REQUIREMENTS AND PROCEDURES
FOR RESEARCH INVOLVING
RECOMBINANT DNA
AT
TEXAS A&M UNIVERSITY
March 1999
REQUIREMENTS AND PROCEDURES
FOR RESEARCH INVOLVING RECOMBINANT DNA
AT
TEXAS A&M UNIVERSITY
CONTENTS
I.
GENERAL REQUIREMENTS AND PROCEDURES FOR
RECOMBINANT DNA RESEARCH
II.
REGISTRATION, REVIEW AND APPROVAL OF
RECOMBINANT DNA RESEARCH
III.
RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS
IV.
THE INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
V.
THE BIOLOGICAL SAFETY OFFICER (BSO)
APPENDICES
A.
Members of the Institutional Biosafety Committee
B.
Form for Submission of Documents for Registration and Review of
Research Involving Recombinant DNA at Texas A&M University
REQUIREMENTS AND PROCEDURES
FOR RESEARCH INVOLVING RECOMBINANT DNA
AT
TEXAS A&M UNIVERSITY
I.
GENERAL REQUIREMENTS AND PROCEDURES FOR RECOMBINANT DNA RESEARCH
Recombinant DNA research is conducted with molecules constructed outside living cells, where DNA segments are joined or
replicated, where a DNA sequence may be modified, or where related research is conducted with this type of material. The purpose of
this document is to summarize requirements, procedures and expectations for conducting recombinant DNA research at Texas A&M
University (including all facilities in Brazos County, Galveston and the Institute for Biosciences and Technology). Certain general
procedures are outlined to aid scientists in compliance.
Any research conducted with recombinant DNA, regardless of the source of funding or source of recombinant material, must be
conducted in accordance with Institutional requirements and federal guidelines. Texas A&M University adheres to NIH Guidelines for
Research Involving Recombinant DNA1 and appropriate Administrative Supplements, as issued. Research on recombinant DNA
should also be conducted in accordance with CDC/NIH Biosafety Guidelines (Biosafety in Microbiological and Biomedical
Laboratories1,2), as appropriate. Experiments involving livestock or plants may require compliance with additional regulations and
approval by the Office of Agricultural Biotechnology, U. S. Department of Agriculture 3. Copies of these references are available for
review in the TAMU Environmental Health and Safety Department.
It is essential that recombinant DNA research be conducted in accordance with the intent, as well as specific requirements and
guidelines. Because research is dynamic, it is not possible to anticipate every situation. The conscientious effort and good judgment of
personnel are essential for protection of health and the environment during recombinant DNA research. Primary responsibility for
compliance with institutional and governmental requirements and for safe and proper experimentation resides with the principal
investigator (PI). The Institutional Biosafety Committee (IBC, APPENDIX A) and the Biological Safety Officer (BSO) are appointed
to review and monitor recombinant DNA research on behalf of Texas A&M University.
II.
REGISTRATION, REVIEW AND APPROVAL OF RECOMBINANT DNA RESEARCH
All recombinant DNA research conducted at Texas A&M University must be registered with the IBC. All proposals for recombinant
DNA research, unless specifically exempted by the NIH Guidelines1, must be reviewed and approved by the IBC prior to initiating
work. This includes, but is not limited to: recombinant products, DNA probes, vector systems, and related material received from
outside sources4. Review and approval by the IBC of cooperating institutions may be required. Coordinated reviews may be arranged
by IBC chairpersons of cooperating institutions or agencies. PIs and unit heads should seek clarification regarding institutional
requirements for protocol or project approval and safety (independent of their own interpretations or uncertainties).
Review by the IBC includes evaluation for compliance and conformance with the NIH Guidelines 1; assessment of the containment
levels required by the Guidelines; assessment of the facilities, procedures and practices; and consideration of the training and expertise
of recombinant DNA personnel.
A.
Research and Related Activities Requiring IBC Review and Approval
1
NIH Guidelines for Research Involving Recombinant DNA Molecules, Federal Register, 62 FR 59032, October 31, 1997 and updates.
2
Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Public Health Service, Centers for
Disease Control and National Institutes of Health, 3rd Edition, May, 1993. HHS Publication No. (CDC) 93-8395.
3
USDA Guidelines for Research with Genetically Modified Organisms Outside Contained Facilities, Office of Agricultural Biotechnology, USDA,
Washington D.C., May, 1989 and updates.
4
Certain restrictions and regulations may apply to shipment and transport of genetically altered material.
1.
2.
3.
4.
III.
