CITI History and Ethical Principles – SBE Already Passed

CITI History and Ethical Principles – SBE Already Passed 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? 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: 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. An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle? Justice - This example demonstrates a violation of the principle of justice which requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience. In simple terms, the principle of justice requires that the selection of subjects is fair. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of: Respect for persons - The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of justice requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience. The Belmont principle of beneficence requires that: Risks to subjects are reasonable in relation to anticipated benefits. - The Belmont principle of beneficence requires that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. This principle is applicable in both minimal risk and greater than minimal risk research. The principle does not address a requirement for significant contribution to generalizable knowledge nor does it require that subjects derive individual benefit from study participation. The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies? "Tastes, Ties, and Time (T3)" study - Although no students were identified by name in the T3 study, some data were specific enough to allow for re-identification of students by an outside researcher. This is an example of the failure to protect subjects from deductive disclosure of their identities. The primary ethical problems of the other studies include physical harms and unanticipated psychological harm.