[Federal Register: June 26, 2008 (Volume 73, Number 124)]
[Notices]
[Page 36341-36343]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn08-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Consultation on a Proposed Framework for Oversight of Dual
Use Life Sciences Research
AGENCY: National Institutes of Health, HHS.
[[Page 36342]]
ACTION: Notice of Public Consultation Meeting.
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SUMMARY: The Federal Government is sponsoring a public consultation to
engage the scientific community and research organizations in a
discussion of a framework for the oversight of dual use life sciences
research proposed by the National Science Advisory Board for
Biosecurity (NSABB), which is an advisory committee to the Federal
Government. In its report, the NSABB posed a series of questions on
which the Board encouraged the Federal Government to solicit public
comment. These questions concerned such matters as the clarity of the
criteria proposed by the Board for identifying dual use research of
concern, institutional oversight responsibilities, who should make
determinations regarding dual use research of concern, and how to
balance appropriate controls with academic freedom and scientific
exchange. This public consultation is an opportunity for members of the
scientific community and general public to provide input on these
important issues.
DATE AND TIME: The one day public consultation will be held on July 15,
2008, from 8:30 a.m. to 5 p.m.
ADDRESSES: The public meeting will be held on the National Institutes
of Health (NIH) campus. The meeting will be in the Natcher Conference
Center, Building 45, Balcony B. The NIH is located at 9000 Rockville
Pike, Bethesda, Maryland. There is a metro stop on the NIH campus--
Medical Center Station on the Red Line. The Natcher Center is a very
short walk from the Metro station and a campus shuttle is also
available.
FOR FURTHER INFORMATION CONTACT: Ms. Ronna Hill, NIH Office of
Biotechnology Activities, by e-mail at hillro@od.nih.gov or by
telephone at 301-435-2137. Faxes may be sent to the NIH Office of
Biotechnology Activities at 301-496-9839.
SUPPLEMENTARY INFORMATION:
Background
The Federal Government is sponsoring a public consultation to
engage the scientific community and research organizations in a
discussion of a framework for the oversight of dual use life sciences
research proposed by the NSABB. The proposed framework (accessible at
http://www.biosecurityboard.gov/news.asp), which has been formally
submitted by the Board to the Federal Government for its consideration,
outlines key features of oversight of dual use research, including
criterion for identifying dual use research of concern, local
oversight, evaluation and risk assessment of research with dual use
potential, responsible communication of research with dual use
potential, considerations in developing codes of conduct, and the need
for outreach and education. The proposed framework also outlines the
roles and responsibilities of key individuals and institutions in
managing dual use research, including researchers, research
institutions, institutional review entities, the NSABB, and the Federal
Government.
The public consultation meeting will focus on a set of questions,
included in Appendix 2 of the proposed framework, on which the USG and
the NSABB would specifically like to solicit comment. These questions
concern such matters as the clarity of the criterion proposed by the
Board for identifying dual use research of concern; institutional
oversight responsibilities, including how to balance appropriate
controls with academic freedom and scientific exchange; and approaches
to education to enhance awareness of the issue.
The meeting will be conducted as a series of panels where invited
speakers and meeting attendees will be asked to discuss particular
topics of interest to the Government. Each panel will include ample
time for in-depth discussion of the issues surrounding each topic. The
three panels will focus on: (1) The criterion for identifying dual use
research of concern and associated guidance, (2) the process for
identification and oversight of dual use research of concern, and (3)
awareness-raising and educational resources. Explanation of and
discussion questions for each panel follow:
Panel I: ``Criterion for Identifying Dual Use Research of Concern''
The NSABB proposed a criterion for identifying ``dual use research
of concern,'' i.e., that research with the highest potential for
yielding knowledge, products, or technology that could be misapplied to
threaten public health or other aspects of national security. The
proposed criterion is: ``Research that, based on current understanding,
can be reasonably anticipated to provide knowledge, products, or
technologies that could be directly misapplied by others to pose a
threat to public health and safety, agriculture, plants, animals, the
environment, or materiel.''
In the NSABB report, the criterion is accompanied by guidance that
provides examples of research that deserves especially careful
consideration with regard to the applicability of the criterion. The
guidance is not meant to be definitive in identifying dual use research
of concern, but rather to serve as a tool for focusing attention and
evaluation. The U.S. Government is seeking input on the utility of the
criterion and the accompanying guidance and on how they could be
implemented. The following questions will be discussed in Panel I:
Is the criterion sufficiently specific and understandable
so that it can be applied consistently? If not, how could it be
improved?
