Two recent news items suggest that venture capital firms are taking extra care to make sure scientific research can properly inform their investment decisions.
A brief item in Science-Business Exchange (full article requires subscription) notes that at least one firm – Atlas Venture – has taken to hiring contract research organizations to independently validate academic science prior to making significant investment. One could consider this simply conducting proper due diligence on the firms in which it may invest. However, this could speak to the increases in retractions and other instances of scientific misconduct. (That I saw this first via a Tweet from one of the folks behind Retraction Watch suggests the second possibility is at least plausible.)
Another venture capital firm will work with a scientific academy to help it assess future opportunities in late-stage biomedical companies. The Academy of Medical Sciences in London will work with Park Vale Capital to connect its Fellows to investment advisors at the firm. The Academy will receive a retainer to assist with administrative costs and receive a certain percentage of performance fees Park Vale receives on its investments. In an effort to manage potential conflicts and avoid disclosures of proprietary or confidential information, the Academy will establish an oversight committee. Relationships that go past the initial Academy-facilitated meetings will be handled through the researchers’ home institutions.
Both of these events are new in the area of venture capital. Whether or not they will be the beginning of trends may depend on how well such arrangements work. But at least in the case of Atlas Venture, these developments should remind us that the reliability of the research data and the processes behind it matter. Put another way, while the moves could bring additional money to research, the additional scrutiny comes at least in part over increasing concerns about the quality assurance behind scientific research.
Last Month the House of Commons Select Committee on Science and Technology released a report on research commercialization. Titled Bridging the valley of death: improving the commercialisation of research the report presupposes a familiarity with U.K. research and commercial practices far beyond my experience. For instance, the competitive environment for small and medium enterprises in the U.K. appears to be qualitatively different from the environment in the U.S. However, the recommendations and other portions of the report have lessons that I think can be learned from by those within and without the U.K.
First was another reminder of how old and outdated cognitive models still dominate policy thinking. From page 9:
“14. The Science and Technology Policy Research Unit (SPRU) at the University of Sussex, and Exeter Business School (EBS) expressed concern that the Government’s strategy for growth “still retains an implicit discredited linear model in many places” mentioning specifically the Knowledge Transfer Partnerships (KTPs). Others who criticised the idea that there was a single ‘valley of death’ tended to argue that the concept encouraged people to think that innovation was linear, and that financial obstacles were only found in one place.”
While other groups who provided testimony echoed the concerns of SPRU and EBS, testimony from others still in the sway of the linear model suggests David Edgerton is doing Sisyphean work.
Second was both the absence of and need for coherent strategies for innovation, as well as the need for broad thinking about the innovation ecosystem. In this report such a need manifests in a call for an innovation agency (or rather the adjustment of an existing agency to more fully embrace that mission).
An added bonus I found is the beta of Gateway to Research – a product of the Research Councils UK (RCUK) It appears to be a one-stop shop for the information each of the seven research councils has on the projects they fund. It currently goes back to 2006, and there are data issues (which you can examine at the website). RCUK is working to have the Gateway ready for alpha later in the year.
Both the President’s Council of Advisers on Science and Technology (PCAST) and the Presidential Commission for the Study of Bioethical Issues will meet in 3 weeks. Given recent developments, it seems likely they will both have a topic in common.
The Commission is scheduled to meet in Washington on April 30. No agenda is available as of the day of this posting, but the Federal Register notice for the meeting indicated that incidental findings would be a focus. Incidental findings have been on the Commission’s agenda for a while. They represent data found from research and experiments that were beyond the scope of the research. Typically this is an ethical challenge because informed consent of human subjects involved in such research is typically focused on the designed purposes of the research.
However, at the beginning of this month the President notified the Commission that he will formally request their input on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) program. This is a new cross-agency (National Science Foundation, National Institutes of Health, Defense Advanced Research Projects Administration/DARPA) program intended to increase our understanding of how the brain functions; how we think, learn and remember. The Commission will be asked to evaluate the ethical, legal and societal implications of the program and related developments in neuroscience. Comparisons to the Human Genome Project have already been made.
Also interested in BRAIN is PCAST. During the public session (there have always been non-public sessions of PCAST meetings, they just started acknowledging it in print) of its May 3rd meeting (draft agenda), PCAST will hear from the DARPA director and the National Science Foundation Assistant Director for Biological Sciences. PCAST has held discussions on neuroscience before. It is possible that PCAST may pursue a report on this topic, but that likely won’t be clear until at least after the upcoming meeting. The other part of the public session (aside from the usual public comment session) will focus on the impact of technological advances on productivity and employment.
