SoCRA Exam 2023
What is an orphan drug program?
Nuremburg Code
Kefauver-Harris Amendment
Adverse Event
Assent
Assurance
Belmont Report
what is beneficence according to the belmont report?
What is respect for persons according to the belmont report?
what is justice accordi...
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
Office of Human Research Protection (OHRP) - ANSWER-federal government office that issues
assurances and overseas complicance
placebo - ANSWER-an inert substance used as a comparison to an active ingredient in clinical trials
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