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GISAID
Global Initiative on Sharing All Influenza Data
FormationDecember 19, 2006; 17 years ago (2006-12-19)[1][2][3]
TypeNonprofit organization[citation needed]
Public–private partnership
PurposeGlobal health, research
Headquarters
MethodDonations and grants
Key people
  • Peter Bogner (president)[6]
  • Jörg Paura and Christoph Wetzler (executive board members)[5]
  • Ron Fouchier and John W. McCauley (co-chairs Scientific Advisory Council)[7]
Websitehttps://gisaid.org

GISAID, the Global Initiative on Sharing All Influenza Data, is a global science initiative and primary source established in 2008 that provides access to genomic data of influenza viruses[8] and the coronavirus responsible for the COVID-19 pandemic.[9][10] The database has become the world's largest repository for SARS-CoV-2 sequences. GISAID facilitates genomic epidemiology and real-time surveillance to monitor the emergence of new COVID-19 viral strains across the planet.[11]

Since its establishment as an alternative to sharing avian influenza data[12] via conventional public-domain archives,[8][13] GISAID has been recognized[by whom?] for incentivizing rapid exchange of outbreak data[13] during the H1N1 pandemic[14][15] in 2009, the H7N9 epidemic[16][17] in 2013, the COVID-19 pandemic[18][19] and the 2022–2023 mpox outbreak.[20]

GISAID was recognized for its importance to global health by G20 health ministers in 2017,[21] and in 2020 the World Health Organization chief scientist Soumya Swaminathan called the data-science initiative "a game changer".[9]

Origin

The acronym GISAID found first mention in a correspondence letter published in the journal Nature in 2006,[22] putting forward an initial aspiration of creating a "consortium" for a new Global Initiative on Sharing Avian Influenza Data (later, "All" would replace "Avian"), whereby its members[13] would release data in publicly available databases up to six months after analysis and validation.[23]

Although no essential ground rules for sharing were established,[24] the correspondence letter was signed by over 70 leading scientists, including seven Nobel laureates, because access to the most current genetic data for the highly pathogenic H5N1 zoonotic virus was often restricted, in part due to the hesitancy of World Health Organization member states to share their virus genomes and put ownership rights at risk.[25] Since 1952, influenza strains had been collected by National Influenza Centers (NICs) and distributed through the WHO's Global Influenza Surveillance and Response System (GISRS). In 2007, Indonesia began withholding H5N1 influenza samples.[26]

It would take another 18 months until an international consensus on actual rules of the GISAID sharing mechanism could be reached among governments and researchers. Thus, GISAID officially launched[11] in May 2008 in Geneva on the occasion of the 61st World Health Assembly, as a publicly-accessible database rather than a consortium requiring membership.[13][14]

Approach

The GISAID model of incentivizing and recognizing those who deposit data has been recommended as a model for future initiatives.[27] Greater transparency and more timely sharing of sequence data has been a goal of many researchers and stakeholders alike. The GISAID platform spans national borders and scientific disciplines, with leaders in the fields of veterinary medicine, human medicine, bioinformatics, epidemiology, and intellectual property. This cross-disciplinary effort provides new means to communicate and share information, as each discipline has distinct interests but also shares similar goals. The Initiative came together in a way that gives credit to those submitting data. The notion of sharing not just data, but also the benefits of resulting research, represented a "paradigm shift" that puts contributors from higher and lower resource environments on more equal footing.[27]

History

Peter Bogner shakes hands with Robert Kloos
Official signing ceremony with GISAID President Peter Bogner (l) and German State Secretary Robert Kloos Source: BMELV (Berlin, April 2010)

The GISAID Initiative was initially funded by Peter Bogner—a strategic advisor and international broadcasting executive—who serves as its founder and principal facilitator. Bogner has been directing the build-up of this platform by bringing together the world's leading scientists and stakeholders who are actively committed to accelerating understanding of this potential human pandemic by rapidly sharing scientific data and results. In January 2006, Bogner met with US Secretary of Homeland Security Michael Chertoff at the World Economic Forum in Davos, Switzerland, and was told about the US government's preparedness concept on dealing with the potential of a flu pandemic.[28] Concerns about a pandemic scenario heightened.[29]

