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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
1) Coordinating the development of initial research study PROTOCOL. 2) Creating study DOCUMENTS. 3) Obtaining research study APPROVAL. 4) Obtaining study PRODUCT, MATERIALS, equipment, tools, and aids. 5) Selecting study SITES. 6) TRAINING research staff members. 7) Evaluating study's COMPLIANCE. Pneumonic/Acronym: ProDocApp ProSitTraCom	What are the points covered in the Research Study Start-Up? Recite them in order.
1) Nuremberg Code 2) Belmont Report 3) Declaration of Helsinki	What are the key documents that serve as the foundation of ethical principles in human research?
This was the first major international statement on the ethics of medical research, published on 1947 in response to unethical human experimentation on concentration camp prisoners during WW2. It was accepted in principle by each nation signing the charter of the United Nations.	What is the Nuremberg Code?
Is a comprehensive statement of the ethics of human subject research, issued by the World Medical Association in 1964. It has been amended several times.	What is the Declaration of Helsinki?
This report outlines ethical principles for clinical research generated by the National Commission for the Protection of Human Subject Research in 1979. It resulted from the United States federal government agencies such the CIA and Department of Energy in the 1970's conducting studies with potentially SAE without the subject's knowledge. Informed Consent forms and IRB review approval became a requirement.	What is the Belmont Report?
1) Respect of Persons 2) Beneficence 3) Justice	What are the basic principles of the Belmont Report?
The ….	Explain Respect of Persons.
The...	Explain Beneficence.
The...	Explain Justice.
Issued by the Department of Health and Human Services and other federal agencies in 1991 as an attempt to standardize human research regilation among the many federal agencies. It formalized the responsibility of the researher and the institution to protect human subjects.	What is the "Common Rule"?