from the existing research base using both public and foundation money. This could have been helpful after the NASDAQ crash, which left venture capital chary of biotechnology. Non-commercial status, broadly echoing that of Britain's Biobank UK - with the difference that Biobank Umeå would have been very locally rooted - could have had advantages". "A bottom-up project could bypass [the problem of ensuring adequate up-front financing], growing within its strength, building on the existing biobank resource, and expanding flexibly to meet scientific and commercial opportunities as they arise. In addition, a social-entrepreneurial model would have enabled biobank research to be attentive to the interests of all, and not just some, of the stakeholders. As Umeå - company, county and university - has sadly learnt, failing to keep all the stakeholders on board is expensive". UmanGenomics (English): Return to Contents ----------------------------------------------------------- * Website for Mannvernd (modified Nov. 3, 2002)
  • Association of Icelanders for Ethics in Science and Medicine: The home page of MANNVERND, the organized opposition to the Icelandic government's Act on a Health Sector Database (HSD). This site provides access to: Latest news and articles; Status of lawsuits (against the HSD Act and related matters); Graph of "opt-outs" from Icelandic HSD (about 7% of the nation, as of 18 Sept. 2002). An example of news available via the Mannvernd website (dated 27 May, 2002): "Iceland's Plan for Genomics Research: Facts and Implications. Henry T. Greely. Jurimetrics 40: 153-191 [2000]". It's noted in the abstract that the author examines "five objections to the law authorizing the database, based on commercialization, lack of informed consent, risks to privacy, the effects on other research, and financial unfairness". The author concludes that "the Icelandic model is not a good precedent for similar research elsewhere".
  • PDF of an article by Hilary Rose: The commodification of bioinformation: the Icelandic Health Sector Database. Wellcome Trust, London, 2000.
  • Genetics Scandal Inflames Iceland: An article in Wired News by Kristen Philipkoski, March 20, 2000. A quotation in this article, attributed to Mike Fortun, an ethicist and professor of science and technology studies at Rensselaer Polytechnic Institute in Troy, New York, who attended a Mannvernd meeting held in March of 2000: "While I very much believe in the promise of commercial genomics, I also believe that that promise has to be analyzed and conducted very differently according to the local circumstances you have". Return to Contents ----------------------------------------------------------- * Quebec Founder Population (updated Nov. 16, 2003)
  • Founder Populations Fuel Gene Discovery Article by Ricki Lewis in The Scientist 2001(16 Apr); 15(8): 8. Three excerpts: "Families have traditionally been used to track monogenic traits, but population-based association studies are more efficient to investigate polygenic traits". "Galileo Genomics, in collaboration with Myriad Genetics of Salt Lake City, is pursuing depression, obesity, and cardiovascular diseases that are complex, which means that they can be attributed to genetics and environmental influences". "In the 19th century, agricultural lands opened up about 150 miles north of Quebec, in the Charlevoix and Saguenay, Lac-St.-Jean (SLSJ) regions. Families migrated north, and their descendants form an incredibly genetically homogeneous subpopulation of founders split off from the original set of founders. 'It is estimated that the population of SLSJ of approximately 300,000 people, roughly the same size as the Icelandic population, has descended from some 600 effective founders of the Charlevoix region, compared to 8,000 to 20,000 founders of Iceland,' says Douville [of Galileo Genomics, Inc.]".
  • According to the "Research: Quebec Founder Population" section of the Galileo Genomics website, the Quebec founder population, because of its relatively young depth in generations (12-16), limited numbers of founders (~2,600), and very large current size (6 million), is one of the best populations in the world for detection of the presence of specific disease genes. Other examples of founder populations are Icelandics, Finns (new settlements), Sardinians, Polynesians, Amerindians, Costa Ricans (from the central valley) and members of certain religious groups such as the Amish, Mormons and Ashkenazi Jewish populations from Eastern Europe. Of these other examples, Costa Ricans and Finns, like Quebecers, are most closely in conformance with proposed "ideal" criteria.
  • Galileo Genomics Secures Funding Article by Dick Eastman, via the website (17 October, 2001). An excerpt: "The contribution of Quebecers to this cause is likely to be substantial, and we look forward to working with our fellow Quebecers in this endeavor. In recognition of this, Galileo is establishing a trust fund for the benefit of Quebecers which will receive three per cent of the company's net profits." Return to Contents ----------------------------------------------------------- * Genomics Collaborative Inc. (added Sep. 13, 2002)
  • CGI information for research collaborators: GCI claims to have "...the world's largest industrial repository of appropriately consented DNA, serum and tissue samples, linked to detailed medical information." Some other information, via GCI's website: "GCI is a privately funded, for-profit genomics company...". "Informed consent and patient rights are key to CGI's operations...". Our Science, Our Collections: An excerpt: "Given the nature of the genetic variants predisposing to common human diseases, it is clear that large-scale association studies are vital to advances in medical understanding. By comparing patterns of variation at hundreds of locations in the human genome, in thousands of individuals, we will be able to find the key genetic changes that predispose humans to disease. It is imperative that these significant associations be confirmed in geographically and ethnically diverse populations, and international sample collections are, therefore, a key part of our effort. Finally, it is clear that temporal data are necessary to tease apart the mechanisms of disease progression, and, consequently, we have ongoing longitudinal collections in most disease states." "Emerging Company Profile (of CGI): by Mary Stuart, July 2001 (PDF, 4 pages). Return to Contents ----------------------------------------------------------- * DNA Bank for Clinical Trials (added Nov. 3, 2002)
  • Department of Veterans Affairs Cooperative Study Program (USA): Abstract of an article on "Principles, organization, and operation of a DNA bank for clinical trials: a Department of Veterans Affairs cooperative study", by Lavori PW, et al., Control Clin Trials 2002(Jun); 23(3): 222-239 (H.T. Greely is one of the co-authors).
