title: Informed Consent in the Changing Landscape of Research
abstract: The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration.  .
authors.affiliation: College of Nursing, New York University in New York.
authors.forename: Marilyn J
authors.identifier: 0000-0002-9561-6144
authors.initials: MJ
authors.lastname: Hammer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research / Q000941:ethics* / Q000266:history / Q000592:standards*; D005260:Female; D017408:Guidelines as Topic; D049669:History, 16th Century; D049670:History, 17th Century; D049671:History, 18th Century; D049672:History, 19th Century; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000266:history / Q000592:standards*; D008297:Male; D008875:Middle Aged; D028681:Moral Obligations; D014481:United States
keywords: biomedical research; clinical trials; human participants; informed consent