Registering with COMS

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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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