  • PDF of a review by H.T. Greely: Informed consent and other ethical issues in human population genetics, Annu Rev Genet 2001; 35: 785-­800. Return to Contents ----------------------------------------------------------- * WMA declaration (modified. Dec. 20, 2002)
  • The Ethics of Health Sector Databases: Provides access to a commentary by Jon Snaedel of the Icelandic Medical Association, in the journal eHealth International, September 2002 (PDF, 6 pages). Some excerpts; "One of the difficult issues to solve is that patients' rights regarding the use of health information does not go against the interest of all". "Databases on cancer have been used for a long time in some countries without them being questioned. Should patients have the right to oppose a transfer of information on their cancer to such a cancer register?". "The case is different for databases that are only used for research". "The expected WMA declaration will have great influence on the progress of this cause in international context ...".
  • WMA Declaration: The World Medical Association Declaration on Ethical Considerations Regarding Health Databases (Adopted October 2002). Return to Contents ----------------------------------------------------------- * Access and Benefit Sharing (modified Dec. 23, 2002)
  • Attention Shoppers: Special Today -- Iceland's DNA: Article by Jeffrey P. Kahn, available via the CNN Interactive website. An excerpt: "It is ironic that such exclusive licensing deals make the quintessentially public resource into a private commodity, and may end up denying access to its benefits to the very individuals whose DNA make discoveries possible".
  • Population genetics and benefit sharing: Abstract of an article by B.M. Knoppers in Community Genet 2000(May); 3(4): 212-214.
  • Community consent versus individual consent: "There's now increasing interest in how local communities might benefit from agreeing to participate in "gene discovery" efforts". The above sentence is excerpted from a letter posted in response to an article in the BMJ 2002 (12 Oct); 325(7368): 796, Developed countries should not impose ethics on other countries. All of the electronic responses to this article are available via: Read all Rapid Responses.
  • Access & Benefit Sharing: Via the website of Genetic Resources Action International. This webpage provides (for example) a PDF of the ASEAN Framework Agreement on Access to Biological and Genetic Resources (2000, draft).
  • Indigenous Peoples Council on Biocolonialism (IPCB): "The IPCB is organized to assist indigenous peoples in the protection of their genetic resources, indigenous knowledge, cultural and human rights from the negative effects of biotechnology. The IPCB provides educational and technical support to indigenous peoples in the protection of their biological resources, cultural integrity, knowledge and collective rights". This webpage provides access to "Resolutions by Indigenous Peoples", including a Model Resolution for Tribal Governments.
  • Canada NewsWire release, September 8 2002: The release is about the Third International Conference on DNA Sampling in Montreal, and a Proposed Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations. The latter "could serve as a model for research involving populations around the world". Le Réseau de médecine génétique appliquée du Québec: Provides access to a Proposed Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations Version 2002 (PDF) An excerpt (from Recommendation 7, on Commercialization): Benefit Sharing * The eventual sharing of any benefits with the population should be discussed at the outset. This sharing could take different forms such as: an access to medical care, to future treatments or drugs developed; a contribution of a portion of the benefits to a humanitarian organization; support for local needs, or support for technological infrastructures or health services to the population, etc. * Benefit sharing cannot be limited to the individuals who participated. The research must, in consideration of the principle of equity, provide advantages for the whole population.
  • Fair Benefits for Research in Developing Countries: Article in Science 2002(13 Dec); 298(5601): 2133-4, by the Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Two excerpts: "An independent body, such as the World Health Organization, could establish a central and publicly accessible repository of all the formal and informal benefit agreements of previous studies." "Over time, such a central repository and the community consultations would generate a collection of critically evaluated benefits agreements that would become a kind of "case law" generating shared standards of fair benefits." Return to Contents ----------------------------------------------------------- * The Quebec-based CARTaGENE project (added Jan. 2, 2003)
  • Biobanks. Population databases boom, from Iceland to the U.S.: Article by Jocelyn Kaiser in Science 2002(Nov 8); 298(5596): 1158-61. An excerpt: "Researchers in Quebec are seeking funding for a $19 million, 5-year project that would initially enroll 50,000 adults, says Claude Laberge of the University of Laval in Quebec City".