Projects - All research (regardless of the source of funding) conducted at Texas A&M University, involving
recombinant DNA (including recombinant DNA used as probes or obtained from another laboratory) must
be registered, reviewed and approved by the IBC. NOTE: Certain types of research that are specifically
exempted (by NIH Guidelines) from review only require registration with the IBC (See II.B below).
Grant Proposals - All extramural grant proposals for research involving recombinant DNA should be
identified as such by the PI, acknowledged by the unit head, and reviewed by the IBC prior to submission to
the sponsor. The project number should be included if the research is supported by the Texas Agricultural
Experiment Station (TAES).
Project Modifications - Additional IBC review and approval is required if the nature or content of research
changes significantly, or if recombinant DNA, either cloned or received from an outside source is involved.
For example, collaborative work may require evaluation of unanticipated recombinant products or in
locations where prior recombinant DNA research was not anticipated. Proposal changes must be reviewed
and approved before work proceeds.
Testing, Evaluation and/or Release - Research plans, protocols and provisions for containment for
recombinant DNA work under field conditions (outside a lab, growth chamber, containment or cage)
require additional information and IBC review. Environmental safety and risk must be considered for
potentially self-replicating biological material. Investigators should anticipate potential testing, evaluation
or release of recombinant DNA products (at least one year lead time) for preparation and review of
approval documents.
B.
Registration of Recombinant DNA Research
All research projects involving recombinant DNA must be registered with the IBC. Completion of the form,
Registration and Review of Research Involving Recombinant DNA Molecules at Texas A&M University
(APPENDIX B) will fulfill this requirement. Submission of additional documentation is not required for research
that is specifically exempted from IBC review1.
C.
Submitting Protocols for IBC Review
1.
The completed form "Registration and Review of Research Involving Recombinant DNA Molecules at
Texas A&M University" (APPENDIX B), must accompany material submitted for review.
2.
Documents for recombinant DNA review by the IBC should be submitted through established
administrative channels; that is, TAMU departments and research groups should route proposals to the Vice
President for Research or the Texas A&M Research Foundation. Proposals from research units,
departments and centers supported by TAES should be routed to the TAES Project Records Office.
3.
NOTE: Prior review by the IBC is required for all documents to be forwarded to the Recombinant DNA
Advisory Committee of the National Institutes of Health (NIH/RAC).
4.
Documents submitted to the IBC for review must include complete and adequate information and protocols
to allow appropriate peer review.
RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS
A.
The Principal Investigator, on behalf of the Institution, is responsible for fully complying with the NIH Guidelines in
conducting any recombinant DNA research. As part of that responsibility, the PI shall:
1.
Be aware of recombinant DNA biosafety requirements and assure that requirements and procedures of
Texas A&M University are followed; assure that all work involving recombinant DNA is registered with the
IBC; assure that necessary safeguards and procedures are maintained in the work place: follow the NIH
Guidelines for Research Involving Recombinant DNA Molecules1 It is essential for PIs working with
recombinant DNA to be thoroughly familiar with the NIH Guidelines and follow appropriate
CDC/NIH Biosafety Guidelines1,2;
a.
Make the initial determination of the required levels of physical or biological containment in
accordance with the NIH Guidelines;
b.
Select appropriate microbiological practices and laboratory techniques to be used in the research;
(See NIH Guidelines for Research Involving Recombinant DNA Molecules for information on
containment requirements. Appendix G specifies physical containment requirements for standard
laboratory experiments and defines Biosafety Level 1 through Biosafety Level 4. For large scale
(>10 liters) research or production, Appendix K (Physical Containment for Large Scale Uses of
Organisms Containing Recombinant Molecules) supersedes Appendix G. Appendix K defines
2.
3.
4.
5.
6.
7.
8.
IV.
Good Large Scale Practice BL1-LS through- BL3-LS. For certain work with plants, Appendix P
(Physical and Biological Containment for Recombinant DNA Research Involving Plants)
supersedes Appendix G. Appendix P defines Biosafety Levels BL1-P through BL4-P. For certain
work with certain animals, Appendix Q (Physical and Biological Containment for Recombinant
DNA Research Involving Animals) supersedes Appendix G. Appendix Q defines Biosafety Levels
BL1-N through BL4-N.)
Assure that all review and approval requirements are fulfilled prior to initiating any new or modified
research procedures;
Comply with shipping requirements for recombinant DNA molecules;
Submit the initial research protocol if required by NIH Guidelines or institutional requirements;
Notify the Biological Safety Officer (BSO) when required safety inspections and certification of
containment facilities and biological safety cabinets are needed;
Notify the IBC of any significant changes in experimental protocol or location of research;
Provide information to the IBC and BSO, as necessary.
