Ethical guidelines for clinical research

BRAF targets in melanoma. Biological mechanisms, resistance, and drug discovery. Cancer drug discovery and development. Volume 82. Ed. Ryan J. Sullivan. Springer (2015)

Throughout history, there have been periods of ethical controversy surrounding clinical research in human subjects. From the atrocities committed by Nazi physicians and medical researchers during the Holocaust to the experiments carried out in African-American patients in the Tuskegee Syphilis Experiment, clinical research has had a complex and sordid past.

Over the past several decades, there have been numerous ethical frameworks proposed by both U.S. and international ethics organizations. Among the most widely cited are the Nuremberg Code [8], the Declaration of Helsinki [18], Belmont Report [13], the International Ethical Guidelines for Biomedical Research Involving Human Subjects [19], and the Common Rule (45 CFR 46) [20]. A detailed exploration of the historical evolution and a critique of the strength and weaknesses of each framework are beyond the scope of this chapter.

The majority of these codes and declarations were created as a response to scandal or controversy, and therefore each can be criticized for a narrowed focus on the issues from which it arose, and most existing frameworks overlook important ethical considerations. Many of the existing guidelines also fail to provide a systematic overview of ethical principles that can be applied to all clinical research involving human participants.

In 2000, Emanuel, Wendler and Grady published a framework of seven core ethical principles that are widely considered a comprehensive guide to both theoretical and practical aspects of clinical research [21]. The 7 requirements proposed by Emanuel et al. are:

  1. Social or scientific value
  2. Scientific validity
  3. Fair subject selection
  4. Favorable risk-benefit ratio
  5. Independent review
  6. Informed consent
  7. Respect for potential and enrolled subjects

This list, with the addition of “collaborative partnership” as an eighth requirement, appears in The Oxford Textbook of Clinical Research Ethics, the most comprehensive research ethics textbook published in the last two decades [22]. Readers are advised to use the Oxford text as a reference for ethical issues in clinical research.

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