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.
Whichofthefollowingstatementsongenetherapyarecorrect?
A. Twodecadesaftertheinitialgenetherapytrialsandmorethan2,000approvedclinicaltrialsworldwidewenotonlyhavegainedmuchnewinformationandknowledgeregardinggenetherapyingeneral,butalsolearnedtounderstandtheconcernthathaspersistedinsociety.
B. Nevertheless,ourknowledgecontinuestogrowandduringthecourseoftimemoresafetydatahasbecomeavailablethathelpsustodevelopbettergenetherapyapproaches.Also,withtheincreasedunderstandingofmolecularmedicine,wehavebeenabletodevelopmorespecificandefficientgenetransfervectorswhicharenowproducingclinicalresults.
C. Despitethesetbacksgenetherapyhasfaced,successstorieshaveincreasinglyemerged.Withoutdoubt,theethicalaspectsregardinggenetherapyneedtobeaddressedthesamewayasthequestionabouttheirefficacyandsafety.
D. Weneedtoacknowledgethefearofsomepatientsinrespecttogenetherapy.Ultimatelyitisthepatientwhodecides,whethershe/hewantstobetreatedwithgenetherapy.
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.
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.
Which of the following statements about gene editing by CRISPR/Cas9 are correct?
A. On Jan 21, 2018, The Wall Street Journal reported that 86 people in China have had their genes edited using CRISPR/Cas9.
B. In April 2015, Chinese scientists reported results of an attempt to alter the DNA of non-viable human embryos using CRISPR/Cas9 to correct a mutation that causes β-thalassemia. The study had previously been rejected by both Nature and Science in part because of ethical concerns. The experiments resulted in changing only some genes, and had off-target effects on other genes. The researchers stated that CRISPR/Cas9 is not ready for clinical application in reproductive medicine.
C. In April 2016, Chinese scientists were reported to have made a second unsuccessful attempt to alter the DNA of non-viable human embryos using CRISPR/Cas9 - this time to alter the CCR5 gene to make the embryo HIV resistant.
D. Heritable modifications could have unintended and far-reaching consequences for human evolution, genetically (e.g. gene/environment interactions) and culturally (e.g. Social Darwinism). Altering of gametocytes and embryos to generate inheritable changes in humans was defined to be irresponsible.
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