Questions and Answers Table of Contents
Policy Implementation |
Why does NIAID impose U.S. standards on biomedical
research abroad? What are the consequences? |
Why do foreign institutions have to follow NIAID select agent policy? |
To work safely with select agents, facilities of a foreign research
site must meet certain requirements. Do these requirements refer
to U.S. standards or those of the foreign country? |
Can U.S. inspectors require more for my BSL-4 lab than what is
stated in the regulations of my country? |
Can a U.S. PI modify his or her plan of work so that the select
agent term does not have to be applied at the foreign site? |
What is the procedure for transporting select
agents between international sites or between domestic and international
sites? |
What is the role of the U.S. awardee in ensuring
that a foreign subcontractor complies with the select agent term? |
Pre-Inspection Documents |
Do I need to include all required information regarding
the possession, use, and transfer of select agents with my application? |
Who is responsible for preparing certified translations
of a country's
select agent rules and regulations? |
Inspection Procedure |
How will a site visit be organized, when will it take
place, and how many inspectors will there be? |
As a subcontractor on an Ebola project who's been asked to collaborate
on another, do I need to be inspected twice? |
If I'm awarded a five-year grant for a select agent project
in my country, will one inspection suffice for the whole project
period? What if I'm awarded another select agent grant? |
Will I need to be re-inspected if we don't "pass" the
first time? How soon would a second inspection take place? |
Will the same inspection team inspect all labs? If not, how will
NIAID ensure consistency in the inspections? |
What is the shortest time between receiving my Notice of Award and having an inspection? |
What are the criteria for performing background checks of people
who have select agent access at foreign institutions? |
ISARG Review and Assessment |
Who is on the Interagency Select Agent Review Group
committee? |
What is the ISARG committee's role, and how
much freedom does it have for determining the sufficiency of an
institution that
does not meet all of the requirements of 42
CFR Part 73? |
How do the site visit and ISARG review take
into account the local jurisdiction's existing rules, policies,
or laws? |
What criteria does the ISARG committee
use to determine if a foreign site's safety and security procedures
are equivalent
to those required in U.S. institutions? |
What determines a pass or fail for an inspection? What if our facility managers do not agree with
the inspectors' evaluations
or recommendations? |
Are minor deviations from 42 CFR Part 73 allowed
or is a considerable amount of leeway permitted? |
If we can't afford expensive surveillance equipment or computer
tracking systems for inventories or monitoring personnel access
to freezers, can we use a paper tracking system? |
Does a foreign institution receive a certification
if a term of award is considered satisfied after ISARG
review? |
If investigators have a select agent approval certification from
their country's
regulatory agency, do they have to go through CDC inspection
and ISARG review? |
What if my question wasn't answered here, or I'd like to suggest a question? |
Policy Implementation
Why does NIAID impose U.S. standards
on biomedical research abroad? What are the consequences?
NIAID-supported researchers abroad must comply with U.S. laws, regulations, and policies for research.
Though some research partners overseas may have concerns about
complying with U.S. requirements, others have found our policies helpful. For example,
researchers in non-U.S. labs may view the CDC inspection report as
a resource for improving the biosafety and biosecurity of their laboratories.
(However, NIH cannot provide additional funding if the report identifies deficiencies.)
Why
do foreign institutions have to follow NIAID select agent policy?
The U.S. Congress, which funds NIH,
expects appropriated dollars to be
spent and programs to be executed lawfully. Further, NIAID is helping to ensure
that its funded researchers conduct their work safely
and securely.
Under the Public
Health Security and Bioterrorism Preparedness and Response Act
of 2002, U.S. institutions that perform research with select agents must be inspected for biosafety and biosecurity. These inspections provide for a level of
safety and security to prevent unwarranted access
to pathogenic
organisms and toxins and ensure a negligible risk to the public.
Until WHO develops
worldwide biosafety and biosecurity standards, NIAID requires review and possible
inspection of foreign sites performing research that involves
select agents.
