[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57589-57596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22770]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Notice Response to Comments and Notice of Final Action Regarding
the United States Government Policy for Institutional Oversight of Life
Sciences Dual Use Research of Concern
SUMMARY: On February 22, 2013, the Office of Science and Technology
Policy (OSTP) published a 60-day public notice in the Federal Register
(Federal Register Volume 78, Number 36, Docket No. 2013-04127) to
invite public
[[Page 57590]]
comment on the proposed United States Government Policy for
Institutional Oversight of Life Sciences Dual Use Research of Concern
(hereafter, Policy for Institutional DURC Oversight or Policy). This
Notice responds to comments received during this 60-day public notice,
sets forth final changes to the Policy for Institutional DURC
Oversight, and implements the final Policy for Institutional DURC
Oversight. The Policy for Institutional DURC Oversight will be updated,
as needed, following domestic dialogue, international engagement, and
input from interested communities including scientists, national
security officials, and global health specialists and announced in the
Federal Register and at http://www.phe.gov/s3/dualuse.
DATES: Policy release date: September 24, 2014. Effective date:
September 24, 2015. The 12-month period between release and effective
date will allow institutions and USG funding agencies subject to this
Policy to establish the procedures necessary to comply with this
Policy. Certification of compliance will be required of institutions to
which the Policy applies, as defined in Section 6.1, at the time of
seeking funding, but no sooner than the effective date of the Policy.
FOR FURTHER INFORMATION CONTACT: Dr. Andrew M. Hebbeler, Assistant
Director for Biological and Chemical Threats, Office of Science and
Technology Policy, Eisenhower Executive Office Building, 1650
Pennsylvania Avenue, Washington, DC 20504, [email protected].
SUPPLEMENTARY INFORMATION: The Policy for Institutional Oversight of
Life Sciences DURC is available on the U.S. Department of Health and
Human Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse.
Background
Life sciences research is essential to the scientific advances that
underpin improvements in the health and safety of the public,
agricultural crops and other plants, animals, and the environment;
materiel\1\; and national security. While life sciences research has
and will continue to yield benefits, no research comes without risk.
Generally speaking, the risks associated with the conduct of life
sciences research, such as accidental exposure of personnel or the
environment to a pathogen or toxin, are addressed by existing and
complementary statutes, regulations, and guidelines \2\ that ensure
that life sciences research is conducted safely and securely.
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\1\ Materiel includes food, water, equipment, supplies, or
material of any kind.
\2\ E.g., the select agent regulations (42 CFR Part 73, 9 CFR
Part 121, and 7 CFR Part 331); NIH Guidelines on Research Involving
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines);
and Biosafety in Microbiological and Biomedical Laboratories (BMBL),
5th Edition.
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However, despite the doubtless value and benefits of the outcomes
of scientific research, there are certain types of legitimately-
conducted research that generate knowledge, information, products, or
technologies that could also be intentionally utilized for harmful
purposes. Such research is deemed to be ``dual use research.'' Within
the life sciences, there exists a subset of dual use research that
merits particular attention due to the magnitude of the potential
consequences of its misuse or misapplication. This research is called
dual use research of concern (DURC) and is defined in the Policy for
Institutional DURC Oversight as life sciences research that, based on
current understanding, can be reasonably anticipated to provide
knowledge, information, products, or technologies that could be
directly misapplied to pose a significant threat with broad potential
consequences to public health and safety, agricultural crops and other
plants, animals, the environment, materiel, or national security.
Funders of life sciences research and the institutions and
scientists who conduct this research have a shared responsibility for
oversight of DURC and for promoting its responsible conduct and
communication. A comprehensive oversight system for DURC includes the
policies, practices, and procedures put in place to ensure DURC is
identified and risk mitigation measures are implemented, where
applicable, and such a system must include both Federal and
institutional oversight processes. Institutional oversight of DURC is a
critical component of a comprehensive oversight system because
institutions are most familiar with the life sciences research
conducted in their facilities and are in the best position to promote
and strengthen the responsible conduct and communication of DURC.
The Policy for Institutional DURC Oversight is one of two USG
policies that apply to the oversight of life sciences research with
dual use potential. The other policy is the USG Policy for Oversight of
Life Sciences Dual Use Research of Concern, issued on March 29, 2012
and hereafter referred to as the March 2012 DURC Policy.\3\ The March
2012 DURC Policy sets forth a process of regular Federal review of USG-
funded or -conducted research and requires Federal agencies that fund
or sponsor life sciences research to identify DURC and evaluate this
research for possible risks, as well as benefits, and to ensure that
risks are appropriately managed and benefits realized. The Policy for
Institutional DURC Oversight complements the March 2012 DURC Policy by
establishing review procedures and oversight requirements for the same
scope of life sciences research at the institutions that receive
Federal funding for such research. Together, the two policies work to
engage the life sciences research community and the Federal departments
and agencies that fund such research in a shared commitment to address
the risk that knowledge, information, products, or technologies
generated from life sciences research could be used for harm. In
addition, the Policy for Institutional DURC Oversight and the March
2012 DURC Policy emphasize a culture of responsibility by reminding all
involved parties of the shared duty to uphold the integrity of science
and prevent its misuse.\4\
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\3\ The United States Government Policy for Oversight of Life
Sciences Dual Use Research of Concern (March 2012 DURC Policy),
March 29, 2012, www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf.
