Issued in 1974, 45 cfr 46 raised to regulatory

General
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issued in 1974, 45 cfr 46 raised to regulatory

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Issued in 1974, 45 CFR 46 Raised to Regulatory

Answer:

45 CFR 46, often referred to as the “Common Rule,” is a set of federal regulations for the protection of human subjects in research. Issued in 1974 by the Department of Health, Education, and Welfare (now the Department of Health and Human Services, HHS), these regulations established a formal framework for ensuring ethical conduct in research involving human subjects.

Background:

  1. Ethical Principles:

    • The regulations were influenced by the ethical principles outlined in the Belmont Report, which was published in 1979. The main principles include respect for persons, beneficence, and justice.

  2. Scope and Applicability:

    • 45 CFR 46 applies to all research involving human subjects conducted or supported by HHS. It sets forth the requirements for Institutional Review Boards (IRBs), informed consent, and assurances of compliance.

  3. Components of 45 CFR 46:

    • Subpart A: Basic policy for the protection of human subjects, also known as the “Common Rule.”
    • Subpart B: Additional protections for pregnant women, human fetuses, and neonates.
    • Subpart C: Protections for prisoners involved in research.
    • Subpart D: Protections for children as research subjects.

Key Aspects:

  1. Institutional Review Boards (IRBs):

    • Mandates the establishment of IRBs to review research proposals and ensure ethical standards are met. IRBs have the authority to approve, require modifications in, or disapprove research projects.

  2. Informed Consent:

    • Requires researchers to obtain voluntary informed consent from participants, providing comprehensive information about the study, risks, benefits, and rights.

  3. Risks and Benefits:

    • Researchers must minimize risks and ensure they are reasonable in relation to anticipated benefits and the importance of the knowledge that may result from the study.

  4. Equitable Selection:

    • Requires fair and equitable selection of research subjects to ensure that no group is unduly burdened or benefitted by the research.

  5. Privacy and Confidentiality:

    • Obligates researchers to maintain the privacy of subjects and confidentiality of data.

Evolution:

  • The regulations have undergone several revisions to adapt to new challenges and ethical considerations in research. The most significant update was in 2018, which aimed to enhance protections and reduce administrative burden.

In summary, 45 CFR 46 serves as the foundational regulatory framework ensuring ethical practices in human research, safeguarding the rights and welfare of participants.