  • Human Population Genetics/Genomics Workshop: Report dated September 11, 2001, of a strategic planning workshop held in Aylmer, Quebec, jointly sponsored by Genome Canada and the CIHR Institutes of Genetics (IG) and Population & Public Health (IPPH). The report provides examples of data sets that are presently in place in Canada, or under development (including the Quebec-based CARTaGENE project). Return to Contents ----------------------------------------------------------- * The Alberta-based Tomorrow Project (modified Jul. 16, 2003)
  • The Tomorrow Project: Three excerpts: "The Tomorrow Project is a long term population-based study looking at the connection between lifestyle and cancer. In partnership with 50,000 Albertans who have never had a diagnosis of cancer, we hope to learn about the factors that are present when people remain healthy and when cancer occurs. The participants in the study are men and women between the ages of 35 - 69 from all parts of Alberta. They will contribute information to the research study about their health, lifestyle and occurrence of illnesses over a long period of follow-up to the age of 85". "As well, the possibility of enhancing the power of an Alberta cohort exists if other Canadian provinces build on our experience by establishing comparable cohorts that can be combined for analyses of important research questions". "Another feature of the study is the collection of biologic material from cohort participants. Collection and storage of biologic samples will enable future researchers to examine gene-environment interactions ..." Return to Contents ----------------------------------------------------------- * DNA databanks and consent (updated Sep. 27, 2003)
  • DNA databanks and consent: A suggested policy option involving an authorization model: Timothy Caulfield, Ross EG Upshur and Abdallah Daar BMC Medical Ethics 2003; 4: 1 An excerpt: "The value of recognizing that existing consent norms are incapable of accommodating much of the research associated with DNA data banks is that it forces policy makers and the public to confront the social tradeoffs inextricably linked to this work. If we are to adhere to the well-established consent norms, a good deal of population research may not occur. On the other hand, if we abandon the current consent model, research participants will be giving up well established rights and a degree of control. By recognizing the choice, society can more clearly debate the benefits and risks of each course of action".
  • Genetic databank launches ethics framework: Kathryn Godfrey, BMJ 2003(27 Sep); 327: 700 Three excerpts: "The UK Biobank, an organisation that plans to collect genetic data from half a million volunteers aged 45-69, has launched a draft ethics and governance framework to address concerns such as confidentiality and the use of its data". "Gene Watch UK continues to be concerned about the relationship between commercial interests and Biobank and is unhappy about the use of a general form of consent". "The draft framework is open to comments for a month, after which it will be adopted by UK Biobank". The framework can be seen at: Return to Contents ----------------------------------------------------------- * Negotiations with National-University Hospital (added Mar. 29, 2003)
  • Genes and ownership: Provides access to: "Decoding broken promises" (by Skúli Sigurdsson, 6-3-2003) An excerpt: "What we do know is that the Icelandic Data Protection Commission (DPC) and deCODE have not reached an agreement on the adequacy of security measures for the HSD. Moreover, negotiations between deCODE and the National-University Hospital in Reykjavík, the largest hospital in Iceland, leading to the construction of the HSD have been postponed indefinitely according to a letter from Dr Kári Stefánsson, CEO of deCODE, to the Director of the National-University Hospital (14 October 2002). As the hospital serves more than half of the population, this postponement effectively signals the end of the HSD project in its current form". Return to Contents ----------------------------------------------------------- * Genetic heterogeneity of Icelanders(?) (updated Nov. 16, 2003)
  • Genetic heterogeneity of icelanders: Abstract of an article by E. Arnason, in Ann Hum Genet 2003(Jan); 67(Pt 1): 5-16. The final sentence of the abstract is: "Claims about special genetic homogeneity of Icelanders are not supported by evidence".
  • A populationwide coalescent analysis of Icelandic matrilineal and patrilineal genealogies: Abstract of an article by Helgason A, Hrafnkelsson B, Gulcher JR, Ward R, Stefansson K (deCODE Genetics), Am J Hum Genet. 2003(Jun); 72(6): 1370-88. An excerpt: "...we traced the matrilineal and patrilineal ancestry of all 131,060 Icelanders born after 1972 back to two cohorts of ancestors, one born between 1848 and 1892 and the other between 1798 and 1742. This populationwide coalescent analysis of Icelandic genealogies revealed highly positively skewed distributions of descendants to ancestors, with the vast majority of potential ancestors contributing one or no descendants and a minority of ancestors contributing large numbers of descendants". Return to Contents ----------------------------------------------------------- * Comparison of Genebanks (updated Nov. 28, 2003)
  • Genebanks: a comparison of eight proposed international genetic databases: Abstract of an article by Melissa A. Austin and colleagues, Community Genet. 2003(Apr); 6(1): 37-45. Proposed genebanks located in Iceland, the UK, Estonia, Latvia, Sweden, Singapore, Quebec and the Kingdom of Tonga are compared. A sentence taken from p. 43: "Groups such as Genewatch UK and Liberty argue that genetic information is itself a personal identifier, and therefore can never be kept truly confidential [19, 37]." Reference 19 is to Liberty. At this website, there's a link to a report, 'Whose Hands on your Genes?': Liberty response to Human Genetics Commission's discussion document on the storage, protection and use of personal genetic information, March 2001 (PDF, 84 kb), available via: Policy Papers 2001. An excerpt from Section 7.3 of this report: "...if it is intended to take a tissue sample not just for an immediate research project but for storage for research perhaps many years or decades away, the institution obtaining the sample and storing it should make it absolutely clear to the individuals donating the tissue whether or not the institution will directly profit from any information obtained from research. If it intends to profit by the research (i.e.: sell the research results or information derived from them to commercial organisations) it must have specific consent for that purpose". Ref. 36 in the article by Austin et al. is to GeneWatch. At this website, the section on Human Genetics provides information about Biobanks in general, and includes Giving Your Genes to BioBank UK - Questions to Ask. An example of a question included in the FAQ: What are the pros and cons of the biobank approach? The last sentence in the 1st paragraph of the answer to this question is: "If we want this type of research, we need to make sure it delivers real benefits and at no cost to the volunteers who take part."