\4\ The March 2012 DURC Policy and the final Policy for
Institutional DURC Oversight are complemented by extant laws and
treaties (e.g., United States Code Title 18 Section 175 and the
Biological and Toxin Weapons Convention) that prohibit the
development, production, acquisition, or stockpiling of biological
agents or toxins of types and in quantities that have no
justification for prophylactic, protective or other peaceful
purposes and that prohibit the use of biological agents and toxins
as weapons.
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Text of the Final Policy for Institutional DURC Oversight
The final Policy for Institutional DURC Oversight is available on
the U.S. Department of Health and Human Services Science Safety
Security (S3) Web site: www.phe.gov/s3/dualuse.
Companion Guide to the USG Policies for Oversight of Life Sciences Dual
Use Research of Concern
The USG has developed a guide to assist in implementation of both
the final Policy for Institutional DURC Oversight and the March 2012
DURC Policy, entitled Tools for the Identification, Assessment,
Management, and Responsible Communication of Dual Use Research of
Concern: A Companion Guide to the USG Policies for Oversight of Life
Sciences Dual Use Research of Concern (hereafter, Companion Guide). The
[[Page 57591]]
comments received in response to the proposed Policy were taken into
consideration in developing the guidance and other information that are
included in the Companion Guide. Use of the Companion Guide by PIs,
institutions, and Institutional Review Entities (IREs) is voluntary.
The Companion Guide will be considered for revisions as experience in
implementing the final Policy for Institutional DURC Oversight and the
March 2012 DURC Policy and in utilizing the tools included in the
Companion Guide accumulates. This review will be carried out
periodically as needed.
The Companion Guide is available on the U.S. Department of Health
and Human Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse/.
Training and Education on DURC and Its Oversight
The USG and individual Federal funding agencies are developing
training and education resources to assist institutions and PIs in
meeting the requirements of Sections 7.2.G and 7.1.E, respectively, of
the final Policy for Institutional DURC Oversight. These resources will
be made available on the U.S. Government Science Safety Security (S3)
Web site, http://www.phe.gov/s3/dualuse/. The training and educational
resources will be considered for revisions as experience in such
training accumulates. This review will be carried out periodically as
needed.
For institutions subject to the final Policy, the USG anticipates
that the requirements for education and training on DURC will be met by
the effective date of the Policy or at the point of providing
certification of compliance to a Federal funding agency or agencies, as
described in Section 7.2.L of the final Policy. The twelve-month time
frame between the release of the final Policy and its effective date
was deemed sufficient to allow institutions to perform outreach and
training for investigators whose research will now be subject to the
Policy for Institutional DURC Oversight.
Summary of Public Comments & Revisions Reflected in the Final Policy
On February 22, 2013, the Office of Science and Technology Policy
(OSTP) published a 60-day public notice in the Federal Register
(Federal Register Volume 78, Number 36, Docket No. 2013-04127) \5\ to
invite public comment on a proposed draft of the Policy for
Institutional DURC Oversight, and to gather specific comments on 16
questions relating to the Policy and its possible implementation.\6\ In
addition to assisting in the development of the final Policy, the
comments were helpful in identifying and developing materials that are
designed to aid institutions in the implementation of the final Policy
for Institutional DURC Oversight and the March 2012 DURC Policy. By the
end of the 60-day comment period, OSTP received 38 responding
commentaries on the proposed Policy from 27 entities, described below.
The majority of the responses (20) represented the viewpoints of
departments and offices of 16 different research institutions: 11
universities, three teaching hospitals, one non-profit owning two of
the commenting teaching hospitals, and one public health reference
laboratory. Six professional associations and one citizens' group each
submitted one response. Eleven of the responses were submitted by
private citizens, eight of whom identified themselves as researchers or
scientists.
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\5\ ``United States Government Policy for Institutional
Oversight of Life Sciences Dual Use Research of Concern; Notice,
Request for Comment,'' 78 Federal Register 36 (22 February 2013), pp
12369-12372, federalregister.gov/a/2013-04127.
\6\ United States Government Policy for Institutional Oversight
of Life Sciences Dual Use Research of Concern (Policy for
Institutional DURC Oversight), February 21, 2013, www.phe.gov/s3/dualuse/Documents/oversight-durc.pdf.
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The following paragraphs review the specific comments received on
each section of the final Policy; the USG's response to those comments;
and the revisions and additions included in the final Policy.
Section 1. Introduction
The introductory text of the final Policy for Institutional DURC
Oversight states that the USG will update the Policy, as warranted,
based on feedback on implementation of the final Policy, evaluation of
the Policy's impact, and assessment of the advantages and disadvantages
of expanding the scope of the Policy. In the final Policy, the
introductory statement was revised to include that the USG will update
the components outlined in the final Policy and the March 2012 DURC
Policy, as needed, following domestic dialogue, international
engagement, and input from interested communities including scientists,
national security officials, and global health specialists.