Is the criterion too broad? Will the criterion capture
research that is not appropriately considered dual use of concern? If
so, what are some examples of research that would be inappropriately
captured?
Is the criterion too narrow? Might it fail to include
research that should be considered dual use of concern? How might it be
modified to be more appropriately encompassing?
Is the guidance that follows the criterion for identifying
dual use research of concern helpful and sufficient? Is it clear and
understandable? Should additional categories of research that may yield
dual use findings of concern be included in the guidance?
What share of research at your institution would likely be
captured with the proposed criterion for dual use research of concern?
Panel II: ``Responsibilities and Process for the Identification and
Oversight of Dual Use Research of Concern''
Everyone involved in life sciences research has a responsibility
for identifying and responding appropriately to dual use research of
concern. The NSABB has put forth recommendations regarding the general
framework within which these responsibilities for oversight would be
carried out. The Federal Government must determine how to translate
those recommendations into policies and requirements that would apply
to investigators, other laboratory staff, senior research
administrators, institutional review committees, and other parties.
Toward that end, the government is seeking input on the following
matters:
Investigator Responsibilities
Should the principal investigator bear primary
responsibility for making the initial determination as to whether his
or her research might be considered dual use of concern?
[squf] If so, how should that determination be made?
[cir] Should the determination routinely include input from others?
If so, who
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else should participate in the initial evaluation?
[cir] To whom should the investigator report this determination?
[squf] If not, who should make this determination?
Institutional Review Responsibilities
What are the characteristics of a dual use research review
committee? What expertise will be needed?
How should institutional review responsibilities be
fulfilled?
[squf] Should institutions be required to establish their own
review committees?
[cir] Can existing institutional review committees fulfill these
characteristics (e.g., the Institutional Biosafety Committee) as is or
with some modification?
[cir] If the IBC, what additional expertise would be needed to
facilitate the review of dual use research of concern?
[cir] Would most institutions likely have the necessary in-house
expertise for this review?
[cir] Would it be helpful to have the option of utilizing a
commercial review entity or the review entity at another institution?
[squf] Should regional committees or a national committee be
established
[cir] As optional review mechanisms?
[cir] In lieu of a requirement to establish committees at the
institutional level?
[cir] In an advisory capacity (e.g., the NIH RAC) to give
recommendations on specific protocols, leaving final approval authority
with the institutions?
[cir] How much of a burden would this proposed oversight system
pose to your institution?
Panel III: ``Guidance and Educational Resources Needed To Assist the
Research Community in its Fulfillment of Oversight Responsibilities for
Dual Use Research''
Since the outset of its deliberations, the NSABB has noted the
importance of awareness in dealing effectively with dual use research
and the need for more outreach and education on this issue,
particularly to the investigator community, where various studies
document a low level of awareness. In its report, the NSABB makes a
number of observations and recommendations for promoting awareness, as
well as receiving stakeholder input on evolving policies. The NSABB
also views several elements of the oversight framework--the code of
conduct, communications guidance, and the guidance on identifying dual
use research--as key educational tools. The U.S. Government is seeking
input on the following matters:
Has the NSABB identified the major educational and
outreach priorities in its report (pages 29-31)? If not, what other
priorities should there be?
How might the following elements of the Oversight
Framework be used as educational tools:
[squf] Criterion and associated guidance.
[squf] Guidance on responsible communication of dual use research
of concern.
[squf] Code of conduct.
What other kinds of educational resources, tools, and
strategies would be helpful or particularly effective in educating
various audiences, such as investigators, research administration,
biosafety staff, and others?
This public consultation is open to the public and is free of
charge. Pre-registration is encouraged, however, due to limited space.
To pre-register, please access the pre-registration link at http://
www.biosecurityboard.gov/meetings.asp.
Any groups or individuals who cannot attend the meeting are
encouraged to submit written comments in advance of the meeting to Mr.
Allan Shipp, NIH Office of Biotechnology Activities by e-mail at
shippa@od.nih.gov or by Fax at 301-496-9839.
Dated: June 19, 2008.
Amy P. Patterson,
Director, Office of Biotechnology Activities, National Institutes of
Health.
[FR Doc. E8-14438 Filed 6-25-08; 8:45 am]
BILLING CODE 4140-01-P