Bioethics Commission Finds National Ebola Response Lacking

Earlier today the Presidential Commission for the Study of Bioethical Issues released a brief (90 pages, so your mileage may vary), Ethics and Ebola.  The report is intended to provide an assessment of the current Ebola outbreak (particularly of the response to cases diagnosed in the U.S.) and recommendations for becoming better prepared for future outbreaks.

The report’s recommendations cover how to prepare for outbreaks, ethical reasons for intervention in outbreaks, guiding principles for deciding to use restrictive public health measures (such as quarantines), and how to conduct research (if warranted) in outrbeak situations.  The recommendations are summarized below: Continue reading

Gain-Of-Function Research ‘Pause’ Continues, With Concerns

ScienceInsider has an update on the review of gain-of-function (GOF) research currently underway at the National Institutes of Health (NIH).  The moratorium was announced last October and is supposed to last for one year.  It covers federal funding for research that would make influenza, MERS or SARS viruses more virulent or easier to transmit.

Reportedly the agency is close to signing a contract with a private company for a risk-benefit analysis.  But, as you might expect with any restriction imposed on active scientific research, there is concern about what NIH has been doing.  Two researchers, Sir Richard Roberts and David Relman, sent the Chairman of the National Science Advisory Board on Biosecurity a letter expressing their concerns over the process by which the pause and review have been conducted.  They would prefer a more open, Asilomar-style conference where scientists and other experts in the area of gain-of-function research would meet to discuss issues and develop a set of guidelines to influence research moving forward.  They are concerned about what appears to be a lack of transparency to the process, limited (if any) opportunities for public input, possible conflicts of interest (the NIH funds much GOF), a lack of risk assessment experience in the Board, and a very U.S.-centric focus.

February Bioethics Commission Meeting Tackled Medical Emergencies

The Presidential Commission on Bioethical Issues met earlier this month in Washington, D.C.  The meeting focused on two major topics – medical emergency research and neuroscience.  The first day dealt with medical emergency research and was heavily influenced by the ongoing Ebola epidemic in west Africa.  The Commission heard from researchers, public health personnel and practitioners on the epidemic in Africa, efforts intended to prevent the spread of the virus in the United States, and the ethical issues associated with research on something like Ebola during an epidemic or other medical emergency.

The Commission is conducting a review of the U.S. response to the Ebola epidemic, with a focus on three issues:

  • The ethics of placebo-control trials in the context of public health emergencies;
  • The ethics of U.S. public policies that restrict association or movement; and
  • The ethical considerations relevant to collecting and storing biospecimens during a public health emergency and sharing them for future research.

On the second day, the meeting shifted to the Commission’s ongoing work in neuroscience.  The Commission intends to release volume two of its report Gray Matters sometime in the spring.  Volume 1 was released in May 2014, and focused on the integration of ethics into neuroscience education.  Volume 2 will tackle neural modifications, neuroscience in the legal system, and how neural capacity can affect the ability to consent in neuroscience research.

The next meeting will take place in Philadelphia May 27 and 28.

International Network For Government Science Advice Ready To Work

Sir Peter Gluckman, Chief Science Adviser to the Prime Minister of New Zealand, has been at the AAAS Annual Meeting in San Jose, California.  Following his activities there, I found out about the International Network for Government Science Advice (INGSA).  The network can be traced back to the international science advice conference held last August in Auckland, New Zealand.

The focus of the INGSA is to serve as a forum for sharing and discussing research and experience in providing science advice to governments.  It is part of the International Council of Science, and the secretariat is presently hosted with Sir Peter in Auckland.  The INGSA’s Network Development Group reflects a diversity of countries and a mix of academic and practitioner experience.

Expect INGSA to leverage other international meetings for opportunities to convene side gatherings.  It would also develop its own events as it sees fit, with a follow up to the 2014 conference presumably on a list of future activities.

So, About Those Scientists On Trial In Italy…

Important disclaimers – I am not a lawyer, either in this country or Italy.  I also don’t speak the language, so I am relying on secondary sources.

