Research on pathogens that could cause a pandemic can involve altering these pathogens to make them more transmissible. This raises the possibility that these altered pathogens could cause a pandemic. Department of Health and Human Services policy calls for additional reviews of and extra safeguards for proposed research involving these altered pathogens. However, the policy is unclear about how the research proposal is actually reviewed for approval. There are also other policy gaps that may allow this research to occur without appropriate oversight.