ONETOX | Neural Exposome and Toxicology Programs
Drug Safety
The mission of the NINDS DTR is to accelerate basic research findings towards patient use for neurological disorders and stroke by providing funding, expertise, and resources to the research community. DTR provides funding and resources through grants, cooperative agreements, and contracts to academic and industry researchers to advance early-stage neurological technologies, devices, and therapeutic programs to industry adoption. Preclinical and Phase 1 clinical safety studies are key components of any drug development activity and are driven by thorough Drug Safety Evaluation. Many candidate drug compounds under development within DTR target the nervous system and are thus scrutinized for potential neurotoxic liabilities. ONETOX provides DTR, NINDS, and the NIH with resources on potential neurotoxic safety liabilities associated with funded projects.
Biohazards
The NIH requires that all extramural and intramural research have materials and procedures in place to prevent hazards to research personnel and/or the environment. Biohazards not only include hazardous biological materials such as viruses, bacteria and fungi but also chemicals that could pose a risk to human health and the environment when handled improperly. Some highly toxic chemicals are recognized for their potential risk when used in research. Other chemicals that are less toxic and used routinely research still have the potential for harm if the researcher is exposed to high enough doses. The NIH Division of Occupational Health and Safety (DOHS) in the Office of the Director maintains the NIH’s policies for storing, working with, and disposing of hazardous biological material in the research environment.
All grant applications that come to the NIH are reviewed for biohazard concerns to ensure that research is conducted in a safe manner. ONETOX represents the NINDS on all NIH Office of the Director committees and initiatives to keep the scientific community safe from biohazards during NIH-funded research. ONETOX also provides NINDS staff with expertise on issues related to biohazards before and during funded research, as well as information on how to determine if proposed biological and chemical agents are potential biohazards.
Select Agents and Dual Use Research of Concern
Select agents and toxins are biological agents and toxins that could pose a severe threat to public health and plant health, or to animal or plant products. The U.S. lists of Select Agents and Toxins are maintained by the Departments of Health and Human Services and Agriculture and can be found within the Federal Select Agent Program. The NIH Office of Science Policy manages the Dual-Use Research of Concern program that minimizes the risk of NIH-funded research that “can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security”. Additionally, ONETOX represents NINDS on NIH committees and initiatives related to Select Agents and Dual-Use Research Concerns by providing the NINDS research community and NINDS staff with resources and expertise on how to determine if there are concerns related to the use of Select Agents and if there are Dual-Use Concerns.
Resources and Tools
Contacts
David A. Jett, Ph.D. | Director, ONETOX
jettd@ninds.nih.gov
Shardell Spriggs, Ph.D. | Program Director
shardell.spriggs@nih.gov
Neel Dhruv, Ph.D. | Health Program Specialist
neel.dhruv@nih.gov
Funding Opportunities
Chemical Safety Funding Opportunities
Chemical Safety Notices
Related Topics
Drug Safety
Searchable Drug Safety Bibliography [in progress]
Searchable FDA Guidance Documents
NIH Resources [in progress]
Biohazards, Select Agents, Dual-Use Research of Concern
NIH Grants Policy Statement (Select Agents, Dual Use Research of Concern, Chemical Weapons)
NIH Policy Manual: Working Safely with Potential Hazardous Biological Materials
Health and safety guidelines for grantees and contractors
General Instructions for NIH and other PHS Agencies (SF424) (G.- 68) (pdf, 8.1 mb)