SOCRA - CCRP (high level) Questions and Answers (2023) (Verified Answers).

Nuremberg Code (1947) - CORRECT ANS A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - CORRECT ANS 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed Belmont Report (1979) - CORRECT ANS Three core principles are identified: respect for persons, beneficence, and justice. Arose in response to Tuskegee Syphilis Study - studying untreated syphilis on African-American men unaware of their true condition and tx plan. Belmont Report - definitions of core - CORRECT ANS 1. Respect for persons: informed consent + no deception 2. Beneficence: maximize benefits and minimize risk 3: Justice: fair procedures considering risk analysis. Belmont Report - current role - CORRECT ANS Serves as a historical document and provides the moral framework for understanding regulations in the United States on the use of humans in experimental methods. Belmont Report - review of 7 items for research trials - CORRECT ANS 1. IRB approved 2. Obtain informed consent 3. Ensure understanding 4. No coercion 5. Monitor adverse events 6. Maintain privacy 7. Ensure patients receive minimal care for their condition Declaration of Helsinki (1964, 1975) - CORRECT ANS Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) - CORRECT ANS ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of a clinical trial. Covers human rights, standards on trial conduct, roles and responsibilities (IRB, PI, sponsor, monitors). GCP v Declaration of Helinski - CORRECT ANS GCP lacks moral principles and guidance surrounding COI, study design, benefits, result reporting. Also restricts placebo in control group v effective alternative tx Common Rule - CORRECT ANS US federal policy that specifies ethics regulations for human subjects research 1. ICF in reasonable language, reasons why they would not want to participate in research 2. Disclosure of use of de-identified data / specimens for future studies, commercial profit, clinically relevant results disclosed, genome sequencing 3. Consent waiver only if research could not be carried out without accessing / using information / specimens in an identifiable format. Pre-screening for trial permitted if able to obtain oral or written communication OR access records / stored biospecimens. 4. Exempt / Limited IRB if - record review both retrospectively AND propectively - benign behavioral interactions - collect identifiable sensitive data via adults in surveys/interviews 5. Continuing review - not required if expedited level 6. Multi-instituitional research studies required to use 1 IRB (effective ) Title 21 US Code of Federal Regulations (11, 50, 56, 312, 812) - CORRECT ANS Title 21 is part of the code of federal regulations governing good and drugs for the FDA, DEA, and ONDCP (office of national drug control policy) 11 - e-records + e-signatures 50 - protection human subjects 56 - IRB that oversee trials 312 - drug trial requirements