The introduction in the final Policy, as well as a short statement
in Section 6.1 (Applicability), include revisions to clarify that while
institutions may, as they deem appropriate, expand their internal
oversight to life sciences research outside the scope of the final
Policy, such an expansion of scope by the institution would not be
subject to oversight as articulated in the final Policy.
Section 4. Definitions
Two new definitions are provided in the final Policy for
Institutional DURC Oversight. The first, a definition of ``to
certify,'' which means to attest to the USG that an institution subject
to this Policy will comply with all aspects of this Policy. A
definition has also been provided for ``Principal Investigator'' (PI).
For the purposes of the Policy, a PI is an individual who is designated
by the research institution to direct a project or program and who is
responsible to the funding agency or the research institution for the
scientific and technical direction of that project or program. There
may be more than one PI on a research grant or project within a single
or multiple institutions.
Two definitions have been modified. The definition for the
Institutional Contact for Dual Use Research (ICDUR) was revised to
clarify that the person serving in this capacity should function as an
institutional point of contact for questions regarding compliance with
and implementation of the requirements for the oversight of DURC as
well as the liaison (as necessary) between the institution and the
relevant USG funding agency. The definition of ``life sciences'' was
also revised to align with the definition of the same term in the March
2012 DURC Policy, i.e., for the purposes of the final Policy, ``life
sciences'' includes the discipline of aerobiology.
Section 5. Policy Statement
Section 5.A of the final Policy for Institutional DURC Oversight
includes slight revisions that clarify that life sciences research that
meets the scope specified in Section 6.2 of the final Policy is subject
to Federal oversight through the March 2012 DURC Policy as well as the
institutional oversight set forth in the final Policy.
Section 6.1 Applicability
In the final Policy for Institutional DURC Oversight, the last
paragraph of the applicability section was revised to clarify that life
sciences research institutions that conduct or sponsor research that is
within the scope of the Policy but receive no USG funds in support of
life sciences research are not required to adhere to the oversight
requirements of the final Policy. These institutions are, however,
strongly encouraged to implement internal
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oversight procedures consistent with the culture of shared
responsibility underpinning the Policy. As noted in the Introduction to
the final Policy, institutions may also, as they deem appropriate,
expand their internal oversight to life sciences research outside the
scope of the final Policy; however such an expansion of scope by the
institution would not be subject to oversight as articulated in the
final Policy.
The final Policy also reflects the relocation of the paragraph
regarding compliance with the Policy from this section to a new
section, Section 6.3.
Section 6.2. Scope of Research Requiring Oversight
The scope of the proposed Policy for Institutional DURC Oversight
includes research that directly involves non-attenuated forms of the 15
agents or toxins listed in Section 6.2.1 of the final Policy, including
the use of botulinum toxin at any quantity, and which also produces,
aims to produce, or can be reasonably anticipated to produce one or
more of the effects listed in Section 6.2.2 of the final Policy.
Comments on the proposed Policy were specifically requested regarding
the appropriateness of the scope of the Policy, including whether the
scope should be expanded to all select agents, microbes, or all life
sciences; what factors should be considered in determining a final or
revised scope; what criteria might be used to determine what research
should or should not be subject to oversight; and what effects such an
expansion might have on the ability to conduct research. In addition,
comments were invited on whether the scope of the proposed Policy
should be expanded to include the use of any of the listed 15 agents or
toxins in attenuated forms; the use of the genes from any of the listed
15 agents or toxins; in silico experiments (e.g., modeling experiments,
bioinformatics approaches) involving the biology of the listed 15
agents or toxins; or research related to the public, animal, and
agricultural health impact of any of the 15 listed agents or toxins
(e.g., modeling the effects of a toxin, developing new methods to
deliver a vaccine, developing surveillance mechanisms for a listed
agent).
Eighteen comments were received on the topic of expanding the scope
of the proposed Policy. Eleven comments favored the proposed scope or
narrowing the proposed scope, while seven comments favored expansion of
the proposed scope. Eight of the comments cited a negative impact on
research should the scope be expanded, while nine comments made no
mention of effects on the ability to conduct the research. One
institution that already conducts DURC reviews of all recombinant DNA
and BSL-3 research cited no additional burden as a result of an
expanded scope for its review process. In general, those in favor of
scope expansion expressed satisfaction with the current scope, with the
understanding that expansion may occur in the future.
Thirteen comments were received in response to the more specific
question on modifications to the scope. Three comments recommended no
expansion or modification to the scope of the Policy, while two
considered the scope appropriate at the current time but acknowledged
that future developments may warrant changes. Five comments suggested
that attenuated forms of agents should be considered for inclusion in
the scope of the Policy if there is sufficient justification. Three
comments expressed support for expanding the scope to include genes
known to increase pathogenicity, virulence, or infectivity; however,
one of these comments proposed limiting the source of these genes to
any of the listed agents, while the other two comments noted that any
genes known to increase these characteristics should be included in the
scope. Two comments supported expansion of the scope to include
consideration of in silico experiments. Two other comments received on
this topic requested additional guidance on review of these types of
studies in the event of an expansion of the Policy's scope. One comment
suggested that the scope of the Policy could permit flexibility beyond
a specific list of pathogens by limiting the scope to only the seven
identified categories of experimental effects (Sec. 6.2.2) and thus the
review process would involve evaluating the dual use implications of
all research meeting one or more of these seven categories.
