Deadline Extended For Comments On Human Subjects Protection Regulations

The agencies working to update federal regulations on human subjects protection (colloquially known as the Common Rule) have extended the deadline for public comments.  Originally set for next Sunday, December 6, it has been extended to January 6, 2016.

(I know in my original post I had made noises about making more detailed comments on the request for comments.  I will do my best to make the original December 6 deadline.)

The extension has been made in part due to requests received from the public for additional time to comment.  Given that the comment period for the Advanced Notice of Proposed Rulemaking released in 2011 was also extended one month, this extension is not surprising.

It would be nice if the Administration would get off of its annoying trend of very short – often 90 days or less – to comment on significant policy documents like the proposed changes to the Common Rule.  Dumping these notices at the beginning of weekends or holiday periods (this was published the day before Thanksgiving) is also annoying, and undercuts any intentions on being really open and transparent with goings-on.


Newest Medal Of Freedom Recipients Include Figures In Science And Science Policy

President Obama recognized the latest recipients of the Presidential Medal of Freedom earlier today in a ceremony at the White House.  It’s the highest civilian honor a president can bestow for services to the country, and this year’s group include two people recognized for their contributions to science or science policy.

Katherine Johnson is a mathematician whose work for the government included service at NASA and its predecessor agency, the National Advisory Committee for Aeronautics (NACA).  Her 33 year career at both agencies included calculations critical to every human spaceflight program from Mercury through the Space Shuttle.  As one of the first African American women who worked for NACA and NASA, Johnson has also worked hard to encourage other women and minorities to pursue education in science, technology, engineering and mathematics.

Also recognized this week is William Ruckelshaus, a two-time Administrator of the Environmental Protection Agency (EPA).  He was the first to head the agency, serving from 1970-1973 under President Nixon.  Ruckelshaus instituted the U.S. ban on the pesticide DDT.  He returned to the agency as President Reagan’s second EPA Administrator from 1983-1985.  Ruckelshaus also served as Deputy Attorney General and Acting FBI Director during the Nixon Administration, and was involved in environmental protection matters during the 1960s in Indiana.  Now living in Washington state, Ruckelshaus has kept active in local and national ocean and environmental matters, being appointed to various panels by both President Clinton and President George W. Bush.

Congratulations to both Ruckelshaus and Williams, and the other medal recipients.

Homeopathy May Receive Heightened Scrutiny From Regulatory Agencies

While it appears (at least to me) to get more attention (and ridicule).  Homeopathy – the attempt to treat conditions with items that produce the same symptoms in healthy patients – is a business of note in the U.S.  While the Food and Drug Administration (FDA) regulates homeopathic treatments, it does not make claims as to their efficacy.

(Let’s put aside the discussion of what reason there might be to regulate a substance without judging whether it does what it is claimed to do.)

That might change soon.  According to Dan Vergano at Buzzfeed, both the FDA and the Federal Trade Commission (FTC) may act soon on homeopathic treatments.  The FTC has raised concerns that FDA practice in this area runs counter to the FTC requirement that health claims in advertising need to be backed up by “competent and reliable scientific evidence.”

This has, apparently, been a longstanding conflict, as the FDA first promised to put homeopathic products up to a standard comparable to the FTC’s in 1972.  Maybe, just maybe, this long standoff is approaching an end.

Behavioral Economist To Write Star Wars Book, Insert Force Joke Here

Academic analyses of various works of fiction aren’t new.  I have at least a shelf’s worth of books that look at Star Trek from a field-specific perspective.  Star Wars is no exception to the efforts to expose new concepts in the midst of popular culture.

However, the announcement that Cass Sunstein, noted behavioral economist and former Obama Administration official, is writing a Star Wars book, is a bit out of the ordinary.  While Sunstein and his publisher are being vague on the theme of the book, the announcement suggests it could be wide raging.  Whether or not it will conduct the kinds of behaviorally tinged analyses some desire remains to be seen.

The most extensive writing I’ve found Sunstein do on Star Wars are two pieces reviewing a history of the franchise (one is essentially an expansion of the other).  Both have titles referencing constitutional law, reflecting how the pieces try to compare certain dramatic revelations in two of the films with notable legal decisions.  He’s trying to compare the way in which George Lucas worked from idea to final films to the way laws and legal interpretations of those laws change from start to current judicial understanding.

If these reviews are an indication of how Sunstein might right a book for a general audience involving a big cultural force, I’d be concerned about his publisher making back the advance.  He makes a decent point, but the effort to do so through the narrative of making a particular set of films doesn’t mesh well with the underlying message.  I don’t think he uses a tortured metaphor, I simply think the effort resembles walking through a swamp when a raft is available.

From One CSA To A Committee Of Seven: EU Science Advice

Back in May the European Commission announced it would set up a Scientific Advice Mechanism (SAM) under the current President.  This was to replace, at least in part, the functions of the chief scientific adviser under the previous administration.  One component of the SAM is the High Level Group of Scientific Advisers, a committee of seven prominent scientists that will provide independent advice to the Commission.

