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26. International Developments: A Context for the Creation of a Microbiology Commons – Anita Eisenstadt69 Department of State I will first lay out a couple of key principles for engaging in international cooperation. Then I will talk about some of the challenges that are particularly associated with biological data. And finally, I will describe the past and present work at the Organisation for Economic Co-operation and Development (OECD). This is an international organization where it may be possible to carry out some of the work we have been discussing. Let me begin with some basic observations. Science, technology, and innovation are accelerated by international cooperation. Science today is absolutely global. I recently attended an event at the Finnish Embassy here in Washington, DC. Finland has developed a new technology award, the Millennium Technology Award, which is their attempt to do the same thing for technology that the Nobel prizes from Sweden do for different areas of science. Some amazing people have won the awards—the researcher who developed the World Wide Web, the scientist who developed the technology for light-emitting diodes, and so forth. The Finnish Embassy had some really amazing speakers at this event. The message that I brought home is that science is global. We have key global challenges that we must address today and together internationally. No one country has the resources or the solutions by itself. Science, technology, and innovation are all key to us resolving these global challenges. I think we all agree that the life sciences will play a major role in resolving these global challenges and that they are a really important future research area. The Obama Administration has been incredibly supportive of science, and one of the early speeches that President Obama gave was here at the National Academy of Sciences. The fact that he chose this place spoke volumes. In his speech he emphasized the importance that science plays in addressing issues in society, such as our economic well-being, and stressed how global and international science needs to be. His administration is also dedicated to ensuring openness and transparency in government, including access to scientific data and information. The U.S. government has a long history of promoting access to federally funded research. The Office of Management and Budget Circular A130 and the Paperwork Reduction Act have been part of the legal and policy foundations for that policy. A study came out in January 2009 called Harnessing the Power of Digital Data for Science and Society which was put together by the National Science and Technology Council’s Interagency Working Group on Digital Data. I am the State Department representative on that Working Group, which represents a large number of science agencies. That report contains this quote: 69 Presentation slides available at isionSelectionMethod=Latest. 185

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The ability to achieve innovation in a competitive global information society hinges on the capability to swiftly and reliably find, understand, share, and apply complex information from widely distributed sources for discovery, progress, and productivity. Limits on information access translate into limits on all other aspects of competitiveness. Thus, digital information preservation and access capability are critical to the progress of individuals, nations, science and society. This states very succinctly the issues that we are dealing with here at this symposium and captures how incredibly important it is to have access to digital information. There are a variety of challenges associated with biological (and other types of) data. First, we have unprecedented amounts of such data. Given all this raw data, how do we enhance access to it? How do we organize it so that researchers working in one discipline can have access to data from a totally different discipline in a different lab? Can we find a way to accelerate understanding and knowledge to facilitate advances in important fields, such as biotechnology, health, agriculture, environmental remediation, and sustainable biofuels? We need a framework with which to compare and combine experimental data collected in different labs so that we can get a fuller understanding of the identity, structure, and biological functions. Science is moving away from looking at small, individual items to looking at the larger system—the systems approach to science. Someone who has collected data for one reason may be shocked at how that data can be used by someone else in a totally different field. The founder of the World Wide Web was at the Finnish Embassy this week. His key message was that it is astounding what other people will do with your data, based on just a few days of you putting the data out there. He urged people not to be so cautious about trying to make their data available in a perfect form on a fancy Web page; even if you do not have time to format the data in a certain way, once you get the data out somebody else might be able to take that next step. One problem with this, of course, is that if you get the data out there, but there is no way to organize it or access it, and there is no shared vocabulary, people will find it difficult to use the data. To address these issues, we probably need some enhanced analysis methods for large databases and we need to pay more attention to data interoperability and compatibility. There are also a variety of legal implications to sharing data, as has been already discussed here. These tend to be more complex when human data are being shared, and they raise questions in the areas of intellectual property, privacy, and dual use. For the rest of my talk I will focus on the OECD. It is headquartered in Paris, has 30 member nations, and was established in 1961. It came out of the Marshall Plan at the end of World War II, and the United States was one of founding members. The OECD brings members together to support sustainable economic growth and maintain financial stability. The idea behind the OECD is to provide a forum in which to compare policy experiences, identify good practices and guidelines, and coordinate national and international policies. It is a very large organization and it would thus be impossible for any one person to keep track of everything that goes on there. Much of what goes on at the OECD is trade-related, or finance-related, but there is a part of the OECD that deals with research 186

