tion are collected, it is critical to ensure adequate protections of the privacy, confidentiality, and security of toxicogenomic information in health records and information used in studies. Safeguarding this information will further advance important individual and societal interests. It will also prevent individuals from being dissuaded from participating in research or undergoing the genetic testing that is the first step in individualized risk assessment and risk reduction.

Toxicogenomics is also likely to play a role in occupational, environmental, and pharmaceutical regulation and litigation. Regulatory agencies and courts should give appropriate weight to the validation, replication, consistency, sensitivity, and specificity of methods when deciding whether to rely on toxicogenomic data.

Ethical, legal, and social issues that affect the use of toxicogenomic data and the collection of data and samples needed for toxicogenomic research should be addressed. This could occur through legislative improvements to enhance individual protection, exploration of how to facilitate large-scale biorepository and database research while protecting individuals, and consideration by courts and regulatory agencies of appropriate factors when deciding how to consider toxicogenomic data. Finally, special efforts should be made to address the impact of toxicogenomic research and findings on vulnerable populations.


Given the complexity of toxicogenomics, the generation, analysis, and interpretation of toxicogenomic information represents a challenge to the scientific community and requires the collaborative cross-disciplinary efforts of scientific teams of specialists. Therefore it is essential that education and training in toxicogenomics become a continuous, ongoing process that reflects the rapid developments in these new technologies. There is a need to develop education and training programs relevant to toxicogenomic applications to predictive toxicology. Specifically, programs are needed to reach the general public, susceptible subgroups, health professionals, government regulators, attorneys and judges, the media, scientists in training, scientists on the periphery of toxicogenomics, and institutions that participate in toxicogenomic research.


In summary, toxicogenomic technologies present a set of powerful tools for transforming current observation-based approaches into predictive science, thereby enhancing risk assessment and public health decision making. To leverage this potential will require more concerted efforts to generate data, make multiple uses of existing data sources, and develop tools to study data in new ways. Beyond the technical challenges and opportunities, other challenges in the communication, education, ethics, and legal arenas will need to be addressed to ensure that the potential of the field can be realized.

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