We The People Streamlines The Process

We The People, the White House petition platform that helps demonstrate how well people understand the separation of powers in the United States, announced a change in how it collects signatures.  The website had required those who signed and/or initiated petitions to establish an account before contributing.  That is no longer the case for signing.

This does not mean that commenting can be anonymous (insert NSA joke here about how it probably never was anonymous).  Signing will require a name, email address and zip code.  Those who want to start a petition must still have an account, which requires the same information as signing.

For what it’s worth (some are generally skeptical of the impact of such online petitions), there have been nearly 350,000 petitions started on the website since November 2011.  There have been over 14.4 million users, and over 21.2 million signatures, in the same time period.

PCAST Mixes Oceans, Nanotech and Microbial Resistance In Next Meeting

The President’s Council of Advisers on Science and Technology (PCAST) will hold its next public meeting on July 11 in Washington.  (For whatever reason, it seems lately that the Federal Register is a more reliable source on meeting information than the PCAST website.)  The meeting will take place between 9 and noon Eastern time, and will be webcast.  Those seeking to attend in person need to register.

While no agenda is presently available, the Federal Register notice indicates that the Council will discuss two reports in progress and hear from one panel of experts.  The reports in progress involve nanotechnology (likely the latest evaluation of the National Nanotechnology Initiative) and antibiotic resistance.  PCAST will hear from speakers on the topic of oceans policy.  Perhaps Beth Kertulla, the new director of ocean policy for the White House, will be one of the speakers.  While the Administration was recently in the news for expanding several ocean sanctuaries, I suspect the panel may be more focused on how the Implementation Plan for the National Ocean Policy (the Obama Administration is the first to establish a National Ocean Policy) is proceeding.  But that’s just mildly informed speculation.

California Jumps On The BRAIN Wagon

Many of the scientists who proposed the national BRAIN Initiative (Brain Research Through Advancement of Innovative Neurotechnologies), and several members of the Advisory Committee to the Director of the National Institutes of Health on the BRAIN program are at California institutions.  California has also established, in part due to a voter initiative, a state institute to support research in stem cells and other regenerative therapies.

So it’s news, but perhaps not surprising, that California has officially started Cal-BRAIN (California Blueprint for Research to Advance Innovations in Neuroscience) (H/T Nature News).  Required under a law passed earlier this year, Cal-BRAIN is a project of the University of California system, with the University of California, San Diego in charge.  The state set aside $2 million for the effort, which is to establish a blueprint for university and industry participation in the program.  The law specifically states that a goal is to have an industrial investment matching the state investment in Cal-BRAIN.  It also requires a technology transfer program and web presence for Cal-BRAIN.  The University of California has yet to determine how much it will invest in the project, but that should be announced soon.

The National Science Board Gets Some New Faces

The 24 member National Science Board has members with staggered terms.  Every two years 8 positions are up for appointment (Senate confirmation used to be required for all members).  Earlier this week the National Science Foundation (NSF) announced who six of the new members will be.  I’ve listed them below with their academic training.  More information on each new member is available via the NSF announcement.

John L. Anderson – chemical engineering
Roger N. Beachy - agriculture
Vicki L. Chandler – plant biology
Robert M. Groves – sociology
James S. Jackson – social psychology
Sethuraman Panchanathan – computer science

Based on the list of desired experience circulated last year, I know that at least Dr. Beachy (who helped found the National Institute of Food and Agriculture) and Dr. Panchanathan address specific areas on the list.  How well the other members address that long list may be easier to determine once the new members attend their first Board meeting in August.

So, That White House Maker Faire Is Tomorrow

Tomorrow is the first White House Maker Faire.  Starting at 10 a.m. Eastern you can watch the festivities, which may or may not strongly resemble the format of the White House Science Fairs (a pre-show with relevant science/technology personality of note, the President visits a few projects, then makes a speech touting an educational program).  Visit whitehouse.gov/live to watch it live, and it will likely be archived within 24 hours.  There will likely be an appearance of the marshmallow cannon from the 2012 White House Science Fair.

