Legal, Ethical, Policy

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

• CDC/ATSDR Policy on Releasing and Sharing Data

  CDC's data release/sharing policy ensures that CDC routinely provides data to its partners for appropriate public health purposes; and all data are released and/or shared as soon as feasible without compromising privacy concerns, federal and state confidentiality concerns, proprietary interests, national security interests, or law enforcement activities.

• National Institute of Health (NIH) Data Sharing Policy and Implementation Guidance

  Guidance provides the NIH policy statement on data sharing and additional information on the implementation of this policy.

• Pregnancy Risk Assessment Monitoring System (PRAMS) Researcher Data Sharing Agreement

  Researchers requesting access to multi-state PRAMS datasets must submit an application and this data sharing agreement. The data sharing agreement is signed by the principal investigator and co-investigators affirming that they and their designated staff will comply with the requirements in the agreement.

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

• Principles of the Ethical Practice of Public Health

  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 Ethics

  CDC'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.

• HIPAA Privacy Rule and Public Health:Guidance from CDC and the U.S. Department of Health and Human Services

  The purpose of this report is to help public health agencies and others understand and interpret their responsibilities under the Privacy Rule, which provides the national standards for protecting the privacy of health information.

• Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules

  Effective March 26, 2013, HHS final rule Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules implements statutory amendments under HITECH.

• Privacy Act Frequently Asked Questions

  FAQs about 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 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.

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.

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