In November 2006, the Initiative received the endorsement of both The Royal Society and Academy of Medical Sciences.[30] In February 2007, it was announced that GISAID and the Swiss Institute of Bioinformatics (SIB) had signed a cooperation agreement.[13] Under this agreement, the Geneva-based institute was to provide services for the secure storage and analysis of genetic, epidemiological, and clinical data.[citation needed]

In January 2007, Indonesia stopped sharing all H5N1 clinical samples with WHO. In March 2007, Siti Fadilah Supari, Indonesia's Minister of Health, announced[31][unreliable source?] the Indonesian government supports the formation of the Global Initiative on Sharing Avian Influenza Database (GISAID) following a high-level WHO meeting in Jakarta on Responsible Practices for Sharing Avian Influenza Viruses.

After a legal clash with the SIB,[32][33] in which GISAID was ultimately compelled by an arbitration tribunal to pay out more than $1M,[34] in April 2010 the Federal Republic of Germany announced during the 7th International Ministerial Conference on Avian and Pandemic Influenza in Hanoi, Vietnam, that GISAID had entered into a cooperation agreement[35] with the German government, making Germany the long-term host of the GISAID platform.[36] Under the agreement, Germany, represented by the Federal Ministry of Food, Agriculture and Consumer Protection BMELV, will ensure the sustainability of the initiative by providing through its Federal Office for Agriculture and Food (BLE) the technical hosting facilities[37] of the GISAID platform and EpiFlu™ database, located in Bonn. Germany's Federal Institute for Animal Health the Friedrich Loeffler Institute (FLI) located on the Isle of Riems, will ensure the plausibility and curation of scientific data in GISAID to meet scientific standards.

Some of the earliest SARS-CoV-2 genetic sequences were released by the Chinese Center for Disease Control and Prevention and shared through GISAID in mid January 2020.[38] Since 2020, millions of SARS-CoV-2 genome sequences have been uploaded to the GISAID database.[39]

The AHF Global Public Health Institute at the University of Miami and GISAID announced in 2022 a collaboration on genetic sequencing, with AHF providing funding for sequencing projects and GISAID leveraging established educational programs.[40]

In 2022, GISAID added Mpox virus[41] and Respiratory syncytial virus (RSV)[42] to the list of pathogens supported by its database.

In March 2023, GISAID became embroiled in a controversy surrounding the temporary suspension of scientists' database access and the temporary removal from their platform of raw data relevant to investigations of the origins of SARS-CoV-2.[43][44][45] In response, GISAID stated that they do not delete records from their database, but data may become temporarily invisible during updates or corrections.[46][47] GISAID justified the scientists' suspension with an accusation of "scooping" the Chinese research team, despite the Chinese team's research being available as a preprint since February 2022 and the scientists having had reached out to the data owners offering to collaborate on their analysis which had according to lead author Florence Débarre never been intended to result in a competing peer-reviewed journal article.[48] The Chinese research team's leader, George F. Gao, is a member of GISAID's scientific advisory board.[49] Eventually, the data in question was made available again by GISAID, with an additional restriction that any analysis based thereon would not be shared with the public.[50]

Database for SARS-CoV-2 genomes

GISAID maintains the world's largest repository of SARS-CoV-2 sequences.[51] By mid-April 2021, GISAID's SARS-CoV-2 database reached over 1,200,000 submissions, a testament to the hard work of researchers in over 170 different countries.[52] Only three months later, the number of uploaded SARS-CoV-2 sequences had doubled again, to over 2.4 million.[53] By late 2021, the database contained over 5 million genome sequences;[54] as of December 2021, over 6 million sequences had been submitted;[55] by April 2022, there were 10 million sequences accumulated; and in January 2023 the number had reached 14.4 million.[56]

