and we wonder how events of 2019 - 2020 just accidently happened.
https://www.science.org/content/article ... us-studies
SCIENCEINSIDERSCIENCE AND POLICY
NIH lifts 3-year ban on funding risky virus studies
New proposals that make pathogens more dangerous will go through special review
19 DEC 2017 BYJOCELYN KAISER
More than 3 years after imposing a moratorium on U.S. funding for certain studies with dangerous viruses, the National Institutes of Health (NIH) in Bethesda, Maryland, today lifted this so-called "pause" and announced a new plan for reviewing such research. But federal officials haven't yet decided the fate of a handful of studies on influenza and Middle East respiratory syndrome (MERS) that were put on hold in October 2014.
https://grants.nih.gov/grants/guide/not ... 7-071.html
Two investigators whose controversial studies on deadly avian influenza viruses are among 11 on hold welcomed the end of the pause. "This NIH decision allows us to move forward," virologist Yoshihiro Kawaoka of the University of Wisconsin in Madison wrote in an email.
NIH officials believe the pending studies are probably outdated and scientists will want to submit new proposals. The new process, NIH Director Francis Collins says, "will help to facilitate the safe, secure, and responsible conduct of this type of research." Critics of the studies, meanwhile, are withholding judgment until they see how the review process plays out.
Concerns over so-called "gain-of-function" (GOF) studies that make pathogens more potent or likely to spread in people erupted in 2011, when Kawaoka's team and Ron Fouchier's lab at Erasmus Medical Center in Rotterdam, the Netherlands, announced that they had modified the H5N1 bird flu virus to enable it to spread between ferrets. Such studies could help experts prepare for pandemics, but pose risks if the souped-up pathogen escapes the lab. After a long discussion, the National Science Advisory Board for Biosecurity (NSABB) decided the two studies should be published and federal officials issued new oversight rules for certain H5N1 studies.
http://www.sciencemag.org/news/2011/11/ ... lu-studies
But U.S. officials grew uneasy after the publication of new GOF papers and several accidents in U.S. biocontainment labs. In October 2014, they announced an unprecedented "pause" on funding for 21 GOF studies of influenza, MERS, and severe acute respiratory syndrome viruses. (At the time, NIH said there were 18 paused studies.) NIH eventually exempted some studies found to pose relatively little risk. But eight influenza studies and three MERS projects remained on hold.
http://www.sciencemag.org/news/2014/10/ ... moratorium
http://www.sciencemag.org/news/2014/12/ ... se-studies
NSABB then developed a set of criteria for determining when such studies should be allowed, such as whether there are less risky ways to address the same question. Last January, White House science officials told NIH's parent, the Department of Health and Human Services (HHS), to craft policies using the criteria for what officials now call "enhanced potential pandemic pathogens" (PPPs).
http://www.sciencemag.org/news/2016/05/ ... us-studies
http://www.sciencemag.org/news/2017/01/ ... us-studies
Today, along with NIH lifting the pause, HHS released its review framework. Any proposal that passes scientific peer review and fits the PPP definition will be reviewed by an HHS group with wide-ranging expertise, from biosafety and security to ethics and law. The panel will weigh the benefits and risks and may recommend that the proposed study be rejected, allowed to move forward, or permitted with modifications.
https://www.phe.gov/s3/dualuse/Documents/p3co.pdf
NIH doesn't expect the investigators whose work was paused to resume where they left off. The studies are "probably obsolete," Collins said in a call with reporters late yesterday. Instead, NIH anticipates that researchers will submit fresh proposals.
Collins says that because NIH has already allowed some of the original paused studies to proceed, the new policy isn't "a dramatic change … but now we have a policy that is much more transparent and clear."
Fouchier says resubmitting proposals won't take much time: "The questions are still the same, but we will want to work with current virus strains," he says. "It's basically a matter of 'find and replace.'" Because his work passed an extensive review in 2014, before the pause took effect, "I assume I'll be able to shepherd it through this time."
