Ethicalissues and concernswithgenetherapyare:
A. Howcan"good" and "bad"usesofgenetherapybedistinguished?Whatactuallyhappenswhenthingsgowrong?Whodecideswhichtraitsarenormal&whichconstituteadisabilityordisorder(decidingproperindications)?
B. Dowehaveenoughknowledgetomaketherightdecisions?Areweabletocontrolgenetherapy?Aretheresituations,whengenetherapyisethicallymoreacceptable?Whatarethecostsforthistypeoftherapyandwhoispayingforit?Willthehighcostsofgenetherapymakeitavailableonlytothewealthy?
Couldthewidespreaduseofgenetherapymakesocietylessacceptingofpeoplewhoaredifferent?Whatisthesocioeconomicimpactofgenetherapyinoursociety?
D. Shouldpeoplebeallowedtousegenetherapytoenhancebasichumantraitssuchasheight,intelligence(IQ),orathleticability(socalledgeneticenhancement)?Whatisthepotentialimpactofgermlinegenetransferonfuturegenerations?
Whatarethemajorconcernswithgermlinegeneediting?
A. Someoftheconcernsraisedaboutsomaticgenetransferarerelatedtothepossibilitythatitcouldinadvertentlyleadtogermlinegenetransfer.Germlinegenetransferatthegamete and zygotestageshavesignificantrisks.
Beyondthemedicalriskstothepotentialchild,anumberoflong-standingethicalconcernsexistregardingthepossiblepracticeofgermlinegenetransferinbothhuman and nonhumancases.
Concernsinvolveissuesrangingfromtheautonomyoffutureindividualstodistributivejustice,fairness, and theapplicationofthesetechnologiesto"enhancement".Concernsrelatedtoeugenicsandsocialjusticeandequalaccesstotechnologies.
D. Unequalaccessandculturaldifferencesaffectinguptakecouldcreatelargedifferencesintherelativeincidenceofagivenconditionbyregion,ethnicgroup,orsocioeconomicstatus.
Which of the following statements aboutsomatic cell gene therapy (SCGT) are correct?
A. In somatic cell gene therapy (SCGT), the therapeutic genes are transferred into any cell other than a gamete, germ cell, gametocyte, or undifferentiated stem cell.
B. Any such modifications affect the individual patient only, and are not inherited by offspring.
C. Somatic gene therapy represents mainstream basic and clinical research, in which therapeutic DNA (either integrated in the genome or as an external episome or plasmid) is used to treat disease.
D. Most focus on severe genetic disorders, including immunodeficiencies, hemophilia, thalassemia, and cystic fibrosis. Such single gene disorders are good candidates for somatic cell therapy.
Which of the following statements about germline gene therapy (GGT) are correct?
A. GGT involves the introduction of new genetic material into either germ cells (sperm or oocytes) or into zygotes in vitro prior to fertilization or implantation.
B. In GGT, germ cells (sperm or egg cells) are modified by the introduction of functional genes into their genomes.
C. Modifying a germ cell causes all the organism's cells to contain the modified gene. The change is therefore heritable and passed on to later generations.
D. Australia, Canada, Germany, Israel, Switzerland, and the Netherlands prohibit GGT for application in human beings, for technical and ethical reasons, including insufficient knowledge about possible risks to future generations and higher risks versus somatic cell gene therapy (SCGT).
Which of the following statements about 'gene therapy by the US FDA are correct?
A. Gene therapy is products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms.
B. The products may be used to modify cells in vivo or transferred to cells ex vivo prior to administration to the recipient.
C. In gene therapy, scientists can do one of several things depending on the problem that is present. They can replace a gene that causes a medical problem with one that doesn't, add genes to help the body to fight or treat disease, or turn off genes that are causing problems.
D. Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.
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