  • Monitoring ethical, legal, and social issues in developing population genetic databases: Abstract of an article by Austin MA, Harding SE, McElroy CE, in Genet Med 2003(Nov-Dec); 5(6): 451-7. Two excerpts from the abstract: "We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection". "... there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks".
  • Common-pool resources and population genomics in Iceland, Estonia, and Tonga. Barker JH, Med Health Care Philos. 2003;6(2):133-44. The concluding sentence of the [PubMed Abstract]: "The paper discusses the degree to which the ethical demands for trust and public trust have been established and maintained in the three national population genomics projects". [The three are in Iceland, Estonia and Tonga]. Two excerpts from the text (p. 140): "The cultural and historical trajectories that separate Iceland and Estonia are many, including their very different experience in World War Two and especially in the post-war period". "That the Estonian debate has focused on the potential for genetic blackmail (among other things) while the Icelandic debate has focused on privacy is important, though equally important is the care with which the Estonian project attempts to prevent abuse. The Estonian example appears to attempt the creation of trust and public trust so important to an ethics of the interhuman. The success of this effort is yet to be seen". Return to Contents ----------------------------------------------------------- * Race cannot be defined by genes (added Aug. 13, 2003) "Ethnicity puts clinical trials to the test", Amy K Erickson, Nature Medicine 2003 Aug; 9(8): 983. [PubMed reference]. [Full text] (free registration is required). An excerpt: "In May, Howard University announced plans to create a database of functional mutations linked to diseases common in blacks (Nat. Med. 9, 809; 2003). But race cannot be defined by genes, argues Troy Duster, a sociologist at New York University. "Once we head down this road of collecting genetic material for different groups, we face a real danger of slippage into the notion that there is a set of genetic differences between groups," Duster says. Proponents of the database maintain that it will provide much-needed information about blacks." Return to Contents ----------------------------------------------------------- * Japan guidelines under fire (added Aug. 23, 2003) Japan Guidelines Under Fire After Protest Halts Study Dennis Normile Science 2003(Aug 22); 301(5636): 1039. Two excerpts: "In its 16 July letter to the Minister of Education, JMA [Japanese Medical Association] specifically mentioned a ministry-sponsored Biobank that will contain genetic information on 300,000 individuals as well as the international Haploid Map project, which originated at the U.S. National Institutes of Health. Like similar biobank projects in other countries, Japan's hopes to link single- nucleotide polymorphisms to diseases and adverse drug reactions as a step toward tailoring medical treatment to genetic characteristics ...". "The charges are unfounded, says the Biobank's principal investigator, Yusuke Nakamura, a physician and geneticist at the University of Tokyo's Institute of Medical Science. The Biobank will ensure privacy through the use of separate databases, encoding, and firewalls. "It will be impossible to connect the genetic information to any individual," Nakamura says". Return to Contents ----------------------------------------------------------- * Population health differs from public health (added Nov. 14, 2003)
  • On the edge of tomorrow: fitting genomics into public health policy. Gerard S, Hayes M, Rothstein MA, J Law Med Ethics. 2002 Fall;30(3 Suppl):173-6. [PubMed Abstract] An excerpt from the Conclusion of the full text: " is important to recognize that genomics and the entire field of genetics is potentially dangerous ground and that public health is not the same as population health. The legal powers conferred on public health agencies currently permit those agencies to perform their functions to protect the public's health, but those same powers applied within the new frontier can foster abuse and misapplication of genetic information".
  • Ethical, Legal and Social Issues in Public Health Genetics Some Key Points are reviewed concisely in a PDF document that's avialable via this site [Download PDF] Two short excerpts: "Taking a genetic approach towards a social problem may also influence funding for more environmentally-oriented approaches. These complexities show why ethical considerations are an important ingredient in the institution of society-wide programs, and why each instance differs. "Broader still is the question of whether modern molecular genetics can avoid the trap of eugenics when harnessed for population health". Return to Contents ----------------------------------------------------------- * The charitable trust model for biobanks (added Dec. 28, 2003)
  • The charitable trust as a model for genomic biobanks: Winickoff DE, Winickoff RN, N Engl J Med 2003(18 Sep); 349(12): 1180-4. Some excerpts: "...biobanks' requests for general permission should be allowed only if additional safeguards are in place. These include review by the IRB of any subsequent research, clearly stated time limits for the project, an absolute right of withdrawal, disclosure of details about commercial arrangements, and provision of information about subsequent contact." "Donors would be asked to give permission for future research projects, but two features of the trust would safeguard their autonomy. First, the trust would keep donors informed about all research projects through a Web site and would specify a period of time during which donors could opt out of the research. This would encourage open-ended participation but would also allow donors to withdraw from a project. Second, the trust would require consultation with and consent by the community for studies that involve particular populations, such as members of an ethnic group. This would help protect group autonomy in genetic research." "We are not rejecting market-based solutions for funding ... For instance, PXE International - a rare-disease group that has established a nonprofit blood and tissue bank - has generated funding by negotiating intellectual- property arrangements with commercial researchers. The nonprofit model will facilitate research by maintaining open access and encouraging such partnerships." "... the channels for public participation and communication provided by a charitable trust would forestall the political battles that have stymied biobanking endeavors such as the Icelandic Health Sector Database and the Framingham genome project. [The charitable-trust model is based] on the principle that genomic biobanking is both a scientific and a social endeavor ...".
