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The Declaration of Helsinki, first published in 1964 by the World Medical Association, established recommendations guiding medical doctors in biomedical research involving human subjects (www.wma.net/e/policy/b3.htm). The Declaration governs international research ethics and defines rules for “research combined with clinical care” and “non-therapeutic research.” The Declaration of Helsinki has been revised periodically and is the basis of Good Clinical Practices used today. A copy of the latest revision is reproduced in this Appendix. The Declaration of Helsinki addressed the following issues:

  • “Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights.”
  • Research protocols should be clearly formulated into an experimental protocol and reviewed by an independent committee prior to initiation.
  • Informed consent from all research participants is necessary.
  • Research should be conducted by medically/scientifically qualified individuals.
  • Risks should not exceed benefits.

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The Belmont Report,Ethical Principles and Guidelines for the Protection of Human Subjects of Research, was published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on April 18, 1979 (http://ohsr.od.nih.gov/mpa/belmont.php3). The Belmont Report identifies three principles, or general prescriptive judgments, that are relevant to research involving human subjects.

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Boundaries between Practice and Research

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  1. Practice refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment, or therapy to particular individuals.

  2. Research designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, eg, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

  3. Experimental is when a clinician departs in a significant way from standard or accepted practice. The fact that a procedure is “experimental,” in the sense of new, untested, or different, does not automatically place it in the category of research.

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Basic Ethical Principles

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  1. Respect for persons

  2. Beneficence

  3. Justice

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Applications

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  1. Informed consent

  2. Assessment of risks and benefits

  3. Selection of subjects

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The United States' Code of Federal Regulations (CFR) publishes regulations for the protection of human subjects. Title 45 Code of Federal Regulations Part 46 (45CFR46) contains federal regulations which directly apply to most of human research done in the United States and are intended to protect all human subjects. 45CFR46 does the following:

  • Defines activities that are subject to regulation.
  • Details the composition and function of an Institutional Review Board (IRB).
  • Describes expedited review procedures.
  • Lists the criteria for review of research.
  • Provides a detailed description of the informed consent process, including waivers.
  • Describes the process for documenting consent, including waivers.
  • There are three subparts of the ...

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