Remain in communication with the IBC throughout the conduct of the project.
B.
Responsibilities of the Principal Investigator prior to initiating research. The PI shall:
1.
Assure that labs and work places are identified with appropriate warning signs; and that personnel are
properly trained and are informed regarding biohazards;
2.
Make available to the laboratory staff, copies of the protocols that describe the potential biohazards and the
precautions to be taken;
3.
Assure that staff members are trained in the safe work practices and techniques and in the procedures for
dealing with accidental spills and personnel exposure;
4.
Inform staff of the reasons and provisions for any precautionary medical practices advised or requested,
such as vaccinations or serum collection;
5.
Prepare a written contingency plan for handling emergency conditions such as spills, personnel exposure,
loss of containment, power failure, etc.
C.
Responsibilities of the Principal Investigator during the research. The PI shall:
1.
Supervise the staff to assure that the required safety practices and techniques are employed, and that the
appropriate containment procedures are followed;
2.
Investigate and provide written report to the BSO, the IBC and the NIH Office of Recombinant DNA
Activities (ORDA) regarding any significant problems pertaining to the operation and implementation of
biohazard-containment practices and procedures, violations of the NIH Guidelines and all significant
research-related accidents and illnesses;
3.
Correct work errors and conditions that may result in the release of recombinant DNA materials;
4.
Ensure the integrity of physical containment (e.g., biological safety cabinets) and the biological containment
(e.g., purity and genotypic and phenotypic characteristics);
5.
Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination;
6.
Assure proper handling and disposal of biohazardous waste.
THE INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
A.
The IBC reviews and oversees all recombinant DNA research at Texas A&M University. The IBC reports directly to
the TAMU Provost through the TAMU Vice President for Research, and has certain additional reporting
responsibilities to NIH. Current members are listed in Appendix A.
B.
Appointment of IBC Members and Chair
1.
IBC members and the Chair are appointed annually, in accordance with NIH Guidelines1 by the TAMU
Vice President for Research. Members are generally appointed to serve a three-year term.
2.
Members shall be qualified, by expertise and experience, to review recombinant DNA research proposals
and shall serve from approximately September 1 through August 31.
3.
Membership and representation on the IBC shall be in accordance with NIH Guidelines 1. At least two
Members-at-Large shall be appointed to represent the community.
4.
An IBC member shall be disqualified from review or approval of a proposal or activity in which he/she has
been or expects to be engaged, except to provide information requested by the IBC.
V.
C.
Specific Responsibilities
1.
Provide interface between the Institution, the BSO and PIs concerning lab review, security, safety,
emergency plans and other activities;
2.
Maintain a registry of research projects and/or proposals involving the use of recombinant DNA at TAMU.
3.
Provide oversight, review and assessment of:
a.
adherence to NIH requirements for recombinant DNA research;
b.
training and expertise of personnel;
c.
laboratory safety, security, and biological containment requirements and practices;
d.
emergency contingency plans including containment and cleanup of spills and exposure of
personnel to biohazardous materials.
4.
Investigate reports of problems of safety or non-compliance. Alert the TAMU Vice President for Research
(or other administration officials as appropriate) and the PI to any non-compliance or other problems, and
monitor corrective action. (NOTE: The IBC reviews and monitors research involving recombinant DNA
and may assist PIs in voluntary compliance. However, the IBC assumes no responsibility for gaining
compliance or for fulfilling research requirements.)
5.
Coordinate and assist the BSO with safety and containment monitoring programs.
6.
Meet as necessary and maintain a permanent record of IBC meetings and activities.
7.
Periodically review the status of current recombinant DNA research at TAMU.
8.
Provide guidance to PIs and review reports or proposals prepared for submission to the NIH Office for
Recombinant DNA Activities (ORDA) and the NIH Recombinant DNA Advisory Committee (RAC).
9.
Inform unit heads of recombinant DNA activities and proposals within their unit.
10.
Other responsibilities as specified by the NIH Guidelines1.
D.
Reporting and Communications
1.
The IBC Chair shall help inform and involve unit heads in the review and compliance of recombinant DNA
research activities in their unit. Proposals, projects or other documents shall reflect unit head awareness and
concurrence prior to IBC review.
2.
Provide an Annual Report (September) on the status of recombinant DNA research, reviews, and
compliance to the TAMU Vice President for Research. The Annual Report should include a summary of
proposals reviewed during the year; status of regulatory compliance, safety and biological containment;
emergency procedures; new issues and other items as appropriate.
