What happens to my protocol after I submit it?
-
Your protocol will be reviewed internally by the
Office of Biological and Chemical Safety (OBCS) staff. At this point,
one of several things will happen:
- If the protocol does not need full committee review and contains
all of the necessary information, it will be approved.
- If the protocol does need full committee review, it will be placed
on the agenda for the next meeting of the IBC (last Wednesday of
every month).
- OBCS staff will request any additional information needed to
assist the IBC in reviewing the protocol.
- Your protocol will require full IBC review
if:
- It involves recombinant DNA subject to
the NIH Guidelines
- It involves Risk Group 2 or higher pathogens
- Please note: review packets are distributed
one week prior to the IBC meeting. For inclusion on the agenda,
protocols and additional information must be submitted before review
packets are distributed.
- If your protocol is reviewed by the IBC, it
could be:
- Approved with contingencies.
- Tabled pending receipt of additional information. In this case,
the protocol will need to be reviewed again at the next IBC meeting.
- If the protocol was approved with contingencies, you will need to
submit an amended protocol addressing the contingencies. The protocol
will not need to be reviewed again by the IBC; OBCS staff can verify
the contingencies and approve the protocol.
Why is my Animal Studies Protocol
not approved?
- If the ASC reviewer determines that your protocol
involves the use of recombinant DNA, pathogens, or hazardous chemicals,
they require that OBCS also approve the protocol.
- If you already have a protocol on file with
OBCS describing the items flagged by the ASC, your ASC protocol will
be approved by our office upon receipt.
- If you need to submit a new protocol or amend
an existing protocol to describe the items flagged by the ASC, your
protocol will enter the process described above.
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