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CIDRAP- WHO report: Global guidance on dual-use research needed

Shiloh

Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/may0113who.html

WHO report: Global guidance on dual-use research needed

Robert Roos * News Editor

May 1, 2013 (CIDRAP News) ? Participants in a World Health Organization (WHO) meeting held in February agreed that a binding global agreement to govern potentially dangerous life-sciences research is unlikely, but global guidance on the thorny issue could help nations figure out their own policies, according to a WHO report of the meeting.

The conference, held Feb 26 to 28, focused on "dual-use research of concern" (DURC)?studies whose results could be used for good or harm. The term gained currency in the wake of the controversy that erupted late in 2011 over experiments in which two teams of scientists developed lab-modified H5N1 viruses capable of airborne transmission in ferrets.

The detailed reports of those two studies were published in 2012, but debate and concern have continued over how to govern research that renders pathogens more dangerous or poses similar kinds of risks.

The sense of the WHO consultation was that governments need help in developing ways to manage DURC, but that a global agreement or set of rules is unlikely to be the answer, according to the WHO report on the meeting, which was posted recently.

"The inventory, sharing, and, where needed, development of guiding principles , toolkits, best practices, and other forms of technical assistance would help countries formulate their own policies and procedures for managing DURC," the report says.

"Although establishment of a legally binding global agreement or regulation is theoretically possible, such an approach would be expensive, slow, likely impractical, and would not necessarily yield the desired results," it adds.

"The lack of global guidance or a framework for management of DURC that bridges the many stakeholder communities was repeatedly noted as a critical gap," the report states. Such guidance might include general principles, types of experiments of potential concern, and strategies for weighing risks and benefits and for reducing risks.

Meeting participants felt that it would take a forum of key stakeholders, governments, and international organizations to develop such a framework, and that the WHO could take the lead in convening such a meeting, the report relates.

Regarding next steps, the report says the WHO will work with "member states and others to assess how best to encourage effective approaches."

So far the agency has had little chance to do further work on the issue, WHO spokesman Gregory Hartl told CIDRAP News today. "We have been so involved in nCoV [novel coronavirus] and then H7N9 that I don't know if there has been time for a lot of anything else," he said.

The meeting, called an informal consultation, stemmed from a "technical consultation" the WHO had convened in February 2012 to address the most urgent issues raised by the two H5N1 transmissibility studies. At that session there was a consensus that the WHO should facilitate a broader discussion of the ethical, societal, scientific, security, and safety implications of DURC, the report explains.

Participants at the recent meeting, who were not named in the report, had a wide range of professional backgrounds and came from countries in all WHO regions. They heard a series of panel presentations offering a range of perspectives on DURC; later they broke into eight groups to discuss various issues, such as research and public health, ethics, security, and publishing and communications.

The report cites the following among additional points that emerged at the meeting:

DURC is an issue for all countries.
"The management of DURC-related risks should take into account all stages of the research cycle, from initial conceptualization and development of a proposal, to provision of funding, to conduct of the research, analysis of results, storage and potential use of material results, including modified biological agents, and dissemination of findings."
Some countries and institutions have developed mechanisms to manage DURC-related risks, but many have not, because of competing demands on resources, limited awareness of the issue, or a perception that it is not relevant to their particular context or priorities.
"Communication and continuing dialogue across a broad range of sectors and stakeholders are essential to create a culture of responsibility, cooperation, and trust. In particular, improving mutual understanding of the various approaches to risk identification and assessment among stakeholders will be critical to establishing that dialogue."

The US government announced a pair of policy moves on DURC in February of this year, shortly after the WHO consultation.

The National Institutes of Health (NIH) released a framework to guide its funding decisions for projects expected to generate respiratory-transmissible H5N1 viruses in mammals. In addition, the White House Office of Science and Technology Policy published a draft policy outlining the roles and responsibilities of institutions and researchers who conduct certain types of work on pathogens.

See also:

Summary of WHO report on DURC meeting

Full report on DURC meeting

Feb 21 CIDRAP News story "Feds unveil new policies for 'dual-use' H5N1 research"
 
Re: CIDRAP- WHO report: Global guidance on dual-use research needed

> but that a global agreement or set of rules is unlikely to be the answer

> countries formulate their own policies and procedures for managing DURC

> Although establishment of a legally binding global agreement or regulation is theoretically
> possible, such an approach would be expensive, slow, likely impractical, and would not
> necessarily yield the desired results,"

> the WHO will work with "member states and others to assess how best to encourage
> effective approaches."