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issues and science policy. This part includes the Committee on Science and Technology Policy and also a Working Party on Biotechnology. A number of years ago at the OECD, we decided it would be helpful to develop guidelines to promote access to publicly funded research data. Paul Uhlir was one of our experts on that working group. A large part of the goal of our working group was to try to get other countries to adopt the U.S. approach, because the United States has one of the strongest records of providing access to federal and federally funded research information. The European Union has a very different approach from ours because of the Directive on the legal protection of databases that they have. Various other countries sometimes have very different approaches as well. So we were pleased to come up with a set of recommended guidelines, released in December 2006,70 which promoted access to publicly funded research data at little or no cost. A second OECD recommendation, this one released in 2008 in preparation for a ministerial on the future of the Internet, offered ways to enhance access to public sector information.71 If you are looking for any kind of guidelines in these areas, you might find these two documents of help. Why did we decide to develop these research guidelines? Because we really believe that the exchange of data, knowledge, and ideas are fundamental to progress. This is particularly true now because the Internet has opened up new applications for research data that were never available before, and you must access to the research data in order to take full advantage of the opportunities afforded by the Internet. Another reason was that access to data increases the return from public investment and reinforces open scientific inquiry. We also wanted to encourage governments around the world to address the issues underlying access to data in their national policies, because some of them had not yet done so. We did not find in other countries many of the things that the United States had done concerning grants, such as the guidelines from the National Science Foundation and the National Institutes of Health that encourage sharing of data. They were hoping that those ideas would be shared and that maybe some of them would be adopted. And we were hoping to enhance international data sharing. A second project at the OECD—and one that is closer to what we are talking about here today—was the development of a set of best practices for biological research centers. These centers are repositories and providers of high-quality biological materials, and there was a concern that there was not enough sharing of these biological materials as well as a concern that there was insufficient control over quality. Some of the countries were interested in having a set of best practices so that when people obtained a sample, there could be some assurances that it had been collected and maintained in accordance with those established practices. The definition for biological resources included living organisms and all the other materials needed for the advancement of biotechnology and human health research, including microbiological materials. 70 Organisation for Economic Co-operation and Development. OECD Principles and Guidelines for Access to Research Data from Public Funding. 2007; 71 Organisation for Economic Co-operation and Development. OECD RECOMMENDATION OF THE COUNCIL FOR ENHANCED ACCESS AND MORE EFFECTIVE USE OF PUBLIC SECTOR INFORMATION. 2008; . 187