Because institutional oversight of DURC will be a new undertaking
for many institutions, the USG has maintained the scope of the final
Policy as a well-defined subset of life sciences research that involves
15 agents \7\ and seven categories of experiments. Of note, the final
Policy is intended to apply only to research that directly involves
non-attenuated \8\ forms of the 15 agents. After implementation of the
final Policy, the USG will assess the advantages and disadvantages of
expanding the scope of the Policy to encompass additional agents and/or
categories of experiments and will update the Policy, as warranted.
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\7\ The 15 agents and toxins listed in the Policy for
Institutional DURC Oversight are subject to the select agent
regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121),
which set forth the requirements for possession, use, and transfer
of select agents and toxins, and have the potential to pose a severe
threat to human, animal, or plant health, or to animal or plant
products. It is important to note, however, that the Federal Select
Agent Program does not oversee the implementation of the Policy for
Institutional DURC Oversight or the March 2012 DURC Policy.
\8\ The only forms of the agents or toxins listed in Section
6.2.1 of the final Policy for Institutional DURC Oversight that, for
the purposes of the Policy, are considered by the USG to be
attenuated and therefore not subject to the requirements of the
Policy, can be found on the Select Agent and Toxin Exclusions list
under ``Attenuated Strains of HHS and USDA Select Agents and
Toxins'' at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusions.html.
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Section 6.3. Compliance
Ten comments were received regarding the issue of compliance with
the proposed Policy for Institutional DURC Oversight. Six of these
comments noted that the proposed Policy contained limited information
on compliance or its implementation or enforcement at institutions and
Federal agencies. In addition, three of the comments indicated
confusion regarding the role of the Institutional Review Entity (IRE)
in ensuring compliance with the Policy. To address confusion and
concerns over the responsibilities for compliance on both the part of
the institution and the Federal funding agency, language regarding
compliance with the Policy has been moved to a separate section
(Section 6.3) and reflects revisions that clarify that any suspension,
limitation, or termination of USG funding or loss of future USG funding
opportunities due to noncompliance with the final Policy will be
consistent with existing regulations and policies governing USG-funded
research and may subject the institution to other potential penalties
under applicable laws and regulations.
Regarding the role of the IRE in ensuring compliance at the
institution, Section 7.2.H of the final Policy includes revisions
intended to clarify that it is the institution, not the IRE, that is
responsible for institutional compliance with the Policy.
Section 7. Organizational Framework for Oversight of DURC
The figure in Section 7 has been modified to correspond to changes
and revisions described below.
Section 7.1. Responsibilities of Principal Investigators
The proposed Policy for Institutional DURC Oversight required PIs
to refer any research involving one or more of
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the 15 listed agents to an IRE, which would then determine whether the
research can be reasonably anticipated to produce any of the seven
effects, and if so, whether that research meets the definition of DURC.
Comments were solicited on whether it is preferable to require PIs
to determine whether their research involves one or more of the listed
agents as well as determine whether any of his or her research
involving one or more of the listed agents can be reasonably
anticipated to produce any of the listed effects before referring the
research to the IRE. Fourteen comments were received on this topic.
Nine of the comments were supportive of a review process that would
require the PI to assess his or her research for both use of one or
more the listed agents and the applicability of the listed experiments.
Furthermore, nine comments indicated that the assessment of the
applicability of the listed experimental effects should be conducted by
both the PIs and the IRE.
Comments from two institutions with extant review systems for dual
use research indicated that their review processes already require that
PIs assess their research for the listed experimental effects and
participate in discussions of the risks and benefits of the research.
These institutions noted that the increased involvement of the PI in
the review process is beneficial for both the PI and the institution
because it promotes a common understanding of DURC, informs the
institution of instances when training on DURC might be needed,
strengthens the review, enhances collaboration, and improves
compliance. Two other comments in support of the expansion of the PI's
role noted that because of the Policy's requirements for ongoing review
by PIs, the expectation of PIs to assess the applicability of the
listed effects at the outset of the research is both reasonable and
beneficial. Four comments opposed expanding the PI's role regarding
review of research for experimental effects. These comments cited
concerns about the subjective nature of the determination, and that PIs
did not have sufficient expertise for the assessment. In response to
these comments, Section 7.1.A of the final Policy includes revisions
that require PIs initiating or conducting research with one or more of
the listed agents to also review the research for the presence or
anticipation of any of the listed experimental effects. Section 7.1.B
also includes revisions that indicate that the PI must work with the
IRE to assess the risks and benefits of the research as well as to
develop the risk mitigation measures for any research determined to be
DURC. For consistency, similar changes were made to the description of
the responsibilities of institutions (Section 7.2.B.iii).
