Office of Public Health Ethics and Regulations (OPHER)

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The Office of Public Health Ethics and Regulations (OPHER) was established within OADS to ensure that CDC science and research activities comply with various federal laws, regulations, and policies. OPHER also combines similar scientific functional areas to facilitate the streamlining and effectiveness of critical scientific support functions often processed in sequential order.

There are several functional areas of OPHER:

    • The Human Research Protection Office (HRPO) leads the agency in protecting the rights and welfare of people who participate in research. HRPO coordinates CDC’s Institutional Review Boards (IRBs), exemptions from research on human subjects, and joint review arrangements with research partners.
    • The Information Collection Review Office (ICRO) is responsible for implementing agency requirements of the Paperwork Reduction Act (PRA) for CDC. ICRO coordinates the PRA clearance process for CDC-sponsored data collections which are regulated by the Office of Management and Budget.
    • The Privacy and Confidentiality Unit provides 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, the Privacy and Confidentiality Unit issues Certificates of Confidentiality and Assurances of Confidentiality which protect an individual’s personal information and protect against compulsory legal disclosure of sensitive data.
    • The Public Health Ethics and Strategy Unit brings considerations, such as ethical principles and values, to discussions of public health policies and actions. Public health ethics 1) helps to build and maintain credibility and public trust in public health recommendations; 2) fosters consensus and resolves values conflicts in an atmosphere of respect; 3) guides decision making when there is scientific uncertainty and many opinions about how to proceed; and 4) increases awareness of the moral claims and values of community stakeholders, particularly of those most impacted by the public health recommendations. The Public Health Ethics Unit works with programs to identify, analyze, and resolve ethical issues that arise in public health practice.

 

To contact the Office of Public Health Ethics and Regulations (OPHER), call (404) 639-7570 or send an email to OADS@cdc.gov.