  • PXE Research: The research section of the website of PXE International. An excerpt: "One of the byproducts of understanding all of the mutations will be a genetic test. If you are interested in contributing your blood, with no results returned to you (until the test is useful), please contact us ...". Return to Contents ----------------------------------------------------------- * A 500,000-person study? [in the USA] (added May 4, 2004)
  • A 500,000-person study?: Gene-environment interactions would be focus of NIH-led effort. Article by Maria W Anderson in The Scientist, May 26, 2004. The first paragraph: "The National Institutes of Health (NIH) is considering undertaking the largest population-based study ever done in the United States. NIH issued a request for information (RFI) from researchers earlier this month about the questions a large cohort study on the gene- environment interactions involved in common human diseases might ask, and how the study might be constructed". Return to Contents ----------------------------------------------------------- * Newfoundland seeks control of its genes (added Nov. 16, 2004)
  • Canadian province seeks control of its genes: An article by Robert Longtin in J Natl Cancer Inst 2004 Nov 3); 96(21): 1567-9. Excerpts from the full text: "As currently envisioned, the board will serve as Newfoundland's primary institutional review board for all research proposals involving genetics and possibly clinical trials, marking the first province-wide ethics panel in Canada. 'What will be especially important for us are the studies that are reviewed outside the province but are conducted here,' [Daryl Pullman, a bioethicist in Newfoundland, said]. 'We want to ensure that they also are reviewed locally.' Pullman said the panel will maintain a much-needed inventory of all genetic studies conducted in Newfoundland". "'The only thing certain about these population-wide, genotype-phenotype resources is that they are staggeringly expensive,' said Hank Greely, J.D., a lawyer and ethicist at Stanford University Law School in Palo Alto, Calif. 'They might be essential to understanding the genetic links to complex diseases. But we don't know, and who wants to bet $10 million on it?'". "With more of a buyer's market for genetically isolated research populations, can Newfoundland afford to adhere to a higher ethical standard than just about anywhere else in the world?". Return to Contents ----------------------------------------------------------- * Cancer in Families in Iceland (added Jan. 3, 2005)
  • Cancer in Families: A Synopsis in PLoS Medicine 2004(Dec); 1(3). An excerpt: "A company, deCODE Genetics, was set up to mine health- care data in Iceland, and to use it to assess the effect of genetics on health. Initially, the company attracted criticism, with some questioning the ethics of providing access to health-care data for many disease projects to a for-profit company. But the company has been supported by many Icelanders themselves, demonstrated by Icelanders donating blood samples with informed consent for research on multiple diseases, and now the project's scientific value is becoming apparent". Return to Contents ----------------------------------------------------------- * Investments in biobanks (added Apr. 13, 2005)
  • Pharmacogenomics J. 2005; 5(2): 75-80. An article by Foster MW & Sharp RR, "Will investments in biobanks, prospective cohorts, and markers of common patterns of variation benefit other populations for drug response and disease susceptibility gene discovery?". An excerpt from the text: "For both relatively small populations (many of which will be economically disadvantaged) and for phenotypes and variants that are truly rare in all populations, continued funding for biobanks or cohorts enriched to support family linkage studies and other smaller scale kinds of approaches should be protected from competing directly with large-scale, more expensive (and more trendy) projects".
  • Environ Health Perspect. 2005(Feb); 113(2): 119-22: An article by Foster MW & Sharp RR, "Will investments in large-scale prospective cohorts and biobanks limit our ability to discover weaker, less common genetic and environmental contributors to complex diseases?". An excerpt from the Conclusions: "We believe that larger cohorts and biobanks need not preclude smaller, finer-grained investigations of community-specific influences on disease". Return to Contents ----------------------------------------------------------- * The Genographic Project (added Apr. 14, 2005)
  • DNA project to trace human steps: BBC News, 13 April, 2005. About the Genographic Project. Excerpts: "We see this as a resource for humanity going into the future. It could potentially become the largest genetic database ever created". "However, this could be challenging in areas where indigenous populations have a history of exploitation such as North America and Australia". "The project's budget will depend on how many test kits are sold to the public. The net proceeds will go back into the research and into "legacy projects" set up to support indigenous peoples". Return to Contents ----------------------------------------------------------- * Conference in Iceland, August 2004 (added Apr. 14, 2005) Proceedings of the International ELSAGEN Conference, University of Iceland, Reykjavik, 25-28 August 2004, have been published: Blood & Data: Ethical, Legal and Social Aspects of Human Genetic Databases, Gardar Árnason, Salvör Nordal, Vilhjálmur Árnason, eds., University of Iceland Press and Centre for Ethics, Reykjavík 2004. This book, which includes 43 contributions, deals with a wide range of topics of relevance to the development of genetic databases. A few excerpts: Árnason G, page 29: "Although plans to construct the HSD [Health Sector Database] seem to be on hold, the company [deCODE] has not officially abandoned them". Cheng W-C, & Li W-P, page 45: "[In Taiwan] the Chinese Genetic Database can be the largest and the most representative genetic database in the world ...". Almarsdottir AB, Traulsen JM, Björnsdottir I, page 199: "This study presents results from three focus group discussions in which all the participants were from the same small town in Iceland. The main theme that emerged from the FGs was that of a national solidarity among Icelanders regarding biotechnology research. There was surprisingly very little concern with issues of confidentiality, privacy, and data protection". Return to Contents ----------------------------------------------------------- * Analysis of the Icelandic Supreme Court judgement (added Oct. 22, 2005)