Comments were also solicited on whether research that has undergone
institutional dual use review, but has been determined by the IRE to
not meet the definition of DURC, should be monitored for emerging DURC
issues. While the proposed Policy for Institutional DURC Oversight did
not place any periodicity or time requirements for the identification
of research that meets the scope of the Policy, comments indicated that
it was not clear whether and how a PI should continue to consider the
dual use potential of his or her work or whether a PI should ever re-
examine work that has been previously determined by the IRE to not meet
the definition of DURC. Twelve of the 16 comments addressing this topic
agreed that some form of ongoing review by the PI and/or the dual use
review entity was reasonable. However, there were concerns regarding
the increased burden that ongoing or periodic review would have on
institutions, in particular the interpretations that this ongoing
review would involve monitoring in perpetuity all research that meets
the scope of the Policy. In response to these comments, Section 7.1.A
of the final Policy includes revisions that require PIs to notify the
IRE as soon as, (1) his or her research involves one or more of the
agents or toxins listed in Section 6.2.1; (2) his or her research with
one or more of the agents or toxins listed in Section 6.2.1 of the
Policy also produces, aims to produce, or can be reasonably anticipated
to produce one or more of the seven effects listed in Section 6.2.2 of
the Policy; or (3) his or her research that is within the scope of
Section 6.2 of the Policy may meet the definition of DURC (as defined
in Section 4 of the Policy).
Section 7.2. Responsibilities of USG-Funded Research Institutions
Section 7.2.B. Section 7.2 of the final Policy details the
oversight process and the roles and responsibilities of research
institutions (Federal and non-Federal) that receive USG funds for life
sciences research and that conduct or sponsor research with any of the
15 agents or toxins listed in Section 6.2.1 of the final Policy. Public
comment was requested on ways to optimize the relationship between the
March 2012 DURC Policy and the proposed Policy for Institutional DURC
Oversight. Nine comments were received related to the requirements in
both policies to review research for DURC potential and develop and
implement risk mitigation plans for any identified DURC. Four of these
comments noted the potential for duplicate reviews for research that is
found to be DURC by both the IRE (per the final Policy for
Institutional DURC Oversight) and the Federal funding agency (per the
March 2012 DURC Policy). Likewise, four of these comments noted that
both policies require the development of risk mitigation plans for any
identified DURC and that this could lead to a single DURC project with
two risk mitigation plans.
In an effort to reduce burden for the implementing institutions,
the final Policy includes revisions that indicate that research that
has already been determined to be DURC under the March 2012 DURC Policy
and is already being conducted under a risk mitigation plan does not
require the development of a new risk mitigation plan. In addition, any
research that has already been determined to be DURC under the March
2012 DURC Policy, and for which a risk mitigation plan has already been
developed, is not required to undergo the review steps outlined in
Sections 7.2.B.i-vi. However, the institutions will remain responsible
for ensuring that the risk mitigation plan is implemented and kept up-
to-date, that the PIs continue to conduct ongoing assessments of their
research, and that the risk mitigation plan undergoes annual review by
the IRE (described below).
Section 7.2.B.iii of the final Policy includes revisions to clarify
that the IRE should include the PI in its review activities, as
appropriate, and that any research that has been determined by an
institution to be DURC should not be conducted until an approved risk
mitigation plan has been implemented.
Section 7.2.B.iv of the final Policy describes the first reporting
requirement of institutions regarding oversight of DURC: Within 30
calendar days of the institutional review of the research for DURC
potential, the institution must notify the USG of any research that
falls within the scope of 6.2, including whether the research meets or
does not meet the definition of DURC. Revisions included in the final
Policy also detail the necessary information to include in this initial
30-day notification: The grant or contract number related to the
research (if the research is funded by the USG); the name(s) of PI(s);
the name(s) of the applicable agent(s) listed in Section 6.2.1 of the
Policy; and a description of why the research is deemed to produce one
or more of the experimental effects listed in Section 6.2.2 of the
Policy. For research that is
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determined by the IRE to meet the definition of DURC, the notification
should also include: The name of the investigator (if different from
the PI) responsible for the performance of the DURC; and a description
of the IRE's basis for its determination.
Section 7.2.B.v-vi. These sections of the final Policy regard the
institution working together with the USG funding agency to develop a
risk mitigation plan for research that has been determined by the
institution to be DURC. In order to clarify this process, the final
Policy includes revisions that require the institution to submit a
draft risk mitigation plan to the USG funding agency within 90 calendar
days of the IRE's determination that the research is DURC. In turn, the
USG funding agency is required to finalize and approve the risk
mitigation plan within 60 calendar days of receipt of the draft plan.
Section 7.2.B.viii-ix. In order to clarify and streamline the
requirements for periodic review by IREs of the risk mitigation plans
developed in response to determinations of DURC, the final Policy for
Institutional DURC Oversight includes revisions that require IREs to
review, at least annually, all active risk mitigation plans and modify
them, as needed. This annual review should apply to all risk mitigation
plans for DURC taking place at the institution, regardless of whether
the DURC was identified per the final Policy for Institutional DURC
Oversight or the March 2012 DURC Policy. The review of risk mitigation
plans would likely include a review of the DURC itself, and may result
in a change in the DURC status of the research (e.g., the research no
longer meets the definition of DURC). Therefore, the final Policy also
includes revisions that require IREs to notify, within 30 calendar
days, the appropriate USG agency of any change in the status of a DURC-
designated project at the institution, and details of any changes to
risk mitigation plans, which need to be approved by the funding agency.
