E8-14438. Public Consultation on a Proposed Framework for Oversight of Dual Use Life Sciences Research

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice of Public Consultation Meeting.

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 [e-mail] 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?

▪ If so, how should that determination be made?

○ Should the determination routinely include input from others? If so, who else should participate in the initial evaluation?

○ To whom should the investigator report this determination?

▪ 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?

▪ Should institutions be required to establish their own review committees?

○ Can existing institutional review committees fulfill these characteristics (e.g., the Institutional Biosafety Committee) as is or with some modification?

○ If the IBC, what additional expertise would be needed to facilitate the review of dual use research of concern?

○ Would most institutions likely have the necessary in-house expertise for this review?

○ Would it be helpful to have the option of utilizing a commercial review entity or the review entity at another institution?

▪ Should regional committees or a national committee be established

○ As optional review mechanisms?

○ In lieu of a requirement to establish committees at the institutional level?

○ In an advisory capacity (e.g., the NIH RAC) to give recommendations on specific protocols, leaving final approval authority with the institutions?

○ 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:

▪ Criterion and associated guidance.

▪ Guidance on responsible communication of dual use research of concern.

▪ 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 [e-mail] or by Fax at 301-496-9839.

Dated: June 19, 2008.

Amy P. Patterson,

Director, Office of Biotechnology Activities, National Institutes of Health.