SOCRA CCRP Certification Exam with complete solution

Nuremburg Code - correct answer The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - correct answer 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjects can withdraw 10. research must end the study if there is probable cause that continuing would lead to injury, disability, or death. Timeline of Historical Events - correct answer Nuremberg Code first (1947). Declaration of Helsinki second (1964). Belmont Report third (1979). Belmont Report Principles and Application - correct answer There are 3: 1. Respect for persons = informed consent 2. Beneficence = risk/benefit analysis 3. Justice = appropriate selection of patients Language Level Recommended for Informed Consent - correct answer 6th-8th grade 8 Basic Elements of informed Consent - correct answer 1. statement explaining the study involves research. 2. description of risks or discomforts. 3. description of benefits. 4. alternative treatments/procedures. 5. confidentiality. 6. compensation for involvement and/or injury. 7. who to contact. 8. voluntary and can discontinue Additional Elements of Informed Consent - correct answer 1. unforeseeable risks to subject. 2. participation can be terminated by investigator. 3. any additional costs. 4. consequences of the subject's decision to withdraw