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Legal, Ethical, Policy

Data Sharing

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

Ethics

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

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

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

Human Subjects Protection

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

  • CDC's Policy on Distinguishing Public Health Research and Public Health Nonresearch

    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 Protections

    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 Manual

    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.

Legal and Regulatory Issues

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 Boilerplate

    General template to be used for collaborations involving no funding.

Meaningful Use

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

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