ScienceInsider has reported on the decision to acquit six of the seven people convicted of manslaughter in connection with the 2009 L’Aquila earthquake.  The people had been convicted due to the poor way they communicated the risk of possible earthquakes leading up to the 6.2 quake that killed 309 people.

It is not, and never was, about the prediction of earthquakes or a misunderstanding of the underlying science.  But that was the easy message, and the one that got through, at least outside of Italy.  I could have been more effective in communicating that in the many posts I made on the topic, and I apologize for that.

Back to the latest developments.  The appellate court which acquitted six of the seven defendants (all of the scientists were acquitted, while the public official remains sentenced to 6 years) ruled that only the public official could be faulted for the reassurances that caused some people to remain indoors.  The scientists, according to the appellate court, should not have been judged by any regulatory responsibilities they had, but by how well they complied with the accepted science of the time.  And because, according to the court, the notion that a cluster of earthquakes can indicate a larger one was not a commonly accepted scientific theory until after the L’Aquila quake.

That last statement seems like it could be subject to debate for years to come.  Perhaps that debate might play out – at least in part – in the next level of appeals.  The chief prosecutor can appeal this latest decision to the top Italian appeals court.  So this may still not be over.

The Materials Genome Initiative Now Has A Strategic Plan

In 2011 the Obama Administration announced the Materials Genome Initiative in connection with its Advanced Manufacturing Partnership.  The initiative, administered by a subcommittee of the National Science and Technology Council and involving seven federal agencies, is focused on coordinating public and private sector activity in developing and commercializing new materials.  Most of this effort would focus on developing the infrastructure necessary to support increased activity in developing new materials – whatever might be the next Kevlar, battery material or superconducting ceramic.

Last week the Initiative released its first Strategic Plan.  The plan describes four strategic goals for the initiative, how the initiative supports various national objectives, and grand challenges in materials science.  The Strategic Goals:

  • Enable a Paradigm Shift in Culture – In order to reduce the time for developing new materials and transferring them to market, there will have to be shifts in how communities conduct research and development as well as the commercial activities that would use the resulting materials.
  • Integrate Experiments, Computation and Theory – The integration described here is between research and development and commercial application.  Ideally this integration would make it easier to identify replacements for critical materials and facilitate introducing them into manufacturing processes.
  • Facilitate Access to Material Data – A suite of data repositories for materials data, with community-developed standards, can help identify gaps in data and areas of redundant research efforts.
  • Equip the Next Generation Materials Workforce – The incoming workforce needs to be trained in the new skills and process encouraged by the Initiative.

Within each of the strategic goals are a series of milestones that should guide Initiative activity until the next Strategic Plan.  It all reads quite well, but I’m still stuck on the use of genome in the initiative’s name.  Perhaps I’m suffering from metaphor lock.

Advisory Board Seeks Clarification On Gain-Of-Function Research ‘Pause’

Happy American Thanksgiving, everyone.

Back in October the U.S. government announced a ‘pause’ in gain-of-function (GOF) research.  GOF research works with existing viruses, exploring how they can become more virulent and/or transmissible.  Per the official announcement, the pause – limited to federal funding – covers the following:

“New USG funding will not be released for gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. The research funding pause would not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses, unless the tests are reasonably anticipated to increase transmissibility and/or pathogenicity.”
Even the layman writing this post can see there is some language – like ‘reasonably anticipated’ – that would be open to interpretation.  The National Science Advisory Board for Biosecurity (NSABB) met earlier this week about the pause (H/T ScienceInsider).  The meeting focused on a statement about the pause, which has not yet been finalized.
National Institutes of Health (NIH) staff have been working with researchers to clarify matters, according to Dr. Dixon, who spoke at the meeting.  Researchers expressed their concerns that the apparent breadth of the pause could have a chilling effect on the field, with possible impacts on public health.  As the NSABB has a year to develop its recommendations, it’s possible that the pause could be lengthy.  While a revised policy may not be ideal, I think greater communication about how NIH and other agencies are implementing the pause is necessary.  What’s in this new FAQ is nice, but it could benefit from follow-up documents from funding agencies with more specifics about how to have research reviewed, and (if needed) exceptions granted).