Harvard University epidemiologist Marc Lipsitch, who co-led a group of researchers that lobbied for the GOF pause, calls the HHS framework "a small step forward." He adds, "The question is how such reviews will play out in practice." Lipsitch is concerned that the HHS panel will interpret the NSABB criteria in such a way that experiments like the 2011 H5N1 studies—which in his view should not be funded—will get the green light.
2017 NIH lifts 3-year ban on funding risky virus studies
Re: 2017 NIH lifts 3-year ban on funding risky virus studies
https://grants.nih.gov/grants/guide/not ... 7-071.html
Notice Announcing the Removal of the Funding Pause for Gain-of-Function Research Projects
Notice Number: NOT-OD-17-071
Key Dates
Release Date: December 19, 2017
Related Announcements
NOT-OD-15-011
Issued by
National Institutes of Health (NIH)
Purpose
The purpose of this Guide Notice is to notify applicants that in accordance with the December 2017 issuance of the Department of Health and Human Services "HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework),” the National Institutes of Health is removing the funding pause on the provision of new or continuation funding for gain-of-function research projects.
Background
On October 17, 2014, the U.S. Government announced that it would be instituting a funding pause on gain-of-function research projects that could be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the resulting virus has enhanced pathogenicity and/or transmissibility (via the respiratory route) in mammals. During the funding pause, the U.S. Government undertook a deliberative process to assess the potential benefits and risks associated with these types of studies. Completion of the deliberative process resulted in the Department of Health and Human Services issuing the HHS P3CO Framework on December 19, 2017. The HHS P3CO Framework is responsive to and in accordance with the "Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight" issued on January 9, 2017 and supersedes the previous "Framework for Guiding U.S. Department of Health and Human Services Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets.”
http://www.whitehouse.gov/blog/2014/10/ ... n-research
The HHS P3CO Framework is intended to guide agency funding decisions on proposed research that is reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens (PPPs). A PPP is any pathogen that satisfies both of the following:
It is likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and
It is likely highly virulent and likely to cause significant morbidity and/or mortality in humans.
An enhanced PPP is defined as a PPP resulting from the enhancement of the transmissibility and/or virulence of a pathogen.
The HHS P3CO Framework ensures a multidisciplinary, department-level pre-funding review and evaluation of proposed research meeting the scope of the framework. The HHS P3CO Framework can be viewed HERE.
https://www.phe.gov/s3/dualuse/Document ... tement.pdf
Impact
The HHS P3CO Framework impacts research with any pathogen that meets the definition of enhanced PPP. NIH will continue to accept applications for research projects including studies that are reasonably anticipated to create, transfer or use enhanced PPPs. As described in the background section of this Guide Notice, NIH will identify meritorious research applications meeting the scope of the HHS P3CO Framework for a multidisciplinary, department-level review prior to any funding decision.
If a Scientific Review Group (SRG) identifies research that may create, transfer, or use enhanced PPPs as described above, the Scientific Review Officer will record this as an administrative note and instruct the SRG members that the presence of such research in the application will not affect their impact scores. Following completion of the SRG review, Program officials will review all proposed research being considered for funding to determine if the research meets the scope of the HHS P3CO Framework, and if it does, will work with the applicant, institution, and funding agency staff, as appropriate, to comply with the HHS P3CO Framework.
Notice Announcing the Removal of the Funding Pause for Gain-of-Function Research Projects
Notice Number: NOT-OD-17-071
Key Dates
Release Date: December 19, 2017
Related Announcements
NOT-OD-15-011
Issued by
National Institutes of Health (NIH)
Purpose
The purpose of this Guide Notice is to notify applicants that in accordance with the December 2017 issuance of the Department of Health and Human Services "HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework),” the National Institutes of Health is removing the funding pause on the provision of new or continuation funding for gain-of-function research projects.
