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What are "recombinant DNA molecules"? Recombinant
DNA molecules (in the context of the NIH Guidelines) are defined
as either molecules that are constructed outside living cells by
joining natural or synthetic DNA segments to DNA molecules that
can replicate in a living cell, or molecules that result from the
replication of those previously described.
The National Institutes of Health (NIH) regulates recombinant DNA molecule use in research. The regulatory document that applies is entitled "NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)". This document can be accessed through the resources link of this website or is available in hard copy through the ORCBS Biosafety Section. To request a hard copy, please do so through the IBC contact link of this website or call the ORCBS Biosafety staff at 355-0153. Included in
the NIH Guidelines is a requirement for the institution to establish
an Institutional Biosafety Committee (IBC) with authority to approve
or disapprove proposed recombinant DNA research using the NIH Guidelines
as a minimum standard. The MSU Institutional Biosafety Committee
was established for this purpose and fulfills these requirements
by holding monthly meetings to review proposed registration documents,
receive reports from the Biosafety Officer regarding inspections
and facility issues, and address other IBC-related issues including
policy development.
Your answer
can be found by reviewing Section III of the NIH Guidelines. Exempt
experiments are covered under Section III-F. If your recombinant
DNA molecule use does not fall within the exempt experiments, you
should review the Section III in whole to determine where your research
falls for registration purposes. To
view Section III of NIH Guidelines, click here.
Currently, the
IBC strongly recommends registration of exempt projects. Registration
is a benefit for the PI because funding sources will often ask for
documentation of IBC review regardless of the exempt status of the
recombinant DNA molecule use. In some cases, the funding source
will not release funds without this documentation. My funding source is not NIH. Do I still need to register my project? YES. MSU has
received some funds for research involving the use of recombinant
DNA molecules. Therefore, under the NIH Guidelines, all MSU research
involving the use of recombinant DNA molecules must be conducted
in accordance with the NIH Guidelines. This includes the provision
for registration on the part of the PI and review and surveillance
on the part of the IBC.
If your recombinant
DNA molecule use is not included as part of a currently approved
IBC registration document filed under your PI's name, a registration
document should be prepared and submitted to the IBC by your PI
on your behalf.
YES. The approval
of an IBC registration documents covers only the recombinant DNA
activities and biological materials listed on the document. The
IBC approval is not indefinite. In fact, beginning with registrations
approved after July 1st, 2002, all registrations will have a 3-year
limit on approval with provision for submission of an annual assurance
document regarding your recombinant DNA molecule use.
NO. One document
is appropriate but when preparing the document, list all applicable
project titles/funding sources. If additional proposals are prepared
after the IBC registration document has been reviewed and by the
IBC, you can add these proposals to the registration by simply preparing
a memo and submitting it to the Biosafety Officer (ORCBS, C-124
Engineering Research Complex). The memo should include the IBC registration
number of the approved registration document, the name of the PI
that the document is registered under, the additional project titles
and funding sources.
Registration documents requiring IBC review and approval will require between 6 and 8 weeks for the review process. Note: If filing
registration documents for recombinant DNA molecules that are in
the exempt experiments category, please allow 2 weeks for the IBC
documentation process. |