To work safely with select
agents, facilities of a foreign research site must meet certain
requirements. Do these requirements refer to U.S. standards or
those of the foreign country?
A responsible official from the foreign institution must certify
that the facility meets the requirements of the local institution
for working safely with select agents. NIAID does not
impose U.S. law on foreign institutions. The
purpose is to ensure safety, security, and responsibility
of all parties.
Can U.S. inspectors require more
for my BSL-4 lab than what is stated in the regulations of my
country?
Only foreign laboratories receiving
NIAID awards are inspected. U.S. government employees
with experience in select agent research or policy review inspection results along with the select agent policies
of the foreign institution.
If they find deficiencies
based on CDC requirements (or USDA requirements
in the case of plants and animals),
the review group can recommend a restriction on the award, prohibiting funding until issues are resolved.
Can a U.S. PI modify his or her
plan of work so that the select agent
term
does not have to be applied at the foreign site?
A U.S. PI should consult an NIAID program officer and grants management specialist before making changes. Some changes require
prior approval, especially
changes in scope.
What is the procedure
for transporting select agents between international sites or between
domestic and international sites?
A permit from CDC or USDA is required for transporting select
agents in the U.S. A
permit issued to a domestic institution does not apply to a project's
foreign subcomponent.
For international sites receiving
NIH funds, transportation procedures and requirements must be
equivalent to those for
U.S. institutions.
For NIAID projects, NIAID representatives must inspect the foreign site for possession,
use, transport, and training procedures.
What is the role of the U.S. awardee
in ensuring that a foreign subcontractor complies with the select agent
term?
Though not part of the site visit team, the U.S. awardee is involved
in all communication with the foreign subcontractor and helps ensure that information is submitted as quickly as possible.
The
quickest communication occurs when the subcontractor works directly
with staff in NIAID's Office
of International Extramural Activities to prepare documents for
submission. The U.S. investigator is copied on all correspondence
but can choose to have all information go through him or her, which
may slow down the process.
Pre-inspection Documents
Do I need to include all required
information regarding the possession, use, and transfer of select agents
with my application?
No. Send them to NIAID after you get your Notice of Award. We prefer that you send them as a complete package, but if that is not possible or would cause significant delays, send the completed APHIS/CDC Form 1 with the signature of the responsible institutional official as soon as possible.
Who is responsible
for preparing certified translations of a country's select agent
rules and regulations?
The foreign institution translates
rules and regulations into English.
Inspection Procedure
How will a site visit be organized,
when will it take place, and how
many inspectors will there be?
CDC inspectors acting on behalf of NIAID will organize the inspection,
which will occur after we receive a completed APHIS/CDC Form 1, and
the
responsible
official and
PI agree on a date. There will be two or three
inspectors, depending on the complexity of the
laboratories and number of different select agents at the site.
As a subcontractor
on an Ebola project who's been asked to collaborate on another project, do
I need to be inspected twice?
If you are working in the same laboratory in the same location, your laboratory (along with your institution's select agents policies) needs to be inspected only once for the Ebola projects. If you begin research with a different agent, you will need a second inspection.
If I'm awarded a five-year grant
for a select agent project in my country, will one inspection
suffice for the whole project period? What if I'm awarded another
select agent grant?
An initial site visit is required for each new award; subsequent visits are conducted every three years. In most cases a second site visit will be needed only if the award uses a new select agent or lab.
Will I need to be re-inspected if we don't "pass" the
first time? How soon would a second inspection take place?
Once issues are resolved, a second inspection may be
needed, depending on the nature of the deficiencies. If
a second inspection
is necessary, inspectors need eight to ten weeks before a return
visit (HHS requires eight weeks' notice).
Will the same inspection team inspect
all labs? If not, how will NIAID ensure consistency in the inspections?
CDC Select Agent Program staff determine the inspection team. There
is no guarantee it will be the same team. Teams ensure consistency by using the same
standards at every site in every country.
What is the shortest time between
receiving my Notice of Award and having an inspection?
