| Activity |
Purpose/Rationale/Action |
When to seek Program Approval
| a. Determine
whether your laboratory has a program
approval. |
All work
that is conducted is done under recommended
containment level, e.g., BL1 and facilities and
practices have been reviewed and approved by the
IBC and a registration number
assigned. |
| b. Determine
whether the proposed research is covered under
the program approval for the
laboratory. |
Used to
cover the recombinant DNA research activity of
the Lab. PI agrees that all work with certain
organisms will be conducted at recommended
containment levels and certifies that the
facilities and practices in the laboratory are
available to achieve this
containment. |
| If
yes, no additional action is needed.
If no, complete the
program approval form. |
|
Steps to Obtain Program Approval
| a.
Determine where the work is to be
conducted. |
Used
to determine which Guidelines/Regulations are
applicable. Research contained inside a
laboratory follows NIH guidelines for
recombinant research.
For research involving
planned introductions outside the laboratory,
USDA or EPA regulations may apply. At present,
the IBC alone cannot provide approvals, but can
provide information. |
| b.
Determine whether the organisms require special
containment for handling, culturing, and other
activities, and if so, what containment level is
recommended. |
To
assure safety of laboratory workers and the
environment.
Complete a comprehensive
risk assessment analysis of the organism(s) to be
used. See NIH Guidelines appendix G (or pages
10-13 of this user's guide) and CDC list of
pathogens for containment desription and
recommended level.
All work with human
pathenogenic or potentially pathogenic material must also be
registered with the NIH Biosafety
Committee/ASU Safety
Office.
All transgenic plants,
animals, and other higher organisms must be
registered and approved by the IBC.
Plant pathogens may
require compliance with USDA/APHIS
regulations. |
| c.
Complete the IBC program approval
form. |
Registers the recombinant
DNA activity with the IBC, which ascertains and
notifies P.I as the type of oversight and
containment levels recommended by the NIH
guidelines that are
necessary. |
Recommendations/Requirements for
Laboratory
Experiments
| a.
Determine whether the cloning work you propose
is exempt from the NIH Guidelines. |
Answer
question 6 on the program approval form as III-E
if you meet conditions of NIH guidelines Section
III-E (see page 9 of this User's Guide). File
with IBC. No action other than registration is
needed. BL1 containment is
recommended. |
| b. If not
exempt, determine the containment recommended by
NIH guidelines and the approval needed. Contact
the BAC for guidance, if needed. |
Answer
question 6 as III-D if you meet the conditions
of NIH Guidelines Section III-D (see page 9 of
this user's guide). Most experiments in this
category can be done at BL1 (See NIH Guidelines,
Appendix G or Page 10 of this guide), and
registered sumultaneously with
initiation.
Answer question 6 as
III-C if you meet the conditions of NIH
Guidelines Section III-C. This approval level
includes
transgenic plants and animals or cloning DNA
into risk group 2 or higher organisms.
Containment with such microorganisms is at BL2
or above, or is determined by the IBC.
Experimental protocol for containment and
practices must be approved prior to installation
or through a program approval.
Answer question as III-A
or III-B if you meet the conditions of NIH
Guidelines Sections III-A or III-B (see page 8
of this user's manual). These experiments must
be reviewed by the NIH-RAC or NIH-ORDA, which
then recommends the conditions under which the
experiment should or should not be
done. |
Recommendations/Requirements for Experiments
Outside the laboratory
| a.
Determine whether the activity proposed
constitutes a planned introductions into the
environment. |
If
yes, it is likely that a permit from a
regulatory agency is needed. |
| b.
Determine, for the organism or application,
which guidelines or regulations apply. NOTE:
Transfer or shipping of organisms from another
laboratory may need special
approval. |
Contact the IBC for further
guidance. |
|