Yesterday the President’s Council of Advisors on Science and Technology (PCAST) issued a letter report to President Obama on climate change strategies. The letter indicates this was in response to a request for input from the President last November. The letter outlines for the President what PCAST considers should be the six key components of any comprehensive strategy on climate change.
(1) focus on national preparedness for climate change;
(2) continue efforts to decarbonize the economy, with emphasis on the electricity sector;
(3) level the playing field for clean-energy and energy-efficiency technologies by removing regulatory obstacles, addressing market failures, adjusting tax policies, and providing time-limited subsidies for clean energy when appropriate;
(4) sustain research on next-generation clean-energy technologies and remove obstacles for their eventual deployment;
(5) take additional steps to establish U.S. leadership on climate change internationally; and
(6) conduct an initial Quadrennial Energy Review (QER).
I think it worth noting that these components encompass both adaptation to climate change and mitigation of any potential damage from climate change. Mitigation, at least from my admittedly outside perspective, does not get as much attention in what passes for climate change policy discussions. (I’m sure Roger Pielke, Jr. has pointers to what I may be missing).
The national preparedness angle, for one, I find particularly overdue. However, I am concerned that such preparedness efforts could get sidetracked by debates over the ultimate cause of specific extreme events. I have similar concerns about the recommendation for an infrastructure renewal plan. The American Society of Civil Engineering has demonstrated the need for such a plan for years. And while the effects of climate change may add to the problem (something not explained in the 9-page letter), there is enough opposition to engaging with the issue that it could sidetrack policies that have plenty of justification without adding climate change to the mix.
The Quadrennial Energy Review, as explained in the letter, would be an extension of an Energy Department Quadrennial Technology Review. It also is a recommendation from a 2010 PCAST report. Such reviews, which started in the Defense Department, have been spreading over the last few years.
The ball is in the President’s court. While there have been rumblings that climate change will be a priority in the second term, the current legislative difficulties make it hard for me to see anything coming out of Congress of substance for a long time.
Yesterday the American College of Medical Genetics and Genomics (ACMG) released a series of recommendations around incidental or secondary findings related to genetic tests (H/T ScienceInsider). This attracted my attention for two reasons:
- The Presidential Commission for the Study of Bioethical Issues will be studying the ethical implications of incidental findings
- Two Scientific American blog posts appear to disagree as to the meaning of the recommendations. (This likely means the recommendations are just hard to effectively distill into short articles.)
Incidental findings refer to discoveries made in the context of looking for something else. Consider it the testing equivalent of finding out that an experiment to test one hypothesis managed to prove another. Genetically speaking this would be something like getting tested for abnormalities on one chromosome, and finding something odd on another chromosome.
The recommendations give additional details to a policy statement issued by ACMG in 2012. But the recommendations move beyond an acknowledgement of incidental findings to an encouragement of seeking them out.
Earlier today the Presidential Commission for the Study of Bioethical Issues released its report on pediatric medical countermeasures research (H/T ScienceInsider). Titled Protecting Children, the report reflects the Commission’s deliberations on the subject over the past 15 months (prompted by recommendations from the National Biodefense Science Board. Commission Chair Amy Gutmann has a Perspectives column in The New England Journal of Medicine on the subject.
Many challenges with research on medical countermeasures for children have to do with issues of consent. Because of their age, children cannot legally give informed consent, and if the research is not likely to present significant benefits to the research subjects, the risk they should be expected to accept should be minimized. But there has been no documented research on the use of current anthrax vaccines on children, leaving us unprepared in the instance of a widespread release of the virus.
The report focuses on two kinds of medical countermeasures research: pre- and post-event. The event in question is exposure to the biological agent. The distinction is critical from an ethical perspective because the obligations to the research subjects shift. In a pre-event research scenario, there has been no exposure to the virus, meaning the threshold of risk exposure needs to be lower to correspond with the reduced (or nil) benefit to the research subjects. Post-event research would help the research subjects as they have been exposed to the agent, and higher levels of risk are considered acceptable in those situations.
The bulk of the report’s recommendations set forth the appropriate review mechanism and standards of harm that it considers appropriate for pre- and post-event medical countermeasure research. Many of these recommendations speak to the relevant federal regulations on human subjects research for children. A good summary of the Commission’s findings and recommendations can be found in Dr. Gutmann’s Perspectives column.
The Commission’s next meeting will be at the end of April in Washington, D.C. While no draft agenda is released as of this writing, guidance on incidental findings is a project the Commission has announced its interest in pursuing.