  • An analysis of the Icelandic Supreme Court judgement on the Health Sector Database Act: Article by Renate Gertz, SCRIPT-ed (Online Journal of Law and Technology) 2004(Jun); 1(2): 290-306. Excerpts: "From this paragraph the Icelandic Supreme Court's opinion on the future of the Health Sector Database can be deduced, namely that the Court seems to believe that the entire project might fail anyway". "To summarise the findings, the Icelandic Supreme Court judgement is a considerable step forward for the opponents of the Health Sector Database, but for international legal scholars hoping for a precedent judgement on genetic databanks, the outcome is limited to the privacy and data protection issue". Return to Contents ----------------------------------------------------------- * Example of a 2006 publication from deCODE Genetics (added Jul. 26, 2006)
  • The BARD1 Cys557Ser Variant and Breast Cancer Risk in Iceland: Article by Stacey SN and 19 other authors, including Gulcher JR and Stefansson K. PLoS Medicine 2006(July); 3(7): e217. Excerpt from the abstract: "We investigated the role of the BARD1 Cys557Ser variant in a population-based cohort of 1,090 Icelandic patients with invasive breast cancer and 703 controls. We then used a computerized genealogy of the Icelandic population to study the relationships between the Cys557Ser variant and familial clustering of breast cancer". Return to Contents ----------------------------------------------------------- * deCODE sues former employees (modified Jun. 22, 2007)
  • deCODE sues former employees (The Scientist, Oct. 11, 2006): Subheading: "CEO Kari Stefansson testifies against employees who left to work for a new genomics program at The Children's Hospital of Philadelphia". An update (June 2007):
  • Iceland's deCODE settles Philadelphia lawsuit: Iceland Review, 16 June 2007.
  • deCODE lawsuit settled: By Susan Warner, The Scientist, 19 June 2007. Return to Contents ----------------------------------------------------------- * Icelandic fire (added Jan. 29, 2007)
  • Icelandic fire, an entry at the Gene Expression site, January 27, 2007. Excerpt: "This week's Lancet has a profile of Kari Stefansson, CEO of DeCode Genetics. Regular readers have been exposed to much of the groundbreaking research done by the company, which has DNA samples from ~65% of the Icelandic population and a geneology that stretches back 1000 years". Return to Contents ----------------------------------------------------------- * Iceland family tree (added Mar. 6, 2007)
  • Iceland's Entire Family Tree is Online, an item in Eastman's Online Genealogy Newsletter (Feb. 8, 2007). Excerpt: "Everyone in Iceland is related. Every member of the 300,000 population derives from the same family tree, according to genealogy website". See also: The Iceland family tree, an item in Iceland Review Online (Feb. 9, 2007). Excerpts: "So, it’s official. Everyone in Iceland is related". "Íslendingabók is the product of a cooperation between Icelandic company deCODE Genetics and Fridrik Skúlason, who first began registering genealogy information in 1988 into a program called Espólín". Return to Contents ----------------------------------------------------------- * Connotea bookmarks matching tag biobanks (added 14 Apr, 2007)
  • For a source of information relevant to biobanks, try Connotea bookmarks matching tag: biobanks. One item tagged in this way is: OICR launches Strategic Plan. This item is available via the Portal Newsletter, Spring 2007, of the Ontario Institute for Cancer Research (OICR). An excerpt: "A major highlight of the plan is a massive cohort study that will involve health care workers, government officials and other stakeholders in an endeavour that will lead to a better understanding of the causes of cancer". Return to Contents ----------------------------------------------------------- * Genetic Test for Type 2 Diabetes (added 23 Apr. 2007)
  • Genetic Test for Type 2 Diabetes: A Marginal Advance: Wired Science, April 16, 2007. The first sentence: "Icelandic biotechnology company DeCode Genetics says it will sell a genetic test for type 2 diabetes, but how useful will the $500 test be?" See also: DeCode to Offer Genetic Test for Type 2 Diabetes Risk in U.S.: By John Lauerman, April 15 (Bloomberg). deCODE T2™ Is Ready To Assess Your Diabetes Risk: JSS Diabetes, April 17, 2007. Return to Contents ----------------------------------------------------------- * Consent for Genomic Epidemiology (modified 27 Jun. 2007)
  • Valid Consent for Genomic Epidemiology in Developing Countries: Chokshi DA, Thera MA, Parker M, Diakite M, Makani J, et al., PLoS Med 2007; 4(4): e95. Excerpt: "In what follows, and bearing in mind that valid consent is a process rather than a simple one-off matter of signing a form, we consider a number of challenges in relation to the achievement of consent in genomic epidemiology. We do so under five headings: (1) disclosure and comprehension of information, (2) voluntariness, (3) competence, (4) 'broad' or 'open-ended' consent for future use of samples, and (5) community dimensions of consent [15]".
