Precision Medicine Initiative Seeks Input On Privacy and Trust Principles

I completely missed this one when it was announced in early July, but the interagency working group on the Precision Medicine Initiative (PMI) is working on privacy and trust principles to guide the project.  It is seeking public comment on a proposed set of principles, but the deadline is Friday, August 7.

The principles are intended to guide the PMI in the large-scale data collection and analysis that is critical to the project.  The PMI is trying to gather data voluntarily from a large cohort (at least one million individuals) and allow responsible access to that information by a large number of researchers and institutions (and the members of the cohort itself).  Solid privacy and trust principles, with an implementation and enforcement regime behind it, can engender sufficient confidence in the public for the project to reach its million-member cohort.

In parallel with this process, the principles indicate there will be work on a data security program for the PMI.  I have not yet found any working documents on that program, but I will link to them from this blog once I do.

Next Bioethics Commission Meeting Will Continue Deliberations On Deliberation

The Presidential Commission for the Study of Bioethical Issues will next meet September 2 in Washington, D.C.  As is the current practice, there will be a live webcast and the Commission staff will liveblog the meeting.

Per the Federal Register notice (a formal agenda is not yet available), the meeting will continue the work it started at its May meeting in Philadelphia.  Topics will include:

  • The role of deliberation and deliberative methods to engage the public in bioethics, and how to integrate pubic dialogue into the bioethics conversation;
  • Bioethics education as a forum for fostering deliberative skills, and preparing students to participate in public dialogue in bioethics;
  • Goals and methods of bioethics education; and
  • Integrating bioethics education across a range of professional disciplines and educational levels.

There may or may not be a formal report coming from these discussions.  Given the nature of these topics, I think the Commission could simply augment its ongoing efforts in bioethics education with some public experiments in new techniques involving deliberation and deliberative methods.  This is a particular theme in Chair Amy Gutmann’s research, so I am not surprised to see the level of commitment to this effort.

(While a very politically charged matter due to recent events, it is possible that the Commission could be tasked with, or asked by the public about, current practices in fetal tissue collection and use.)

Fish And Wildlife Service Providing Additional Details For New Chimp Research Requirements

Earlier this summer the Fish and Wildlife Service (FWS) classified captive chimpanzees as endangered – the same as chimpanzees found in the wild.  Starting September 14, most biomedical research involving captive chimpanzees will require a permit.

In a meeting with staff of the Federation of American Societies for Experimental Biology and the American Physiological Society, the FWS provided additional information about the process.  The permits would be required for most instances where the research would harm, harass, kill or injure a chimpanzee, as this is otherwise a violation of the Endangered Species Act.  There will be two types of research eligible for a permit: research that directly benefits conservation efforts for wild chimpanzee populations and research that doesn’t directly benefit such conservation efforts but includes support for in situ conservation efforts (though federal grant money cannot be used to pay for such efforts).  In other words, if there’s no direct benefits to conservation efforts in the research, a successful permit will involve a little extra support (not from the government) to support conservation efforts.

Permits should take about 3 months to complete, which includes a 30 day public comment period.  Once approved, such permits will be valid for five years, with annual reports required.  Entities interested in the permitting process should reach out to the FWS for a conversation.

White House Demo Day Strategy Seems Counterproductive

Earlier this year the White House announced (earlier than I thought) a White House Demo Day, scheduled for August 4.  This is not to be confused with the Demo Day held at the White House today, which was focused on disaster response and recovery.  Entrepreneurs will be demonstrating their products and/or services with an eye toward a

The Demo Day, per this White House post on Medium, ties into a larger Administration effort to encourage entrepreneurship, especially in underrepresented communities.  Like the Science Fairs, the messaging around the Demo Day (at least for me) runs counter to the pre-screened nature of who is present (selected from nominations accepted over a three-day period in April).  A quick search of the White House recommended Twitter hashtag (#WHDemoDay) shows a lot of people still just finding out about the event, and interested in participating.

But the people have already been selected, and the livestream of the event may not reach beyond the already engaged audience that the White House is interested in expanding.  I wouldn’t blame any entrepreneurs who felt frustrated by a White House that on the one hand seems to encourage participation in something that has been closed off for a while.  I think the messaging needs to be more consistent, thorough, and for longer.

What am I missing here?  It’s never been clear to me after any of the Science Fairs how someone watching could work to be one of those presenting, and I think the same thing will happen after next week’s Demo Day.  That seems like such a lost opportunity.