Review of research proposals. Thirteen comments were received in
response to the request for feedback on whether research institutions
should review life sciences research proposals for DURC issues prior to
their submission to a funding agency. Eight of the comments noted that
fewer proposals are funded than are submitted, and thus a requirement
for institutional reviews of proposals before funding is secured could
result in a waste in effort and an unnecessary burden upon the
institution.
In response to these comments, references to the institutional or
IRE review of research proposals for DURC concerns prior to submission
to a funding agency have been removed. However, it should be noted that
institutions that conduct Federally-funded life sciences research are
required, at the time of application for USG funds for life sciences
research, to provide certification to the USG funding agency or
agencies that the institution is in full compliance with all aspects of
the Policy or will be at the time the research is initiated. In
addition, the Policy for Institutional DURC Oversight requires PIs to
identify any and all research involving one or more of the 15 listed
agents and refer such research to the IRE, along with the PIs
assessment of the applicability of the listed experimental effects.
Thus, institutions will have a process in place for reviewing research
for dual use concerns before the research is initiated, and this review
must be done by the time this research begins.
Comments on the proposed Policy also indicated that guidance was
needed for institutions and IREs to meet the review and reporting
requirements set forth in Section 7.2.B. To assist institutions and
their IREs, Section C of the Companion Guide contains more information
on the reporting requirements for institutions with respect to findings
of DURC. Also, Section D of the Companion Guide contains guidance and
tools to assist IRE's in the drafting of risk mitigation plans for
DURC.
Section 7.2.D. The proposed Policy for Institutional DURC Oversight
described the role of an Institutional Contact for Dual Use Research
(ICDUR), who is designated by the institution to serve as a point of
contact for questions regarding compliance with and implementation of
the requirements for the oversight of research that falls within the
scope of and/or meets the definition of DURC. When questions arise
regarding compliance or implementation of the final Policy or the March
2012 DURC Policy, the assessment of DURC, or the development of risk
mitigation plans, the ICDUR also serves as the liaison (as necessary)
between the institution and the relevant program officers at the
Federal agencies.
Comments were solicited regarding the feasibility of a single
individual serving in the capacity of the ICDUR. Nine of the thirteen
comments were supportive of the ICDUR's role, with two comments voicing
concerns about the expertise and training needed for performing the
role of the ICDUR. Based on the comments received concerning the role
and expertise of the ICDUR, the final Policy clarifies that the ICDUR
is not expected to be able to answer all DURC-related questions, but
rather would serve as the institutional point of contact for questions
and would ensure that all questions are adequately addressed by the
appropriate subject matter experts. Furthermore, it is at the
discretion of the institution to decide whether the position of ICDUR
should be a new full-time position or whether the responsibilities of
the ICDUR should be assigned to an extant institutional staff member or
official.
Section 7.2.E. The final Policy for Institutional DURC Oversight
details the responsibility of institutions subject to the Policy to
establish an IRE, describes the range of mechanisms available to
institutions in meeting this requirement, and details the required
attributes of an IRE. Comments were requested on how DURC oversight
could be usefully integrated with other existing institutional
oversight processes in order to reduce duplication and burdens on
institutions, as well as the feasibility, benefits, and limitations of
using an institution's Institutional Biosafety Committee (IBC) to
conduct the DURC institutional review process.
Twelve of the nineteen comments received on the topic of utilizing
extant IBCs for dual use reviews posited that integration of DURC
review with existing IBC processes would be less of a burden for the
institution than establishing a new entity for the sole purpose of
conducting DURC reviews. These institutions noted that, because some
IBCs already conduct some form of review for dual use concerns, they
are familiar with the concept already. In addition, the commenting
institutions noted that using an extant body would eliminate a
duplicative process of standing up yet another entity for a similar
submission and review process. A few (four) of the respondents either
opposed the use of the IBC for DURC review or requested more
information on the process. These comments described potential
challenges to using the IBC for dual use reviews, including that review
of research for dual use concerns would be an entirely new role for the
IBC and that committee members may not have the expertise to conduct
such reviews. Also, the time required to review research projects could
increase significantly for IBCs, reducing the efficiency of both the
recombinant DNA and dual use reviews. Many comments were also concerned
with the ability of IREs to recognize and assess the risks associated
with DURC. A few comments noted that institutions may not have the
expertise required to identify DURC and that the consistency of DURC
reviews
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among institutions may vary considerably. Other comments requested more
guidance and tools for the institution and its IRE to assist in the
review and oversight processes.
To address the comments and concerns on the composition and
expertise of the IRE, the final Policy clarifies that: the IRE is to be
composed of no fewer than five members; the IRE membership should be
empowered by the institution to execute the actions listed in Sections
7.2.B.i-iii, v, and viii, of the final Policy; the IRE should include
members that understand biosafety and biosecurity considerations; and
the IRE may include as a member or as a consultant at least one
individual knowledgeable of the institution's policies and procedures.
