Human Subjects Research Rule Revisions Finally Proposed

More than four years after the federal government introduced an advanced notice of proposed rulemaking on federal regulations on human subjects research (called the Common Rule), there has been another regulatory step (H/T ScienceInsider).

The Federal Register has a draft edition of the notice of proposed rulemaking it will publish on September 8.  Comments will be due in 90 days from the date of publication, which would be around December 6.  The draft notice is over 500 pages, so I will have additional posts on the subject once I have the chance to review this in more detail.

Quick thoughts on a first glance.

If this is implemented as written, it will affect researchers in a number of different fields (16 federal agencies are listed in the proposed rules, but not the Office of Science and Technology Policy), and it seeks to define areas of activity that would or would not be covered under the proposed rules.

(Two agencies – the Department of Housing and Urban Development and the Consumer Product Safety Commission – will update their Common Rule regulations through separate proceedings.  The Department of Labor is not currently covered by the Common Rule, but has joined this rulemaking in order to adopt those regulations.)

The proposed changes are necessary to do the heavy lifting required to update a 24 year-old rule.  With the continued changes in technology, whatever final rule that emerges will become dated quickly.  Having a means of effectively assessing and adapting to future changes in technology and research capabilities would be nice to have.

Even if you don’t think work you’re engaged with isn’t covered by federal human subjects research regulations, read the notice.  You might be surprised.

Colo(u)r Me Optimistic About A Canadian Science Debate

Last month I noted the call for a science debate among party leaders in Canada in advance of the October 19 Parliamentary elections.  With my usual measure of skepticism (easily conflated with cynicism, even by me), I suggested that those advocating for such a debate aim a bit lower, say at the ministerial level rather than at the party leaders.

If you follow Science Borealis, a Canadian science policy blog of note, you can read about how successful (certainly compared to U.S. efforts) Canadians have been in getting science debates held in connection with provincial elections.

And at least one media program is trying to produce one.  All they can say at the moment is…

And this, about an event in Victoria, presumably focused on candidates in British Columbia.

This is very encouraging.

Latest PCAST Report Encourages New Categories For IT Investments

Earlier this month the President’s Council of Advisers on Science and Technology (PCAST) released its latest report, focused on the Network and Information Technology Research and Development (NITRD) program.  PCAST is required by law to evaluate the program, which coordinates federal investment across the government in information technology research.

As is regrettably the case with many government programs in technology, the organization of NITRD reflects what was close to cutting edge thinking of the time it was created.  A major recommendation of this report is to reorganize the NITRD program to better reflect the state of research in information technology and the current priorities for the government.

The report focuses on the following areas of information technology: cybersecurity, health, Big Data and data-intensive computing, IT and the physical world (any IT connected to something that isn’t a computer or a phone), privacy protection, cyber-human systems, high-capability computing, and foundational computing research.  The authors consider each of these areas as critical to success in any national priority related to information technology research.  However, there remain gaps in access to large-scale infrastructure and other resources that make it harder to effectively support federal research in these areas.

In order to establish a more nimble NITRD program, the authors recommend establishing new program component areas (PCAs) that are used to organize NITRD funding.  Most of these categories have remained unchanged for twenty years.  What the report recommends is establishing eight new PCAs for the 2017 budget cycle, and that these PCAs should be updated every five or six years.  The PCAs recommended in the report are:

  • Large-scale data management and analysis;
  • Robotics and intelligent systems;
  • Computing-enabled networked physical systems (such as distributed sensor networks);
  • Cybersecurity and information assurance;
  • Computing-enabled human interaction, communication, and augmentation;
  • IT foundational research and innovation;
  • Enabling-IT for high-capability IT systems; and
  • Large-scale research infrastructure.

The recommendations would need to be implemented by the Office of Science and Technology Policy and the Office of Management and Budget.  Both agencies have expressed support for such changes.  They would also need to develop, with other NITRD stakeholders, the process for judging when and how to modify these PCAs based on changes in the field.

Unsolicited Advice To Canada – Follow A UK Model For Science Debates

Thanks to Twitter, I read this opinion piece in The Toronto Star advocating for science to be part of the leaders’ debates leading to the October 19 Parliamentary election.  Breaking from previous tradition, there will be not two debates (one in English, one in French), but at least six.  (One has already been held, and there are proposals for additional debates beyond the five currently scheduled.)

The authors would love to have a debate focused on science matters.  That’s understandable, especially given how science has fared under the current Canadian government’s efforts to tightly control the information it produces.  However, I think the compressed campaign schedule (though it is the longest Canadian campaign in history) will make it difficult to get either a debate exclusively on science questions or science questions into the debates that will be held.

That’s not to say it shouldn’t be tried.  But I would recommend not copying those of us on your southern border concerning science debates.  Rather I suggest you review our British cousins and adapt your strategy accordingly.  Two science questions were part of a UK leaders debate in the 2010 campaign (though it was the one conducted over YouTube and Facebook), but that same campaign saw three cross-party debates at the science ministerial level.  The science minister for the then-ruling Labour party debated shadow ministers from the two next largest parties (the Conservatives and the Liberal Democrats).

