CITI Training: Biomedical Research Investigator & Social and Behavioral Research

What is included in the Nuremberg Code - Answer- voluntary consent the National Research Act of 1974: - Answer- established the National Commission Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer- US Public Health Service Policy What Belmont principle describes the application of informed consent - Answer- respect of persons Result of Beecher article: - Answer- ethical abuses are not limited to Nazi regime Use of prisoners in research is a concern under the the Belmont principle of justice because: - Answer- Prisoners can only be used in research that benefits the larger society What brought attention to the problems of the IRB system? - Answer- Death of Jesse Gelsinger Under HIPAA, "disclosure accounting" is required: - Answer- for all human subject research that uses PHI without authorization from the data subject, except for limited data sets When required, the information provided to the data subject in HIPAA disclosure accounting - Answer- must be detailed for disclosures that involve less than 50 subject records HIPAA's protections for health information used for research purposes: - Answer- supplement those of Common Rule and FDA