Overview

Oversight for federally mandated regulatory activities is located in the Office of Scientific Regulatory Services (OSRS) at CDC which provides guidance and assistance to all CDC programs. There are three offices within OSRS in addition to several other regulatory functions:

The Human Research Protection Office (HRPO) leads the agency in protecting the rights and welfare of human beings who participate in research. HRPO coordinates CDC's institutional review boards (IRBs), exemptions from human subjects research, and joint review arrangements with research partners.

The Information Collection Review Office (ICRO) (formerly OMB PRA activities) ensures that federal agencies do not overburden the public with requests for federally sponsored data collections according to the Office of Management and Budget (OMB) Paperwork Reduction Act (PRA). ICRO also works with CDC National Centers and other federal agencies to protect the privacy of individuals when records are maintained by a federal agency by applying the Privacy Act as required.

The Animal Care and Use Program Office (ACUPO) is responsible for ensuring compliance with federal laws and principles in the care and use of laboratory animals at CDC. ACUPO works closely with the CDC Institutional Animal Care and Use Committee (IACUC), the CDC Animal Resources Branch, the CDC Scientific Resources Program, and with individual investigators.

OSRS is also responsible for providing technical assistance on the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule which regulates the use and disclosure of protected health information by covered entities and the Family Educational Rights and Privacy Act (FERPA) which regulates the disclosure of personally identifiable information contained in an education (school) record. In addition, OSRS issues Assurances of Confidentiality and Certificates of Confidentiality which protect against compulsory legal disclosure of sensitive data and an individual’s personal information.

OSRS achieves its mission through the following core functions:

• Protecting the rights and welfare of human beings who participate in research by coordinating CDC's institutional review boards (IRBs), exemptions from human subjects research, and joint review arrangements with research partners.
  
• Ensuring that federal agencies do not overburden the public with requests for federally sponsored data collections according to the Office of Management and Budget (OMB) Paperwork Reduction Act (PRA).
  
• Protecting the privacy of individuals when records are maintained by a federal agency by applying the Privacy Act as required.
  
• Ensuring compliance with federal laws and principles in the care and use of laboratory animals at CDC by working closely with the CDC Institutional Animal Care and Use Committee (IACUC), the CDC Animal Resources Branch, the CDC Scientific Resources Program, and with individual investigators.
  
• Providing technical assistance on the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule which regulates the use and disclosure of protected health information by covered entities and the Family Educational Rights and Privacy Act (FERPA) which regulates the disclosure of personally identifiable information contained in an education (school) record.
  
• Issuing Assurances of Confidentiality and Certificates of Confidentiality which protect against compulsory legal disclosure of sensitive data and an individual’s personal information.