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
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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.
Which of the following statements about the Good Clinical Practice Guideline (ICH/GCP) are correct?
A. The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalized in 1996 describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors, & IRBs. GCP covers aspects of monitoring, reporting, & archiving of clinical trials & incorporating addenda on the Essential Documents & on the Investigator's Brochure.
B. This harmonized guideline has been amended in 2016 with an integrated Addendum to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, & reporting while continuing to ensure human subject protection & reliability of trial results.
C. Standards regarding electronic records & essential documents intended to increase clinical trial quality & efficiency have also been updated in 2016.
D. This ICH GCP Guideline Integrated Addendum provides a unified standard for the European Union, Japan, the US, Canada, & Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.
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