No changes were made regarding the range of mechanisms available to
institutions in fulfilling the requirement to establish an IRE; the
final Policy retains the flexibility for institutions to create or
designate the review entity best suited for their needs, as long as the
review entity is appropriately constituted (per Section 7.2.E.ii-iv) to
meet the requirements of the final Policy. In addition, guidance on the
establishment of an IRE has been provided in the Companion Guide and
training materials have been developed to assist institutions and their
IREs in implementing the requirements of the final Policy.
Of note, the final Policy identifies resources for institutions
with questions regarding DURC reviews or oversight. The final Policy
describes the USG's responsibility to provide guidance to institutions
on the sharing of DURC research products and on the communication of
DURC, as well as convene advisory bodies such as the National Science
Advisory Board for Biosecurity (NSABB), when necessary, to develop
recommendations on particularly complex cases of DURC. In addition, per
Section 8.B, institutions may, with the participation of the designated
ICDUR, consult with the USG department or agency that is funding the
research (or in the case of non-USG funded research, with the NIH or
with the USG funding agency designated by the NIH) for advice on
matters related to DURC.
Section 7.2.F. Retention of records. The proposed Policy for
Institutional DURC Oversight required institutions to maintain records
of institutional DURC reviews, risk mitigation plans, and personnel
training on dual use research for three years. Comments were solicited
regarding the appropriate amount of time that institutions should be
required to retain such records. Twelve comments were received on this
topic. Nine recommended that records be retained for or beyond the
period of time of the research grant or contract. Five of the comments
indicated that records should be retained, at a minimum, for the length
of the grant or contract period and then three additional years
following project termination or completion. Two comments indicated
that indefinite records retention was too burdensome for institutions.
The comments also indicated that while research institutions may have
different records retention requirements, these requirements are
generally record-specific; that is, each type of record may have its
own retention schedule and requirement. Three comments considered the
records retention requirements of the Policy for Institutional DURC
Oversight to be repetitive and unnecessary considering that the
laboratories conducting research subject to the Policy for
Institutional DURC Oversight are also complying with biological select
agents and toxins (BSAT) related record-keeping requirements,
Occupational Safety and Health Administration regulations,
Environmental Protection Agency regulations, and biosafety-related
requirements--some of which have record retention requirements that
exceed the length of time indicated in the proposed Policy. These
comments recommended that the USG harmonize the recordkeeping
requirements.
The final Policy includes revisions that require institutions to
maintain records of institutional DURC reviews and completed risk
mitigation plans for the term of the research grant or contract plus
three years after its completion, but no less than eight years, unless
a shorter period is required by law or regulation. This revision
accommodates the period of performance for most life sciences research
grants and contracts.
Section 7.2.H. The final Policy for Institutional DURC Oversight
includes revisions to clarify that it is the institution, not the IRE,
that is responsible for institutional compliance with the final Policy.
While institutions are required to empower their IRE to execute the
requirements listed in Section 7.2.B.i-iii, v, and viii, the
responsibility to ensure compliance with the final Policy and with
approved risk mitigation plans, as well as report instances of non-
compliance, rests with the institution. The final Policy incorporates
revisions to clarify these points. As noted earlier, language regarding
compliance with the final Policy has been moved to a new section
(Section 6.3).
Section 7.2.K. Accessibility of Institutional Review Procedures.
The proposed Policy for Institutional DURC Oversight required IREs to
make their procedures for reviewing life sciences research for dual use
potential accessible to the public. Further, it stipulated that the
posted policies of the institution should include an overview of the
institution's procedures or review process, but should not include
details of particular cases or the minutes of the DURC review entity's
proceedings. The final Policy includes revisions to clarify that
institutions should make documentation of their DURC review process
available to the public upon request, as consistent with applicable
law. In addition, the final Policy has been updated to indicate that
the provision of DURC review procedures is an institutional
responsibility that may be delegated to IREs.
7.2.L. Certification of compliance. The proposed Policy for
Institutional DURC Oversight required institutions to provide, on an
annual basis, a formal assurance to the appropriate Federal funding
agency or agencies that the institution is in compliance with all
aspects of the Policy. Two comments addressed the process for providing
institutional assurances of compliance with the Policy. Suggestions for
reducing burden associated with providing assurances included
lengthening the period of time between assurances and allowing
institutions to file a single assurance with a single entity (as is the
case for the Common Rule) rather than requiring institutions to provide
an assurance to each Federal funding agency that they work with.
The final Policy contains revisions clarifying that certification
of compliance must be provided by an institution at the time of seeking
funding for life sciences research, but no sooner than the effective
date of the final Policy. Each USG funding agency will be implementing
the certification requirement for applicants and grantees according to
their own agency policies. More information and guidance on meeting the
institutional requirement to provide certification of compliance with
the Policy for Institutional DURC Oversight can be obtained in the
grants and contracting policies of the funding agency.