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We came up with four sets of best practices. The first one focused on generic quality aspects that could apply to labs that were collecting and maintaining any type of biological materials. The second set of guidelines concerned biosecurity practices. We understand that these have been adopted by a number of countries since they were developed. These first two sets apply to all types of biological resource centers (BRCs). The third set was specific to BRCs holding and supplying microorganisms, and it is probably the one most relevant to your discussions here. Finally the fourth set was for BRCs holding and supplying human-derived materials. The guidelines set forth methodologies for preservation, replication, and quality control, and they attempted to provide internationally unified quality control. The recommendations include such things as minimum data sets—that is, the minimum amount of information that should be collected for the samples—and various other practices aimed at insuring good quality. One thing that came out of this discussion was that a number of countries were very interested in forming a global biological research centers network, or GBRCN. The idea was to develop an international mechanism for cooperating and linking these various biological centers and for sharing data. Although there has been no consensus at the OECD on a specific recommendation, the GBRCN is now a pilot project. The GBRCN is headquartered in Germany. It has 15 countries participating in it, and the World Federation of Culture Collections is a major player as well. The goal of this pilot project is to look at whether it is possible to create networks that are more valuable than the status quo. If so, this pilot may end up being a model for a broader network. Another issue that has been discussed is certification of BRCs. There are differing views on this. Some countries want the OECD to put in place a certification process that would review the practices of a BRC and provide a certificate if it met the requirements of the best practices. The Unites States was not comfortable with that approach, and so at this time it is optional whether a country chooses to have a national certification process for BRCs, as opposed to having BRCs accredited by private third parties. France and Germany, by the way, were quite interested in national accreditations systems. We heard some discussion this morning about knowledge markets. In October 2008 the OECD Working Party on Biotechnology held a workshop here at the National Academies to examine the different practices for knowledge market mechanisms and to try to identify the knowledge markets in the biomedical sector. Knowledge markets can include both proprietary intellectual property and goods in the public domain. They are intended to facilitate the sharing of intellectual assets, including data, materials, expertise, and services. The report that came out of the workshop is very useful. It provides details about knowledge markets and offers examples of where they have worked. One of the key things we are looking at now at the OECD is putting together a topology of knowledge markets. We are also thinking about doing further work in this area. One thing that I would be most grateful for is if any of you have suggestions on what we might do to move forward in the area of knowledge markets related to biotechnology. At the moment, OECD is putting great effort into understanding exactly what innovation is and how countries can best promote it. The work we are doing on knowledge markets will be incorporated into next year’s ministerial on an innovation 188

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strategy, so this work could get quite a bit of attention if we do some sound work over the next year. My final example is a current effort by the OECD Committee on Science and Technology Policy to examine multilateral scientific cooperation and look at new approaches and governance mechanisms for multilateral cooperation in international science. We have a steering group meeting later this month. It will be a two-year project, and we will be looking for proposals on ways to set forth better frameworks for promoting international science and technology cooperation. This is another area in which, if the participants in this symposium have ideas you would like me to carry forward, I would be really open to hearing your suggestions. We are at a pivotal point right now in steering that group in directions that we think would be useful. Question and Answer Session PARTICIPANT: There have been a number of countries that did not have any data policies, which have sought to implement national policies since the OECD guidelines were written—notably South Africa, Chile, and some other countries that recently joined OECD. So these things do matter. MS. EISENSTADT: Yes, and the OECD is doing a lot of work now with developing countries as well. So some of the guidelines are not only going to be used by member countries but will be very useful examples for developing countries as well. PARTICIPANT: In addition to the groups that you mention in OECD, there is also a working group on harmonization of regulation of biotechnology and a microorganisms sub-working group. One of the projects they have been dealing with is the development of a unique identifier for certain kinds of microorganisms used in biotechnology. OECD is looking for feedback on the kind of proposal it had in mind. PARTICIPANT: My experience in directing an OECD effort for neuroinformatics led me to understand that OECD basically anoints or allows a group to commission an effort—a community group—and most often steps back and just encourages member nations to participate in that community effort. I am glad to hear about the kind of thing you spoke about because it says that the OECD is actually getting involved in helping to promote standards that allow for interoperability, which it particularly important. Our experience with 15 member nations was that there was, of course, reluctance to participate. Even though it was something that they were encouraged to do through their country’s membership, they did not actually understand how to participate because there were few guidelines about data sharing. Even if they wanted to share data—this was in brain research, which spans the range from molecular and genomic on up to information that is clinically relevant—they did not know how to operate with regard to identifying or making useful the information that was put away in data collections. So when you talk about the Berners-Lee World Wide Web activity and being able to find things on the Web, I think what people are missing is the real challenge of what we call the long tail of small data. That is the data that we get together and figure out that we can put in collections, whether they are physical collections or data collections. How do we make sure they are well-curated, so they can be more easily discovered? We are really dealing with a lot of data that are not discoverable because people do not organize 189

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them in any way that makes them easy to find. It would be great if the OECD would organize an effort with the information technologists—the knowledge management engineers, if you like—to help make that easier for the inexperienced scientists who are dealing with this problem. 190