IBC "Broadscope" Registrations
This is a new procedure at the UConn Health Center IBC. Please contact the IBC Coordinator
(IBCC).
This is the general idea of a broadscope registration:
A new discussion has arisen in our IBC regarding "Broadscope Registrations". In this scenario, the components of a set of rDNA experiments in a particular line of research would be broken down
into the following categories hosts, vectors and their parts, and sequences of interest (SOI). A
broadscope registration would have all the questions included in typical registration (Section
III-D)
HOSTS: The PI would be required to list all the hosts that would be used in a line of research, such as strains of
E. coli K12, mouse background strains, cell lines, etc. If a
different host was needed, a modification of the registration would be required with the IBC.
VECTORS AND THEIR PARTS: In order to keep with the NIH rDNA Guidelines, it would be necessary to list and characterize all vectors (plasmids, viruses, etc.) as well as all other
vector sequence variables other than SOI, such as positive and negative
selectable markers, promoters, terminators etc. Again, if a different
sequence component was needed, a modification of the registration would
be required with the IBC by contacting the
IBCC by email.
SEQUENCES OF INTEREST: This would be the most undefined category. All known information about genes or other SOI would be specified (such as hazardous characteristics,
Entrez Nucleotide and/or
Entrez Gene ID number), but at a
minimum, the sequences would be characterized as far as their source organism and their expected function. That is, the category would be defined not by characterizing particular sequences or
fragments, but by a generalization such as Drosophila melanogaster genes that have neurological function in vivo.
The PI would also describe all the types of rDNA experiments that would be performed, such as gene replacement, allelic exchange, gene silencing, ectopic expression or gene over-expression
experiments.
Among these components, the IBC would be on the lookout for toxins, disease sustaining antibiotic resistance elements, oncogenes and etc. The PIs would be able to register and, for a period
of time, use these components in various combinations without continually returning to the IBC to register each individual experiment. The PIs would be required to make a list as a matter of
record, separately from their scientific records, of constructs that were inserted into hosts, specifying which components make up each construct and characterizing the SOI to the extent
possible. In the event of an exposure to personnel, the PI would be required to be able to analyze the construct to the level of sequence. Storage of a sample of the construct might be a
reasonable solution for record keeping in case later analysis was deemed necessary. This list would be required for renewal of the registration.
As an example, a PI is interested in genes involved in neurological functions using Drosophila as a surrogate system: In the blanket registration, the PI will provide a detailed
description of all possible vectors that will be used to introduce sequences of interest into the flies, the origin and the potential function of these sequences of interest (say human, mouse
or genes from other subspecies of flies that have potential neurological functions), any reporters (say GFP or beta-galactosidase), and any markers (say the white marker or any other
positive selectable marker). The PI will also describe all the types of rDNA experiments that will be performed (say gene silencing, ectopic expression and gene over-expression experiments).
If approved by the IBC, the approval would be indefinite with a biannual reporting function where the PI could state that the system would be used as is for the next reporting period,
supply their list/characterization of completed constructs and get approval. It would be required by the IBC that any new components in the system that did not fit the specified criteria would
have to be registered. The IBC would also set a Biosafety Level unless this was specified in the Guidelines.
The Office of Biotechnology Activities emphasized that the following be part of this process:
- a process is in place to capture changes from the original registration appropriately,
- a means for routinely capturing the biosafety levels proposed by the PI for experiments is implemented,
- the IBC's review and either approval or modification of biosafety level determinations is captured.
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