Background
On October 17, 2014, the U.S. Government announced that it would be instituting a funding pause on gain-of-function research projects that could be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the resulting virus has enhanced pathogenicity and/or transmissibility (via the respiratory route) in mammals. During the funding pause, the U.S. Government undertook a deliberative process to assess the potential benefits and risks associated with these types of studies. Completion of the deliberative process resulted in the Department of Health and Human Services issuing the HHS P3CO Framework on December 19, 2017. The HHS P3CO Framework is responsive to and in accordance with the "Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight" issued on January 9, 2017 and supersedes the previous "Framework for Guiding U.S. Department of Health and Human Services Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets.”
http://www.whitehouse.gov/blog/2014/10/ ... n-research
The HHS P3CO Framework is intended to guide agency funding decisions on proposed research that is reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens (PPPs). A PPP is any pathogen that satisfies both of the following:
It is likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and
It is likely highly virulent and likely to cause significant morbidity and/or mortality in humans.
An enhanced PPP is defined as a PPP resulting from the enhancement of the transmissibility and/or virulence of a pathogen.
The HHS P3CO Framework ensures a multidisciplinary, department-level pre-funding review and evaluation of proposed research meeting the scope of the framework. The HHS P3CO Framework can be viewed HERE.
https://www.phe.gov/s3/dualuse/Document ... tement.pdf
Impact
The HHS P3CO Framework impacts research with any pathogen that meets the definition of enhanced PPP. NIH will continue to accept applications for research projects including studies that are reasonably anticipated to create, transfer or use enhanced PPPs. As described in the background section of this Guide Notice, NIH will identify meritorious research applications meeting the scope of the HHS P3CO Framework for a multidisciplinary, department-level review prior to any funding decision.
If a Scientific Review Group (SRG) identifies research that may create, transfer, or use enhanced PPPs as described above, the Scientific Review Officer will record this as an administrative note and instruct the SRG members that the presence of such research in the application will not affect their impact scores. Following completion of the SRG review, Program officials will review all proposed research being considered for funding to determine if the research meets the scope of the HHS P3CO Framework, and if it does, will work with the applicant, institution, and funding agency staff, as appropriate, to comply with the HHS P3CO Framework.
Re: 2017 NIH lifts 3-year ban on funding risky virus studies
read://https_www.science.org/?url=https%3A%2F%2Fwww.science.org%2Fcontent%2Farticle%2Fwhite-house-announces-review-process-risky-virus-studies
9 Jan 2017
White House announces review process for risky virus studies
Plan could lead to end of 2-year moratorium on handful of controversial flu studies
Federal officials today released a plan to help U.S. agencies decide whether to fund controversial studies that make viruses more dangerous. The guidance may finally bring an end to a moratorium that has kept a handful of experiments funded by the Department of Health and Human Services (HHS) on hold for more than 2 years.
The policy from the White House Office of Science and Technology Policy (OSTP) essentially follows recommendations from last May from an advisory committee that attempted to define the riskiest experiments and spell out when they should be funded. Both critics and supporters of these hotly debated studies welcomed the policy, which some feared would languish if left to the incoming administration of President-elect Donald Trump. But some are reserving judgment until they see the results of the reviews.
https://www.whitehouse.gov/blog/2017/01 ... -oversight
Although the new guidance provides no timelines, HHS is working to put the review process in place "as quickly as possible," said an agency spokesperson on background. The agency says that "any projects that are determined suitable to proceed will do so with appropriate risk mitigation measures in place."
https://www.phe.gov/s3/dualuse/Pages/Ga ... ction.aspx
Concerns about so-called "gain-of-function" (GOF) virus studies—which make viruses more transmissible in humans or able to cause sickness or death—ignited 6 years ago when two virologists revealed that they had tweaked the deadly H5N1 avian influenza to make it spread more easily in mammals. Although meant to help experts prepare for pandemics, some worried that these studies could result in a lab escape of a deadly humanmade virus. Scientists themselves briefly halted, then resumed the H5N1 studies.
