CITI History and Ethical Principles – SBE 2024

CITI History and Ethical Principles – SBE 2024 Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection? - answer-PHS Tuskegee Study - In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from syphilis in the PHS Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects and created the Belmont Report that ultimately informed federal regulations for the protection of human subjects. The Tearoom Trade Study and the Stanford Prison Experiment both occurred prior to the codification of federal regulations but are not directly linked to the establishment of the National Research Act of 1974. The T3 study occurred after the codification of federal regulations. Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - answer-Respect for persons - Humphreys' collecting data for the Tearoom Trade study while posing as a lookout is an example of a violation of the principle of respect for persons. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent). The principle of beneficence requires balancing the risk of harms with the potential benefits. The principle of justice requires that benefits and burdens are equitably distributed and subject populations are not chosen due to convenience.