Tomorrow is also designated as a Day Of Making.  The White House encourages people to share their making experiences online and/or in person.  Their preferred hashtag for the social media is #NationofMakers.  MAKE magazine will hold an all-day meetup at its headquarters, including an online event from 5-7 p.m. Pacific time.

One of the Makers featured tomorrow will be an entrepreneur – Lisa Qiu Fetterman of Nomiku – who developed a sous vide cooking system for home use.  It will be interesting to see how well the White House meets the breadth of the Maker movement (which includes art and craft as well as science and technology) or if it sees the effort predominantly through the eyes of manufacturing and small business. The visibility of Mike Wright (a Maker of wide interests), might be an indicator.

NIH Advisory Group Outlines Long-Term Plan For BRAIN Initiative

While budget pressures may turn it into a wish list, the Advisory Committee to the Director of the National Institutes of Health (NIH) has outlined a long-term plan for the NIH portion of the BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies).  NIH is one of three federal agencies involved, along with several private sector entities and foundations.  The NIH intends, per its press release, to “map the circuits of the brain, measure the fluctuating patterns of electrical and chemical activity flowing within those circuits, and understand how their interplay creates our unique cognitive and behavioral capabilities.”

The estimated necessary investment is significantly larger than the $140 million expected between the current fiscal year and fiscal year 2015.  The Advisory Committee sees a 12-year investment of $4.5 billion as important toward achieving its vision, which would include doing the following (again, from the press release):

  • Pursu[ing] human studies and non-human models in parallel
  • Cross[ing] boundaries in interdisciplinary collaborations
  • Integrat[ing] spatial and temporal scales
  • Establish[ing] platforms for preserving and sharing data
  • Validat[ing] and disseminat[ing] technology
  • Consider[ing] ethical implications of neuroscience research
  • Creat[ing] mechanisms to ensure accountability to the NIH, the taxpayer, and the community of basic, translational, and clinical neuroscientists

The Advisory Committee describes its plan in a report released last week.  BRAIN 2025 is pretty thorough, certainly for a policy document (rather than a research paper).  It covers why the Initiative is needed, a scientific review intended to justify the choices for high-priority research areas, and a detailed implementation plan that includes deliverables, milestones, and cost estimates.  It’s worth taking the time to review and digest.

As ambitious, and arguably as valuable, as the BRAIN Initiative is, the recent budget fights suggest to me that there is no stomach in Congress for major scientific investments.  There’s barely enough interest in maintaining a status quo that doesn’t consider inflation.  I strongly suspect that a large chunk of the $4.5 billion (again, this would be spread out over 12 years) will come – if it comes at all – from non-governmental sources.  That may not be a problem, depending on what expectations come with the additional outside funding.

The White House intends to hold an event later this year to discuss further efforts supporting the BRAIN Initiative.  No date has been announced as yet.

Bioethics Commission Continues Assessment Of Neuroscience Research

The Presidential Commission for the Study of Bioethical Issues will hold its next meeting on Monday and Tuesday, June 9 and 10, in Atlanta.  Per the draft agenda, it will continue the work it started last summer on the ethics of neuroscience research and its applications.  As is customary, the meeting will be webcast, simply visit the Commission website during the meeting.

On the first day the Commission will hear from experts on data sharing in neuroscience research, the potential in the field, and the differences in neuroscience research for various stages of life.  On the second day the focus shifts slightly to the ethical and social implications of neuroscience research.  The material on the second day will likely inform the second volume of the Commission’s report, Gray Matters.  The first volume was released in May and focuses more on how to better integrate ethical principles into neuroscience research.  During this meeting, the Commission may give some idea of when that report might be available.

White House Maker Faire Is In Less Than 2 Weeks! Quick, Get Involved!

Yesterday the White House announced that its first Maker Faire will take place on June 18th.  The Administration had members of the band OK Go (who are arguably a Maker group that occasionally makes music) spread the word.