  • Consent for Genomic Epidemiology in Developing Countries: Added Human Subject Protection Also Needed: Letter by Robert Reinhard, PLoS Med 2007(Jun); 4(6): e214. About the article by Chokshi et al. Excerpts: "The authors deserve thanks for laying out decent principles of communication [1]". "Improved consent: Yes, but linked to and inseparable from strong protections and added benefits for participants". Return to Contents ----------------------------------------------------------- * American Cancer Society cohort study (modified 4 Jul. 2007)
  • U.S. cancer group launches mass cancer study: Reuters Health, April 26, 2007. The first sentence: "The American Cancer Society said it was looking for half a million volunteers willing to let researchers watch them for the next 20 years to see if they get cancer". Return to Contents ----------------------------------------------------------- * Genetic variations and increased heart attack risk (added 5 May 2007)
  • Gene mutations tied to increase heart attack risk: CBC News, May 3, 2007. Excerpts: "Canadian and international researchers have discovered genetic variations that may increase susceptibility to heart disease regardless of other risk factors". "The two studies used samples from 40,000 people in Canada, the U.S. and Iceland". "Caucasians who carried two mutated copies of a stretch of DNA known as 9q21 had a 30 to 40 per cent higher risk of coronary heart disease, compared with people without the mutated versions..." The second study was carried out by Anna Helgadottir and Kari Stefansson of the Iceland-based deCODE Genetics team and their colleagues in the U.S. "DeCODE said it plans to develop a test based on the findings that could be available before the end of the year". Return to Contents ----------------------------------------------------------- * Public Population Project in Genomics: P3G (added 15 Jun. 2007)
  • P3G Observatory: Excerpts: "The Public Population Project in Genomics (P3G) is a not-for-profit and non-commercial organization whose objective is to promote collaboration between researchers in the field of population genomics. ..." "P3G seeks to: * Foster collaboration between biobanks ..." "Study Catalogue: A catalogue of large population-based studies around the world." Return to Contents ----------------------------------------------------------- * Genome Quebec unveils biobank (added 28 Aug. 2007)
  • Genome Quebec unveils biobank: Laboratory Products News, 27 Aug. 2007. Excerpt: The biobank is part of the P3G/CARTaGENE project that was announced in May. Primarily created for storing and managing biological samples collected by the CARTaGENE project from 20,000 citizens of Quebec, it will also support other key projects. The biobank will receive also financing of $9.6 million over three years. Return to Contents ---------------------------------------------------------- * Wikipedia entry for deCODE Genetics (modified Sep. 26, 2008)
  • deCODE genetics: Wikipedia entries evolve across time. Return to Contents ----------------------------------------------------------- * Recent articles by David Winickoff (added Sep. 26, 2008)
  • Partnership in U.K. Biobank: A Third Way for Genomic Property? Abstract of an article in The Journal of Law, Medicine & Ethics 2007(Fall); 35(3): 440-56. The Abstract: A property analysis of the U.K. Biobank reveals a new imagination of the genomic biobank as a national commonpool resource. U.K. Biobank's treatment of property and governance exhibit both strengths and weaknesses that may be instructive to genome project planners around the world. Another relevant review:
  • Genome and Nation: Iceland's Health Sector Database and its Legacy, David E. Winickoff, Innovations 2006(Spring); 12): 80-105. Excerpts from the last two sentences of the text: The Icelandic Health Sector Database controversy ... underscores how smaller nations and their innovations, not just those of the major powers, can and do become critical sites for the formation of global order. Return to Contents ----------------------------------------------------------- * Canadian Partnership for Tomorrow Project (added Nov. 19, 2008)
  • Launch of Canadian 30-year cancer prevention study, Canadian Partnership Against Cancer, June 11, 2008. Excerpt: The largest of its kind in this country, the pan-Canadian study will track randomly selected Canadians (ages 35 to 69) [N=300,000] for at least the next 20 to 30 years. It will gather information on health and lifestyle through surveys and the collection of blood and other specimens. The information will help researchers, policy-makers and others understand how different combinations of risk-factors lead to cancer. Return to Contents ----------------------------------------------------------- * Ontario Health Study (updated Apr. 6, 2010)
  • Ontario Health Study. Excerpt: The Ontario Health Study is a long-term study that began in Spring 2009. Its goal is to help learn more about the causes of chronic diseases and how to prevent them. We are recruiting Ontario residents to look at their health status, family medical histories, work, community and living environment. This not-for-profit Study is one of several across the country that are following 300,000 Canadians for the next 20 years. Return to Contents ----------------------------------------------------------- * deCODE files for bankruptcy protection (updated May. 11, 2010)
  • deCODE Files for Bankruptcy Protection and Sells Subsidiaries and Drug Programs, Genetic Engineering & Biotechnology News, November 17, 2009.
  • Iceland’s deCODE Sold to Saga Investments, Iceland Review, November 17, 2009.
  • Exiting Bankruptcy, DeCode Lands in V.C. Hands, DealBook blog, New York Times, January 22, 2010.
  • Meet the New deCODE, Same as the Old deCODE? Dan Vorhaus, Genomics Law Report, January 25, 2010.
