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/)
查看答案
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.
Which of the following are the 8 principles of the "Ethical Framework" proposed by Emanuel Eet al. in 2000?
A. collaborative partnership, valuable scientific question
B. valid scientific methodology, fair subject selection
C. favorable risk-benefit, independent review
D. informed consent, respect for enrolled subjects
Collaborativepartnershipisimportantforethicalclinicalresearch,including:
A. Ethicalclinicalresearchshouldbeacollaborativepartnershipwiththerelevantpartners.
B. Collaborative partnership is facilitated by planning and working with policy makers and health systems, patient advocates on scientific advisory boards, & advocates for research funding.
Collaborative partnership is facilitated by planning and working with community advisory boards and communities, collaborating investigators, & practicing clinicians.
D. Collaborationinplanning,conductingandoverseeingresearchisencouraged,eventuallyintegratingresearchresultsintothehealthsystem.
Ethicalclinicalresearchhasfavorablerisk-benefit,featuring:
A. TheIRBevaluationshouldconsideralltheriskstheinterventionspose,includingphysical,psychological,social,andeconomicrisks.Areriskstosubjectsnecessaryandminimized?Butminimizingriskscanunderminesocialvalueandraiseconcernsoffairness.
B. Arerisksjustifiedbybenefittoindividualsubjectsand/ortheimportanceoftheknowledgetosociety?Toevaluatetherisksofresearch,itisimportanttohavereliableinformationonexistingcarefortheparticipants.
C. Atrialmayberiskyinsomeplacesandpotentiallybeneficialinothers.Arebenefitsenhanced?
D. Risk and benefit judgments rely on comparison to some baseline. For example, does a phase II study of a treatment that has been shown safe and offers a small chance of helping subjects qualify as prospect of benefit? Most commentators argue that IRBs should consider only the clinical or 'direct' benefits of research, not any indirect, inclusion, or financial benefits.
微信支付 
支付宝支付