I agree that we all should get involved, and I like how the White House wants to make June 18th a Day of Making.  But that seems tough to do with just two weeks notice.  The Administration announced back in February that there would be a Maker Faire.  That would have been an excellent time to make the suggestions for how individuals could celebrate the White House Maker Faire (or the Day of Making) in their own communities.  Instead there were vague suggestions of how universities and companies could get involved.  They were good suggestions, but not really directed at getting people Making.

I’m concerned that the Maker Faire will end up being the same kind of showcase/good publicity opportunity that the Science Fair can be.  Sure, there are plenty of efforts to communicate the value of learning science and technology connected to the Fair, but the event does not seem to be something that an average kid could look at, decide they want to participate in, and know how to make that happen.  The participants appear to have already been chosen well before the date of the Fair is announced, and I wouldn’t argue with you if you thought the projects were window dressing for announcing the latest education initiative.

That’s troubling for a science fair.  But with the participatory and community elements of Maker Faires, the apparent lack of individual public engagement in the White House Maker Faire strikes me as a bigger problem.  It’s okay if the participants for this Maker Faire have already been selected (as this MAKE article suggests), but I wish the White House was more explicit about it.

Gene Therapy May Have Revised Oversight

The National Institutes of Health (NIH) will stop requiring special review of gene therapy trials (H/T ScienceInsider) currently conducted by the Recombinant DNA Advisory Committee (RAC).  NIH Director Francis Collins justified the decision, which is based on recommendations from a study it requested of the Institute of Medicine, by noting the progress in the field since the formation of the RAC over 40 years ago, as well as the additional regulatory reviews in place for this kind of research.  The RAC would remain to review special kinds of gene therapy trials, provided they meet the following requirements:

  1. The protocol review could not be adequately performed by other regulatory and oversight processes (for example, the institutional review boards, institutional biosafety committees, and the FDA).
  2. One or more of the following criteria are satisfied:
    • Protocol uses a new vector, genetic material, or delivery method that represents a first-in-human experience, thus representing unknown risk.
    • Protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value.
    • Proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for local and federal regulatory bodies to evaluate the protocol rigorously.

I understand the idea that the RAC likely conducts a certain amount of review that is redundant.  Given the challenges facing other bodies with NIH-relevant ethics responsibilities, I would certainly understand if anyone took pause in response to the decision.  Especially since the NIH has yet to decide whether to follow another IOM recommendation – to replace the RAC with another body focused on gene therapy and other kinds of risky research.

NIH Needs Help In Its Ethics House

This week we can read about how National Institutes of Health (NIH) and Department of Health and Human Services (HHS) officials may have influenced the investigation of a study by the HHS Office of Human Research Protections (OHRP).  In short, Public Citizen is claiming, based on documents obtained from a Freedom of Information Act request, that NIH and HHS officials worked to change the response of OHRP to concerns about informed consent procedures in a study involving premature babies.  Public Citizens complaint is with the HHS inspector general and at least one member of Congress, Rosa DeLauro of Connecticut, has expressed interest in the case.

This matter comes to light just as a sister office at HHS, the Office of Research Integrity (ORI), is closing the submission process for its Director search.  The former Director, David Wright, resigned in March due to what he characterizes as a ‘remarkably dysfunctional’ bureaucracy.  He served for just over 2 years, and the office was without a director for two years before then.  He described his frustrations to a Science reporter in April, and felt that greater authority, if not outright independence, would make it easier for ORI to deal with its caseload.

While the two offices, ORI and OHRP, and separate, and deal with different parts of the scientific process, they both serve the broader interest of providing guidance toward more ethical research conducted with federal dollars.  But these two incidents suggest the Department, and NIH, are not committed to that goal.  The lack of progress on proposed changes to the ‘Common Rule’ that guides research involving human subjects adds to this negative impression.

If an Inspector General investigation recommends changes to the authority and resources of OHRP, it seems likely such changes could benefit ORI.  Hopefully a new HHS Secretary will have the interest and will to make the necessary changes to demonstrate the Department’s commitment to ethical research oversight and guidance.  (And if they shove the changes to the Common Rule forward, all the better.)