For more on this topic, see the Biodefense and Select Agents section of NIAID Research Funding.
Preparing for award
- Program
officers identify applications with select
agents on the program
officer checklist.
- Grants management staff place a select agents term on relevant awards to:
- Ensure that the grantee is aware of NIAID's select agents policy,
which indicates that no funds on select
agent work can be used until it is reviewed and approved
by the NIAID Interagency Select Agent Review Group.
- Provide the application number to the Office of International
Extramural Activities (OIEA) in the Division of Extramural
Activities (DEA).
Institute review
- OIEA requests that the principal
investigator and responsible
official at
the foreign institution provide the following information
for review by the NIAID
Interagency Select Agent Review Group (ISARG):
- Completed
Form 1 Application for Laboratory Registration from APHIS and CDC Forms (based on the select agent(s) being used.) The
application Web sites also provide a list of
select agents as well
as information to help in determining which
form to complete.
- Because the form will not be used for registration with the CDC Select Agent Program, completed forms must be sent to NIAID, not to CDC or USDA as indicated in the application form instruction.
- Information provided on Form 1 will be reviewed during the
laboratory inspection. Every foreign laboratory
will be
inspected.
- Information about policies for possession, use, and/or transfer
of select agents, and assurance from
the institutional responsible official that a process (comparable
to that described in 42 CFR 73 for US institutions)
is
in place and will be administered on behalf of
all select agent work
sponsored by NIH funds.
- Institutions that currently do not have a policy
equivalent to 42 CFR 73 must provide information delineating any laws, regulations,
policies, and procedures applicable
to the institution for the safe and
secure possession, use,
and/or transfer of select agents. If needed, an NIAID contractor can assist
in
gathering and submitting
information.
- The
institutional responsible official
and the alternate responsible official must certify that facilities meet their institution's requirements
to
work safely with select agent(s), that only
authorized personnel have access to select agents,
and the institution
keeps
records of
select agents
transferred to and from their facilities.
- CDC performs foreign laboratory inspections of NIAID awards that include foreign institutions.
- ISARG reviews each awardee's research
project, laboratory inspection report,
and institutional policies and certification. ISARG members are Federal employees with experience in select agent research or policies.
Outcome of NIAID review
- ISARG makes a recommendation to the DEA director whether satisfactory select agent compliance has been met and whether the restriction
should be waived.
Continuing and existing awards
For continuing grants or awards made before July 2003, when NIAID implemented
this process, the principal investigator and responsible official
were encouraged to quickly submit information described in Item
3 above. The principal
investigator did not have to stop performing the research in the
interim.
More information
If your research involves select agents, see the Biodefense and Select Agents section of NIAID Research Funding. If your research involves human subjects, read our human subjects information.
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