On November 10 the Commissioner for Research, Science and Innovation, Carlos Moedas, named the seven members of the high level group.  They are:

  • Janusz M. Bujnicki
    Professor, Head of the Laboratory of Bioinformatics and Protein Engineering, International Institute of Molecular and Cell Biology, Warsaw
  • Pearl Dykstra
    Professor of Sociology, Erasmus University, Rotterdam
  • Elvira Fortunato
    Professor, Materials Science Department of the Faculty of Science and Technology, NOVA University, Lisbon
  • Rolf-Dieter Heuer
    Director-General, European Organization for Nuclear Research (CERN)
  • Julia Slingo
    Chief Scientist, Met Office, Exeter
  • Cédric Villani
    Director, Henri Poincaré Institute, Paris
  • Henrik C. Wegener
    Executive Vice President, Chief Academic Officer and Provost, Technical University of Denmark

The group is expected to hold its first meeting in January.  Between now and then (and probably for some time after) the group and its staff will be developing processes and guidelines for its work and the plethora of questions about how it will provide independent scientific advice to the Commission.  Given the way in which the Commission decided to create this body, a lot of people will be watching.

Ministerial Mandate Letters Help Detail Expectations For Canadian Government

New Prime Minister of Canada, Justin Trudeau, has released the Ministerial Mandate Letters he submitted to his Cabinet Ministers (H/T The Frogheart Daily).  They outline PM Trudeau’s expectations for his ministers, which focus a great deal on collegiality with members of Parliament outside of the Liberal Party and being open and transparent in their dealings.

But the letters also outline priorities and goals for the ministries.  As Science is part of the job title for two different Ministers, these letters help define which areas of science and science policy will fall under which Minister.  Other Ministers have science and technology responsibilities (I’ve described these in a separate post) and you can check out their letters as well.

The new Science Minister, Kirsty Duncan, was given the following priorities in her letter:

  • Create a Chief Science Officer mandated to ensure that government science is fully available to the public, that scientists are able to speak freely about their work, and that scientific analyses are considered when the government makes decisions.
  • Support your colleagues in the review and reform of Canada’s environmental assessment processes to ensure that environmental assessment decisions are based on science, facts, and evidence.
  • Support the Minister of Employment, Workforce Development and Labour in efforts to help employers create more co-op placements for students in science, technology, engineering, mathematics, and business programs.
  • Support your Ministerial colleagues as they re-insert scientific considerations into the heart of our decision-making and investment choices.
  • Lead the establishment of new Canada Research Chairs in sustainable technologies, working with the Minister of Innovation, Science and Economic Development.
  • Work in collaboration with the Minister of Fisheries, Oceans and the Canadian Coast Guard and the Minister of Environment and Climate Change to examine the implications of climate change on Arctic marine ecosystems.
  • Examine options to strengthen the recognition of, and support for, fundamental research to support new discoveries.

The following paragraph from the letter outlines Trudeau’s philosophy with respect to the role of science in this government.

“We are a government that believes in science – and a government that believes that good scientific knowledge should inform decision-making.  We believe that investments in scientific research, including an appropriate balance between fundamental research to support new discoveries and the commercialization of ideas, will lead to good jobs and sustainable economic growth. As Minister of Science, your overarching goal will be to support scientific research and the integration of scientific considerations in our investment and policy choices.  Support for science is an essential pillar in our strategy to create sustainable economic growth and support and grow the middle class.”
It’s worth noting – because it often gets lost – that this philosophy sees scientific knowledge and scientific considerations are but one input into policy and decision making.  Inform, not dictate.
It’s also worth noting that the Minister of Innovation, Science and Economic Development (MP Navdeep Bains) is mentioned just once in the Minister of Science letter.  Looking at the letter sent to Minister Bains, it would seem that PM Trudeau sees science in this portfolio in service to economic development and innovation.  The role as outlined in the letter:

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Precision Medicine Initiative Working On Its Privacy

On Monday the Obama Administration released Privacy and Trust Principles for the Precision Medicine Initiative.  This follows a public comment period responding to the draft principles released this summer.

My comparison of the draft and final principles suggest that most of the changes are in terms of streamlining and reorganizing the document.  The concerns I had at the time I posted about the draft principles remain.  An enforcement regime for these principles is not within the document, and I think it is critical to success in obtaining the data from the million individuals the Initiative wants.  The same is true of the Security Policy Framework (what was probably the Security Framework in the draft principles).

The broad Privacy and Trust Principles described by the document are:

  • Creating a dynamic and inclusive governance structure
  • Building trust and accountability through transparency
  • Respecting participant preferences
  • Empower Participants through Access to Information
  • Responsible data sharing, access and use
  • Maintaining data quality and integrity