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Conducting Risk Assessments for rDNA

When utilizing recombinant DNA technology, a thorough risk assessment should be conducted for all projects. The potential risks to personnel and the environment need to be evaluated should an exposure or release occur.

A few basic factors to consider when conducting a risk assessment include what host vector system will be utilized, what the gene of interest is, what the risk groups associated with the agents in use are, what the scale of the work is, what training the individuals involved in the project have received, and where the research work will be done. Knowledge of if the resulting genetically modified organism will have more or less risk associated with it is a critical component of any risk assessment. Consideration around if the gene of interest is an oncogene or an antibiotic resistant gene should also be part of the risk assessment.

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules stipulates that investigators make an initial risk assessment based on the Risk Group of an agent. The completed risk assessment is then used to decide the appropriate containment level for the experiment, protecting both the personnel involved and the environment.

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