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Protecting human research subjects.

R L Bertholf1

  • 1Department of Pathology, University of Florida Health Science Center/Jacksonville, 32209, USA. roger.bertholf@jax.ufl.edu

Annals of Clinical and Laboratory Science
|April 21, 2001
PubMed
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Ethical research on humans follows core principles. Regulations protect subjects, with Institutional Review Board approval often required, though some pathology research may have expedited or exempted review.

Area of Science:

  • Medical Ethics
  • Pathology Research Regulations

Background:

  • Human research is guided by principles of respect for persons, beneficence, and justice.
  • Historical abuses led to strict guidelines for protecting human research subjects.
  • U.S. government-funded research requires Institutional Review Board (IRB) approval.

Purpose of the Study:

  • To inform academic pathologists and laboratorians about regulations for human subject research.
  • To highlight the conditions under which human research may be exempted or expedited.
  • To clarify the applicability of these regulations to research involving pathological specimens.

Main Methods:

  • Review of ethical guidelines and governmental regulations for human subject research.
  • Analysis of exemption and expedited review criteria.

Related Experiment Videos

  • Examination of research scenarios involving pathological specimens and diagnostic studies.

    • Main Results:

    • Human subject research is governed by established ethical principles and regulatory frameworks.
    • IRB approval is a standard requirement, but exceptions exist.
    • Certain research with pathological specimens may qualify for limited review categories.

    Conclusions:

    • Pathologists and laboratorians must understand human subject research regulations.
    • Awareness of expedited and exempted review pathways is crucial for research efficiency.
    • Compliance with ethical and regulatory standards ensures the protection of human participants.