> We have been so involved in nCoV [novel coronavirus] and then H7N9 that I don't know
> if there has been time for a lot of anything else," Hartl said.

### ahh, no time. apparently they consider this less important than coronavirus or H7N9
### (is this a Hartl-risk assessment ?)

from the full report at http://www.who.int/csr/durc/durc_feb2013_full_mtg_report.pdf

1, There was general agreement that WHO should facilitate a broader discussion.

### I think WHO should involve the public in this fundamental discussion.
### They should establish an internet discussion forum where interested
### people from all countries can participate without having to travel to Geneva meetings.


5, The potential risks of full and open communication would be expected to outweigh
the benefits in only the rarest circumstances.

### which we have here. NSABB got involved (rare)

6. The inventory, sharing, and, where needed, development, of guiding principles, toolkits, ´
best practices and other forms of technical assistance would help countries formulate
their own policies and procedures for managing DURC. Although establishment of a
legally binding global agreement or regulation is theoretically possible, such an approach
would be expensive, slow, likely impractical and would not necessarily yield the desired benefits.

6, unevenly implemented across countries, they are not coordinated or harmonized and none
of them sufficiently addresses DURC

6, critical gap

7, It was acknowledged that at times a certain amount of tension or distrust has
characterized the relationship between the security and scientific communities.
The inability of security experts to share specific information about the likelihood
of misuse and harm from research findings creates a level of asymmetry in the
relationship between the two groups.

7, It was observed that a very similar challenge was faced by public health scientists
working on severe emerging diseases, and that there might be ways to develop a
common language and compatible methodologies for describing risk. An optimally
functioning relationship between scientists and security experts requires mutual
engagement to bridge gaps in communication, collaboration and culture.

8, The lack of standardized definitions and terminology that are universally accepted
across sectors and stakeholders leads to confusion and misunderstanding as does the
lack of harmonization among existing guidelines, regulations, codes of conduct and the like.


### than "common language and compatible methodologies for describing risk" does exist.
### It's called probability theory and risks are being assigned numbers, called probabilities.








[further quotes and comments to be added here later]
 
Re: CIDRAP- WHO report: Global guidance on dual-use research needed

the whole way how this was handled gave me the impression that there was a strategy
to "dilute" the whole concern with introductions, general descriptions to compare the concern
with previous concerns and general blabla about methology while avoiding to investigate
the issues directly, to actually assess the risk.


I think we should seriously consider and discuss the option to all this influenza
gain of function research, all what can lead to pandemic strains, as secret.
Like military research on new weapons. But on an international level.
Only some few labs are involved and they are being internationally surveilled
to keep things secret that are critical to gof knowledge.
That is the typical reassortment,passenging,reverse genetics experiemts
that lead to more transmissible viruses but have little use for vaccine
or antiviral production.
The general risk, as interpreted from the secret experiments can still be
communicated, but not the actual viruses and strains that are being created,
that pose the main danger. Some vaccine producers could be involved, if this
knowledge is important for timely prepandemic vaccines, but afaics
this is currently probably not a big issue.

We must have a plan, what to do when someone creates
a (likely) pandemic strain. We won't want to disclose that strain, of course.
But should we talk about it at all ? There certainly would be a need to prepare
but also a curiosity to figure out what that strain is, to repeat the process
and independently create it from hints.
Or to use the idea to create other pandemic strains.
Or just to intensify the search for other pandemic strains

Once we (might) have created such a pandemic strain of great virulence,
say comparable with 1918flu (as it was on the current immunological background
of that time.) that might be a red flag and a point of re-discussion.
Most people seem to consider this unlikely and would have to rethink once
it (might) happen. But -just hypothetically if you want- what could and should
we do then ?
Shut down all flu-labs, destroy all flu viruses, strongly forbid and control the possession
and work on these things worldwide ? Stop science, even in similar nondangerous areas
like creating new cold-viruses ? IMO : yes.

Through big international efforts and investments we had been able to advance
science. Shouldn't we be able to stop it, when necessary ?
It just needs the political will to do so. And the international consensus for it
should be established now.
 
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