超星 - test 5 - 查题吧

单选题

In a world first, a Chinese team led by Dr. Junjiu Huang at Sun Yat-Sen University in Guangzhou have reported editing the genomes of human embryos and the results are published in the journal Protein and Cell in ________; 6(5):363-372.

A. 2011
B. 2013
C. 2015
D. 2017

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单选题

The recent approvals of gene therapeutic agents by the Food and Drug Administration (FDA) in the United States are milestones in the field of gene therapy and raise hope for many patients suffering from ________ diseases (usually rare genetic diseases) as well as many other more common illnesses.

A. complicated
B. individual
C. unique
D. orphan

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单选题

Safety of the ______________ and future generations is a major concern for human germline gene editing.

A. parents
B. child
C. family members
D. attending physicians

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多选题

Researchersaretestingseveralapproachestogenetherapy,including:

A. replacingamutatedgenethatcausesthediseasewithahealthycopyofthegene
B. inactivating,or"knockingout,"amutatedgenethatisfunctioningimproperly
C. introducinganewgeneintothebodytohelpfightadisease
D. usingantibodies

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多选题

How does US FDA regulate gene therapy products?

A. Comprehensive federal laws, regulations, & guidelines help protect people who participate in clinical trials. The US FDA regulates all gene therapy products in the United States & oversees research in this area.
B. FDA's regulation includes scientific review, regulatory research, testing, & compliance activities (inspection & education). Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA.
C. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. As with other kinds of drugs, FDA regulates the quality & safety of gene therapy products and supervises how these products are used clinically.
D. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed & approved by the FDA and an Institutional Review Board.

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多选题

How does US NIH regulate gene therapy study?

A. NIH provides guidelines for investigators & institutions (such as universities & hospitals) to follow when conducting clinical trials with gene therapy.
B. These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities.
C. The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at one of the RAC's public meetings.
D. NIH does not regulate gene therapy trials that are not funded by NIH.

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多选题

Whichofthefollowingstatementson"NIHGuidelinesforResearchInvolvingRecombinantorSyntheticNucleicAcidMolecules(2016)"arecorrect?

A. Theguidelinesdetailsafetypracticesandcontainmentproceduresforbasicandclinicalresearchinvolvingrecombinantorsyntheticnucleicacidmolecules,includingthecreationanduseoforganismsandvirusescontainingrecombinantorsyntheticnucleicacidmolecules.
B. ThepurposeoftheNIHGuidelinesistospecifythepracticesforconstructingandhandling:(i)recombinantnucleicacidmolecules,(ii)syntheticnucleicacidmolecules,includingthosethatarechemicallyorotherwisemodifiedbutcanbasepairwithnaturallyoccurringnucleicacidmolecules,and(iii)cells,organisms,andvirusescontainingsuchmolecules.
C. InthecontextoftheNIHGuidelines,recombinantandsyntheticnucleicacidsaredefinedas:(i)moleculesthata)areconstructedbyjoiningnucleicacidmoleculesandb)thatcanreplicateinalivingcell,i.e.,recombinantnucleicacids;(ii)nucleicacidmoleculesthatarechemicallyorbyothermeanssynthesizedoramplified,includingthosethatarechemicallyorotherwisemodifiedbutcanbasepairwithnaturallyoccurringnucleicacidmolecules,i.e.,syntheticnucleicacids,or(iii)moleculesthatresultfromthereplicationofthosedescribedin(i)or(ii)above.
D. ForaclinicaltrialsitethatisaddedafterthecompletionoftheNIHprotocolregistrationprocess,noparticipantsshouldbeenrolledattheclinicaltrialsiteuntilIBCapprovalandIRBapprovalfromthatsitehavebeenobtained.

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多选题

Whichofthefollowingstatementsongenetherapyarecorrect?

A. Twodecadesaftertheinitialgenetherapytrialsandmorethan2,000approvedclinicaltrialsworldwidewenotonlyhavegainedmuchnewinformationandknowledgeregardinggenetherapyingeneral,butalsolearnedtounderstandtheconcernthathaspersistedinsociety.
B. Nevertheless,ourknowledgecontinuestogrowandduringthecourseoftimemoresafetydatahasbecomeavailablethathelpsustodevelopbettergenetherapyapproaches.Also,withtheincreasedunderstandingofmolecularmedicine,wehavebeenabletodevelopmorespecificandefficientgenetransfervectorswhicharenowproducingclinicalresults.
C. Despitethesetbacksgenetherapyhasfaced,successstorieshaveincreasinglyemerged.Withoutdoubt,theethicalaspectsregardinggenetherapyneedtobeaddressedthesamewayasthequestionabouttheirefficacyandsafety.
D. Weneedtoacknowledgethefearofsomepatientsinrespecttogenetherapy.Ultimatelyitisthepatientwhodecides,whethershe/hewantstobetreatedwithgenetherapy.

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多选题

Whyshouldweengagethepublicwhenarguingaboutgermlinegeneediting?

A. Ethicalandsocialvaluesregardinggermlinegenomeeditingneedtobesolicitedandconsidered.
B. Therearethreegeneralapproachestoaddressingtheethicaljustificationandstakeholderassessmentofgermlinegenomeediting:conductingprimaryresearch;conductingsecondaryanalysesofpublishedliteratureontheperceptions,acceptability,qualityoflife,attitudes,orvaluesofstakeholders;andcommissioninganexpertreview.
C. Engagingbroaderstakeholdergroups,includingthemedicalandscientificcommunities,personsandfamiliesdealingwithgeneticallybaseddisabilities,andthegeneralpublic,wouldbewarrantedgiventhepotentialusesandimpactsofgermlinegenome-editingtechnology.
D. Thesedebatesandengagementsshouldweightherisks,benefits,alternatives,unknownconsequences,andaccess,aswellasdistributiveandproceduraljustice,bothonasocietallevel(acrossandwithinsocieties)andonanindividualorcommunitybasis.Ultimately,thesedebatesandengagementswillinformtheframeworkstoenableethicalusesofthetechnologywhileprohibitingunethicalones.

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多选题

How does the European Medicines Agency (EMA) define gene therapy medicinal products (GTMPs)?

A. EMA defines "gene therapy medicinal products (GTMPs) generally consist of a vector or delivery formulation/system containing a genetic construct engineered to express a specific transgene ('therapeutic sequence') for the regulation, repair, replacement, addition or deletion of a genetic sequence. The active substance is the nucleic acid sequence(s), or genetically modified microorganism(s), virus(es) or cells.
B. EMA defines that a gene therapy medicinal product is a biological medicinal product.
C. EMA defines that a gene therapy medicinal product fulfills the following two characteristics: (a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; (b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
D. Gene therapy medicinal products shall not include vaccines against infectious diseases.

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