Potentialundesired(unwanted)effectsofdrugnanocarriersinclude:
A. organaccumulationinthebody
B. activeinteractionswithbloodcomponentsinthebody
C. cytotoxicity,reproductivetoxicity,carcinogenicity,&immunogenicity
D. damagetotargetorganssuchasliver,lung,kidneys,brain,orheart
Healthriskassessmentofnovelnanomaterialsincludes:
A. exposurestudies
B. invitrostudies
C. smallanimal(invivo,e.g.fish,miceorrats)studies
D. computationalstudies,systemsbiologyapproachesaswellashigh-throughputscreeningplatforms
Regulatoryoptionsforthesafetymeasuresofnanomaterialsbygovernmentsinclude:
A. workplace & administrative controls,classification&labeling of potential risks
B. controlofemissionstoair&water,minimizedexposuretohumanbodiesandlivingenvironment
C. wastedisposalrestrictions,marketing&userestrictions,distributioncontrol
D. laws,guidelines,policies,etc.
TheNanoethicsGroup&EuropeanGrouponEthics&NewTechnologiestotheEuropeanCommission'sOpinionsontheSafetyIssuesofNanomedicinein2002declaresthat:
A. — Safety:relevantauthoritiesshouldcarryoutaproperassessmentoftherisks&safetyofnanomedicine.Suchriskassessmentshouldcoverthewholelifecycleoftheproducts,fromproductiontohandlingofwaste.Thesamelevelofsafetycurrentlyappliedtomedicine&medicaldevicesshouldapplytonanomedicalproducts.— Riskassessment:theGroupproposesthatinitiativesbetakenatnational&Europeanleveltofacilitatecooperationbetweeninstitutionsdealingwithriskassessment.TheGroupconsidersitparamountthatnonano-basedproductsenterthemarketwithoutriskassessment,therebysecuringthesafetywithregardtotheuser'shealth.
B. — Assessmentofsocialeffects:TheGroupproposesthatsuchprospectivetechnologyassessmentshouldconsiderissuesofsafety(agri-food&environment)&security(includingdualuse,impactsofbioterrorism&militaryresearch).Socialeffectsshouldalsobeaddressed(fairdistributionofgoods).— Information&consent:TheGroupencouragesfurthereffortsatnational&Europeanleveltodevelopimprovedmethodsofprovidinginformation&obtainingconsente.g.throughresearchprojectsundertheELSI(Ethical,Legal&SocialImplications)program.
C. — TheneedforinterdisciplinaryresearchonEthical,Legal&SocialImplications(ELSI)ofnanomedicine:theGroupproposesthataconsiderableamount–upto3%-ofthebudgetinvestedinresearchinnanotechnologyshouldbesetasideforELSIresearch.— Ethicaldeliberationontheconceptofhumanity,humanright,social&politicalconflictsinrelationtoNanotechnology:TheGroupalsosuggeststhatinitiativesbetakenatEuropeanleveltopromotemoreresearchonphilosophical,ethical&anthropologicalquestionsraisedbyrecentdevelopmentsinnanomedicine(individualresponsibility,conceptoftheself,personalidentity,societalgoals&globalhealthcare).
D. — Sharingofinformation&establishingdatabases:theGroupproposesthatinitiativesbetakenatEuropeanleveltoestablishdatabanks,nononlyonscientificaspectsofnanomedicinebutalsoonELSI-relatedaspects.— TheneedforrevisionofthisOpinion:sinceresearchintheareaofnanomedicineisundergoingrapiddevelopment,thistextshouldbereconsidered&possiblerevisedinthelightofscientific,legal&socialdevelopmentswithinthenextfiveyears.
DesigningdialoguesontheELSEissuesofnanotechnologiesshouldinclude:
A. incorporatingpublic's valuesindecisions
B. improvingdecisionquality
C. improvingdecisionmakingprocess,engagingthepublicwhenkeydecisionsaretobemade
D. resolvingconflict,improvingtrustininstitutions&informingoreducatingpeople
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