CITI Training Review: Human Subjects 45 final exam Questions And Answers

"The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" Study - ️️The study most directly linked to the establishment of the "National Research Act" (1974) and ultimately the "Belmont Report and Federal Regulations for Human Subject Protection" A criterion for waiving informed consent: - ️️When appropriate, subjects are provided additional pertinent information after the study A researcher leaves a research file in her car while she attends concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. - ️️Neither a Breach of Confidentiality or a Violation of Subject's Privacy A subject in a clinical trial experiences a serious, unanticipated adverse drug experience. The investigator should proceed, with respect to the IRB, after the discovery of the adverse event occurrence by: - ️️Reporting the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB A Violation of Subjects' Privacy - ️️The right of the individuals to be protected against intrusion into their personal lives or affairs A waiver of the requirement for documentation of informed consent may be granted when: - ️️- The only record linking the subject and the research is the consent document - AND the principal risk is a breach of confidentiality Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: - ️️The changes must be immediately implemented for the health and well-being of the subject An investigator is required to keep consent documents, IRB correspondence, and research records for: - ️️A minimum of 3 years after completion of the study Anonymity - ️️Implies that the researcher or readers of the final research report or paper cannot identify a given response with a specific respondent As a part of the consent process, researchers are required (by the Federal regulations) to provide subjects with information: - ️️At the appropriate reading comprehension level