Ethical Issues in Surgical Research
In the twentieth century, ethical evaluation of human subject research was dependent on various guidelines, each developed in response to unethical behavior to avoid repetition of past misdeeds. This piecemeal system left gaps that continued to permit ethical flaws and failure in research. In 2001, Emanuel et al. proposed a set of requirements that now serves as the “gold standard” for ethical conduct of human subject research. These guidelines apply to all forms of investigation, including surgical interventions. Investigators must be familiar with these guidelines and the context in which they arose to prevent future ethical violations.
KeywordsResearch ethics Human subject research Quality improvement Sham surgery Authorship
A systematic investigation designed to produce generalizable knowledge from observations of human subjects. This term applies broadly, and investigations classified as human subject research are generally subject to IRB review.
Personally identifiable health information (by which the identity of a study subject could be ascertained) maintained in a medical record that includes data on physical health, mental health, payment information, or genetic information.
A state in which two or more therapeutics exist that could treat a given condition; however a lack of strong evidence regarding superiority of either treatment exists. Equipoise is essential to the ethical conduct of clinical research.
The relative truth of conclusions drawn through experimentation. Internal validity is directly related to the accuracy with which experimental conditions eliminate confounding and minimize bias. A study with high internal validity can make strong claims regarding causality, rather than simple associations.
The extent to which the results of a study apply to the population being modeled. A study with high external validity is highly generalizable to large patient populations.
Any systematic, data-guided analysis of healthcare processes to improve the quality of care by measuring adherence to evidence-based guidelines of clinical best practice.
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