Scientific Regulation

There are a number of federally mandated regulations and clearance functions that affect the research and practice of CDC which apply to all CDC employees, contractors, and awardees conducting data collection activities, whether the activities are for research or public health practice or occur in domestic or global settings.

CDC sponsored data collection activities are required to comply with the U.S. Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations for the protection of human research participants and to comply with the federal Animal Welfare Act (AWA) as well as the Public Health Service Policy on Humane Care and Use of Laboratory Animals. In addition, the Paperwork Reduction Act (PRA), the Privacy Act, the Public Health Service Act (PHSA), the E-Government Act of 2002, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, and the Family Educational Rights and Privacy Act (FERPA) all include legislation or regulations that affect the research and public health practice of CDC.

Within the Office of the Chief Science Officer, the Office of Scientific Regulatory Services (OSRS) is responsible for providing oversight and ensuring adherence to these regulations and clearance requirements.