Then more papers on GOF experiments, as well as accidents at some U.S. pathogen labs, prompted U.S. officials in October 2014 to impose a top-down moratorium. HHS "paused" funding for 18 GOF projects on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome viruses funded by the National Institutes of Health (NIH). (Some were later exempted, but seven flu studies and three MERS projects remain on hold, NIH says.)
http://www.sciencemag.org/news/2014/11/ ... ions-limbo
http://www.sciencemag.org/news/2014/12/ ... se-studies
The new policy aligns with recommendations made last May by the National Science Advisory Board for Biosecurity (NSABB), with a few tweaks. It covers research that creates "potential pandemic pathogens" or PPPs, rather than adopting NSABB's term, GOF research of concern. Agencies will decide whether a proposed study involves an "enhanced" PPP by looking at whether the resulting pathogen is "likely" to be highly transmissible and capable of wide and uncontrollable spread in humans, highly virulent, and likely to cause significant sickness and deaths.
http://www.sciencemag.org/news/2016/05/ ... us-studies
Projects involving enhanced pathogens that meet this definition will then be reviewed using eight criteria, such as whether the project is scientifically justified and the benefits outweigh the risks. The report specifically exempts from the reviews certain enhanced PPP studies, such as routine flu surveillance (which involves characterizing viruses found circulating in nature) and the development of high-growth flu strains for vaccines.
Critics have long complained that HHS officials should not be involved in reviewing GOF research that the agency funds because it presents a conflict of interest. The new policy says that agencies "are encouraged to vest oversight for their enhanced PPP review mechanisms in offices that do not report to the head of the agency component" that would fund the research. The HHS spokesperson said that experts from both HHS and other U.S. departments will conduct the reviews.
Harvard University epidemiologist Marc Lipsitch, a longtime critic of GOF studies, says: "I will be watching to see … whether the reviews are robust and free of conflicts of interest real or perceived."
Virologist Ronald Fouchier of Erasmus University Medical Center in Rotterdam, the Netherlands, who has H5N1 GOF studies on hold, says he is glad to see the OSTP policy. He is "positive that our projects will be reviewed favorably once more … under the new process, and that we can all continue our important work shortly, with negligible risks," he said.
OSTP also says that NSABB, an advisory group that has no regulatory authority and has struggled at times to address concerns about risky research, is still needed to offer feedback on HHS's enhanced PPP review process and to provide other policy advice. David Relman, a microbiologist at Stanford University in Palo Alto, California, says he thinks NSABB, which is staffed by NIH, should be moved outside of HHS to avoid conflicts of interest. "The location of its 'home' is very important," Relman says.
9 Jan 2017
White House announces review process for risky virus studies
Plan could lead to end of 2-year moratorium on handful of controversial flu studies
Federal officials today released a plan to help U.S. agencies decide whether to fund controversial studies that make viruses more dangerous. The guidance may finally bring an end to a moratorium that has kept a handful of experiments funded by the Department of Health and Human Services (HHS) on hold for more than 2 years.
The policy from the White House Office of Science and Technology Policy (OSTP) essentially follows recommendations from last May from an advisory committee that attempted to define the riskiest experiments and spell out when they should be funded. Both critics and supporters of these hotly debated studies welcomed the policy, which some feared would languish if left to the incoming administration of President-elect Donald Trump. But some are reserving judgment until they see the results of the reviews.
https://www.whitehouse.gov/blog/2017/01 ... -oversight
Although the new guidance provides no timelines, HHS is working to put the review process in place "as quickly as possible," said an agency spokesperson on background. The agency says that "any projects that are determined suitable to proceed will do so with appropriate risk mitigation measures in place."
https://www.phe.gov/s3/dualuse/Pages/Ga ... ction.aspx
Concerns about so-called "gain-of-function" (GOF) virus studies—which make viruses more transmissible in humans or able to cause sickness or death—ignited 6 years ago when two virologists revealed that they had tweaked the deadly H5N1 avian influenza to make it spread more easily in mammals. Although meant to help experts prepare for pandemics, some worried that these studies could result in a lab escape of a deadly humanmade virus. Scientists themselves briefly halted, then resumed the H5N1 studies.
