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Requirements and Procedures for Recombinant DNA
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 DNA 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 Laboratories), 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. 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 and Biological Safety Officer are appointed to review and monitor recombinant DNA research on behalf of Texas A&M University.
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 Guidelines, 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 sources. 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; 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
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 IBC
application will fulfill this requirement. Submission of additional
documentation is not required for research that is specifically exempted from
IBC review.
C. Submitting Protocols for IBC Review
The IBC
application must accompany material submitted for review.
Documents for recombinant DNA review by the IBC should be submitted through
established administrative channels; that is, Texas A&M departments and
research groups should route proposals to the Vice President for Research,
Research Compliance 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.
D. Records Retention
All research related records must be maintained for at least 3 years after the project expiration.
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).
Documents submitted to the IBC for review must include complete and adequate information and protocols to allow appropriate peer review.