Throughout the first year of the COVID-19 pandemic, most of the SARS-CoV-2 whole-genome sequences that were generated and shared globally were submitted through GISAID.[57] When the SARS-CoV-2 Omicron variant was detected in South Africa, by quickly uploading the sequence to GISAID, the National Institute for Communicable Diseases there was able to learn that Botswana and Hong Kong had also reported cases possessing the same gene sequence.[58]

Governance

GISAID's administrative affairs are overseen by a board[49] comprising Peter Bogner, and German lawyers[59][60] Jörg Paura and Christoph Wetzler.[5] Scientific oversight of the initiative comes from its Scientific Advisory Council made up of directors of leading public health laboratories including all six WHO Collaborating Centres for Influenza, and directors of animal health reference laboratories for research on avian influenza for the World Organisation for Animal Health and the Food and Agriculture Organization of the United Nations.

In 2023, GISAID's lack of transparency was criticized by multiple current and potential funders. Long-term funding had been denied from the International Federation of Pharmaceutical Manufacturers and Associations for governance issues.[61]

Access and intellectual property

Unlike public-domain databases such as GenBank and EMBL, users of GISAID must have their identity confirmed and agree to a Database Access Agreement[62] that governs the way GISAID data can be used. These Terms of Use prevent users from sharing any data with other users who have not agreed to the Terms of Use. The Terms of Use require that users of the data must acknowledge the data generators in published work, and also make a reasonable attempt to collaborate with data generators and involve them in research and analysis that uses their data.[citation needed]

A difficulty that GISAID's Data Access Agreement attempts to address is that many researchers fear sharing of influenza sequence data could facilitate its misappropriation through intellectual property claims by the vaccine industry and others, hindering access to vaccines and other items in developing countries, either through high costs or by preventing technology transfer. While most public interest experts agree with GISAID that influenza sequence data should be made public, and this is the subject of agreement by many researchers, some provide the information only after filing patent claims while others have said that access to it should be only on the condition that no patents or other intellectual property claims are filed, as was controversial with the Human Genome Project.[63] GISAID's Data Access Agreement addresses this directly to promote sharing data. GISAID's procedures additionally suggest that those who access the EpiFlu database consult the countries of origin of genetic sequences and the researchers who discovered the sequences. As a result, the GISAID license has been important in rapid pandemic preparedness.[64] These restrictions evidence common criticisms to an open data model.

GISAID describes itself as "open access", which is naturally replicated by the media and in journal publications. This description indeed aligns with the original announcement of the consortium,[23] which also mentioned depositing the data to the databases participating in the INSDC. As of March 2023, this is not the case, as "GISAID does not offer a mechanism to release data to any other database".[65] A few academic papers have compared GISAID's licensing model to unrestricted, open databases,[66][64][67] highlighting the differences.

In 2017, GISAID's Editorial Board stated that "re3data.org and DataCite, the world’s leading provider of digital object identifiers (DOI) for research data, affirmed the designation of access to GISAID's database and data as Open Access".[68] However, after several researchers had their accounts suspended in March 2023 as reported by the journal Science[69] and other news outlets,[70] its open access status was revoked by the Registry of Research Data Repositories (re3data), which now classifies it as a "restricted access repository".[71]

According to the Berlin Declaration on Open Access, authors must grant an irrevocable license to distribute the work publicly, and a copy of such work must be deposited online to a well-established organization which enables unrestricted distribution. Mechanisms for proper attribution of authorship cannot circumvent these requirements.[72] In January 2021, GISAID's restricted access led a group of scientists to write a open letter asking for SARS-CoV-2 sequences to be deposited in open databases,[73] which was replicated in the journals Nature[74][75] and Science.[6] Furthermore, the article from Science points out that the lack of transparency in access to the database also prevents many scientists from even criticising the platform.[6] A paper from 2017 describing the success of GISAID mentions that revoking researchers' credentials was rare, but it did happen.[76] The same publication described a "perceived merit in GISAID's formula for balancing the need for control and openness".

See also

References

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Further reading

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