Then more papers on GOF experiments, as well as accidents at some U.S. pathogen labs, prompted U.S. officials in October 2014 to impose a top-down moratorium. HHS "paused" funding for 18 GOF projects on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome viruses funded by the National Institutes of Health (NIH). (Some were later exempted, but seven flu studies and three MERS projects remain on hold, NIH says.)
http://www.sciencemag.org/news/2014/11/ ... ions-limbo
http://www.sciencemag.org/news/2014/12/ ... se-studies
The new policy aligns with recommendations made last May by the National Science Advisory Board for Biosecurity (NSABB), with a few tweaks. It covers research that creates "potential pandemic pathogens" or PPPs, rather than adopting NSABB's term, GOF research of concern. Agencies will decide whether a proposed study involves an "enhanced" PPP by looking at whether the resulting pathogen is "likely" to be highly transmissible and capable of wide and uncontrollable spread in humans, highly virulent, and likely to cause significant sickness and deaths.
http://www.sciencemag.org/news/2016/05/ ... us-studies
Projects involving enhanced pathogens that meet this definition will then be reviewed using eight criteria, such as whether the project is scientifically justified and the benefits outweigh the risks. The report specifically exempts from the reviews certain enhanced PPP studies, such as routine flu surveillance (which involves characterizing viruses found circulating in nature) and the development of high-growth flu strains for vaccines.
Critics have long complained that HHS officials should not be involved in reviewing GOF research that the agency funds because it presents a conflict of interest. The new policy says that agencies "are encouraged to vest oversight for their enhanced PPP review mechanisms in offices that do not report to the head of the agency component" that would fund the research. The HHS spokesperson said that experts from both HHS and other U.S. departments will conduct the reviews.
Harvard University epidemiologist Marc Lipsitch, a longtime critic of GOF studies, says: "I will be watching to see … whether the reviews are robust and free of conflicts of interest real or perceived."
Virologist Ronald Fouchier of Erasmus University Medical Center in Rotterdam, the Netherlands, who has H5N1 GOF studies on hold, says he is glad to see the OSTP policy. He is "positive that our projects will be reviewed favorably once more … under the new process, and that we can all continue our important work shortly, with negligible risks," he said.
OSTP also says that NSABB, an advisory group that has no regulatory authority and has struggled at times to address concerns about risky research, is still needed to offer feedback on HHS's enhanced PPP review process and to provide other policy advice. David Relman, a microbiologist at Stanford University in Palo Alto, California, says he thinks NSABB, which is staffed by NIH, should be moved outside of HHS to avoid conflicts of interest. "The location of its 'home' is very important," Relman says.
Re: 2017 NIH lifts 3-year ban on funding risky virus studies
https://www.science.org/content/article ... us-studies
SCIENCEINSIDERSCIENCE AND POLICY
U.S. advisers sign off on plan for reviewing risky virus studies
Report from NSABB now goes to U.S. officials, who say policy will be out this year
27 MAY 2016 BYJOCELYN KAISER
A board of advisers this week signed off on a proposal for how the U.S. government should go about deciding whether to fund certain studies that could potentially create dangerous human pathogens. The plan now goes to government officials, who say they hope to put out a policy by the end of year. Still unclear, however, is exactly when they will lift an 19-month-old ban that has halted a handful of virology studies.
The report from the National Science Advisory Board for Biosecurity (NSABB) is meant to guide decisions about so-called gain-of-function (GOF) studies—experiments that modify a pathogen in ways that could make it more transmissible and more pathogenic in humans. Such studies can help experts prepare for pandemics, but they also pose risks if the altered pathogen should escape the lab. In 2011, two GOF studies with the deadly H5N1 avian influenza virus sparked a lengthy NSABB discussion over whether the work should even be published. (Ultimately, the NSABB said it should be.) The studies also led to a new oversight policy for certain H5N1 experiments.
