Which of the following items can protect human subjects?
A. International ethical codes and guidelines
B. US ethical regulations, policies & laws
C. Laws, regulations, policies and official statements from other jurisdictions and reputable academic organizations
D. Institutional ethics policies and guidelines
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Ethical clinical research should focus its scientific validity considerations on:
A. choice of proper endpoints – e.g. blood glucose control
B. choice of design – e.g. randomized double blinded control or noninferiority or superiority
C. choice of procedures – e.g. measures of outcome, length of follow-up
D. statistical methods (e.g. power, sample size, methods, & level of significance) & feasibility
Whichofthefollowingitemsarefamousethicscodes&guidelinesintendedfortheprotectionofhumansubjects?
A. NurembergCode(1947)
B. DeclarationofHelsinki(1964-multiplerevisions-2013)
C. TheBelmontReport(1979)
D. CIOMS/WHOInternationalGuidelines(1993,2002,&2015)&ICH/GCP-InternationalConferenceonHarmonization-GoodClinicalPractice(1996&2016)
Whichofthefollowing US regulations & offices are for the protection of humansubjects?
A. TheCommonRule(DHHS-US45CFR.46)&45CFR.46SubpartsB,C,D
B. FDAregulations(US21CFR50,56,aswellasINDandIDEregs)&FederalWideAssurance(FWA)
C. OfficeofHumanResearchProtections(OHRP,http://www.hhs.gov/ohrp)
D. IntramuralOfficeofHumanSubjectsResearch(http://ohsr.od.nih.gov/)
Ethical clinical research should ensure fair subject selection, featuring:
A. Scientific objectives should guide inclusion criteria, recruitment strategies, and selection (not privilege or easy availability or vulnerability).
B. The harms to subjects are minimized and harms and benefits arefairly distributed.
C. Hvae you selected the appropriate participants? e.g. is it preferable to test an early potentially risky therapy in healthy affected adults who can consent but have mild disease or in severely ill infants who are otherwise likely to die as infants?
D. There is no exclusion without justification. Justice and beneficence are attended. Vulnerable groups are well protected.
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