Forms and Instructions
Application Process
Principal investigators
(PIs) are required to submit
an application to use rDNA,
biohazardous agents or
unfixed human fluids and
tissues prior to the initiation
of the research. An application
(IBC
Form 1A) has been developed
for this purpose. If at
any time, the research
expands or changes beyond
the current protocol description
an amendment describing
the changes must be submitted
to the IBC before work
is initiated (IBC
Form 2a). For example,
changes in the type of
organism being studied
or a change in biosafety
level containment will
require that an amendment
be submitted. Initial protocol
application forms and protocol
amendment forms are available
below.
Send
forms by campus mail to:
Institutional
Biosafety Committee Secretary
Bob Golden
REM/CIVL
To drop off forms: Visit
the IBC Office at PUSH,
B21
The IBC
recommends that PIs develop
an umbrella rDNA application
describing their research
projects. This umbrella
application would ideally
encompass most, if not
all, of the PI’s
current and anticipated
research designs in sufficient
detail to enable review.
However, if the research
involves the use of a select
agent, a seperate protocol
must be submitted for review
and approval for each select
agent proposed for study.
Investigators
using or obtaining unfixed
human blood, blood products,
body fluids, tissue or
cell lines in the course
of their research are now
required to complete the
biohazards/rDNA application
in addition to a human
subjects application
to use these materials.
This is being done in order
to facilitate training
and monitor the use of
these materials in research.
This monitoring process
is being phased in by the
IBC in cooperation with
the Office of Research
Administration (ORA) as
protocols come in for review
or renewal, or at the time
when grant accounts are
established for new awards
or non-competing renewals.
Customarily
all IBC applications or
amendments will be reviewed
within two weeks of receipt.
Protocols requesting use
of any Class III, IV, and
V biohazardous agents,
as well as all Select Agents,
must be presented for full
committee review and approval.
If applications are incomplete
or further information
is needed (e.g. documentation
if field-testing is involved),
the PI will be contacted
by the Chair or the IBC
Secretary. PIs are advised
to have their protocols
reviewed and approved in
advance of submitting any
proposals. Failure to have
a current IBC approval
reference number on file
will delay the receipt
of any grant funding until
such approval is obtained.
|
