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CDC procedures for protection of human research participants
  • Published Date:
    October 1997
Filetype[PDF-118.95 KB]

  • Alternative Title:
    Procedures for protection of human research participants
  • Description:
    Assurance -- Institutional responsibilities -- Special populations -- Research involving Food and Drug Administration (FDA) regulated products -- Establishment and composition of CDC's IRBs -- Conflict of interest -- IRB meetings -- IRB actions on research protocols -- Appeal of IRB actions -- Reporting of adverse events -- IRB records management -- Protocol handling -- Expedited review -- Suspensions or terminations -- Exempt research -- Cooperative research -- Noncompliance by an investigator -- Noncompliance by an IRB -- References

    This manual of procedures applies to all research involving human participants conducted by the Centers for Disease Control and Prevention (CDC)2 or funded in whole or in part by CDC. (1) This includes research conducted by CDC employees, either directly through grants, cooperative agreements or contracts, or in collaboration with outside parties. (2) It also includes research conducted or funded by CDC outside the United States. The Office for Protection from Research Risks (OPRR), National Institutes of Health, is responsible for overseeing the implementation of the Federal Policy (Common Rule for protecting human subjects) throughout the Department of Health and Human Services (DHHS). CDC has provided written assurance to OPRR that it will comply with this policy codified at Title 45, Code of Federal Regulations, Part 46. CDC's Multiple Project Assurance (MPA) contains a detailed description of applicability, principles, CDC policy, responsibilities of CDC staff, and Institutional Review Board (IRB) structure, membership requirements, authorities and responsibilities, and procedures.

  • Content Notes:
    Includes bibliographical references (p. 42).
  • Document Type:
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  • Supporting Files:
    No Additional Files
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