Legal, Ethical, Policy

Click on the plus ( + ) sign to expand the list of resources under the following topics:

Policy on data sharing as well as data sharing agreement templates.

Links to information on ethical issues in the practice of public health.

  • Principles of the Ethical Practice of Public Healthexternal icon
    The Code is intended principally for public and other institutions in the United States that have an explicit public health mission. Contains values and beliefs underlying the code, principles of the ethical practice of public health, and supplemental materials.
  • Public Health EthicsCDC’s webpage for public health ethics with description and point of contact for questions.

Guidance on the Privacy Rule, which provides the national standards for protecting the privacy of health information.

Documents addressing the importance of protecting the rights of research participants.

  • CDC’s Policy on Distinguishing Public Health Research and Public Health Nonresearchpdf icon

    Addresses guidelines for compliance with Title 45, Code of Federal Regulations, Part 46 in assuring human research protections, definitions of research and nonresearch activities and examples of different categories of each, and responsibilities of investigators, supervisors, and other stakeholders necessary to support the program.

  • CDC’s Policy on Human Research Protectionspdf icon

    Defines and describes the human research protection program, explains the supporting regulation requirements, provides example of activities not covered by human research regulations, and delineates responsibilities of investigators, supervisors, and other stakeholders necessary to support the human research protection program.

  • Pregnancy Risk Assessment Monitoring System (PRAMS) Humans Subjects Training Manualpdf icon

    Emphasizes the importance of protecting the rights of participants. Project staff that have contact with participants or access to identifiable information about participants are required to complete this training. Module 1 gives an overview of human subjects protection. Module 2 presents problems that arise during research (breaches and adverse events). Module 3 discusses confidentiality and security of PRAMS data.

  • Human Participant Protection in CDC Research

    CDC’s webpage for human participation protection with description and useful links. All research involving human participants that is conducted or supported by CDC must comply with the HHS Policy for Protection of Human Research Subjects.

Documents addressing other legal and regulatory issues faced when practicing surveillance.

  • Certificates and Assurances of Confidentiality

    Contains information about the background, purpose, application instructions, and FAQs for the Certificate of Confidentiality, issued by CDC to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project.

  • Memorandum of Understanding Boilerplatepdf icon

    General template to be used for collaborations involving no funding.

Guidance on “meaningful use” of interoperable electronic health records throughout the U.S health care delivery system under the American Reinvestment & Recovery Act.

  • Meaningful Use FAQ

    Answers general questions pertaining to CDC’s role in Meaningful Use. FAQ describes how CDC will leverage Meaningful Use for the benefit of public health and provide links to additional information and resources

Page last reviewed: November 27, 2019