NIH Statement On Lifting Of The H5N1 Research Moratorium

 

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Just over a year ago, in response to safety concerns raised by biosecurity experts over certain types of H5N1 research, a group of researchers proposed a temporary (60 day) moratorium on their work. 

 

After more than a year, that self-imposed moratorium was lifted earlier this week (see Scientists Declare End To H5N1 Research Moratorium).

 

Here in the United States, the NIH has yet to put the finishing touches on their framework policies for H5N1 research, and so research here won’t restart immediately.

 

Today, the directors of the NIH and NIAID released a joint statement, indicating that decisions should be forthcoming in the next few weeks.

 

 

Statement of Drs. Collins and Fauci concerning intention to lift moratorium

January 25, 2013

One year ago, scientists in the H5N1 influenza research community announced that they would voluntarily suspend certain “gain-of-function” experiments involving highly pathogenic avian influenza (HPAI) H5N1 viruses pending a broad international dialogue about the future direction of this research.

 

That dialogue — which has included experts in the life sciences, public health, biosecurity, biosafety, law, and science policy communities — has been highly productive, with numerous meetings and publications helping to clarify the most critical issues associated with this type of research.

 

Countries where this research is (or might be) conducted have had the opportunity to review their policies and parameters for funding, conducting, and communicating about this research. In this context, the H5N1 influenza research community has announced their intention and support for resuming their research in those countries with final guidelines in place.

 

The Department of Health and Human Services (HHS) has worked in a transparent and collaborative fashion to develop a framework for reviewing funding decisions regarding research that might increase mammalian transmission of HPAI H5N1 viruses by respiratory droplets. We anticipate that the final framework for HHS funding decisions regarding HPAI H5N1 gain-of-function experiments will be complete in the next several weeks. In the meantime, U.S.-funded researchers (both those working in the United States, including those in government laboratories, as well as those working overseas) have agreed not to resume these types of HPAI H5N1 gain-of-function experiments pending finalization of the HHS Framework.

 

Understanding how influenza viruses become human pandemic threats is vitally important to global health preparedness. We applaud the international H5N1 influenza research community for the spirit in which they instituted this extended “pause” on their work, which has provided time for thoughtful consideration of its implications.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

Anthony S. Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases
National Institutes of Health

Scientists Declare End To H5N1 Research Moratorium

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

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Just over a year ago, in the face of mounting concerns over the safety and wisdom of certain avenues of H5N1 `bird flu’ research, a group of internationally renown Scientists Announced a 60 Day Moratorium On Some Types of H5N1 Research.

 

Concerns were raised initially after the 2011 ESWI Influenza Conference in Malta, where Dutch researcher Ron Fouchier revealed that he’d created a more `transmissible’ form of the H5N1 virus (see Debra MacKenzie’s New Scientist: Five Easy Mutations)

 

That discovery, along with similar news coming from Yoshihiro Kawaoka, a highly respected virologist at the University of Wisconsin-Madison School of Veterinary Medicine, set alarm bells ringing in the biosecurity community.

 

The voluntary moratorium was later extended beyond two months to give time for international debate, and the formulation of safety rules.

 

During that time we’ve seen considerable and often heated discussion over the merits (and dangers) of this type of research, including:

 

mBio: Should The H5N1 Research Moratorium End? 

Science Publishes The Fouchier Ferret Study 

H5N1 Research: A Plethora Of Positions

WHO News Release On Geneva H5N1 Technical Meeting

 

Today, that same group of scientists published a letter simultaneously in the Journal Nature and the Journal Science, announcing the end to that self-imposed moratorium.

 

While these scientists have withdrawn their voluntary moratorium on certain types of H5N1 research, that does not negate any oversight regulations (and funding restrictions) that individuals countries and governmental agencies (like the NIH) have, or may, adopt.

 

Last March, the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC (Duel Use Research of Concern) projects, and ordered a review of all current life sciences projects (see U.S. Issues new DURC Oversight Rules).

 

And last October the HHS Called For Public Comment On H5N1 Research, in advance of an NIH workshop held in mid December. Details on that two-day meeting are available from CIDRAP NEWS.

 

Experts at NIH meeting say H5N1 research moratorium may end soon Lisa Schnirring 

 

H5N1 researchers question proposed HHS funding framework Lisa Schnirring

 

Which means that it remains up to the NIH to decide how, when, and under what circumstances government funded H5N1 research will proceed here in the United States.

CIDRAP News Coverage Of The H5N1 NIH Workshop

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

 

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For the past couple of days researchers and policy makers have been meeting at the National Institutes of Health (NIH) to discuss the future of HHS funded H5N1 avian influenza gain-of-function studies – research that seeks to enhance the host range, transmissibility, or pathogenicity of the H5N1 virus.

Research of this type has been voluntarily suspended since very early this year when – due to a prolonged debate over the publication of a pair of controversial research papers (see The Furor Over H5N1 Research Continues) - a group of the world’s leading researchers announced a moratorium on specific types of bird flu research (see Scientists Announce 60 Day Moratorium On Some H5N1 Research).

 

Although not being webcast, Lisa Schnirring at CIDRAP NEWS has been providing excellent daily coverage of this NIH workshop. 

 

Follow the links below to get the details.

 

H5N1 researchers question proposed HHS funding framework

Lisa Schnirring Staff Writer

Dec 17, 2012 (CIDRAP News) – Federal health officials are in the midst of crafting a framework for funding H5N1 avian influenza gain-of-function studies, and today at a workshop they heard varied feedback from researchers, biosecurity experts, and others.

 

The 2-day workshop, held at the National Institutes of Health (NIH), is the latest chapter in an intense scientific controversy that was triggered by the publication of two recent studies involving lab-engineered H5N1 strains that showed signs of being transmissible in mammals.

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Experts at NIH meeting say H5N1 research moratorium may end soon

Lisa Schnirring Staff Writer

Dec 18, 2012 (CIDRAP News) – As a meeting to discuss issues related to federally funded H5N1 avian influenza research wrapped up today, experts anticipated that a voluntary moratorium on work with lab-modified strains that have increased transmissibility might end soon and said they sensed agreement about lab biosecurity levels.

 

The National Institutes of Health (NIH) held the 2-day meeting to gather feedback from flu researchers, others in the science community, and the public on its draft framework for funding H5N1 gain-of-function studies and to continue an international dialogue on issues related to benefits and risks of the research.

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Branswell On Lifting The H5N1 Research Moratorium

 

BSL-4 Lab Worker - Photo Credit –USAMRIID  

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Six months ago, in response to the rising chorus of concern over the biosecurity aspects of conducting H5N1 research, a 60 day moratorium was announced by a group of 39 leading scientists (see Scientists Announce 60 Day Moratorium On Some H5N1 Research).

 

While the research papers that originally sparked this controversy have now been published, the self-imposed moratorium remains in place.

 

Next week a meeting will be held in New York City of members of the Centers of Excellence for Influenza Research and Surveillance (CEIRS), and the subject of what to do about these research restrictions is expected to be part of their talks.

 

The inimitable Helen Branswell of the Canadian Press brings us the inside details on the difficult and controversial path ahead to undoing the H5N1 research moratorium:

 

 

As key flu scientists meet, question looms: When will bird flu studies resume?

By Helen Branswell, The Canadian Press | The Canadian Press – 42 minutes ago

Six months after leading influenza scientists announced they would voluntarily halt research into what it takes to make bird flu viruses transmit among mammals, it's still not clear when and how the cease-work order will be lifted.

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Highly recommended.