  • How Emerald BioStructures Escaped deCode’s Bankruptcy With Help From Boston VCs, Luke Timmerman, Xconomy, May 10, 2010. Return to Contents ----------------------------------------------------------- * Articles in Newsweek about deCODE (added Apr. 6, 2010)
  • The World’s Most Successful Failure, Mary Carmichael, Newsweek,
    February 12, 2010. An excerpt: If deCODE's new, consulting-heavy business model can keep it afloat, the company will almost certainly continue to discover new genes. Even while it was in bankruptcy, it kept publishing.
  • Genetics Is Good Science, But Is It Good Business?,
    Mary Carmichael, Newsweek, April 01, 2010. An excerpt: It’s tempting to read the last few weeks (and deCODE’s entire history) as evidence that genetics makes for great basic science and lousy business models, given how many technical and legal roadblocks a company can run into in the course of doing good research. Return to Contents ----------------------------------------------------------- * Amgem buys deCODE (added Dec. 11, 2012)
  • Amgen buys Icelandic gene hunter Decode for $415 million, Ben Hirschler, Reuters, December 10, 2012. An excerpt: The acquisition leaves Decode's diagnostics business facing an uncertain future, with Amgen likely to evaluate this and other parts of the business after the deal closes. Return to Contents ----------------------------------------------------------- * Amgen claimed Big Data software prize in $415M deCODE buyout (added Apr. 1, 2013)
  • Amgen claimed Big Data software prize in $415M deCODE buyout, Ryan McBride, FierceBiotech IT, March 31, 2013. An excerpt: The uncertain future of the CSM tech gives the bioinformatics sector its own interesting storyline to watch as the deCODE saga unfolds under new ownership at Amgen. Return to Contents ----------------------------------------------------------- * Nordic Gene Study Requires Consent (added Jun. 25, 2013)
  • A company has been ordered to stop estimating Icelanders' genotypes and linking them to hospital records, Kate Yandell, TheScientist, June 24, 2013. An excerpt: ...Iceland’s Data Protection Authority (DPA) ruled last month (May 28) that the company [deCODE Genetics] must seek consent before continuing genetics studies using estimated data on 280,000 Icelanders—some living and some dead— who did not agree to be studied. See also: Pioneering Icelandic Genetics Company Denied Approval for Data-Mining Plan. Jocelyn Kaiser, ScienceInsider, June 20, 2013. An excerpt: The current dispute involves an approach in which geneticists calculate the odds of whether an individual carries a particular genetic variant without directly sequencing their DNA. Return to Contents ----------------------------------------------------------- * Privacy on Ice:This company wants to collect DNA from one-third of Iceland’s population (added May 23, 2014)
  • Privacy on Ice Alda Sigmundsdóttir, May 21, 2014. An excerpt: Decode is using ICE-SAR, one of the most respected and best-loved institutions in Iceland, as couriers. This is because Decode promises that if 100,000 Icelanders give samples, it will donate ISK 200 million (more than $1.7 million) to ICE-SAR. The search and rescue team can really use the funds. Return to Contents ----------------------------------------------------------- * Iceland's genomes offer glimpse into mutations' varied effects (modified Apr. 7, 2015)
  • Iceland's genomes offer glimpse into mutations' varied effects Jessica Wright, April 3, 2015. An excerpt: Through a clever combination of sequencing genomes and tracing family ties, Icelandic researchers have gleaned genomic information for nearly one-third of their nation’s population. See also:
  • Icelandic population genetically mapped Tim Sandle, Digital Journal, April 5, 2015. An excerpt: Scientists have performed whole-genome sequencing on roughly 1 percent of the Icelandic population. This is one of the largest studies ever performed of a distinct nation. Return to Contents ----------------------------------------------------------- * In Iceland, Debate Simmers Over Imputed Genotypes, Preventive Medicine,and Public Health (added Jan. 15, 2016)
  • In Iceland, Debate Simmers Over Imputed Genotypes, Preventive Medicine, and Public Health Justin Petrone, GenomeWeb, January 14, 2016. An excerpt: The question of whether or not DeCode could approach people who were at heightened risk of developing a lethal cancer, had [sic] who had consented to being genotyped by the firm, though not consented to being contacted about health risks, has not yet been addressed to the DPA. [DPA=Data Protection Authority in Iceland.] Return to Contents ----------------------------------------------------------- * Iceland's genetic goldmine, and the man behind it (added Apr 20, 2017)
  • Iceland's genetic goldmine, and the man behind it Meg Tirrell, CNBC, Apr 6, 2017. An excerpt: A "simple man, living in a backwater country, with modest aspirations" — that's how Iceland's Kari Stefansson described himself this week from his office in Reykjavik. Return to Contents ----------------------------------------------------------- * Another Iceland Experiment, on a "hydrogen economy" (modified Jul. 26, 2003)
  • Hydrogen Economy (BBC News, Aug. 21, 2002): An excerpt: Their ancestors the Vikings are better known for the way they pillaged and despoiled. But now Icelanders are offering to show the rest of the world how best to clean the planet up and protect the fragile resources of the earth. See also: Hydrogen economy(From Wikipedia, the free encyclopedia). Return to Contents ----------------------------------------------------------- Copyright 1999-2017 by Jim Till Send me an email message, to: Go to my Links page about cancer Disclaimer Go to Part 1

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