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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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.
The Declaration of Helsinki (2013, Article 33) by WMA declares that, "The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:"
A. Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
B. Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.
C. The placebo is effective.
D. The placebo is cheap.
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