A public registry would give patients, their doctors, and their parents access to information essential to making informed decisions about genetic testing, Zonno said. It should include the name of the laboratory performing tests, the name of the test developer, and facts about the test’s ability to enhance existing care.

Genetic Alliance suggested that the National Center for Biotechnology Information maintain the registry and that the FDA oversee it so information could be combined with other genetic resources. One such resource already available from the NCBI, GeneTests, provides “current, authoritative information on genetic testing and its use in diagnosis, management, and genetic counseling.” A public registry with the characteristics Zonno recommended would be more comprehensive than the current GeneTests system.

When FDA sends warning letters to pharmaceutical companies, only some are made public. After FDA released a group of these letters last year, former CAP senior fellow Rick Weiss wrote that although the “rare bit of transparency” was good news, the delay in disclosure leaves time for patients and physicians to be affected by the companies’ “bold twists of truth.” In a warning letter to Novartis Pharmaceuticals concerning the ADHD drug Focalin XR, FDA warned Novartis to remove the claim that the drug’s benefits are sustained for over six months since the effectiveness of Focalin XR had never been studied beyond seven weeks. Over at TechPresident, Nancy Scola considers a new open document management project, DocumentCloud, that could support this sort of transparency.

The Transparency Task Force, formed in January to address the Obama Administration’s Transparency and Open Government agenda, is led by FDA deputy commissioner Joshua Sharfstein. The task force is considering all views including supporters of strong trade secret protection and a comprehensive report will be submitted to FDA commissioner Margaret A. Hamburg in five months.

This morning, the Senate Environment and Public Works Committee and Subcommittee on Oversight held a joint hearing on “Scientific Integrity and Transparency Reforms at the Environmental Protection Agency,” which included discussion of the new procedures. Lisa Jackson, administrator of the EPA, testified on how the new IRIS process will help fulfill President Obama’s memorandum on scientific integrity by increasing transparency in science-based regulation.

EPA will now manage the entire IRIS review process, rather than the Office of Management and Budget, Jackson said. Dr. Francesca Grifo, Senior Scientist and Director of the Scientific Integrity Program at the Union of Concerned Scientists, discussed the importance of this change in control in a Science Progress podcast last month. The OMB previously had the power to change scientific advice, Grifo said, and described the problematic regulatory process under the Bush administration. “What we saw in the past was, rather than be courageous and come out and talk about which parts were policy and which parts were science, we saw changes in the science to cover up an often unpopular policy decision,” she said. Grifo explained in that interview that administration policy could break with the scientific advice, but the reasoning had to be clear, rather than resorting to an obfuscation of the data. “The key here is for all of us to see the scientific basis,” she said.

The new IRIS process requires that all written scientific comments on IRIS drafts provided by federal agencies be made public. Furthermore, most contaminant evaluations will be available on IRIS within two years of the review start date, Jackson said. The condensed process not only presents health-related information to the public more quickly, but also eliminates steps agencies could potentially use to inhibit the process, explained John B. Stephenson, director of natural resources & environment at the U.S. Government Accountability Office. Under the old rules, agencies could declare a need for additional research to suspend the IRIS process and prevent or delay a substance from being added to the database. This gave agencies time to present studies that conflicted with the original “best available science,” Stephenson said.

Image: AP

Beth Noveck was a member of the transition team and spent the 120 days following the president’s Memorandum on Transparency and Open Government of January 21 working to ready this project, which she joined us this week to discuss (see the sidebar for the full conversation). She is now the deputy chief technology officer for open government in the Office of Science and Technology Policy.

The January memorandum, the first of the administration, outlined the three guiding principles of transparency, participation, and collaboration, she explains. “The reason we want to have transparency is to create more accountability in government.” And participation from citizens, according to Noveck, is not solely a matter of inclusion; it also ensures that those working in government are getting the best expertise so they can make decisions about health care reform, environmental sustainability—and be certain those decisions are based on the best possible data and science.

Addressing the importance of the effort for the scientific community, Noveck pointed to Data.gov, the new catalog of bulk technical information created as part of the initiative. “If we don’t make it easy to find that information,” she said, “it’s very difficult for the scientific community to do research on it, to analyze it, to assess the quality, and then, in turn, to hold government accountable.”

Noveck has first-hand experience using technology tools to crowdsource research that informs government decisions. She spearheaded the successful Peer-to-Patent pilot project that allows volunteer experts to assist with the prior art research for patent applications. Their suggestions get voted on by other participants and the top finds became part of the docket of materials sent to the overworked patent examiners who might not otherwise know about the valuable resources or preexisting intellectual property.

The lesson from the project for the current initiative is clear: “The intelligence and expertise that we need to make the best quality decisions is not all located in Washington. We don’t have a monopoly on all the good information that we need to make decisions,” she said.