3.
Interim reports regarding significant deficiencies, non-compliance, or other emergency issues may be
prepared and forwarded to the TAMU Vice President for Research, and others, as necessary.
4.
The TAMU Vice President for Research should be provided advance written notification of any proposed
IBC communication with federal agencies or committees, other than proposal review assessments and
approvals.
THE BIOLOGICAL SAFETY OFFICER
The Biological Safety Officer is the designated administrative officer who assists in assuring compliance and biosafety of
recombinant DNA research conducted at Texas A&M University.
A.
Appointment
The BSO shall be designated by the TAMU Vice President for Research to provide services and assistance as
required by federal guidelines and regulations and institutional requirements.
B.
Specific Duties and Responsibilities
1.
Serve as an ex-officio member of the IBC to provide a focal point for compliance with recombinant DNA
biological safety (lab, human and environmental aspects), biological containment, lab practices, and
monitoring requirements in accordance with Federal Guidelines1,2 and institutional requirements.
2.
Conduct or supervise annual inspection and review of recombinant DNA laboratories or facilities and
authorize qualified labs to conduct recombinant DNA research following CDC/NIH Biological Safety
Guidelines1,2 and institutional requirements.
3.
Assist in certification of biological safety cabinets and BL-3 laboratories. Conduct or supervise safety
inspection and testing of containment facilities. Maintain documents and results of certification.
4.
5.
C.
Provide technical advice to investigators and the IBC on safety procedures and lab containment. Assist
investigators in defining and interpreting safety and regulatory requirements; identify procedures to be
followed; assist PIs, staff and unit heads in maintaining awareness of responsibilities and regulatory
developments; identify safety problems, seek voluntary compliance and report significant problems (such as
containment, safety, lab techniques, and facilities) to the IBC, the PI, and others, as appropriate.
Assist investigators in developing emergency plans for containment and cleanup accidental spills or
releases; assist in emergencies; investigate and review recombinant DNA lab accidents. Maintain
documents and reports associated with the investigations and actions.
Reporting and Communications
1.
The BSO shall inform unit heads, PIs, and others of biosafety requirements and assist with maintaining
compliance with institutional and governmental guidelines and regulations.
2.
The BSO shall assist the IBC chair with preparation of an annual report summarizing activities and findings
during the past year. Interim reports or notifications may be forwarded any time that significant
deficiencies, non-compliance or other emergency issues develop.
3.
Inform the IBC Chair and others, as appropriate, of instances of safety problems or non-compliance with
institutional and regulatory requirements.
APPENDIX A.
MEMBERS OF THE INSTITUTIONAL BIOSAFETY COMMITTEE
Dr. Van Wilson, Chair
(1999)
Medical Microbiology & Immunology
College of Medicine
Texas A&M University
College Station, TX 77843-1114
(409) 845-5207
Rev. Robert Leslie* (2001)
First Presbyterian Church
1100 Carter Creek Parkway
Bryan, TX 77802
(409) 823-8073
Virginia (Ginger) Brown, Ex-Officio
Safety Coordinator , Biological Safety
Environmental Health and Safety Department
Texas A&M University
College Station, TX 77843-4472
(409) 862-4038
Dr. Roger Smith (1999)
Veterinary Pathobiology
College of Veterinary Medicine
Texas A&M University
College Station, TX 77843-4463
(409) 845-5167
Dr. Laura Hendrix (2001)
Medical Biochemistry & Genetics
College of Medicine
Texas A&M University
College Station, TX 77843-1114
(409) 845-1313
Dr. Tom McKnight (2001)
Department of Biology
College of Science
Texas A&M University
College Station, TX 77843-3258
(409) 845-3896
Dr. Richard Miller (Ex-Officio)
Director, Research Services Administration
312 Administration Building
Texas A&M University
College Station, TX 77843-1112
(409) 845-8585
Mr. Stephen W. Rogers* (2001)
Caperton, Rogers & Miller, P.C.
4444 Carter Creek Parkway
Bryan, TX 77802
(409) 260-9911
Dr. Jon Skare (2001)
Medical Microbiology & Immunology
College of Medicine
Texas A&M University
College Station, TX 77843-1114
(409) 845-1376
Dr. Ryland Young (1999)
Biochemistry & Biophysics
College of Agriculture & Life Sciences
Texas A&M University
College Station, TX 77843-2128
(409) 845-2087
*Community Representatives