Then in 2014, more papers on risky flu viruses, along with some mishaps at federal labs, convinced U.S. officials that existing policies weren't enough. In October 2014, the White House announced a "pause" on new funding for 18 GOF studies of influenza, SARS, and MERS viruses (although several projects were later exempted). Officials then asked a revived NSABB to come up with a process for overseeing risky GOF studies.
New process recommended
Now, after six meetings, two National Academy of Sciences workshops, and a 1000-page risk assessment by a contractor, the NSABB on 24 May approved a final proposal. Their latest report is similar to an earlier draft that found that only a "small subset" of studies are of concern. But this time, the board provides examples—for instance, GOF studies to develop seasonal flu vaccines are not worrisome. The board has also modified its definition of what it now calls Gain of Function Research of Concern (GOFROC). An earlier definition, for instance, covered experiments that generated a pathogen that is highly transmissible, highly virulent, and "resistant to public health control measures." The new definition, however, drops the "resistant" wording, because not all nations might be able to deploy antiviral drugs or other countermeasures.
Like the previous draft, the new plan lays out a process for reviewing studies: The investigator and his or her institution will determine if a proposed study is potentially GOFROC. If it passes peer review, the funding department—such as the Department of Health and Human Services (HHS)—will then evaluate the experiment using eight criteria. For example, it will look at whether the investigators' lab has sufficient safety measures in place and the benefits outweigh the risks to society.
The final report also calls for creating a new federal advisory board (something like the NSABB) to publicly review GOFROC policies (but not specific experiments). It suggests GOFROC oversight should extend to privately funded studies, which now are not reviewed by government bodies unless they involve regulated pathogens. And it urges officials to create a system for tracking lab accidents—a suggestion other experts have made. In their meeting, advisers also recommended a system for sharing the experiences of institutional review boards with GOFROC proposals.
The report has new wording that is apparently aimed at critics who have argued that the HHS should not review studies it funds, because that would represent a conflict of interest. The report says the HHS review "should be structured to avoid real or apparent conflicts of interest," but doesn't specify how that can be done. Harvard University epidemiologist Marc Lipsitch, one of the critics, says the review group should "have wide representation from well beyond the agencies with vested interest."
The new review process should ensure that risky GOF research is evaluated early, before it is funded, said NSABB chair Samuel Stanley of Stony Brook University in New York. "We can start to avoid situations where [GOFROC] is only first identified at the publication stage," as happened with the H5N1 papers, he said.
How hard to implement?
Agencies shouldn't have trouble implementing the GOFROC policy because it's similar to the review process for so-called Dual Use Research of Concern, an overlapping category of studies on agents potentially used as bioweapons, said Dennis Dixon of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, which funds GOF research. "We've done it before," Dixon said.
Implementation will require "from light to heavy lifts," Gerald Epstein of the White House Office of Science and Technology Policy told the NSABB. For example, although HHS can easily set up new review processes, new rules for university investigators receiving federal grants may have to go through a formal rulemaking process. And oversight of nonfederally funded may require action by Congress. But Epstein promised to "get something done" in the next few months that will "supersede the existing funding pause … It is certainly something I don't think anybody wants to permit to go into the next administration," he said.
Stanley urged officials to "move as quickly as possible." The pause may have only stopped a few studies, he said, but he's worried that is has "had a broader effect on the infectious disease research community" by creating "uncertainty" that has convinced some young scientists to "rethink careers in certain areas."
SCIENCEINSIDERSCIENCE AND POLICY
U.S. advisers sign off on plan for reviewing risky virus studies
Report from NSABB now goes to U.S. officials, who say policy will be out this year
27 MAY 2016 BYJOCELYN KAISER
A board of advisers this week signed off on a proposal for how the U.S. government should go about deciding whether to fund certain studies that could potentially create dangerous human pathogens. The plan now goes to government officials, who say they hope to put out a policy by the end of year. Still unclear, however, is exactly when they will lift an 19-month-old ban that has halted a handful of virology studies.