The
shortest possible time between receipt of the Notice of Award and inspection
is 10 weeks, assuming that the foreign site completes
and submits the
laboratory application form immediately after receipt of the notice
and has no scheduling delays.
What are the criteria for performing
background checks of people who have select agent access at foreign
institutions?
Background checks are the responsibility of the foreign institution
as part of its security risk assessments.
Foreign institutions must submit their procedure for personnel background checks or the comparable personnel security risk assessment procedure for clearing people who have access to select agents in NIAID-funded research to NIAID's Office
of International Extramural Activities. The procedure must be signed by the institution's signing official.
ISARG Review and Assessment
Who is on the Interagency Select
Agent Review Group committee?
Interagency Select Agent Review Group (ISARG) members include U.S.
federal employees who have experience in select agent research or policies.
Members
include NIH scientific
program, grants, and contracts staff along with employees from the CDC,
Department of Justice, Department of State, and other appropriate federal
agencies.
The committee will meet about three times a year.
What is the ISARG committee's role,
and how much freedom does it have
for determining the sufficiency of an institution that does not
meet all of the requirements of 42
CFR Part 73?
ISARG recommends to NIAID whether
a restriction on research involving select agents should be removed
from an award.
The final decision on what is "sufficient" is based
on a group decision made by ISARG members. The group has sufficient
information and freedom to make a thoughtful and informed recommendation.
The recommendation is sent to NIAID's Division
of Extramural Activities director for approval.
How
do the site visit and ISARG review take into account the local
jurisdiction's
existing rules, policies, or laws?
The rules, policies, and laws of the foreign institution are assessed
along with the inspection report for similarity to U.S. requirements.
What
criteria does the ISARG committee use to determine if a foreign site's
safety and security procedures are equivalent to those required
in U.S. institutions?
ISARG reviews foreign institutions for comparable select
agent requirements for registration, security risk assessments, safety
plans, security plans, emergency response plans, training, transfers,
record keeping, laboratory inspections, and notifications.
What
determines a pass or fail for an inspection?
What if our facility managers do not agree with the inspectors' evaluations
or recommendations?
ISARG checks that foreign laboratories have facilities
that meet minimum biosafety and biosecurity requirements. Managers
at foreign
institutions who disagree with the inspectors' evaluations can
provide additional information or clarification for ISARG review.
Are minor deviations
from 42 CFR Part 73 allowed or is a considerable amount
of leeway permitted?
Foreign institutions that do not have a process similar to the one
in 42 CFR Part 73 should provide information about applicable laws,
regulations and policies, safety, security, training, and procedures
to ensure that only approved and appropriate persons (approved by
the foreign institution) have access to select agents.
ISARG discusses the information provided and determines what is sufficient and how much leeway can be permitted.
Every situation will be considered separately but with a goal of establishing
some consistency in approach.
If we can't afford expensive surveillance
equipment or computer tracking systems for inventories or monitoring
personnel access to
freezers, can we use a paper tracking system?
Expensive
surveillance equipment is not a requirement for award, but you must have minimum
biosafety and biosecurity procedures. If the
inspection report indicates the paper tracking system and padlocks are
sufficient, that is all the laboratory needs to do.
Once your institution
submits the completed inspection application, the inspection team leader
will contact the PI or institutional
responsible official. The team leader can answer questions about
the requirements.
For further information, go to CDC's Select
Agent Program and
USDA's Agricultural
Select Agent Program.
Does a foreign institution receive
a certification if a term of award is considered
satisfied after ISARG review?
No. There are no certifications for foreign institutions. Rather,
NIAID informs foreign institutions that they have been approved
to use NIH funds for select agent work. This approval is valid for
three years.
If investigators have
a select agent approval certification from their country's regulatory agency, do they
have to go through CDC inspection and ISARG review?
Yes. All foreign laboratories and institutions are required to have their select agent policies (or comparable policies) reviewed by ISARG.
What if my question wasn't answered here, or I'd like to suggest a question?
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