The administration’s government transparency work has drawn some criticism for hosting discussions with stakeholders behind closed doors—though information on the content or results of those talks, as well as other ideas on transparency, is now available on OSTP’s “From the Inbox” page. “For far too long, too much of the way that we have made policy has happened behind closed doors, without adequate opportunities for participation,” Noveck said, “and also without adequate rationale and feedback at the back end when decisions are made that actually justify and explain why a certain decision was made.”

The first public phase of the transparency idea-generation process is an online brainstorming session at the Open Government Dialogue. The final day to submit and vote on ideas is tomorrow, May 28th, after which the second “discussion” phase begins on June 3. When the coordinators—the White House Chief Technology Officer in OSTP, the Office of Management and Budget, and the General Services Administration—have digested all the input from this multi-stage process, OMB will prepare a set of open policy directives for federal departments, which have already been asked to create more of what Noveck calls “open government innovations.” A gallery of such innovations already in place appears on the White House website.

But part of open governance, Noveck emphasizes, is decentralization, and transparency is not the sole responsibility of any one person or single office. “Everyone is in charge. We’re all responsible,” she said.

The government transparency movement is waiting for a deluge of public data from Congress and the Obama administration. Developers are ready with open-source software and protocols for structuring data on everything from lobbying disclosures to pending legislation to stimulus allocations. And once the data is free and flowing through RSS feeds, Application Programming Interfaces, and Twitter messages, others are poised to mash it up in visualizations, plot it on Google maps, and ferry it out for discussion with social networking tools.

But as the Washington Post reports today, the administration isn’t moving fast enough for the transparency community, and the reason isn’t technological; it’s operational. That is, the new media team at the White House, which is currently taking a lot of the heat on transparency issues, knows what technology it needs and how to use it to share info about what President Obama is doing and to solicit citizen input on policymaking. But there are operational issues built into the 20th-century rules that govern how executive offices can—and cannot—post information online.

The lesson that the first issue in transparency isn’t technology, but rather operations, isn’t trivial. How do you break down the red tape to allow discussion of unfinalized agency decisions on official blogs? How you dedicate staff and resources to maintain the quality and accuracy of complex technical data? How do you do build the concept of transparency into the DNA of a department when many have spent the last two terms operating behind an executive-mandated veil? These sort of questions have to come before a decision on what sort of markup language is right for the data or how a discussion board for regulations rules will thread comments.

Over the weekend, a few hundred developers, new media strategists, government information experts, and technology advocates converged on George Washington University for the first Transparency Camp, a BarCamp-style “unconference” designed to drive the discussion about how to get the federal government to open up and put its information online. In a discussion early Saturday, technology guru and O’Reilly Media founder Tim O’Reilly posed the fundamentals like this: “What are the most basic primitives for open government?” To put it another way, where do we start before we get into software specs? The difference between operations and technology will be crucial as advocacy groups continue to work with federal agencies as the latter open their data and the former start to analyze it.

The second issue that must inform effective transparency policy is that it must shape good public policy outcomes. Transparency is, in and of itself, an important principle in progressive governance, but the technologies that will enable radical transparency are not themselves policy solutions. Transparency has to work in the service of larger public policy goals: improving access to affordable health care, preventing environmental degradation, and reducing inequalities in the education system, to name a few.

The onus is on the advocacy groups to take federal data, analyze it, and create compelling arguments for public policy changes. That loop running from open government data to compelling projects that influence policy changes and back to more open data is what will drive future sectors of the government to open up and future advocacy groups to innovate.

So what do we need first? Many discussions at Transparency Camp boiled it down to this: structured data. Too many arms of the government lock their data in pdfs, text files, scanned images, or difficult-to-navigate databases. At another panel, O’Reilly recommended that the systems to start overhauling first are the ones that developers are already scraping and scouring for information, like the THOMAS database that houses information about Congressional legislation. Notoriously hard to query, the main page of the site currently has a link at the top directing visitors to the stimulus bill—because it’s that hard to find. “Follow the alpha geeks,” O’Reilly said. If they’re already hacking a site, then maybe it’s time to build them an API to give them access to the information inside.

After people have the data and the tools to access it, the next priority will be effective case examples borne of collaboration between advocacy groups and federal agencies opening up their processes and information. To be sure, some of these collaborations will fail, and that’s okay; smart groups will take the lessons learned and apply them to the next effort. But if the nonprofit community simply comes to the government demanding transparency, gets it, and there are no identifiable public policy reforms that benefit the people on main street, then there won’t be continued momentum on the issue to warrant future collaboration.

The potential of radical transparency for government data is immense, but at the same time, there’s an analog to the current state of genetics research: in both arenas, we have huge amounts of data with only a limited number of effective interpretations we use to make informed decisions.

It’s hard to communicate the energy and potential of this tech-savvy community—it’s also hard to predict just how transparency with change the way government and citizens interact. Yet as SP contributor Nancy Scola argued at TechPresident, it’s the end of transparency camp, but the beginning of what’s next.

Images: flickr.com/Avelino_Maestas and flickr.com/justgrimes