Charter for the Recombinant DNA Safety Committee
Convening Authority and Composition
The Scientific Director and President for Children’s Memorial Research Center (CMRC) upon recommendation of Chief Administrative Officer, CMRC shall appoint an Institutional Biosafety Committee (IBC). The IBC shall consist of no fewer than five members, selected to provide a diversity of disciplines relevant to recombinant DNA technology so that collectively the members have the capability to assess the safety of recombinant DNA research experiments. One member shall be a person who does not have a doctoral degree from the laboratory technical staff, preferably with experience in recombinant DNA technology. At least two members shall not be affiliated with Children’s Memorial Hospital (CMH) or other CMH affiliates. The chairperson of the IBC shall be appointed by the Scientific Director and President. Membership on the committee will be rotated so that approximately one-third of the members change each year. Appointments will be for three years.
The Institutional Biosafety Committee (IBC) shall be established for the purpose of overseeing all recombinant DNA experimentation that is conducted at CMH and other CMH affiliates. regardless of the source of funding. The IBC is responsible for recommending policies that will implement the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) to the Scientific Director and President and providing appropriate protection to the CMH, community and the community at large.
The Institutional Biosafety Committee (IBC) shall be responsible for reviewing all recombinant DNA research to be conducted at or sponsored by CMH and approving those research projects that it finds are in conformity with the NIH Guidelines. This review shall include:
A. An independent assessment of the containment levels required by the NIH Guidelines for the proposed research, and
B. An assessment of the facilities, procedures, practices, and training and expertise of personnel involved in recombinant DNA research.
C. Notifying the Principal Investigator (PI) of the results of the committee’s review.
D. Periodically reviewing recombinant DNA research conducted at CMH to ensure compliance with the NIH Guidelines.
E. Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research.
F. Reporting any significant problems with or violations of the NIH Guidelines, and any significant research related accidents or illnesses to the Scientific Director and President, the CAO of CMRC, and NIH/ORDA promptly but no later than 30 days after its initial scientific findings.
G. Establishing subcommittees or ad hoc committees, as necessary, to carry out its overall or specific responsibilities.
H. Providing advice to the Principal Investigator regarding laboratory safety procedures.
I. Assisting PIs and others to develop emergency plans for dealing with accidental spills and personnel contamination and investigating recombinant DNA research incidents.
The Office of Sponsored Programs is responsible for:
A. Maintaining records of all IBC actions and the minutes of the IBC meetings. The minutes shall be available for public inspection.
B. Assisting the IBC in ensuring that laboratory standards are followed through periodic inspections. The Chair or his/her designee has the authority to close at once any laboratory in which a required safety procedure is violated. Such action and the safety violations shall be reported immediately to IBC, the Scientific Director and President, or the CAO of CMRC.
A. The new policies and procedures recommended by the committee and approved by the Scientific Director and President shall be carried out by individuals and offices designated by the Scientific Director and President.
B. All members of the IBC except ex-officio members shall have voting rights. Ex-officio members do not have voting rights and are not considered voting members of the IBC.
C. The IBC shall meet as often as necessary to implement the NIH Guidelines. A meeting must be called by the chairperson at the earliest opportunity if requested by any three members of the committee, the Scientific Director and President or his/her designee, or the CAO of CMRC.
D. The IBC may take appropriate action in instances where, in its judgment, personnel property or community may be endangered.
E. A quorum shall consist of 50 percent or greater of the voting members of the committee.
F. Approval of motions shall require a majority of the quorum.
G. Unanimous approval of the members present and voting is necessary for acceptance of a Registration Document for regulated Recombinant DNA Research.
H. The Principal Investigator may appeal the decision of the IBC to the Scientific Director and President for final decision.
I. Neither the Scientific Director and President nor any other official of CMH or other CMH affiliates CMH or other CMH affiliates may approve any protocol which the IBC has disapproved. The Scientific Director and President or his/her designee may disapprove any protocol which the IBC has approved. Such disapproval may not be appealed and is final.
Amendment to the Charter
This charter may be amended upon three-fourths vote of the members present and voting at a duly covered meeting of the IBC. All recommended amendments become effective upon approval by the Scientific Director and President.