For all the talk about evidence-based policy in the United States, we don’t seem to have much institutional capacity for developing it. I don’t claim that this is an easy problem to solve, but with the amount of ink spilled (electronic and otherwise) on having science inform policy, I’d have expected something to emerge.
It may happen in the U.K. Recently the U.K. Government announced a What Works Network (WWN), a collection of centers that will produce and disseminate research to local decision makers. Building on the success of centers focused on health and education, the network will help inform decisions on approximately £200 billion of government spending. The new centres will target local economic growth, early childhood intervention, crime prevention and ‘ageing better’ – improved health for the elderly.
Such centres would be independent of government, and their research work would focus on policies within and without the U.K. While the report on the WWN cites the Washington State Institute for Public Policy as an example of this kind of work, I think the Public Policy Institute of California would be comparable.
What is new, and I think it will have effects beyond the network, is the appointment of a National Adviser for the network. As described in the announcement by Minister of Government Oliver Letwin:
The next meeting of the President’s Council of Advisers on Science and Technology (PCAST) will meet (at least in public session) on Friday morning, March 15. You can register for the meeting online, which will take place at the National Academies Lecture Room in their building on Constitution Avenue in Washington. It will be webcast as well (which requires no registration, the link will be available at the PCAST website on the day of the meeting.
According to the agenda as of February 12, the focus of this public session will be on reports. Most of them will be PCAST reports. There will be updates on projects concerning forensic science (the over/under on CSI references is arbitrarily set at 5 for the entire meeting) and energy and climate change. One of the members of the working group on the PCAST report on undergraduate science, technology, engineering and mathematics education is schedule to present on the progress in implementing that report’s recommendations.
The lone outside report discussed at this meeting will be the American Chemical Society’s graduate education report. It was released in December 2012 and proposes some significant changes in the way chemical scientists are prepared in graduate school.
Please note that with two weeks remaining before the meeting, the agenda may change.
European Commission President José Manuel Barroso has created a Science and Technology Advisory Council (H/T ScienceInsider). Its members were appointed by President Barroso in consultation with his Chief Scientific Adviser, Professor Anne Glover. According to ScienceInsider, Glover will chair the council.
There are 15 scientists, all but one from Europe, in the Council, which will report directly to the President. It’s characterized as an independent and informal advisory body, suggesting it will function in a way similar to the President’s Council of Advisors on Science and Technology (PCAST) in the United States. But that’s highly speculative prior to any meeting outcomes (the Council did meet in Brussels earlier today). The intention for the group is:
“to provide advice directly to the President on how to create the proper environment for innovation by shaping a European society that embraces science, technology and engineering. In particular, the Council will advise on the opportunities and risks stemming from scientific and technological progress. It will also advise on how to communicate these in order to foster an informed societal debate and ensure that Europe does not “miss the boat” and remains a global leader in cutting-edge technologies.”
A list of the Advisory Council members is at the end of this Commission press release. While I don’t know the background of all the members (aside from their respective countries), there is one Nobel laureate and one Fields Medal recipient among them.
Shortly after it’s recent meeting in Miami, the Presidential Commission for the Study of Bioethical Issues noted its next big project. Once it has wrapped up work on medical countermeasures research for children, it will focus on what’s known as incidental findings to research. Such findings would represent meaningful information that was not the target of the study. As this was information that would not typically be covered under common informed consent practices, there are some ethical concerns over what can be done with the resulting information, and what obligations come attached to that information.
Genetics offers a good example of incidental findings, and the Commission discussed them on its blog last November.. Very often, genetic testing for particular traits and/or diseases can tell something about the person, and their relatives. It may also reveal genetic conditions that were not tested for. If information like this comes up, what are the obligations of the researchers? Does this possibility need to be raised prior to the research and/or testing? How can you effectively make an informed consent form for things that might emerge in an area unrelated to the focus of the test?
These and other questions will require deep thought and consideration, which the Commission seems very capable of doing. An indication of its thinking can be found in its report Privacy and Progress in Whole Genome Sequencing.
On page 98, the report recommends (Recommendation 3.3) that “researchers … make individuals aware that incidental findings are likely to be discovered in the course of whole genome sequencing. The consent process should convey whether these findings will be communicated, the scope of communicated findings, and to whom the findings will be communicated.”
The next meetings of the Commission will be April 30-May 1 in Washington, D.C., and August 19-20 in Philadelphia. Presumably this issue will show up on the agenda for at least one of these events.