The report from the National Science Advisory Board for Biosecurity (NSABB) is meant to guide decisions about so-called gain-of-function (GOF) studies—experiments that modify a pathogen in ways that could make it more transmissible and more pathogenic in humans. Such studies can help experts prepare for pandemics, but they also pose risks if the altered pathogen should escape the lab. In 2011, two GOF studies with the deadly H5N1 avian influenza virus sparked a lengthy NSABB discussion over whether the work should even be published. (Ultimately, the NSABB said it should be.) The studies also led to a new oversight policy for certain H5N1 experiments.
Then in 2014, more papers on risky flu viruses, along with some mishaps at federal labs, convinced U.S. officials that existing policies weren't enough. In October 2014, the White House announced a "pause" on new funding for 18 GOF studies of influenza, SARS, and MERS viruses (although several projects were later exempted). Officials then asked a revived NSABB to come up with a process for overseeing risky GOF studies.
New process recommended
Now, after six meetings, two National Academy of Sciences workshops, and a 1000-page risk assessment by a contractor, the NSABB on 24 May approved a final proposal. Their latest report is similar to an earlier draft that found that only a "small subset" of studies are of concern. But this time, the board provides examples—for instance, GOF studies to develop seasonal flu vaccines are not worrisome. The board has also modified its definition of what it now calls Gain of Function Research of Concern (GOFROC). An earlier definition, for instance, covered experiments that generated a pathogen that is highly transmissible, highly virulent, and "resistant to public health control measures." The new definition, however, drops the "resistant" wording, because not all nations might be able to deploy antiviral drugs or other countermeasures.
Like the previous draft, the new plan lays out a process for reviewing studies: The investigator and his or her institution will determine if a proposed study is potentially GOFROC. If it passes peer review, the funding department—such as the Department of Health and Human Services (HHS)—will then evaluate the experiment using eight criteria. For example, it will look at whether the investigators' lab has sufficient safety measures in place and the benefits outweigh the risks to society.
The final report also calls for creating a new federal advisory board (something like the NSABB) to publicly review GOFROC policies (but not specific experiments). It suggests GOFROC oversight should extend to privately funded studies, which now are not reviewed by government bodies unless they involve regulated pathogens. And it urges officials to create a system for tracking lab accidents—a suggestion other experts have made. In their meeting, advisers also recommended a system for sharing the experiences of institutional review boards with GOFROC proposals.
The report has new wording that is apparently aimed at critics who have argued that the HHS should not review studies it funds, because that would represent a conflict of interest. The report says the HHS review "should be structured to avoid real or apparent conflicts of interest," but doesn't specify how that can be done. Harvard University epidemiologist Marc Lipsitch, one of the critics, says the review group should "have wide representation from well beyond the agencies with vested interest."
The new review process should ensure that risky GOF research is evaluated early, before it is funded, said NSABB chair Samuel Stanley of Stony Brook University in New York. "We can start to avoid situations where [GOFROC] is only first identified at the publication stage," as happened with the H5N1 papers, he said.
How hard to implement?
Agencies shouldn't have trouble implementing the GOFROC policy because it's similar to the review process for so-called Dual Use Research of Concern, an overlapping category of studies on agents potentially used as bioweapons, said Dennis Dixon of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, which funds GOF research. "We've done it before," Dixon said.
Implementation will require "from light to heavy lifts," Gerald Epstein of the White House Office of Science and Technology Policy told the NSABB. For example, although HHS can easily set up new review processes, new rules for university investigators receiving federal grants may have to go through a formal rulemaking process. And oversight of nonfederally funded may require action by Congress. But Epstein promised to "get something done" in the next few months that will "supersede the existing funding pause … It is certainly something I don't think anybody wants to permit to go into the next administration," he said.
Stanley urged officials to "move as quickly as possible." The pause may have only stopped a few studies, he said, but he's worried that is has "had a broader effect on the infectious disease research community" by creating "uncertainty" that has convinced some young scientists to "rethink careers in certain areas."