I think it manageable to have the science minister and his shadow minister counterparts in the major Canadian parties debate each other.  In particular, MP Kennedy Stewart, shadow minister for science and technology of the National Democratic Party, may be strongly motivated to have such a debate, given his interest in establishing a Parliamentary science officer.  The bigger challenge may be getting something to happen during the current campaign.  Good luck!

Postscript – The parliamentary system underlying these minister-level debates is not present in the United States, so it’s a bit harder to identify an American equivalent.  For instance, I see little in it for the leaders and ranking members of the relevant Congressional committees to debate in an election year when they aren’t running against each other.  And given the stronger division between the executive and legislative branches in the U.S., such a debate wouldn’t cover what a President might do.  For that you might have to have candidates who could identify a Presidential science adviser early in their campaign – a rarity.

Nominations Sought For Sustained National Climate Assessment Advisory Committee

The U.S. Global Change Research Program (USGCRP) has produced three national climate assessments since 2000.  The program is also developing a sustained assessment process to provide a more robust climate change information source.  It would inform both the quadrennial assessments and other elements of the USGCRP.

To assist in that end, there will be an Advisory Committee for the Sustained National Climate Assessment.  The National Oceanic and Atmospheric Administration (NOAA) has chartered the Committee, and will forward its work to the Director of the Office of Science and Technology Policy.  The Committee would provide advice on the engagement of stakeholders and on sustained assessment activities and the quadrennial National Climate Assessment report.

NOAA is seeking nominations for the committee, which will close on September 14.  The call for nominations says that the committee should have people with the following areas of expertise:

  • Communications, engagement, and education;
  • Risk management and risk assessment;
  • Economics and social sciences;
  • Technology, tools, and data systems; and
  • Climate change and variability, including impacts and societal responses

Individuals can self-nominate or nominate another individual.  An application package is required, which includes the individuals contact information, institutional affiliation, area of expertise, short description of qualifications and a résumé (no longer than four pages).  Consult the call for nominations for how to submit this information.

Demo Day Includes Announcement Of I-Corps Expansion

The first White House Demo Day was on Tuesday, and is sometimes the case with White House events like this, the Administration took the time to announce other news related to the topic of the day.  The topic of the Demo Day was entrepreneurship, and the related announcements included commitments from federal agencies and private companies to further support entrepreneurship, with an emphasis on increasing participation from underrepresented groups.

One of the government announcements concerned the Innovation Corps, or I-Corps, started at the National Science Foundation in 2011.  The program pairs government-funded scientists and engineers with entrepreneurs to assist them in translating their lab work into marketable products.  Since the 2011 launch the I-Corps is now part of two Energy Department components (the Advanced Research Projects Agency – Energy, and the Office of Energy Efficiency and Renewable Energy) and the National Institutes of Health (NIH).  The expansion announced this week will include the following agencies:

  • NIH will expand its I-Corps program to include projects funded through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) as well as some programs at the National Center for Advancing Translational Sciences.
  • Several programs at the Department of Defense.
  • The National Security Agency will start an I-Corps program geared toward the Intelligence Community which would be expanded to three other intelligence agencies.
  • The Agricultural Research Service and the National Institute of Food and Agriculture at the Department of Agriculture.
  • The Science and Technology Directorate of the Department of Homeland Security will put its SBIR-funded researchers through the I-Corps program.
  • The Small Business Administration will use I-Corp curricula for several of its resource and mentorship organizations, including the Small Business Development Centers.

Do read the full fact sheet to learn of the other announcements made by the administration on Demo Day.

Some Movement On Science And Technology Nominations

This month has produced some motion on filling vacant science and technology positions.  Whether this represents forward momentum or the bureaucratic equivalent of Brownian motion remains to be seen.

There is one vacancy remaining on the Nuclear Regulatory Commission, even with two nominees being confirmed around the beginning of the year.  Jessie Roberson has been nominated to fill that vacancy (technically last held by a current Commissioner, Jeff Baran).  Roberson is currently Vice Chairman of the Defense Nuclear Facilities Security Board, and has worked for the Department of Energy both in Washington and at two different Department nuclear facilities.

This week the President also nominated people to fill vacancies at the National Science Foundation and the Department of Energy.  Richard Buckius has been nominated to fill the position of Deputy Director at the National Science Foundation (NSF), which has been vacant since August 2014.  Dr. Buckius has worked at NSF before, and currently serves as both Chief Operating Officer and Senior Science Officer.  His academic training is in engineering, and Buckius served as head of the Engineering Directorate from 2006 to 2008.

Cherry Murray, a Harvard physicist who received the National Medal of Technology and Innovation last year, has been nominated to serve as Director of the Office of Science at the Department of Energy.  There has not been a confirmed Director of the Office since 2013.  Marc Kastner was nominated to the position in 2013, but did not receive a Senate vote before the end of that Congress in December 2014.  Cherry worked at Bell Labs for much of her career, and also at the Department of Energy’s Lawrence Livermore Laboratory.  She currently holds academic appointments in Technology and Public Policy as well as Physics at Harvard.