SoCRA Exam Questions & Answers Graded A+

What is an orphan drug program? - ANSWER-FDA program that provides development of drugs for rare diseases Nuremburg Code - ANSWER-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - ANSWER-Amendment to Food Drug and Cosmetic Act that requires informed consent for experimental drugs Adverse Event - ANSWER-any unfavorable or unintended event associated with a research study Assent - ANSWER-a child's affirmative agreement to participate in a clinical investigation Assurance - ANSWER-renewable permit granted by a federal department to an institution to conduce research Belmont Report - ANSWER-Ethical principle and guidelines for protection of human subjects of research. Cornerstone document of ethical principles. Federal regulation of subject protection based on respect for persons, beneficence and justice----1979 what is beneficence according to the belmont report? - ANSWER-ratio/risk, doing no harm, maximizing benefits while minimizing risks What is respect for persons according to the belmont report? - ANSWER-informed consent, autonomy, protect the vulnerable, protect confidentiality what is justice according to the belmont report? - ANSWER-subject selection is fair, benefits and burdens should be justly distributed Clinical research - ANSWER-study of drug, biologic or device in human subjects with the intent to DISCOVER potential beneficial effects and/or determine its safety and efficacy. common rule - ANSWER-also known as 45 CFR 46 Subpart A --ABC's of this are Assurance, Board review (IRB), Consent declaration of helsinki - ANSWER-statement of ethical principles first published by world medical association in 1964 to define rules for therapeutic and non-therapeutic research food drug and cosmetic act - ANSWER-states only drugs, biologics and devices proven safe and effective can be marketed--1938 good clinical practice (GCP) - ANSWER-international ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate and that the subject's rights and confidentiality are protected human subject - ANSWER-a patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction International Conference of Harmonization (ICH) - ANSWER-an organazation composed of expert working groups from industry and regulatory bodies in the European Union, Japan and the US. This publishes guidelines for worldwide GCP with the goal of standardization for clinical trials of drugs. National Research Act - ANSWER-this Act created the National Commission for Protection of Human Subjects of Biomedical and Behavioral research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent