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WHAT:
Biosafety concerns itself with protecting staff, patients, the public
and the environment from dangerous biologicals.
HOW: Any
investigator wishing to work with recombinant DNA, pathogenic microbiologicals,
or human studies involving recombinant DNA or animal to human transplants
must register with the COMS. Some forms have to be filled out so that the
committee knows what the investigator plans to do. The forms can be found
at Forms.
.
HOW SOON:
For most laboratory studies the approval process takes about 2 weeks. If there are unusual features in the protocol approval can take longer. Some studies involving Recombinant DNA may take up to 6 weeks for approval.
Approval for clinical human gene transfer studies can take from 3 weeks
to > 8 months. This is because the process is governed by the actions
of the NIH Recombinant DNA Advisory Committee (the RAC). Our local committee
is forbidden to approve a study until the RAC has passed judgment on the
protocol. This can take from 3 weeks to 8 months, depending on the "novelty" of the protocol.
Approval for clinical xenotransplantation protocols requires evaluations
by a special Xenotransplantation Advisory Committee. Their comments are
generally forwarded to the investigator. After the investigator responds
the Committee sends a recommendation to the full Biosafety Committee. From
the time an application is received to approval can take as little as three
weeks or as much as 2 months.
WHY: Institutional
Biosafety Committees (IBCs) are a creation of the NIH. They are mandated
by the NIH Recombinant DNA Guidelines as a means of setting local policies
for the conduct of studies involving recombinant DNA. Among the provisions
of the Guidelines is the absolute requirement that all human gene transfer
studies be approved by the local IBC. The cities of Boston and Cambridge
have adopted the NIH Guidelines and have required research laboratories
and hospitals to adhere to the Guidelines.
Some years ago Harvard created separate IBCs for Cambridge (Committee for
the Regulation of Hazardous Biological Agents) and Boston (Committee on
Microbiological Safety). The 1977-8 document establishing the committees
is at this
link. In 1995 the two committees were united by votes of the faculties
involved. The combined committees regulate biological laboratories in all
University schools, and nearly all affiliated hospitals. A copy of the current
COMS policies is at Policy
Manual.
The US Food and Drug Administration (FDA) requires all studies involving
human Xenotransplantation (the transfer of animal tissues to humans) be
approved by the IBC.
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