We The People Petition Process Opens Up

The Obama Administration started the We the People petition process in 2011.  If a petition reaches a set signature threshold within a set time period (currently 100,000 signatures within 30 days), then the Administration guarantees that it will respond to that petition.  It doesn’t guarantee what that action will be (and it will be unable to act in certain circumstances), which likely disappoints many petitioners and signers.

Another issue that draws complaints is the timeliness of the Administration’s responses.  One of a series of changes announced today will attempt to address this.  In releasing responses to 20 petitions today, the Administration has cleared its backlog, and has now responded to all 275 petitions that met the signature threshold.  Going forward, the Administration intends to respond to all petitions that meet the threshold within 60 days (the specific language allows for some wiggle room).

In addition, the petition platform will become more open.  The petition website will integrate with We the People, and the code supporting will soon be available on Drupal and Github.  This will enable other governments to make use of this code for their own purposes.

While it is easy to be skeptical, if not cynical, of the utility of such petitions, the White House has cited a We the People petition as an important part of why it supported reversing a Library of Congress decision that made cell phone unlocking illegal in the U.S.  It also credited the petition site for other Administration actions, as it describes on the White House website.

I note that a few of the 20 petitions responses released today deal with science and/or technology matters.  I’ll dive into those responses over the next week or so.

NIH Looking For Input On Strategic Plan

The National Institutes of Health (NIH) has to submit a new strategic plan to Congress by December of 2015.  This is an agency-wide strategic plan, and is focused on general goals and cross-cutting plans for the NIH.  Specific disease and/or research strategies will be covered in the strategic plan(s) for the relevant institute, office or center at NIH that is focused on that matter.

The NIH is seeking comment on the framework for its strategic plan, and released the Request for Information on July 22nd.  Comments are due by August 16th, and must run 300 words or fewer.  The questions for which the NIH seeks information are:

  • Potential benefits, drawbacks/challenges, and areas of consideration for the current framework
  • Compatibility of the framework with the broad scope of the NIH mission
  • Additional concepts in [individual institute, center or office] strategic plans that are cross-cutting and should be included in this trans-NIH strategic plan
  • Comprehensive trans-NIH research themes that have not been captured in the Areas of Opportunity that Apply Across Biomedicine
  • Components of the Areas of Opportunity that Apply Across Biomedicine that are not applicable to an NIH-wide Strategic Plan
  • Future opportunities or emerging research needs

The Areas of Opportunity that Apply Across Biomedicine listed in the framework are:

  • Promote Fundamental Science
    • Basic Science is the foundation for progress
    • Consequences of basic science discoveries are often unpredictable
    • Advances in clinical research methodologies stimulate scientific progress
    • Leaps in Technology often catalyze major scientific advances
    • Data science increases the impact and efficiency of research
  • Improve Health Promotion and Disease Prevention
    • Importance of studying healthy individuals
    • Advances in early diagnosis/detection
    • Evidence-Based interventions to eliminate health disparities
  • Advance Treatments and Cures
    • Unprecedented opportunities on the basis of molecular knowledge
    • Breakdown of traditional disease boundaries
    • Breakthroughs need partnerships and often come from unexpected directions

Again, comments are due by August 16th.  Submissions should be sent via email at the appropriate address listed in the Request for Information.

Attention Public Radio Listeners – The Surgeon General Knows His Soaps

Earlier tonight I was at the taping of this week’s edition of the NPR news quiz show “Wait Wait…Don’t Tell Me!” The program was taped at Wolf Trap this evening for broadcast this weekend.  It should be available online by Sunday morning.

One segment of the program – “Not My Job” – has notable guests answer questions about things quite unrelated to their jobs.  On occasion those guests have held science and/or technology jobs in the U.S. government.  This week the guest was (will be) Surgeon General of the United States Dr. Vivek Murthy (and no, there was no discussion of why he’s a Surgeon General if he holds the rank of a Vice Admiral).  After describing his work, and his background, General Murthy was asked questions about the long-running television program General Hospital.

Murthy joins other science and technology officials that have participated in the program, usually in person.  The list now includes two Secretaries of Energy, one Director of the Centers for Disease Control, and the Director of the National Institutes of Health.

If you listen to the rest of the program (once it’s available), you will note panelist Paula Poundstone raising concerns about the studies referred to in the show.  Personally, I look at this as reasonable skepticism to the frequent conversion of study information into short soundbites that rarely communicate the full extent of the research.  Of course, that’s just my opinion, I could be wrong.