Notes at the End of 7.2
DURC research at multiple institutions. The proposed Policy for
Institutional DURC Oversight noted that there will be situations where
a PI is conducting potential DURC at multiple institutions and proposed
that it should be the purview of each institution to
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review these projects and, if appropriate, develop and implement a risk
mitigation plan. Examples of DURC projects involving more than one
institution include cases where the DURC is a collaboration between PIs
at different institutions or when the DURC is undertaken by a single PI
who maintains laboratories at more than one institution. Comments were
requested regarding whether each institution participating in a multi-
site DURC project should have oversight of their portion of the
projects and, if DURC is being conducted at their institution, develop
and implement their own risk mitigation plans, or whether the primary
institution should have the responsibility for meeting the requirements
for oversight of DURC.
Twelve comments were received related to the oversight of DURC
taking place at multiple institutions. Seven of the comments expressed
the view that each institution conducting DURC should be responsible
for the assessment of its research for DURC potential, and, in cases
where DURC is determined, develop and implement a risk mitigation plan.
Comments differed, however, on how institutions should work together to
coordinate the oversight responsibilities of the DURC. Two comments
suggested that in cases of multiple PIs (and their institutions)
collaborating on a single DURC project, the institutions of the
collaborating investigators should report any findings of DURC to a
single, primary institution. Conversely, another comment stated that
DURC assessment should be a responsibility of the primary or lead
institution in the DURC collaboration, but that the individual
collaborating institutions should be responsible for risk mitigation
plan development and implementation of their portion of the project.
Some (five) of the comments were concerned with how differences in
institutional DURC assessments and mitigation plans should be handled,
how these differences are arbitrated, and how the risk mitigation
plan(s) should be implemented in cases of differing institutional
resources and capabilities.
The oversight of research that falls within the scope and
applicability of the final Policy should be consistent, regardless of
whether the research is undertaken by a single investigator at a single
institution, by a single investigator holding multiple research
positions at different institutions, or by multiple investigators
collaborating across institutions. When DURC research is undertaken at
multiple institutions, these institutions should work together to
ensure that DURC oversight, including the DURC reviews and any
resulting risk mitigation plans, is implemented consistently across the
collaborating entities. Consequently, in the final Policy, the note at
the conclusion of Section 7.2 includes revisions to clarify that in the
case of DURC collaborations involving multiple institutions, the
primary institution (i.e., the institution in receipt of the grant or
contract from the USG funding agency) is responsible for notifying the
funding agency of research that falls within the scope of the Policy
and, if that research is determined to be DURC, providing copies of
each collaborating institution's risk mitigation plan. Furthermore, the
primary institution should ensure that DURC oversight is consistently
applied by all entities participating in the collaboration.
The final Policy includes an additional note in this section
regarding cases in which a Federal department or agency simply passes
through funding from another Federal department or agency to support
life sciences research at an institution that conducts or sponsors
research involving any of the agents listed in Section 6.2.1. In such
cases, the agency originally providing the funding shall be considered
the USG funding agency, and the ultimate recipient of the funds shall
be considered the institution, and respectively shall fulfill the
requirements expected of each under this Policy.
Section 7.3. Responsibilities of USG Funding Agencies
In order to facilitate timely finalization of risk mitigation plans
drafted by the IRE (per Section 7.2.B.v) and submitted by institutions
(per Section 7.2.B.vi), the final Policy for Institutional DURC
Oversight requires the appropriate USG agencies to provide an initial
response to institutions within 30 calendar days and finalize the plan
within 60 calendar days of receipt of the draft plan. This change is,
in part, due to two comments received that suggested a specified time
frame for USG funding agencies to respond.
Section 8. Resources for Institutional Oversight of DURC
The final Policy contains no revisions to Section 8. However, as
referenced in Section III of this Notice, Section 8.A of the Policy
describes an implementation guide (i.e., a ``compendium of tools'') for
use with both the Policy for Institutional DURC Oversight and the March
2012 DURC Policy. Comments were requested on the sufficiency of the
tools and guidance material, and approximately one-third of the 26
comments received indicated the list to be sufficient. However, many
more comments included suggestions of additional tools and how tools
should be developed. These suggestions include provision of real or
hypothetical case studies illustrating the DURC assessment process,
provision of example or template risk mitigation plans, and additional
guidance for interpreting the seven experimental effects enumerated in
the Policy. Comments received in response to the proposed Policy were
helpful in developing and revising the guide's components, including: A
tool to assist PIs and IREs in assessing the applicability of the
listed experimental effects; points to consider in the assessment of
risks and benefits; guidance on developing a risk mitigation plan for
IRE-identified DURC; and guidance regarding the responsible
communication of DURC.
The compendium of implementation tools is titled Tools for the
Identification, Assessment, Management, and Responsible Communication
of Dual Use Research of Concern: Companion Guide to the USG Policies
for Oversight of Life Sciences Dual Use Research of Concern (Companion
Guide), and is posted on the U.S. Department of Health and Human
Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse. Use of the Companion Guide by PIs, institutions, and
Institutional Review Entities (IREs) is, however, not a requirement of
the Policy for Institutional DURC Oversight or the March 2012 DURC
Policy.
Cristin A. Dorgelo,
Chief of Staff, Office of Science and Technology Policy.
[FR Doc. 2014-22770 Filed 9-24-14; 8:45 am]
BILLING CODE 3270-F4-P